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    • 专利摘要:
    implantable device to treat heart valve regurgitation. the present invention relates to an implant 10; 100; 200; 300 to treat heart valve regurgitation, device 10; 100; 200; 300 being configured to expand from a compressed state into an expanded state. The device according to the invention comprises a stent element 11 consisting of (i) an atrial anchoring stent portion 12, and (ii) a valve-loading stent portion 14 being fixedly connected to each other, and an atrial anchoring stent portion 14. valve 18. the atrial anchoring stent portion 12 has a balloon-like shape 13 and the valve-loading stent portion 14 has a cylindrical shape 15 such that the valve-loading stent portion 14 is positioned intracranially. annular without contacting the ring 70 of a native heart valve 66.
    公开号:BR102015024747B1
    申请号:R102015024747-8
    申请日:2015-09-25
    公开日:2022-01-11
    发明作者:Emilia Kawa；Marcos Centola
    申请人:Medira Ag；
    IPC主号:
    专利说明:

    [0001] The present invention relates to an implantable device for treating heart valve regurgitation and the use of such a device to treat a diseased or otherwise dysfunctional heart valve, preferably the mitral valve.
    [0002] The mammalian heart comprises four chambers, namely two atria, which are the filling chambers, and two ventricles, which are the pumping chambers. In a mammalian heart, there are four heart valves present that normally allow blood to flow in only one direction through the heart, via a heart valve that opens or closes depending on the differential blood pressure on each side.
    [0003] The four main valves in the heart are the mitral valve, representing a bicuspid valve, and the tricuspid valve, which are between the upper atria and lower ventricles, respectively, and so are called atrioventricular (AV) valves. Additionally, there is the aortic valve and the pulmonic valve which are in the arteries leaving the heart. The mitral valve and the aortic valve are in the left heart and the tricuspid valve and the pulmonic valve are in the right heart.
    [0004] Valves incorporate leaflets or cusps, each valve having three cusps, except for the mitral valve, which has only two.
    [0005] The tricuspid and mitral valves are situated respectively between the atria and ventricles and prevent backflow from the ventricles to the atria during systole. They are anchored to the walls of the ventricles by chordae tendineae that prevent the valves from inverting. The chordae tendineae are attached to the papillary muscles that cause tension to better contain the valve. Together, the papillary muscles and chordae tendineae are known as the subvalvular apparatus. Since the function of the subvalvular apparatus is to maintain the valves so that there is no displacement in the atria when they close, the subvalvular apparatus, however, has no effect on the opening and closing of the valves, which are caused entirely by the pressure gradient across the valve. .
    [0006] During diastole, a normally functioning mitral valve opens as a result of elevated left atrium pressure as it fills with blood (preloading). As atrial pressure rises above that of the left ventricle, the mitral valve opens. The opening facilitates passive flow of blood into the left ventricle. Diastole ends with atrial contraction, which ejects the final 20% of blood that is transferred from the left atrium to the left ventricle, and the mitral valve closes at the end of atrial contraction to prevent a reversal in blood flow.
    [0007] Several different types of valve disorders are known, such as stenosis, which occurs when a heart valve does not open completely due to stiffness or fused leaflets preventing it from opening properly, or prolapse, when the valve flaps do not open properly. close gently, or quietly, but causing the heart chamber they were supposed to seal to collapse in reverse.
    [0008] Valve regurgitation (backflow) is also a common problem and occurs when a heart valve does not close tightly, as a consequence of the valve not sealing and blood leaking backwards through the valve. This condition - also called valvular insufficiency - reduces the heart's pumping efficiency: When the heart contracts, blood is pumped forward in the proper direction, but it is also forced backwards through the damaged valve. As the leak gets worse, the heart has to work harder to compensate for the leaking valve and less blood must 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] Mitral regurgitation, i.e. the abnormal leakage of blood from the left ventricle through the mitral valve and into the left atrium when the left ventricle contracts, is a common valvular abnormality, being present in 24% of adults with heart disease valvular and in 7% of the population aged 75 years. Surgical intervention is recommended for symptomatic severe mitral regurgitation or asymptomatic severe mitral regurgitation with left ventricular enlargement or dysfunction. Surgical treatment of severe degenerative mitral regurgitation was developed from mitral valve replacement to mitral valve repair, since a mitral valve repair proved to produce superior results.
    [0010] Meanwhile, a mitral valve replacement and repair was also achieved using minimally invasive procedures. The desire for less invasive approaches is linked to the fact that a significant proportion of patients, especially elderly people or those with significant comorbidities or severe left ventricular dysfunction, are not referred for surgery (opening heart).
    [0011] Various percutaneous technologies have emerged and are in different stages of development. Current percutaneous technologies for mitral valve repair or replacement are, for example, percutaneous mitral valve replacement, advanced mitral coaptation, end-to-end percutaneous mitral valve repair (application), percutaneous chordal repair, percutaneous mitral annuloplasty, and reshaping. left ventricle.
    [0012] However, the different percutaneous repair approaches do not offer the same degree of effectiveness as a surgical mitral valve repair.
    [0013] Since percutaneous mitral valve replacement technology is a possible alternative in a selected group of patients with a low probability of successful repair, the challenges of this technique are very high: the mitral annulus has an asymmetric trestle shape , and different anchor designs may be required for different etiologies of mitral regurgitation. Additionally, left ventricular outflow obstruction may occur due to retained native valve tissue, and paravalvular leakage may also pose problems.
    [0014] For example, WO 2013/178335 A1 discloses an implantable device for improving or correcting a heart valve insufficiency, such as mitral valve regurgitation, and comprises a contact strip attached to a closure element, such a contact forms a loop in the atrium, thus making contact with the inner wall of the heart and trapping the device in it.
    [0015] Additionally, US 2014/0121763 A1 discloses a mitral valve prosthesis including a self-expanding frame and two or more hook arms. The self-expanding frame carries a valve. each of the engagement arms corresponds to a native mitral valve leaflet. The prosthesis also comprises anchoring points of attachment, whereby such anchors are connected to anchor the prostheses in the heart.
    [0016] In view of the above, there is still a need for a prosthetic heart valve whereby heart valve regurgitation can be efficiently treated, while at the same time traumatic impact on the heart is minimized.
    [0017] In accordance with the invention, this and other points are addressed by an implantable device for treating heart valve regurgitation, the device being configured to expand from a compressed state into an expanded state, and comprising: - an element stent consisting of (i) an atrial anchoring stent portion, and (ii) a valve-loading stent portion, the atrial anchoring stent portion being fixedly connected with the valve-loading stent portion; the atrial anchoring portion, in the expanded state of the device, has a balloon-like/balloon-shaped shape and has a diameter (d1) that is greater than the diameter of a ring of a native heart valve present between a atrium and a ventricle of a heart to be treated, and is sized and configured to anchor the device by radial force in an atrium of a heart to be treated when the device is in the expanded state; additionally, the valve loading stent portion, in the expanded state of the device, has a substantially cylindrical shape with a preferably continuous diameter d3 along its cylindrical length (l), such diameter d3, in the expanded state, is smaller than the diameter of the native heart valve ring, such that there is no contact between the native heart valve ring and the valve-loading stent portion, and allowing the native heart valve to maintain its function. In accordance with the invention, the implantable device also comprises a valve element comprising a skirt portion and a valve portion, with the skirt portion being mounted externally to the valve-loading stent portion, and with the valve portion being mounted internally to the valve-loading stent portion.
    [0018] With the implantable device according to the invention and its use in the treatment of heart valve regurgitation, in particular mitral valve regurgitation, it is possible to safely and conveniently position the implantable device in the heart of a patient to be treated: by means of its anchoring stent portion the implantable device is anchored in the atrium of a patient's heart, preferably in the left atrium of a heart, while its valve-loading stent portion is retained intra-annular; in this way, the native annular structure is not touched by the device, and the native - dysfunctional - valve, insofar as it can open and close, can still function, insofar as its function allows. This is possible due to the fact that the implantable device has a valve carrying portion with a diameter that is smaller than the diameter of the native valve.
    [0019] The atrial anchoring stent portion thus represents a self-expanding anchoring element with a balloon or ball suit shape, which is placed within the left atrial space and fixed in the atrium by radial force. As the internal atrial main cavity has a nearly spherical anatomy, this element, using a ball-in-ball radial compression arrangement, maintains the stability necessary to maintain the implanted valve, or rather than the stent-loading portion of valve, within the intra-annular space without touching the annular structure.
    [0020] With this arrangement, the native valve, which does not close completely, is not replaced: instead, the native valve leaflets - as well as the implantable device valve - open diastolic phase, allowing blood to enter the left ventricle without restriction. In the systolic phase, i.e. when the left ventricle contracts, the valve of the implantable device, as well as the native valve can still close, in which the valve of the implantable device serves as a spacer, increasing coaptation of the native mitral leaflets . In other words, the native valve leaflets, during the systolic phase, close/abut against the valve-carrying portion of the implantable device, while the valve of the implantable device closes intra-annular, thus ensuring adequate closure between the atrium and the left ventricle. during systole.
    [0021] Thus, with the device according to the invention, an effective hybrid solution for treating heart valve regurgitation is provided, comprising means for mitral replacement combined with means for increased coaptation.
    [0022] Currently, the term “balloon-like” shall comprise any bulb, or rounded shape, which may also, but does not necessarily have to, narrow at one end; consequently, the "balloon-like" shape also comprises spherical or ball-like shapes.
    [0023] Presently, and as generally understood, the term "stent" shall comprise a cylindrical, tubular, or otherwise shaped radially expandable metal body or frame, and thus comprises any device or structure that adds rigidity, expansion, or support for a prosthesis, as "stent graft" refers to a prosthesis comprising a stent material and an associated graft that forms a fluid-tight or substantially fluid-tight lumen through at least a portion of its length. The stent/stent graft body is inserted into the recipient/organ to be treated and is expanded or self-expanding and fixed or fixed in place in order to keep the lumen of the recipient/organ open or in order to anchor a prosthesis comprising the stent.
    [0024] The metal frame of the stent members and elements of the device according to the invention may be laser cut or woven or braided or joined or comprise a metal mesh interconnected in some other way.
    [0025] Stent grafts and/or stents generally comprise, for example, a series of stent elements or, respectively, a wire skeleton made of a self-expanding material.
    [0026] In this regard, it is noted that the anchoring stent portion is designed such that it is not covered or is not covered at least partially in order to allow the pulmonary veins to deliver blood from the lungs to the atrium. left; thus, it is necessary that the blood flow within the left atrium is not obstructed by the atrial stent portion.
    [0027] The valve-loading stent portion may also represent single metal rings forming a metal mesh, the rings circumferentially sinusoidal and being successively arranged in the direction/longitudinal axis of the valve-loading stent portion, wherein the rings metal pieces have a Z-shaped profile with pointed arcs pointing alternately toward the proximal and distal end of the device. The metal rings are thus indirectly connected through the valve skirt portion.
    [0028] Presently, the expressions "substantially cylindrical" or "a substantially cylindrical shape" or a "substantially cylindrical shape" presently mean that any three-dimensional shape that is of a certain length, and that has a substantially rounded cross section, in which are also shapes comprise cross-sections, of which are, for example, an ellipse, parabola, or hyperbola, and wherein the cross-section need not necessarily have a regular circumference, but also include irregular circumferences, since the substantially cylindrical shape of the portion of stent carrying valve is retained. Also, by the term "substantially cylindrical" shapes are understood to conform or substantially conform to the anatomical ring shape of the treated valve.
    [0029] Similar, the expression "substantially continuous" in connection with the diameter of the substantially cylindrical shape of the valve-loading stent portion means that, generally, the diameter of the cylindrical shape is approximately the same around its length, where it will be clear to one skilled in the art that there may be slight or slight variations in diameter due to manufacturing points.
    [0030] The components of the device, i.e. the stent element comprising the anchoring stent portion and the valve loading stent portion including the valve, can be variably sized (i.e., length, diameter, etc. ) as appropriate for an intended use and as depending on a specific condition and the shape and size of the patient's heart, wherein the diameter of the anchoring stent portion, in the expanded state, is preferably greater than the diameter of the atrium in order to allow fastened fixation of the implantable device in the atrium.
    [0031] In accordance with the preferred embodiment of the invention, the stent element of the implantable device is self-expanding, wherein the device is configured such that it is convertible from a compressed state to introduce the device into a mammalian heart to a expanded state within the heart.
    [0032] According to the preferred embodiment, the valve element, upon implantation of the device, is sized and configured such that the native heart valve function is supported without replacing or imparting the native heart valve function.
    [0033] With the function of the "native heart valve", at present, the opening and closing of the heart valve, preferably the mitral valve, is intended as the heart valve is closing. The latter means that if the function of the native heart valve is impaired in such a way, i.e. prior to implantation of the implantable device according to the invention, it does not close properly leading to a leaking heart valve regurgitation. However, upon implantation of the device according to the invention, the leaflets of the diseased heart valve can still perform a closing movement, as it is obvious that they abut against the valve-carrying stent portion of the implantable device.
    [0034] According to another embodiment of the implantable device according to the invention, the atrial anchoring stent portion and the valve-loading stent portion are integrally formed.
    [0035] According to this embodiment, the atrial anchoring stent portion and the valve loading stent portion are manufactured in one piece. This embodiment is an advantage over devices comprising a stent element that has been fabricated from two different stent portions due to the facilitated fabrication processes. While the one-piece stent element is preferred, embodiments comprising a one-piece stent element, together or coupled together, are also understood and understood within the meaning of the present invention.
    [0036] According to another embodiment of the device according to the invention, the atrial anchoring stent portion is capable of anchoring in the atrium of a heart, such that the anchoring stent portion comes into contact at least partially with the walls of the atria.
    [0037] As mentioned above, the expandable atrial anchoring stent portion expands, in the expanded state of the device, within the atrium of the heart of a patient being treated, and thereby anchors or secures the entire device within the heart. Due to the dimensions of the atrial anchoring device, the anchoring stent portion, upon the expansion anchor itself, abuts at least partially against the atrial walls, thereby also anchoring the other portions of the device. As a consequence, the valve-loading stent portion of the stent element is positioned and secured intra-annular without touching the native annular structures.
    [0038] According to the preferred embodiment, in the device according to the invention, the skirt portion and the valve portion of the valve element are made of the same material, preferably mammalian pericardium.
    [0039] Consequently, in a preferred embodiment, the biological valve and the skirt comprise or consist of a material that is selected from an animal pericardium, porcine, equine, particular bovine pericardium, or from native leaflets from of a human heart or veins.
    [0040] In yet another embodiment of the valve according to the invention, the valve element comprises a bi- or tri-leaf valve.
    [0041] The healthy human tricuspid valve comprises three leaflets, or cusps, named by their positions: anterior, posterior, and septal. Thus, according to one aspect, the valve of the valve made of stent mounted on the stent graft member also comprises three leaflets, and thus represents a tricuspid valve, while also a valve having only two leaflets and, thus, having a "bicuspid" architecture, or even a leaflet, i.e. a monocuspid valve, can be used with the implantable device according to the invention.
    [0042] The human mitral valve has two leaflets, the anterior leaflet which has a semicircular shape, and the posterior leaflet which has a quadrangular shape.
    [0043] As mentioned above, such valves can be created from human or animal donors. They can be created, for example, from the pericardium of a human or any mammal, or from native leaflets from heart or veins, or from any other biological material suitable for the intended purpose. Generally, such valves are also called tissue or biological valves - as opposed to mechanical valves.
    [0044] According to another embodiment, in the device according to the invention the stent element is made of a shape memory material, preferably Ninitol. Nitinol proved to be suitable for implantable medical devices and used in different medical applications.
    [0045] In a preferred embodiment of the device according to the invention the stent element is a laser-cut stent element and/or composed of wires, preferably from Nitinol.
    [0046] In this regard, it is preferred that the atrial anchoring stent portion and/or the valve loading stent portion is made from stranded or otherwise intercepted wires, preferably from Nitinol.
    [0047] In accordance with yet another embodiment, the atrial anchoring stent portion and/or the valve-loading stent portion is made of wire loops.
    [0048] In this embodiment, the anchoring stent portion has a basket-shaped shape, shaped by loops of wires; in this respect it is preferred that between 3 and 15, preferably at least three, four, five, six, seven, eight, nine, ten, eleven loops are present.
    [0049] According to another aspect of the device of the invention, the device further comprises display elements, in particular radiopaque markers, wherein the display elements are attached to the stent element of the device in one or more positions.
    [0050] Presently, "display elements" means any appropriate aids attached or otherwise provided to the device facilitating exact placement of the device. According to one aspect of the invention, those display elements are radiopaque markers comprising or consisting of any suitable material, such as, for example, gold, tantalum, platinum.
    [0051] In another aspect, in the device according to the invention, the substantially cylindrical shape of the valve-loading stent portion, in the expanded state of the device, has a substantially continuous diameter (d3) along its cylindrical length. (l).
    [0052] The present invention also relates to a device according to the invention and as detailed above for use in treating heart valve regurgitation, the heart valve regurgitation being selected from mitral valve regurgitation and/or tricuspid valve regurgitation. In other words, the invention also relates to the use of the device according to the invention to treat heart valve regurgitation, and to a method of treating heart valve regurgitation, the method comprising the step of implanting the implantable device according to with the invention and as detailed above.
    [0053] When delivered by catheter, the method according to the invention may also include the step of inserting a delivery catheter including the implantable device, the implantable device being in a compressed state when loaded into the delivery catheter loading and upon insertion of the device in the heart of a subject who requires treatment, i.e. is suffering from heart valve regurgitation.
    [0054] The patient or subject in need of treatment, i.e., the patient or subject suffering from heart valve regurgitation, is a mammal, preferably a human.
    [0055] As mentioned at the beginning, heart valve regurgitation is a medical condition of the heart in which a heart valve does not close properly when the heart pumps blood. Consequently, mitral regurgitation is the abnormal leakage of blood from the left ventricle through the mitral valve into the left atrium when the left ventricle contracts. The symptoms for this heart disorder depend on what stage of the disease process the individual is in. Individuals with acute mitral regurgitation will have the signs and symptoms of decompensated congestive heart failure, i.e., shortness of breath, pulmonary edema, orthopnea, and paroxysmal nocturnal dyspnea, as well as symptoms suggestive of a low cardiac output state, i.e., decreased exercise tolerance.
    [0056] The invention also relates to the use of the device according to the invention for treating tricuspid regurgitation in a mammal, as well as a method for treating tricuspid regurgitation in a mammal, comprising the step of delivering and/or implanting a delivery device. according to the invention to a position within a patient's heart in need thereof in order to replace or support said patient's native tricuspid valve.
    [0057] The device according to the invention can be either surgically implanted or delivered by transcatheter methods. In the latter case, that is, with a transcatheter method, the device according to the invention is loaded onto a suitable positioning catheter, being compressed by a retractable clamp or tube or the like. The positioning catheter is inserted into the heart of a patient whose mitral or tricuspid valve needs replacement or support.
    [0058] When the tricuspid valve is to be treated, the positioning catheter having the device according to the invention loaded into it in a compressed state, is advanced via the jugular vein into the superior vena cava into the right atrium, where it is positioned in order to expand the atrium anchoring stent portion and the intraannular valve loading stent portion. Alternatively, the positioning catheter having the device according to the invention loaded into it in a compressed state can be advanced via the femoral shaft into the inferior vena cava in the right atrium. Correct placement can be monitored, for example, by means of display elements present in the implantable device according to the invention.
    [0059] Upon correct placement, the cuff or other otherwise compressible means is retracted step by step to release the device according to the invention, by such action the stent limbs of the device can expand and secure the device in the vena cava top and bottom, respectively.
    [0060] When treating the mitral valve, the positioning catheter having the device according to the invention loaded into it in a compressed state is advanced transapically into the left ventricle by crossing the mitral valve into the left atrium where it is positioned in order to expand the anchoring stent portion in the atrium and the valve-loading stent portion in the intra-annular position. Also, the compressed device can be introduced via the femoral vein or jugular vein into the right atrium and transseptal to the left atrium where it is positioned in order to expand the anchoring stent portion in the atrium and the valve-loading stent portion in the left atrium. intra-annular position. Additionally, the compressed device can be introduced via a small surgical thoracotomy into the pulmonary vein (right inferior left superior pulmonary vein) into the left atrium where it is positioned in order to expand the anchor stent portion in the atrium and the stent portion valve loading in the intra-annular position.
    [0061] Advantages and additional aspects of the Invention are defined in the following description and in the following figures.
    [0062] It will be understood that aspects mentioned and aspects yet to be mentioned below may be used not only in the specified combination respectively, but also in combinations otherwise, without departing from the scope of the present invention.
    [0063] The mentioned aspects of the invention and the aspects yet to be possessed below are shown in the figures, in which:
    [0064] Fig. 1 shows a schematic figure of a human heart;
    [0065] Fig. 2 shows a schematic figure of an exemplary embodiment of the device according to the invention placed in the correct position in the left atrium of a heart;
    [0066] Fig. 3 schematic figures of various exemplary embodiments (A - D) of the device according to the invention showing various designs.
    [0067] In Fig. 1, 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 fig. 1 is a portion of the superior vena cava 52, entering the heart 50 through the right atrium 54, and a portion of the inferior vena cava 53.
    [0068] In more detail, the superior vena cava 52 returns blood from the upper half of the body, and opens into the lower rear of the right atrium 54, the direction of its orifice 52a being downward and forward. Its orifice 52a has no valve.
    [0069] 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 opens into the lower part of the right atrium 54, its orifice 53a being directed upward and behind, and protected by a rudimentary valve, the inferior vena cava valve (Eustachian valve, not shown).
    [0070] The right ventricle 55 has a triangular shape, and extends from the right atrium 54 to near the tip 59 of the heart 50.
    [0071] The right atrioventricular orifice (not shown in fig. 1) is the great oval opening of communication between the right atrium 54 and ventricle 55, and is protected by the tricuspid valve 60.
    [0072] The opening 61 of the pulmonary artery 62 is circular in shape, and is placed above and to the left atrioventricular opening; is protected by the pulmonary valves 63.
    [0073] The tricuspid valve 60 consists of three cusps or segments or nearly triangular leaflets 64, the anterior, posterior and medial or septal cusps. The bases of these are attached to a fibrous ring (not pictured in fig. 1) surrounding the atrioventricular orifice and are also combined with each other to form a continuous annular membrane. Their atrial surfaces are directed towards the blood flowing from the atrium 54, while their ventricular surfaces are directed towards the wall of the ventricle 55; together with the apices and margins of the cusps, they give connection to the chordae tendineae (not pictured in fig. 1).
    [0074] As discussed above, the function of the tricuspid valve is to prevent backflow of blood into the right atrium 54; arrows 70 and 71 indicate normal blood flow in the right atrium 54.
    [0075] The left atrium 56 is smaller than the right atrium 54. The left ventricle 57 is larger and more conical in shape than the right ventricle 55. The left atrioventricular opening (mitral orifice, not shown in fig. 1) is placed to the left of the aortic orifice 65, and is protected by the mitral or bicuspid valve 66.
    [0076] The aortic opening 65 is a circular opening, in front and to the right of the atrioventricular opening, and its orifice is protected by the three aortic valves 67. The reference number 68 designates the aorta.
    [0077] Separating the left atrial chamber or left atrium 56 from the left ventricle 57, the mitral valve 66 is, as mentioned above, an atrioventricular valve, with the mitral annulus 70 constituting the anatomical junction between the ventricle 57 and the left atrium 56; ring 70 also serves as an insertion site for the leaflet tissue (not shown).
    [0078] The normal mitral valve 66 opens when the left ventricle 57 relaxes (diastole) allowing blood from the left atrium 56 to fill the decompressed left ventricle 57. During systole, that is, when the left ventricle 57 contracts, the increase in pressure within the ventricle 57 causes the mitral valve 66 to close, preventing blood from leaking into the left atrium 56 and ensuring that all blood leaving the left ventricle is ejected through the aortic valve 67 into the aorta 68 and into the body. Proper mitral valve function is dependent on a complex interaction between the annulus 70, leaflets, and subvalvular apparatus (not shown in Fig. 1, respectively).
    [0079] The mitral valve 66 has two leaflets (not shown), namely the anterior and posterior leaflets. As mentioned above, the anterior leaflet has a semicircular shape, and the posterior leaflet has a quadrangular shape. The movement of the anterior leaflet defines an important boundary between the auger of inflow and outflow of the left ventricle 57. The anterior leaflet is attached to two-fifths of the annular circumference, while the posterior leaflet is attached to approximately three-fifths of the circumference. cancel. The posterior leaflet typically has two well-defined notches that divide the leaflet into three individual curved indentations, which are designated as P1, P2, P3; the three corresponding segments of the anterior leaflet are designated A1, A2, A3. The notches assist in opening the posterior leaflet during systole.
    [0080] On the atrial surface of the leaflets there are two zones, the peripheral smooth zone and the central coaptation zone. The two areas are separated by the slightly curved line of coaptation between the two leaflets evident from the atrial view.
    [0081] Mitral valve 66 and tricuspid valve 60 regurgitation is present when the respective valves 66, 60 do not close completely, causing blood to leak back into the respective atria 56, 54.
    [0082] With the device according to the invention, heart valve regurgitation, in particular mitral valve regurgitation, must be treated, and the placement and an exemplary embodiment of the device according to the invention is shown in fig. 2 attached.
    [0083] Fig. 2 shows the schematic drawing of the heart as already portrayed in fig. 1. For better understanding, fig. 2 does not include all reference numbers as shown in fig. 1, but should show the same aspects of the human heart 50, with slight differences in the designs.
    [0084] As can be seen in Fig. 2, the device 10 according to the invention is placed in the expanded state in the human heart 50. The device as shown in more detail in fig. 3A, and as reference will be made to both figs. 2 and 3A (3D); for the purpose of better understanding, not all aspects of the device designated in fig. 3 are designated in fig. 2, however, the aspects are no different.
    [0085] In Fig. 2, the exemplary implantable device 10 according to the invention - as shown in more detail in Fig. 3A and as is possible with alternative formats of devices 100, 200, 300 shown in Figures 3B, 3C and 3D - is positioned in the left atrium 56 of the heart 50 in an expanded state of the device 10.
    [0086] The implantable device 10 comprises a stent element 11 consisting of an atrial anchoring stent portion 12 and a valve-loading stent portion 14, wherein the atrial anchoring stent portion 12 and the atrial anchoring stent portion 12 valve heads 14 are fixedly connected to each other, and are preferably integrally formed, i.e. manufactured as one piece.
    [0087] In the expanded state of the device 10, the atrial anchoring stent portion 12 of the stent element 11 has a balloon-like shape 13, or, so to speak, a spherical or ball-like shape, made of a frame of stent or stent mesh 16, which is preferably laser cut or interwoven or braided from a nitinol tube or nitinol wires.
    [0088] With its outermost boundaries 17, the atrial anchoring stent portion 12, contacts the walls (not shown) of the left atrium 56, thus securely anchoring the device in the left atrium, without contacting the annulus. 70 of the native valve 66. This is accomplished by the atrial anchoring stent portion 12 of the stent element 11 having, at its widest or largest circumference, a diameter d1 that is greater than the diameter 71 of the ring 70, and by the valve loading stent 14 having a cylindrical shape 15 with a continuous diameter D3 along its cylindrical length l which is in turn smaller than the diameter of the ring 70 of native heart valve 66 being mounted on the stent portion 12 such that the atrial anchoring stent portion does not contact or touch the ring or reach within the intra-annular space.
    [0089] Also, due to the smaller diameter d3 of the valve-loading stent portion 14 it does not contact or touch the ring 70 of the native valve 66, which is the reason the still remaining dysfunctional closing movement of the native valve 66 is withheld.
    [0090] As mentioned above, the valve-loading stent portion 14 has a cylindrical shape 15 with a continuous diameter d3 connected to the valve-loading stent portion 14 is a valve element 18. The valve element 18 comprises a skirt portion 19 and valve portion 20, skirt portion 19 being mounted externally to valve-loading portion 14, and valve portion 20 being mounted internally to valve-loading stent portion 14. Valve member 18 may be of any suitable material, preferably pericardium. The valve portion 20 may be, for example, a tri, bi, or monocuspid valve portion 20, and may be derived, for example, from a mammal.
    [0091] It should be understood that the valve portion 20 has the functions of a native valve, i.e. it can open and close as a native valve does. As a consequence, upon implantation of the device 10, 100, 200, 300 of the invention, there are - so to speak - two valves opening and closing, i.e. the native valve and the valve 20 of the device 10, 100, 200, 300, instead of a native (mitral) valve 66. As a consequence, the valve member 18 supports the closing of the native mitral valve 66.
    [0092] In accordance with the invention, the device 10 provides a valve 20 with a diameter d3 smaller than the native valve ring 70, which valve 20 is in an intra-annular position towards the middle of the spherical self-expanding atrial anchoring stent portion. 12 is placed within the left atrium 56 and secured to the atrium 56 by radial force of the stent element 11. As the internal atrial main cavity has a nearly spherical anatomy, the atrial anchoring stent portion 12 of the device 10, 100, 200, 300 in accordance with the invention, and using a ball-on-ball radial compression arrangement, provides the stability necessary to maintain the implanted valve device 10, 100, 200, 300 within the intra-annular space without coming into contact. or touch ring structure 70.
    [0093] This hybrid solution, i.e. (mitral) valve replacement plus improved coaptation, also solves the problem of the so-called spacer technique, i.e., thrombus formation and spacer stenosis behavior.
    [0094] The device 10, 100, 200, 300 according to the invention can be implanted, for example, by means of transcatheter or surgically implanted. When using a catheter, the device 10, 100, 200, 300 according to the invention is loaded onto the catheter in a compressed state, which is retained by a tube or clamp (not shown) guided into the device 10, 100, 20, 300 thus compressing the same. The catheter having loaded into it the device 10, 100, 200, 300 according to the invention, can be introduced through the patient's vessels and into the heart: For a mitral application, a direct apical access through the tip of the left ventricle and through the mitral valve to the left atrium is possible, but also a femoral vein or jugular vein access followed by a transseptal crossing into the left atrium and through the pulmonary veins with a small thoracotomy. For tricuspid application, a femoral vein or jugular vein access via the superior or inferior vena cava to the right atrium is possible. In the respective atrium - upon removal/withdrawal of the cuff - the expandable device 10, 100, 200, 300 is allowed to expand in its expanded state, thereby contracting and forcing itself against the atrial walls. As a consequence, the atrial anchoring stent portion 12 of the device 10, 100, 200, 300 is anchored within the atrium 56, while the valve-loading stent portion 14 is positioned intra-annular where its valve element 18 supports native valve 66.
    [0095] Fig. 3B, 3C and 3D show exemplary embodiments 100, 200, 300 of a device according to the invention. Rather than being manufactured differently, they all share the same shape, which is characterized by the balloon-like shape of the atrial anchoring stent portion 12 and the cylindrical valve-loading stent portion 14 attached thereto.
    [0096] Fig. 3B shows an embodiment in which the atrial anchoring stent portion is made of zigzag-shaped circumferentially sinuous stent rings, whereby the stent rings, in a longitudinal direction, are connected by additional wires. (nitinol), thus providing a stent frame.
    [0097] Fig. 3C shows an embodiment in which the balloon-like shape of the atrial anchoring stent portion 12 is made of metal wires, preferably nitinol wires, with the wire(s) being outward, that is, convex, curved or connected in the form of fingers.
    [0098] Fig. 3D shows an embodiment in which the atrial anchoring stent portion 12 is formed from interwoven or braided metal wires into a spherical/ball-like shape.
    [0099] The valve-loading stent portion 12 of the different embodiments shown in Figs. 3A to 3D are - substantially - fabricated in the same manner, and depict a cylindrical tubular stent scaffold.
    权利要求:
    Claims (12)
    [0001]
    1. Implantable device (10; 100; 200; 300) for treating mitral valve regurgitation, characterized in that the device (10; 100; 200; 300) is configured to expand from a compressed state into an expanded state , and comprising: - a stent element (11) consisting of (i) an atrial anchoring stent portion (12), and (ii) a valve-loading stent portion (14), the atrial anchoring stent portion (12) being fixedly connected with a valve-carrying stent portion (14), wherein the atrial anchoring portion (12), in the expanded state of the device (10) has a balloon-like shape (13) and has a diameter (d1) which is larger than the diameter (71) of a ring (70) of a native mitral valve (60; 66) present between an atrium (56; 54) and a ventricle (57; 55) of a heart ( 50) to be treated, and to be sized and configured to anchor the device (10) by radial force in an atrium (56; 54) of a heart (50) to be treated when the device (10; 100; 200; 300) is in the expanded state; and wherein the valve-loading stent portion (14), in the expanded state of the device (10; 100; 200; 300), has a substantially cylindrical shape (15) with a diameter (d3) which, in the expanded state, is smaller than the diameter (71) of the ring (70) of the native mitral valve (60; 66), such that there is no contact between the ring (70) of the native mitral valve (60; 66) and the stent portion of valve loading (14), and allowing the native mitral valve (60; 66) to maintain its function; - a valve element (18) comprising a skirt portion (19) and a valve portion (20), the skirt portion (19) being mounted externally to the valve-loading stent portion (14), and the portion valve (20) being mounted internally to the valve-loading stent portion (14).
    [0002]
    2. Device (10; 100; 200; 300), according to claim 1, characterized in that, when implanted, the valve element is sized and configured such that the function of the mitral valve (60; 66) is supported without replacing or imparting native mitral valve function (60; 66).
    [0003]
    3. Device (10; 100; 200; 300), according to claim 1 or 2, characterized in that the atrial anchoring stent portion (12) and the valve-loading stent portion (14) are fully formed.
    [0004]
    4. Device (10; 100; 200; 300), according to claims 1 to 3, characterized in that the atrial anchoring stent portion (12) is capable of anchoring in the atrium (54; 56) of a heart (50), such as the anchoring stent portion (12) at least partially contacting the walls of the atria (54a; 56a).
    [0005]
    5. Device (10; 100; 200; 300) according to any one of claims 1 to 4, characterized in that the skirt portion (19) and the valve portion (20) of the valve element (18) are made of the same material, preferably pericardium.
    [0006]
    6. Device (10; 100; 200; 300), according to any one of claims 1 to 5, characterized in that the valve element (18) is a bi- or tri-leaf valve.
    [0007]
    7. Device (10; 100; 200; 300), according to any one of claims 1 to 6, characterized in that the stent element (11) is made of a shape memory material, preferably Ninitol.
    [0008]
    8. Device (10; 100; 200; 300), according to claim 7, characterized in that the stent element (11) is a laser-cut stent element (11) and/or composed of wires.
    [0009]
    9. Device (10; 100; 200; 300), according to claim 7 or 8, characterized in that the atrial anchoring stent portion (12) and/or the valve-loading stent portion (14) ) is made of strands twisted or otherwise intersected (30).
    [0010]
    10. Device (10; 100; 200; 300), according to claim 7 or 8, characterized in that the atrial anchoring stent portion (12) and/or the valve-loading stent portion (14) ) is made of loops of yarn (32).
    [0011]
    11. Device (10; 100; 200; 300), according to any one of claims 1 to 10, characterized in that the substantially cylindrical shape (15) of the valve-loading stent portion (14), in the state device (10; 100; 200; 300), has a substantially continuous diameter (d3) along its cylindrical length (l).
    [0012]
    12. Device (10; 100; 200; 300), according to any one of claims 1 to 11, characterized in that it is for use in the treatment of mitral valve regurgitation.
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    同族专利:
    公开号 | 公开日
    US9839517B2|2017-12-12|
    EP3000437A1|2016-03-30|
    ES2676060T3|2018-07-16|
    CN105455924A|2016-04-06|
    BR102015024747A2|2016-08-02|
    US20160089238A1|2016-03-31|
    CN105455924B|2019-01-15|
    EP3000437B1|2018-05-30|
    JP2016067931A|2016-05-09|
    PL3000437T3|2018-10-31|
    JP6473682B2|2019-02-20|
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    法律状态:
    2016-08-02| B03A| Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette]|
    2018-10-30| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2020-03-10| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-09-29| B25A| Requested transfer of rights approved|Owner name: MEDIRA AG (CH) |
    2021-11-09| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2022-01-11| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 25/09/2015, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    EP14186503.0|2014-09-26|
    EP14186503.0A|EP3000437B1|2014-09-26|2014-09-26|Implantable device for treating mitral valve regurgitation|
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