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WO2025176333A1 - Cathéter à ballonnet traversant - Google Patents

Cathéter à ballonnet traversant

Info

Publication number
WO2025176333A1
WO2025176333A1 PCT/EP2024/076236 EP2024076236W WO2025176333A1 WO 2025176333 A1 WO2025176333 A1 WO 2025176333A1 EP 2024076236 W EP2024076236 W EP 2024076236W WO 2025176333 A1 WO2025176333 A1 WO 2025176333A1
Authority
WO
WIPO (PCT)
Prior art keywords
crossing
balloon catheter
inflatable member
lobes
lumen
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2024/076236
Other languages
English (en)
Inventor
Marc Gianotti
Andreas Bodmer
Ulf Fritz
Dragana MARGETA
Michael Jetter
Adrienne Mueller
Deborah LUETHI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CTI Vascular AG
Original Assignee
CTI Vascular AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by CTI Vascular AG filed Critical CTI Vascular AG
Publication of WO2025176333A1 publication Critical patent/WO2025176333A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B17/2202—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being inside patient's body at the distal end of the catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22025—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement applying a shock wave
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22042—Details of the tip of the guide wire
    • A61B2017/22044—Details of the tip of the guide wire with a pointed tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22055—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation with three or more balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22069—Immobilising; Stabilising
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22094—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for for crossing total occlusions, i.e. piercing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1047—Balloon catheters with special features or adapted for special applications having centering means, e.g. balloons having an appropriate shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1072—Balloon catheters with special features or adapted for special applications having balloons with two or more compartments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1084—Balloon catheters with special features or adapted for special applications having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape

Definitions

  • the current disclosure is directed to medical devices and methods of using such devices in the therapeutic treatment of vascular disease.
  • 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.
  • 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.
  • 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.
  • a balloon catheter 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.
  • 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.
  • 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.
  • the plaque 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.
  • angioplasty balloons are commonly non-compliant or semi- compliant, such balloons are comparatively rigid and exhibit relatively poor flexibility and/or conform ability to curved vessel anatomies, and increasingly so, when the balloon length is increased.
  • the expansion of conventional angioplasty balloons is therefore frequently accompanied by a tendency of the balloons to straighten - regardless of the underlying vessel morphology.
  • the straightening effect is particularly exacerbated in tortuous anatomies, and can result in undue pinching, bending or straightening stress on the vessel during the angioplasty treatment.
  • a conforming contact surface between the lesion and balloon cannot in all circumstances be reliably established.
  • 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.
  • inflation of a conventional balloon easily causes pinching or straightening of the vessel.
  • 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.
  • 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.
  • 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.
  • 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.
  • POBA conventional balloon catheter
  • ‘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.
  • 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.
  • dilators and support catheters 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.
  • 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.
  • 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.
  • high pressure balloon angioplasty can be traumatic to the vessel walls and is frequently accompanied by vessel wall dissections, which may require placement of stents or immediate surgical intervention. Procedurally, the higher the pressure of balloon angioplasty and the more rapidly the target pressure is approached, the risk for more severe dissection is increased.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • Segmented, notched, multi-lobed and/or multiple, individual balloons are generally known in the art.
  • international patent application WO 2023/126091 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the balloon segments, lobes or notches achieve the technical effect of axial flexibility by various means.
  • 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.
  • none of the prior art teaches 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 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.
  • 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.
  • 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 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.
  • 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.
  • OGW over-the-wire
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the hemostatic valve can optionally include a torquer, a clip, or locking aid, as applicable.
  • 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.
  • 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.
  • RX rapid-exchange
  • Such second guide-wire exit port can be provided as a lateral opening on the elongated member 15, proximal to the inflatable member 14.
  • 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 member 13, rather than through the guide-wire exit port 53 proximal to manifold 17.
  • 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).
  • the RX configuration enables using guide-wires of considerably shorter length in comparison to the OTW configuration.
  • 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.
  • a OTW lumen configuration is generally preferred over an RX lumen configuration.
  • therapeutic and diagnostic liquids as well as 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.
  • FIG. 7 illustrates a cross-sectional view of an inflatable member of the crossing balloon catheter in accordance with the present disclosure.
  • 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.
  • each spacing element 41 may also include or comprise of radiopaque materials or markers positioned along a length 85 of the spacing element 41.
  • 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 a corresponding vertical cross-section ‘A-A’ that further illustrates the coaxial triplelumen configuration.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • each set of multiple lobes corresponds to one or more of a length and one or more of a diameter
  • 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.
  • 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.
  • the coaxial lumen configuration can include stabilization welds, preferably along a proximal lumen portion of the elongated member.
  • 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.
  • 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
  • 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.
  • 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').
  • 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.
  • each waist portion 39, 39' exhibits a waist angle 78 that is formed between the legs 72-73.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • one or more of a length and a diameter of the at least three lobes of the inflatable member 14 is varied.
  • one or more of a length and a diameter of the at least three lobes of the inflatable member 14 is kept constant.
  • each set of lobes corresponds to one or more of a length and one or more of a diameter
  • 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.
  • 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.
  • an amount of friction and axial tension that can be reduced is defined by a length 84 and a diameter of the transition member.
  • 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.
  • the outer diameter of the proximal portion 22' is commensurate with an inner diameter of the transition member.
  • 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.
  • 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 .
  • 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 .
  • 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.
  • 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.
  • 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.
  • a radiopaque material enhances a shape stability and a crossing capability of the crossing tip.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • the reduction of emitters further simplifies the construction, saving cost and reducing risk of vessel trauma, particularly when treating focal calcified lesions.
  • 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.
  • IVL intravascular lithotripsy
  • Such configuration of the lumen 25 comprising multiple emitters can be intended for the efficient treatment of long calcified lesions.
  • 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).
  • 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.
  • 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.
  • the position of the radiopaque markers, and particularly, the position of the emitters 96-99 is positionally stabilized and centered within the vessel anatomy, thereby avoiding direct contact with the inner surface of the inflatable member, and maintaining a constant, safe distance to the vessel anatomy, for controlled delivery of shockwaves, while reducing risk of vessel trauma.
  • the one or more emitters 96-99 are also perpendicularly oriented towards the surrounding vessel anatomy 90.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 accordance with 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 ).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • emitters 100-105 present on the lumen 125, 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’.
  • 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.
  • 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.
  • the lumen can tilt off-axis, disorienting the emitter surface, risking loss of focus, orientation, and/or causing fluctuation or dispersion of energy.
  • the individual geometries of the two or more waist portions (39, 39') 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 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • ‘distribution’ can generally refer to one or more of a suitable amplitude, frequency, pulse, modulation, profile, direction, focal zone, duration, energy and penetration depth.
  • each emitter 96, 97 is capable of transmitting a distribution of shockwaves 112, 113 along an optimal, perpendicular orientation facing the vessel wall 94.
  • 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).
  • 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.
  • 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.
  • the crossing catheter allows for performing additional lithotripsy treatments of severely calcified lesions (95).
  • 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.
  • the catheter components can be manufactured from biocompatible, polymeric, metallic and ceramic materials.
  • 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
  • PA aliphatic, semi-aromatic and aromatic polyamides
  • the catheter components can be fabricated in a single layer, dual-layer, or in multi-layer configuration.
  • 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.
  • the multiple layers are not required to be attached, glued or welded together; instead, the multiple layers may be allowed to move independently.
  • the elastic modulus, durometer or hardness of the materials selected for each layer or component of the catheter can be varied to beneficially alter the performance aspects of the individual catheter components.
  • 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.
  • 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.
  • other suitable techniques may incorporate additives, adhesives and/or filling agents, which can introduce other beneficial properties to the catheter materials.
  • the components of the catheter may incorporate radiopaque elements embedded within polymeric materials to selectively increase fluoroscopic visibility at desired locations.
  • the components of the catheter may incorporate dyes or pigments at select locations to provide visible color-indications to a treatment provider.
  • 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.
  • the catheter components, including the shaft and inflatable member can be provided reinforced and may contain metal or polymer-based strands, fibers, wires, braids, meshes and/or fabrics embedded as layers, sections or regions into the base-material.
  • 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.
  • 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.
  • 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 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).
  • the desired compliance characteristics of the inflatable member can favorably be controlled through the manufacturing process.
  • the inflatable members of the present disclosure can be manufactured using known manufacturing methods such as balloon blowing, blow molding, thermoforming, dip molding, or any other manufacturing methods suitable for the manufacture of balloons. It shall be understood to one of ordinary skill in the art that conventional balloon manufacturing techniques can be utilized within the manufacture of balloons of the present disclosure.
  • the materials of the balloon may be subjected to mechanical processes before, during or after the manufacture of the balloon.
  • the tubular member from which the balloon is to be formed can be stretched before, during or after the blowing process.
  • 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.

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  • Anesthesiology (AREA)
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  • Vascular Medicine (AREA)
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  • Orthopedic Medicine & Surgery (AREA)
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Abstract

La présente divulgation concerne un cathéter à ballonnet traversant et un procédé d'utilisation d'un tel cathéter à ballonnet traversant, qui est conçu individuellement pour se conformer sans heurts à au moins l'une d'une courbure d'une anatomie vasculaire occluse contenant une lésion calcifiée, qui permet l'ancrage et le franchissement de la lésion calcifiée sans échanger le cathéter à ballonnet. Le cathéter à ballonnet traversant comprend un élément allongé ayant une extrémité proximale, une extrémité distale et au moins deux lumières s'étendant au moins partiellement à travers l'élément allongé, un élément gonflable fixé de manière proximale à l'élément allongé adjacent à l'extrémité distale et en communication fluidique avec au moins l'une des deux lumières ou plus, un élément de transition, qui s'étend de manière distale à partir de l'extrémité distale de l'élément allongé et en communication avec au moins l'une des deux lumières ou plus, une pointe de franchissement (traversante) fixée de manière proximale à l'élément de transition et fournissant un accès à au moins l'une des deux lumières ou plus, l'élément gonflable ayant au moins un rayon R et comprenant au moins trois lobes, les au moins trois lobes étant séparés les uns des autres par au moins deux parties de taille.
PCT/EP2024/076236 2024-02-23 2024-09-19 Cathéter à ballonnet traversant Pending WO2025176333A1 (fr)

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Application Number Priority Date Filing Date Title
EP24159498 2024-02-23
EP24159498.5 2024-02-23

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WO2025176333A1 true WO2025176333A1 (fr) 2025-08-28

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Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5147377A (en) * 1988-11-23 1992-09-15 Harvinder Sahota Balloon catheters
DE20006443U1 (de) * 2000-04-07 2000-10-05 Fischbach, Georg, Dr.med., 34125 Kassel Mehrkammeriger Ballonkatheter zur Dilatation von Stenosen in Gefäßen mit gebogem Verlauf
US6527739B1 (en) * 2000-12-29 2003-03-04 Advanced Cardiovascular Systems, Inc. Spiraled balloon arrangement for treatment of a tortuous vessel
US20090216185A1 (en) 2008-02-26 2009-08-27 Boston Scientific Scimed, Inc. Balloon catheter with durable tip portion
US20090306597A1 (en) * 2008-03-28 2009-12-10 Henry William Lupton Device for unblocking an occluded vessel, and a method for unblocking an occluded vessel
US20140135891A1 (en) * 2012-11-13 2014-05-15 Biotronik Ag Balloon Catheter for Curved Vessels
EP3322470B1 (fr) 2015-07-13 2018-11-28 CTI Vascular AG Système de cathéter actionné hydrauliquement et intégrable fonctionnellement pour le traitement de maladies vasculaires et non vasculaires
EP2937108B1 (fr) 2014-04-25 2019-03-13 Asahi Intecc Co., Ltd. Cathéter
CN110339456A (zh) 2019-08-22 2019-10-18 贝克顿·迪金森公司 球囊扩张导管及其球囊
US20200129742A1 (en) * 2018-10-25 2020-04-30 Medtronic Vascular, Inc. Cavitation catheter
WO2023017006A1 (fr) 2021-08-10 2023-02-16 Biotronik Ag Système de cathéter traversant pour traverser une occlusion totale chronique et procédé pour faire fonctionner le système de cathéter traversant
WO2023126091A1 (fr) 2022-01-03 2023-07-06 Cti Vascular Ag Cathéter à ballonnet pour angioplastie pour le traitement d'une maladie vasculaire

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5147377A (en) * 1988-11-23 1992-09-15 Harvinder Sahota Balloon catheters
DE20006443U1 (de) * 2000-04-07 2000-10-05 Fischbach, Georg, Dr.med., 34125 Kassel Mehrkammeriger Ballonkatheter zur Dilatation von Stenosen in Gefäßen mit gebogem Verlauf
US6527739B1 (en) * 2000-12-29 2003-03-04 Advanced Cardiovascular Systems, Inc. Spiraled balloon arrangement for treatment of a tortuous vessel
US20090216185A1 (en) 2008-02-26 2009-08-27 Boston Scientific Scimed, Inc. Balloon catheter with durable tip portion
US20090306597A1 (en) * 2008-03-28 2009-12-10 Henry William Lupton Device for unblocking an occluded vessel, and a method for unblocking an occluded vessel
US20140135891A1 (en) * 2012-11-13 2014-05-15 Biotronik Ag Balloon Catheter for Curved Vessels
EP2937108B1 (fr) 2014-04-25 2019-03-13 Asahi Intecc Co., Ltd. Cathéter
EP3322470B1 (fr) 2015-07-13 2018-11-28 CTI Vascular AG Système de cathéter actionné hydrauliquement et intégrable fonctionnellement pour le traitement de maladies vasculaires et non vasculaires
US20200129742A1 (en) * 2018-10-25 2020-04-30 Medtronic Vascular, Inc. Cavitation catheter
CN110339456A (zh) 2019-08-22 2019-10-18 贝克顿·迪金森公司 球囊扩张导管及其球囊
WO2023017006A1 (fr) 2021-08-10 2023-02-16 Biotronik Ag Système de cathéter traversant pour traverser une occlusion totale chronique et procédé pour faire fonctionner le système de cathéter traversant
WO2023126091A1 (fr) 2022-01-03 2023-07-06 Cti Vascular Ag Cathéter à ballonnet pour angioplastie pour le traitement d'une maladie vasculaire

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