Multi-lumen balloon catheter

Abstract

An improved multi-lumen balloon catheter, in which the balloon (40) has upper and lower lobes (50 and 52) extending longitudinally and forming a stenosis along either side thereof, and at least one lumen (46) for the insertion of a second guidewire (66) extending in a pattern adjacent a surface (41) of at least one of the lobes (50) and forming a perforation in the arterial wall in the same location as the end of the second guidewire, the device allowing an Antegrade Re-entry (TAR) procedure to be performed successfully even by operators who are not very experienced in this particular technique.

Description

[Technical field]

[0001] The present invention relates to multi-lumen balloon catheters and to endovascular surgical procedures using such catheters. [Background technology]

[0002] 2. Background of the Invention The goal of endovascular intervention is to restore the normal physiological state of arteries, which, for example, due to aging or improper dieting, can show a gradual reduction in the lumen available for the passage of blood flow due to the deposition of fat and plaque.

[0003] When a coronary artery becomes narrowed or blocked, the lack of blood flow prevents the heart from functioning properly and can cause irreversible damage.

[0004] Coronary artery disease has two opposing clinical variants: acute coronary syndrome (ACS), in which the coronary artery luminal narrowing progresses rapidly due to thrombotic occlusion, leading to myocardial infarction unless blood flow is rapidly restored, and chronic angina syndrome (CAS), in which the luminal narrowing gradually reduces blood flow and progressive myocardial ischemia leads to angina pectoris and chronic ischemic heart disease.

[0005] In some cases, the narrowing of a coronary artery continues until it is completely blocked, but a mechanism of collateral circulation, which is not yet fully understood, can provide sufficient blood flow to keep the myocardium viable, albeit with some degree of ischemia. This is the classic scenario presented as chronic total occlusion (CTO) of a coronary artery, and when present in an artery that supplies blood to a large portion of the myocardium, cardiac surgery is required to restore normal blood flow. One of these surgical interventions is the placement of a coronary stent, which expands the artery where the coronary lesion is restricting blood flow, with the aim of restoring the coronary artery's patency and ability to supply blood to the heart.

[0006] Although placement of coronary stents is relatively straightforward in cases of chronic angina syndrome (CAS), it is more challenging in cases of chronic total occlusion (CTO) of a coronary artery due to the lack of rapid access to the distal portion of the lesion, resulting in the need for the use of a coronary wire that extends through or passes around the lesion plaque to act as a guide for subsequent stent placement.

[0007] Many techniques are known for treating chronic total occlusions (CTOs). Briefly, they can be classified as antegrade and retrograde approaches, depending on the side of the lesion that is initially attempted to be passed. The basic goal of each approach is to pass a guidewire through the lesion, with both ends of the wire positioned within the lumen of the artery, regardless of the trajectory of the wire in or out of the lesion, and to place a stent to restore patency of the artery.

[0008] Currently, among antegrade techniques, antegrade dissection and re-entry (ADR) is recommended for obstructions of 20 mm or greater. TM Although the adoption of the endoscopic system (Boston Scientific, Marlborough, MA) has facilitated the implementation and success of ADR, the equipment used requires thorough and dedicated training of the operator and incurs high economic costs. Moreover, the occurrence of compressible subintimal hematomas further limits its effectiveness.

[0009] Carlino et al., “Antegrade fenestration and re-entry: a novel controlled subintimal technique for recanalization of chronic total occlusions,” Catheter. Cardiovasc. Interv. 2018; 92:497-504, describe a novel controlled subintimal technique for recanalization of chronic total occlusions, called “antegrade fenestration and re-entry” (AFR), in which the Stingray TM We describe for the first time a new ADR technique as an alternative to system-based re-entry. This technique can be used in three specific clinical scenarios: i) as a first-line ADR; ii) as an alternative technique to the antegrade approach, but when the wire is advanced subintimally; and iii) as an alternative technique to other ADR techniques, e.g., when the Crossboss / Stingray system has failed.

[0010] As described in the aforementioned paper by Dr. Carlino and colleagues, the AFR technique involves five steps: Step 1: The guidewire inadvertently follows a subintimal course around the occlusion and is positioned in the subintimal space beyond the distal portion of the occlusion.

[0011] Step 2: Remove the microcatheter (according to the conventional technique), leave the first guidewire in place, and insert a second guidewire, passing it again through the subintimal space around the occlusion while bringing the tip of the second guidewire as close as possible to the first wire and viewing it in several projections.

[0012] Step 3: A balloon sized 1:1 to the diameter of the artery is advanced over the first guidewire and passed distal to the occlusion.

[0013] Step 4: Inflate the balloon to at least the nominal pressure.

[0014] Step 5: The balloon is deflated and a second guidewire is rapidly advanced through the temporary openings (called "fenestrations") between the subintimal space and the true lumen created by the balloon, so that the fenestrations are thus closed again, allowing the insertion of a second guidewire into the now accessible true lumen of the artery.

[0015] US 2014 / 0277053 Al discloses a subintimal re-entry catheter with a shape-controlled balloon. The catheter includes an elongate shaft and an inflatable balloon attached to a distal region of the elongate shaft. The catheter can include a re-entry device lumen having a guidewire lumen and an inflation lumen and communicating with a side port of the catheter. The inflation lumen communicates with the inflatable balloon and is configured to direct the side port of the catheter toward the vessel lumen. The balloon is also configured to inflate to first and second inflated states. A guidewire or an elongate penetrating member is advanced through the guidewire lumen and the side port of the catheter until it penetrates the true lumen distal to the occlusion so that a therapeutic procedure can be performed. The balloon body does not have a lumen for the wire or the penetrating member.

[0016] US 2017 / 0100141 A1 discloses an occlusion bypass device for re-entering the true lumen of a blood vessel. The device includes an outer shaft with a needle lumen, a side port at the distal end, a needle, and an inflatable balloon. A curved portion of the needle housing allows the needle to exit the side port in the correct orientation for re-entering the true lumen of the blood vessel. The balloon body does not have a lumen for a wire or a penetrating member.

[0017] A conventional balloon catheter according to the prior art is shown in FIG.

[0018] WO 2019 / 112781 Al describes devices and methods for passing across a chronic total occlusion (CTO) in an artery using the AFR technique as described above. Figures 2-4 correspond to Figures 3, 5, and 6, respectively, of WO 2019 / 112781 Al and show the steps of the AFR technique performed with the balloon catheter described herein, which are briefly described below.

[0019] 2 shows a catheter 20 with a balloon 26, a first guidewire 22 inserted into the main lumen of the catheter and projecting from its distal end, and a second guidewire 24 inserted into the secondary lumen of the catheter and projecting from a hole upstream of the balloon. After the balloon catheter and the first and second guidewires are inserted into the true lumen 12 of the artery 14, they are advanced through the subintimal space 16 of the artery such that the balloon is positioned at the chronic total occlusion CTO 18. This positioning is achieved in steps 1, 2, and 3 of the AFR technique described above.

[0020] FIG. 3 shows balloon inflation in step 4 of the AFR technique.

[0021] Figure 4 shows a balloon inflation 26 obtained using means and devices not shown as they are known to those skilled in the art, resulting in the formation of at least one perforation 29 whose flaps 28, 28' are provisionally opened to allow the advancement of the second guidewire 24 to re-enter the true lumen 12 as in step 5 of the AFR technique. A stent is then advanced over the second guidewire to push plaque outwards and restore vascular patency, as shown in Figure 10.

[0022] The AFR technique described above has several important and unique features.

[0023] First, while the first guidewire can be selected according to operator preference, the second guidewire must be a polymer-coated guidewire with low tip load so that it can be easily manipulated quickly to pass through the perforation 29 formed between the false lumen of the subintimal space 16 and the true lumen 12 without risking perforation of the blood vessel.

[0024] Second, re-entering the true lumen 12 is an iterative process that may require several attempts before effectively passing through the perforation.

[0025] Third, re-entry into the true lumen 12 must be performed as close as possible to the distal part of the occlusion and far from the attachment of the side branch of the vessel. This minimizes the risk of losing the subintimal pathway and the side branch and maximizes the chance of obtaining good distal outflow. All these are important factors in the success of percutaneous coronary intervention (PCI) for the treatment of CTO based on AFR and ensures long-term patency rates. Fourth, the second guidewire must be initially advanced as close as possible to the first guidewire to increase the chance of passing through the perforation created by the balloon inflation.

[0026] Therefore, performing AFR requires considerable operator proficiency and expertise; in fact, in a multicenter validation study reported by Azzalini et al., Multicenter experience with the antegrade fenestration and reentry technique for chronic total occlusion recanalization, Catheter. Cardiovasc. Interv. 2021;97:E40-E50, the success rate of this technique was only 66%.

[0027] US Pat. No. 5,342,301 describes a multi-lumen balloon catheter which allows the passage of a guidewire, a fiberglass bundle, or other instruments.

[0028] Thus, new devices and techniques are needed that incorporate the lessons learned from AFR, while improving the success rate of AFR by essentially eliminating those steps of AFR that are associated with failed re-crossing from the subintimal space to the true lumen, ultimately increasing the likelihood of successful recanalization by operators with less expertise. Summary of the Invention [Problem to be solved by the invention]

[0029] Summary of the Invention The objective of the present invention is to provide an improved multi-lumen balloon catheter that allows for a new and different iteration of a technique that the author-inventors have previously termed the Antegrade Fenestration and Re-entry (AFR) procedure. This new, never-before-described device and technique are intended to be successfully used by operators without deep expertise in complex coronary manipulation. The special nature of this new device eliminates the need for a critical step in AFR, namely, the creation of a "perforation" that has a complex three-dimensional nature and a transient and variable ability to connect the subintimal space to the true lumen for a limited time. This requires that the crossing wire be engaged within a limited time (30 seconds according to the relevant literature) in order to cross from the subintimal space to the true lumen. The improvement according to the present invention is achieved by co-localization of a second wire (tasked with crossing from the subintimal to the true lumen) with the balloon that is responsible for the mechanical disruption of the membrane separating the subintimal space from the true lumen.

[0030] To further effectively innovate known devices and set them apart from any prior devices and techniques, the wire aimed at re-entering the true lumen is itself an agent that causes targeted perforation of the subintimal membrane on the surface of the balloon resulting from limited, operator-directed exposure of the wire outside the balloon prior to balloon inflation. The second wire (i.e., the cross wire) is propelled against the subintimal membrane by the combined action of the balloon inflation and the special shape of the underlying balloon where the wire exits the balloon (nose shape or straight lumen on the top surface of the balloon). The wire's contact with the surface of the inflating balloon locally changes the balloon's inflation profile and compliance, further enhancing the selective disruptive action of the balloon by its mere presence, thus biasing the wire to re-enter across the membrane at the true lumen.

[0031] Prior AFR techniques and devices that attempt to perforate the subintimal membrane have targeted the immediate presence of the subintimal membrane and crossed wires at an operator-selected location and did not utilize crossed wires as an agent to selectively target perforation of the subintimal membrane. As previously mentioned, AFR relies on extensive subintimal destruction and the ability of the wire operator to travel this subintimal labyrinth with the chance of ultimately finding its way to the true lumen (the wire journey).

[0032] The aforementioned wire journey, as described in known devices, takes a finite amount of time until the tip of the wire detaches from the device shaft, runs over the deflated balloon, engages, and (hopefully) finds a patent fenestration where it re-engages the true lumen.

[0033] In the devices and their relative uses (or techniques) presented in this application, the amount of time required to perform the "wire journey" is zero, i.e., the wire that causes localized perforation of the subintimal membrane is already ahead of the balloon when it crosses into the true lumen, so none of the steps described in the wire journey are present or are no longer required. In TAR (Target Antegrade Re-Entry), the wire is fed directly to the tip (or other exit point). The wire is exposed to the subintimal space (similar to many other CTO techniques, e.g., re-CART, parallel wiring, LAST), the balloon is inflated, and as a result of its own action, the wire propels the membrane through the inflation of the balloon and into the true lumen. Having undergone a profound conceptual transformation from AFR to TAR, the only common features shared by TAR and AFR, as with many other devices and techniques, are the use of a dual lumen catheter and the presence of a balloon in the subintimal space.

[0034] Another object of the present invention is to provide a novel endovascular surgical procedure of re-entry technique (TAR) that is more effective and simpler than the previously described AFR by means of an improved multi-lumen balloon catheter. [Means for solving the problem]

[0035] Accordingly, one aspect of the present invention relates to a multi-lumen balloon catheter comprising: a catheter having a first lumen for inserting a first guidewire, a second lumen for inserting a second guidewire, and a third lumen for inflating a balloon; an inflatable multi-lumen balloon having a first lumen extending through the balloon from a proximal end to a distal end and communicating with the first lumen of the catheter, and at least a second lumen for inserting the second guidewire; The present invention is characterized in that the balloon has an upper leaflet and a lower leaflet, the upper leaflet and the lower leaflet being located above and below a horizontal plane that intersects the balloon at a portion between the upper leaflet and the lower leaflet, the upper leaflet and the lower leaflet extending in a longitudinal direction and forming a constriction along a side of the balloon; the second lumen of the balloon extends from the proximal end to the distal end following a pattern adjacent and parallel to a surface of at least one of the upper and lower leaves, the second lumen of the balloon communicating with the second lumen of the catheter; The second lumen of the catheter communicates with a pair of side exit holes upstream of the proximal end of the balloon.

[0036] According to one aspect of the invention, the second lumen of the balloon communicates with at least one exit hole in the surface of one of the upper and lower lobes and is located upstream of the distal end of the balloon, in particular in the distal half of the balloon relative to a centerline that ideally divides the balloon into proximal and distal halves.

[0037] According to one aspect of the invention, the balloon extends from the proximal end to the distal end in a pattern adjacent to the other surface of the upper or lower leaflet and has a third lumen beginning at a branch that communicates with the second lumen of the catheter.

[0038] According to one aspect of the invention, the third lumen of the balloon communicates with at least one exit hole in the surface of the other of the upper or lower lobes, the exit hole being located upstream of the distal end of the balloon, in particular in the distal half of the balloon relative to a centerline that ideally divides the balloon into proximal and distal halves.

[0039] Another aspect of the present invention relates to an endovascular surgical procedure for placing a guidewire downstream of a total occlusion in an artery of a patient, the endovascular surgical procedure comprising: advancing a first guidewire into the subintimal space of the artery and positioning a multi-lumen inflatable balloon catheter at the total occlusion, the balloon having a first lumen for accommodating the first wire and at least a second lumen for accommodating a second guidewire; advancing the second guidewire into the second lumen of the balloon with its tip exposed outside the balloon to form a targeted perforation of the subintimal membrane within the true lumen of the artery or penetrate the subintimal space and the intimal layer into the true lumen; inflating and deflating the balloon to selectively stress the subintimal space and form at least one targeted perforation in the subintimal space; introducing the second guidewire into the target perforation in the subintimal membrane and advancing the second guidewire into the true lumen downstream of the total occlusion; Includes. [Brief description of the drawings]

[0040] [Figure 1] 1 shows a prior art balloon catheter in various operating configurations. [Diagram 2] 1 shows a prior art balloon catheter in various operating configurations. [Diagram 3] 1 shows a prior art balloon catheter in various operating configurations. [Figure 4] 1 shows a prior art balloon catheter in various operating configurations. [Diagram 5] FIG. 1 is a side elevational view of a balloon catheter according to a first embodiment of the present invention. [Figure 6] FIG. 6 is a perspective view of the balloon catheter of FIG. [Figure 7] FIG. 7 is a cross-sectional view taken along line VII-VII in FIG. [Figure 8] FIG. 4 is a partial cross-sectional view of a balloon catheter according to a second embodiment of the present invention. [Figure 9] FIG. 11 is a longitudinal sectional view of a balloon catheter according to a third embodiment of the present invention. [Figure 10]FIG. 2 is a longitudinal sectional view of a stent applied to a blood vessel. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0041] Detailed Description of the Invention The present invention relates to a multi-lumen balloon catheter for performing targeted antegrade and re-entry (TAR) procedures in blood vessels, particularly in coronary arteries.

[0042] The Antegrade Fenestration and Re-entry (AFR) procedure in blood vessels, particularly in the coronary arteries, was briefly described in the introduction to the state of the art herein, and this procedure (Target Antegrade Re-entry (TAR)) will be mentioned again in the description of the use of the novel multi-lumen balloon catheter according to the present invention.

[0043] In describing balloon catheters and TAR procedures using such balloon catheters, the following terms have the meanings defined below: - "balloon catheter" refers to a catheter equipped with a balloon that can be inflated and deflated several times; - "proximal end" refers to the end of the balloon closer to the operator and "distal end" refers to the end of the balloon further from the operator; - The "longitudinal extension" of a balloon refers to its extension from the proximal end to the distal end; - "lumen" refers to both the ductal and vascular lumen present in catheters and balloons; - "true lumen" refers to the natural cavity of the blood vessel, and "false lumen" refers to the cavity created in the subintimal space by the advancement of the balloon catheter; - the terms "first guidewire" and "first wire" are used interchangeably and have the same meaning, as are the terms "second guidewire" and "second wire"; the upper leaflet of the balloon is the leaflet located above the horizontal plane AA which intersects the balloon in the area between said upper and lower leaflets (Figure 7); the lower leaflet of the balloon is the leaflet that is located below the horizontal plane AA that intersects the balloon in the area between said upper and lower leaflets (FIG. 7).

[0044] 5-7, a balloon catheter according to the present invention comprises a microcatheter 30, of which only the distal end connected to the proximal end of the balloon is shown, and a balloon 40 having an elongated shape tapered at the proximal and distal ends, the latter being formed with a nose 42.

[0045] The balloon 40 is of the multi-lumen type. It comprises a first lumen 44 that runs through the balloon along its longitudinal axis from the proximal end to the distal end, and a second lumen 46 that also runs from the proximal end to the distal end of the balloon, but according to a pattern adjacent to the upper surface 41 of the balloon. The term "pattern adjacent to the upper surface 41 of the balloon" means that when the balloon is in an inflated state, the second lumen 46 runs substantially parallel to and in the vicinity of the upper surface 41 of the balloon, i.e. the distance between a point of the surface having a common normal and a point of the second lumen is substantially constant.

[0046] With particular reference to FIGS. 5 and 6, the nose 42 of the balloon is the distal tip of the balloon and is formed above the first lumen 44 .

[0047] As shown in FIG. 5, the second lumen 46 emerges on the nose 42 at a point more anterior than the point at which the first lumen 44 emerges, ie, at a location more distal than the point at which the first lumen 44 emerges.

[0048] In the illustrated embodiment, there is also a third lumen 48 which also extends from the proximal end to the distal end of the balloon, but follows a pattern adjacent the underside 43 of the balloon.

[0049] The term "pattern adjacent to the lower surface 43 of the balloon" means that when the balloon is in an inflated state, the third lumen 48 runs substantially parallel to and adjacent to the lower surface 43 of the balloon, i.e., the distance between a point on the surface having a common normal and a point on the third lumen is substantially constant.

[0050] The terms "upper surface" and "lower surface" of the balloon are defined below.

[0051] The second lumen 46 and the third lumen 48 have a common origin at a bifurcation 47 that connects the two lumens 46, 48 of the balloon to the lumen 36 of the catheter 30. The second lumen 46 is provided with holes 45, 45', 45", and the third lumen 48 is provided with at least one hole 49 on each of the upper and lower surfaces 41, 43 of the balloon. Referring to FIG. 5, a centerline YY ideally divides the balloon into a proximal half that is connected to the catheter 30 and a distal half that terminates at the nose 42. The holes 45, 45', 45", 49 are provided in the distal half of the balloon 40 relative to the centerline YY.

[0052] The second lumen 46 has an aperture 45'' above the nose 42 at the distal end of the balloon, and the third lumen 48 has an aperture 49' below the nose 42 at the distal end of the balloon.

[0053] With particular reference to Figure 7, the balloon 40 is formed with an upper leaflet 50 and a lower leaflet 52 that extend longitudinally throughout the extension of the balloon from the proximal end to the distal end. Between the two leaflets 50, 52 is defined a constriction that forms two longitudinal channels in the side of the balloon. With reference to Figure 7, which is a view toward the distal end of the balloon, the channels are shown as left channel 56 and right channel 58.

[0054] To more clearly define the shape and portions of balloon 40, line AA defines a horizontal plane that intersects the balloon laterally in the portion between the two lobes 50, 52, and line BB defines a vertical plane that intersects the balloon longitudinally through the entire length of balloon 40. Thus, lobe 50 is defined as the upper lobe and lobe 52 is defined as the lower lobe, regardless of the balloon's actual position or orientation when inflated within the artery.

[0055] The term "upper surface" 41 of the balloon refers to the upper surface of the upper leaflet 50 of the balloon 40, and the term "lower surface" 43 of the balloon refers to the lower surface of the lower leaflet 52 of the balloon 40.

[0056] Referring to the vertical plane BB, when the balloon is viewed from the proximal end, i.e., from the end of the balloon closest to the operator, the plane BB divides the balloon into a left half and a right half.

[0057] According to an embodiment, the leaves 50, 52 are not of the same size. In the illustrated embodiment, the upper leaflet 50 has a larger volume than the lower leaflet 52. Furthermore, the first lumen 44 is contained in the larger sized leaflet 50. While FIG. 7 shows the lumens 44, 46 and 48 aligned on the same vertical axis, in other embodiments not shown, the second lumen 46 and the third lumen 48 may not be aligned with the lumen 44, even though they are always adjacent the upper and lower surfaces, respectively.

[0058] The balloon 40 is inflatable by introducing a gas or a suitable liquid into the cavity 54, as is known in the art.

[0059] The catheter 30 is provided with at least three lumens: a first lumen 34 aligned with the first lumen 44 of the balloon for insertion of a first guidewire 64, a second lumen 36 for insertion of at least one second guidewire 66, and a third lumen for inflating the balloon, designated 32. In one embodiment, the catheter is a tube with a diameter of 1.8-3.1 Fr (1 Fr=0.33 mm). The first guidewire is for delivery of the device to the chronic total occlusion CTO, and the second wire is for insertion into the true lumen of the artery.

[0060] The second lumen 36 also has a pair of exit holes 38 upstream of the proximal end of the balloon disposed on the side of the catheter. Only one of the side holes 38 is shown in Figures 5 and 6, but a corresponding hole is provided in an opposite location. The lateral location of the holes 38 corresponds to the side of the balloon, i.e., both holes are substantially aligned with the longitudinal channels 56, 58 on the side of the balloon 40.

[0061] After being introduced into the lumen 36 of the catheter, the second guidewire 66 may either exit through one of the exit holes 38 upstream of the proximal end of the balloon or may be advanced to the bifurcation 47 where it may be introduced by the operator into either the second lumen 46 or the third lumen 48 of the balloon, as described below. Once the second guidewire 66 exits through one of the catheter's side holes 38 upstream of the balloon, it may be advanced within and along the longitudinal channels 56, 58 outside of the balloon 40, as described below.

[0062] FIG. 8 shows a second embodiment of a balloon catheter according to the present invention, in which the distal end is rounded and does not have a protruding nose as in the previously described embodiments.

[0063] Retaining the same reference numbers as used in connection with the previously described embodiments, a second lumen 46 and a third lumen 48 are present in the balloon 40, as well as a first lumen for the insertion of a first guidewire, not shown.

[0064] In this embodiment, the second lumen 46 protrudes from the interior of the balloon in the distal half and is contained within an outer rib 47 that protrudes from the upper surface 41 of the balloon. In a similar variation, not shown, the outer rib is symmetrically formed on the lower surface 43 of the balloon and defines a similar pattern of a third lumen 48.

[0065] 9 shows a cross-sectional view of a third embodiment of a balloon catheter according to the invention, in which the distal end is again rounded and does not have a nose or protruding ribs. The first 44, second 46 and third 48 lumens of the balloon are shown, as well as the interior cavity 54.

[0066] A balloon catheter is used to perform an endovascular surgical procedure of the TAR according to a method forming another aspect of the present invention, the goal of which is to create one or more connections between the subintimal space and the true lumen by making targeted perforations in the subintimal membrane suitable to allow the introduction of a second guidewire into the true lumen of the artery.

[0067] The balloons of the present invention may be used to make these connections using a variety of mechanisms, both at non-specific locations and at specific locations in the area surrounding the balloon.

[0068] With reference to the various steps of the TAR technique described in the introduction of this specification and with reference to Figures 5-8, it must be taken into account that the first guidewire 64 introduced in the first lumen 34 of the catheter 30 and in the first lumen 44 of the balloon 40 is advanced in a subintimal path around the total occlusion (CTO) 18 of Figure 2 and is positioned in the subintimal space beyond the distal portion of the occlusion, e.g., as shown in Figure 2 for a conventional catheter.

[0069] 5 and 8, a second wire 66 introduced into the second lumen 36 of the catheter advances to the bifurcation 47 and engages the second lumen 46 of the balloon and protrudes therefrom over the nose 42 with its end or tip above the first guidewire 44. In this case, the tip of the second wire 66 is designated 66a. This path of the second wire is defined as the "upper portion."

[0070] Alternatively, upon reaching the bifurcation 47, the operator can advance a second guidewire 66 into the third lumen 48 of the balloon so that its tip protrudes from the distal end of the balloon below the first guidewire 44. In this case, the tip of the second wire 66 is designated 66b. This path of the second wire is defined as the "lower portion."

[0071] The catheter and balloon configuration of the present invention provides the operator with another opportunity to advance a second wire 66, typified by exiting the catheter 30 through one of the side holes 38 upstream of the balloon 40. In this case, the second guidewire 66 is advanced outside the balloon along one of the channels 56, 58 defined by the narrowing of the two lobes 50, 52 until it reaches the distal end of the balloon. In this case, the tip of the second wire 66 is designated 66c. This path of the second wire is defined as the "side."

[0072] The balloon catheter of the present invention can form a perforation at a specific site, and at that time, the tip of the second guide wire 66 is also positioned and exposed, so that it can be quickly introduced into the opening of the subintimal membrane and ultimately into the true lumen 12, as described below.

[0073] Technique 1 ("Cut Through") By forming longitudinal linear perforations along the longitudinal axis of the balloon from the upper path of the second wire 66 to the second lumen 46 of the balloon or from the lower path of the second wire 66 to the third lumen 48 of the balloon, these areas of the balloon will be subjected to greater pressure on the intimal layer upon inflation. This pressure is further increased if the first or second lumen is inside a rib protruding from the surface of the balloon, as shown in FIG. 8.

[0074] Furthermore, the holes 45, 45' or 49 on the upper and lower balloon surfaces 41 and 43, respectively, allow the tip of the second guide wire to exit the balloon and be exposed at various points on the balloon surface selected by the operator, close to the location of the targeted subintima perforation. This allows the "co-positioning of the tip of the second wire and the perforation", which is a fundamental feature of the device and method according to the invention. In this way, the temporary nature of the perforations, previously described as part of the key features of the AFR technique, is no longer a limiting factor, since when they are created the wire is in the same position as the connection and its close proximity favors rapid insertion into the true lumen.

[0075] Technique 2 ("Punch Through") The targeted perforation of the subintimal membrane to establish a direct connection between the subintimal space and the true lumen is formed from a break point distal to the second wire 66 which protrudes beyond the nose 42 from the terminal hole of the second lumen 46 of the balloon, with the tip of the wire designated as 66a and exiting the balloon through the hole 45" of the balloon. Inflation of the balloon causes the conical nose 42 and tip 66a of the second wire to impinge on the membrane of the cul-de-sac and be propelled beyond the membrane of the cul-de-sac, opening a perforation through which the wire 66 co-localized with the perforation passes, carrying the wire into the true lumen. Again, the principle of co-localization of the perforation and the tip of the wire is fulfilled.

[0076] Technique 3 ("Horizontal Slice Through") A linear perforation is formed forward along the cross section of the balloon on the intimal-cul-de-sac in the membrane interposed between the subintimal space and the true lumen. The second wire 66 protrudes from the terminal hole 45" of the second lumen 46 of the balloon beyond the nose 42, the tip of the wire designated 66a with a variable stiffness selected by the operator. In this case, the inflation / deflation cycle of the balloon determines the vertical movement of the tip of the second wire, i.e. perpendicular to the longitudinal extension of the balloon, which "scratches" the distal membrane of the cul-de-sac and repeatedly and successively exerts vertical pressure, eventually causing a tear and thus a linear perforation. The tip 66a is in a position to pass through the opening and enter the true lumen. Here again, the principle of co-localization of the perforation and the second wire is fulfilled.

[0077] Technique 4 ("Side Slide") Lateral engagement: this applies when the upper or lower path of the second wire does not form a passable connection between the subintimal space and the true lumen. In this case, the second guidewire is retracted into the catheter 30 and re-advanced so that it exits one of the catheter's side holes 38 upstream of the balloon. The channels 56, 58 on the outside of the balloon, preferably coated with a hydrophilic material, guide the sliding movement of the second wire on the balloon side and help the operator to position the wire 66 along one side of the balloon. The balloon is left inflated, stretching and stabilizing the perforation in the subintimal membrane obtained by the combined inflation action of the balloon while the wire is exposed. At any point, the second wire 66 with the tip 66c can be advanced beyond the balloon to engage and pass through the right or left opening that is inaccessible from the upper or lower surface for anatomical reasons. The principle of colocalization of perforation and wire passage also applies to this technique. Of note, this technique is likely to be the last procedure attempted if other techniques have been unsuccessful.The major difference from AFR described above is that this technique requires passing a wire into the subintimal space while the balloon is inflated.

[0078] Each of the techniques 1 to 4 allows the creation of targeted perforations in the subintimal membrane to establish a direct connection between the subintimal space and the true lumen at predictable regions along the balloon profile. This specific feature is unique to the device of the present invention, allowing the operator to focus their efforts on inserting the second wire in a specific region of the balloon, unlike prior art devices that randomly explore a dead end with the wire after multiple inflations of the balloon. The essential feature is the colocalization of the tip of the second wire with the target re-entry zone, allowing the device to omit a whole step of the wire journey as described in the original AFR technique (see above). As mentioned above, instead of creating a temporary perforation as described in the original AFR (Azzalini et al, 2018), each of the techniques 1 to 4 simply penetrates the subintimal space and the intimal layer, allowing the second wire to enter the true lumen.

[0079] Advancement techniques #1, #2 and #3 should be performed with the balloon either deflated or inflated (i.e., whether the balloon is inflated or not is no longer a critical aspect of the technique).

[0080] Advancement Technique #4 must be performed with an inflated balloon.

[0081] As shown in Fig. 10, when the second wire 66 re-enters the true lumen 12, the stent advances over it, pushing the plaque outwards and restoring vascular patency. The use of the multi-lumen balloon catheter according to the invention is not limited to surgical interventions on the coronary arteries. In fact, the device can be used for vascular surgical interventions in any area of ​​arteries and / or veins, for recanalization or perforation of various types of total occlusions, calcified or thrombosed, in peripheral vessels, for example iliac, infrapopliteal and / or supraplicular, subclavian, etc.

[0082] More generally, the device may be used in any area of ​​the body where there is a total obstruction or perforation of a tubular structure, such as the common bile duct, requiring a recanalization procedure, both acute and chronic.

[0083] Indeed, the multi-lumen balloon catheter according to the invention has the specific ability to: 1) create limited ablation in the vessel wall; 2) create and / or maintain guidewire / catheter access to the lumen beyond the obstruction (e.g. ERCP / biliary obstruction) along two transverse grooves with the balloon inflated.

Claims

1. a catheter (30) having a first lumen (34) for inserting a first guidewire (64), a second lumen (36) for inserting a second guidewire (66), and a third lumen (32) for balloon inflation; an inflatable multi-lumen balloon (40) having a first lumen (44) extending through the balloon from a proximal end to a distal end and communicating with the first lumen (34) of the catheter (30), and at least one second lumen (46) for inserting the second guidewire (66); The present invention is characterized by comprising: the balloon (40) has an upper leaflet (50) and a lower leaflet (52), the upper leaflet and the lower leaflet being respectively located above and below a horizontal plane that intersects the balloon at a portion between the upper leaflet and the lower leaflet, the upper leaflet and the lower leaflet extending longitudinally and forming a constriction along a side of the balloon; the second lumen (46) of the balloon (40) extends from the proximal end to the distal end in a pattern adjacent to and parallel to the surface (41) of at least one of the upper and lower leaves (50, 52), the second lumen of the balloon communicating with the second lumen (36) of the catheter; A multi-lumen balloon catheter, wherein the second lumen (36) of the catheter communicates with a pair of side exit holes (38) upstream of the proximal end of the balloon (40).

2. 2. The multi-lumen balloon catheter of claim 1, wherein the second lumen (46) of the balloon (40) is in communication with at least one exit hole (45, 45', 45") provided in the surface (41) of at least one of the upper and lower leaves (50, 52) of the balloon, the exit hole (45, 45', 45") being provided in the distal half of the balloon (40) relative to a centerline (YY) that ideally divides the balloon into proximal and distal halves.

3. 3. The multi-lumen balloon catheter of claim 1, wherein the balloon (40) comprises a third lumen (48) extending from the proximal end to the distal end of the balloon according to a pattern adjacent to the lower surface (43) of the lower leaflet (52), and the second lumen (46) and the third lumen (48) originate from a branch (47) communicating with the second lumen (36) of the catheter (30).

4. 3. The multi-lumen balloon catheter of claim 1, wherein the balloon (40) is tapered at its proximal and distal ends, and the distal end is formed with a nose (42) that protrudes above the first lumen (44).

5. 3. A multi-lumen balloon catheter according to claim 1, wherein the second lumen (46) protrudes from the interior of the balloon in the distal half and forms an outer rib (47) protruding from the upper surface (41) of the balloon.

6. 3. The multi-lumen balloon catheter of claim 1, wherein the third lumen (48) protrudes from the interior of the balloon in the distal half and forms an outer rib protruding from the underside (43) of the balloon.

7. 3. A multi-lumen balloon catheter according to claim 1, wherein the second lumen (46) is in communication with at least one exit hole (45) provided in the upper surface (41) of the upper leaflet (50) of the balloon, the exit hole (45) being provided in the distal half of the balloon (40) relative to a centerline (YY) that ideally divides the balloon into a proximal half and a distal half.

8. 3. The multi-lumen balloon catheter of claim 1, wherein the third lumen (48) is in communication with at least one exit hole (49) provided in the lower surface (43) of the lower leaflet (52) of the balloon, the exit hole (49) being provided in the distal half of the balloon (40) relative to a centerline (YY) that ideally divides the balloon into a proximal half and a distal half.

9. 3. The multi-lumen balloon catheter of claim 1, wherein the upper leaflet (50) has a volume greater than the volume of the lower leaflet (52).

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