WO2025176332A1

WO2025176332A1 - Curvature-compliant balloon catheter for delivering focalized pressure

Info

Publication number: WO2025176332A1
Application number: PCT/EP2024/076234
Authority: WO
Inventors: Marc Gianotti; Andreas Bodmer; Ulf Fritz; Dragana MARGETA; Michael Jetter; Adrienne Mueller; Deborah LUETHI
Original assignee: CTI Vascular AG
Current assignee: CTI Vascular AG
Priority date: 2024-02-23
Filing date: 2024-09-19
Publication date: 2025-08-28
Anticipated expiration: 2026-08-23

Abstract

In accordance with the present disclosure there is provided a curvature-compliant angioplasty balloon catheter that is individually configured to seamlessly conform to at least one of one or more of a curvature of a vessel anatomy without pinching or straightening of the vessel. The angioplasty catheter comprises an elongated member (12) having a proximal end, a distal end (12), and at least one lumen extending at least partially through the elongated member; and an inflatable member (13) proximally affixed to the elongated member adjacent to the distal end and in fluid communication with the at least one lumen, the inflatable member having at least one radius R and including at least three lobes (21-29), the at least three lobes separated from each other by two or more waist portions (37,37').

Description

CURVATURE-COMPLIANT BALLOON CATHETER FOR DELIVERING FOCALIZED PRESSURE

TECHNICAL FIELD

[0001 ] The current disclosure is directed to medical devices and methods of using such devices in the therapeutic treatment of vascular disease. In particular, the invention is directed to a curvature-compliant balloon catheter capable of delivering focalized pressure, comprising an elongated member having a proximal end, a distal end, and at least one lumen extending at least partially through the elongated member; and an inflatable member proximally affixed to the elongated member adjacent to the distal end and in fluid communication with the at least one lumen, the inflatable member having at least one radius R and including at least three lobes, the at least three lobes separated from each other by two or more waist portions. The devices of the present disclosure are individually configured to seamlessly conform to at least one of one or more of a curvature of a vessel anatomy without pinching or straightening of the vessel, while allowing the control of one or more of a magnitude and distribution of radial and straightening force components that are directed by the inflatable member on an inward and outward oriented portion of a vessel curvature containing a lesion.

BACKGROUND

[0002] Different types of catheter systems have been developed to treat a variety of different manifestations of vascular disease and other conditions within patients' veins and arteries that, when not treated, often lead to increasingly serious health conditions and complications, including ischemia, heart attacks, embolisms, and strokes. Contemporary diagnostic and therapeutic interventions for the treatment of vascular conditions are carried out using minimally invasive catheter devices, such as balloon catheters, that are administered percutaneously into a patient’s vasculature. For enabling vascular access, a treatment provider performs a puncture at a variety of different blood-vessel access points, including the femoral, subclavian, radial, and brachial arteries. The treatment provider then inserts a guidewire through the puncture site into the blood vessel, and places an introducer or sheath in the wound canal, so that the catheter can be safely delivered into the blood vessel and advanced in or near the target region of the blood vessel to be treated.

[0003] For treatment of malformations, constrictions, obstructions, lesions, and blockages within patients' blood vessels, a balloon catheter is advanced and positioned by guiding the catheter over a guide wire so that the balloon portion of the catheter is placed in the target region of treatment. The balloon is subsequently inflated, typically utilizing a mixture of saline and contrast agent applied to the inflation port of the balloon catheter, to controllably expand the balloon within the lesion, break up and push the lesion into the vessel wall and, subsequent to deflation and removal of the device, re-enable patency and thus blood flow within the target vessel. During the inflation procedure, the appropriately positioned balloon transmits a radial force dependent on the inflation pressure, resulting in a dimensional change applied to a designated target area of the vessel, such as the lesion. The efficacy of the procedure foreseeably depends on multiple factors, including the vessel anatomy, lesion morphology, lesion composition and degree of calcification, ratio of balloon and vessel diameter, balloon expansion behavior and compliance, balloon geometry, contact area formed between balloon and lesion, amount of pressure exerted by the balloon, pressurization rate and dwell time in the lesion, among others.

[0004] The expansion of a conventional balloon during angioplasty procedures not only results in a desired radial expansion, but also in an undesired formation of axial, radial, torsional-, and/or shear stress on the surrounding vessel wall. Axial stress can cause an unfavorable proximal and/or distal distension of healthy tissue adjacent to a lesion. Because healthy, soft tissue responds more readily to the application of stress as compared to diseased, hardened and/or calcified tissue, the resulting axial strain may cause major undesired dissections and ruptures proximal to, distal to, and/or within the lesion. Radial stress, exemplarily caused by over-inflation of the balloon and/or application of exceedingly high pressures can result in undesirable persistent distention of a blood vessel which, in turn, may result in vessel diameter variations, that disrupt laminar blood flow within and near the distention and lead to regrowth of the treated lesion or the formation of new lesions, and ultimately blockage or restenosis of the vessel. Localized forces produced by balloon inflation can also induce fissures and tears in the inner blood- vessel-wall lining that result in blood flow into a false lumen, or channel, between blood-vessel-wall, referred to as "dissection." A dissection occurs when a portion of the plaque, including intima, is lifted away from the vessel wall and does not remain adherent. The portion of the plaque that has been disrupted by dissection may then protrude into the vessel lumen. When the plaque completely lifts from the vessel wall, it can further impede blood flow, cause acute occlusion of the blood vessel, or trigger an embolic event further downstream of the treatment site. In more serious cases, these localized forces may result in a rupture, hematoma or pseudoaneurysm. Torsional- and/or shear stress on the other hand applies tangential forces to the lesion and/or vessel wall along the entire length of the balloon, which can abrade the lesion, damage the vessel, weakening the vessel wall and thereby, further exacerbate the formation of dissections and ruptures.

Because angioplasty balloons are commonly non-compliant or semi-compliant, such balloons are comparatively rigid and exhibit relatively poor flexibility and/or conform ability to curved vessel anatomies, and increasingly so, when the balloon length is increased. The expansion of conventional angioplasty balloons is therefore frequently accompanied by a tendency of the balloons to straighten - regardless of the underlying vessel morphology. The straightening effect is particularly exacerbated in tortuous anatomies, and can result in undue pinching, bending or straightening stress on the vessel during the angioplasty treatment. In addition, a conforming contact surface between the lesion and balloon cannot in all circumstances be reliably established. Accordingly, when the balloon lacks conformal contact to the vessel to be treated, there is an inherent risk, that the vessel cannot be uniformly dilated, that balloon expansion forces are uncontrollably released, and/or that the balloon position becomes unstable. In addition, when semi- compliant or non-compliant balloons are inflated against an eccentric lesion, or when a portion of the plaque is more resistant to dilatation than the remainder of the plaque, due to the inherent balloon compliance, the balloon has a tendency to follow the path of least resistance, thereby forcing the unconstrained portions of the balloon to expand first. Because softer tissue can be more easily displaced as compared to a calcified lesion, undesired dissections and ruptures may occur at the lesion-tissue interface. Further, because complex lesions can generally be heterogeneous in nature, balloon expansion may proceed in a non-uniform manner, wherein the depth, direction, location and number of the lesion fracture(s) cannot be reliably controlled.

[0005] While conventional balloon dilation catheters can perform sufficiently well to adequately treat moderate forms of vessel narrowing and obstruction, frequently lesions can be situated in more tortuous vessel paths or present themselves as ‘complex lesions’, or both, where a hardened plaque situated in the vessel is increasingly impenetrable or hardened due to calcification, such that the lesion cannot be effectively reached, dilated, modified or broken with a conventional angioplasty balloon. With regard to the foregoing description, one particularly challenging problem arises in the treatment of lesions that are situated on an inward- oriented portion of a curved and/or bifurcated vessel anatomy. Such anatomies are present, for example, in an ostium, such as that of the aorta, or the kidney, and in anastomotic vessels. Anastomotic vessels are natural and/or artificial connections between blood vessels. A classic example for an artificial anastomosis is an arteriovenous shunt created between the brachial artery and cephalic vein. The arteriovenous shunt can then be used by treatment providers as a means to gain access for hemodialysis treatment. Frequently, in such curved and/or bifurcated vessels, non-ideal or non-laminar blood flow conditions persist, that can lead to the continued build-up of plaques on an inward oriented portion of the vessel, thereby resulting in the gradual narrowing and ultimately, blockage of the vessel, necessitating further treatment. When a conventional balloon catheter (POBA, i.e. ‘plain old balloon angioplasty catheter’) is placed in such a vessel anatomy having a curvature and containing a lesion, upon inflation, straightening forces are generated, that pull the conventional balloon away from the inward-oriented portion of the lesion, thereby reducing the amount of available radial forces or focalized pressures that are necessary to open up the lesion, thus severely impairing treatment capability. Although some of the above-described disadvantages of conventional balloons can be mitigated through the use of increasingly smaller-sized balloon lengths, that would in turn decrease straightening tendency and effectiveness of delivering focalized pressure, the latter approach would be entirely impractical: Short-sized balloons would be much more prone to loss of position, due to minimal or complete lack of stabilization within the vessel and lack of anchoring capability, for example by slipping out of the lesion during pressurization, and thereby, effectively requiring multiple procedural steps and/or frequent device exchanges, such as would be needed for opening increasingly long lesions relative to the balloon size. Thus, because a physician user can not entirely forego the use of longer-sized balloons, the previously discussed disadvantages of straightening force generation cannot be readily mitigated. While other types of specialized medical devices and procedures have been developed that can apply a comparably greater amount of focalized pressure than a regular balloon, all of these devices share the same drawback of straightening force generation and hence, lack of focal pressure delivery on an inward oriented portion of the vessel during their application, which is particularly exacerbated in curved vessel anatomies.

[0006] Current state-of-the-art devices and methods capable of delivering greater amounts or magnitudes of focalized pressure, as compared to conventional balloons, may include for example high-pressure balloon angioplasty procedures, as well as so-called ‘cutting’ or ‘scoring’ balloons. A cutting or scoring balloon is a balloon catheter which includes cutting or scoring elements that are typically mounted onto the balloons outer surface. When the cutting or scoring balloon is inflated, the cutting or scoring elements act as stress concentrator sites that concentrate the backpressure generated by the balloon and directly focus them onto the target lesion surface, which can result in a more effective way to facilitate the desirable breaking of the lesion/plaque upon inflation of the balloon. Regarding aforementioned devices and methods, high pressure balloon angioplasty can be traumatic to the vessel walls and is frequently accompanied by vessel wall dissections, which may require placement of stents or immediate surgical intervention. Procedurally, the higher the pressure of balloon angioplasty and the more rapidly the target pressure is approached, the risk for more severe dissection is increased. In comparison, cutting or scoring balloons can be expanded at lower pressures than high pressure balloon angioplasty, and the focused forces of the cutting or scoring elements can directly penetrate the vessel wall including the lesion. However, cutting and scoring elements act as stiffening members that negatively impact the flexibility of the balloon, and, at the same time, increase their crossing profile. Thus, these specific types of balloons do not typically outperform conventional balloon catheters when considering their access and maneuvering capability. Further, because the deployment of cutting-, or scoring balloons is accompanied by torsional- and/or shear stress e.g. due to balloon unfolding during expansion, and because the cutting-, or scoring elements come in contact with the vessel wall by design, the risk of generating undesired vessel wall damage and/or dissections is inherently higher than compared to conventional and high-pressure angioplasty balloons. Damage or injury to the vessel wall will not only promote the adherence of blood cells passing through the vessel at the point of injury, which can lead to acute thrombotic occlusions in the short term, but also promote restenosis in the long-term, thereby necessitating eventual re-intervention. In turn, vessel trauma, dissections and recoil may contribute to poor long term clinical results and restenosis even if a stent is placed in the treated lesion.

[0007] Taken together, current angioplasty balloon catheter systems and available angioplasty treatment procedures exhibit at least one or more of the following deficiencies or problems: a) lack of adequate vessel conformity and/or compliance due to lack of axial flexibility, based on single-membered balloon construction, resulting in lack of conformal contact between balloon, vessel and lesion, particularly pronounced for comparably long-sized balloons; b) lack of positional stability and anchoring capability, due to lack of conformal contact, particularly pronounced for comparably short-sized balloons; c) lack of positional stability, due to tendency to straighten, particularly pronounced for comparably long-sized balloons; d) lack of adequate axial and/or radial stability and/or compliance, due to singlemembered balloon construction, resulting in length and/or diameter mismatch between target vessel and/or lesion; e) lack of torsional stability, due to presence of surface features, such as balloon folds, and cutting, - or scoring elements along the length of the entire balloon, that result in high crossing profiles, and that apply a torsional load on vessel and/or lesion during inflation of the balloon, the latter particularly pronounced for comparably long-sized balloons; f) lack of control in delivering focalized pressure to complex lesions due to specific anatomical conditions, including location of the lesion on an inward- oriented portion of a vessel curvature, general vessel tortuosity, and presence of bifurcations; g) lack of control in delivering focalized pressure to complex lesions due to product design factors including balloon geometry, balloon expansion behavior and axial, radial and/or torsional stability or compliance; and h) lack of control over achieving efficient modulation, modification, and/or fracture of target lesions and plaques due to procedural factors, including the amount of focal pressure exerted by the balloon, pressurization rate and dwell time in the lesion, wherein these limitations contribute to a lack of focalized pressure, that can be exerted onto a vessel anatomy having a curvature and containing a lesion, such that opening of the lesion and/or adequate patency of the vessel cannot be reliably achieved. Therefore, procedural inefficiencies and limitations continue to exist due to the inherent limitations in product design and patient anatomical complexities. There is an unmet need to provide improved medical devices and methods for treating vascular disease, including complex lesions.

[0008] In view of the above considerations, it is desirable to provide an improved angioplasty catheter and method for using such angioplasty catheter that facilitates controllably delivering focalized pressure to complex lesions without having the limitations or drawbacks of the known angioplasty catheters. In one aspect, it is desirable to provide an improved angioplasty catheter that exhibits improved positional stability and anchoring capability at short balloon lengths. In another aspect it is desirable, to provide an improved angioplasty catheter, that exhibits improved positional stability at long balloon lengths. Further, it is desirable to provide an angioplasty catheter and method for using such angioplasty catheter system, wherein an application of focalized pressure to a lesion results in a controllable fracture of the lesion at preferably multiple locations. More particularly, it is desirable to provide an improved angioplasty catheter and method for using such angioplasty catheter that flexibly adapts to the three-dimensional morphology and curvature of a lesion, resulting in maximized conformal contact or compliance to a lesion, while maintaining enhanced axial, radial, and/or torsional stability. Yet still, it is desirable to provide an angioplasty catheter and method for using such angioplasty catheter that facilitates an efficient and selective modulation, modification, and/or fracture of target lesions at substantially lower pressure ranges compared to conventional angioplasty catheters and associated angioplasty procedures, that in turn result in the reduction of trauma while enabling a safe and clinically more effective treatment of the patient. Finally, it is an object of the present invention to provide an improved angioplasty catheter, and method for using such angioplasty catheter, that is individually configurable to seamlessly conform to at least one of one or more of a curvature of a vessel anatomy without pinching or straightening of the vessel, while allowing the control of one or more of a magnitude and distribution of radial and straightening force components that are directed by the inflatable member on an inward and outward oriented portion of a vessel curvature containing a lesion.

[0009] Certain angioplasty catheters are disclosed in the following prior art documents. However, none of the known angioplasty catheters comprise the certain combination of features of the angioplasty catheter of the present disclosure and, therefore, none of the known angioplasty catheters solve the above-described problems. RELATED PRIOR ART

[0010] Segmented, notched, multi-lobed and/or multiple, individual balloons are generally known in the art. For example, US patent 4,983, 167 teaches a multi- lobed dilatation balloon that readily deforms to assume the shape of the artery, so that acute bends can be dilated without substantial risk of straightening out the artery. The individual balloon lobes are substantially spherical or dumbbell-shaped. US patent 5’395’333 teaches a multi-lobed perfusion balloon catheter, wherein a plurality of independent balloon lobes extends from the catheter body to engage a vessel wall and are oriented so as to form a flow passage to allow blood to perfuse the vessel. US patent 7’658’744 teaches a balloon catheter with multiple balloons, wherein at least one of the balloons may include at least one blade. The one or more blades are not formed along the entire length of a balloon so as to achieve greater flexibility. US patent 6’761’734 teaches a segmented balloon catheter for stenting bifurcation lesions, wherein the segmented balloon catheter comprises an elongated shaft, and first and second cylindrical balloon portions mounted on the distal end of the shaft, which are secured and sealed to the shaft. The segmented balloon catheter remedies the problem of delivering and deploying a stent at or adjacent a bifurcation in a blood vessel. US patent 6’022’359 teaches a surgical stent positioning and radial expansion system that features a balloon having an outer surface that is broken into separate sections axially spaced from each other by notches, and a segmented stent having flexible links that conform with the structural details of the balloon. The notches can more readily flex axially resulting in the balloon to more easily conform to tortuous arterial pathways. When the stent is radially expanded, the balloon can radially expand the stent with a minimal tendency to straighten. US patent application 2013/0238038 teaches a medical device with a series of inflatable balloons coupled longitudinally, each having individually controlled inflation volumes, and dimensions, such that upon inflation of the balloons, a composite profile shape is achieved. International patent application WO 2023/126091 , by the present inventors, teaches an angioplasty balloon catheter that enables enhanced modes of device-tissue interaction, wherein the depth, direction, location and number of the lesion fractures is reliably controlled, and wherein the devices are operated by static or pulsatile pressure means that enable three- dimensional plaque modification for use in complex lesion treatment and intramural drug delivery.

[0011 ] In the above cited prior art, the balloon segments, lobes or notches achieve the technical effect of axial flexibility by various means. However, none of the means described in the prior art teach an angioplasty catheter according to the present disclosure, wherein an inflatable member is individually configurable to seamlessly conform to at least one of one or more of a curvature of a vessel anatomy without pinching or straightening of the vessel, while allowing the control of one or more of a magnitude and distribution of radial and straightening force components that are directed by the inflatable member on an inward and outward oriented portion of a vessel curvature containing a lesion. Further, none of the problems associated with the application of short- or long-sized balloons are systemically resolved in the prior art.

[0012] The present inventors now found that the above problems can be solved by a curvature-compliant angioplasty balloon catheter, and methods for using such angioplasty balloon catheter, comprising an elongated member having a proximal end, a distal end, and at least one lumen extending at least partially through the elongated member; and an inflatable member proximally affixed to the elongated member adjacent to the distal end and in fluid communication with the at least one lumen, the inflatable member having a radius R and including at least three lobes, the at least three lobes separated from each other by two or more waist portions. SUMMARY

[0013] In accordance with the present invention there is provided a curvature- compliant angioplasty balloon catheter comprising an elongated member having a proximal end, a distal end, and at least one lumen extending at least partially through the elongated member; and an inflatable member proximally affixed to the elongated member adjacent to the distal end and in fluid communication with the at least one lumen, the inflatable member having a radius R and including at least three lobes, the at least three lobes separated from each other by two or more waist portions. The devices of the present disclosure are individually configured to seamlessly conform to at least one of one or more of a curvature of a vessel anatomy without pinching or straightening of the vessel, while allowing the control of one or more of a magnitude and distribution of radial and straightening force components that are directed by the inflatable member on an inward and outward oriented portion of a vessel curvature containing a lesion. As a result of the specific construction, when the inflatable member is placed in a vessel anatomy having one or more of a curvature and containing a lesion, at least one lumen is positionally stabilized along a rotational axis of the inflatable member, thereby centering the position of the at least one lumen within the vessel anatomy.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] FIG.1 illustrates a perspective view of a curvature-compliant angioplasty balloon catheter in accordance with the present disclosure.

[0015] FIG. 2 illustrates a cross-sectional view of an inflatable member of a curvature-compliant angioplasty balloon catheter conforming to one or more of a curvature and/or bending radius in accordance with the present disclosure.

[0016] FIG.3 illustrates a cross-sectional view of an individual geometry of a waist portion that separates lobes of the inflatable member, in an unfolded state, in accordance with the present disclosure.

[0017] FIG. 4A and FIG. 4B illustrate cross-sectional views of individual geometries of two or more waist portions separating at least three lobes of the inflatable member, shown in (i) an unpressurized state (FIG.4A), and (ii) a pressurized state (FIG.4B), in accordance with the present disclosure.

[0018] FIG. 5A and FIG. 5B illustrate optical microscope images of an inflatable member of the curvature-compliant angioplasty balloon catheter in a pressurized state, conforming to one or more of a curvature and/or bending radius (FIG.5A), in accordance with the present disclosure, in comparison to a conventional balloon angioplasty catheter (POBA) (FIG.5B).

[0019] FIG. 6 is a X-Y diagram illustrating control of a waist angle of an individual geometry of a waist portion in an unpressurized state, through an adjustment of a dimensionless ratio defined between a first depth and a length of two legs of the individual geometry, in accordance with the present disclosure.

[0020] FIG. 7 is a X-Y diagram illustrating control of a lobe-to-lobe angle of an individual geometry of a waist portion in a pressurized state, through an adjustment of a dimensionless ratio defined between a lower base length and a length of two legs of the individual geometry, in accordance with the present disclosure.

[0021 ] FIG. 8 is a X-Y diagram illustrating control of an intrinsic bending radius or radius of curvature of the inflatable member of the present disclosure, in a pressurized state, through an adjustment of a length of a balloon lobe of the inflatable member.

[0022] FIG. 9 is a X-Y diagram illustrating control of an intrinsic bending radius or radius of curvature of the inflatable member of the present disclosure, in a pressurized state, through an individual lobe-to-lobe angle.

[0023] FIG. 10 is a X-Y diagram illustrating control of an intrinsic bending radius or radius of curvature of the inflatable member of the present disclosure, in a pressurized state, through an adjustment of an outer diameter or radius of two or more balloon lobes of the inflatable member.

[0024] FIGS. 11A - 11 F illustrate a series of optical microscope images of identically configured inflatable members of the curvature-compliant angioplasty balloon catheter at nominal pressure (FIGS. 11A - 11 C) and rated burst pressure (FIGS. 11 D - 11 F), each conforming to three different bending radii, in accordance with the present disclosure.

[0025] FIGS. 12A - 12F illustrate a series of optical microscope images of identically configured inflatable members of a conventional angioplasty catheter at nominal pressure (FIGS. 12A - 12C) and rated burst pressure (FIGS. 12D - 12F), each demonstrating various drawbacks in comparison to the curvature-compliant angioplasty balloon catheter of the present disclosure.

[0026] FIG. 13 depicts a cross-sectional view of an inflatable member of a curvature-compliant angioplasty balloon catheter in a 180° curvature, illustrating one or more of a magnitude and distribution of radial and straightening force components that can be directed by the inflatable member on an inward and outward oriented portion of a vessel curvature, in accordance with the present disclosure.

[0027] FIG. 14 is a bar chart illustrating the relative distribution of inward- and outward-oriented radial and straightening force components (left vs right bars) of an inflatable member of a curvature-compliant angioplasty balloon catheter, each determined at a distal, middle and proximal position (from top to bottom), in accordance with the present disclosure.

[0028] FIG. 15 depicts a cross-sectional view of an inflatable member of a conventional angioplasty balloon catheter in a 180° curvature, illustrating one or more of a magnitude and distribution of radial and straightening force components, in comparison to curvature-compliant angioplasty balloon catheter of the present disclosure.

[0029] FIG. 16 is a bar chart illustrating the relative distribution of inward- and outward-oriented radial and straightening force components (left vs right bars) of an inflatable member of a conventional balloon angioplasty balloon catheter, each determined at a distal, middle and proximal position (from top to bottom), in comparison to curvature-compliant angioplasty balloon catheter of the present disclosure.

[0030] FIG. 17 is a X-Y diagram illustrating control of an outward-oriented straightening force component of several differently configured inflatable members, each determined at its distal end at nominal pressure and rated burst pressure, through an adjustment of a combination of one or more of a number n and one or more of a length L of lobes of an inflatable member of a curvature-compliant angioplasty balloon catheter, in accordance with the present disclosure.

[0031] FIGS. 18A - 18B depict cross-sectional views of axial straightening force components acting on an inflatable member of a curvature-compliant angioplasty balloon catheter of the present disclosure (FIG.18A), in comparison to axial straightening force components acting on an inflatable member of a conventional angioplasty balloon catheter (FIG. 18B).

[0032] FIGS. 19A - 19B depict cross-sectional views of radial force components acting on an inflatable member of a curvature-compliant angioplasty balloon catheter of the present disclosure (FIG.19A), in comparison to radial force components acting on an inflatable member of a conventional angioplasty balloon catheter (FIG. 19B).

[0033] FIG. 20 illustrates a perspective view of a curvature-compliant angioplasty balloon catheter placed in a vessel anatomy having one or more of a curvature and containing a lesion, in accordance with the present disclosure.

[0034] FIG. 21 illustrates a perspective view of a curvature-compliant angioplasty balloon catheter with a centered lumen configuration suitable for intravascular lithotripsy in a vessel anatomy having one or more of a curvature and containing a lesion, in accordance with the present disclosure.

[0035] FIG. 22 illustrates a perspective view of a curvature-compliant angioplasty balloon catheter with an alternative, centered lumen configuration suitable for intravascular lithotripsy in a vessel anatomy having one or more of a curvature and containing a lesion, in accordance with the present disclosure.

[0036] FIG. 23 illustrates a perspective view of a contemporary angioplasty balloon catheter with a non-centered lumen configuration suitable for intravascular lithotripsy in a vessel anatomy having one or more of a curvature and containing a lesion, not in accordance with the present disclosure.

[0037] FIG. 24 depicts a cross-sectional view of a curvature-compliant angioplasty balloon catheter with a centered lumen configuration suitable for intravascular lithotripsy in a vessel anatomy having one or more of a curvature, in accordance with the present disclosure. [0038] FIG. 25 depicts a cross-sectional view of a contemporary angioplasty balloon catheter with a non-centered lumen configuration suitable for intravascular lithotripsy in a vessel anatomy having one or more of a curvature, not in accordance with the present disclosure.

[0039] FIG. 26 depicts a cross-sectional view of one or more of a lobe length of an inflatable member of a curvature-compliant angioplasty balloon catheter having a centered lumen configured for intravascular lithotripsy, in relation to one or more of a vessel diameter and an emitter position, in accordance with the present disclosure.

[0040] FIG. 27 depicts a cross-sectional view of one or more of an emitter position of an inflatable member of a curvature-compliant angioplasty balloon catheter having a centered lumen configured for intravascular lithotripsy, in a vessel anatomy having a 180° curvature, in accordance with the present disclosure.

DETAILED DESCRIPTION

CURVATURE-COMPLIANT ANGIOPLASTY BALLOON CATHETER

[0041 ] The various components and features of the angioplasty balloon catheter of the present invention are next described with reference to FIGS. 1 -5. FIG.1 illustrates a perspective view of a curvature-compliant angioplasty balloon catheter in accordance with the present disclosure. In FIG. 1 , the balloon catheter 10 includes, from left to right, a catheter tip 12, an inflatable member or balloon 13, an elongated tubular member or catheter shaft 14, a kink protection sleeve 15, and a manifold 16, that in turn comprises an inflation port 17 and a guide wire port 18. The elongated member 14 extends from the catheter tip 12 or distal end of the catheter to the guide wire port 18 or proximal end of the catheter. The elongated tubular member further 14 includes at least one lumen that is in fluid communication with the inflatable member 13 mounted adjacent to the distal end 12 of the catheter 10. In the implementation shown in FIG.1 the catheter shaft 14 includes two internal lumens: (i) a first lumen intended as an inflation lumen (20, not shown) connected to the inflation port 17; and (ii) a second lumen intended as a guide-wire lumen (19, not shown) connected to the guide-wire port 18. The angioplasty catheter 10 is arranged in an over-the wire configuration, wherein a guidewire 11 extends from an opening at the distal end or tip 12 of the catheter through an opening at the guidewire port 18 at the proximal end. In alternate arrangements, the angioplasty catheter 10 may be provided in a rapid exchange configuration, wherein the guidewire lumen extends only partially through the elongated member 14, and the guide-wire port 18 is situated distally to the manifold 16. Further, the elongated member of the angioplasty catheter 10 that is configured as a dual-lumen shaft may include a dual-lumen configuration selected from a group consisting of a parallel arrangement, a coaxial arrangement and a combination of coaxial and parallel arrangements. The inflatable member 13 of the angioplasty balloon catheter 10 is shown in a pressurized state, and individually configured to seamlessly conform to at least one of one or more of a curvature of a vessel anatomy.

[0042] FIG. 2 illustrates a cross-sectional view of an inflatable member of a curvature-compliant angioplasty balloon catheter conforming to one or more of a curvature and/or bending radius in accordance with the present disclosure. In FIG. 2, the inflatable member 13 of the curvature-compliant angioplasty balloon catheter 10 is proximally affixed to the elongated member 14 adjacent to the distal end and in fluid communication with at least one lumen (inflation lumen 20, not shown). The inflatable member exhibits at least one radius R (47, not shown) and includes at least three lobes, e.g. 21 -29, wherein the at least three lobes are separated from each other by two or more waist portions (37, 37', not shown). Starting from the distal end or catheter tip 12, the series of at least three lobes 21 -29, is further divided into several distinct groups of adjacent pairs of lobes selected from lobes 21 -24 and 25- 29, wherein the at least three lobes are separated from each other by two or more waist portions. An individual geometry 33, 35, that in turn is representative for each waist portion, separates the distinct groups of adjacent pairs of lobes from each other, and is indicated by a dashed black circle. Generally, in an unpressurized state, the at least three lobes 21 -29 of the inflatable member 13 are provided each folded and pleated, such that subsequent pressurization of the inflatable member individually unfolds each of the two or more lobes. As a characteristic feature, in a pressurized and vessel and lesion-contacting state, the individual geometry 33, 35 deflects an adjacent pair (e.g. 22-23; 27-28) of two or more of the at least three lobes at one or more of an individual lobe-to-lobe angle. In consequence, the distinct groups of adjacent pairs of lobes of the inflatable member 13 are capable of forming a first intrinsic bending radius or radius of curvature 34, and a second intrinsic bending radius or radius of curvature 36, each depicted in the drawing as a dashed quarter circle, with their respective center points shown as crosshairs. Thereby, the inflatable member 13 is enabled to form one or more individual bending radii 34, 36 that each seamlessly conform to at least one of the one or more of a curvature of the vessel anatomy without pinching or straightening of the vessel. Further, in the above, a guidewire lumen 19, extends from a catheter tip 12, through the inflatable member 13, and at least a portion of the catheter shaft 14, to a guidewire port located proximal to the inflatable member, exemplarily at a proximal end 18 of the catheter. As a specific feature, the individual geometries 33, 35 of the waist portion(s) positionally stabilize the at least one lumen 19 along a rotational axis (center-line) of the inflatable member 13. When the inflatable member is placed in a vessel anatomy and transitioned from an unpressurized state to a pressurized state, the position of the lumen 19 is thereby centered within the vessel anatomy.

WAIST PORTION GEOMETRY

[0043] FIG.3 illustrates a cross-sectional view of an individual geometry of a waist portion that separates lobes of the inflatable member, in an unfolded state, in accordance with the present disclosure. In FIG. 3, an inflatable member 13 is formed from at least three lobes 22-23 (27-28, not depicted), spaced apart by two or more waist portion(s) 37. The waist portion 37, as shown, includes a lower base length 39 and an upper base length 40, and two legs 41 , 42, each having a (shoulder) length 43. Further, the upper base of the waist portion 37 of the inflatable member 13 exhibits a first, radial distance or depth 45 relative to the lower base of the waist portion 37, and the lower base of the inflatable member 13 exhibits a second, radial distance or depth 46 relative to a rotational axis 38 (indicated as a dash-dotted line), of the inflatable member 13. In turn, in an extended and unpressurized state, a waist angle 44 is defined by the first and second lengths 39, 40 and radial distances 45, 46 between the lower and upper base. Consecutively, the sum of the first and second distances, or depths 45, 46 of the waist portion 37 yield an outer radius 47 (R) of the inflatable member 13. Specific technical effects of the segmentation of the inflatable member into the at least three lobes via the two or more waist portions will be further described in reference to FIGS. 4 - 5.

[0044] FIG. 4A and FIG. 4B illustrate cross-sectional views of individual geometries of two or more waist portions separating at least three lobes of the inflatable member, shown in (i) an unpressurized state (FIG. 4A), and (ii) a pressurized state (FIG. 4B), in accordance with the present disclosure. As described previously in reference to FIG. 3, in FIG. 4A, adjacent individual geometries 33 (35) of each of the two or more waist portions 37, 37’ separating the at least three lobes 22, 23, 24 of the inflatable member 13, are shown along an extended rotational axis 38. The individual geometries are spaced apart from each other by a (lobe) length 50 of the two or more of the at least three lobes. In an extended and unpressurized state, each waist portion 37, 37’ exhibits a waist angle 44, 44’ that is formed between the legs 41 -42, and 4T-42’, respectively. Each waist portion 37, 37’ further comprises contact points 48-49 and 48’-49’, that demarcate a transition between the waist portion and the (mantle) length of the adjacent lobes. In FIG. 4B, when the inflatable member is placed in a vessel anatomy having one or more of a curvature (indicated by a curved rotational axis 38’), in a curved and pressurized state, the individual geometries 33 (35) of each of the two or more waist portions 37, 37’ separating the at least three lobes 22, 23, 24 of the inflatable member 13 are capable of seamlessly conforming to at least one of the one or more of a curvature of the vessel anatomy without pinching or straightening of the vessel, by controllably folding back upon themselves at the contact points 48-49 and 48’-49’. During the above-described folding operation, the waist angle 44, 44’ is reduced such, that contact points 48-49 and 48’-49’ are in direct proximity to each other. As a result, in the curved and pressurized state, the adjacent pairs (22-23; 23-24) of two or more of the at least three lobes of the inflatable member 13 form individual lobe-to-lobe angle(s) 51 , 51 '. The individual lobe-to-lobe angle that can be formed between an adjacent pair of two or more of the at least three lobes of the inflatable member is defined by a ratio between the second length 39 and a length 43 of the two legs 41 , 42 of the individual geometry 33, 35 of the two or more waist portions 37, 37’. As a result, a combination of the one or more individual lobe-to-lobe angles formed between the adjacent pair(s) and a length 50 of the two or more of the at least three lobes enables the inflatable member 13 to form one or more individual bending radii 34, 36 that each seamlessly conform to at least one of the one or more of a curvature of the vessel anatomy without pinching or straightening of the vessel.

BENEFITS OF THE CURVATURE-COMPLIANT ANGIOPLASTY CATHETER

[0045] FIG. 5A and FIG. 5B illustrate optical microscope images of an inflatable member of the curvature-compliant angioplasty balloon catheter in a pressurized state, conforming to one or more of a curvature and/or bending radius (FIG. 5A), in accordance with the present disclosure, in comparison to a conventional balloon angioplasty catheter (POBA) (FIG. 5B). In FIG. 5A, the inflatable member 13 of the curvature-compliant angioplasty balloon catheter has been placed around a bending radius 62 that simulates a curvature of a vessel anatomy. Upon pressurization to nominal pressure (NP) or rated burst pressure (RBP) conditions, as shown, the inflatable member 13 of the present disclosure readily assumes a curved state, that is conforming with the bending radius 62. The individual geometries present at the waist portions readily deform such, that the legs of the waist portion 41 -42, and 4T-42’ oriented towards the inner portion of the curvature, become angled towards each other so that the contact points previously discussed are in direct proximity, whereas on the opposite side of the inflatable member 13, the legs of the waist portion, that are facing away from the curvature become angled away from each other. The individual geometries of the waist portion therefore can be seen to act as articulating joints or axial stress relief or flex zones, that enable the inflatable member of the present disclosure to seamlessly conform to at least one of the one or more of a curvature of the vessel anatomy without pinching or straightening of the vessel. As a result of this specific construction, when the inflatable member is placed in a vessel anatomy having one or more of a curvature and containing a lesion, at least one lumen, such as the inner guidewire lumen 19 is positionally stabilized along a rotational axis (center-line) of the inflatable member, thereby centering the position of the lumen 19 within the vessel anatomy. Further, an outer diameter 58 of the inflatable member 13 is stabilized against radial changes across the lobes 22-24. Finally, a length of the inflatable member 13 is stabilized against an axial (length) change across the entire length of the inflatable member.

[0046] In comparison, in FIG. 5B, a conventional angioplasty catheter 52, constructed from a single-membered balloon 54, is placed around the same bending radius 62 that simulates a curvature of a vessel anatomy. Upon pressurization to nominal pressure (NP) or rated burst pressure (RBP) conditions, as shown, the conventional balloon 54 does not readily assume a state, that conforms with the bending radius 62. Instead, the mantle portion of the balloon that is oriented towards the inner portion of the curvature deforms such, that wrinkles or folds 55-57 are generated in direct proximity to the bending radius, that in turn is equivalent to a vessel wall of the vessel curvature. Further, the position of the guidewire lumen 53 of the balloon 54 has clearly shifted during pressurization and is tensioned against the bending radius 62. In addition, the outer radius 59 of the conventional balloon 54 has slightly collapsed against the bending radius 62, and is no longer uniform along a rotational or bending axis. As a result, such conventional balloon construction may easily entrap or constrict portions of the adjacent vessel wall, and thereby, result in undue pinching, compression or confinement and thus trauma to the vessel. Specifically, due to the intrinsic compliance of the balloon, inward portions of the vessel curvature are predominantly axially, but not radially compressed, while outward portions of the vessel curvature are predominantly axially straightened, and radially compressed. As a result of the above-described ill combination of tensioning and straightening effects, pulling, bending, torsioning or straightening stress on the vessel may easily occur during the angioplasty treatment with conventional balloon angioplasty catheters, when placed in vessel anatomies having one or more of a curvature and containing a lesion.

[0047] Summarizing the aforementioned constructional aspects and features of the balloon catheter in accordance to the present disclosure, the curvature- compliant balloon angioplasty catheter 10 capable of delivering focalized pressure, at least comprises: an elongated member 14 having a proximal end 18, a distal end 12, and at least one lumen 19, 20 extending at least partially through the elongated member; and an inflatable member 13 proximally affixed to the elongated member adjacent to the distal end and in fluid communication with the at least one lumen 20, the inflatable member having at least one radius R 47 and including at least three lobes, e.g. 21-29, the at least three lobes separated from each other by two or more waist portions 37, 37'; wherein in an unpressurized state, the at least three lobes of the inflatable member 13 are provided each folded and pleated, such that subsequent pressurization of the inflatable member individually unfolds each of the three or more lobes; wherein, when the inflatable member is placed in a vessel anatomy having one or more of a curvature 34, 36 and containing a lesion, an individual geometry 33, 35 of each of the two or more waist portions separating the at least three lobes of the inflatable member, in a pressurized and vessel and lesion-contacting state, deflects an adjacent pair, e.g. 22-23; 27-28 of two or more of the at least three lobes at one or more of an individual lobe to lobe angle 51 , 51 ’, characterized in that a combination of the one or more individual lobe to lobe angles formed between the adjacent pair(s) and a length 50 of the two or more of the at least three lobes enables the inflatable member 13 to form one or more individual bending radii 34, 36 that each seamlessly conform to at least one of the one or more of a curvature of the vessel anatomy without pinching or straightening of the vessel.

[0048] In addition to the above, the curvature-compliant balloon angioplasty catheter 10 capable of delivering focalized pressure, further comprises: a catheter tip 12; a kink-protection sleeve 15, and a manifold 16, wherein the manifold 16 further comprises: an inflation port 17; and a guide-wire port 18.

[0049] With respect to the foregoing, the elongated member 14 of the curvature-compliant balloon angioplasty catheter 10 further comprises: a guide-wire lumen 19, and an inflation lumen 20, wherein the guidewire lumen 19 extends at least partially through the elongated member; wherein the guide wire lumen 19 connects the catheter tip 12 to the guidewire port 18; wherein the inflation lumen 20 is in fluid communication with the inflatable member 13, and wherein the elongated member (14) is configured as a dual-lumen shaft and a dual-lumen configuration of the elongated member is selected from a group consisting of a parallel arrangement, a coaxial arrangement and a combination of coaxial and parallel arrangements.

CURVATURE COMPLIANCE

[0050] Various constructional aspects relating to the specific curvature- compliant behavior of the angioplasty balloon catheter of the present invention are next described with reference to FIGS. 6-10. FIG. 6 is a X-Y diagram illustrating control of a waist angle of an individual geometry of a waist portion in an unpressurized state, through an adjustment of a dimensionless ratio defined between a first depth and a length of two legs of the individual geometry, in accordance with the present disclosure. In FIG. 6, several implementations of an individual geometry of a waist portion of the curvature-compliant balloon catheter, each yielding a distinct waist angle 44, are provided. In the given example, a first depth 45 is selected from at least a set of ranges that includes 0.50 - 1 .50 mm, 0.55 - 0.65 mm, 0.75 - 0.85 mm, 0.95 - 1.05 mm, 1.10 - 1.20 mm, and 1.20 - 1.30 mm; and a length 43 of the two legs 41 , 42 is selected from at least a set of ranges that includes 0.60 - 1.40 mm, 0.65 - 0.75 mm, 0.80 - 0.90 mm, 1.00 - 1.10 mm, 1.15 - 1 .25 mm, and 1 .25 - 1 .35 mm. As a result, the dimensionless ratio defined between the first depth 45 and the length 43 of the two legs of the individual geometry is variably adjusted such, that the corresponding waist angle 44 is selectable from at least a set of ranges that includes 50 - 90 °, 50 - 60 °, 60 - 70 °, 70 - 80 °, and 80 - 90 °.

[0051 ] FIG. 7 is a X-Y diagram illustrating control of a lobe-to-lobe angle of an individual geometry of a waist portion in a pressurized state, through an adjustment of a dimensionless ratio defined between a lower base length and a length of two legs of the individual geometry, in accordance with the present disclosure. In FIG. 7, several implementations of an individual geometry of a waist portion of the curvature- compliant balloon catheter, each yielding a distinct lobe-to-lobe angle 51 , are provided. In the given example, a lower base length 39 is selected from at least a set of ranges that includes 0.10 - 0.50 mm, 0.10 - 0.20 mm, 0.30 - 0.40 mm, and 0.40 - 0.50 mm; and a length 43 of the two legs 41 , 42 is selected from at least a set of ranges that includes 0.60 - 1 .40 mm, 0.65 - 0.75 mm, 0.80 - 0.90 mm, 1 .00 - 1 .10 mm, 1 .15 - 1 .25 mm, and 1 .25 - 1 .35 mm. As a result, the dimensionless ratio defined between the lower base length 39 and the length 43 of the two legs of the individual geometry is variably adjusted such, that the corresponding lobe-to-lobe angle 51 is selectable from at least a set of ranges that includes 150 - 170 °, 155 - 160 °, 160 - 165 °, and 165 - 170 °.

[0052] FIG. 8 is a X-Y diagram illustrating control of an intrinsic bending radius or radius of curvature of the inflatable member of the present disclosure, in a pressurized state, through an adjustment of a length of a balloon lobe of the inflatable member. In FIG. 8, several implementations of a lobe length 50 of the curvature- compliant balloon catheter, each yielding a distinct bending radius or radius of curvature 34 (36), are provided. In the given example, a lower base length 39 is selected from at least a set of ranges that includes 0.30 - 0.40 mm, and an upper base length 40 selected from at least a set of ranges that includes 0.90 - 1.10 mm. In turn, the lobe length 50 is selected from at least a set of ranges that includes 3.0

- 20.0 mm, 3.5 - 4.5 mm, 4.5 - 5.5 mm, 5.5 - 6.5 mm, 6.5 - 7.5 mm, 7.5 - 8.5 mm,

8.5 - 9.5 mm, 9.5 - 10.5 mm, 10.5 - 11 .5 mm, 11 .5 - 12.5 mm, 12.5 - 13.5 mm, 13.5

- 14.5 mm, 14.5 - 15.5 mm, 15.5 - 16.5 mm, 16.5 - 17.5 mm, 17.5 - 18.5 mm, and

18.5 - 20.0 mm. As a result, the lobe length 50 is variably adjusted such, that the corresponding radius of curvature 34 (36) is selectable from at least a set of ranges that includes 5 - 50 mm, 5 - 10 mm, 10 - 15 mm, 15 - 20 mm, 20 - 25 mm, 25 - 30 mm, 30 - 35 mm, 35 - 40 mm, and 45 - 50 mm.

[0053] FIG. 9 is a X-Y diagram illustrating control of an intrinsic bending radius or radius of curvature of the inflatable member of the present disclosure, in a pressurized state, through an individual lobe-to-lobe angle. In FIG. 9, several implementations of a lobe-to-lobe angle 51 of an individual geometry of a waist portion of the curvature-compliant balloon catheter, each yielding a distinct bending radius or radius of curvature 34 (36), are provided. In the given example, a lower base length 39 is selected from at least a set of ranges that includes 0.30 - 0.40 mm, and an upper base length 40 selected from at least a set of ranges that includes 0.90 - 1.10 mm. In turn, a lobe-to-lobe angle 51 is selected from at least a set of ranges that includes 150 - 170 °, 155 - 160 °, 160 - 165 °, and 165 - 170 °. As a result, the lobe-to-lobe angle 51 is variably adjusted such, that the corresponding radius of curvature 34 (36) is selectable from at least a set of ranges that includes 10 - 25 mm, 10 - 15 mm, 15 - 20 mm, and 20 - 25 mm.

[0054] FIG. 10 is a X-Y diagram illustrating control of an intrinsic bending radius or radius of curvature of the inflatable member of the present disclosure, in a pressurized state, through an adjustment of an outer diameter or radius of two or more balloon lobes of the inflatable member. In FIG. 10, several implementations of an outer diameter 58 or radius 47 of two or more balloon lobes of an individual geometry of a waist portion 37 of the curvature-compliant balloon catheter are provided. Each implementation yields a distinct bending radius or radius of curvature 34 (36). In the given example, a lower base length 39 is selected from at least a set of ranges that includes 0.30 - 0.40 mm, and an upper base length 40 selected from at least a set of ranges that includes 0.90 - 1.10 mm. In turn, the outer diameter 58 is selected from at least a set of ranges that includes 1 .0 - 5.0 mm, 1 .0 - 2.0 mm, 2.0 - 3.0 mm, 3.0 - 4.0 mm, and 4.0 - 5.0mm. As a result, the outer diameter 58 is variably adjusted such, that the corresponding radius of curvature 34 (36) is selectable from at least a set of ranges that includes 10 - 30 mm, 10 - 15 mm, 15 - 20 mm, 20 - 25 mm, and 25 - 30 mm.

[0055] Summarizing the aforementioned constructional aspects and features of the curvature-compliant balloon angioplasty catheter 10 capable of delivering focalized pressure, an individual geometry of the two or more waist portions 37, 37' between the at least three lobes, e.g. 21 -29, of the inflatable member 13 includes: an upper base having a first length 40 that is equivalent to a length of the waist portion(s); a lower base having a second length 39 smaller than the first length; a first depth equivalent to a radial distance 45 between the upper base and the lower base; a second depth equivalent to a radial distance 46 between the lower base and a rotation axis 38 of the inflatable member; two legs 41 , 42 formed at a waist angle 44 that is defined by the first and second lengths 39, 40 and radial distances 45, 46 between the lower and upper base, wherein a sum of the first and second depths 45, 46 are equivalent to an outer radius 47 of the inflatable member, and wherein the first depth is equivalent to the depth of the waist portion(s).

[0056] With respect to the foregoing, in an extended and unfolded state, the waist angle 44 is defined by a ratio between the first depth 45 and a length 43 of the two legs 41 , 42.

[0057] Further, in a curved and pressurized state, the individual lobe to lobe angle 51 , 51 ' formed between an adjacent pair of two or more of the at least three lobes is defined by a ratio between the second length 39 and a length 43 of the two legs 41 , 42 of the individual geometry 37, 37' of the two or more waist portions.

[0058] In addition, the radius of curvature 34, 36 formed between an adjacent pair of two or more of the at least three lobes is defined by the individual lobe to lobe angle 51 , 51 ' and one or more of a length 50 of the at least three lobes.

[0059] Finally, when the inflatable member is partitioned into a number n of the at least three lobes, an associated number of the two or more waist portions includes n-1 , and a length of the inflatable member is determined by a sum of n-1 times the first length 40 and n times the lobe length L 50. STRAIGHTENING FORCE GENERATION

[0060] FIGS. 11A - 11 F illustrate a series of optical microscope images of identically configured inflatable members of the curvature-compliant angioplasty balloon catheter at nominal pressure (FIGS. 11A - 11 C) and rated burst pressure (FIGS. 11 D - 11 F), each conforming to three different bending radii, in accordance with the present disclosure. In FIGS. 11A - 11 C, the inflatable member 13 of the curvature-compliant angioplasty balloon catheter has been placed, from left to right, around three bending radii 60, 61 and 62 that simulate, in order of decreasing radii, increasingly challenging curvatures 34 (36) of vessel anatomies selected from at least a set of ranges that include 10 - 20 mm, such as 20 mm (60), 15 mm (61 ), and 10 mm (62). Upon pressurization to nominal pressure (NP), as shown, the inflatable member 13 of the present disclosure readily assumes a curved state, that is conforming with the three bending radii 60, 61 and 62. When the radius of curvature approaches a minimum bending radius reflective of a minimum lobe-to-lobe angle of an individual geometry of a waist portion of the curvature-compliant balloon catheter, the individual geometries present at the waist portions deform until the legs of the waist portion 41-42, and 4T-42’, oriented towards the inner portion of the curvature, are in direct proximity to each other, whereas on the opposite side of the inflatable member 13, the legs of the waist portion, that are facing away from the curvature become angled away from each other. Upon further pressurization from nominal pressure (NP) to rated burst pressure (RBP) conditions, as shown in FIGS. 11 D - 11 F, the outer radius (58) of the at least three lobes 22-24 of the inflatable member 13’ increases slightly, and thereby, increases the attainable minimum radius of curvature, in analogy to the relationship presented in FIG. 10. In both cases, at different states of pressurization (NP-RBP), the individual geometries of the waist portion act as articulating joints or axial stress relief zones, that enable the inflatable member of the present disclosure to seamlessly conform to at least one of the one or more of a curvature of the vessel anatomy without pinching or straightening of the vessel, yielding the benefits previously described in reference to FIGS. 5A. [0061 ] FIGS. 12A - 12F illustrate a series of optical microscope images of identically configured inflatable members of a conventional angioplasty catheter at nominal pressure (FIGS. 12A - 12C) and rated burst pressure (FIGS. 12D - 12F), each demonstrating various drawbacks in comparison to the curvature-compliant angioplasty balloon catheter of the present disclosure. In FIGS. 12A - 12C, the balloon 54 of the conventional angioplasty catheter has been placed, from left to right, around three bending radii 60, 61 and 62 that simulate, in order of decreasing radii, increasingly challenging curvatures of vessel anatomies selected from at least a set of ranges that include 10 - 25 mm, such as 20 mm (60), 15 mm (61 ), and 10 mm (62). Upon pressurization to nominal pressure, as shown, the balloon 54 of the conventional angioplasty catheter does not readily assume a state, that conforms with the three bending radii 60, 61 and 62. Instead, when the radius of curvature approaches a minimum bending radius that is already significantly larger than compared to a minimum bending radius of a curvature compliant angioplasty catheter of substantially similar or the same length and/or diameter, the mantle portion of the balloon 54 that is oriented towards the inner portion of the curvature deforms such, that wrinkles or folds 55-57 are generated in direct proximity to the bending radius, as evidenced in FIGS. 12B-12C. In addition, upon further pressurization from nominal pressure to rated burst pressure conditions, as shown in FIGS. 12D - 12F, the balloon 54 begins to increasingly straighten out and lift away from the inner portion of the curvatures represented by the bending radii 60, 61 and 62, respectively. While this phenomenon at first appears to remediate the previously observed wrinkles, that are representative of a pinching, compression or confinement problem, it conceals the fact, that at increasingly higher pressures, increasingly higher straightening forces are built up, that further exacerbate the magnitude of vessel trauma present with conventional balloon angioplasty catheters. Thus, based on the foregoing, conventional angioplasty catheters do not readily support placement in vessel anatomies having one or more of a minimum curvature, without exhibiting the disadvantages described above and previously in reference to FIG. 5B. STRAIGHTENING FORCE MITIGATION

[0062] The inventors now have surprisingly found, that the above-described deleterious effects present in conventional balloon angioplasty catheters, when applied in vessel anatomies having one or more of a curvature, and containing a lesion, can be controllably remediated by the curvature-compliant balloon angioplasty catheter of the present disclosure. In particular, it has been found, that the individual geometry 33, 35 of each of the two or more waist portions separating the at least three lobes of the inflatable member, in a pressurized and vessel and lesion-contacting state, is capable of controllably distributing one or more radial and straightening force components exerted by the inflatable member 13 on an inward and outward oriented portion of the vessel curvature. The various novel features of the curvature-compliant balloon angioplasty catheter of the present invention are next described with reference to FIGS. 13-17.

[0063] FIG. 13 depicts a cross-sectional view of an inflatable member of a curvature-compliant angioplasty balloon catheter in a 180° curvature, illustrating one or more of a magnitude and distribution of radial and straightening force components that can be directed by the inflatable member on an inward and outward oriented portion of a vessel curvature, in accordance with the present disclosure. In FIG. 13, the inflatable member 13 of the curvature-compliant angioplasty balloon catheter 10 includes at least three lobes 21 -32, and is placed over a guidewire 11 and into a 180° vessel curvature. The position of the lobes relative to the inflatable member and the vessel curvature, is further referenced by a distal position 63, a middle position 64, and a proximal position 65. Drawn around each lobe are a magnitude and distribution of radial 66, 67 and straightening force components facing towards an inward (66) and outward oriented (67) portion of the vessel curvature. Straightening force components are virtually absent, leaving a full complement of radial force components that can be directed by the inflatable member on an inward and outward oriented portion of a vessel curvature. An overlay of the radial and straightening force (vector) components is indicated as a dashed black line surrounding each individual lobe 21 -32. [0064] FIG. 14 is a bar chart illustrating the relative distribution 140 of inward- and outward-oriented radial and straightening force components (left vs right bars) of an inflatable member of a curvature-compliant angioplasty balloon catheter, each determined at a distal, middle and proximal position (from top to bottom), in accordance with the present disclosure. In FIG. 14, a relative magnitude of radial 66, 67 and straightening force components 68, 69 facing towards an inward oriented (66, 68) portion of the vessel curvature is depicted as a light striped bar that ranges from 0 to 150% (towards the left side of the bar chart), while a relative magnitude of radial 66, 67 and straightening force components 68, 69 facing towards an outward oriented (67, 69) portion of the vessel curvature is depicted as a dark striped bar that ranges from 0 to 150% (towards the right side of the bar chart). From top to bottom of the bar chart, each relative distribution of inward- and outward-oriented radial and straightening force components has been determined at a distal (63), middle (64) and proximal (65) position, as previously referenced in FIG. 13. As evident from these force measurements, at each lobe position, the relative amount or magnitude of radial 66, 67 and straightening force components 68, 69 facing towards an inward and outwards oriented portion of the vessel curvature is substantially the same, or similar (96-104%, left side of graph, versus 96-104% on the right side of the graph). Thus, straightening force components are fully minimized or virtually absent, while radial force components, that represent an amount of focal pressure that can be delivered by the inflatable member on an inward and outward oriented portion of a vessel curvature and onto a lesion, are substantially or fully maximized, regardless of their relative orientation towards a vessel curvature.

[0065] FIG. 15 depicts a cross-sectional view of an inflatable member of a conventional angioplasty balloon catheter in a 180° curvature, illustrating one or more of a magnitude and distribution of radial and straightening force components, in comparison to curvature-compliant angioplasty balloon catheter of the present disclosure. In FIG. 15, a single-membered balloon 54 of a conventional angioplasty balloon catheter 52 is placed over a guidewire 11 and into a 180° vessel curvature. The position of the balloon relative to the vessel curvature, is further referenced by a distal position 63, a middle position 64, and a proximal position 65. Drawn around each lobe are a magnitude and distribution of radial 66, 67 and straightening force components 68, 69 facing towards an inward (66, 68) and outward oriented (67, 69) portion of the vessel curvature. Straightening force components 68, 69 are strongly pronounced at a distal 63 and proximal balloon position 65, pulling the balloon 54 away from the middle position 64, and thereby, reducing an amount or magnitude of radial forces 66, 67, that could otherwise be directed by the balloon on an inward oriented portion of a vessel curvature, while being overly increased towards an outward oriented portion of the vessel curvature. An overlay of the radial force components 66, 67 is indicated as a dashed black line, and an overlay of the straightening force components 68, 69 is indicated as a dash-dotted black line.

[0066] FIG. 16 is a bar chart illustrating the relative distribution of inward- and outward-oriented straightening force components (left vs right bars) of an inflatable member of a conventional balloon angioplasty balloon catheter, each determined at a distal, middle and proximal position (from top to bottom), in comparison to curvature-compliant angioplasty balloon catheter of the present disclosure. In FIG. 16, a relative magnitude of radial 66, 67 and straightening force components 68, 69 facing towards an inward oriented (66, 68) portion of the vessel curvature is depicted as a light striped bar that ranges from 0 to 150% (towards the left side of the bar chart), while a relative magnitude of radial 66, 67 and straightening force components 68, 69 facing towards an outward oriented (67, 69) portion of the vessel curvature is depicted as a dark striped bar that ranges from 0 to 150% (towards the right side of the bar chart). From top to bottom of the bar chart, each relative distribution of inward- and outward-oriented radial and straightening force components has been determined at a distal (63), middle (64) and proximal (65) balloon position, as previously referenced in FIG. 15. As evident from these force measurements, at each balloon position, the relative amount or magnitude of radial 66, 67 and straightening force components 68, 69 facing towards an outward oriented portion of the vessel curvature is overly increased (122-135%, left side of graph), while the relative amount or magnitude of radial 66, 67 and straightening force components 68, 69 facing towards an inward oriented portion of the vessel curvature is substantially decreased (64-77%, right side of graph), with an apparent minimum at the middle position. Thus, as a particular noteworthy result, an amount or magnitude of radial forces 66, 67 present at a middle position, that could otherwise be directed by the balloon 54 on an inward oriented portion of a vessel curvature and onto a lesion, are fully minimized, while the (vector) sum of radial and straightening force components available at the distal and proximal positions or ends of the balloon are near or fully maximized. Hence, the above-described distribution of straightening forces is a clear limitation of conventional angioplasty catheters, that presents the actual root for the lack of focalized pressure, that can be exerted onto a vessel anatomy having a curvature and containing a lesion, such that opening of the lesion and/or adequate patency of the vessel cannot be reliably achieved.

[0067] FIG. 17 is a X-Y diagram illustrating control of an outward-oriented straightening force component of several differently configured inflatable members, each determined at its distal end at nominal pressure and rated burst pressure, through an adjustment of a combination of one or more of a number n and one or more of a length L of lobes of an inflatable member of a curvature-compliant angioplasty balloon catheter, in accordance with the present disclosure. In FIG. 17, several different lobe configurations 72, 73 of a curvature-compliant angioplasty balloon catheter are contrasted with a single-membered conventional balloon angioplasty catheter configuration 74. The differing types of balloon angioplasty catheters are shown at a nominal pressure regime (dash-dotted black line) and rated burst pressure regime (continuous black line).

[0068] In the given example, lobe configuration 72 (diamond symbol) of the curvature-compliant angioplasty balloon catheter is constructed from a number n of 12 lobes, each lobe having a length L of 6.0 mm, while lobe configuration 73 (triangle symbol) is constructed from a number n of 8 lobes, each having a length L of 9.0 mm. In comparison, the conventional balloon angioplasty catheter configuration 74 (circle symbol) is formed from a number n of 1 “lobe”, and a length L of 80 mm. Including the waist portion lengths of the curvature-compliant angioplasty balloon catheter configurations, all inflatable members shown exhibit the same balloon length (80.0 mm) and outer balloon diameter (3.0 mm).

[0069] At nominal pressure conditions, the straightening force 69 determined at the distal end of the curvature-compliant angioplasty balloon catheter ranges from about 0.05 to 0.07 N for the lobe configurations 72 and 73, while the lobe configuration 74 that is representative of a conventional angioplasty catheter is already about fourfold that value. Under rated burst pressure conditions, lobe configurations 72 and 73 of the curvature-compliant angioplasty balloon catheter increase only marginally, while the “lobe” configuration 74 of the conventional angioplasty catheter is now already at about the nine-fold value, in comparison. Thus, these measurements of the outward-oriented straightening force component, exemplarily determined at the distal position of each inflatable member, clearly demonstrate that a magnitude and distribution of the radial and straightening force components can be controllably adjusted through a combination of one or more of a number n and one or more of a length L of the at least three lobes of an inflatable member of a curvature-compliant angioplasty balloon catheter, particularly when at least the one or more of a number n of the at least three lobes is increased or the one or more of the length L (50) of the at least three lobes is reduced, or both. Further application specific features of the curvature-compliant balloon angioplasty catheter of the present invention are next described with reference to FIGS. 18-20.

[0070] FIGS. 18A - 18B depict cross-sectional views of axial straightening force components acting on an inflatable member of a curvature-compliant angioplasty balloon catheter of the present disclosure (FIG.18A), in comparison to axial straightening force components acting on an inflatable member of a conventional angioplasty balloon catheter (FIG. 18B). In FIG. 18A, the inflatable member 13 of the curvature-compliant angioplasty balloon catheter 10 includes, starting from the distal end or catheter tip 12, a series of at least three lobes 21 -32, wherein the at least three lobes are separated from each other by two or more waist portions (37). An individual geometry 33 (35), that is representative for each waist portion, separates the groups of adjacent pairs of lobes from each other, and is indicated by a dashed black circle. In a pressurized state, each individual lobe builds up an amount of axial straightening forces 75, 76 that pull in a distal and proximal direction, indicated in the drawing as hollow arrows 75, and solid arrows 76. As illustrated in the drawing, the axial straightening forces 75, 76 present at each waist portion are of substantially equivalent magnitude, but opposite direction, thereby cancelling or minimizing any axial straightening effect that could otherwise act on the inflatable member as a whole. Because the axial straightening effect is minimized, the positional stability of the inflatable member in a vessel having one or more curvature is maximized. This outcome is particularly noteworthy, as it infers, that for both comparably short- and long-sized inflatable members of the curvature- compliant angioplasty balloon catheter of the present disclosure positional stability as well as anchoring capability are increased. In comparison thereto, in FIG. 18B, the conventional angioplasty balloon catheter 52 includes only a single-membered balloon 54, that does not contain any waist portions. As a result, the magnitude of available axial straightening forces 75, 76, that pull the balloon in a distal and proximal direction, are maximized, leading to the known disadvantages described previously in reference to conventional angioplasty catheters.

[0071 ] FIGS. 19A - 19B depict cross-sectional views of radial force components acting on an inflatable member of a curvature-compliant angioplasty balloon catheter of the present disclosure (FIG.19A), in comparison to radial force components acting on an inflatable member of a conventional angioplasty balloon catheter (FIG. 19B). In FIG. 19A, the inflatable member 13 of the curvature-compliant angioplasty balloon catheter 10 includes, starting from the distal end or catheter tip 12, a series of at least three lobes 21 -32, wherein the at least three lobes are separated from each other by two or more waist portions (37). An individual geometry 33 (35), that is representative for each waist portion, separates the groups of adjacent pairs of lobes from each other, and is indicated by a dashed black circle. In a pressurized state, each individual lobe builds up an amount or magnitude of radial forces 66, 67 that enlarge a first outer diameter 58 (lobe outline indicated as a solid line) at, for example, a nominal pressure, to a second outer diameter 58’ (lobe outline indicated by a dotted line), at a rated burst pressure. As illustrated in the drawing, the radial forces 66, 67 present at each waist portion are acting over the respective length 50 of each individual lobe, leading to an individual expansion of each lobe in radial direction, wherein the radial expansion does not proceed over an entire length of the inflatable member 13, and thereby, cancelling or minimizing a radial (balloon compliance) effect that could otherwise act on the inflatable member 13 as a whole.

[0072] In comparison thereto, in FIG. 19B, the conventional angioplasty balloon catheter 52 includes only a single-membered balloon 54, that does not contain any waist portions. As a result, the radial forces 66, 67, enlarge an outer diameter 59 (balloon outline indicated as a solid line) at, for example, a nominal pressure, to a second outer diameter 59’ (balloon outline indicated as a dotted line), for example at a rated burst pressure, and over an entire length 90 of the singlemembered balloon 54. Because radial balloon compliance is a property that depends, among others, not only on the balloon material, but more specifically, on an aspect ratio determined by an outer balloon diameter and a balloon length (for example 58/50 or 59/90), the amount of radial enlargement or radial compliance is maximized for a conventionally built angioplasty balloon, while at the same time, minimized for the curvature-compliant angioplasty balloon catheter of the present disclosure.

[0073] In turn, because the curvature-compliant angioplasty balloon catheter of the present disclosure provides multiple radial force components across the at least three lobes, that are equivalent to an amount or magnitude of focalized pressure, the radial force is not exerted as continuous radial force or focalized pressure along the entire length of the inflatable member 13, but instead, the radial force or focalized pressure is exerted along each lobe length individually, through separation across the two or more waist portions of the at least three lobes. In consequence, when the curvature-compliant angioplasty balloon catheter of the present disclosure is placed in a vessel anatomy having one or more of a curvature and containing a lesion, the lesion can be opened up in a very atraumatic and localized manner, taking into account both the lesion morphology and vessel curvature. Because these beneficial effects are prevalent for both comparably short- and long-sized inflatable members, the curvature-compliant angioplasty balloon catheter of the present disclosure effectively mitigates the drawbacks commonly observed for conventional angioplasty catheters having comparably short- or longsized balloons.

[0074] FIG. 20 illustrates a perspective view of a curvature-compliant angioplasty balloon catheter placed in a vessel anatomy having one or more of a curvature and containing a lesion, in accordance with the present disclosure. In FIG. 20, an anastomotic vessel anatomy 77 is shown. A main vessel 78, such as the brachial artery, is connected to side branch vessel, such as the cephalic vein, at a bifurcation 79. The curved branch vessel contains a lesion with an inward oriented portion 80, and an outward oriented portion 81 . A curvature-compliant angioplasty balloon catheter 10 has been inserted over a predisposed guidewire 11 into the vessel anatomy 77. The lobes 26, 27 have been positioned within the lesion, and the remaining lobes 21 -32 of the inflatable member 13 seamlessly conform to at least one of one or more of a curvature of the vessel anatomy without pinching or straightening of the vessel. Because the magnitude and distribution of the radial and straightening force components of the inflatable member 13 have been controllably adjusted, a maximum amount of focal pressure (e.g. 66 at 64) can be directed by the inflatable member on a lesion located on the inward oriented portion 80 of the vessel curvature. Further, because the curvature-compliant angioplasty balloon catheter of the present disclosure seamlessly adapts to the curvature of the vessel anatomy, the straightening forces are minimized, and the inflatable member is effectively stabilized in position. Thereby, application of the curvature-compliant angioplasty balloon catheter results in much reduced vessel trauma, without pinching or straightening of the vessel, and accordingly reduced risk of vessel rupture or dissection, while allowing for a very effective treatment of vessel anatomies having one or more of a curvature and containing a lesion. CURVATURE-COMPLIANT BALLOON ANGIOPLASTY CATHETERS FOR INTRAVASCULAR LITHOTRIPSY (IVL)

[0075] In the following, specific benefits of applying curvature-compliant balloon angioplasty catheters of the present invention in the field of intravascular lithotripsy (IVL) are next described in reference to FIGS. 21 -27.

[0076] FIG. 21 illustrates a perspective view of a curvature-compliant angioplasty balloon catheter with a centered lumen configuration suitable for intravascular lithotripsy in a vessel anatomy having one or more of a curvature and containing a lesion, in accordance with the present disclosure. In comparison to FIG. 20, lobes 21-32 are displayed in cross-section to reveal a configuration of the lumen 19 of the curvature-compliant angioplasty balloon catheter. In Fig. 21 , the configuration of the lumen 19 comprises one or more distal radiopaque marker 82 positioned within the most distal lobe 21 , and/or a proximal radiopaque marker 82’, positioned in the most proximal lobe 32, the set of radiopaque markers 82, 82’ positioned around an outer surface of the lumen 19 and thereby demarcating a length of the inflatable member 13. Further, the configuration of the lumen 19 comprises one or more emitters 83-93 suitable for use in intravascular lithotripsy (IVL), each emitter 83-93 positioned in a corresponding lobe 22-31. Such configuration of the lumen 19 comprising multiple emitters can be intended for the efficient treatment of long lesions. The set of emitters 83-93 can generally be selected from a variety of different types, including but not limited to e.g. ultrasonic, piezoelectric, or electromagnetic transducers, electrohydraulic and/or laser-based emitters, and equivalents. These emitters are capable of producing various pressure-, sound- or shock waves of variable amplitude, frequency, pulse, modulation, profile, direction, focal zone, duration, energy and penetration depth. In the provided example, when the inflatable member (13) is placed in a vessel anatomy 77 having one or more of a curvature (34, 36) and containing a lesion, the activation of one or more of the one or more emitters 83-93 projects one or more shockwaves radially away from the surface of each of the one or more activated emitters and through the corresponding lobe(s) of the inflatable member. These shockwaves thereby exert a temporary pressure gradient on the surrounding vessel anatomy, and accordingly, ease breaking up the calcified lesion, as a basis for intravascular lithotripsy. In the shown implementation, because the individual geometries of the waist portions of the lobes 21 -32 positionally stabilize the at least one lumen 19 along a rotational axis (center-line) of the inflatable member 13, when the inflatable member is placed in a vessel anatomy and transitioned from an unpressurized state to a pressurized state, the position of the lumen 19 is thereby centered within the vessel anatomy. As a result, the position of the radiopaque markers, and particularly, the position of the emitters 83-93 is positionally stabilized and centered within the vessel anatomy, thereby avoiding direct contact with the inner surface of the inflatable member, and maintaining a constant, safe distance to the vessel anatomy, for controlled delivery of shockwaves, while reducing risk of vessel trauma. Furthermore, as a result of the lumen 19 being centered, the one or more emitters 83-93 are also perpendicularly oriented towards the surrounding vessel anatomy 77.

[0077] FIG. 22 illustrates a perspective view of a curvature-compliant angioplasty balloon catheter with an alternative, centered lumen configuration suitable for intravascular lithotripsy in a vessel anatomy having one or more of a curvature and containing a lesion, in accordance with the present disclosure. In comparison to FIG. 21 , the alternative configuration of the lumen 19 comprises only one emitter 87, suitable for use in intravascular lithotripsy (IVL), the emitter 87 positioned in a corresponding lobe 26, and around an outer surface of the lumen 19. Further, the emitter exhibits radiopaque properties, and is positioned along a length of the lumen 19, in-between the set of the one or more radiopaque markers 82, 82’. The inflatable member (13) has been positioned in the vessel anatomy 77 by angiographic verification using said radiopaque markers 82, 82’, and the lobe 26 comprising the emitter 87 has been exactly positioned in the lesion that contains an inward oriented portion 80, and an outward oriented portion 81. Upon activation of the emitter 87, the alternative lumen configuration is thereby able to exert a very localized, temporary pressure gradient on the portions 80, 81 of the lesion, without affecting the healthy portions of the surrounding vessel anatomy 77. Such configuration of the lumen 19 comprising one emitter can be intended for the efficient treatment of focal lesions. In comparison to the lumen configuration of FIG. 21 , the reduction of emitters further simplifies the construction, saving cost and further reducing risk of vessel trauma. Additional benefits over current state of the art catheters will next be described in reference to FIG. 23.

[0078] FIG. 23 illustrates a perspective view of a contemporary angioplasty balloon catheter with a non-centered lumen configuration suitable for intravascular lithotripsy in a vessel anatomy having one or more of a curvature and containing a lesion, not in accordance with the present disclosure. A contemporary angioplasty balloon catheter (52) is shown inserted over a predisposed guidewire 11 and into the vessel anatomy 77. Similar to FIG. 21 -22, a configuration of the lumen 53 of a contemporary angioplasty balloon catheter comprises a pair of distal and proximal radiopaque markers 82, 82’ positioned within the inflatable member 54, around an outer surface of the lumen 53 and thereby demarcating a length (90) of the inflatable member 54. Further, the lumen 53 comprises a set of emitters 83’-88’, suitable for use in intravascular lithotripsy (IVL), each emitter 83’-88’ positioned around an outer surface of the lumen 53, and situated along the length of the lumen 53, in-between the pair of radiopaque markers 82, 82’. However, in comparison to the curvature- compliant angioplasty catheters shown in FIGs. 21 -22, the single-membered balloon 54 does not contain any waist portions, and as a result, does not seamlessly conform to the curvature of the vessel anatomy without pinching or straightening of the vessel. In consequence, the lumen 53 situated in the inflatable member is not positionally stable, shifting away from the center-line, tensioning against the anatomic curvature of the vessel anatomy 77, and against an inner surface of the inflatable member 54, during pressurization, as shown (effect also previously illustrated in FIGs. 5 and 12).

[0079] FIG. 24 depicts a cross-sectional view of a curvature-compliant angioplasty balloon catheter with a centered lumen configuration suitable for intravascular lithotripsy in a vessel anatomy having one or more of a curvature, in accordance with the present disclosure. Similar to the shown implementation of Fig. 21 , in Fig. 24, the individual geometries of the waist portions of the lobes 21 -26 positionally stabilize the at least one lumen 19 along a rotational axis 38 (center-line) of the inflatable member 13, when the inflatable member is placed in a curved vessel anatomy and transitioned from an unpressurized state to a pressurized state. Thereby, the at least one lumen 19 is centered within the vessel anatomy, and the one or more emitters 83-87 present on the at least one lumen 19 maintain an equivalent, safe distance at any position along the rotational axis 38 from the surrounding vessel walls of the curved vessel anatomy 77. As highlighted in the circular insert of FIG. 24, due to the positional stabilization of the at least one lumen 19 along a rotational axis 38 of the inflatable member, the orientation of each of the one or more emitters 83-87, exemplarily emitter 85, is maintained along a perpendicular direction 97 facing towards the vessel wall of the surrounding vessel anatomy 77. Further, as a result, the one or more emitters are positioned at equivalent and safe distances 95, 96 away from the vessel anatomy. Because the emitters are maintained at equivalent distances, a desired level of energy, intensity or pressure gradient can be controllably and efficiently transferred onto the surrounding vessel anatomy without risk of losing focus, orientation, or causing undesired fluctuation or dispersion of energy, thereby allowing the controlled delivery of shockwaves, while reducing risk of vessel trauma.

[0080] In contrast thereto, FIG. 25 depicts a cross-sectional view of a contemporary angioplasty balloon catheter (52) with a non-centered lumen configuration suitable for intravascular lithotripsy in a vessel anatomy having one or more of a curvature, not in accordance with the present disclosure. In Fig. 25, similar to the illustration of Fig. 23, because the single-membered balloon 54 does not contain any waist portions, during pressurization, the lumen 53 situated in the inflatable member is not positionally stable, shifting away from the center-line 38’, tensioning against the anatomic curvature of the vessel anatomy 77’, and against an inner surface of the inflatable member 54. In consequence, emitters 83’-87’ present on the lumen 53, in particular emitter 85’, as highlighted in the circular insert of FIG. 25, are tilted away at an undesirable angle 97’, from an optimal, perpendicular orientation 94’ facing the vessel anatomy 77’ along the centerline 38’, to an unfavorable, non-perpendicular orientation 95’. Further, as a result of the tensioning of the lumen 53 during pressurization, emitter 85’ maintains a comparatively short, and potentially unsafe distance 96’ from an inside bend of vessel anatomy 77, and a comparatively long distance 95’, potentially ineffective for IVL treatment. Because the emitters are not maintained at equivalent distances, a desired level of energy, intensity or pressure gradient cannot be controllably and efficiently transferred onto the surrounding vessel anatomy, thereby risking loss of focus and/or orientation, potentially causing undesired fluctuation or dispersion of energy, and thereby, negating a controlled delivery of shockwaves and increasing risk of vessel trauma.

[0081 ] The above illustrations therefore demonstrate, that conventional angioplasty catheters (POBA), as well as contemporary catheters for intravascular lithotripsy (IVL) both suffer from the same constructional drawback, when deployed in a vessel anatomy having a curvature, in that lumens situated in the inflatable member are not positionally stable, tensioning against the anatomic curvature during pressurization, and positionally shifting against an inner surface of the inflatable member. In IVL catheters, emitters are typically placed on a lumen situated in the inflatable member. The subsequent operation of IVL catheters in a vessel anatomy having a curvature may therefore result in the emitters directly contacting the inner surface of the inflatable member, and even worse, the adjacent vessel anatomy. Further, because the intensity or energy density of the one or more shockwaves is generally the highest directly on the surface of the emitter, and can be assumed to dissipate radially, e.g. as a function of the distance and the surface area, the transferred energy may directly damage the inflatable member, thereby reducing the lifetime of the instrument, and further, aggravate vessel trauma. In addition, the lumen can tilt off-axis, disorienting the emitter surface, risking loss of focus, orientation, and/or causing fluctuation or dispersion of energy. In the current disclosure, however, because the individual geometries of the waist portions of the lobes 21-32 positionally stabilize the at least one lumen 19 along a rotational axis 38 (center-line) of the inflatable member 13, when the inflatable member is placed in a vessel anatomy and transitioned from an unpressurized state to a pressurized state, the position of the lumen 19 is thereby centered within the vessel anatomy. As a result, the position of the radiopaque markers, and particularly, the position of the emitters 83-93 is positionally stabilized and centered within the vessel anatomy, thereby avoiding direct contact with the inner surface of the inflatable member, while maintaining a constant, safe distance and perpendicular orientation to the vessel anatomy, for controlled delivery of shockwaves, while reducing risk of vessel trauma. An additional benefit can be seen, in that the individual geometries (33, 35) of the two or more waist portions (37, 37') act as articulating joints, where positioning of the at least three lobes (21 -32) of the inflatable member (13) aligns an orientation of the one or more emitters (83-93) in a vessel anatomy having one or more of a curvature and containing a lesion. Additional implementations of lumen configurations of a curvature-compliant angioplasty balloon catheter configured for intravascular lithotripsy are next described in reference to FIGs. 26-27.

[0082] FIG. 26 depicts a cross-sectional view of one or more of a lobe length of an inflatable member of a curvature-compliant angioplasty balloon catheter having a centered lumen configured for intravascular lithotripsy, in relation to one or more of a vessel diameter and an emitter position, in accordance with the present disclosure. In the implementation shown in FIG. 26, an inflatable member 13 of the curvature-compliant angioplasty balloon catheter (10) comprises at least three lobes 25-27, and is configured with a lumen 19 that comprises one or more emitters 87 suitable for intravascular lithotripsy, the emitter 87 positioned in the center of lobe 26. The inflatable member is placed within a vessel anatomy 77 having a small vessel radius corresponding with a first outer radius 47 (outer diameter 58) of the lobes 25-27 of the inflatable member 13. A first lobe length 50 of lobe 26 is configured to pass a desired distribution of shockwaves 98 (generated by emitter 87 upon activation) along the entire lobe length 50, the lobe length and distribution of shockwaves suitably adapted for small vessel diameters. As an overlay in Fig. 26, in a second implementation, a lobe 26’ is placed within a vessel anatomy 77’ having a larger vessel radius corresponding with a second outer radius 47’ of the inflatable member 13. The second lobe length 50’ is configured to pass the same, a similar or equivalent distribution of shockwaves 98 along the entire lobe length 50’, the lobe length and distribution of shockwaves suitably adapted for large vessel diameters. In the two related implementations, a ratio of the lobe lengths 50 / 50’ can be seen proportionate to a ratio formed between the outer radii 47 1 47’ of the at least three lobes of the inflatable member 13. Further, lobe lengths 50, 50’ and outer radii 47, 47’ of the at least three lobes of the inflatable member are provided adapted to vessel radii of vessel anatomies 77, 77’ such, that a same, similar or equivalent distribution of shockwaves 98 can be maintained across a variable range of small and large vessel diameters. Or, in other words, the lobe lengths can be varied with respect to a vessel diameter and an emitter position such, that a same, similar or equivalent distribution of shockwaves is obtained. In this respect, ‘distribution’ can generally refer to one or more of a suitable amplitude, frequency, pulse, modulation, profile, direction, focal zone, duration, energy and penetration depth.

[0083] FIG. 27 depicts a cross-sectional view of one or more of an emitter position of an inflatable member of a curvature-compliant angioplasty balloon catheter having a centered lumen configured for intravascular lithotripsy, in a vessel anatomy having a 180° curvature, in accordance with the present disclosure. In FIG. 27, an inflatable member 13 of the curvature-compliant angioplasty balloon catheter (10) comprises at least three lobes 25-28, and is configured with a lumen 19 that comprises one or more emitters 87, 88 suitable for intravascular lithotripsy. The emitters 87, 88 are positioned in the respective centers of adjacent lobes 26, 27, and placed in a vessel anatomy having a 180° curvature. As described previously in reference to FIG.4, when the inflatable member 13 is placed in a vessel anatomy having one or more of a curvature (34, 36) and containing a lesion, an individual geometry (33, 35) of each of the two or more waist portions separating the at least three lobes 25-27 of the inflatable member, in a pressurized and vessel and lesioncontacting state, deflects an adjacent pair 25,26; 26,27 of two or more of the at least three lobes at one or more of an individual lobe to lobe angle (51 , 51 ’). Because the individual geometries (33, 35) of the two or more waist portions (37, 37') act as articulating joints, the positioning of the at least three lobes (21 -32) of the inflatable member (13) in a vessel anatomy 77 having one or more of a curvature therefore not only aligns an orientation of the one or more emitters 87, 88 perpendicular to a rotational axis 38 of the inflatable member and the surrounding vessel wall, but also aligns pairs of adjacent emitters 87,88 at one or more of an individual emitter to emitter angle, that in turn corresponds to the one or more of an individual lobe to lobe angle (51 , 51’). Further, in reference to FIG. 3, when each of the emitters 87, 88 is placed centered in each corresponding lobe 26, 27, as shown, a distance between each emitter (along the rotational axis 38) corresponds to a sum of a lobe length (50) and a length of the waist portion (40). Upon activation, each emitter 87, 88 is capable of transmitting a distribution of shockwaves 98, 99 along an optimal, perpendicular orientation facing the vessel anatomy 77. Further, upon concerted activation, pairs of adjacent emitters are enabled to overlap a distribution of shockwaves 98, 99 at a lobe-to-lobe angle (51 , 51’), in turn forming a pressure interference zone 100 that is focused onto an inward oriented portion of a vessel anatomy having one or more of a curvature and containing a lesion. Thus, the concerted activation of one or more adjacent pairs of the one or more emitters 87, 88 at an individual emitter to emitter angle, that corresponds to the one or more of an individual lobe to lobe angles, controllably forms a pressure interference zone 100, that further modulates one of an amplitude, frequency, pulse, modulation, profile, direction, focal zone, duration, energy and/or penetration depth of the distribution of shockwaves, which by design is favorably focused onto an inward oriented portion of a vessel curvature (which typically contains the lesion). In addition, a combination of the individual emitter to emitter angles formed between adjacent pair(s) of the one or more emitters located in one or more of the at least three lobes of the inflatable member, and an emitter distance along the rotational axis 38 of the inflatable member, formed from the sum of the lobe length (50) and the length of the waist portion (40) allows to controllably modulate a distribution of shockwaves 98, 99, including one or more of an amplitude, frequency, pulse, modulation, profile, direction, focal zone, duration, energy and/or penetration depth, in a vessel anatomy having one or more of a curvature and containing a lesion.

[0084] Summarizing the aforementioned constructional aspects and features of the curvature-compliant balloon angioplasty catheter 10 capable of delivering focalized pressure, in accordance to the present disclosure, when the inflatable member 13 is placed in a vessel anatomy 77 having one or more of a curvature 34, 36 and containing a lesion, the individual geometry 33, 35 of each of the two or more waist portions separating the at least three lobes of the inflatable member, in a pressurized and vessel and lesion-contacting state, distributes one or more radial and straightening force components 66-69 exerted by the inflatable member 13 on an inward and outward oriented portion, e.g. 80, 81 , of the vessel curvature; further characterized in that the inflatable member comprises a combination of one or more of a number n and one or more of the length L 50 of the at least three lobes; wherein the combination of one or more of a number n and one or more of a length L 50 of the at least three lobes controls one or more of a magnitude and distribution of the radial and straightening force components 66, 67, 68, 69 that are directed by the inflatable member on an inward 80 and outward oriented portion 81 of a vessel curvature, and wherein the combination controls an amount of focal pressure, e.g. 66 at 64, that is directed by the inflatable member on a lesion located on the inward oriented portion of the vessel.

[0085] Concerning the magnitude and distribution of the radial and straightening force components directed by the inflatable member on an inward and outward oriented portion 81 of a vessel curvature, the magnitude of the inward and outward oriented radial and straightening force components 66-69 are of substantially equivalent magnitude, but opposite direction, thereby cancelling or minimizing a straightening effect that would otherwise act on the inflatable member, and thereby, stabilizing a position of the inflatable member in the vessel anatomy 77 having one or more of a curvature 34, 36. [0086] Further, the cancellation or minimization of the straightening effect increases the amount of focal pressure, e.g. 66 at 64, that is directed by the inflatable member on a lesion located on the inward oriented portion 80 of the vessel.

[0087] With respect to the foregoing, the combination of the one or more of a number n and one or more of the length L 50 of the at least three lobes decreases the straightening force components 66-69 exerted by the inflatable member on an inward and outward oriented portion of a vessel curvature, when at least the one or more of a number n of the at least three lobes is increased or the one or more of the length L 50 of the at least three lobes is reduced, or both.

[0088] Accordingly, the individual geometry 33, 35 of the two or more waist portions 37, 37’ of the at least three lobes 21-32 acts as a stress relief zone, that

(i) disrupts and thereby reduces an axial, e.g. 75, 76, radial and torsional strain on the vessel anatomy exerted by the inflatable member;

(ii) equally distributes an axial, radial, e.g. 66, 67, 68, 69 and torsional force component across the at least three lobes 21-32 of the inflatable member, and

(iii) positionally stabilizes the at least one lumen 19 along a rotational axis 38 of the inflatable member, thereby centering the position of the at least one lumen in the vessel anatomy, when the inflatable member transitions from the unpressurized state to the pressurized state.

[0089] In one implementation of the above, the individual geometry of the two or more waist portions is varied between the at least three lobes 21 -32 of the inflatable member 13.

[0090] In an additional implementation, one or more of a length L 50 and a waist angle 44 of the at least three lobes 21 -32 is variied. Alternatively, or complementary thereto, one or more of a length L 50 and a waist angle 44 of the at least three lobes 21 -32 is kept constant.

[0091 ] With respect to the foregoing, when the inflatable member 13 of the curvature-compliant balloon angioplasty catheter 10 is placed in a vessel anatomy 77 having one or more of a curvature 34, 36 and containing a lesion, the second depth [46], the second length [39] and the length [43] of the two legs [41 , 42] of the individual geometry [37, 37'] of the two or more waist portions, and the combination of the one or more of a number n and one or more of the length L [50] of the at least three lobes control a magnitude and distribution of radial and straightening force components 66, 67, 68, 69 exerted by the inflatable member on an inward and outward oriented portion of a vessel curvature in a pressurized state.

[0092] As a specific technical feature of the curvature-compliant balloon angioplasty catheter 10, when the inflatable member 13 transitions from the unpressurized state to the pressurized state, a radial stability of the individual geometry 37, 37' of the two or more waist portions is ensured by maintaining a ratio between the first length 40 of the waist portion and the at least one radius R 47 at or below 1 .0, and a ratio between the first depth 45 and the at least one radius R 47 at or above 2.5.

[0093] As an additional characteristic feature of the curvature-compliant balloon angioplasty catheter 10, when the inflatable member 13 transitions from the unpressurized state to the pressurized state, the radial stability of the individual geometry of the two or more waist portions is further ensured by forming the waist angle 44 at or above 50 degrees and below 80 degrees in the unpressurized state.

[0094] In one implementation, the inflatable member 13 is constructed in sets of multiple lobes, e.g. 22-24; 25-29, each set of lobes having a radius of curvature 34, 36 that, in a curved and pressurized state (e.g. 33, 35), corresponds with one of the one or more of a curvature of the vessel anatomy 77 along at least a portion of the length of the inflatable member.

[0095] In an additional implementation, the inflatable member 13 is constructed from one or more sets of multiple lobes, e.g. 22-24; 25-29, each set comprising a number n lobes selected from a Fibonacci number, optionally shifted by an integer value. In an alternate implementation, each length of the one or more sets of multiple lobes is selected from a Fibonacci number, optionally shifted by an integer value. In yet another implementation, one or more of a curvature of the curvature-compliant angioplasty catheter is selected from a Fibonacci number, optionally shifted by an integer value, wherein the inflatable member 13 is constructed from one or more sets of multiple lobes, e.g. 22-24; 25-29, each set comprising an integer number n of lobes. Alternatively, the inflatable member 13 is constructed from one or more sets of multiple lobes, e.g. 22-24; 25-29, each set having a length, that corresponds to a Fibonacci number, optionally shifted by an integer value. In one implementation, the inflatable member 13 is constructed from two or more sets of multiple lobes, e.g. 22-24; 25-29, wherein a ratio of the lengths of each adjacent set of multiple lobes corresponds to an approximation of a golden ratio (1.618), or in other words, each consecutive set of multiple lobes exhibits a length that is approximately 1.618 times longer than a length of a preceding or adjacent set of multiple lobes. By selecting one or more of the constructional principles above, the curvature-compliant balloon angioplasty catheter can exhibit combinations of one or more of a curvature, that resemble natural curvature combinations that are observed in vascular anatomy, for example in bifurcated vessels.

[0096] In the various implementations, the at least one lumen can be provided reinforced, such that a flexibility along the length of the inflatable member is reduced. Alternatively, or complementary thereto, a reinforcement of the at least one lumen enhances a stiffness, such that pushability of the balloon catheter is increased. [0097] In another implementation, the at least one lumen comprises one or more emitters [83-93] for use in intravascular lithotripsy (IVL), each emitter (83-93) positioned in one or more corresponding lobes (22-31 ) of the inflatable member 13, and positioned around an outer surface of the at least one lumen; wherein the one or more emitters (83-93) are positionally stabilized and centered within a vessel anatomy, thereby avoiding direct contact with the inner surface of the inflatable member, and maintaining a constant, safe distance to the vessel anatomy, for controlled delivery of shockwaves while reducing risk of vessel trauma. Further, in this implementation, the individual geometries (33, 35) of the two or more waist portions (37, 37') act as articulating joints, such that positioning of the at least three lobes (21 -32) of the inflatable member (13) aligns an orientation of the one or more emitters (83-93) in a vessel anatomy having one or more of a curvature and containing a lesion. In a related implementation, a concerted activation of one or more pairs of the one or more emitters 87, 88 at one or more of an individual emitter to emitter angle that corresponds with the one or more of the individual lobe to lobe angle (51 , 51’), controls a distribution of shockwaves 98,99, resulting in a pressure interference zone 100, that further modulates one of an amplitude, frequency, pulse, modulation, profile, direction, focal zone, duration, energy and penetration depth, and that is directed on an inward oriented portion of a vessel anatomy having one or more of a curvature and containing a lesion.

[0098] The above-described curvature compliant balloon catheter can be favorably utilized in the treatment of vascular pathologies. A preferred method for treating a vascular pathology with a curvature-compliant balloon catheter [10] capable of delivering focalized pressure comprises: introducing a guide wire 11 through a puncture site into a patient's blood vessel; positioning the guide wire into a vessel anatomy 77 having one or more of a curvature 34, 36 and containing a lesion 80, 81 ; inserting a curvature-compliant balloon catheter 10 over the guidewire 11 into the vessel anatomy 77; positioning an inflatable member 13 of the curvature-compliant balloon catheter 10 into the vessel anatomy 77 having one or more of a curvature 34, 36 and containing a lesion 80, 81 , and transitioning the inflatable member 13 from an unpressurized to a pressurized state, and seamlessly conforming the inflatable member 13 to at least one of the one or more of the curvature 34, 36 of the vessel anatomy without pinching or straightening of the vessel.

The preferred method can further include: delivering an amount of focalized pressure 66 on an inward oriented portion 80 of the lesion, that is substantially equivalent in magnitude to an amount of focalized pressure 67 on an outward oriented portion 81 of the lesion;and alternatively, or supplementarily, delivering shockwaves 98, 99 on an inward oriented portion of a vessel anatomy 77 having one or more of a curvature and containing a lesion.

MANUFACTURING ASPECTS

[0099] Concerning the general construction aspects of the curvature- compliant angioplasty balloon catheter of the present disclosure, the catheter components can be manufactured from biocompatible, polymeric, metallic and ceramic materials. For example, the catheter components, including the inflatable member, can be manufactured from aliphatic, semi-aromatic and aromatic polyamides (PA); polyether ether ketones (PEEK); polyethers; polyimides (PI); linear and nonlinear, branched or non-branched, low molecular weight, medium molecular weight, or high molecular weight; low density, medium density, or high density polyolefins, including polyethylene (PE, LD-PE, HD-PE) and polypropylene (PP), silicones, thermoplastic elastomers, such as polyurethanes (TPEs) and fluoroelastomers, for example FEP or PTFE, polycarbonates (PC), polyesters such as polyethylene terephthalate (PET) and combinations, including blends and copolymers of any of these materials, such as polyether block amides (PEBA), for example.

[00100] Further, the catheter components, including the inflatable member, can be fabricated in a single layer, dual-layer, or in multi-layer configuration. In the instance of dual-layer or multi-layer configurations, certain catheter elements, including for example the shaft or the inflatable member, may utilize the same material for each layer or may utilize different materials for each layer. The multiple layers may be glued, melted or fused together with or without an adhesive, or by employing a co-extrusion or welding process. Alternatively, the multiple layers are not required to be attached, glued or welded together; instead, the multiple layers may be allowed to move independently. Additionally, the elastic modulus, durometer or hardness of the materials selected for each layer or component of the catheter can be varied to beneficially alter the performance aspects of the individual catheter components.

[00101 ] In addition, the chemical functionality and/or physical polarity of the catheter materials can be changed to enhance interfacial adhesion between the differing layers and/or to provide surfaces and/or inner lumen with an increased lubriciousness or changed surface energy when in contact with guide wires, therapeutic and diagnostic liquids, or functional coatings, for example. These chemical and physical treatments or alternations may include for instance chemical additives that can introduce another chemical functionality to the interfacial surface, when added to an exemplary base polymer formulation intended to form one or more layers of the catheter component, for example, including functional groups such as carboxy- and/or amino groups, which can effectively enhance the underlying polarity of the layer and the substrate, thus facilitating enhanced adhesion and mechanical fixation strength in between one or more layered structures of catheter components.

[00102] Other surface modifications, such as coatings and/or plasma techniques can be employed for further changing the chemical and/or the mechanical properties of the materials, layers or components of the angioplasty catheter, wherein the modification of the catheter materials may affect the polarity, surface energy and/or friction coefficient of layers and/or surfaces of the catheter components. Still, other suitable techniques may incorporate additives, adhesives and/or filling agents, which can introduce other beneficial properties to the catheter materials. For example, the components of the catheter may incorporate radiopaque elements embedded within polymeric materials to selectively increase fluoroscopic visibility at desired locations. Alternatively, or supplementary, the components of the catheter may incorporate dyes or pigments at select locations to provide visible color-indications to a treatment provider. Additionally, the shaft may incorporate fluoropolymer-based filler particles/fibers to permanently decrease the frictional coefficient as compared to an untreated base-polymer formulation or activatable, single-use coatings. Furthermore, the catheter components, including the shaft and inflatable member can be provided reinforced and may contain metal or polymer- based strands, fibers, wires, braids, meshes and/or fabrics embedded as layers, sections or regions into the base-material.

[00103] Concerning the constructional characteristics of the inflatable member, the materials utilized in the construction can be selected, configured and formulated such, that the balloon responds in specific ways to the application of external pressure. By way of construction, the elongated tubular member responds to the application of pressure by two distinct growth mechanisms, namely by a change of axial length and radial diameter. This characteristic change of the balloons’ dimensional characteristics during application of pressure is generally referred to as dimensional compliance. Particularly with respect to the target vessel diameter of the treated lesion, the radial compliance, often termed ‘balloon compliance’ as listed on the product label (or recorded as ‘compliance curve’), describes the way of which the diameter of the balloon is going to respond to the application of pressure. The change in axial (longitudinal) dimensions is accordingly referred to as axial compliance. By choice of materials, the dilation elements or balloons can be embodied as compliant balloons, semi-compliant and non-compliant balloons. Compliant medical balloons may expand by 100% or greater upon inflation. Non- compliant dilation balloons expand very little, if at all (< 7%), when pressurized from a nominal diameter to a rated burst pressure. Semi-compliant balloons exhibit a moderate degree of expansion (> 7-12%), when pressurized from its nominal or operating pressure (e.g. the pressure at which the balloon reaches its nominal diameter) to its rated burst pressure (e.g. the undesirable pressure threshold at which the balloon can be subject to rupture or burst). Other than by choice of materials and constructional aspects, the desired compliance characteristics of the inflatable member can favorably be controlled through the manufacturing process.

[00104] The inflatable members of the present disclosure can be manufactured using known manufacturing methods such as balloon blowing, blow molding, thermoforming, dip molding, or any other manufacturing methods suitable for the manufacture of balloons. It shall be understood to one of ordinary skill in the art that conventional balloon manufacturing techniques can be utilized within the manufacture of balloons of the present disclosure. For example, the materials of the balloon may be subjected to mechanical processes before, during or after the manufacture of the balloon. For instance, when a blowing process is utilized for the manufacturing process, the tubular member from which the balloon is to be formed can be stretched before, during or after the blowing process. Yet still, the temperature as well as the inflation pressure or other parameters can be changed during the manufacturing process to affect the properties of the manufactured balloon.

[00105] The foregoing description, for purposes of explanation, refers to specific nomenclature to provide a thorough understanding of the invention. However, it will be apparent to one skilled in the art that the specific details are not required in order to practice the invention. The foregoing descriptions of specific implementations of the present invention are presented for purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Certainly, many modifications and variations are possible in view of the above teachings. The embodiments are shown and described in order to best explain the principles of the invention and practical applications, to thereby enable others skilled in the art to best utilize the invention and various implementations with various modifications as suitable for the particular uses contemplated. It is intended that the scope of the invention be defined by the following claims and their equivalent.

Claims

1. A curvature-compliant balloon catheter [10] capable of delivering focalized pressure, comprising: an elongated member [14] having a proximal end [18], a distal end [12], and at least one lumen [19, 20] extending at least partially through the elongated member; and an inflatable member [13] proximally affixed to the elongated member adjacent to the distal end and in fluid communication with the at least one lumen [20], the inflatable member having at least one radius R [47] and including at least three lobes [21 -32], the at least three lobes separated from each other by two or more waist portions [37, 37']; wherein in an unpressurized state, the at least three lobes [21-32] of the inflatable member [13] are provided each folded and pleated, such that subsequent pressurization of the inflatable member individually unfolds each of the three or more lobes; wherein, when the inflatable member is placed in a vessel anatomy [77] having one or more of a curvature [34, 36] and containing a lesion [80, 81 ], an individual geometry [33, 35] of each of the two or more waist portions separating the at least three lobes of the inflatable member, in a pressurized and vessel and lesioncontacting state, deflects an adjacent pair [e.g. 22-23; 27-28] of two or more of the at least three lobes at one or more of an individual lobe to lobe angle [51 , 51 '], characterized in that a combination of the one or more individual lobe to lobe angles formed between the adjacent pair(s) and a length [50] of the two or more of the at least three lobes enables the inflatable member [13] to form one or more individual bending radii [34, 36] that each seamlessly conform to at least one of the one or more of a curvature of the vessel anatomy without pinching or straightening of the vessel.

2. The balloon catheter according to claim 1 , further comprising: a catheter tip [12]; a kink-protection sleeve [15]; and a manifold [16],

3. The balloon catheter according to claim 2, wherein the manifold [16] further comprises: an inflation port [17]; and a guide-wire port [18],

4. The balloon catheter according to claim 1 , wherein the elongated member [14] further comprises a guide-wire lumen [19] and an inflation lumen [20], the guidewire lumen extending at least partially through the elongated member.

5. The balloon catheter according to claim 4, wherein the guide wire lumen [19] connects the catheter tip [12] to the guide-wire port [18], and wherein the inflation lumen [20] is in fluid communication with the inflatable member [13],

6. The balloon catheter according to any of claims 1 - 5, wherein the elongated member [14] is configured as a dual-lumen shaft and a dual-lumen configuration of the elongated member is selected from a group consisting of a parallel arrangement, a coaxial arrangement and a combination of coaxial and parallel arrangements.

7. The balloon catheter according to claim 1 , wherein an individual geometry of the two or more waist portions [37, 37'] between the at least three lobes [21-32] of the inflatable member [13] includes: an upper base having a first length [40] that is equivalent to a length of the waist portion(s); a lower base having a second length [39] smaller than the first length; a first depth equivalent to a radial distance [45] between the upper base and the lower base; a second depth equivalent to a radial distance [46] between the lower base and a rotation axis [38] of the inflatable member; two legs [41 , 42] formed at a waist angle [44] that is defined by the first and second lengths [39, 40] and radial distances [45, 46] between the lower and upper base, wherein a sum of the first and second depths [45, 46] are equivalent to an outer radius [47] of the inflatable member, and wherein the first depth is equivalent to the depth of the waist portion(s).

8. The balloon catheter according to claims 1 and 7, wherein, in an extended and unfolded state, the waist angle [44] is defined by a ratio between the first depth [45] and a length [43] of the two legs [41 , 42],

9. The balloon catheter according to claims 1 and 7, wherein, in a curved and pressurized state, the individual lobe to lobe angle [51 , 5T] formed between an adjacent pair of two or more of the at least three lobes is defined by a ratio between the second length [39] and a length [43] of the two legs [41 , 42] of the individual geometry [37, 37'] of the two or more waist portions.

10. The balloon catheter according to claims 1 , 7, 8 and 9, wherein the radius of curvature [34, 36] formed between an adjacent pair of two or more of the at least three lobes is defined by the individual lobe to lobe angle [51 , 51 '] and one or more of a length [50] of the at least three lobes.

11. The balloon catheter according to claims 1 and 10, wherein, when the the inflatable member is partitioned into a number n of the at least three lobes, an associated number of the two or more waist portions includes n-1 , and a length of the inflatable member is determined by a sum of n-1 times the first length [40] and n times the lobe length L [50],

12. The balloon catheter according to claims 1 and 7, wherein, when the inflatable member is placed in a vessel anatomy [77] having one or more of a curvature [34, 36] and containing a lesion [80, 81 ], the individual geometry [33, 35] of each of the two or more waist portions separating the at least three lobes of the inflatable member, in a pressurized and vessel and lesion-contacting state, distributes one or more radial and straightening force components [66-69] exerted by the inflatable member [13] on an inward and outward oriented portion [e.g. 80, 81] of the vessel curvature; further characterized in that the inflatable member comprises a combination of one or more of a number n and one or more of the length L [50] of the at least three lobes; wherein the combination of one or more of a number n and one or more of a length L [50] of the at least three lobes controls one or more of a magnitude and distribution of the radial and straightening force components [66, 67, 68, 69] that are directed by the inflatable member on an inward and outward oriented portion [e.g. 80, 81] of a vessel curvature, and wherein the combination controls an amount of focal pressure [e.g. 66 at 64] that is directed by the inflatable member on a lesion located on the inward oriented portion of the vessel.

13. The balloon catheter according to claim 12, wherein the magnitude of the inward and outward oriented radial and straightening force components [66, 67, 68, 69] are of substantially equivalent magnitude, but opposite direction, thereby cancelling or minimizing a straightening effect that would otherwise act on the inflatable member, and thereby, stabilizing a position of the inflatable member in the vessel anatomy [77] having one or more of a curvature [34, 36],

14. The balloon catheter according to claims 12 and 13, wherein the cancellation or minimization of the straightening effect increases the amount of focal pressure [e.g. 66 at 64] that is directed by the inflatable member on a lesion located on the inward oriented portion [80] of the vessel.

15. The balloon catheter according to claims 12, 13 and 14, wherein the combination of the one or more of a number n and one or more of the length L [50] of the at least three lobes decreases the straightening force components [66, 67, 68, 69] exerted by the inflatable member on an inward and outward oriented portion of a vessel curvature, when at least the one or more of a number n of the at least three lobes is increased or the one or more of the length L [50] of the at least three lobes is reduced, or both.

16. The balloon catheter according to claims 1 , 7 and 12, wherein the individual geometry [33, 35] of the two or more waist portions [37, 37'] acts as a stress relief zone, that

(i) disrupts and thereby reduces an axial [e.g. 75, 76], radial and torsional strain on the vessel anatomy exerted by the inflatable member;

(ii) equally distributes an axial, radial [e.g. 66, 67, 68, 69] and torsional force component across the at least three lobes [21-32] of the inflatable member, and

(iii) positionally stabilizes the at least one lumen [19] along a rotational axis [38] (center-line) of the inflatable member, thereby centering the position of the at least one lumen in the vessel anatomy, when the inflatable member transitions from the unpressurized state to the pressurized state.

17. The balloon catheter according to claims 1 , 7 and 12, wherein the individual geometry of the two or more waist portions is varied between the at least three lobes [21 -32] of the inflatable member [13],

18. The balloon catheter according to claims 1 , 7, 12 and 17, wherein one or more of a length L [50] and a waist angle [44] of the at least three lobes [21-32] is variied.

19. The balloon catheter according to claims 1 , 7, 12, 17 and 18, wherein one or more of a length L [50] and a waist angle [44] of the at least three lobes [21-32] is kept constant.

20. The balloon catheter according to claims 1 and 7-15, wherein the second depth [46], the second length [39] and the length [43] of the two legs [41 , 42] of the individual geometry [37, 37'] of the two or more waist portions, and the combination of the one or more of a number n and one or more of the length L [50] of the at least three lobes control a magnitude and distribution of radial and straightening force components [66, 67, 68, 69] exerted by the inflatable member on an inward and outward oriented portion of a vessel curvature in a pressurized state.

21 . The balloon catheter according to any of the proceeding claims, wherein, when the inflatable member transitions from the unpressurized state to the pressurized state, a radial stability of the individual geometry [37, 37'] of the two or more waist portions is ensured by maintaining a ratio between the first length [40] of the waist portion and the at least one radius R [47] at or below 1.0, and a ratio between the first depth [45] and the at least one radius R [47] at or above 2.5.

22. The balloon catheter according to any of the proceeding claims, wherein, when the inflatable member transitions from the unpressurized state to the pressurized state, the radial stability of the individual geometry of the two or more waist portions is further ensured by forming the waist angle [44] at or above 50 degrees and below 80 degrees in the unpressurized state.

23. The balloon catheter according to any of the proceeding claims, wherein the inflatable member is constructed in sets of multiple lobes [e.g. 22-24; 25-29], each set of lobes having a radius of curvature [34, 36] that, in a curved and pressurized state [e.g. 33, 35], corresponds with one of the one or more of a curvature of the vessel anatomy [77] along at least a portion of the length of the inflatable member.

24. The balloon catheter according to any of the proceeding claims, wherein the inflatable member is constructed from one or more sets of multiple lobes [e.g. 22-24; 25-29], each set comprising a number n lobes selected from a Fibonacci number.

25. The balloon catheter according to claim 1 , wherein the at least one lumen is provided reinforced, such that a flexibility along the length of the inflatable member is reduced.

26. The balloon catheter according to claims 1 and 12, wherein a reinforcement of the at least one lumen enhances a stiffness, such that pushability of the balloon catheter is increased.

27. The balloon catheter according to any of the proceeding claims, wherein the at least one lumen comprises one or more emitters [83-93] for use in intravascular lithotripsy (IVL), each emitter [83-93] positioned in one or more corresponding lobes [22-31 ] of the inflatable member 13, and positioned around an outer surface of the at least one lumen.

28. The balloon catheter according to claims 1 , 7, 12, 13 and 27, wherein the one or more emitters [83-92] are positionally stabilized and centered within a vessel anatomy, thereby avoiding direct contact with the inner surface of the inflatable member, and maintaining a constant, safe distance to the vessel anatomy, for controlled delivery of shockwaves while reducing risk of vessel trauma.

29. The balloon catheter according to claims 1 , 7, 12, 27 and 28, wherein the individual geometries [33, 35] of the two or more waist portions [37, 37'] act as articulating joints, such that positioning of the at least three lobes [21 -32] of the inflatable member [13] aligns an orientation of the one or more emitters [83-93] in a vessel anatomy having one or more of a curvature and containing a lesion.

30. The balloon catheter according to claims 1 , 7, 12, 27, 28 and 29, wherein a concerted activation of one or more pairs of the one or more emitters 87, 88 at one or more of an individual emitter to emitter angle that corresponds with the one or more of the individual lobe to lobe angle (51 , 5T), controls a distribution of shockwaves 98,99, resulting in a pressure interference zone 100, that further modulates one of an amplitude, frequency, pulse, modulation, profile, direction, focal zone, duration, energy and penetration depth, and that is directed on an inward oriented portion of a vessel anatomy having one or more of a curvature and containing a lesion.

31 . A method for treating a vascular pathology with a curvature-compliant balloon catheter [10] capable of delivering focalized pressure, according to any of claims 1 - 30, the method comprising: introducing a guide wire [11 ] through a puncture site into a patient's blood vessel; positioning the guide wire into a vessel anatomy [77] having one or more of a curvature [34, 36] and containing a lesion [80, 81 ]; inserting a curvature-compliant balloon catheter [10] over the guidewire [11] into the vessel anatomy [77]; positioning an inflatable member [13] of the curvature-compliant balloon catheter [10] into the vessel anatomy [77] having one or more of a curvature [34, 36] and containing a lesion [80, 81], and transitioning the inflatable member [13] from an unpressurized to a pressurized state, and seamlessly conforming the inflatable member [13] to at least one of the one or more of the curvature [34, 36] of the vessel anatomy without pinching or straightening of the vessel.

32. The method of claim 31 , further including delivering an amount of focalized pressure [66] on an inward oriented portion [80] of the lesion, that is substantially equivalent in magnitude to an amount of focalized pressure [67] on an outward oriented portion [81] of the lesion.

33. The method of claim 31 , further including delivering shockwaves [98, 99] on an inward oriented portion of a vessel anatomy [77] having one or more of a curvature and containing a lesion.