Device for treating bifurced blood vessels

Description

1 / 29 DEVICE FOR TREATING BIFURCED BLOOD VESSELS Field

[001] The present invention relates to medical devices and methods for treating lesions in a bifurcated blood vessel. The invention also relates to a system for treating aortoiliac occlusive disease (AIOD) in a retrograde approach. Background

[002] Aortoiliac occlusive disease (AIOD) is a narrowing or stenosis of the blood vessels surrounding the abdominal aorta at its transition to the two iliac arteries. This narrowing or blockage is typically caused by plaque buildup in the aorta, at the aortic bifurcation, and in the iliac arteries. As a result of the plaque, the diameters of the flow lumens in the iliac arteries are reduced, thus restricting blood flow to the patient's legs and pelvic organs.

[003] Endoluminal procedures for the treatment of AOIA generally involve the placement of an uncovered or covered stent within the bifurcation. The stent may be self-expanding or balloon-expandable. Two types of treatment are generally used for the treatment of AOIA involving the aortoiliac bifurcation: kissing stents and covered endovascular aortic bifurcation reconstruction (CERAB). The kissing stent technique is a procedure in which two stents are positioned at the aortic bifurcation and intersect above the aortic bifurcation. Similarly, covered endovascular reconstruction is a procedure in which a main stent body is implanted in the aorta above the aortic bifurcation and separate stent branches for each of the iliac arteries are implanted so that they intersect within the main stent body above the aortic bifurcation. Petition 870250091008, dated 06 / 10 / 2025, page 6 / 61 2 / 29

[004] Both techniques involve the simultaneous placement of two stents parallel or in contact across the bifurcation, as well as the placement of a stent or stent in the aorta.

[005] A common drawback of these two techniques is the interruption of natural blood flow through the bifurcation, which can lead to thrombosis, hemolysis, emboli, and restenosis. Another drawback is the need for precise simultaneous placement of the two stents in contact and the high technical skill required to perform this procedure. Furthermore, the two stents in contact make reintervention procedures using a retrograde approach (up-and-over technique) very challenging. Additionally, another disadvantage is that the use of conventional balloons for dilation or redilation of the main stent in the aorta prevents stent placement in direct proximity to the bifurcation, as the balloon protrusion, which is necessarily relatively long for balloons with a diameter suitable for the aorta, forces the physician to maintain a certain distance from the bifurcation to avoid the risk of excessive vessel dilation in that area.Since the balloon protrusion is symmetrical at both ends, this disadvantage exists for both approaches, retrograde or anterograde, with the retrograde approach being widely preferred due to fewer complications during the procedure.

[006] There is an obvious need for medical devices and methods for the treatment of DAIO involving the aortoiliac bifurcation that overcome the shortcomings of existing methods listed above. These shortcomings are addressed by the medical device and methods for treating bifurcated blood vessels involving the aortoiliac bifurcation described herein. Description

[007] Medical devices and methods for the treatment of any disease involving a bi are described here in general terms. Petition 870250091008, dated 06 / 10 / 2025, p. 7 / 61 3 / 29 furcation in the body lumen. In some embodiments, the devices and methods are for the treatment of aortoiliac occlusive disease (AOD). The devices and methods described herein may also be used for the treatment of an aortic aneurysm or any other disease in the body involving a bifurcation in the body lumen.

[008] For consistency purposes, when describing the present devices, the direction toward the external end of the catheter, outside the body, is termed proximal and the direction away from the external end of the catheter is termed distal. The side on which the catheter is inserted into peripheral arteries is termed ipsilateral, and the opposite side is termed contralateral. For example, if the catheter is inserted into an artery in the right leg, the right side of the body is termed ipsilateral and the right iliac artery is termed the ipsilateral iliac artery. The left side is termed contralateral and the left iliac artery is termed the contralateral iliac artery.

[009] In some embodiments, a bifurcated stent comprises a main body stent, a first branch stent, and a second branch stent. In other embodiments, a bifurcated stent comprises a main body stent and a branch stent. In some embodiments, the bifurcated stent may comprise more than two branch stents. In some embodiments, the bifurcated stent comprises a main body and two non-tubular stent extensions to reach the lateral branches of the vessel.

[0010] The bifurcated stent may be an uncoated metal stent. In other embodiments, the bifurcated stent may be a coated stent. In other embodiments, the stent may be a coated stent, also called a stent graft or endoprosthesis. In a further embodiment, the bifurcated stent may be any combination of a plain stent and / or a coated stent and / or a coated stent. In an alternative embodiment, the stent may be produced from ma Petition 870250091008, dated 06 / 10 / 2025, p. 8 / 61 4 / 29 polymeric or biodegradable material.

[0011] Stents can be coated with a layer of polymer or animal tissue. The sheaths can be produced from woven or knitted fibers, polymers, porous material, or non-porous material. The sheath material can be produced from polyurethane, PET (polyethylene terephthalate), unexpanded PTFE (polytetrafluoroethylene), expanded ePTFE, or ultra-high-density polyethylene (UHDPE). The sheath can be connected to the stent by any suitable means well known in the art, such as fibers, sutures, adhesives, or by fixing the sheath between the stent struts, sintering, bonding, fusion, linking, or encapsulation of the stent by the membrane.

[0012] The stent may be composed of a metal, metal alloy, polymer(s) and / or a combination thereof. The stent sheath may be produced from a polymer or mammalian tissue. The bifurcated stent may comprise a series of stent rings connected by longitudinal struts or by means of a sheath.

[0013] In some embodiments, the stent may be laser-cut from a metal or polymer tube. In other embodiments, the stent may be formed from a metal or polymer wire. In some embodiments, the main body stent and the two branch stents may be welded or connected by another mechanism, such as, but not limited to, suture(s), adhesive(s), connector(s), ligature(s), and / or a combination thereof. In some embodiments, the main body stent and the two branch stents are connected by a material different from the material used to compose the stents.

[0014] A bifurcated stent may comprise a series of individual stent rings connected by the cap. A bifurcated stent may comprise at least two overlapping stents, such that the proximal segment of each stent forms a respective branch and the distal segment of each stent forms the main body. In some Petition 870250091008, dated 06 / 10 / 2025, page 9 / 61 In 5 / 29 embodiments, the bifurcated stent comprises two or more overlapping stents. In some embodiments, the main body stent and the two branch stents are formed integrally, i.e., the bifurcated stent is manufactured in a single piece. In other embodiments, the bifurcated stent is formed by 3 individual stents welded together.

[0015] A catheter for bifurcated stent delivery comprises a catheter shaft and a single balloon mounted on a distal portion of the catheter shaft. In other embodiments, the catheter includes a catheter shaft and two balloons, a first single balloon mounted on a distal portion of the catheter shaft and a second balloon mounted on the catheter shaft at a location proximal to the first balloon.

[0016] The catheter shaft includes an inflation lumen in fluid communication with a hub at the proximal end of the shaft (external to the patient's body) and in fluid communication with the single balloon.

[0017] In another embodiment, where the catheter comprises two balloons, the catheter includes two inflation lumens, a first inflation lumen in fluidic communication with a first hub at the proximal end of the shaft and in fluidic communication with a first balloon, and a second inflation lumen in fluidic communication with a second hub at the proximal end of the shaft and in fluidic communication with a second balloon, so that the two balloons can be inflated separately.

[0018] The catheter shaft further includes a guidewire lumen, the guidewire lumen connecting a first opening in the catheter shaft at the distal end of the catheter and a second opening at the proximal end of the catheter. The guidewire lumen houses a preloaded guidewire. The catheter may be in an over-the-guidewire configuration or constructed as a quick-change catheter. In another embodiment, the catheter shaft includes a fixed guidewire. When a fixed guidewire is employed, the catheter does not necessarily need a lumen of Petition 870250091008, dated 06 / 10 / 2025, p. 10 / 61 6 / 29 guide wire. Instead, or additionally, the guide wire is integrated into the shaft or in another embodiment directly connected to the shaft.

[0019] The single balloon can have any shape. In some embodiments, the balloon can have a cylindrical shape. In other embodiments, the balloon has a first distal portion, a second central portion, and a third proximal portion. The balloon portions are arranged along the catheter axis in a row, so that the single balloon can assume a linear configuration. Each of the portions can have any shape. Each portion can have the same shape as the other two portions, each portion can have an individual shape, or the first and third portions can have the same shape, while the second portion has a different shape. In a preferred embodiment, the balloon comprises at least one first waist portion between the first distal portion and the second central portion and at least one second waist portion between the second central portion and the third proximal portion of the balloon.In the context of this application, a waist portion is defined as an area of ​​the balloon with a reduced outer diameter compared to the adjacent balloon portions flanking both ends of the waist portion. The diameter reduction in the waist portion is at least 50% compared to the adjacent balloon portions. It is explicitly stated that the balloon wall is not fixed to the catheter axis in the waist portion area. This means that the balloon has a single lumen and a single inflation or deflation lumen; that is, the balloon segments share a single lumen, the balloon lumen.

[0020] In some embodiments, the individual portions of the balloon may have a rotationally symmetrical shape, a cylindrical shape, a conical shape, or a spherical shape, a concave or convex shape, a stepped shape, or any combination thereof. If the individual portions of the balloon have a stepped shape, the diameter of the balloon portion Petition 870250091008, dated 06 / 10 / 2025, page 11 / 61 7 / 29 The larger portion of the balloon is increased by a maximum of 50% compared to the diameter of the smaller portion of the balloon along the step. In one embodiment, a proximal portion of the third proximal portion of the balloon has a diameter that is increased by up to 50% relative to the distal portion of the third proximal portion of the balloon. In another embodiment, a distal portion of the first distal portion of the balloon has a diameter that is increased by up to 50% relative to the proximal portion of the first distal portion of the balloon. In yet another embodiment, both a distal portion of the first distal portion of the balloon and a proximal portion of the third proximal portion of the balloon have a diameter that is up to 50% larger than a proximal portion of the first distal portion of the balloon and / or over a distal portion of the third proximal portion of the balloon.

[0021] In some embodiments, the central portion of the balloon may have a spherical shape. In other embodiments, the central portion itself comprises one or more additional waist portions, that is, portions of reduced outer diameter compared to the adjacent portions of the balloon.

[0022] The single balloon may have a first distal portion including at least one first diameter, a second central portion including at least one second diameter, and a third distal segment including a third diameter. In some embodiments, the first diameter is smaller than the second diameter. In other embodiments, the third diameter is smaller than the second diameter. In some embodiments, the first and third diameters are equal. In some embodiments, the first, second, and third diameters are equal. In other embodiments, each portion of the balloon may have an individual shape, such as, but not limited to, rotationally symmetrical shape, cylindrical shape, conical shape, spherical shape, concave or convex shape, stepped shape, or which Petition 870250091008, dated 06 / 10 / 2025, page 12 / 61 8 / 29 wants a combination of these.

[0023] The catheter can be transferred from a delivery configuration to a retractable configuration.

[0024] In its distribution configuration, the first distal portion of the single balloon is bent downward toward the third proximal portion of the balloon, so that the first distal portion and the second proximal portion of the balloon are adjacent to each other. In one configuration, the first distal portion and the second proximal portion of the balloon are substantially parallel to each other. In one configuration, the first distal portion and the second proximal portion of the balloon are parallel to each other. In one configuration, a proximal portion of the distal portion of the balloon and a distal portion of the proximal portion of the balloon are parallel to each other, that is, the first distal portion and the third proximal portion of the balloon are at least partially parallel to each other. In the catheter distribution configuration, where the first distal portion of the balloon is bent downward toward the third proximal portion of the balloon, the intermediate portion of the balloon serves as the balloon flexion position.The middle portion of the balloon allows it to fold 180° without bending or blocking the balloon lumen.

[0025] The bifurcated stent can be mounted on a catheter comprising a balloon with 3 balloon portions, mounting a first branched stent of the bifurcated stent on a first balloon portion, a second branched stent of the bifurcated stent on a third balloon portion, and a main body of the bifurcated stent on the first balloon portion and the third balloon portion. The second intermediate portion of the balloon does not contain any stent. The intermediate portion serves as the balloon's flexing position.

[0026] In its retractable configuration, the first distal portion, the second central portion, and the third proximal portion of the single balloon of Petition 870250091008, dated 06 / 10 / 2025, page 13 / 61 9 / 29 catheters are arranged in a straight linear configuration along the catheter axis, meaning the first distal portion of the balloon is not curved downwards toward the third proximal balloon.

[0027] Consequently, the catheter can be transferred from its delivery configuration, which is a curved downward configuration, to a retractable configuration, which is a straight single balloon catheter configuration.

[0028] Methods for placing a stent at the aortoiliac bifurcation are also described here. The methods may utilize the stents, bifurcated stents, and catheters described herein.

[0029] In some embodiments, the method for placing a stent in a vessel in immediate proximity to a bifurcation in a patient's vessel comprises: a) mounting a main body stent on a catheter with a single balloon containing a first distal portion, a second central portion, and a third proximal portion; wherein the main body stent is crimped onto a proximal portion of the first distal portion and onto a distal portion of the third proximal portion of the balloon, wherein the first portion of the balloon is folded down over the third portion of the balloon; b) advancing the catheter with the balloon-mounted stent from an ipsilateral vessel past the bifurcation; c) placing the stent in a patient's main vessel in immediate proximity to a vessel bifurcation into the bifurcated blood vessel, partially retracting the catheter;d) Expand the main body stent in the main vessel by inflating the single balloon, e) Deflate the balloon, f) Retract the catheter through the ipsilateral side vessel, g) Remove the catheter from the patient.

[0030] In one embodiment, a method for treating a lesion in a bifurcated blood vessel, including a main vessel and two branching vessels, comprises: a) mounting a first branch of a bifurcated stent on a first balloon portion and a second Petition 870250091008, dated 06 / 10 / 2025, page 14 / 61 10 / 29 of the bifurcated stent branch into a third balloon portion, and the main body of the bifurcated stent into the first balloon portion and the third balloon portion of a balloon catheter; b) advance the catheter with the stent mounted on the balloon portions from an ipsilateral side vessel, passing through the bifurcation; c) place the bifurcated stent at the bifurcation so that the main body is in direct proximity to the bifurcation, partially retracting the catheter; d) expand the bifurcated stent at the bifurcation by inflating the single balloon; e) deflate the balloon; f) retract the catheter through the ipsilateral side vessel; g) remove the catheter from the patient. In some embodiments, a loop may be advanced from the contralateral side to capture the guidewire and facilitate placement of the second stent in the contralateral vessel or to facilitate placement of the main stent in direct proximity to the bifurcation.

[0031] If necessary, post-ballooning of the bifurcated stent can be performed to conform the main body stent and at least two branch stents to the main vessel wall and vessel branches, respectively. The same or similar steps can be used to treat several different bifurcations in the body.

[0032] Furthermore, in certain embodiments, it may be desirable to insert a sheath from the contralateral side adjacent to the bifurcation in order to allow placement of a sheath-protected endoprosthesis. Consequently, in further embodiments of the present invention, a catheter is provided in which the distal portion of the catheter is equipped with an aligner to ensure proper alignment of the sheath tip and the contralateral portion of the balloon-mounted endoprosthesis to prevent damage to the endoprosthesis. Such an aligner may be a damper located distally to the distal end of the balloon or a damper located within the distal end of the balloon, a skirt mounted on the catheter at its distal tip and covering the distal portion of the catheter, including a distal portion of the contralateral part of the endo Petition 870250091008, dated 06 / 10 / 2025, p. 15 / 61 11 / 29 prosthesis. Alternatively, the aligner may be an expandable cage provided with a guide wire and located adjacent to the distal end of the catheter. Brief Description of the Drawings

[0033] Figs. 1A and B illustrate the conventional placement of a stent in the main vessel of a bifurcation.

[0034] Fig. 2 illustrates a catheter device according to the present application in its distribution configuration.

[0035] Fig. 3 illustrates a catheter device according to this application in its retractable configuration.

[0036] Fig. 4 illustrates another embodiment of the catheter device described herein.

[0037] Figs. 5A and B illustrate a medical device according to the present invention.

[0038] Figs. 6A to C illustrate another embodiment of the medical device according to the present invention.

[0039] Figs. 7A to D illustrate a medical device described herein.

[0040] Figs. 8A to D illustrate another embodiment of the medical device described herein.

[0041] Figs. 9A to C illustrate another embodiment of the medical device described herein.

[0042] Figs. 10A to C illustrate another embodiment of the medical device described herein.

[0043] Figs. 11A to C illustrate another embodiment of the medical device described herein.

[0044] Figs. 12 to 16 illustrate various embodiments of a catheter device comprising an aligner. Detailed Description

[0045] Detailed reference will be made to the present achievements. Petition 870250091008, dated 06 / 10 / 2025, p. 16 / 61 12 / 29 preferred aspects of the invention, examples of which are illustrated in the accompanying drawings. The method and corresponding steps of the invention will be described together with the detailed description of the intravascular stent introduction catheter device.

[0046] When treating aortoiliac occlusive disease (AIOD) conventionally, for example, using the CERAB technique, a stent or endoprosthesis must be inserted into the aorta. To optimize the outcome of the stent placement procedure, it is highly beneficial to position this main stent as close as possible to the bifurcation site. Firstly, such close positioning ensures good opening of the stenosed aorta and, secondly, close positioning of the aortic stent at the bifurcation site ensures that the neobifurcation created by stent placement at the bifurcation is as close as possible to the original anatomy of the vessel. However, the balloon 10 of conventional introduction catheters has a relatively large balloon protrusion, mainly due to the relatively large size of these balloons. As can be seen in Fig.1A, due to the balloon protrusion, there is a high risk of excessive dilation of the side branch vessel if the 60 stent is positioned too close to the bifurcation. On the other hand, once it is ensured that the balloon protrusion does not excessively dilate the side branches, the distance between the proximal end of the 60b stent and the bifurcation is too great to allow for smooth placement of the stent at the bifurcation (see Fig. 1B). This problem with the current procedure is independent of whether the treatment is performed retrogradely (from below) or anterogradely (from above), since the balloon protrusion at the distal end of the stent is similar to the balloon protrusion at the proximal end of the balloon. Due to the lower incidence of side effects, physicians generally prefer the retrograde approach.

[0047] According to the present invention, a device is provided Petition 870250091008, dated 06 / 10 / 2025, p. 17 / 61 13 / 29 catheter device that overcomes the problems mentioned above and allows for precise stent placement in a bifurcated vessel using a retrograde approach.

[0048] Fig. 2 illustrates a catheter device according to the present application in its delivery configuration. The balloon catheter 1 for delivery of a bifurcated stent into a bifurcated blood vessel comprises a hub 20; a shaft 2; and a single balloon 10 connected to the shaft at a distal portion of the shaft; an inflation port 21 in the hub in fluid communication with the balloon. The shaft further has a guidewire lumen 22 extending through the hub, shaft, and balloon that houses a pre-loaded guidewire 80. The balloon comprises a first distal portion 11, a second central portion 12, also called the second intermediate portion, and a third proximal portion 13, such that, in its delivery configuration, the first distal portion 11 of the balloon is bent downward toward the third proximal portion 13 of the balloon, so that the first distal portion and the third proximal portion of the balloon are adjacent to each other. In Fig.2, the first distal portion 11 and the third proximal portion 13 of the balloon are shown arranged in a parallel configuration. However, it is readily understood by those skilled in the art that the first and third balloons may also be arranged partially parallel to each other, where a distal portion of the third proximal portion and a proximal portion of the first distal portion are arranged parallel to each other, while a distal portion of the first distal portion of the balloon and a proximal portion of the third proximal portion of the balloon are arranged at an angle to each other.

[0049] As illustrated in Fig. 2, in the catheter distribution configuration, where the first distal portion 11 of the balloon is folded down or folded down towards the third proximal portion 13 of the balloon, the second central portion 12 of the balloon serves as Petition 870250091008, dated 06 / 10 / 2025, page 18 / 61 14 / 29 balloon bending position. The central or intermediate portion of the balloon allows the balloon to bend 180° without bending or blocking the guidewire lumen and without blocking the balloon lumen.

[0050] In general, a variety of dilation balloon catheters are known and suitable for the stent delivery system of the invention. The elongated catheter is sized and configured for delivery through tortuous anatomy. For illustrative purposes only, the catheter shaft 2 incorporated herein comprises an outer tubular element 24 and an inner tubular element 25. As shown in Fig. 2, the inner tubular element 25 defines the guidewire lumen 22 for a preloaded guidewire 80. Although Fig. 2 illustrates the guidewire lumen 22 with an over-the-wire (OTW) configuration, the guidewire lumen 22 can be configured for rapid exchange (RX) delivery, as is well known in the art. Alternatively, the catheter body may include a fixed guidewire to allow the catheter to be delivered to a vessel site without the use of a separate guidewire. The fixed guidewire extends beyond the distal end of the balloon.Optionally, the distal end of the guide wire may be hook-shaped.

[0051] Between the outer tubular element 24 and the inner tubular element 25, an inflation lumen 30 is defined, extending between the proximal end portion and the distal end portion of the catheter shaft 2. Specifically, as illustrated in Fig. 2, the coaxial relationship between the inner tubular element 25 and the outer tubular element 24 defines an annular inflation lumen 30 between them. The balloon 10 is provided in fluid communication with the inflation lumen 30. The inflation lumen 30 can supply fluid under pressure to expand the balloon 10 to an expanded condition and, if desired, establish negative pressure to deflate the balloon 10. The expandable balloon 10 can therefore be inflated and deflated using the inflation lumen. Petition 870250091008, dated 06 / 10 / 2025, page 19 / 61 15 / 29 tion 30. Suitable materials and techniques are well known for catheter shaft construction.

[0052] As illustrated in Fig. 2, the single balloon 10 of the balloon catheter of the present invention may comprise at least a first waist portion 101 between the first distal portion 11 and the second central portion 12 and at least a second waist portion 102 between the second central portion 12 and the third proximal portion of the balloon 13.

[0053] A waist portion is defined as an area of ​​the balloon with a reduced outer diameter compared to adjacent portions of the balloon. In one embodiment, the waist portion has a diameter reduced by at least 50% compared to adjacent portions of the balloon. The length of the waist portion is short, so that the waist portion constitutes a local constriction or narrowing. In one embodiment, the length of the waist is up to 4 mm, preferably up to 2 mm, preferably up to 1 mm. It is explicitly stated that the balloon wall is not fixed to the catheter axis in the area of ​​the waist portion. This means that the balloon has a single lumen and a single inflation or deflation lumen, i.e., the balloon segments share a single lumen, the balloon lumen. The purpose of waist portions 101 and 102 is to increase the bending flexibility of the balloon when inflated.The intermediate portion of the balloon allows it to bend 180° without bending or blocking the balloon lumen. Furthermore, with the intermediate portion of the balloon acting as a bending element, the balloon, according to the invention, will maintain its downward-curved distribution configuration during inflation. Even high pressure in the balloon lumen does not force the balloon to unfold into its retracted configuration or reduce the angle at which the first portion of the balloon is curved downwards over the third portion of the balloon. Additionally, the second portion... Petition 870250091008, dated 06 / 10 / 2025, page 20 / 61 The 16 / 29 balloon, or balloon catheter flexing element, provides high torqueability to the catheter, allowing the physician to rotate the catheter within the body's vessels to facilitate correct positioning of the distal portion of the balloon in the contralateral branch.

[0054] While Fig. 2 shows the balloon catheter of the present invention in a downward curved configuration, which is the configuration in which the balloon is to be deployed to the treatment site, as well as the configuration in which the balloon is inflated for the treatment of a bifurcated blood vessel injury, Fig. 3 illustrates an embodiment of the balloon catheter 1 in its retracted configuration, where the single balloon 10 is shown substantially straight to illustrate the construction principle. The balloon catheter will assume this configuration when removed from the bifurcated blood vessel after deflation.

[0055] As can be seen in Fig. 3 in more detail, in one embodiment of the present application, the balloon catheter comprises a catheter shaft 2; and a single balloon 10 connected to the shaft at a distal portion of the catheter. The catheter shaft 2 comprises an outer tubular member 24 and an inner tubular member 25. The inner tubular member 25 defines the lumen of the guidewire 22 for a guidewire (not shown). Between the outer tubular member 24 and the inner tubular member 25, an inflation lumen 30 extends between the proximal end portion and a distal end portion of the catheter shaft 2. A distal end of the balloon 16 is hermetically attached to the distal end of the inner tubular member 25 to form a catheter tip 40. A proximal end of the balloon 17 is hermetically attached to the distal end of the outer tubular member 24.

[0056] As illustrated in Figs. 2 and 3, the coaxial relationship between the inner tubular element 25 and the outer tubular element 24 defines an annular inflation lumen 30 between them. The balloon 10 is therefore provided with fluid communication with the inflation lumen 30. The balloon Petition 870250091008, dated 06 / 10 / 2025, page 21 / 61 17 / 29 of the balloon catheter represented in Figure 3 comprises a first waist portion 101 between the first distal portion of balloon 11 and the second central portion of balloon 12 and a second waist portion 102 between the second central portion of balloon 12 and the third proximal portion of balloon 13.

[0057] Fig. 3 is an illustration of a catheter device according to the present application in its retractable configuration. In its retractable configuration, which is a straight configuration, the first distal portion 11, the second central portion 12 and the third proximal portion 13 of the single balloon 10 of the catheter 1 are arranged in a straight linear configuration along the axis 2 of the catheter.

[0058] As can be seen in Fig. 3, waist portions 101 and 102 are areas of reduced balloon diameter. The reduction in diameter is at least 50%. The balloon is fixed to the catheter shaft only at its distal 16 and proximal 17 ends. The balloon is not fixed to the catheter shaft (or to the inner or outer tubular limb) at its waist portions.

[0059] This configuration of the second intermediate portion 12 of the balloon being delimited by at least one portion of the waist 101 distal to the second intermediate portion of the balloon and at least one portion of the waist 102 proximal to the second intermediate portion of the balloon allows the balloon to be folded or bent down 180° in its intermediate portion without stretching the balloon and without constriction of the inflation lumen. The individual balloon can thus be inflated and deflated easily and quickly.

[0060] As mentioned earlier, the individual portions of the balloon may have a rotationally symmetrical shape, a cylindrical shape, a conical shape, a stepped shape, or a conical shape. For the central portion of balloon 12, a spherical shape is preferred. In some further embodiments, the central portion of balloon 12 may comprise Petition 870250091008, dated 06 / 10 / 2025, page 22 / 61 18 / 29 one or more additional waist portions, that is, portions of reduced outer diameter compared to the adjacent portions of the balloon. As illustrated in Fig. 3, by way of example, but not limited to, the central portion of the balloon may be configured with a series of shorter balloon portions, interspersed with one, two, three, four, five, six, seven, eight, nine, ten or more additional waist portions. The shorter balloon portions may be spherical in shape or assume any other shape suitable to allow bending or folding of the balloon without constriction.

[0061] After placement of a bifurcated stent in a bifurcated vessel, post-dilation of a proximal portion of the main stent or aortic stent is frequently performed, regardless of the system or technique applied, using a larger diameter balloon. This is done to ensure better contact of the main portion of the stent with the vessel wall, in order to guarantee a smooth transition and avoid turbulence, blood clotting, and restenosis in that area. This procedure requires an additional balloon.

[0062] To meet this need, a further embodiment of the present invention comprises a balloon catheter according to the present invention, as described in detail above, the balloon catheter further comprising a second additional balloon located proximal to the first balloon and mounted on the catheter shaft. The second balloon is in fluidic communication with a second inflation lumen and a second inflation port in the hub at the proximal end of the shaft.

[0063] As shown in Fig. 4, in one embodiment, the balloon catheter 1 for the introduction of a stent into a bifurcated blood vessel comprises a proximal hub 20; a shaft 2; and a single balloon 10 connected to the shaft at a distal portion of the shaft; a first inflation port 21 in the hub in fluid communication with the balloon. The Petition 870250091008, dated 06 / 10 / 2025, page 23 / 61 The 19 / 29 shaft also has a guidewire lumen 22 that houses a preloaded guidewire 80 and extends through the hub, shaft, and balloons 10 and 210. The single balloon comprises a first distal balloon portion 11, a second central balloon portion 12, and a third proximal balloon portion 13, such that, in its release configuration, the first distal balloon portion 11 is folded downward toward the third proximal balloon portion 13, so that the first distal and third proximal balloon portions are arranged adjacent to each other (Figure 4 illustrates the catheter in its unfolded configuration). The catheter further comprises an additional balloon 210 located proximal to the first single balloon 10 and mounted on the catheter shaft. The second balloon 210 is in fluid communication with a second inflation lumen 230 and a second inflation port 221 in the hub at the proximal end of the shaft.

[0064] The second balloon 210 has an outer diameter greater than the maximum diameter of the single balloon 10. In another embodiment, the outer diameter of the second additional balloon is equal to or greater than the outer diameter of the first distal portion and the third proximal portion of the balloon in the downward curved configuration.

[0065] As illustrated above, methods for placing a stent or endoprosthesis at the aortoiliac bifurcation are also described herein. The methods may utilize the stents, endoprostheses, bifurcated stents or bifurcated endoprostheses and catheters described herein.

[0066] In some embodiments, the method for placing a stent or stent graft in a vessel in immediate proximity to a bifurcation in a patient's vessel comprises: a) mounting a main body stent on a catheter having a single balloon having a first distal portion, a second central portion, and a third proximal portion; wherein the main body stent is crimped onto a proximal portion of the first distal portion and onto a distal portion Petition 870250091008, dated 06 / 10 / 2025, page 24 / 61 20 / 29 of the third proximal portion of the balloon, where the first portion of the balloon is folded down into the third portion of the balloon; b) retrogradely advance the catheter with the balloon-mounted stent or stent graft beyond the bifurcation; c) place the stent in a patient's main vessel in immediate proximity to a vessel bifurcation by partially retracting the catheter; d) expand the main body stent into the main vessel by inflating the single balloon; e) deflate the balloon; f) retract the catheter; g) remove the catheter from the patient.

[0067] In one embodiment, a method for treating a lesion in a bifurcated blood vessel, including a main vessel and two branching vessels, comprises: a) mounting a first branch of a bifurcated stent or stent graft on a first balloon portion and a second branch of the bifurcated stent on a third balloon portion, and the main body of the bifurcated stent on the first balloon portion and the third balloon portion of a balloon catheter; b) retrogradely advancing the catheter with the stent mounted on the balloon portions of a vessel on the ipsilateral side through the bifurcation; c) placing the bifurcated stent or stent graft in the bifurcation so that the main body is in direct proximity to the bifurcation, the first branch seated in the vessel on the ipsilateral side and the second branch seated in the vessel on the contralateral side, partially retracting the catheter;d) Expand the bifurcated stent or stent graft at the bifurcation by inflating the single balloon; e) Deflate the balloon; f) Retract the catheter through the ipsilateral vessel; g) Remove the catheter from the patient.

[0068] In some embodiments, a loop may be advanced from the contralateral side to capture the balloon catheter guidewire and facilitate placement of the second arm in the contralateral vessel or to facilitate placement of the bifurcated stent main body in direct proximity to the bifurcation. Petition 870250091008, dated 06 / 10 / 2025, page 25 / 61 21 / 29

[0069] Furthermore, in certain embodiments, such as, but not limited to, cases where the contralateral vessel comprises narrow lesions, it may be preferable to introduce a sheath into the contralateral vessel prior to stent or endoprosthesis implantation, thus allowing for sheath-protected introduction of the stent or endoprosthesis on the contralateral side.

[0070] Referring now to Figures 5A and B, which illustrate a medical device according to an embodiment of the present invention. The medical device comprises the catheter of the present invention and a stent mounted on it.

[0071] Fig. 5A illustrates a medical device system for treating a lesion in a bifurcated blood vessel, the system comprising a stent 60 consisting of a main body 65 and the catheter of the present invention for delivering the stent into the bifurcated blood vessel.

[0072] The catheter comprises a single balloon with a first distal portion 11, a central portion 12 and a third proximal portion 13, wherein a main body of a stent 65 is pressed into a proximal portion of the first distal portion and into a distal portion of the third portion of the balloon, wherein the first portion of the balloon 11 is folded down over the third portion of the balloon 13. The first distal portion of the balloon and the third proximal portion of the balloon are therefore arranged side by side, and the main portion of the stent is pressed into both the first and third portions of the balloon.

[0073] As can be seen in Figure 5B, which illustrates the medical device of Figure 5A being placed and expanded near the bifurcation in a bifurcated vessel, the use of the balloon folded downwards or curved in a retrograde delivery approach allows for proper positioning of the main portion of the stent in the main vessel, but close to the bifurcation, without the risk of excessive dilation of the Petition 870250091008, dated 06 / 10 / 2025, p. 26 / 61 22 / 29 branches. Consequently, the balloon catheter of the present invention allows for the accurate, precise, and damage-free delivery of a stent into the main artery, close to the branches of the bifurcated vessel.

[0074] In other preferred embodiments of the present invention, the stent 60 is a bifurcated stent comprising a main body stent 65, a first branch stent 63 and a second branch stent 61, which is mounted on a balloon catheter of the present invention for delivery into a bifurcated vessel. Fig.Figure 6A illustrates a medical device for treating a lesion in a bifurcated blood vessel, the system comprising a bifurcated stent comprising a main body stent portion, a first branched stent portion 63 and a second branched stent portion 61; a catheter for introducing the bifurcated stent into the bifurcated blood vessel, the catheter comprising a single balloon with a first distal portion, a second central portion and a third proximal portion; wherein the first branched stent 63 is crimped into a distal portion of the first distal portion 11, the second branched stent 61 is crimped into a proximal portion of the third proximal portion 13 and the main body stent 65 is crimped into a proximal portion of the first distal portion and into a distal portion of the third proximal portion, wherein the first balloon portion is folded down over the third balloon portion.

[0075] As illustrated in Fig. 6B, the medical device is introduced into the bifurcation of a vessel through an ipsilateral access. After the balloon catheter is deflated and removed, the bifurcated stent completely covers the bifurcation of the treated vessel (see Fig. 6C).

[0076] Another device and approach for treating a lesion in a bifurcated vessel are illustrated in Figs. 7A to D. The device illustrated in Fig. 7A corresponds to the device shown and described in Fig. 5. A 65 main stent is placed near the bifurcation, using Petition 870250091008, dated 06 / 10 / 2025, page 27 / 61 23 / 29 a balloon catheter of the present invention and using an ipsilateral access site. To further cover the legs of the bifurcation, a first leg stent 161 is employed in the first lateral branch, using ipsilateral access, and a second leg stent 163 is employed in the second lateral branch, using a contralateral access site. The leg stents may be placed adjacent to the main stent or in an overlapping configuration with a proximal portion of the main stent.

[0077] A similar approach is illustrated in Figs. 8A to D. The main stent in this embodiment differs from the main stent shown in Figs. 7A to D, as the main stent 65 of this alternative embodiment comprises two wing-shaped structures 69a and 69b at its proximal end. Each of these wings reaches one of the lateral branches of the bifurcation, thus increasing wall coverage and support in the transition area between the main body stent 65 and the lateral branches. If the lateral branch stents 161 and 163 are employed in two subsequent deployment steps, in the same manner described for the embodiment of Figures 7A to D, the wings overlap the distal portions of the lateral branch stents, thus increasing wall coverage and support in the transition area between the main body stent 65 and the lateral branch stents 161 and 163.

[0078] In other embodiments, the bifurcated stent mounted on the balloon catheter of the present invention comprises a main body stent 65 and a branch stent 61 formed integrally, i.e., in a single piece. As shown in Figs. 9A to 9C, a stent comprising a main body stent 65 and a branch stent are loaded onto the balloon catheter by mounting the main body of a stent 65 on a proximal portion of the first distal portion 11 and on a distal portion of the third balloon portion 13, in Petition 870250091008, dated 06 / 10 / 2025, page 28 / 61 24 / 29 where the first balloon portion is folded down onto the third balloon portion, and where the one-branch stent is crimped onto a proximal portion of the third proximal balloon portion so that the side-branch stent covers the branch of the bifurcation that was used as an access site for the catheter, i.e., the ipsilateral vessel.

[0079] As shown in Figures 10A to C, a stent comprising a main body stent 65 and a branch stent 63 is loaded onto the balloon catheter by mounting the main body of a stent 65 onto a proximal portion of the first distal portion 11 and onto a distal portion of the third portion of the balloon 13, so that the first portion of the balloon is folded down over the third portion of the balloon and the branch stent 63 is crimped onto a distal portion of the first distal portion of the balloon, so that the side branch stent 63 covers the vessel of the contralateral branch of the bifurcation, i.e., the vessel. In a second step, a second branch stent 161 can then be implanted into the ipsilateral vessel, using the same access site as in the procedure.

[0080] In a further embodiment of the present invention (Figs. 11A to C), a first stent comprising a main body stent 65a and a first branch stent 63 and a second stent comprising a main body stent 65b and a second branch stent 61 are loaded onto the balloon catheter by mounting the main bodies 65a and 65b of the first and second stents overlapping onto a proximal portion of the first distal portion 11 and onto a distal portion of the third portion of the balloon 13, wherein the first portion of the balloon is folded down over the third portion of the balloon, and wherein the first branch stent 63 of the first stent is crimped onto a distal portion of the first distal portion 11 of the balloon, and wherein the second branch stent 61 of the second stent is crimped 870250091008, dated 06 / 10 / 2025, page 29 / 61 25 / 29 padded into a proximal portion of the third proximal portion 13 of the balloon.

[0081] Referring now to Figs. 12 to 16, which illustrate various embodiments of a further aspect of the present invention. As illustrated above, in some embodiments, a loop can be advanced from the contralateral side to capture the guidewire of the device and facilitate placement of the distal end of the stent or endoprosthesis into the contralateral vessel. Furthermore, in certain embodiments, it is preferable to introduce a sheath into the contralateral vessel and position the tip of the sheath beyond the lesion to allow sheath-protected introduction of the contralateral stent or endoprosthesis branch prior to endoprosthesis implantation.

[0082] To ensure smooth entry of the distal portion of the balloon carrying the stent or endoprosthesis when pulling the distal balloon into the contralateral vessel by pulling the distal end of the guidewire, the first distal portion of the balloon carrying the stent and the sheath are preferably aligned along their axis to avoid damage to the stent or endoprosthesis upon entering the sheath. Such alignment of the first portion of the balloon and the sheath can be improved or ensured by an aligner. Consequently, the present invention also relates to a balloon catheter carrying a stent or endoprosthesis and comprising an aligner distal to the distal end of the crimped stent or endoprosthesis.

[0083] In some embodiments, such an aligner is fixed to the catheter shaft in a distal portion thereof. As illustrated in Fig. 12, in a first embodiment, the aligner 200 is a shock absorber 201 fixed to the catheter shaft 2, below the distal end of the distal portion of the balloon 11, distal to the distal end of the stent 63.

[0084] Fig. 13 depicts an alternative embodiment of the aligner 200. A shock absorber 202 is attached to the tip of the catheter 40, distal Petition 870250091008, dated 06 / 10 / 2025, p. 30 / 61 26 / 29 to the distal end of balloon 11. In both embodiments, the buffer 201, 202 is dimensioned so that the outer diameter of the buffer is approximately the outer diameter of the distal portion of the stent or stent graft 63 pressed into the balloon. The diameter of the buffer may be equal to the diameter of the distal end of the crimped stent or stent graft, or it may be up to 10% larger or up to 20%, preferably 10%, preferably 5% smaller than the diameter of the distal end of the crimped stent or stent graft. The buffer may have any shape sufficiently smooth to guide the catheter of the present invention smoothly into a vascular lesion or sheath, the buffer, in particular, having a spherical shape. The buffer may be produced from any material suitable for being firmly attached to the catheter shaft and having a surface sufficiently smooth to ensure proper functioning of the balloon and catheter.The preferred materials are polymers or metal alloys.

[0085] In an alternative embodiment, as illustrated in Fig. 14, the aligner 200 may be in the form of a skirt 203 attached to a portion of the catheter tip 40, located at the distal end of the balloon 11. The skirt covers the distal cone of the balloon as well as a distal portion of the stent or stent graft 63, pressed into the balloon. The skirt may be made of a highly flexible material to ensure proper stent expansion after balloon inflation or, in an alternative embodiment (not shown), the skirt may have one or more perforation lines in the longitudinal direction that serve as predetermined rupture points to allow smooth and complete stent expansion.

[0086] In a further alternative embodiment, the 200 catheter aligner may be provided with the 80, 500 guidewire supplied with the catheter, prefixed or preloaded onto the catheter. As illustrated Petition 870250091008, dated 06 / 10 / 2025, p. 31 / 61 27 / 29 in Fig. 15, the guidewire 500 comprises a grooved tube that expands under tension to form a cage 205 around the guidewire. This cage is positioned adjacent to the distal end of the catheter and functions as the aligner 200.

[0087] Such a cage guidewire generally comprises a first proximal guidewire portion, a second distal guidewire portion, and a cage portion comprising a grooved tube, wherein the distal end of the proximal guidewire portion is fixed to the distal end of the grooved tube and the proximal end of the distal guidewire portion is fixed to the proximal end of the grooved tube. Thus, the grooved tube expands when the ends of the guidewire are pulled apart. To ensure that the cage recovers its original flat structure after the release of the tensile force, a shape-memory metal alloy can be used to form the grooved tube. In an alternative embodiment, a metal spring can be attached to the ends of the grooved tube to ensure the elongation of the cage after the release of the tensile forces.

[0088] As an example, and not as a limitation, an embodiment of such a guide wire comprising an aligner is illustrated in Fig. 16.

[0089] The guide wire 500 comprises a metallic core 501, which determines the individual stiffness of the guide wire, and an ePTFE-coated spring 502 that surrounds the metallic core. The spring and core are welded together at the proximal end of the guide wire 402. In addition, a proximal flat metallic wire 505 is welded to the proximal end of the guide wire, the proximal flat metallic wire extending through the spring 502 parallel to the core of the guide wire 501.

[0090] A grooved tube 510 is provided, which will be able to form a cage under tension, providing the catheter aligner. The tube may have 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 or more grooves. Petition 870250091008, dated 06 / 10 / 2025, pp. 32 / 61 28 / 29 grooves. The grooves can be arranged symmetrically around the tube or at irregular distances from each other.

[0091] The proximal end of the grooved tube is welded to the distal end of the ePTFE-coated proximal spring 502, as well as to the proximal end of a metal spring 520 supplied below the grooved tube 510 and to the proximal end of a distal flat wire 506 at welding point 403. The metal core 501 and the proximal flat wire 305 pass through the tube and spring. The guide wire core extends further beyond the distal part of the grooved tube 510. The distal end of the grooved tube 510 is welded to the proximal end of an ePTFE-coated distal spring 503, to the distal end of the metal spring 520 and to the distal end of the proximal flat wire 505 at welding point 407. The distal end of a distal flat wire 506 is welded to the distal end of the ePTFE-coated distal spring 503 at welding point 409.

[0092] In this configuration, pulling the guidewire at its distal end, while keeping the proximal end of the guidewire fixed, will force the grooved tube 510 to compress, resulting in a cage-like state.

[0093] Due to the metal spring 520 under the grooved tube 510, the grooved tube is stretched backward and flattened when the tensile force at the distal end ceases. The metal core 501 of the guide wire ends just after the distal end of the tube. This prevents accidentally pulling the metal core. In addition, the metal core 501 moves within the grooved tube 510 and the ePTFE-coated distal spring 503.

[0094] This descriptive report describes, by way of example and not limitation, a possible implementation mechanism for a guide wire cage aligner. However, those skilled in the art will be readily aware of any variations and modifications to the Petition 870250091008, dated 06 / 10 / 2025, pp. 33 / 61 29 / 29 indeed.

[0095] It should be noted that any aligner specification described above may be used alone or in any combination thereof. Consequently, the present invention relates to a balloon catheter, wherein the balloon catheter comprises one or more aligners positioned distally to the distal end of the stent, which is mounted on the balloon.

[0096] Although the above is a complete description of preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. The various features of the embodiments disclosed herein may be combined or substituted for one another. Therefore, the above description should not be considered limiting to the scope of the invention, which is defined by the appended claims. Furthermore, any combination of the elements described above, in all its possible variations, is encompassed by the invention, unless otherwise indicated herein or clearly contradicted by the context. It should be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not limitation, alternative configurations of the present invention may be used in accordance with the teachings presented herein. Petition 870250091008, dated 06 / 10 / 2025, pp. 34 / 61

Claims

1 / 3 CLAIMS 1. Balloon catheter for delivering a bifurcated stent into a bifurcated blood vessel, the balloon catheter characterized in that it comprises: a hub; a shaft; and a single balloon connected to the shaft; an inflation port in the hub in fluid communication with the single balloon; wherein the single balloon comprises a first distal portion, a second central portion and a third proximal portion, wherein in its delivery configuration the first distal portion of the balloon is bent down to the third proximal portion of the balloon so that the first distal portion and the third proximal portion of the balloon are arranged adjacent to each other.

2. Balloon catheter, according to claim 1, characterized in that the balloon catheter comprises a guidewire lumen that hosts a pre-loaded guidewire and extends through the hub, shaft and balloon.

3. Balloon catheter, according to claim 1, characterized in that the balloon catheter comprises a fixed guidewire extending beyond the distal end of the balloon.

4. Balloon catheter, according to any one of claims 1 to 3, characterized in that the single balloon comprises at least one first waist portion between the first distal portion and the second central portion and at least one second waist portion between the second central portion and the third proximal portion of the balloon.

5. Balloon catheter, according to any one of claims 1 to 4, characterized in that the first distal portion and the third proximal portion of the single balloon are of rotationally symmetrical shape, and / or cylindrical shape, and / or conical shape, and / or stepped cylindrical shape.

6. Balloon catheter, according to any of claims 1 to 5, characterized in that the second central portion of the single balloon has a spherical shape.

7. Balloon catheter, according to any one of claims 1 to 5, characterized in that the second central portion of the single balloon is formed by a series of spherically shaped balloon portions interspersed with 1 to 10 waist portions.

8. Balloon catheter, according to any one of claims 1 to 7, characterized in that the single balloon maintains its downward curved configuration when inflated in the bifurcated blood vessel.

9. Balloon catheter, according to any one of claims 1 to 8, characterized in that the balloon catheter comprises a second balloon mounted on the proximal catheter shaft of the single balloon and being in fluid communication with a second inflation lumen.

10. Balloon catheter, according to claim 9, characterized in that the second balloon has an outer diameter larger than the maximum diameter of the single balloon.

11. Balloon catheter, according to any one of claims 1 to 10, characterized in that with a stent being mounted on the single balloon, wherein a main body of a stent is mounted on a proximal portion of the first distal portion and on a distal portion of the third portion of the balloon, while the first portion of the balloon is folded down onto the third portion of the balloon.

12. Balloon catheter, according to any one of claims 1 to 10, characterized in that with a bifurcated stent comprising a main body stent, a first branch stent and a second branch stent being mounted on the single balloon, wherein the first branch stent is mounted on a distal portion of the first distal portion, the second branch stent is mounted on a proximal portion of the third proximal portion, and wherein the main body of the stent is mounted on both a proximal portion of the first distal portion and a distal portion of the third balloon portion, while the first balloon portion is folded down onto the third balloon portion.

13. Balloon catheter, according to claim 12, characterized in that the main portion of the stent body, the first portion of the stent branching, and the second portion of the stent branching are formed in a single piece, or in that the main portion of the stent body, the first portion of the stent branching, and the second portion of the stent branching are each formed from a single stent.

14. Balloon catheter, according to any of the preceding claims, characterized in that the stent is a stent graft.

15. Balloon catheter, according to any one of claims 11 to 14, characterized in that the balloon catheter comprises one or more aligners positioned distally to the distal end of the stent that is mounted on the balloon. Petition 870250091008, dated 06 / 10 / 2025, p. 37 / 61

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