Oval balloon catheter and method of manufacturing
Patent Information
- Application Number
- PCT/EP2026/060759
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2025-04-14
- Filing Date
- 2026-04-14
- Publication Date
- 2026-10-22
Smart Images
Figure EP2026060759_22102026_PF_FP_ABST
Abstract
Description
[0001] Applicant: CardiaNova GmbH
[0002] Our Ref.: CMG29733PCT
[0003] Date: April 14, 2026
[0004] 1
[0005] Description
[0006] Balloon catheter, method of manufacturing a balloon catheter and method for treatment of a heart valve
[0007] The present invention relates to a balloon catheter, a method of manufacturing a balloon catheter and a method for treatment of a heart valve.
[0008] The invention is used for the treatment of stenosed heart valves. In order for a valve to function correctly, it must open as well as possible and close completely. Due to degeneration processes such as calcification and fibrosis, the leaflets of the valve become immobile and stenosis occurs. Balloon dilatation can improve the mobility of the leaflets, reduce the transvalvular pressure gradients and increase the opening area. Balloon dilations are also performed during minimally invasive heart valve implantation (transcatheter aortic valve implantation, TAVI). This is done both for predilatation of the valve and for post-dilatation in the event of insufficient expansion and apposition of the inserted valve prosthesis.
[0009] Aortic stenosis is the most common valve disease and affects around 5% of people over the age of 75. If left untreated, aortic stenosis leads to performance intolerance, reduced quality of life, heart failure, cardiac arrhythmia and death. TAVI is significantly less invasive than open surgical valve replacement and is therefore being used more and more frequently. To enable the insertion of a transcatheter valve, the native, stenosed valve is pre-stretched with a balloon catheter. If the valve prosthesis does not expand sufficiently, the valve is also post-dilated, again with a balloon catheter. Balloon dilatation can also be used as the sole treatment for aortic stenosis, for example as an emergency treatment for patients with cardiovascular decompensation or if TAVI is not available.Applicant: CardiaNova GmbH
[0010] Our Ref.: CMG29733PCT
[0011] Date: April 14, 2026
[0012] 2
[0013] In such treatments of the valve, it is desirable to apply homogeneous pressure from the circumference of the balloon to the valve.
[0014] The balloons traditionally used are usually made from a plastic that is extruded into the balloon shape. The plastic used is polyamide (PA) or polyethylene (PE), for example. However, these materials can tear under heavy stress, for example due to severe calcification of the valve or high pressure.
[0015] The object of the present invention is therefore to create a solution by means of which a balloon catheter can be used in a simple, reliable and more effective manner during an interventional procedure.
[0016] According to a first aspect, the problem is solved by a balloon catheter with the features of claim 1.
[0017] In particular, the problem is solved by a balloon catheter comprising a tube and an expandable balloon. The tube can also be referred to as a shaft. The expandable balloon will hereinafter also be referred to a balloon. The balloon catheter is characterized in that in the expanded state of the balloon, the balloon at least partially has an oval cross-section perpendicular to the longitudinal axis of the balloon and the balloon and / or the tube comprises at least one radiopaque marker.
[0018] A balloon catheter is a catheter which has a tube on which a balloon is provided which can be expanded at least in the diametrical direction of the tube. For this purpose, a fluid, for example gas, can be fed to the balloon via the tube. At least one inlet opening is provided in the tube, via which the fluid can enter the interior of the balloon.
[0019] The expandable balloon can be made of an expandable material. Alternatively or additionally, the balloon can have a shape that allows an increase in theApplicant: CardiaNova GmbH
[0020] Our Ref.: CMG29733PCT
[0021] Date: April 14, 2026
[0022] 3
[0023] circumference of the balloon between a folded state and an expanded state. In this case, the balloon can be made of a non-stretchable material.
[0024] According to the invention, the balloon has at least partially an oval cross-section in the expanded state perpendicular to the longitudinal axis of the balloon. The longitudinal axis of the balloon is defined as its extension, which lies in the direction of the longitudinal axis of the tube of the balloon catheter.
[0025] Preferably, the balloon has an oval cross-section at least in the central area in which the balloon has the largest diameter in the expanded state. The balloon, which at least partially has an oval cross-section, can also be referred to as an oval balloon or elliptical balloon. The cross-section of the oval balloon has a long and a short axis. The long and the short axes are preferably perpendicular to each other in the oval cross-section.
[0026] An elliptical or oval balloon according to the invention can be used to accommodate the patient's native anatomy. The base of the aortic valve, the so-called annulus, is usually an oval structure, i.e. has a long axis and a short axis. It has been shown that in most patients the long axis of this oval is approx. 5 mm longer than the short axis. This applies both to small annuli, where the difference averages around 4.5 mm, and to large annuli with an average difference of around 5.2 mm. The long axis extends from the commissure between the non-coronary and right coronary pocket to the center of the left coronary pocket. If a balloon with a circular cross-section, i.e. with a constant radius over the circumference, is expanded in this oval structure, the tissue is not dilated evenly everywhere. The short axis of the annulus is stretched more than the long axis. A balloon can therefore not be too large, as this can lead to tissue damage and even rupture, which is usually fatal. In addition, the risk of cardiac arrhythmia and the need for a pacemaker implantation increase. For this reason, a smaller balloon is usually used, for example for pre-stretching in a TAVI procedure. The same applies to the post-dilation of transcatheter valves. Self-expanding valves are also oval in the annulus area. In the event of malapposition, this results in anApplicant: CardiaNova GmbH
[0027] Our Ref.: CMG29733PCT
[0028] Date: April 14, 2026
[0029] 4
[0030] increased transvalvular pressure gradient and a leak next to the valve (paravalvular leak). In addition, underexpansion of the annulus may lead to premature degeneration of the valve and localized clot formation, which may increase the risk of stroke. Similar to post-expansion of the native valve, post-expansion of the prosthetic valve carries a risk of annulus rupture, arrhythmias, implantation of a temporary pacemaker and dislocation of the valve. In addition, most paravalvular leaks occur in the area of the left coronary pocket, in the long axis.
[0031] Since it has been found, that the annulus of the aortic valve is an oval structure in most patients, the balloon catheter according to the present invention with an oval balloon is advantageous. In particular, the aortic valve as well as an aortic valve prosthesis can be pre- and post-expanded more safely and effectively with an oval balloon, thus preventing the disadvantages that can occur when using a balloon with a circular cross-section.
[0032] According to the invention, the balloon and / or the tube has at least one radiopaque marker. The radiopaque markers may also be referred to as markers, markings or radiopaque markings. The markers, which are visible in a fluoroscopic procedure, can serve for indicating the orientation of the oval cross-section of the balloon during the procedure. Thus, by providing at least one marker on the balloon or tube, reliable positioning of the balloon in the patient's body can be ensured. In particular, the balloon can be aligned with the patient's anatomy by means of the markers.
[0033] According to an embodiment of the balloon catheter, where a tissue-like coating is applied to at least part of the balloon, the markers may be applied a tissue-like coating or incorporated into a tissue-like coating of the balloon. The marker or markers may be provided at a section of the tissue-like coating extending over the longitudinal ends of the balloon. In these sections, the tissue-like coating is attached to the tube.Applicant: CardiaNova GmbH
[0034] Our Ref.: CMG29733PCT
[0035] Date: April 14, 2026
[0036] 5
[0037] According to a preferred embodiment, the at least one radiopaque marker is provided at the balloon and / or tube at a position corresponding to the short axis (kA) and / or long axis (IA) of the balloon. Preferably, the markers are provided at a position corresponding to the circumferential position of an end of the respective axis. The marker is preferably positioned at the circumferential position of one or both ends of the respective axis. The markers may be positioned at the balloon at the one or both ends of the respective axis. Alternatively, the markers may be positioned at the tube in a circumferential position which corresponds to the circumferential position of one or both ends of the respective axis at the balloon but which is distal to a distal end or proximal to a proximal end of the balloon.
[0038] By using one or more markers which correspond to the circumferential position of the short or long axis of the balloon, the physician can use these markers to adjust the position of the balloon by rotation to align the long axis of the balloon with the long axis of the annulus and thereby the short axis of the balloon with the short axis of the annulus.
[0039] In order to allow rotation of the balloon by rotating the tube, the tube preferably has a high torsional stiffness. Only with a sufficient rigidity and stability of the tube, it can be assured, that by rotating the proximal end of the tube by the physician, also the rotational position of the balloon, which is normally positioned at or near the distal end of the tube, will be changed and can thus be adjusted.
[0040] On the oval balloon according to the invention, the markers are preferably positioned in such a way that they visualize at least one of the long and short axes of the balloon. For example, a marker can be positioned at each end of the long axis and the short axis of the oval or elliptical cross-section on the balloon, on / in the coating and / or at the corresponding positions on the tube. This allows the orientation of the long and short axis of the balloon to be visualized.Applicant: CardiaNova GmbH
[0041] Our Ref.: CMG29733PCT
[0042] Date: April 14, 2026
[0043] 6
[0044] The orientation of the long axis of the annulus of the aortic valve almost always runs in the same direction: from the commissure between the non-coronary and right coronary pocket to the left coronary pocket. This means that the oval balloon can be anatomically correctly aligned and expanded, in particular deployed, in the patient by means of fluoroscopy using appropriate markers that are visible on the X-ray. In particular, the so-called LAO (left anterior oblique) cranial projection (from the upper left) of the C-arm usually represents the long axis of the annulus and the so-called RAO (right anterior oblique) caudal projection (from the lower right, also known as cusp-overlap view or two-cusp view) represents the short axis. The exact projection of the short and long axes can be determined using a computer tomography scan of each patient with commercially available software packages. The radiopaque markers of the oval balloon catheter can then be aligned in the respective projection. In this way, the anatomically correct deployment of the balloon is achieved.
[0045] According to one embodiment, the marker comprises a circumferential section and a longitudinal section. The sections can form a single marker or can be separate to each other.
[0046] The circumferential section may have the shape of a stripe. The stripe may extend over the entire circumference of the balloon or the entire circumference of the tube. Alternatively, the stripe may extend over only part of the circumference balloon or of the tube.
[0047] The longitudinal section of the marker may have the shape of a stripe. This stripe may extend from the circumferential section in distal or proximal direction. The width of this stripe is preferably smaller than the diameter of the tube, if it is provided on the tube.
[0048] By providing a longitudinal section of a marker, a rotation of the tube and thereby of the balloon can be visualized and the physician is able to adjust the rotational position of the balloon accordingly.Applicant: CardiaNova GmbH
[0049] Our Ref.: CMG29733PCT
[0050] Date: April 14, 2026
[0051] 7
[0052] According to one embodiment, the longitudinal section of the marker is provided at a circumferential position corresponding to the circumferential position of at least one end of the long axis. With this configuration of the marker, the physician can align this marker section with the long axis of the annulus and thereby assure, that the long axis of the balloon will be parallel to the long axis of the annulus.
[0053] According to one embodiment, the balloon and / or the tube comprises at least two radiopaque markers. In this embodiment, each marker preferably comprises a circumferential section. For example, two markers may be provided at or close to the proximal end of the balloon and at or close to the distal end of the balloon, respectively. With this embodiment the positioning of the balloon in the heart valve can be facilitated for the physician.
[0054] The balloon preferably has a high form stability. In particular, the ballon material and / or - if present - a coating on the balloon material, provide a form stability which allows expansion of the balloon without being pushed into any recesses in the heart valve. Thereby, also with calcified leaflets of the heart valve, an even pressure for dilatating the heart valve can be ensured and damage to the balloon can be avoided.
[0055] According to a preferred embodiment, a fabric-like coating is applied to at least part of the balloon. The balloon preferably has a central area which merges into a tapered area at each of the two longitudinal ends. The central area can is an oval area and the tapered areas can be conical areas. The transition between the central area and each of the tapered areas is also referred to as a balloon shoulder. Preferably, the coating is applied to at least the central region. In addition, the coating can also extend over at least part of the tapered areas, i.e. cover the balloon shoulder. It is also possible for the coating to cover both the central area and the entire tapered areas. Finally, it is also possible for the coating to extend beyond the ends of the tapered areas and thus to also cover part of the tube.Applicant: CardiaNova GmbH
[0056] Our Ref.: CMG29733PCT
[0057] Date: April 14, 2026
[0058] 8
[0059] The central area can represent an area over the length of which the cross-section is constant. However, it is also within the scope of the invention that the cross-section in the central area increases from the two axial ends towards the middle of the length of the central area. However, the increase in cross-section is small.
[0060] According to a preferred embodiment, the balloon shoulders are not steps, but represent a rounded transition.
[0061] According to a further preferred embodiment, the transition from the tube to the balloon, in particular to the tapered areas, is also not a step, but a rounded transition.
[0062] The coating of the balloon is a fabric-like coating. A coating that consists of threads that at least intersect is referred to as a fabric-like coating. The fabric-like coating can therefore be a fabric, mesh or grid.
[0063] By providing the balloon at least partially with a fabric-like coating, damage to the balloon can be prevented or at least minimized. In particular, the fabric-like coating can prevent the balloon from bursting, if it is accidentally overstretched beyond its maximum diameter. In addition, the tissue-like coating can prevent accidental puncturing, for example by a wire from an implant that is positioned over the balloon. Should the balloon nevertheless be punctured, the tissue-like coating prevents or stops the formation of a tear. The tissue-like coating can therefore also be referred to as balloon protection.
[0064] Finally, the shape of the balloon in the expanded state, in particular its cross -section, can be defined by the fabric-like coating. In this embodiment, the coating is preferably not expandable or only slightly expandable and the balloon is expanded by unfolding a balloon folded in the unexpanded state.Applicant: CardiaNova GmbH
[0065] Our Ref.: CMG29733PCT
[0066] Date: April 14, 2026
[0067] 9
[0068] In the embodiment, where the balloon of the balloon catheter has a tissue-like coating, the shape of the balloon in the expanded state of the balloon can preferably be predetermined by the tissue-like coating. The fabric-like coating can therefore also be referred to as a fabric-like surface support structure. A suitable shape of the fabric-like coating can therefore be used, in particular, to ensure that the balloon takes on an elliptical rather than a circular shape in cross-section when unfolded.
[0069] According to one embodiment, the coating is applied to at least that part of the balloon which has the largest diameter when the balloon is expanded. The expanded state is the state of the balloon in which the balloon is expanded, i.e. inflated. If the balloon is overstressed, in particular if fluid is supplied in excess of a maximum quantity, the balloon will generally fail at the part with the largest diameter. By applying the coating to this part of the balloon, the balloon can be reliably prevented from bursting. In the case of a balloon that has a central area with adjoining tapered areas, the coating is applied to the central area and preferably covers it completely.
[0070] According to one embodiment, the balloon material and / or the coating has shape memory. The balloon material is the material from which the balloon is made and to which the coating is applied. Material with shape memory is a material that returns to its original shape after evacuation of the liquid that inflates the balloon. This ensures reliable removal of the balloon after positioning of the implant or treatment of a vessel by the balloon without damaging the balloon.
[0071] According to one embodiment, the coating is a fabric. In this embodiment, the coating can also be referred to as a fabric layer. A woven fabric is a textile fabric that consists of at least two thread systems that cross at an angle of exactly or approximately 90° when viewed from the fabric surface. The thread systems are also referred to as warp threads and weft threads. By forming a fabric, the coating can withstand a certain degree of expansion of the balloon without tearing, as the warp and weft threads can move against each other by a certain amount.Applicant: CardiaNova GmbH
[0072] Our Ref.: CMG29733PCT
[0073] Date: April 14, 2026
[0074] 10
[0075] According to one embodiment, the warp and weft threads in the coating are inclined at an angle to the longitudinal axis of the balloon. The angle between the threads of the fabric and the longitudinal axis of the balloon can be 45°, for example. By positioning the warp threads and weft threads at an angle to the longitudinal axis of the balloon, the formation of cracks running in the longitudinal direction or in the circumferential direction of the balloon can be reliably prevented or at least stopped by both the warp threads and the weft threads.
[0076] According to an alternative embodiment, the warp threads or the weft threads in the coating lie parallel to the longitudinal axis of the balloon.
[0077] According to a preferred embodiment, the coating is attached to the outside of the balloon by adhesive. The adhesive can be applied to the outside of the balloon, in particular the area to which the coating is to be applied, after the balloon has been manufactured. Alternatively, or additionally, the adhesive can be applied to the coating before it is placed on the balloon. The adhesive can be applied, for example, by dipping, spraying, rolling or brushing. The adhesive can correspond to the balloon material. For example, the adhesive may contain polyurethane (Pll) or polyethylene (PE).
[0078] Alternatively, or in addition to the use of adhesive, the coating can be attached to the outside of the balloon by ultrasonic welding.
[0079] According to one embodiment, the coating contains an X-ray contrast agent. In particular, the X-ray contrast agent may comprise barium sulphate. This makes it possible to avoid the contrast agent injection that would otherwise be required during the surgical procedure.Applicant: CardiaNova GmbH
[0080] Our Ref.: CMG29733PCT
[0081] Date: April 14, 2026
[0082] 11
[0083] According to one embodiment, the coating has a tubular shape. Preferably, the coating is formed into the tubular shape before being applied to the balloon and the balloon is then inserted into the coating. The tubular coating can be longitudinally welded, for example. The cross-section of the tubular coating is preferably elliptical. Thereby, the oval cross-section of the balloon in the expanded state can be ensured.
[0084] According to one embodiment, the balloon has a diameter in the range of 15 to 35 mm, preferably 18 to 30 mm, and a length in the range of 30 to 60 mm, preferably 35 to 55 mm, when expanded. The dimension of the diameter refers to the largest diameter of the balloon in the expanded state.
[0085] According to one embodiment, the cross-section of an oval balloon in the expanded state has a long axis that is 2-8 mm, preferably 5 mm, larger than the short axis. This means that the long axis is approx. 10-30% larger than the short axis. For example, the long axis can be 15 to 20% larger than the short axis.
[0086] The mesh size of the coating can be less than or equal to 5mm. According to a preferred embodiment, the mesh size is 20pm, 40pm or 100pm. However, it is also possible to use a mesh size in the range of 1 to 5mm. The small mesh size prevents puncturing of the balloon particularly reliably and improves the resistance of the coating to bursting. The mesh size is defined as the clear distance between two adjacent warp threads or weft threads.
[0087] According to one embodiment, the threads of the coating have a diameter in the range from 30 to 80pm, preferably in the range from 35 to 40pm, for example 37pm, or in the range from 35 to 45pm, for example 40pm, or in the range from 75 to 80pm, for example 77pm.
[0088] The number of warp threads and weft threads can be in the range of 150 to 200 / cm, preferably in the range of 175 to 180 / cm, with a thread diameter of 30 to 80pm.Applicant: CardiaNova GmbH
[0089] Our Ref.: CMG29733PCT
[0090] Date: April 14, 2026
[0091] 12
[0092] The number of warp threads and weft threads can be in the range of 110 to 140 / cm, preferably in the range of 120 to 130 / cm, with a thread diameter of 35 to 45pm.
[0093] The number of warp threads and weft threads can be in the range of 40 to 70 / cm, preferably in the range of 50 to 60 / cm, for a thread diameter in the range of 75 to 80pm.
[0094] According to a preferred embodiment, the coating consists of polyethylene terephthalate (PET).
[0095] According to one embodiment, the coated balloon withstands an internal pressure in the range from 6 to 12 bar.
[0096] According to a further aspect, the invention relates to a method of manufacturing a balloon catheter according to the invention. The method is characterized in that the coating is applied to the balloon after it has been formed.
[0097] Advantages and features described with respect to the balloon catheter apply - if applicable - correspondingly to the method of manufacturing and vice versa.
[0098] According to one embodiment, the coating is attached by spraying or rolling adhesive onto the balloon surface, onto the coating prior to application to the balloon surface, or onto the coating applied to the balloon surface.
[0099] According to an alternative embodiment, the coating is attached to the balloon surface by ultrasonic welding.
[0100] According to one embodiment, the coating is positioned as a tube around the balloon surface and the balloon is then expanded. Preferably, the tube has an ovality corresponding to the ovality that the balloon is to assume in the expanded state.Applicant: CardiaNova GmbH
[0101] Our Ref.: CMG29733PCT
[0102] Date: April 14, 2026
[0103] 13
[0104] According to a further aspect, the present invention relates to a method for treatment of a heart valve. The method is characterized in that a balloon catheter according to the present invention is used in the treatment.
[0105] Advantages and features described with respect to the balloon catheter and method of manufacturing of the balloon catheter apply - if applicable - correspondingly to the method for treatment of a heart valve and vice versa and will not be repeated.
[0106] According to one embodiment, the treatment method comprises the step of aligning the balloon catheter with the annulus of the heart valve in longitudinal direction and rotational direction before the balloon is inflated in the heart valve. When aligning of the balloon catheter in the longitudinal direction, the balloon is advanced into the heart valve to such an extent that the central area of the balloon, where the balloon has the largest circumference in the expanded state, is in the plane of the annulus and leaflets of the heart valve.
[0107] The alignment in the longitudinal direction and the alignment in the rotational direction can be performed simultaneously.
[0108] According to one embodiment, in the step of alignment in rotational direction the balloon is rotated until the at least one of the axes of the cross-section of the balloon is aligned with the respective axis of the annulus of the heart valve before the balloon is inflated. Preferably, the long axis of the balloon is aligned with the long axis of the annulus and the short axis of the balloon is aligned with the short axis of the annulus.
[0109] According to one embodiment, in the step of alignment in rotational direction the balloon catheter is rotated until the long axis or the short axis of the cross-section of the balloon are aligned with the long axis or short axis of the annulus of the heart valve, respectively, before the balloon is inflated.Applicant: CardiaNova GmbH
[0110] Our Ref.: CMG29733PCT
[0111] Date: April 14, 2026
[0112] 14
[0113] Preferably, the balloon is positioned in the heart valve such that the long axis of the balloon is in the same direction as the long axis of the annulus. Thereby, when the balloon is inflated, an even pressure on the annulus can be applied by the balloon.
[0114] According to one embodiment, the balloon catheter in the heart valve is monitored in a cusp overlap view.
[0115] The cusp overlap view is a fluoroscopic imaging technique. Fluoroscopy images during TAVI / TAVR are typically acquired at different orientations, e.g. a C-arm may have a cranial (CRA), caudal (CAU), left anterior oblique (LAO), or right anterior oblique (RAO) orientation. In the cusp overlap view, the C-arm is aligned to overlap the right and left coronary cusps. According to a preferred embodiment, the X-ray camera of a C-arm is positioned RAO caudally, i.e. lower right of the patient.
[0116] When the X-ray camera of a C-arm is positioned RAO caudally, the short axis of the annulus is in the plane of this projection.
[0117] According to one embodiment, the balloon catheter has a marker on the balloon and / or tube which is discernible, when the short axis of the cross-section of the balloon is visible in the cusp overlap view and the method comprises rotating the balloon catheter until this marker is discernible before inflating the balloon. A marker discernible or recognizable in a certain view, is a marker which has a predetermined appearance in this view. In a preferred embodiment, the marker may have a circumferential section and a longitudinal section, wherein the two sections in one view represent a T-shape, when the short axis of the cross-section of the balloon is visible in the cusp overlap view. The longitudinal section is thus aligned with the circumferential position of an end of the long axis of the balloon. That means, once the T-shape is recognizable in the cusp overlap view (RAO caudally) the long axis of the of the balloon is aligned with the long axis of the annulus. As long as the circumferential section and longitudinal section of the marker form an L-shape ora T-shape, where the longitudinal section is offset to the middle of the circumferentialApplicant: CardiaNova GmbH
[0118] Our Ref.: CMG29733PCT
[0119] Date: April 14, 2026
[0120] 15
[0121] section in that view, the physician knows, that the axes of the balloon are not yet aligned with the axes of the annulus.
[0122] The treatment of the heart valve, which is carried out in the method according to the present invention, may be a dilatation of the native heart valve, in particular a balloon valvuloplasty.
[0123] Alternatively, the treatment may be a pre-dilatation or post-dilatation for a transcatheter aortic valve implantation, TAVI / TAVR. When performing post-dilatation, it is important to note, that self-expanding valves also have to have an oval crosssection after implantation. If the self-expanding valve is not brought into this oval cross-section, leaks may occur along the long axis. The oval balloon used according to the present invention allows for better post-dilatation and treatment of such paravalvular leaks.
[0124] The invention is described again below with reference to the accompanying figures, showing:
[0125] Figure 1 : a schematic cross-sectional view of a first embodiment of a balloon catheter in an expanded state in a heart valve;
[0126] Figure 2: a schematic longitudinal sectional view of the first embodiment of a balloon catheter in an inflated state in a heart valve according to Figure 1;
[0127] Figure 3: a schematic cross-sectional view of a balloon catheter of the prior art in a heart valve;
[0128] Figure 4: a schematic longitudinal sectional view of a second embodiment of a balloon catheter according to the invention;
[0129] Figure 5: a schematic side view of the embodiment of the balloon catheter according to Figure 4;
[0130] Figures 6a and 6b: Embodiments of the coating;Applicant: CardiaNova GmbH
[0131] Our Ref.: CMG29733PCT
[0132] Date: April 14, 2026
[0133] 16
[0134] Figure 7: a schematic side view of a third embodiment of the balloon catheter according to the invention in the area of the balloon;
[0135] Figure 8: a schematic cross-sectional view of a fourth embodiment of the balloon catheter according to the invention in the region of the balloon;
[0136] Figure 9: a schematic cross-sectional view of a fifth embodiment of the balloon catheter according to the invention in the region of the balloon;
[0137] Figure 10: a schematic side view of a sixth embodiment of the balloon catheter according to the invention in the region of the balloon; and Figure 11 : another schematic side view of the sixth embodiment of the balloon catheter according to Figure 10.
[0138] In the figures, the components of the balloon catheter are only shown schematically in order to better explain the present invention. Further details of the balloon catheter, such as lumens in the balloon catheter, are therefore not always shown in the figures. Furthermore, the figures are not to scale, but merely serve as a schematic representation.
[0139] Figures 1 and 2 show a first embodiment of the balloon catheter 1 according to the present invention in an expanded state in a heart valve. The balloon catheter 1 comprises a tube 10 and a balloon 11. The ballon catheter 1 is guided over a guidewire 13 extending beyond the distal end of the tube 10. The balloon catheter 1 is advanced through the arteria and the balloon 11 is positioned in the heart valve HV. Once at this position, the balloon 11 is inflated, as shown in Figures 1 and 2. The balloon 11 according to the present invention has an oval cross-section perpendicular to the longitudinal axis of the balloon 11. In particular, the oval crosssection of the balloon 11 has a long axis IA and a short axis kA perpendicular to each other. Also, the annulus has an oval cross-section. As can be derived from Figure 1 , the balloon 11 , due to its oval cross-section, can cover the entire annulus of the heart valve HV and can be in contact with the entire circumference of the annulus.
[0140] Thereby, pressure can evenly be applied on the circumference of the annulus and an even dilatation can be achieved.Applicant: CardiaNova GmbH
[0141] Our Ref.: CMG29733PCT
[0142] Date: April 14, 2026
[0143] 17
[0144] As a comparative example, Figure 3 shows a balloon according to the prior art with a circular cross-section, that means having a constant radius over the cross-section perpendicular to the longitudinal axis of the balloon. Even though the balloon in Figure 3 is in an expanded state, it is only in contact with part of the circumference of the annulus. Thus, the dilatation which can be achieved by the circular balloon is insufficient as it only occurs in the direction of the short axis of the annulus. If a circular balloon having a diameter corresponding to the long axis of the annulus, would be used, the heart valve would be over-stretched.
[0145] Figures 4 and 5 show a schematic longitudinal sectional view of a second embodiment of a balloon catheter 1 according to the invention. As the first embodiment, the balloon catheter 1 of the second embodiment consists of a tube 10, on the circumference of which a balloon 11 is provided. The interior of the balloon 11 is connected to the interior of the tube 10 via inlet openings (not shown) on the tube 10, so that fluid for expanding the balloon 11 can enter the interior of the balloon 11. A guide wire 13 is guided through the tube 10.
[0146] In the embodiment shown in Figures 3 and 4, the balloon 11 has a central region 110, which is an oval tubular region, and two tapered regions 112, which may be conical regions, adjoining the ends of the central region 110, via which the balloon 11 is connected to the tube 10. The transition from the central region 110 to the respective tapered region 112 is referred to as the balloon shoulder 111.
[0147] A coating 12 is applied to the outer circumference of the central area 110. In the embodiment shown, the coating 12 extends over the entire length of the central region 110.
[0148] The coating 12 is a fabric-like coating comprising warp yams 120 and weft yarns 121.Applicant: CardiaNova GmbH
[0149] Our Ref.: CMG29733PCT
[0150] Date: April 14, 2026
[0151] 18
[0152] Figures 6a and 6b schematically show two possible embodiments of the coating 12. The courses of the warp threads 120 and weft threads 121 are only shown in one part of the coating 12 in Figures 6a and 6b, but extend over the entire surface of the coating 12. In the embodiment of Figure 6a, the warp threads 120 and weft threads 121 are inclined at an angle of 45° to the longitudinal axis A (see Figure 4) of the balloon 11 , which is also the longitudinal axis of the tube 10. In Figure 6b, the weft threads 121 are aligned parallel to the longitudinal axis A (see Figure 4) of the balloon 11 , which is also the longitudinal axis of the tube 10.
[0153] Figure 7 shows a third embodiment of the balloon catheter 1 according to the invention. In Figure 7, only the area of the balloon 11 of the balloon catheter 1 is visible. However, in this embodiment, the balloon catheter 1 also has a tube 10, which is not visible in Figure 7. The third embodiment of the balloon catheter 1 according to Figure 7 differs from the second embodiment in that the coating 12 extends over the entire length of the balloon 11. The coating 12 covers the central area 110 as well as the balloon shoulders 111 and the tapered areas 112. In the embodiment shown, the coating 12 even extends over the ends of the tapered areas 112, where these merge into the tube 10. As a result, the areas of the tube 10 adjacent to the balloon 11 (not shown in Figure 7) are covered by the coating 12.
[0154] Furthermore, the shape of the balloon 11 in the third embodiment according to Figure 7 differs from the shape of the second embodiment. In particular, the balloon shoulders 111 are rounded in the third embodiment. In this embodiment, the transition from the central region 110 to the tapered region 112 and from the tapered region 112 to the tube 10 each has a radius of curvature.
[0155] Figure 8 shows a fourth embodiment of the balloon catheter 1 according to the invention in cross-section. The cross-section of the balloon 11 and thus also of the coating 12 has an oval shape. The cross-section of the balloon 11 thus has a long axis IA and a short axis kA.Applicant: CardiaNova GmbH
[0156] Our Ref.: CMG29733PCT
[0157] Date: April 14, 2026
[0158] 19
[0159] Figure 9 shows a fifth embodiment of the balloon catheter 1 according to the invention in cross-section. This embodiment differs from the fourth embodiment in that markers 122 are provided on the balloon 11. In the embodiment shown, the markers 122 are located at the ends of the short axis and the long axis. The markers 122 may be arranged on or in the coating 12. The markers 122 may extend along the entire length of the coating 12 in the longitudinal direction of the balloon 11.
[0160] Figures 10 and 11 show schematic side views of a sixth embodiment of the balloon catheter 1. In the sixth embodiment markers 14 are provided on the tube 10. The markers 14 may be applied to the tube 10 directly or may be provided on part of a coating (not shown) that extends over the length of the balloon 11 onto the tube 10. In the sixth embodiment, two markers 14 are provided, wherein one is provided on the tube 10 at the distal end of the balloon 11 and the other is provided on the tube 10 at the proximal end of the balloon 11. It is, however, also possible that only one marker 14 at the proximal or at the distal end of the balloon 11 is provided. The marker 14 consists of a circumferential section 140 and a longitudinal section 141.
[0161] The longitudinal section 141 has the shape of a stripe extending in the longitudinal direction of the tube 10. The width of the longitudinal section 141 is preferably smaller than the diameter of the tube 10. The circumferential section 140 has the shape of a strip extending over at least part of, preferably over the entire circumference of the tube 10.
[0162] In the embodiment shown in Figures 10 and 11, the longitudinal section 141 is arranged at a position which is in line with one end of the long axis kA of the balloon 11.
[0163] Thereby, if the longitudinal section 141 and circumferential section 140 are viewed during the treatment of the heart valve in a cusp overlap view (RAO) caudally, the physician will see a T-shape. This view is shown in Figure 10. In this view, the projection is parallel to the long axis IA of the balloon 11. Otherwise, the physicianApplicant: CardiaNova GmbH
[0164] Our Ref.: CMG29733PCT
[0165] Date: April 14, 2026
[0166] 20
[0167] will see the marker 14 as an L-shape or offset T-shape, if the physicians view is parallel to the short axis kA of the balloon 11. This view is shown in Figure 11.
[0168] Thereby, the physician can adjust the position of the long axis IA to the anatomy by rotating the tube 10 and thereby the balloon 11 around the longitudinal axis A of the balloon catheter 10. In particular, the balloon 11 can be rotated until the long axis IA of the balloon 11 corresponds to the long axis of the annulus of the heart valve.
[0169] In addition, the circumferential section 140 of two markers 14 positioned at opposite ends of the balloon 11 , as shown in Figures 10 and 11 , allows for the physician to correctly adjust the aortic-ventricular position of the balloon 11 , that means how far the balloon 11 is advanced with respect to the heart valve.
[0170] With the present invention it is possible to reliably position the balloon of the balloon catheter within the heart valve. This positioning not only concerns the aortic-ventricular position, that means how far the ballon catheter is advanced within the heart valve, but also concerns the rotational orientation based on the ovality of the balloon’s cross-section and the anatomy of the patient. The positioning with respect to the orientation can be achieved by rotating the tube of the balloon catheter and thereby also the oval balloon to the required orientation. The positioning with respect to orientation is further facilitated, by providing markers on the tube or balloon that are not limited to ring-shaped markers. The preferred markers are rather designed to visualize the orientation of the balloon in the heart valve. The markers may for example be lines which, when in the balloon is in the right position are visible as a T-shape. While, if only an L shape or offset T-shape is visible, it indicates that the balloon is not in the right orientation towards the heart valve.
[0171] It is also important, that it has been found, that the ovality of the annulus of the patient is always oriented in the same direction. This allows for alignment of the oval balloon in the so-called cusp overlap view.Applicant: CardiaNova GmbH
[0172] Our Ref.: CMG29733PCT
[0173] Date: April 14, 2026
[0174] 21
[0175] The present invention is not limited to the embodiments shown. Rather, individual features of one embodiment may be combined with features of another embodiment.Applicant: CardiaNova GmbH
[0176] Our Ref.: CMG29733PCT
[0177] Date: April 14, 2026
[0178] 22
[0179] List of reference signs
[0180] I balloon catheter
[0181] 10 tube
[0182] II balloon
[0183] 110 central area
[0184] III balloon shoulder
[0185] 112 tapering area
[0186] 12 coating
[0187] 120 warp thread
[0188] 121 weft thread
[0189] 122 marker
[0190] 13 guide wire
[0191] 14 marker
[0192] 140 circumferential section of marker 141 longitudinal section of marker
[0193] A Longitudinal axis
[0194] kA short axis
[0195] IA long axis
[0196] HV heart valve
Claims
Applicant: CardiaNova GmbHOur Ref.: CMG29733PCTDate: April 14, 202623Claims1. Balloon catheter comprising a tube (10) and an expandable balloon (11 ), characterized in that in the expanded state, the balloon (11) at least partially has an oval cross-section perpendicular to the longitudinal axis (A) of the balloon (11) and the balloon (11) and / or the tube (10) comprises at least one radiopaque marker (122, 14).
2. Balloon catheter according to claim 1 , wherein the oval cross-section of the balloon (11 ) has a long axis (IA) and a short axis (kA) and the at least one radiopaque marker (122, 14) is provided at the balloon (11) and / or tube (10) at a position corresponding to the short axis (kA) or long axis (IA) of the balloon (11).
3. Balloon catheter according to anyone of claims 1 or 2, wherein the marker (122, 14) comprises a circumferential section (140) and a longitudinal section (141).
4. Balloon catheter according to claim 3, wherein the longitudinal section (141) is provided at a circumferential position corresponding to the circumferential position of at least one end of the long axis (IA) of the balloon (11).
5. Balloon catheter according to any one of claims 1 to 4, wherein the balloon (11 ) and / or the tube (10) comprises at least two radiopaque markers (122, 14).
6. Balloon catheter according to anyone of claims 1 to 5, wherein the balloon (11 ) comprises a fabric-like coating (12) which is applied to at least part of the balloon (11).
7. Balloon catheter according to claim 6, wherein the coating (12) is applied at least to that part of the balloon (11 ) which has the largest diameter in the expanded state of the balloon (11 ).
8. Balloon catheter according to one of claims 6 or 7, wherein the balloon material and / or the coating (12) has a shape memory.Applicant: CardiaNova GmbHOur Ref.: CMG29733PCTDate: April 14, 2026249. Balloon catheter according to any one of claims 6 to 8, wherein the coating (12) is a fabric.
10. Balloon catheter according to claim 9, wherein the warp threads (120) and weft threads (121) in the coating (12) are inclined at an angle to the longitudinal axis (A) of the balloon (11 ) or the warp threads (120) or weft threads (121 ) in the coating (12) are parallel to the longitudinal axis (A) of the balloon (11).
11. Balloon catheter according to any one of claims 6 to 10, wherein the coating (12) is attached to the outside of the balloon (11 ) by adhesive.
12. Balloon catheter according to any one of claims 6 to 11 , wherein the coating (12) contains an X-ray contrast agent and preferably wherein the X-ray contrast agent comprises barium sulphate.
13. Balloon catheter according to any one of claims 1 to 12, wherein the coating (12) has a tubular shape.
14. Balloon catheter according to claim 13, wherein the coating (12) is longitudinally welded.
15. Balloon catheter according to one of claims 1 to 15, wherein the balloon (11) in the expanded state has a diameter in the range from 18 to 30 mm and a length in the range from 35 to 55 mm.
16. Balloon catheter according to any one of claims 2 to 15, wherein the long axis (IA) of the cross-section is 10-30% larger than the short axis (kA).
17. Balloon catheter according to any one of claims 6 to 16, wherein the mesh size of the coating is less than or equal to 5mm, preferably 20pm.
18. Balloon catheter according to any one of claims 6 to 17, wherein the coated balloon (11 ) withstands an internal pressure in the range of 6 to 12 bar.Applicant: CardiaNova GmbHOur Ref.: CMG29733PCTDate: April 14, 20262519. Balloon catheter according to any one of claims 6 to 18, wherein the coating (12) is made of polyethylene terephthalate, PET.
20. Method for producing a balloon catheter according to any one of claims 6 to 19, characterized in that the coating (12) is applied to the balloon (11) after it has been formed.
21. Method according to claim 20, wherein the coating (12) is attached by spraying or rolling adhesive onto the balloon surface or onto the coating (12) applied to the balloon surface.
22. Method according to claim 21 , wherein the coating (12) is attached to the balloon surface by ultrasonic welding.
23. Method according to any one of claims 20 to 22, wherein the coating (12) is positioned as a tube around the balloon surface and the balloon (11) is subsequently expanded.
24. Method for treatment of a heart valve, characterized in that a balloon catheter (1 ) according to any one of claims 1 to 19 is used in the treatment.
25. Method according to claim 24, wherein method comprises aligning the balloon catheter (1 ) with the annulus of the heart valve (HV) in longitudinal direction and rotational direction before the balloon (11) is inflated.
26. Method according to claim 25, wherein in the step of alignment in rotational direction the balloon (11 ) is rotated until the at least one of the axes of the crosssection of the balloon (11 ) is aligned with the respective axis of the annulus of the heart valve before the balloon (11) is inflated.
27. Method according to claim 25 or 26, wherein the balloon catheter (1) in the heart valve (HV) is monitored in a cusp overlap view.Applicant: CardiaNova GmbHOur Ref.: CMG29733PCTDate: April 14, 20262628. Method according to claim 27, wherein the balloon catheter (1 ) has at least one marker (122, 14) on the balloon (11) and / or tube (10) discernible, when the short axis (kA) of the cross-section of the balloon (11) is visible in the cusp overlap view and the method comprises rotating the balloon catheter (1) until this marker (122, 14) is discernible before inflating the balloon.
29. Method according to anyone of claims 25 to 28, wherein the treatment of the heart valve (HV) is a dilatation of the native heart valve, in particular a balloon valvuloplasty.
30. Method according to anyone of claims 25 to 28, wherein the treatment of the heart valve (HV) is a pre-dilatation or post-dilatation for a transcatheter aortic valve implantation, TAVI / TAVR.