Prosthetic device for implantation in the aortic valve region of the heart

Abstract

The present invention relates to a prosthetic device (100) for deployment in the native aortic valve region of the heart, comprising a tubular spacer element (110) configured to be placed in the native aortic valve region of the heart without contacting the native aortic valve annulus; the prosthetic device (100) further comprising at least one anchoring element (130) designed to anchor the prosthetic device (100) within the heart, and at least one connecting element (140) coupling the spacer element (110) to the at least one anchoring element (130); in the prosthetic device (100), the tubular spacer element (110) further comprising a coupling skirt element (125) coupled to the outer surface of the spacer element (110) such that the coupling skirt element (125) is inflatable during diastole.

Description

[0001] The present invention relates to an implantable prosthetic device for implantation in the region of the native aortic valve of the heart, in particular for treating aortic regurgitation, and the use of such a device for treating a diseased or otherwise dysfunctional aortic valve.

[0002] Today, prosthetic aortic valve devices are used as a possible treatment for aortic regurgitation (also known as aortic regurgitation). Such prosthetic valves are delivered through traditional surgical implantation methods or through less invasive percutaneous catheter or minimally invasive methods.

[0003] The mammalian heart consists of four chambers, two atria (which are the filling chambers) and two ventricles (which are the pumping chambers). In the mammalian heart, there are four heart valves that normally allow blood to flow through the heart in only one direction, whereby the heart valves open or close depending on the difference in blood pressure on each side.

[0004] The four main valves in the heart are the mitral valve (which appears as the mitral valve) and the tricuspid valve, which are located between the upper atrium and lower ventricle, respectively, and are therefore called the atrioventricular (AV) valves. There are also the aortic valve and the pulmonary valve (which are located in the arteries leaving the heart). The mitral and aortic valves are located in the left side of the heart, and the tricuspid and pulmonary valves are located in the right side of the heart.

[0005] The valves incorporate multiple leaflets or cusps, with each valve having three cusps except for the mitral valve which has only two.

[0006] The aortic valve, which normally has three cusps, is located between the left ventricle and the aorta. The aortic valve is the last structure in the heart that blood passes through before it stops flowing through the systemic circulation. The aortic valve (similar to the pulmonary valve), also called the "semilunar valve," allows blood to be forced into the aorta and prevents backflow from the aorta into the ventricles during diastole. During ventricular systole, pressure rises in the left ventricle, and when this pressure is greater than the pressure in the aorta, the aortic valve opens, allowing blood to leave the left ventricle and enter the aorta. When ventricular systole ends, the pressure in the left ventricle drops rapidly, and the pressure in the aorta forces the aortic valve to close.

[0007] Several different kinds of valve disease are known, such as stenosis, which occurs when a heart valve does not open fully because stiff or fused leaflets prevent them from opening properly, or prolapse, in which the valve leaves do not close smoothly or evenly but collapse backward into the heart chamber they are supposed to be sealing.

[0008] Valvular regurgitation (backward flow) is also a common problem and occurs when the heart valves do not close tightly, with the result that the valves do not seal and blood leaks backward across the valve. This condition, also called valvular regurgitation, reduces the heart's pumping efficiency: when the heart contracts, blood is pumped forward in the correct direction, but is also forced backward through the damaged valve. As the leak worsens, the heart has to work harder to compensate for the leaking valve, and less blood can flow to the rest of the body. Depending on which valve is affected, the condition is called tricuspid regurgitation, pulmonary regurgitation, mitral regurgitation, or aortic regurgitation.

[0009] Aortic regurgitation, the abnormal leakage of blood from the aorta through the aortic valve and into the left ventricle when the left ventricle contracts, is a common valve abnormality. Poor valve function leads to left ventricular hypertrophy and heart failure. Common causes of aortic regurgitation include aortic vasodilation, previous rheumatic fever, infections such as infective endocarditis, degeneration of the aortic valve, and Marfan's syndrome. Aortic stenosis can also be caused by rheumatic fever and degenerative calcification. The most common congenital heart anomaly is the bicuspid aortic valve, where the two cusps are fused.

[0010] Surgical intervention is recommended for symptomatic severe aortic regurgitation or asymptomatic severe aortic regurgitation associated with left ventricular dysfunction or enlargement.

[0011] At the same time, as mentioned at the outset, aortic valve repair and replacement has also been performed using minimally invasive procedures. The desire for less invasive methods is related to the fact that a large proportion of patients, especially the elderly or those with severe comorbidities or severe left ventricular dysfunction, do not undergo (open-heart) surgery.

[0012] Various percutaneous techniques have emerged and are at different stages of development.Current percutaneous techniques for aortic valve repair or replacement are, for example, percutaneous aortic valve replacement, augmented aortic coaptation, percutaneous aortic valvuloplasty, and percutaneous aortic annuloplasty (inferior commissural annuloplasty).

[0013] However, different percutaneous repair methods still do not offer the same degree of efficacy as surgical repair of the aortic valve.

[0014] While percutaneous aortic valve replacement for aortic regurgitation is a possible alternative in a select group of patients with a low probability of successful repair, the challenges are high: the aortic annulus is often much larger than usual, and different anchor designs may be required for different causes of aortic regurgitation. Furthermore, paravalvular leaks can be problematic.

[0015] For example, WO 2013 / 178335 A1 discloses an implantable device for improving or correcting heart valve regurgitation and includes a contact band attached to a closure element, which forms a ring in the atrium, thereby contacting the inner wall of the heart and attaching the device therein.

[0016] In view of the above, there remains a need for a heart valve prosthesis with the help of which heart valve regurgitation can be effectively treated while minimizing the traumatic effects on the heart.

[0017] According to the present invention, this and other objects are solved by a prosthetic device for implantation in the region of a native aortic valve of a heart having a native valve annulus and native valve leaflets, the prosthetic device comprising a tubular spacer element comprising an outer surface, an inner surface, a length, a proximal inflow end, a distal outflow end, and an inner lumen defined therebetween, the spacer element being configured to be placed in the region of the native aortic valve of the heart without contacting the native aortic valve annulus, and comprising a valve element attached to the inner surface of the spacer element at the proximal inflow end within the inner lumen; and at least one anchoring element, wherein the anchoring element The prosthetic device of the present invention is characterized in that the tubular spacer element is spatially separated from the tubular spacer element, and wherein the anchoring element is capable of anchoring the prosthetic device in the native aortic valve area of ​​the heart, and at least one connecting element that couples the spacer element to the at least one anchoring element so that the spacer element is coaxially aligned and suspended within the native aortic valve without contacting the aortic valve annulus; in the prosthetic device according to the present invention, the tubular spacer element includes an engagement skirt element having a distal end and a proximal end, the engagement skirt element being connected to the outer surface of the spacer element via its distal outflow end and its proximal inflow end, so that the engagement skirt element is inflatable during diastole.

[0018] The present invention also relates to the use of the device for treating aortic regurgitation in a patient (preferably a human) in need thereof, and a method for treating aortic regurgitation in a patient (preferably a human) in need thereof.

[0019] With the prosthetic device according to the present invention, the space left by the malcoaptation of the native aortic leaflets can be filled, and thus, when the device according to the present invention is placed within the annulus of the native aortic valve at the corresponding coaptation line, aortic regurgitation can be reduced or even eliminated.

[0020] By virtue of the size of the tubular spacer of the device according to the present invention being smaller than the native aortic annulus, the disclosed prosthetic device allows for launch through and alongside the device to the aorta and body extremities during systole and thereby minimizes the gradient between the left ventricle and the aorta.

[0021] In a healthy heart, when the left atrium contracts at the end of diastole, it pumps blood into the larger, lower left ventricle. When the lower ventricular chamber is full and the mitral valve to the left atrium closes, the ventricle undergoes isovolumetric contraction (ventricular contraction with the mitral valve closed), marking the first phase of systole. The second phase of systole pumps blood from the left ventricle to the aorta and extremities.

[0022] As mentioned above in the introduction, the human aortic valve comprises three leaflets, or cusps, poles, or flaps of connective tissue that passively move apart or together in response to the forces exerted by blood flow. Thus, the term "valve poles" refers to the three aligned locations, 120 degrees apart from each other on the circumferential edge of the stent, to which the commissures of the valve leaflets are sutured.

[0023] As also described in the introductory section above, when aortic valve closure is impaired and the leaflets do not seal properly, blood leaks and flows back from the aorta into the left ventricle, which can increase left ventricular end-diastolic pressure (which can ultimately lead to increased left atrial and pulmonary pressures, resulting in pulmonary edema), as well as a decreased coronary perfusion gradient (which can potentially cause myocardial ischemia and even sudden cardiac death).

[0024] With the device according to the present invention, a unidirectional flow is generated, preventing flow from the aorta to the left ventricle during diastole and allowing flow from the ventricle to the aorta during systole: the leaflets of the native aortic valve coapt / abut against the inflated coaptation skirt element of the tubular spacer attached to the prosthetic device according to the present invention, thereby sealing the aortic valve annulus during diastole and reestablishing the valve function of the structure. Thus, the space left between the poorly coapted aortic leaflets can be filled without enlarging the space and forcing the improperly closed valve to open even further.

[0025] By means of the anchoring element of the prosthetic device of the present invention, the device as a whole is fixed in the aortic valve region of the heart, while at the same time ensuring that the native aortic valve engages against the inflatable engagement skirt attached to the tubular spacer element: via the anchoring element, the tubular spacer element carrying the valve element is suspended within the native aortic valve without contacting the aortic valve annulus. Therefore, the tubular spacer element has a size and shape suitable for ensuring this function (i.e., "free-floating" within the native aortic valve). This suspension is provided via the anchoring element, which is anchored in the aortic valve region, and the connecting element connecting the tubular spacer element to the anchoring element.

[0026] Furthermore, coaptation is provided by virtue of the coaptation skirt element provided by the prosthetic device according to the present invention, and its specific attachment to the tubular spacer element, such that it is "inflated" during diastole.

[0027] "Joint skirt element" means a sheet-like element for at least partially covering the outer surface of the tubular spacer, which is circumferentially "wrapped" around the outer surface of the tubular spacer element, thereby defining the distal end and proximal end of the joining skirt element; the joining skirt element is fixedly attached (for example, sewn or otherwise mounted) to the outer surface of the tubular spacer only via its proximal end and distal end, so that the portion between the proximal end and distal end of the joining skirt element is not fixedly attached to the outer surface of the tubular spacer.

[0028] As used herein with respect to the engagement skirt element, "inflatable" and "inflatable" refer to attachment of the engagement skirt element to the tubular spacer such that the engagement skirt element (which is attached to the tubular spacer only via its distal end and its proximal end)—or more precisely, its unattached portion—can be detached from the outer surface in a balloon-like manner during diastole. In this way, the native valve can engage against the inflated skirt, thereby closing the valve.

[0029] Here, with regard to the tubular spacer element - or more precisely with regard to the engagement skirt element attached thereto, the expression "adapting to the engagement area of ​​the native aortic valve" or "engaging abutment" means that the tubular spacer together with the engagement skirt element attached thereto has such a shape and design that it adapts to and fills the space left by the improperly closed leaflets of the native, dysfunctional aortic valve, without the tubular spacer contacting the native aortic valve annulus.

[0030] According to the invention, the tubular spacer element, the anchoring element and the connecting element form three separate parts. In particular, the at least one anchoring element and the spacer element are separate parts, and the anchoring element does not form a direct part of the spacer element, the two parts being connected only via the at least one connecting element.

[0031] Furthermore, the term "proximal end" of the body is used to refer to the inflow section of the lumen of the device body, i.e., the end of the lumen where blood enters to flow into the aorta. Thus, the term "distal end" of the lumen refers to the outflow end of the lumen, i.e., the end where blood exits the lumen.

[0032] With the prosthetic device of the present invention, during diastole and after outflow from the aorta, the valve elements within the spacer element close, causing pressure to build up within the spacer element, which in turn causes the loose coaptation skirt elements on the outer surface of the spacer element to inflate, causing the coaptation skirt elements to come into contact with the leaflets of the dysfunctional native aortic valve, filling the coaptation gaps and re-establishing the integrity of the valve closure, thereby preventing backward flow.

[0033] According to a preferred embodiment, in the prosthetic device of the present invention, the engagement skirt element, starting from the proximal inflow end of the spacer element, circumferentially covers up to 30%, 40%, 50%, 60%, 70%, 80%, 90% or up to 100% of the outer surface of the spacer element.

[0034] For these embodiments, the engagement skirt element is attached to the outer surface of the proximal inflow end of the spacer element via its proximal end and circumferentially covers the outer surface of the spacer element by a specified percentage. For example, when the engagement skirt element circumferentially covers 100% of the outer surface of the spacer element, the distal end of the engagement skirt element is attached to the outer surface of the distal outflow end of the spacer element.

[0035] According to another preferred embodiment, in the prosthetic device of the present invention, the engaging skirt element comprises or consists of a material selected from the group of biocompatible artificial materials or biocompatible natural materials, and in particular selected from the group consisting of human or animal pericardium, polytetrafluoroethylene (PTFE), polyurethane and polyester.

[0036] Typically, the dimensions of the engagement skirt element are such that it can be “wrapped” / guided circumferentially around the tubular spacer element, circumferentially covering its outer surface, being attached—via its proximal end—to the proximal inflow end and, therefore, providing up to 100% coverage “starting” from the proximal inflow end towards the distal outflow end.

[0037] Preferably, in the device according to the invention, the tubular spacer element comprises or consists of a tubular stent frame and has a cross section selected from substantially circular, oval and triangular. Thus, according to a preferred embodiment, the tubular spacer has a cylindrical shape.

[0038] The overall shape of the tubular spacer element of the device according to the invention is tubular, either having a uniform cross-sectional diameter over the entire length or having a cross-sectional diameter at the proximal end that is larger than that at the distal end, giving the body a substantially conical or convex form.

[0039] As used herein, and as generally understood, the term "stent frame" is intended to include a radially expandable metal frame or body of cylindrical, tubular, or other tubular shape, and thus includes any device or structure that adds stiffness, expansion force, or support to a prosthesis. A stent frame may also be comprised of a substantially hollow expandable structure that can be filled or inflated to achieve its functional shape.

[0040] The metal frame of the stent frame of the tubular spacer element may be laser cut or woven or braided or knitted or comprise otherwise interconnected metal meshes.

[0041] According to one embodiment, in the device according to the present invention, the stent frame is preferably made of a shape memory material, preferably Nitinol. Nitinol has been proven to be suitable for implantable medical devices and is used in different medical settings.

[0042] According to a preferred embodiment, the stent framework comprises or consists of a series of individual stent elements or filamentary wire frames made of self-expanding material.

[0043] According to a preferred embodiment, the stent framework may further comprise individual metal rings forming a metal mesh, which rings meander circumferentially and are continuously arranged along the longitudinal axis / direction of the tubular spacer element, wherein the metal rings have a Z-shaped profile, wherein the cusps point alternately towards the proximal and distal ends of the device.

[0044] The valves carried within the tubular spacer elements of the prosthetic device can be created / harvested from human or animal donors. They can be created / harvested, for example, from the pericardium of a human or any mammal, or from natural leaflets from the heart or veins, or from any other biological material suitable for the intended purpose. Generally speaking, such valves are also referred to as bioprosthetic or tissue valves—as opposed to mechanical valves.

[0045] In devices according to the present invention, the valve can comprise a flexible material or utilize a rigid mechanical valve mechanism, such as a single leaflet, a double leaflet, a ball cage, or a caged disc. Flexible materials include animal-harvested aortic leaflets, animal pericardial tissue, tissue-processed materials, harvested human pericardial tissue, or synthetic materials. The design can utilize one, two, three, or more individual leaflets of equal or varying sizes.

[0046] Here, the expression "substantially cylindrical" or "substantially circular, oval" is intended to mean any three-dimensional form having a certain length and a substantially circular cross-section, including forms such as elliptical, parabolic, or hyperbolic cross-sections, and wherein the cross-section does not necessarily need to have a regular perimeter, but also includes irregular perimeters, as long as the substantially cylindrical form of the stent portion carrying the valve is maintained. Furthermore, the expression "substantially cylindrical" includes forms that conform to or substantially conform to the shape of the anatomical annulus of the valve being treated.

[0047] Similarly, the expression "substantially continuous", for example with reference to the diameter of a substantially cylindrical shape of a tubular spacer element, means that the diameter of the generally cylindrical form is substantially the same over its length, wherein it will be clear to those skilled in the art that there may be small or slight variations in diameter due to manufacturing issues.

[0048] The components of the device, i.e., the tubular spacer element, the anchoring element, and the connecting element, can be designed in various sizes in terms of length, diameter, etc., suitable for the intended use and depending on the corresponding condition and the shape and size / shape of the patient's heart, while at the same time including the features of the device protected by protection.

[0049] According to a preferred embodiment of the present invention, the stent frame of the tubular spacer of the prosthetic device is self-expanding, wherein the device is configured such that it can be transitioned from a compressed state for introduction of the device into a mammalian heart to an expanded state within the heart.

[0050] According to a preferred embodiment, the anchoring element of the prosthetic device according to the invention consists of a cylindrical stent element.

[0051] A "cylindrical stent element" - as discussed above with respect to the stent frame - is intended to include a substantially cylindrical / tubular radially expandable metal frame or body, and thus includes any device or structure having rigidity and expansion force suitable for anchoring a prosthetic device in the aortic valve region of the heart. Thus, the stent element may be laser cut or woven or braided or knitted, or comprise otherwise interconnected metal meshes. The stent element may be made of a shape memory material, preferably nitinol.

[0052] According to a preferred embodiment, the stent element comprises (or consists of) a stent ring or a plurality of stent rings interconnected with one another, or another filamentary framework / metal mesh (made of a self-expanding material).

[0053] According to a preferred embodiment, the stent element may further comprise a plurality of single metal rings forming a metal mesh, the rings being circumferentially meandering and being continuously arranged along the longitudinal axis / direction of the tubular spacer element, wherein the metal rings have a Z-shaped profile, wherein the pointed arches are alternately directed towards the proximal and distal ends of the device.

[0054] Furthermore, according to a preferred embodiment, the anchoring element may be covered on its outer and / or inner surface with any suitable biocompatible material.

[0055] In a preferred embodiment of the prosthetic device of the present invention, the anchoring element is composed of a cylindrical stent element and the at least one connecting element is composed of one or more single non-tubular, straight flexible connecting elements, which connecting elements include a first end, a second end and a length extending therebetween, wherein the connecting elements are coupled to the spacer element via their respective first ends and to the anchoring element via their respective second ends, wherein the length of the connecting elements is such that when the anchoring element is placed downstream of the coronary arteries, preferably in the ascending aorta, the spacer element is suspended within the native aortic valve region of the heart without contacting the native aortic valve annulus.

[0056] For this embodiment, the anchoring element and the spacer element are spaced apart from each other—via the connecting element—so that the anchoring element is anchored downstream of the coronary artery; as a result, the spacer element is suspended in the native aortic valve and floats freely therein. The coronary arteries exit the aorta just above the level of the aortic valve. There are two coronary arteries in the body, the origin of the right coronary artery is in the right coronary cusp and the origin of the left coronary artery is in the left coronary cusp. Accordingly, "downstream" generally refers to the direction of blood flow. Thus, "downstream of the coronary arteries" means that the anchoring element is placed in the ascending aorta downstream of the aortic valve cusp; via the connecting element, the spacer element is suspended within the valve annulus without contacting the native valve annulus.

[0057] The connecting elements are preferably flexible such that they allow the spacer elements to be tilted relative to the anchoring elements while maintaining their axial length; thus, the connecting elements are preferably not axially compressible, but rather bendable.

[0058] Furthermore, in this embodiment, the connecting element needs to have a certain length to provide distance between the anchoring element and the spacer element, as well as to provide coaxial alignment of the spacer element within the annulus of the native aortic valve.

[0059] Thus, the term "straight" with respect to a connecting element means any long rod-like or ribbon-like structure whose length is greater than its width. In some embodiments, the connecting member can be a wire, rod, ribbon, thread, or other and made of any inert material with sufficient strength commonly used in the medical field.

[0060] In this regard, a "rod" element or "belt" element or member is any long structure that is sufficiently rigid and flexible to be coupled to a device according to the present invention via one end and to a structure of the heart and / or another anchoring element (e.g., a plug) via its second end. The long structure / rod / belt element can be of any material suitable for these purposes, and is preferably an inert, substantially rigid material such as a metal, e.g., nitinol, stainless steel, titanium, a polymer, e.g., polyetheretherketone (PEEK), polyoxymethylene (POM), polyether (PE), polyamide (PA), polytetrafluoroethylene (PTFE), which can also be reinforced with fibers to improve stability), ceramics, materials of animal or human origin, or generally synthetic materials. These structures can also be substantially hollow structures that are inflatable or fillable to achieve their stability. They can also be combinations of the above. To promote biocompatibility, the surface of the structure can be coated or otherwise treated.

[0061] According to another embodiment of the prosthetic device of the present invention, the anchoring element is composed of a cylindrical stent element and the at least one connecting element is composed of one or more single non-tubular, curved flexible connecting elements, which include a first end, a second end and a length extending therebetween, wherein the connecting elements are coupled to the spacer element via their respective first ends and to the anchoring element via their respective second ends, wherein the length and shape of the connecting elements are such that when the anchoring element is placed in the aortic root, the spacer element is suspended within the native aortic valve region of the heart without contacting the native aortic valve annulus.

[0062] In this embodiment, the anchoring element is placed within the aortic root and the spacer element is suspended—via a curved, curved connecting element—within the native aortic annulus.The anchoring element and the spacer element are again coaxially aligned.

[0063] According to another embodiment of the prosthetic device of the present invention, at least one connecting element is composed of one or more U-shaped long attachment arm elements, which include a first end, a second end and a length extending therebetween, wherein the attachment arm elements are coupled to the spacer element via their respective first ends and include at least one anchoring element at their respective second ends, wherein the anchoring element is composed of an attachment member for anchoring the device in tissue around the native aortic valve annulus, the attachment member being selected from one or more of a hook, a nail or an arrow.

[0064] By means of this embodiment, suspension of the spacer element within the native valve area - without contacting the native valve annulus - is also achieved: an anchoring element, i.e. an attachment member such as a hook, a nail, an arrow anchor is inserted / hooked into the tissue of the aortic root and a U-shaped connecting member connects the attachment member to the tubular spacer, such that the tubular spacer floats freely within the native aortic valve.

[0065] According to a preferred embodiment, the prosthetic device of the invention comprises a combination of one or more anchoring elements as defined above.

[0066] As mentioned above, the present invention also relates to the use of the prosthetic device of the present invention and as defined and described above and in the accompanying drawings for treating aortic regurgitation in a patient.

[0067] The present invention also relates to a method for treating aortic regurgitation, comprising the steps of providing a prosthetic device of the present invention and as described and defined above and in the accompanying drawings, and deploying the device in the aortic valve area of ​​the heart of a patient in need thereof to replace its function or support the patient's native aortic valve.

[0068] According to one embodiment, the method comprises the steps of providing a prosthetic device according to the invention, in particular a prosthetic device comprising a stent element as an anchoring element, introducing the prosthetic device into the aortic valve region of the heart of a patient in need of treatment, deploying the anchoring element downstream of the coronary arteries, preferably in the ascending aorta, thereby suspending the spacer element within the native aortic valve annulus.

[0069] According to another embodiment, the method comprises the steps of providing a prosthetic device according to the invention, in particular a prosthetic device comprising a stent element as an anchoring element, introducing the prosthetic device into the aortic valve region of the heart of a patient in need of treatment, deploying the anchoring element in the aortic root behind the native aortic leaflets, i.e. upstream of the coronary arteries, thereby suspending the spacer element within the native aortic valve annulus.

[0070] The patient or subject in need of treatment, ie, a patient or subject suffering from aortic regurgitation, is a mammal, preferably a human.

[0071] It will be appreciated that the treatment options provided by the present invention are not limited to the aortic valve, but devices according to the present invention may also be used to treat pulmonary valve regurgitation.

[0072] The device according to the present invention can be delivered by surgical implantation or by a transcatheter approach. In the latter case, i.e., in the case of a transcatheter approach, the device according to the present invention is loaded onto a suitable deployment catheter, where it is compressed by a retractable sheath or tube or the like. The deployment catheter is inserted into the heart of the patient whose tricuspid or aortic valve needs to be replaced or supported.

[0073] When treating the aortic valve, a deployment catheter loaded with the device according to the present invention in a compressed state is advanced transapically into the left ventricle (across the aortic valve to the annulus), where it is deployed to expand the sealing segment within the annulus of the aortic valve at the coaptation line, as well as the valve-bearing segment in the ascending aorta. The compression device can also be introduced into the right atrium via the femoral vein or jugular vein, through the septum to the left atrium, across the mitral valve to the left ventricle and to the aorta, where it is deployed to expand the sealing segment in the annulus and the valve-bearing segment. In addition, the compression device can be introduced into the pulmonary vein (right, left, inferior or superior pulmonary vein) to the left atrium, across the mitral valve to the left ventricle and to the aorta via a mini-thoracotomy, where it is deployed to expand the sealing segment in the annulus and the valve-bearing segment. Moreover, the compression device can be introduced via the femoral artery, thereby allowing the prosthetic device to be positioned within the native aortic valve through the aorta.

[0074] After proper placement, the sheath or other compression member is retracted to release the prosthetic device in a stepwise manner according to the present invention, in which action the anchoring elements of the device can anchor the prosthetic device and thereby suspend the tubular spacer in the native aortic valve area.

[0075] Other advantages and features of the present invention are set forth in the following description and the accompanying drawings.

[0076] It will be understood that the features mentioned above and the features yet to be explained below can be used not only in the respectively specified combination but also in other combinations or alone, without departing from the scope of the present invention.

[0077] The above-mentioned features of the present invention and the features still to be explained below are illustrated in the accompanying drawings, in which:

[0078] FIG1 shows a schematic diagram of a human heart (A) and a schematic enlarged view of the aortic root (B);

[0079] FIG2 is a schematic diagram illustrating a top view of an exemplary dysfunctional aortic valve in a closed position without a prosthetic device (A) or with a prosthetic device (B);

[0080] FIG3 shows a schematic diagram of one embodiment of a prosthetic device according to the present invention, the prosthetic device being placed in the aortic valve region of a heart (A), with (B) showing the placement of (A) in more detail;

[0081] Figure 4 is a schematic diagram of another embodiment of a prosthetic device according to the present invention, the prosthetic device being placed in the aortic valve region of the heart; and

[0082] Figure 5A schematic diagram of yet another embodiment of a prosthetic device according to the present invention is shown, the prosthetic device being placed in the aortic valve region of the heart.

[0083] exist Figure 1A , a human heart 50 is depicted having a right atrium 54, a right ventricle 55, a left atrium 56, and a left ventricle 57. Also depicted in FIG1 are a portion of the superior vena cava 52 (which enters the heart 50 via the right atrium 54) and a portion of the inferior vena cava 53.

[0084] In more detail, the superior vena cava 52 returns blood from the upper half of the body and opens to the upper and rear part of the right atrium 54, with its orifice 52a directed downward and forward. Its orifice 52a does not have a valve.

[0085] The inferior vena cava 53, which has a larger diameter than the superior vena cava 52, returns blood from the lower half of the body and leads to the lowest part of the right atrium 54. Its orifice 53a is directed upward and backward and is protected by a degenerate valve, namely the valve of the inferior vena cava (inferior vena cava valve, not shown).

[0086] The right ventricle 55 has a triangular form and extends from the right atrium 54 to near the apex 59 of the heart 50 .

[0087] The right atrioventricular orifice (not depicted in FIG. 1 ) is a large, oval-shaped orifice communicating between the right atrium 54 and ventricle 55 and is protected by the tricuspid valve 60 , which includes three triangular cusps or segments or leaflets 64 .

[0088] The opening 61 of the pulmonary artery 62 is circular in form and is located to the upper left of the atrioventricular opening; it is protected by the pulmonary valve 63 .

[0089] As discussed above, the function of the tricuspid valve 60 is to prevent blood from flowing backward into the right atrium 54 ; arrows 70 and 71 indicate normal blood flow into the right atrium 54 .

[0090] The left atrium 56 is smaller than the right atrium 54. The left ventricle 57 is longer and more tapered than the right ventricle 55. The left atrioventricular opening (mitral valve opening, not depicted in FIG1 ) is located to the left of the aortic opening 65 and is protected by the mitral valve or mitral valve 66.

[0091] The aortic opening 65 is a circular hole located right in front of the atrioventricular opening, and its opening is protected by the tricuspid aortic valve 67. Reference numeral 68 denotes the aorta.

[0092] As mentioned in the introduction, and in general, the aortic valve 67 helps keep blood flowing through the heart in the correct direction. It separates the heart's left ventricle 57 from the aorta 68, which supplies oxygen-rich blood to the body. With each contraction of the ventricle 57, the aortic valve 67 opens and allows blood to flow from the left ventricle 57 into the aorta 68. When the ventricle 57 relaxes, the aortic valve 67 closes to prevent blood from flowing backward into the ventricle 57. When the aortic valve 67 does not function properly, it can interfere with blood flow and force the heart to work harder to pump blood to other parts of the body, causing symptoms such as shortness of breath, dizziness, fainting, irregular heartbeats, etc. In aortic regurgitation, the aortic valve 67 does not close properly, causing blood to flow backward into the left ventricle 57.

[0093] Figure 1B An enlarged view of the aortic root 96 of the heart 50 is shown. As used herein, the term "aortic root" refers to the aortic valve from its location at the outlet of the left ventricle to its connection to the ascending aorta, as is commonly understood. Anatomically, this entire structure is the aortic valve. The three leaflets / cusps of the aortic valve 67 are designated 67a, 67b, and 67c, respectively, and the commissures 74 are shown where the cusps 67a and 67b join together. Figure 1B As shown, a left coronary artery 90 and a right coronary artery 91 bifurcate, thereby supplying oxygen-rich blood to the entire heart 50. Reference numeral 73 denotes an interleaflet triangle, and reference numeral 72 denotes a native valve annulus.

[0094] FIG2 shows a schematic diagram of a top view of a dysfunctional aortic valve 67 in a closed state, wherein the three cusps 67 a, 67 b and 67 c of the tricuspid aortic valve 67 are shown. It should be noted that bicuspid aortic valves are also known and represent congenital heart defects. Diseases with only one or four cusps are also known, but are rare. Moreover, there are cases in which the bicuspid aortic valve does not close properly, which—in addition to aortic regurgitation—leads to aortic enlargement and thus the risk of dissection. Therefore, the prosthetic device according to the present invention can also be used to treat bicuspid aortic valve diseases.

[0095] If you can Figure 2A As seen in , the native aortic valve 67, or more precisely its three cusps 67a, 67b, 67c, does not / does not close properly, resulting in a closed "gap" 80, which in turn allows blood to flow back into the left ventricle during diastole, which is known as aortic regurgitation. Figure 2A In this embodiment, the aortic valve is not supported by the prosthetic device according to the present invention.

[0096] With the device according to the present invention, aortic regurgitation can be treated and in the attached Figure 2BAn exemplary embodiment of an apparatus according to the present invention is depicted in FIG. Figure 2A placement in a diseased native aortic valve, which is also shown in more detail in the different embodiments shown in Figures 3 to 5.

[0097] In an exemplary embodiment of a prosthetic device 100 according to the present invention, as shown in FIG3 , the device 100 is depicted in its expanded state, which is the state that the device would have when implanted in the heart of a patient being treated. The compressed state, on the other hand, is the state that the device 100 would have when loaded onto a transcatheter delivery system, wherein the compressed device 100 would be introduced via a blood vessel of the body.

[0098] Figures 3 to 5 show different embodiments of a prosthetic device according to the present invention, wherein like features are denoted by like reference numerals in the different embodiments.

[0099] The prosthetic device 100 of the present invention comprises a tubular spacer element 110 to be placed within a patient's native aortic valve without contacting the native annulus. The tubular spacer element 110 comprises an outer surface 112, an inner surface 113, a length 114, a proximal inflow end 115, a distal outflow end 116, and a lumen 117 defined between the inflow end 115 and the outflow end 116.

[0100] The tubular spacer element further comprises a flap element 120 attached intraluminally to the inner surface 113 of the spacer element 110 at the proximal end inflow 115; for clarity of the drawings, the flap element 120 is shown only in FIG. Figure 3B Schematically depicted in FIG, but omitted in other figures.

[0101] As can be seen in the embodiment of Figure 3, the tubular spacer element 110 has a tubular stent frame 121 made of interconnected wires forming a mesh with a diamond-shaped grid 122. The tubular spacer element / stent frame as depicted in Figure 3 has a substantially circular cross-section, and thus the tubular spacer has a cylindrical form, but other forms such as triangular or more ovoid may also be applied.

[0102] As described in detail below, the tubular spacer element 110 also has attached thereto a joining skirt element 125 having a distal end 126 and a proximal end 127. The joining skirt element 125 is wrapped circumferentially around the spacer element 110 and is fixedly connected / attached to the outer surface 112 of the spacer element 110 only via its distal outflow end 126 and its proximal inflow end 127. By virtue of this attachment (i.e., attachment to the spacer element 110 only via its distal ends), the portion of the joining skirt element 125 between the distal ends 126, 127 can separate during diastole and is therefore "inflatable" during diastole, as in Figure 3B In this manner, the native valve engages / abuts to the inflated skirt element 125 and does not directly engage / abut to the stent frame of the spacer element 110.

[0103] In the embodiment shown in FIG. 3 , the prosthetic device 100 (which is Figure 3B 3 , the anchoring element 130 is shown as a stent element 132, which is tubular and has a circumferentially serpentine stent ring. The stent element has a proximal end 132a and a distal end 132b, wherein a connecting element 140 is attached to the proximal end 132a. In FIG3 , the connecting element 140 includes three individual non-tubular, straight, flexible connecting elements, each of which has a first end 140a, a second end 140b, and a length 140c extending between the ends 140a, 140b. The connecting elements 140 are coupled to the spacer element 110 via their respective first ends 140a and to the anchoring element 130 via their respective second ends 140b, wherein the length 140c of the connecting elements 140 is such that when the anchoring element 130 is positioned downstream of the coronary arteries 90, 91, the spacer element 110 is suspended within the native aortic valve region 95 of the heart without contacting the native aortic valve annulus.

[0104] Figure 4 Another embodiment of a prosthetic device 100 according to the present invention is shown. Here, the anchoring element 130 is also composed of a cylindrical support element 132. The device also includes three individual non-tubular, curved, flexible connecting elements 140, each of which includes a first end 140a, a second end 140b, and a length 140c extending between the ends 104a, 140b. The connecting elements 140 are coupled to the spacer element 110 via their respective first ends 140a and to the anchoring element 130 via their respective second ends 140b. The length 104c and shape of the connecting elements 140 are such that when the anchoring element 130 is placed in the aortic root 96 behind the native aortic leaflets 97, the spacer element 110 is suspended within the native aortic valve region 95 of the heart without contacting the native aortic valve annulus.

[0105] Figure 5Yet another embodiment of a prosthetic device according to the present invention is shown, further comprising a tubular spacer element 110 that is suspended in the region of the native aortic valve without contacting the native aortic annulus. Here, a connecting element 140 is comprised of three long, U-shaped attachment arm elements 141, each comprising a first end 141a, a second end 141b, and a length 141c extending between the ends 141a, 141b, wherein the attachment arm elements 141 are coupled to the spacer element 110 via their respective first ends 141a and, at their respective second ends 141b, comprise at least one anchoring element 130. In the embodiment shown in FIG3C , the anchoring element 130 is comprised of an attachment member 135, shown as a staple in FIG3C , for anchoring the device 100 in tissue surrounding the native aortic annulus.

Claims

1. A prosthetic device (100) for deployment in a native aortic valve region (95) of a heart (50), the native aortic valve region (95) comprising a native aortic valve (67) having a native aortic valve annulus (72) and native valve leaflets (67a, 67b, 67c), the prosthetic device (100) comprising: a tubular spacer element (110) comprising an outer surface (112), an inner surface (113), a length (114), a proximal inflow end (115), a distal outflow end (116), and a lumen (117) defined therebetween, the tubular spacer element (110) being configured to be placed within the native aortic valve region (95) of the heart (50) without contacting the native aortic valve annulus (72), and comprising a valve element (120) attached to the inner surface (113) of the tubular spacer element (110) at the proximal inflow end (115) within the lumen (117); at least one anchoring element (130), wherein the anchoring element (130) is spatially separated from the tubular spacer element (110), and wherein the anchoring element (130) is designed to anchor the prosthetic device (100) within the native aortic valve region (95) of the heart (50); and at least one connecting element (140) coupling the tubular spacer element (110) to the at least one anchoring element (130) such that the tubular spacer element (110) is coaxially aligned and suspended within the native aortic valve (67) without contacting the native aortic valve annulus (72), It is characterized by: The tubular spacer element (110) comprises a joining skirt element (125) having a distal end (126) and a proximal end (127), wherein the joining skirt element (125) is connected to the outer surface (112) of the tubular spacer element (110) only via its distal end (126) and its proximal end (127), such that the joining skirt element (125) is inflatable during diastole.

2. The prosthetic device (100) according to claim 1, characterized in that The engagement skirt element circumferentially covers up to 30%, 40%, 50%, 60%, 70%, 80%, 90% or up to 100% of the outer surface of the tubular spacer element starting from the proximal inflow end of the tubular spacer element.

3. The prosthetic device (100) according to claim 1, characterized in that The engaging skirt element (125) comprises or consists of a material selected from the group of biocompatible artificial materials or biocompatible natural materials.

4. The prosthetic device (100) according to claim 1, characterized in that The engaging skirt element (125) comprises or consists of a material selected from the group consisting of human or animal pericardium, polytetrafluoroethylene (PTFE), polyurethane and polyester.

5. The prosthetic device (100) according to claim 1, characterized in that The tubular spacer element (110) comprises or consists of a tubular stent frame (121) and has a cross-section selected from circular, oval or triangular.

6. The prosthetic device (100) according to claim 1, characterized in that The anchoring element (130) consists of a cylindrical support element (132).

7. The prosthetic device (100) according to claim 1, characterized in that The anchoring element is comprised of a cylindrical stent element (132), and the at least one connecting element (140) is comprised of one or more single non-tubular, straight flexible connecting elements (140), the connecting elements (140) comprising a first end (140a), a second end (140b), and a length (140c) extending therebetween, wherein the connecting elements (140) are coupled to the tubular spacer element (110) via their respective first ends (140a) and to the anchoring element (130) via their respective second ends (140b), wherein the length (140c) of the connecting elements (140) is such that when the anchoring element (130) is positioned downstream of the coronary arteries (90, 91), the tubular spacer element (110) is suspended within the native aortic valve region (95) of the heart (50) without contacting the native aortic valve annulus (72).

8. The prosthetic device (100) according to claim 1, characterized in that The anchoring element (130) is comprised of a cylindrical stent element (132), and the at least one connecting element (140) is comprised of one or more single non-tubular, curved, flexible connecting elements (140), the connecting elements (140) comprising a first end (140a), a second end (140b), and a length (140c) extending therebetween, wherein the connecting elements (140) are coupled to the tubular spacer element (110) via their respective first ends (140a) and to the anchoring element (130) via their respective second ends (140b), wherein the length (140c) and shape of the connecting elements (140) are such that when the anchoring element (130) is placed into the aortic root (96), the tubular spacer element (110) is suspended within the native aortic valve region (95) of the heart (50) without contacting the native aortic valve annulus (72).

9. A prosthetic device (100) according to claim 1, wherein the at least one connecting element (140) is composed of one or more U-shaped long attachment arm elements (141), the attachment arm elements (141) including a first end (141a), a second end (141b) and a length (141c) extending therebetween, wherein the attachment arm elements (141) are coupled to the tubular spacer element (110) via their respective first ends (141a) and include the at least one anchoring element (130) at their respective second ends (141b), wherein the anchoring element (130) is composed of an attachment member (135) for anchoring the device in the tissue around the natural aortic valve annulus (72), the attachment member (135) being selected from one or more of a hook, a nail or an arrow.

10. The prosthetic device (100) of claim 1, comprising a combination of one or more of the anchoring elements (130) as defined in any one of claims 6 to 9.

11. The prosthetic device (100) of claim 1 for treating aortic regurgitation.

Images