Crossing balloon catheter

Abstract

In accordance with the present disclosure there is provided a crossing balloon catheter and method for using such crossing balloon catheter, that is individually configured to seamlessly conform to at least one of one or more of a curvature of an occluded vessel anatomy containing a calcified lesion, that allows anchoring to, and crossing of the calcified lesion without exchanging the balloon catheter. The crossing balloon catheter comprises an elongated member having a proximal end, a distal end, and two or more lumen extending at least partially through the elongated member, an inflatable member proximally affixed to the elongated member adjacent to the distal end and in fluid communication with at least one of the two or more lumen, a transition member, that extends distally from the distal end of the elongated member and in communication with at least one of the two or more lumen, a crossing tip proximally affixed to the transition member and providing access to at least one of the two or more 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.

Description

CROSSING BALLOON CATHETERTECHNICAL 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 crossing balloon catheter comprising an elongated member having a proximal end, a distal end, and two or more lumen extending at least partially through the elongated member, an inflatable member proximally affixed to the elongated member adjacent to the distal end and in fluid communication with at least one of the two or more lumen, a transition member, that extends distally from the distal end of the elongated member and in communication with at least one of the two or more lumen, a crossing tip proximally affixed to the transition member and providing access to at least one of the two or more 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 an occluded vessel anatomy containing a calcified lesion, while stabilizing the crossing tip extending distal from the inflatable member, such that the crossing tip enables anchoring to, and crossing of the calcified lesion, and thereby, creating a working channel that enables placing the inflatable member in the calcified lesion without exchanging the balloon catheter, wherein one or more of the at least three lobes of the inflatable member enable a consecutive dilation of the working channel to one or more of a vessel diameter.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 guide-wire 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 vesselwall. 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 pseudo-aneurysm. 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.

[0005] 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 unduepinching, 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. Further, when the vessel anatomy is curved, inflation of a conventional balloon easily causes pinching or straightening of the vessel. 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.

[0006] 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. Chronic plaque build-up can eventually reach a state, where blood flow becomes entirely insufficient to support the perfusion of local tissues, leading to a condition known as "chronic total occlusion" (CTO). Percutaneous guide-wire negotiation by intraluminal intervention can be attempted to cross and recanalize chronic occlusions. However, the application of standard guide-wires and catheter devices to enable percutaneous intraluminal recanalization of CTOs have shown only moderate procedural success. Failure inguide-wire negotiations can lead to failure in CTO recanalization. With regard to the foregoing description, one particularly challenging problem arises in the treatment of chronic total occlusions and / or calcified 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 calcified lesion, upon inflation, straightening forces are generated, that pull the conventional balloon away from the inward-oriented portion of the calcified 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.

[0007] 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 straighteningforce generation cannot be readily mitigated. In addition, guide-wire negotiation and intraluminal intervention, including the penetration of chronic total occlusions and / or calcified lesions becomes increasingly difficult, as there is no means to effectively support and anchor a guide- or crossing wire in a curved vessel anatomy. As a result, adjunct medical devices, such as dilators and support catheters have to be deployed, possibly requiring the exchange of multiple devices, including the balloon catheter during the procedure. 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. In addition, all of these devices lack the capability to effectively support and anchor a guide- or crossing wire in such curved vessel anatomies. Because significant push force can be needed to cross a chronic total occlusion and / or calcified lesion with a guide- or crossing wire, these wires may easily deflect, deform, or worse, penetrate healthy adjacent tissues. As such, when chronic total occlusions and / or calcified lesions in a curved vessel anatomy can neither be easily navigated nor penetrated, no working channel can be effectively generated that would otherwise enable placing a balloon catheter for subsequent treatment.

[0008] 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 betraumatic 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.

[0009] 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 ability to effectively support and / or anchor a guide- or crossing wire in a curved vessel anatomy b) lack of ability to effectively navigate or penetrate a chronic total occlusion and / or calcified lesion in a curved vessel anatomy due to lack of anchoring and support.c) 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; d) lack of positional stability and anchoring capability, due to lack of conformal contact, particularly pronounced for comparably short-sized balloons; e) lack of positional stability, due to tendency to straighten, particularly pronounced for comparably long-sized balloons; f) lack of adequate axial and / or radial stability and / or compliance, due to single-membered balloon construction, resulting in length and / or diameter mismatch between target vessel and / or lesion; g) 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; h) 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; i) 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 j) lack of control over achieving efficient modulation, modification, dilation, 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 calcified lesion, such that navigation, penetration, opening of the chronic total occlusion and / or calcified 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.

[0010] 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 crossing 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. Further, it is desirable 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 calcified lesion.

[0011] Finally, it is an object of the present invention to provide an improved crossing balloon catheter, and method for using such crossing balloon catheter, that seamlessly conforms to at least one of one or more of a curvature of an occluded vessel anatomy containing a calcified lesion, and that stabilizes the crossing tip extending distal from the inflatable member, such that the crossing tip enables anchoring to, and crossing of a chronic total occlusion and / or calcified lesion, and thereby, creating a working channel that enables placing the inflatable member in the calcified lesion without exchanging the balloon catheter, wherein one or more of the at least three lobes of the inflatable member enable a consecutive dilation of the working channel to one or more of a vessel diameter

[0012] 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

[0013] Segmented, notched, multi-lobed and / or multiple, individual balloons are generally known in the art. For example, 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. However, while adequate for curved vessel anatomies, the aforementioned balloon design lacks anchoring and crossing capability for chronic total occlusions and / or calcified lesions. Catheter systems with anchoring and crossing capability are generally known in the art. For example, European patent EP 3322470 B1 , also by the present inventors, teaches a multifunctionalcatheter system for treatment of chronic total occlusions, comprising among others, a support catheter, a mechanically actuatable dilator, a PTA catheter and a lockgrip handle. In a similar field of endeavor, international patent application WO 2023 / 017006 is directed to a crossing catheter system for crossing a chronic total occlusion comprising, among others, a support catheter, a locking handle, and a dilator having a distal end. However, both aforementioned catheter systems are not specifically designed for the treatment of curved vessel anatomies, and have to rely on adjunct medical devices in the form of at least an additional dilator, and an additional support catheter to perform lesion crossing. Other exemplary crossing catheters known in the art include, for example, those of European patent EP 2937108 B1 , that teaches a catheter capable of passing a hard lesion, that includes a tubular, metallic tip. The tip is slotted to more easily bend in order to avoid getting caught on a lesion. Similarly, Chinese patent application CN 110339456A is directed to a balloon dilation catheter and a balloon for performing percutaneous nephrolithotomy, wherein the balloon tip includes a metal, in order to easily locate the catheter under ultrasound guidance. Further, US patent application US 2009 / 0216185 A1 discloses a balloon catheter including a distal ring portion configured to enhance a durability of the distal end of the catheter.

[0014] 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 a crossing balloon 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 an occluded vessel anatomy containing a calcified lesion, while stabilizing a crossing tip extending distal from the inflatable member, such that the crossing tip enables anchoring to, and crossing of the calcified lesion, and thereby, creating a working channel that enables placing the inflatable member in the calcified lesion without exchanging the balloon catheter, wherein one or more of the at least three lobes of the inflatable member enable a consecutive dilation of the working channel to one or more of a vessel diameter. In addition, none of the prior art teaches allowing the control of one or more of a magnitude and distribution of radial and straighteningforce components that are directed by the inflatable member on an inward and outward oriented portion of a occluded vessel curvature containing a lesion. Further, none of the problems associated with the application of short- or longsized balloons are systemically resolved in the prior art.

[0015] The present inventors now found that the above problems can be solved by a crossing balloon catheter, and methods for using such crossing balloon catheter, comprising an elongated member having a proximal end, a distal end, and two or more lumen extending at least partially through the elongated member, an inflatable member proximally affixed to the elongated member adjacent to the distal end and in fluid communication with at least one of the two or more lumen, a transition member that extends distally from the distal end of the elongated member and in communication with at least one of the two or more lumen, a crossing tip proximally affixed to the transition member and providing access to at least one of the two or more 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.SUMMARY

[0016] In accordance with the present invention there is provided a crossing balloon catheter, comprising an elongated member having a proximal end, a distal end, and two or more lumen extending at least partially through the elongated member, an inflatable member proximally affixed to the elongated member adjacent to the distal end and in fluid communication with at least one of the two or more lumen, a transition member that extends distally from the distal end of the elongated member and in communication with at least one of the two or more lumen, a crossing tip proximally affixed to the transition member and providing access to at least one of the two or more 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 oneof one or more of a curvature of an occluded vessel anatomy containing a calcified lesion, while positionally stabilizing the crossing tip extending distal from the inflatable member, such that the crossing tip enables anchoring to, and crossing of the calcified lesion, and thereby, creating a working channel that enables placing the inflatable member in the calcified lesion without exchanging the balloon catheter, wherein one or more of the at least three lobes of the inflatable member enable a consecutive dilation of the working channel to one or more of a vessel diameter. Further, as a result of the specific construction, at least one of the at least two lumen of the elongated member 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

[0017] FIG.1 illustrates a perspective view of a first implementation of a crossing balloon catheter, wherein a transition member is fixedly attached to an elongated member, in accordance with the present disclosure.

[0018] FIG. 2 illustrates a perspective view of an inflatable member of a crossing balloon catheter, having at least one radius R and including at least three lobes, in accordance with the present disclosure.

[0019] FIG. 3 illustrates a perspective view of an inflatable member of a crossing balloon catheter, constructed in sets of multiple lobes, each set of lobes corresponding to one or more of a length and one or more of a diameter, in accordance with the present disclosure.

[0020] FIG. 4 illustrates a perspective, distal view of a second implementation of a crossing balloon catheter, wherein a transition member is slideably and rotatably positioned in one of the at least two or more lumen of an elongated member, in accordance with the present disclosure.

[0021] FIG. 5 illustrates a perspective, proximal view of a second implementation of a crossing balloon catheter illustrating additional elements of a transition member, in accordance with the present disclosure.

[0022] FIG. 6 illustrates a cross-lateral view of a dual-lumen configured inflatable member of a crossing balloon catheter of the present disclosure for use in over-the-wire (OTW) configuration.

[0023] FIG. 7 illustrates a cross-sectional view of an inflatable member of the crossing balloon catheter in accordance with the present disclosure.

[0024] FIG.8 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.

[0025] FIG. 9 and FIGS. 10A-10C illustrate cross-sectional views of various implementations of a crossing tip of a crossing balloon catheter, in accordance with the present disclosure.

[0026] FIGS. 11A - 11 F illustrate a series of phases of performing an angioplasty treatment in a vessel anatomy having one or more of a curvature and containing a calcified lesion, using a second implementation of a crossing balloon catheter in accordance with the present disclosure.

[0027] FIGS. 12A - 12F illustrate a series of phases of performing an angioplasty treatment in a vessel anatomy having one or more of a curvature and containing a calcified lesion, using a first implementation of a crossing balloon catheter in accordance with the present disclosure.

[0028] FIG. 13 illustrates a perspective view of a third implementation of a crossing 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 calcified lesion, in accordance with the present disclosure.

[0029] FIG. 14 illustrates a perspective view of a fourth implementation of a crossing 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 calcified lesion, in accordance with the present disclosure.

[0030] FIG. 15 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.

[0031] FIG. 16 depicts a cross-sectional view of a fifth implementation of a crossing 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.

[0032] FIG. 17 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.

[0033] FIG. 18 depicts a cross-sectional view of one or more of a lobe length of an inflatable member of a crossing 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.

[0034] FIG. 19 depicts a cross-sectional view of one or more of an emitter position of an inflatable member of a crossing 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 DESCRIPTIONCROSSING BALLOON CATHETER

[0035] The various components and features of the crossing balloon catheter of the present invention are next described with reference to FIGS. 1-3. FIG.1 illustrates a perspective view of a first implementation of a crossing balloon catheter, wherein a transition member is fixedly attached to an elongated member, in accordance with the present disclosure. In FIG. 1 , the crossing balloon catheter 10 includes, from left to right, a crossing tip 20, a transition member 13, an inflatable member or balloon 14, an elongated member or catheter shaft 15, a kink protection sleeve 16, and a manifold 17, that in turn comprises an inflation port 18 and a guide-wire port 19. The crossing tip 20 is proximally affixed to the transition member 13, that in turn, extends distally from a distal end 12 of the elongated member 15. The elongated member 15 extends from the distal end 12 to the guide-wire port 19 or proximal end of the catheter. In the implementation shown in FIG.1 , the elongated member 15 includes at least two or more lumen, which extend at least partially through the elongated member: (i) a first lumen intended as an inflation lumen (26, not shown) connected to the inflation port 18; and (ii) a second lumen intended as a guide-wire lumen (25, not shown) connected to the guide-wire port 19. In turn, the inflatable member 14 is proximally affixed to the elongated member adjacent to the distal end and in fluid communication with at least one (26) of the two or more lumen.

[0036] The crossing balloon catheter 10 is arranged in an over-the-wire (OTW) configuration, wherein a guide-wire 11 extends from an opening at the crossing tip 20 of the catheter, through the transition member 13 and the elongated member 15, to an opening at the guide-wire port 19 at the proximal end of the catheter 10. In this implementation, the transition member is fixedly attached to the elongated member, and the guide-wire lumen 25 seamlessly extends as a composite lumen between the crossing tip 20, the transition member 13, the elongated member 15, and the guide-wire port 19. In alternate arrangements, thecrossing catheter 10 may be provided in a rapid exchange configuration, wherein one or more guide-wire lumen (25, 25', not shown) extend at least partially through the elongated member 15, and exit either at a first guide-wire exit port 19, or a second, additional guide-wire exit port (53, not shown). Such second guide-wire exit port can be provided as a lateral opening on the elongated member, proximal to the inflatable member 14, or as a separate guide-wire exit port proximal to manifold 17, in each case connecting to the one or more of the guide-wire lumen. Further, the elongated member of the angioplasty catheter 10 that is at least 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, thereby enabling a selective inflation of different sets of multiple lobes via the one (26) or more inflation lumen (27, not shown). The inflatable member 14 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.

[0037] When the inflatable member is placed in an occluded vessel anatomy having one or more of a curvature and containing a calcified lesion, the crossing tip extending distal from the inflatable member is stabilized such, that the crossing tip enables an anchoring to, and crossing of the calcified lesion, and thereby, creates a working channel that enables placing the inflatable member in the calcified lesion without exchanging the balloon catheter. Subsequently, the inflation of one or more of the at least three lobes of the inflatable member enable a consecutive dilation of the working channel to one or more of a vessel diameter. Further, the inventors have surprisingly found, that an individual geometry 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 14 on an inward and outward oriented portion of the occluded vessel curvature. When the inflatable member is placed in an occluded vessel anatomy having one or more of a curvature and containing a calcified lesion, one or more of a magnitude and distribution of radial and straightening forcecomponents that can be directed by the inflatable member on an inward and outward oriented portion of a vessel curvature have experimentally been determined in a 180° vessel curvature as follows:Crossing Catheter POBAForce Distribution [%]inward outward inward outwardProximal Position: 95.7 104.3 73.9 126.1Middle Position: 98.9 101.1 64.3 135.7Distal Position: 104.3 95.7 77.3 122.7Table 1 : Relative distribution of inward- and outward-oriented radial and straightening force components of an inflatable member of the crossing catheter of the present disclosure versus a conventional balloon catheter (POBA).In the above, proximal, middle and distal position refer to a measurement position located on a proximal end, a middle position, and a distal end of the respective inflatable member. As evident from these force measurements, for the crossing catheter of the present disclosure, at each proximal, middle or distal lobe position, the relative amount or magnitude of radial and straightening force components facing towards an inward and outwards oriented portion of the vessel curvature is substantially the same, or similar (96-104%, left side of table) versus 96-104%, right side of table). 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. In comparison, force measurements for a conventional balloon catheter (POBA), obtained at each balloon position show the relative amount or magnitude of radial and straightening force components facing towards an outward oriented portion of the vessel curvature is overly increased (122-135% right side of table), while the relative amount or magnitude of radial and straightening force components facing towards an inward oriented portion of the vessel curvature issubstantially decreased (64-77%, left side of table), with an apparent minimum at the middle position. Thus, as a particular noteworthy result, an amount or magnitude of radial forces present at a middle position, that could otherwise be directed by the conventional balloon on an inward oriented portion of a vessel curvature and onto a lesion, are fully minimized, while the 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 an occluded 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.

[0038] FIG. 2 illustrates a perspective view of an inflatable member of a crossing balloon catheter, having at least one radius R and including at least three lobes, in accordance with the present disclosure. In FIG. 2, the inflatable member 14 of the crossing balloon catheter 10 is proximally affixed to the elongated member 15 adjacent to the distal end (12) and in fluid communication with at least one of the two or more lumen (inflation lumen 26, 27, not shown). The inflatable member exhibits at least one radius R and includes at least three lobes 31-33, wherein the at least three lobes are separated from each other by two or more waist portions (39, 39', not shown). Further, the transition member 13 extends distally from the distal end (12) of the elongated member, and is in communication with at least one of the two or more lumen (guide-wire lumen 25, 25', not shown). In turn, the crossing tip 20 is proximally affixed to the transition member and provides access to at least one of the two or more lumen.

[0039] FIG. 3 illustrates a perspective view of an inflatable member of a crossing balloon catheter, constructed in sets of multiple lobes, each set of lobes corresponding to one or more of a length and one or more of a diameter, in accordance with the present disclosure. In FIG. 3, the inflatable member 14 of the crossing balloon catheter 10 includes a series of at least three lobes 31-37,proximally affixed to the elongated member adjacent to the distal end and in fluid communication with at least one of the two or more lumen (inflation lumen 26, 27, not shown). In comparison to FIG. 2, the series of at least three lobes 31-37, is further divided into several distinct groups of adjacent pairs of lobes selected from lobes 31-33 and 35-37, wherein these sets of multiple lobes are further separated by one or more of a spacing element 41 present on the elongated member 15. Each set of lobes 31-33 and 35-37 corresponds to one or more of a length and one or more of a diameter. In addition, a length (85) of the spacing element 41 exceeds a length (71) of at least one of the two or more waist portions (39, 39'), and a diameter of the spacing element 41 is smaller than an outer radius (77) of the inflatable member. Accordingly, each of the sets of multiple lobes each comprise a portion of the length of the inflatable member, and a sum of the length portions define a total length of the inflatable member. Further, each individual set of lobes exhibits an individual radius of curvature that, in a curved and pressurized state, corresponds with one of the one or more of a curvature of the vessel anatomy along at least a portion of a length of the inflatable member. In the first implementation of the crossing balloon catheter 10, the transition member 13 includes a fixed length 84, that spans from a distal end 12 of the elongated member to a proximal end 22 of the crossing tip, as shown.

[0040] Generally, in an unpressurized state, the at least three lobes 31-37 of the inflatable member 14 are provided each folded and pleated, such that subsequent pressurization of the inflatable member individually unfolds each of the at least three lobes. As a characteristic feature, in a pressurized and vessel and lesion-contacting state, an individual geometry of the waist portion deflects an adjacent pair (e.g. 31-32; 35-37) 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 14 are capable of forming a first intrinsic bending radius or radius of curvature, and a second intrinsic bending radius or radius of curvature, Thereby, the inflatable member 14 is enabled to form one or more individual bending radii that each seamlessly conform to at least oneof the one or more of a curvature of the vessel anatomy without pinching or straightening of the vessel.

[0041] FIG. 4 illustrates a perspective, distal view of a second implementation of a crossing balloon catheter, wherein a transition member is slideably and rotatably positioned in one of the at least two or more lumen of an elongated member, in accordance with the present disclosure. In FIG. 4, a distal portion of the crossing balloon catheter 10 includes, from left to right, a crossing tip comprising a distal portion or end 21 and a proximal portion or end 22, a transition member 13, an inflatable member or balloon 14, and an elongated member or catheter shaft 15. The proximal portion 22 of the crossing tip is proximally affixed to the transition member 13, that in turn, extends distally from a distal end 12 of the elongated member 15. However, in comparison to FIGS. 1-3, in the second implementation of the crossing balloon catheter 10, the transition member 13 is slideably and rotatably positioned in a lumen of the elongated member 15 (guidewire lumen 25, not shown), and extends beyond a proximal end of the elongated member, which will be further described in reference to FIG.5. In the second implementation of the crossing balloon catheter 10, the transition member 13 includes an adjustable length 84, that extends from a distal end 12 of the elongated member to a proximal end 22 of the crossing tip, as shown. In FIG. 4, the inflatable member 14 of the crossing balloon catheter 10 is further partitioned into two distinct sets of multiple lobes, that comprise a first, distal set consisting of 4 lobes (31 -34), and a second, proximal set consisting of 4 lobes (35-38), wherein, in a pressurized state, in the first set, each lobe exhibits a first diameter, that is lower than a second diameter exhibited by the second set of lobes. In this implementation, the first set of multiple lobes is intended for pre-dilation of a working channel or a calcified lesion, whereas the second set of multiple lobes is intended for dilation of the calcified lesion. In other implementations, either the first or second set of multiple lobes can be configured for anchoring, whereas the remaining set of lobes is configured for pre-dilation, dilation or both, and vice versa. Alternatively or complementary thereto, in the first set of lobes, each lobe may exhibit a firstdiameter, that is higher than a second diameter exhibited by the second set of lobes, or a diameter across the two or more sets of multiple lobes is varied.

[0042] FIG. 5 illustrates a perspective, proximal view of a second implementation of a crossing balloon catheter illustrating additional elements of a transition member, in accordance with the present disclosure. In FIG. 5, a proximal portion 50 of the crossing balloon catheter 10 includes, from left to right, an elongated member 15, a kink protection sleeve 16, and a manifold 17, that in turn comprises an inflation port 18 and a hemostatic valve 61 , operationally coupled to the guide-wire exit port (19). In comparison to the first implementation of the crossing balloon catheter 10, the transition member 13 further includes a shaft portion 51 , that extends proximally beyond the first guide-wire port (19), a manifold 52, a guide-wire lumen (25', not shown), and a second guide-wire exit port 53. In this implementation, the manifold 52 is used as a handle, that facilitates extension, retraction or rotation of the transition member 13, while the hemostatic valve serves to lock the relative position and / or an orientation of the transition member along a length and a rotation axis of the crossing catheter, such that a position of the crossing tip is reliably adjusted or maintained. The crossing catheter 10 is arranged in an over-the-wire configuration, wherein a guide-wire 11 extends from an opening at the distal portion or end 21 of the crossing tip of the catheter (FIG. 4), through the guide-wire lumen (25', not shown) of the transition member 13 and the elongated member 15, to an opening at the second guide-wire exit port 53. The hemostatic valve 61 comprises a proximal port or female luer, which is used to introduce and hemostatically arrest in position a shaft portion 51 of the transition member 13 slideably, and optionally rotatably, disposed within the guide-wire lumen 25 of the elongated member 15. Further, the hemostatic valve 61 as shown, contains an additional side port, from which a side port tubing 62 extends. The side port tubing is coupled to a three-way stopcock valve 63 via a luer coupling. The three-way stopcock valve is used for performing flushing and aspiration functionalities, and may comprise a male luer coupling, a first port, a valve lever, and a second port. For enhanced mechanical fixation of insertable components, the hemostatic valve can optionally include a torquer, a clip, or locking aid, asapplicable. The components referenced above can be provided as part of a kit, together with a crossing balloon catheter 10 and / or provided separately. Alternatively, such components can be provided fully integrated with a crossing balloon catheter of the present disclosure and equivalents.LUMEN CONFIGURATIONS

[0043] FIG. 6 illustrates a cross-lateral view of a dual-lumen configured inflatable member of a crossing balloon catheter of the present disclosure for use in over-the-wire (OTW) configuration. In FIG. 6, the inflatable member 14 of the crossing balloon catheter 10 is shown in an over-the-wire configuration, wherein the elongated member 15 comprises a dual-lumen consisting of a guide-wire lumen 25 and an inflation lumen 26. The guide-wire lumen 25 is disposed along the entire length of the catheter 10, and extends from an opening at the crossing tip 20 through the transition member 15, the inflatable member 14 and the elongated member 15 to an opening at the guide-wire port 19 at the proximal end of the crossing catheter 10. This particular guide-wire lumen configuration enables over- the-wire (OTW) operation of the catheter, meaning that the crossing balloon catheter can be slideably mounted onto a guide-wire 11 and translated in either direction along an entire indwelling portion of the guide-wire lumen during insertion of a portion of the catheter shaft into a patient's blood vessel. The OTW configuration therefore may utilize up to the complete usable length of the catheter, which spans from a distal end of the kink-protection sleeve 16 to the crossing tip 20 of the catheter. Further, the first implementation of the crossing balloon catheter of the present disclosure can alternatively be used in a rapid-exchange (RX) configuration, wherein one of the one or more guide-wire lumen 25, 25' extend at least partially through the elongated member 15, and exit at a second, additional guide-wire exit port. Such second guide-wire exit port can be provided as a lateral opening on the elongated member 15, proximal to the inflatable member 14. Similarly, in the second implementation of the crossing balloon catheter 10, a guide-wire 11 can optionally be passed through guide-wire lumen 25, and through guide-wire exit port 19, in parallel to guide-wire lumen 25' of the transition member13, rather than through the guide-wire exit port 53 proximal to manifold 17. Thereby, such guide-wire lumen configurations of the first and second implementation of the crossing balloon catheter 19 enable rapid-exchange operation of the catheter 10, meaning that the crossing balloon catheter can be slideably mounted onto a guide-wire and translated in either direction such that the guidewire passes along a portion of the guide-wire lumen 25, 25' during insertion of a portion of the shaft into a patient's blood vessel. The RX configuration therefore may utilize a shorter usable length of the catheter, which spans from crossing tip of the crossing balloon catheter to at least (i) a lateral opening on the elongated member 15 proximal to the inflatable member; or (ii) one of the first (19) of the one or more guide-wire exit ports (19, 53). As a result, the RX configuration enables using guide-wires of considerably shorter length in comparison to the OTW configuration. In RX operation, the guide-wire 11 is partially exposed alongside the catheter shaft, when located within an indwelling portion, whereas in OTW operation, the guide-wire 11 is fully shielded by the catheter shaft, when located within the indwelling portion. For enabling increased pushability and kink resistance of the crossing balloon catheter, in each of the first and second implementation of the crossing balloon catheter, a OTW lumen configuration is generally preferred over an RX lumen configuration.

[0044] In FIG. 6, the inflation lumen 26 extends from the inflation port 18 adjacent to the proximal end of the catheter 10 to an opening 24 connected to an interior space or lumen of a first lobe 38 of the inflatable member 14. The interior lumen of the first lobe 38 of the balloon 13 in turn is shown fluidly connected to one or more adjacent lobes via one or more waist portions 39. Thereby, therapeutic and diagnostic liquids as well as gases, including contrast-agent and saline formulations, drug-formulations, air, and other such liquids and / or gases, may be transferred, under positive pressure inside the inflation lumen or at the inflation port, respectively, from the inflation port 18 through the inflation lumen 26 to one or more lobes 31-38 of the inflatable member 14, resulting in an inflation of the inflatable member. The various liquids and / or gases are transferred, under negative pressure inside the inflation lumen 26 or at the inflation port, respectively,from the inflated balloon 14 back through the inflation lumen and out through the inflation port 18, deflating the inflatable member. "Positive pressure" and "negative pressure" designate pressures which are larger than, or smaller than, respectively, the pressure around balloon 14.INFLATABLE MEMBER CONFIGURATION

[0045] FIG. 7 illustrates a cross-sectional view of an inflatable member of the crossing balloon catheter in accordance with the present disclosure. In FIG. 7, the inflatable member 14 of the crossing balloon catheter 10 includes a series of at least three lobes 31-38, proximally affixed to the elongated member 15 adjacent to the distal end and in fluid communication with at least one of the two or more lumen 26, 27. Similar to the depiction in FIG. 3, the series of the at least three lobes 31-38, is further divided into several distinct groups of adjacent pairs of lobes selected from lobes 31-34 and 35-38, wherein these sets of multiple lobes are further separated by one or more of a spacing element 41 present on the elongated member 15. In addition, the individual lobes of each set of multiple lobes are separated from each other by two or more waist portions 39, 39’, each having a waist gap length 71. For enabling angiographic visibility, radiopaque materials or markers 55-56 and 57-58 are attached to the elongated member 15 at shaft locations, that indicate a proximal and distal end of each set of multiple lobes 31-34 and 35-38, respectively. In alternate or complementary implementations, for demarcating a division between each set of multiple lobes, each spacing element 41 may also include or comprise of radiopaque materials or markers positioned along a length 85 of the spacing element 41. FIG. 7 provides an implementation of a coaxial triple-lumen configuration that is similar to the coaxial dual-lumen configuration shown in FIG. 6. In FIG. 7, however, the triple lumen configuration comprises a central guide-wire lumen 25, a first inflation lumen 26, and a second inflation lumen 27, wherein the inflation and guide-wire lumen are separate lumens that are not in fluid communication with each other, and coaxially arranged around the guide-wire lumen 25. An additional insert beneath lobe 34 shows a vertical, dashed line at a position ‘A’ along a length of the elongated member 15, and acorresponding vertical cross-section ‘A-A’ that further illustrates the coaxial triplelumen configuration. As evidenced from the horizontal and vertical cross-sections, the first inflation lumen 26 extends from an inflation port 18 located at the manifold (17, not shown) into an opening 29 located distal to the waist portion 39' that is part of the set of multiple lobes 35-38 of the inflatable member 14. Similarly, a second inflation lumen 26 can extend from a second inflation port located at the manifold (17, not shown) into an opening 28 located proximal to the waist portion 39 that is part of the set of multiple lobes 31 -34 of the inflatable member 14.

[0046] In the above provided example, the spacing element 41 that separates the sets of multiple lobes 31-34 and 35-38 is shown sealingly adhered to an external surface of the elongated member 14. Further, the distal and proximal ends of the sets of multiple lobes 31-34, 35-38 of the inflatable member 14 are each affixed to a portion of the elongate member 15, while the waist portions 39, 39' are not adhered to an external surface of the elongated member. Thereby, two separate fluid-tight spaces or interior lumen exist between an inner surface of each set of multiple lobes of the inflatable member and an external surface of the elongated member, each fluid-tight space individually addressable through the separate inflation lumen 26 and 27. As a result, subsequent pressurization of the inflatable member 14 via the separate inflation lumen 26 and 27 individually unfolds each set of multiple lobes 31-34, 35-38. In alternate implementations, the spacing element 41 can be provided not attached to the external surface of the elongated member 15, such that the sets of multiple lobes 31-34 and 35-38 of the inflatable member are unfolded and inflated at substantially the same time. In addition, the two or more waist portions 39, 39' of the inflatable member 14 of the crossing balloon catheter 10 can be one or more of: attached, partially attached and not attached to the elongated member 15, to enable the select or individual inflation of each of the three or more lobes, or the sets of multiple lobes, as applicable. Thereby, the triple lumen configuration enables the inflation / deflation of the at least three lobes 31-38, or the sets of multiple lobes, at substantially the same, similar or different stages of the treatment procedure. In the above, when one set of multiple lobes is intended for anchoring / positioning inside the vessel,and another set intended for pre-dilation / dilation, the anchoring / positioning set can comprise lobes that require smaller amounts of a first pressure for inflation as compared to a second pressure required for inflation of the set intended for pre- dilation / dilation, exemplarily such that P(2)Diiation > P(1 positioning. Because each set of multiple lobes corresponds to one or more of a length and one or more of a diameter, when the crossing balloon catheter is placed in an occluded vessel anatomy having one or more of a curvature and containing a calcified lesion, the individual inflation of the at least three lobes of the inflatable member allows for a consecutive dilation of a working channel to one or more of a vessel diameter, without requiring exchanging the balloon catheter to one of a different length or diameter.

[0047] In additional implementations, individual coaxial lumens can be adhered, partially adhered or non-adhered to each other along a length of the lumen. Such means may serve to reinforce or stabilize a position of one or more of the coaxial lumens with respect to the elongated member. For example, the coaxial lumen configuration can include stabilization welds, preferably along a proximal lumen portion of the elongated member. In similar implementations, at least one (25) of the two or more lumen (25-27) of the elongated member can be reinforced, such that a kink resistance along the length of the inflatable member 14 is reduced. In an alternate or complementary implementation to the above, a reinforcement of at least one (25) of the two or more lumen (25-27) of the elongated member enhances a stiffness, such that pushability of the balloon catheter is increased. With respect to the foregoing, the transition member 13 may further comprise a reinforcement selected from a group consisting of one or more of an axial, angled, helical, interwoven, stacked, reticulated, or multi-layered braid, thread, fiber, a hypotube and any combinations formed therefrom. In addition, the various openings, structures and / or ports present at the crossing tip 20, the transition member 13, the elongated member, and the manifold 17, 52 used for exchanging of guide-wires, and for transferring of therapeutic and diagnostic liquids, and / or gases can be structurally reinforced.

[0048] Summarizing the aforementioned constructional aspects and features of the crossing balloon catheter in accordance to the present disclosure, the crossing balloon catheter 10 comprises: an elongated member 15 having a proximal end, a distal end 12, and two or more lumen (25-27) extending at least partially through the elongated member; an inflatable member 14 proximally affixed to the elongated member adjacent to the distal end and in fluid communication with at least one (26, 27) of the two or more lumen; a transition member 13, that extends distally from the distal end of the elongated member and in communication with at least one of the two or more lumen (25); a crossing tip 20 proximally affixed to the transition member and providing access to at least one of the two or more lumen (25, 25'); the inflatable member having at least one radius R (77) and including at least three lobes 31-38, the at least three lobes separated from each other by two or more waist portions (39, 39’); wherein in an unpressurized state, the at least three lobes of the inflatable member 14 are provided each folded and pleated, such that subsequent pressurization of the inflatable member individually unfolds each of the three or more lobes; characterized in that, when the inflatable member is placed in an occluded vessel anatomy (90) having one or more of a curvature and containing a calcified lesion (95), the crossing tip extending distal from the inflatable member is stabilized such, that the crossing tip enables an anchoring to, and crossing of the calcified lesion, and thereby, creates a working channel that enables placing the inflatable member in the calcified lesion without exchanging the balloon catheter, wherein one or more of the at least three lobes of the inflatable member enable a consecutive dilation of the working channel to one or more of a vessel diameter.

[0049] In addition to the above, the crossing balloon catheter 10 further comprises:a kink-protection sleeve 16, and a manifold 17, wherein the manifold further comprises: one or more inflation port 18, and a first guide-wire exit port 19.

[0050] With respect to the foregoing, the elongated member 15 of the crossing balloon catheter 10 further comprises: one or more inflation lumen (26, 27), and one or more guide-wire lumen (25, 25').

[0051] In a first implementation of the crossing balloon catheter 10, the transition member 13 is fixedly attached to the elongated member 15.

[0052] In a second, alternate implementation of the crossing balloon catheter 10, the transition member 13 is slideably and rotatably positioned in one (25) of the at least two or more lumen (25-27) of the elongated member 15. In this implementation, the transition member 13 further comprises: a shaft portion 51 , that extends proximally beyond the first guide-wire port 19; a manifold 52; a guide-wire lumen (25'), and a second guide-wire exit port 53.

[0053] In both implementations of the crossing balloon catheter 10, as described above, at least one of the one or more guidewire lumen (25, 25') extends from a distal end of the crossing tip 20 through the elongated member to one of the first 19 and second guide-wire exit port 53, and the one or more inflation lumen (26, 27) are in fluid communication with the inflatable member 14.

[0054] In an additional implementation, at least one (25) of the two or more lumen (25-27) of the elongated member is reinforced, such that a kink resistance along the length of the inflatable member 14 is reduced.

[0055] In an alternate or complementary implementation to the above, a reinforcement of at least one (25) of the two or more lumen (25-27) of the elongated member enhances a stiffness, such that pushability of the balloon catheter is increased.

[0056] With respect to the foregoing, the transition member 13 may further comprise a reinforcement selected from a group consisting of one or more of an axial, angled, helical, interwoven, stacked, reticulated, or multi-layered braid, thread, fiber, a hypotube and any combinations formed therefrom.WAIST PORTION GEOMETRY

[0057] FIG.8 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. 8, an inflatable member 14 is formed from at least three lobes 31 / 35, 32 / 36 (33-34, 37-38 not depicted), spaced apart by two or more waist portion(s) 39 (39', not shown). The waist portion 39 includes an upper base having a first length 71 and a lower base having a second length 70, and two legs 72, 73, each having a (shoulder) length 74. Further, the upper base of the waist portion 39 of the inflatable member 14 exhibits a first, radial distance or depth 75 relative to the lower base of the waist portion 39, and the lower base of the inflatable member 14 exhibits a second, radial distance or depth 76 relative to a rotational axis 80 (indicated as a dash-dotted line), of the inflatable member 14. In turn, in an extended and unpressurized state, a waist angle 78 is defined by the first and second lengths 71 , 70 and radial distances 75, 76 between the lower and upper base. Consecutively, the sum of the first and second distances, or depths 75, 76 of the waist portion 39 yield an outer radius 77 (R) of the inflatable member 14. The individual geometries of the two or more adjacent waist portions 39, 39' are spaced apart from each other by an individuallobe length of the at least three lobes. Further, in an extended and unpressurized state, each waist portion 39, 39’ exhibits a waist angle 78 that is formed between the legs 72-73. When the inflatable member is placed in a vessel anatomy having one or more of a curvature, in a curved and pressurized state, the individual geometries of each of the two or more waist portions 39, 39’ separating the at least three lobes 31-38 of the inflatable member 14 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. During the above-described folding operation, the waist angle 78 is reduced such, that the shoulders of the adjacent pairs of the two or more of the at least three lobes of the inflatable member 14 are in direct proximity to each other. As a result, in the curved and pressurized state, the adjacent pairs of the two or more of the at least three lobes (selected from the sets of multiple lobes 31-34, 35- 38) of the inflatable member 14 form individual lobe-to-lobe angles. 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 70 and a length 74 of the two legs 72, 73 of the individual geometry of the two or more waist portions 39, 39’. Summarily, in an extended and unfolded state, the waist angle 78 is defined by a ratio between the first depth 75 and a length 74 of the two legs 72, 73. Further, in a curved and pressurized state, an individual lobe to lobe angle formed between an adjacent pair of two or more of the at least three lobes is defined by a ratio between the second length 70 and a length 74 of the two legs 72, 73 of the individual geometry of the two or more waist portions 39, 39'. In addition, the radius of curvature that can be formed between an adjacent pair of two or more of the at least three lobes is defined by the individual lobe to lobe angle and one or more of a length of the at least three lobes.

[0058] As a result, a combination of the one or more individual lobe-to-lobe angles formed between the adjacent pair(s) and a length of the two or more of the at least three lobes enables the inflatable member 14 to form one or more individual bending radii, that each seamlessly conform to at least one of the one or more of a curvature of the occluded vessel anatomy without pinching(compression) or straightening of the vessel. 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 occluded vessel anatomy without pinching or straightening of the vessel. As a result of this specific construction, when the inflatable member is placed in an occluded vessel anatomy having one or more of a curvature and containing a calcified lesion, the at least two lumen of the elongated member, such as the one or more guide-wire lumen 25, 25' and the one or more inflation lumen 26, 27 are positionally stabilized along a rotational axis (center-line) of the inflatable member. Further, an outer diameter of the inflatable member is stabilized against radial changes across the lobes 31-38. Finally, a length of the inflatable member is stabilized against an axial (length) change across the entire length of the inflatable member. Because the inflatable member: (i) stabilizes a position of at least two lumen; (ii) minimizes radial changes across the lobes and (iii); minimizes axial length changes across the entire length of the inflatable member, and (iv) seamlessly conforms to at least one of one or more of a curvature of an occluded vessel anatomy, the crossing tip, that extends distally from the inflatable member becomes centered in the occluded vessel anatomy, and thereby, is positionally stabilized such, that the crossing tip enables an anchoring to, and crossing of the calcified lesion. As a result, the crossing of the calcified lesion creates a working channel that enables placing the inflatable member in the calcified lesion without exchanging the balloon catheter, wherein one or more of the at least three lobes of the inflatable member enable a consecutive dilation of the working channel to one or more of a vessel diameter. In comparison, if a conventional angioplasty balloon were to be used in place of the inflatable member of the present disclosure, a lack of lumen stabilization, and presence of straightening forces, that arise as a result of the described axial and radial changes would easily pull a crossing tip off-center from an axis of the vessel lumen, thereby not only risking puncture, rupture or dissection of healthy adjacent tissues, but also resulting in severe trauma to the patient.

[0059] The inventors have surprisingly found, that in order to maintain a shape stability of the individual geometries of the two or more waist portions of the at least three lobes of the inflatable member in a pressurized state, it becomes vital to maintain certain dimensional requirements. As a specific technical feature of the crossing balloon angioplasty catheter 10, when the inflatable member 14 transitions from an unpressurized state to a pressurized state, a radial stability of the individual geometry of the two or more waist portions 39, 39' is ensured by maintaining a ratio between the first length 71 of the waist portion and the at least one radius R 77 at or below 1.0, and a ratio between the first depth 75 and the at least one radius R 77 at or above 2.5. In addition to the above, when the inflatable member 14 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 78 at or above 50 degrees and below 80 degrees in an unpressurized state.

[0060] Summarizing the aforementioned constructional aspects and features of the crossing balloon catheter 10 in accordance to the present disclosure, an individual geometry of the two or more waist portions 39, 39' between the at least three lobes 31-38 of the inflatable member 14 includes: an upper base having a first length 71 that is equivalent to a length of the waist portion(s); a lower base having a second length 70 smaller than the first length; a first depth equivalent to a radial distance 75 between the upper base and the lower base; a second depth equivalent to a radial distance 76 between the lower base and a rotation axis 80 of the inflatable member; two legs 72, 73 formed at a waist angle 78 that is defined by the first and second lengths 71 , 70 and radial distances 75, 76 between the lower and upper base,wherein a sum of the first and second depths 75, 76 are equivalent to an outer radius 77 of the inflatable member, and wherein the first depth is equivalent to the depth of the waist portion(s).

[0061] With respect to the foregoing, when the inflatable member transitions from the unpressurized state to the pressurized state, a radial stability of the individual geometry of the two or more waist portions is ensured by maintaining a ratio between the first length 71 of the waist portion and the at least one radius R 77 at or below 1.0, and a ratio between the first depth 75 and the at least one radius R 77 at or above 2.5.

[0062] In addition to the above, 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 78 at or above 50 degrees and below 80 degrees in the unpressurized state.

[0063] Further, an individual geometry of the two or more waist portions 39, 39' between the at least three lobes 31-38 of the inflatable member 14 positionally stabilizes the at least two lumen 25-27 of the elongated member along a rotational axis 38 of the inflatable member 14, such that the crossing tip that extends distal from the inflatable member via the transition member is positionally centered (and / or stabilized) in the occluded vessel anatomy having one or more of a curvature and containing a calcified lesion.

[0064] In one implementation of the above, an individual geometry of the two or more waist portions is varied between the at least three lobes 31-38 of the inflatable member 14.

[0065] In an alternate or supplemental implementation, an individual geometry of the two or more waist portions is kept constant between the at least three lobes 31-38 of the inflatable member 14.

[0066] Further to the above, in one implementation, one or more of a length and a diameter of the at least three lobes of the inflatable member 14 is varied.

[0067] Alternatively, or complementary thereto, one or more of a length and a diameter of the at least three lobes of the inflatable member 14 is kept constant.

[0068] In addition, when the inflatable member is constructed in sets of multiple lobes, each set of lobes corresponds to one or more of a length and one or more of a diameter, and each set of lobes exhibits a radius of curvature that, in a curved and pressurized state, corresponds with one of the one or more of a curvature of the vessel anatomy (90) along at least a portion of a length of the inflatable member.

[0069] With respect to the foregoing, each of the sets of multiple lobes each comprise a portion of the length of the inflatable member, and a sum of the length portions define a total length of the inflatable member.

[0070] In addition, the sets of multiple lobes can be further separated by one or more of a spacing element 41 having a length, that exceeds the first length 71 of at least one of the two or more waist portions 39, 39', and a diameter smaller than the outer radius 77 of the inflatable member.

[0071] In one implementation to the above, the sets of multiple lobes may comprise a first, distal set consisting of 4 lobes (31-34), and a second, proximal set consisting of 4 lobes (35-38), wherein, in a pressurized state, in the first set, each lobe exhibits a first diameter, that is lower than a second diameter exhibited by the second set of lobes.CROSSING TIP

[0072] FIG. 9 and FIGS. 10A-10C illustrate cross-sectional views of various implementations of a crossing tip of a crossing balloon catheter, in accordance with the present disclosure. The crossing tip will be next described in reference to FIG. 9. In FIG. 9, a first implementation of a crossing tip 20 of the crossing ballooncatheter 10 is formed as a composite body that includes a distal end 21 and a proximal end 22, and surface structures 23. In turn, the proximal end 22 of the crossing tip is formed over a portion of the distal end 21 , and proximally affixes to the transition member 13 through the surface structures 23. The proximal end 22 of the crossing tip is seamlessly tapered to the taper of the distal end 21 and includes a lumen 25, 25' that dimensionally corresponds to the lumen 25, 25' of the transition member, to avoid edge formation at the transition between the crossing tip and the transition member. Thus, the inner lumen of the crossing tip 25, 25' seamlessly extends along a length from between the distal end 21 to the proximal end 22 of the crossing tip, and through a distal end of the transition member 13 and the elongated member 15, to one of the first or second guidewire port 19, 53. Further, the opening at the distal end 21 of the crossing tip tapers outwards to ease insertion or positioning over guide-wires. In FIG. 9, the lumen 25, 25' of the crossing tip 20 is shown positioned in the center of a rotational axis 80 of the transition member 13. Further, as shown, a length (84) of the transition member 13 exhibits at least one diameter smaller than a diameter of one of the crossing tip and the inflatable member, exemplarily observed at the largest circumference of the proximal end 22, such that during crossing of a calcified lesion, displaced material of the calcified lesion is readily received in the interstitial space formed between the lesion and an external surface of the transition member and the inflatable member, thereby reducing an amount of friction and axial tension generated between the calcified lesion, and one or more of the crossing tip, the transition member and the inflatable member. Thereby, an amount of friction and axial tension that can be reduced is defined by a length 84 and a diameter of the transition member. In addition, or vice versa, the crossing tip exhibits at least one maximum diameter that is larger than a diameter of one of the elongated member, the inflatable member, and the transition member. Additional implementations of the crossing tip are next described in reference to FIGS. 10A-10C.

[0073] In FIG. 10A, a second implementation of a crossing tip 20 includes a distal end 21 formed as a conical tip, that progressively tapers distally. A proximal portion 22' of the crossing tip cylindrically extends from the distal end 21 , having anouter diameter that is smaller than one of the distal end of the crossing tip and an outer diameter of the transition member 13. As a result, an edge 82 is formed at the transition between the proximal portion 22' and the distal end 21 of the crossing tip. The outer diameter of the edge 82 is commensurate to an outer diameter of the transition member 13. Thereby, edge formation between an outer diameter of the crossing tip and an outer diameter of the transition member is avoided. Further, the outer diameter of the proximal portion 22' is commensurate with an inner diameter of the transition member. Thus, the crossing tip is dimensioned such, that it can be seamlessly inserted into an inner diameter of the transition member. Circular openings or surface structures 23 that laterally extend through the proximal portion 22' of the crossing tip 20 allow the tip to be fixedly embedded or bonded to an inner surface at a distal end of the transition member 13. Further, the distal end 21 of the crossing tip comprises a recessed length portion between the edge 82 and the tapering end of the tip that acts a friction relief zone 81 . The friction relief zone 81 exhibits at least one diameter smaller than the maximum diameter of crossing tip, that, during crossing of the calcified lesion, reduces an amount of friction generated between the calcified lesion and the crossing tip, thereby enabling an enhanced crossing capability of the tip.

[0074] In FIG. 10B, a third implementation of a crossing tip 20 includes a distal end 21 formed as a conical tip, that progressively tapers distally. The construction is similar to the implementation shown in FIG. 10A, but does not include friction relief zone 81 .

[0075] In FIG. 10C, a fourth implementation of a crossing tip 20 includes a distal end 21 formed as a conical tip, that evenly tapers distally. The construction is similar to the implementation shown in FIG. 10A-B, but without friction relief zone 81.

[0076] Based on the foregoing, in the implementations described in FIG. 9 and 10A, at least one of the transition member and the crossing tip can exhibit a coefficient of friction that is lower than at least one of the elongated member and the inflatable member. In order to achieve a substantially equivalent or betterreduction of friction, in the implementations of FIG. 9 and FIGS. 10A-10C, the coefficient of friction of at least one of the transition member and the crossing tip can be further lowered by incorporation of one or more low-friction material selected from a group consisting of one or more of a fluoroelastomer, a polyether ether ketone, a polyethylene, a polyamide, a polydimethylsiloxane, a radiopaque material including metals, a diamond-like coating, a sintered ceramic and any combinations formed therefrom.

[0077] In the above implementations of the crossing tip, a distal length portion of the transition member can exhibit a larger inner diameter than the remainder of the transition member, so as to more easily accommodate the proximal end 21 of the crossing tip, and to avoid edge formation between a lumen of the crossing tip and the transition member. In alternate implementations, an inner diameter of the proximal end 22 of the crossing tip 20 can be larger than an outer diameter of the transition member, so as to allow the insertion of the crossing tip over a distal portion of the transition member. Further, in these implementations of the crossing tip, the elastic modulus or hardness of the crossing tip 20 (that includes the distal end 21) can exceed a range of elastic moduli or hardness present in the vasculature thereby enabling crossing capability of the tip. In addition, the distal end 21 and the proximal end 22 of the crossing tip 20 can be formed from the same or different materials that in turn exhibit the same or differing degrees of elastic modulus, durometer or hardness. In addition, an elastic modulus or hardness of the distal end of the tip can be higher than an elastic modulus or hardness of the proximal end, and an elastic modulus or hardness of the proximal end can exceed an elastic modulus or hardness of one of the transition member, the elongated member and the inflatable member. In alternative implementations, the elastic modulus, durometer or hardness of one of the crossing tip, the transition member, the elongated member and the inflatable member can all be the same or individually different, or be adjusted such that the elastic modulus, durometer or hardness of one of the crossing tip, the transition member, the elongated member and the inflatable member gradually increases or decreases in a proximal direction. Concerning the attachment means of the crossing tip and the transition member,the attachment means are not limited as to the exact shape or disposition of the surface structures present on each of the components, for example, the surface structures can be provided in the form of regular, random, and / or interlocking surface structures that may be attached, glued, melted or fused together with or without an adhesive, or by employing a co-extrusion or welding process, and equivalents.

[0078] For enabling enhanced crossing capability and angiographic visibility of the crossing tip, at least a distal portion 21 of the crossing tip is formed from a radiopaque material, including but not limited to metals and their alloys, such as gold, tungsten, tantalum, platinum, iridium, titanium, stainless steels; polymers and polymer blends compounded with radiopaque metallic fillers, such as tungsten and / or inorganic and ceramic compounds, such as barium sulfate, bismuth oxide and zirconium oxide. As an additional result, the radiopaque material enhances a shape stability and a crossing capability of the crossing tip. In alternate implementations, radiopaque markers can be attached to the circumference along the length of the crossing tip at locations that demarcate one or both of the distal and proximal ends of the crossing tip. The radiopaque materials or markers generally indicate a position of the crossing tip relative to the crossing balloon catheter, and additionally, can be used to indicate positions relative to one or more of an introducer, short or long sheath, guiding- or support catheter or equivalents, within a patient’s vasculature. In addition, the radiopaque materials or markers of the crossing tip can be used to indicate relative alignment positions to other radiopaque materials or markers present on inflatable member 14, the spacing element 41 , the elongated member 15, or other adjunct medical devices, as applicable. Further still, in the first and second implementation of the crossing balloon catheter 10, such position indications may serve to indicate a relative distance defined between a proximal end of the crossing tip 20 and the distal end 12 of the crossing balloon catheter, and thus may serve to indicate procedurally relevant positions of the crossing tip, relative to one of the distal end of the inflatable member, and / or a calcified lesion, such as an accessing position, an anchoring position, a crossing position, a pre-dilation position, a dilation position,and multiple treatment positions, including resting and movement positions and equivalents. In these implementations, the radiopaque materials or markers, positioning elements or surface structures of the crossing tip can be formed in bulk, or as annular bands, tubes or rings that preferably comprise radiopaque materials. However, concerning the individual form, composition and arrangement of these radiopaque materials, markers, positioning elements or surface structures, the latter are not limited as to the exact shape or disposition of materials, for example, the elements can be formed from elastomeric or radiopaque, as well as colored or pigmented materials, or from a combination of elastomeric, radiopaque, colored or pigmented materials, that in turn are adhered, bonded, fused, welded, joined, or glued to, molded, embossed or embedded into, or layered onto or into a surface or volume of the crossing tip, respectively.

[0079] Summarizing the aforementioned constructional aspects and features of the crossing balloon catheter 10 in accordance to the present disclosure,

[0080] a length 84 of the transition member 13 of the crossing balloon catheter 10 exhibits at least one diameter smaller than a diameter of one of the crossing tip and the inflatable member, that, during crossing of the calcified lesion, allows displaced material of the calcified lesion to be readily received, thereby reducing an amount of friction and axial tension generated between the calcified lesion, and one or more of the crossing tip, the transition member and the inflatable member.

[0081] Further to the above, the crossing tip of the crossing balloon catheter 10 exhibits at least one maximum diameter that is larger than a diameter of one of the elongated member, the inflatable member, and the transition member.

[0082] In one implementation, the crossing tip of the crossing balloon catheter 10 exhibits a friction relief zone 81 comprising a recessed length portion having at least one diameter smaller than the maximum diameter of crossing tip, that, during crossing of the calcified lesion, reduces an amount of friction generatedbetween the calcified lesion and the crossing tip, thereby enabling an enhanced crossing capability of the tip.

[0083] In the various implementations of the crossing balloon catheter 10, the crossing tip is formed from a radiopaque material, wherein the radiopaque material of the crossing tip of the crossing balloon catheter 10 enhances a shape stability and a crossing capability of the crossing tip.

[0084] In addition to the foregoing, at least one of the transition member and the crossing tip exhibits a coefficient of friction that is lower than at least one of the elongated member and the inflatable member.

[0085] Alternatively, or complementary thereto, the coefficient of friction of at least one of the transition member and the crossing tip is further lowered by incorporation of one or more low-friction material selected from a group consisting of one or more of a fluoroelastomer, a polyether ether ketone, a polyethylene, a polyamide, a polydimethylsiloxane, a radiopaque material including metals, a diamond-like coating, a sintered ceramic and any combinations formed therefrom.PROCEDURAL ASPECTS

[0086] FIGS. 11A - 11 F illustrate a series of phases of performing an angioplasty treatment in a vessel anatomy having one or more of a curvature and containing a calcified lesion, using a second implementation of a crossing balloon catheter in accordance with the present disclosure. In FIGS. 11A-11 F, an anastomotic vessel anatomy 90 is shown. A main vessel 91 , such as the brachial artery, is connected to a side branch vessel, such as the cephalic vein 92, at a bifurcation 93. The curved side branch vessel 92 contains a chronic total occlusion or calcified lesion 95, with an inward oriented portion, and an outward oriented portion.

[0087] In FIG. 11 A, as the first step in the series of phases, a guide-wire 11 is introduced through a puncture site into a patient's blood vessel, positioned in the side branch vessel 92, and navigated across the calcified lesion 95. When the lesion cannot be effectively navigated or crossed by guide-wire 11 , the guide-wire remains proximal to the calcified lesion 95 during this step.

[0088] In FIG. 11 B, as the next step in the series of phases, a crossing balloon catheter 10 is inserted over the predisposed guide-wire 11 into the vessel anatomy 90. A distal end 21 of the crossing tip is positioned across the side branch vessel and proximal to the calcified lesion, while the inflatable member remains in an unpressurized and folded state.

[0089] In FIG. 11 C, as the next step in the series of phases, the inflatable member 14 of the crossing balloon catheter 10 is transitioned from an unpressurized to a pressurized state, thus anchoring the series of at least three lobes 31-33 of the inflatable member against a vessel wall 94, and thereby, effectively anchoring the crossing tip to the calcified lesion. If the previous navigation of the calcified lesion, as described in FIG. 11 A, remained unsuccessful, the anchored crossing tip provides structural support, so that the guide-wire 11 or a supplemental crossing wire can effectively navigate / penetrate the calcified lesion, as shown.

[0090] In FIG. 11 D, as the next step in the series of phases, the crossing tip of the crossing balloon catheter is slideably extended over the guidewire across the calcified lesion, while maintaining the inflatable member in a pressurized state, and thereby, creating a working channel inside the calcified lesion.

[0091] In FIG. 11 E, as the next step in the series of phases, the inflatable member 14 of the crossing balloon catheter 10 is transitioned from a pressurized to an unpressurized state, and a first set of lobes 31-33 of the inflatable member is positioned across the working channel inside the calcified lesion.

[0092] In FIG. 11 F, as the closing step in the series of phases, the inflatable member 14 of the crossing balloon catheter 10 is transitioned from an unpressurized to a pressurized state, inflating the series of at least three lobes 31- 33 of the inflatable member against the calcified lesion, and thereby dilating the working channel and the lesion to one or more of a diameter corresponding to the diameter of the inflatable member in a pressurized state.

[0093] FIGS. 12A - 12F illustrate a series of phases of performing an angioplasty treatment in a vessel anatomy having one or more of a curvature and containing a calcified lesion, using a first implementation of a crossing balloon catheter in accordance with the present disclosure.

[0094] In FIG. 12A, as the first step in the series of phases, a guide-wire 11 is introduced through a puncture site into a patient's blood vessels and positioned in the side branch vessel 92.

[0095] In FIG. 12B, as the next step in the series of phases, the guide-wire 11 is navigated across the calcified lesion 95. When the lesion cannot be effectively navigated or crossed by guide-wire 11 , the guide-wire remains proximal to the calcified lesion 95 during this step, as shown previously in FIG. 11 A.

[0096] In FIG. 12C, as the next step in the series of phases, a crossing balloon catheter 10 is inserted over the predisposed guide-wire 11 into the vessel anatomy 90. A distal end 21 of the crossing tip of the crossing balloon catheter is extended over the guidewire, and across the calcified lesion, thereby creating a working channel inside the calcified lesion. A first set of lobes 31-33 of the inflatable member 14 is then positioned across the working channel inside the calcified lesion. If the previous guide-wire navigation of the calcified lesion, as described in FIG. 12B, remained unsuccessful, the anchored crossing tip can provide additional structural support, so that the guide-wire 11 or a supplemental crossing wire can effectively navigate / penetrate the calcified lesion during this step, as previously shown in FIGS. 11 B-C.

[0097] In FIG. 12D, as the next step in the series of phases, the first set of lobes 31-33 of the inflatable member 14 is transitioned from an unpressurized to a pressurized state, thus selectively inflating the series of at least three lobes 31-33 of the inflatable member against the calcified lesion, and thereby pre-dilating the working channel and the lesion to a first diameter corresponding to one or more of a diameter of a first set of lobes of the inflatable member in a pressurized state.

[0098] In FIG. 12E, as the next step in the series of phases, the inflatable member 14 of the crossing balloon catheter 10 is transitioned from a pressurized to an unpressurized state, and a second set of lobes 35-37 of the inflatable member is positioned across the working channel inside the calcified lesion.

[0099] In FIG. 12F, as the closing step in the series of phases, the second set of lobes 35-37 of the crossing balloon catheter 10 is transitioned from an unpressurized to a pressurized state, thus selectively inflating the series of at least three lobes 35-37 of the inflatable member against the calcified lesion, and thereby dilating the working channel and the lesion to a second diameter corresponding to one or more of a diameter of a second set of lobes 35-37 of the inflatable member in a pressurized state.

[0100] Because the crossing balloon catheter of the present disclosure seamlessly adapts to the curvature of the occluded vessel anatomy during the above-described procedures, the generation of straightening forces is minimized, and the inflatable member is effectively stabilized (‘anchored’) in position. Thereby, application of the crossing balloon catheter in occluded vessel anatomies having one or more of a curvature and containing a calcified lesion results in much reduced vessel trauma, without pinching or straightening of the vessel, while stabilizing the crossing tip extending distal from the inflatable member, such that the crossing tip enables anchoring to, and crossing of the calcified lesion, and thereby, creating a working channel that enables placing the inflatable member in the calcified lesion without exchanging the balloon catheter, wherein one or more of the at least three lobes of the inflatable member enable a consecutive dilation of the working channel to one or more of a vessel diameter.

[0101] The above-described crossing balloon catheter can be favorably utilized in the treatment of vascular pathologies. A preferred method for treating a vascular pathology with a crossing balloon catheter 10 comprises: introducing a guide wire 11 through a puncture site into a patient's blood vessel; positioning the guide wire into an occluded vessel anatomy 90 having one or more of a curvature and containing a calcified lesion 95; inserting a crossing balloon catheter 10 over the guidewire 11 into the vessel anatomy 90; anchoring a crossing tip 20-22 of the crossing balloon catheter 10 to the calcified lesion; crossing the calcified lesion with the guidewire; extending the crossing tip of the crossing balloon catheter over the guidewire across the calcified lesion, thereby creating a working channel inside the calcified lesion; positioning a first set of lobes 31-33 of the inflatable member 14 of the crossing balloon catheter 10 across the working channel inside the calcified lesion; transitioning the inflatable member 14 from an unpressurized to a pressurized state, and pre-dilating the first set of lobes 31-33 of the inflatable member 14 to a first diameter; transitioning the inflatable member 14 from a pressurized to a unpressurized state; positioning a second set of lobes 35-37 of the inflatable member 14 of the crossing balloon catheter 10 across the working channel inside the calcified lesion, andtransitioning the inflatable member 14 from an unpressurized to a pressurized state, and dilating the second set of lobes 35-37 of the inflatable member 14 to a second diameter.

[0102] In an alternate implementation of the above described method, the step of: extending the crossing tip of the crossing balloon catheter over the guidewire across the calcified lesion, thereby creating a working channel inside the calcified lesion can be replaced with: slideably, and optionally rotatably, extending the transition member 13 through one (25) of the at least two or more lumen (25-27) of the elongated member 15, while maintaining a position of the balloon catheter, thereby extending the crossing tip of the crossing balloon catheter over the guidewire across the calcified lesion, and creating a working channel inside the calcified lesion.CROSSING BALLOON ANGIOPLASTY CATHETERS FOR INTRAVASCULAR LITHOTRIPSY (IVL)

[0103] In the following, specific benefits of applying crossing balloon angioplasty catheters of the present invention in the field of intravascular lithotripsy (IVL) are next described in reference to FIGS. 13-19.

[0104] FIG. 13 illustrates a perspective view of a third implementation of a crossing balloon catheter with a lumen configuration suitable for intravascular lithotripsy in a vessel anatomy having one or more of a curvature and containing a calcified lesion, in accordance with the present disclosure. In comparison to FIG. 12E, lobes 31-37 are displayed in cross-section to reveal a configuration of the two or more lumen 25 (-27) of the crossing balloon catheter. In Fig. 13, the configuration of the lumen 25 comprises one or more distal radiopaque marker 55positioned within the most distal lobe 31 , and / or a proximal radiopaque marker 58, positioned in the most proximal lobe 37, the set of radiopaque markers 55, 58 positioned around an outer surface of the lumen 25 and thereby demarcating a length of the inflatable member (14). Further, the configuration of the lumen 25 comprises one emitter 96, suitable for use in intravascular lithotripsy (IVL), the emitter 96 positioned in a corresponding lobe 32. Emitter 96 exhibits radiopaque properties, and is positioned along a length of the lumen 25, in-between the set of the one or more radiopaque markers 55, 58. The inflatable member has been positioned in the vessel anatomy 90 by angiographic verification using said radiopaque markers 55, 58, and the lobe 32 comprising the emitter 96 has been exactly positioned in the calcified lesion 95. Upon activation of the emitter 96, the lumen configuration is thereby able to exert a very localized, temporary pressure gradient on an inward and outward oriented portion of the calcified lesion 95, without affecting the healthy portions of the surrounding vessel anatomy 90. Such configuration of the lumen 25 comprising one emitter can be intended for the efficient treatment of focal calcified lesions. As such, when the lumen 25 of the crossing catheter 10 of the current disclosure is further configured for intravascular lithotripsy, the crossing catheter allows for performing additional lithotripsy treatments of severely calcified lesions 95, for example, in reference to the previously described method of treating a vascular pathology with a crossing balloon catheter, during or after pre-dilating the first set of lobes 31-33 of the inflatable member 14 to a first diameter; and before, during or after dilating the second set of lobes 35-37 of the inflatable member 14 to a second diameter. In comparison to conventional intravascular lithotripsy catheters, that contain multiple emitters, the reduction of emitters further simplifies the construction, saving cost and reducing risk of vessel trauma, particularly when treating focal calcified lesions.

[0105] FIG. 14 illustrates a perspective view of a fourth implementation of a crossing balloon catheter with an alternative lumen configuration suitable for intravascular lithotripsy in a vessel anatomy having one or more of a curvature and containing a calcified lesion, in accordance with the present disclosure. Similar toFIG. 13, in FIG. 14 the configuration of the lumen 25 comprises one or more distal radiopaque marker 55 positioned within the most distal lobe 31 , and / or a proximal radiopaque marker 58, positioned in the most proximal lobe 37, the set of radiopaque markers 55, 58 positioned around an outer surface of the lumen 25 and thereby demarcating a length of the inflatable member (14). In comparison to FIG. 13, however, the configuration of the lumen 25 comprises multiple emitters 96-99 suitable for use in intravascular lithotripsy (IVL), each emitter 96-99 positioned in a corresponding lobe 32,33; 35,36. Such configuration of the lumen 25 comprising multiple emitters can be intended for the efficient treatment of long calcified lesions.

[0106] In the preceding implementations, the set of the one or more emitters 96-99 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 these implementations, when the inflatable member (14) is placed in a vessel anatomy 90 having one or more of a curvature and containing a calcified lesion, the activation of one or more of the one or more emitters 96-99 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) 31-37 of the inflatable member (14). 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 implementations, because the individual geometries of the two or more waist portions (39, 39') positionally stabilize the at least one lumen 25 along a rotational axis (center-line, 80) of the inflatable member 14, 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 25 is thereby centered within the vessel anatomy. As a result, the position of the radiopaque markers, and particularly, the position of the emitters 96-99 is positionally stabilized and centeredwithin 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 25 being centered, the one or more emitters 96-99 are also perpendicularly oriented towards the surrounding vessel anatomy 90. These additional benefits over current state of the art catheters will next be described in reference to FIG. 15.

[0107] FIG. 15 illustrates a perspective view of a contemporary angioplasty balloon catheter with a lumen configuration suitable for intravascular lithotripsy in a vessel anatomy having one or more of a curvature and containing a calcified lesion, not in accordance with the present disclosure. A contemporary angioplasty balloon catheter is shown inserted over a predisposed guidewire 11 and into the vessel anatomy 90. Similar to FIG. 13-14, a configuration of the lumen 125 of a contemporary angioplasty balloon catheter comprises a pair of distal and proximal radiopaque markers 155, 158 positioned within the inflatable member 114, around an outer surface of the lumen 25 and thereby demarcating a length of the inflatable member. Further, the lumen 125 comprises a set of emitters 100-105, suitable for use in intravascular lithotripsy (IVL), each emitter 100-105 positioned around an outer surface of the lumen 125, and situated along the length of the lumen 125, inbetween the pair of radiopaque markers 155, 158. However, in comparison to the crossing catheters shown in FIGs. 13-14, the single-membered balloon 114 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 125 situated in the inflatable member is not positionally stable, shifting away from the center-line, tensioning against the anatomic curvature of the vessel anatomy 90, and against an inner surface of the inflatable member 114 during pressurization, as shown.

[0108] FIG. 16 depicts a cross-sectional view of a fifth implementation of a crossing balloon catheter with a lumen configuration suitable for intravascular lithotripsy in a vessel anatomy having one or more of a curvature, in accordancewith the present disclosure. The fifth implementation is very similar to the fourth implementation, differing only in the number of emitters and the location of the extension member (41 ). Similar to the shown implementation of Fig. 14, in Fig. 16, the individual geometries of the waist portions of the lobes 31-36 positionally stabilize the at least one lumen 25 along a rotational axis 80 (center-line) of the inflatable member 14, when the inflatable member is placed in a curved (e.g. side branch) vessel 92 and transitioned from an unpressurized state to a pressurized state. Thereby, the at least one lumen 25 is centered within the vessel anatomy, and the one or more emitters 96-99, 106 present on the at least one lumen 25 maintain an equivalent, safe distance at any position along the rotational axis 80 from the surrounding vessel wall (94) of the curved vessel 92. As highlighted in the circular insert of FIG. 16, due to the positional stabilization of the at least one lumen 25 along a rotational axis 80 of the inflatable member, the orientation of each of the one or more emitters 99-106, exemplarily emitter 98, is maintained along a perpendicular direction 109 facing towards the vessel wall of the surrounding vessel 92. Further, as a result, the one or more emitters are positioned at equivalent and safe distances 107, 108 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.

[0109] In contrast thereto, FIG. 17 depicts a cross-sectional view of a contemporary angioplasty balloon catheter with a 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. 17, similar to the illustration of Fig. 15, because the single-membered balloon 114 does not contain any waist portions, during pressurization, the lumen 125 situated in the inflatable member is not positionally stable, shifting away from the center-line 80’, tensioning against the anatomic curvature of the curved vessel 92, and against an inner surface of the inflatable member 114. In consequence, emitters 100-105, present on the lumen125, in particular emitter 103, as highlighted in the circular insert of FIG. 17, are tilted away at an undesirable angle 110, from an optimal, perpendicular orientation 109 facing the curved vessel 92 along the centerline 80’, to an unfavorable, nonperpendicular orientation 108’. Further, as a result of the tensioning of the lumen 125 during pressurization, emitter 103 maintaina a comparatively short, and potentially unsafe distance 107’ from an inside bend of the curved vessel 92, and a comparatively long distance 108’, 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.

[0110] 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 two or more waist portions (39, 39') of the lobes 31-36 positionally stabilize theat least one lumen 25 along a rotational axis 80 (center-line) of the inflatable member 14, 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 25 is thereby centered within the vessel anatomy. As a result, the position of the radiopaque markers, and particularly, the position of the emitters 96-103 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 of the two or more waist portions (39, 39') act as articulating joints, where positioning of the at least three lobes (31-36) of the inflatable member (14) aligns an orientation of the one or more emitters (96-99; 106) in a vessel anatomy having one or more of a curvature and containing a calcified lesion. Additional implementations of lumen configurations of a crossing balloon catheter configured for intravascular lithotripsy are next described in reference to FIGs. 18-19.

[0111] FIG. 18 depicts a cross-sectional view of one or more of a lobe length of an inflatable member of a crossing balloon catheter having a 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. 18, an inflatable member 14 of the crossing balloon catheter (10) comprises at least three lobes 31-33, and is configured with a lumen 25 that comprises one or more emitters 96 suitable for intravascular lithotripsy, the emitter 96 positioned in the center of lobe 32. The inflatable member is placed within a vessel anatomy (90), adjacent to a vessel wall 94, having a small vessel radius corresponding with a first outer radius 77 of the lobes 31-33 of the inflatable member 14. A first lobe length 111 of lobe 32 is configured to pass a desired distribution of shockwaves 112 (generated by emitter 96 upon activation) along the entire lobe length 111 , the lobe length and distribution of shockwaves suitably adapted for small vessel diameters. As an overlay in Fig. 18, in a second implementation, a lobe 32’ is placed within a vessel anatomy (90), adjacent to avessel wall 94’ having a larger vessel radius corresponding with a second outer radius 77’ of the inflatable member 14. The second lobe length 11 T is configured to pass the same, a similar or equivalent distribution of shockwaves 112 along the entire lobe length 111’, the lobe length and distribution of shockwaves suitably adapted for large vessel diameters. In the two related implementations, a ratio of the lobe lengths 111 I 11 T can be seen proportionate to a ratio formed between the outer radii 77 I 77’ of the at least three lobes of the inflatable member 14. Further, lobe lengths 111 , 11 T and outer radii 77, 77’ 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 112 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.

[0112] FIG. 19 depicts a cross-sectional view of one or more of an emitter position of an inflatable member of a crossing balloon catheter having a lumen configured for intravascular lithotripsy, in a vessel anatomy having a 180° curvature, in accordance with the present disclosure. In FIG. 19, an inflatable member 14 of the crossing balloon catheter (10) comprises at least three lobes 31- 34, and is configured with a lumen 25 that comprises one or more emitters 96, 97 suitable for intravascular lithotripsy. The emitters 96, 97 are positioned in the respective centers of adjacent lobes 32, 33, and placed in a vessel anatomy having a 180° curvature. As described previously in reference to FIG.3, when the inflatable member 14 is placed in a vessel anatomy having one or more of a curvature and containing a calcified lesion, an individual geometry of each of the two or more waist portions (39, 39') separating the at least three lobes 31-34 of the inflatable member, in a pressurized and vessel and lesion-contacting state, deflects an adjacent pair 31-32; 33-34) of two or more of the at least three lobes at one or more of an individual lobe to lobe angle. Because the individual geometries of thetwo or more waist portions (39, 39') act as articulating joints, the positioning of the at least three lobes of the inflatable member (14) in a vessel anatomy 90 having one or more of a curvature and containing a calcified lesion therefore not only aligns an orientation of the one or more emitters 96, 97 perpendicular to a rotational axis 80 of the inflatable member and the surrounding vessel wall 94, but also aligns pairs of adjacent emitters 96, 97 at one or more of an individual emitter to emitter angle 116, that in turn corresponds to the one or more of an individual lobe to lobe angle. Further, when each of the emitters 96, 97 is placed centered in each corresponding lobe 32, 33, as shown, a distance between each emitter (along the rotational axis 80) corresponds to a sum of a lobe length (111 ) and a length of the waist portion (71 ). Upon activation, each emitter 96, 97 is capable of transmitting a distribution of shockwaves 112, 113 along an optimal, perpendicular orientation facing the vessel wall 94. Further, upon concerted activation, pairs of adjacent emitters are enabled to overlap a distribution of shockwaves 112, 113 at a lobe-to-lobe angle, in turn forming a pressure interference zone 114 that is focused onto an inward oriented portion of a vessel anatomy having one or more of a curvature and containing a calcified lesion. Thus, the concerted activation of one or more adjacent pairs of the one or more emitters 96, 97 at an individual emitter to emitter angle 116, that corresponds to the one or more of an individual lobe to lobe angles, controllably forms a pressure interference zone 114, 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 calcified 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 (111 ) and the length of the waist portion (71) allows to controllably modulate a distribution of shockwaves 112, 113, 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 calcified lesion.

[0113] Summarizing the above, in the various implementations of the crossing balloon catheter (10) in accordance to the present disclosure, the crossing balloon catheter can further include a lumen configured for intravascular lithotripsy, wherein the at least one of the two or more lumen (25-27) of the crossing balloon catheter comprises one or more emitters (96-99, 106) for use in intravascular lithotripsy (IVL), each emitter positioned in one or more corresponding lobes (31- 38) of the inflatable member 14, and positioned around an outer surface of the at least one lumen (25); wherein the one or more emitters (96-99, 106) are positionally stabilized and centered within an occluded vessel anatomy (90) having one or more of a curvature and containing a calcified lesion (95), 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 the above implementations, the individual geometries of the two or more waist portions (39, 39') act as articulating joints, such that positioning of the at least three lobes (31- 38) of the inflatable member (14) aligns an orientation of the one or more emitters (96-99, 106) in an occluded vessel anatomy having one or more of a curvature and containing a calcified lesion. In a related implementation, a concerted activation of one or more pairs of the one or more emitters (96, 97) at one or more of an individual emitter to emitter angle (116) that corresponds with one or more of an individual lobe to lobe angle, controls a distribution of shockwaves (112, 113), resulting in a pressure interference zone 114, 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 an occluded vessel anatomy having one or more of a curvature and containing a calcified lesion. When at least one of the two or more lumen of the crossing catheter (10) of the current disclosure is configured for intravascular lithotripsy, the crossing catheter allows for performing additional lithotripsy treatments of severely calcified lesions (95). In reference to the previously described method of treating a vascular pathology with a crossing balloon catheter, the crossing balloon catheter thereby allows delivering shockwaves (112, 113) to the calcified lesion, the delivery exemplarily taking place before, during or after pre-dilating with a first set of lobes(31-33) of the inflatable member (14) to a first diameter; and alternatively or complementary thereto, before, during or after dilating with a second set of lobes 35-37 of the inflatable member 14 to a second diameter.MANUFACTURING ASPECTS

[0114] Concerning the general construction aspects of the crossing 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 transition member, the elongated member and 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.

[0115] 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 thecatheter can be varied to beneficially alter the performance aspects of the individual catheter components.

[0116] 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.

[0117] 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, includingthe 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.

[0118] 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.

[0119] 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 suitablefor 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.

[0120] 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 crossing balloon catheter [10] comprising: an elongated member [15] having a proximal end, a distal end [12], and two or more lumen [25-27] extending at least partially through the elongated member; an inflatable member [14] proximally affixed to the elongated member adjacent to the distal end and in fluid communication with at least one [26, 27] of the two or more lumen; a transition member [13], that extends distally from the distal end of the elongated member and in communication with at least one of the two or more lumen [25]; a crossing tip [20] proximally affixed to the transition member and providing access to at least one of the two or more lumen [25, 25']; the inflatable member having at least one radius R [77] and including at least three lobes [31-38], the at least three lobes separated from each other by two or more waist portions [39, 39’]; wherein in an unpressurized state, the at least three lobes of the inflatable member [14] are provided each folded and pleated, such that subsequent pressurization of the inflatable member individually unfolds each of the three or more lobes; characterized in that, when the inflatable member is placed in an occluded vessel anatomy [90] having one or more of a curvature and containing a calcified lesion [95], the crossing tip extending distal from the inflatable member is stabilized such, that the crossing tip enables an anchoring to, and crossing of the calcified lesion, and thereby, creates a working channel that enables placing the inflatable member in the calcified lesion without exchanging the balloon catheter, wherein one or more of the at least three lobes of the inflatable member enable a consecutive dilation of the working channel to one or more of a vessel diameter.

2. The balloon catheter according to claim 1 , further comprising: a kink-protection sleeve [16], and a manifold [17],3. The balloon catheter according to claim 2, wherein the manifold [17] further comprises:one or more inflation port [18], and a first guide-wire exit port [19],4. The balloon catheter according to claims 1-3, wherein the elongated member [15] further comprises: one or more inflation lumen [26, 27], and one or more guide-wire lumen [25, 25'].

5. The balloon catheter according to claims 1-4, wherein the transition member [13] is fixedly attached to the elongated member [15],6. The balloon catheter according to claims 1-4, wherein the transition member [13] is slideably and rotatably positioned in one [25] of the at least two or more lumen [25-27] of the elongated member [15],7. The balloon catheter according to claims 1-4 and 6, wherein the transition member [13] further comprises: a shaft portion [51], that extends proximally beyond the first guide-wire port [19 a manifold [52]; a guide-wire lumen [25'], and a second guide-wire exit port [53],8. The balloon catheter according to claims 1-7, wherein at least one of the one or more guidewire lumen [25, 25'] extend from a distal end of the crossing tip [20] through the elongated member to one of the first [19] and second guide-wire exit port [53], and the one or more inflation lumen [26, 27] are in fluid communication with the inflatable member [14],9. The balloon catheter according to claim 1 , wherein an individual geometry of the two or more waist portions [39, 39'] between the at least three lobes [31-38] of the inflatable member [14] includes:an upper base having a first length [71] that is equivalent to a length of the waist portion(s); a lower base having a second length [70] smaller than the first length; a first depth equivalent to a radial distance [75] between the upper base and the lower base; a second depth equivalent to a radial distance [76] between the lower base and a rotation axis [80] of the inflatable member; two legs [72, 73] formed at a waist angle [78] that is defined by the first and second lengths [70, 71] and radial distances [75, 76] between the lower and upper base, wherein a sum of the first and second depths [75, 76] are equivalent to an outer radius [77] of the inflatable member, and wherein the first depth is equivalent to the depth of the waist portion(s).

10. The balloon catheter according to claim 9, wherein, when the inflatable member transitions from the unpressurized state to the pressurized state, a radial stability of the individual geometry of the two or more waist portions is ensured by maintaining a ratio between the first length [71 ] of the waist portion and the at least one radius R [77] at or below 1.0, and a ratio between the first depth [75] and the at least one radius R [77] at or above 2.5.

11. The balloon catheter according to claim 9, 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 [78] at or above 50 degrees and below 80 degrees in the unpressurized state.

12. The balloon catheter according to claims 1 and 9, wherein an individual geometry of the two or more waist portions [39, 39'] between the at least three lobes [31-38] of the inflatable member [14] positionally stabilizes the at least two lumen [25-27] of the elongated member along a rotational axis [38] of the inflatable member [14], such that the crossing tip that extends distal from the inflatablemember via the transition member is positionally centered in the occluded vessel anatomy having one or more of a curvature and containing a calcified lesion.

13. The balloon catheter according to claim 9, wherein an individual geometry of the two or more waist portions is varied between the at least three lobes [31-38] of the inflatable member [14],14. The balloon catheter according to claim 9, wherein an individual geometry of the two or more waist portions is kept constant between the at least three lobes [31-38] of the inflatable member [14],15. The balloon catheter according to claims 1 and 9, wherein one or more of a length and a diameter of the at least three lobes is varied.

16. The balloon catheter according to claims 1 and 9, wherein one or more of a length and a diameter of the at least three lobes is kept constant.

17. The balloon catheter according to claims 1 and 9-16, wherein the inflatable member is constructed in sets of multiple lobes, each set of lobes corresponding to one or more of a length and one or more of a diameter, and each set of lobes having a radius of curvature that, in a curved and pressurized state, corresponds with one of the one or more of a curvature of the vessel anatomy [90] along at least a portion of a length of the inflatable member.

18. The balloon catheter according to claim 17, wherein each of the sets of multiple lobes each comprise a portion of the length of the inflatable member, and a sum of the length portions define a total length of the inflatable member.

19. The balloon catheter according to claims 9 and 17-18, wherein the sets of multiple lobes are further separated by one or more of a spacing element [41] having a length [85], that exceeds the first length [71] of at least one of the two ormore waist portions [39, 39'], and a diameter smaller than the outer radius [77] of the inflatable member.

20. The balloon catheter according to any of the preceding claims, wherein a length [84] of the transition member [13] exhibits at least one diameter smaller than a diameter of one of the crossing tip and the inflatable member, that, during crossing of the calcified lesion, allows displaced material of the calcified lesion to be readily received, thereby reducing an amount of friction and axial tension generated between the calcified lesion, and one or more of the crossing tip, the transition member and the inflatable member.

21. The balloon catheter according to any of the preceding claims, wherein the crossing tip exhibits at least one maximum diameter that is larger than a diameter of one of the elongated member, the inflatable member, and the transition member.

22. The balloon catheter according to any of the preceding claims, wherein the crossing tip exhibits a friction relief zone [81] comprising a recessed length portion having at least one diameter smaller than the maximum diameter of crossing tip, that, during crossing of the calcified lesion, reduces an amount of friction generated between the calcified lesion and the crossing tip, thereby enabling an enhanced crossing capability of the tip.

23. The balloon catheter according to claim 1 , wherein the crossing tip is formed from a radiopaque material.

24. The balloon catheter according to claim 23, wherein the radiopaque material enhances a shape stability and a crossing capability of the crossing tip.

25. The balloon catheter according to any of the preceding claims, wherein at least one of the transition member and the crossing tip exhibits a coefficient of friction that is lower than at least one of the elongated member and the inflatable member.

26. The balloon catheter according to claim 25, wherein the coefficient of friction of at least one of the transition member and the crossing tip is further lowered by incorporation of one or more low-friction material selected from a group consisting of one or more of a fluoroelastomer, a polyether ether ketone, a polyethylene, a polyamide, a polydimethylsiloxane, a radiopaque material including metals, a diamond-like coating, a sintered ceramic and any combinations formed therefrom.

27. The balloon catheter according to claim 1 , wherein at least one [25] of the two or more lumen [25-27] of the elongated member is reinforced, such that a kink resistance along the length of the inflatable member [14] is reduced.

28. The balloon catheter according to claims 1 and 27, wherein a reinforcement of at least one [25] of the two or more lumen [25-27] of the elongated member enhances a stiffness, such that pushability of the balloon catheter is increased.

29. The balloon catheter according to any of the preceding claims, wherein the sets of multiple lobes comprise a first, distal set consisting of 4 lobes [31-34], and a second, proximal set consisting of 4 lobes [35-38], wherein, in a pressurized state, in the first set, each lobe exhibits a first diameter, that is lower than a second diameter exhibited by the second set of lobes.

30. The balloon catheter according to claims 1 and 27-28, wherein the transition member [13] further comprises a reinforcement selected from a group consisting of one or more of an axial, angled, helical, interwoven, stacked, reticulated, or multilayered braid, thread, fiber, a hypotube and any combinations formed therefrom.31 . The balloon catheter according to any of the proceeding claims, wherein at least one of the two or more lumen [25-27] comprises one or more emitters [96-99, 106] for use in intravascular lithotripsy (IVL), each emitter positioned in one or more corresponding lobes [31-38] of the inflatable member [14], and positioned around an outer surface of the at least one lumen [25],32. The balloon catheter according to any of the proceeding claims, wherein the one or more emitters [96-99, 106] are positionally stabilized and centered within an occluded vessel anatomy [90] having one or more of a curvature and containing a calcified lesion [95], 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.

33. The balloon catheter according to any of the proceeding claims, wherein the individual geometries of the two or more waist portions [39, 39'] act as articulating joints, such that positioning of the at least three lobes [31-38] of the inflatable member [14] aligns an orientation of the one or more emitters [96-99, 106] in an occluded vessel anatomy having one or more of a curvature and containing a calcified lesion.

34. The balloon catheter according to any of the proceeding claims, wherein a concerted activation of one or more pairs of the one or more emitters [96, 97] at one or more of an individual emitter to emitter angle [116] that corresponds with one or more of an individual lobe to lobe angle, controls a distribution of shockwaves [112, 113], resulting in a pressure interference zone [114], 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 an occluded vessel anatomy having one or more of a curvature and containing a calcified lesion.

35. A method for treating a vascular pathology with a crossing balloon catheter [10] according to any of claims 1 - 34, the method comprising the steps of: introducing a guide wire [11] through a puncture site into a patient's blood vessel; positioning the guide wire into an occluded vessel anatomy [90] having one or more of a curvature and containing a calcified lesion [95];inserting a crossing balloon catheter [10] over the guidewire [11] into the vessel anatomy [90]; anchoring a crossing tip [20-22] of the crossing balloon catheter [10] to the calcified lesion; crossing the calcified lesion with the guidewire; extending the crossing tip of the crossing balloon catheter over the guidewire across the calcified lesion, thereby creating a working channel inside the calcified lesion; positioning a first set of lobes [31-33] of the inflatable member [14] of the crossing balloon catheter [10] across the working channel inside the calcified lesion; transitioning the inflatable member [14] from an unpressurized to a pressurized state, and pre-dilating the first set of lobes [31-33] of the inflatable member [14] to a first diameter; transitioning the inflatable member [14] from a pressurized to a unpressurized state; positioning a second set of lobes [35-37] of the inflatable member [14] of the crossing balloon catheter [10] across the working channel inside the calcified lesion, and transitioning the inflatable member [14] from an unpressurized to a pressurized state, and dilating the second set of lobes [35-37] of the inflatable member [14] to a second diameter.

36. The method for treating a vascular pathology with a crossing balloon catheter [10] according to claim 35, the method replacing the step of: extending the crossing tip of the crossing balloon catheter over the guidewire across the calcified lesion, thereby creating a working channel inside the calcified lesion with: slideably, and optionally rotatably, extending the transition member [13] through one [25] of the at least two or more lumen [25-27] of the elongatedmember [15], while maintaining a position of the balloon catheter, thereby extending the crossing tip of the crossing balloon catheter over the guidewire across the calcified lesion, and creating a working channel inside the calcified lesion.

37. The method for treating a vascular pathology with a crossing balloon catheter [10] according to claims 35 and 36, the method further including the step: delivering shockwaves [112, 113] to the calcified lesion.

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