prosthetic device for a heart valve and its method of mounting

专利摘要:
PROSTHETIC DEVICE FOR A HEART VALVE. The present invention relates to a prosthetic device for a heart valve, comprising a valve portion with prosthetic cusps capable of reproducing the valve cusps function of a native heart valve, selectively expandable from a collapsed configuration for implantation to an expanded working configuration. The prosthetic device also comprises a containment portion that encircles the valve portion to contain its expansion in the expanded working configuration. The prosthetic device also comprises a connecting part which stably connects the valve part to the containment part by means of connecting elements. The invention allows for both the use of minimally invasive surgical implantation procedures and implantation procedures completely based on transcatheter techniques.
公开号:BR112016017196B1
申请号:R112016017196-9
申请日:2015-02-04
公开日:2021-05-04
发明作者:Giovanni Righini；Sarah Zanon
申请人:Innovheart S.R.L.；
IPC主号:

专利说明:

APPLICATION FIELD
[0001] The present invention relates to a prosthetic device for a heart valve. The prosthetic device can be implanted to replace the physiological function of a malfunctioning heart valve. The invention was developed with special attention to a prosthetic device for an atrioventricular heart valve. BACKGROUND OF THE INVENTION
[0002] Heart valves are complex and delicate organs that regulate the correct functioning of the human heart. Its main function is to make the blood flow within the cardiac cavities unidirectional, which is essential not only for the phase of filling the cavities, known as the diastolic phase, and the blood ejection phase, known as the systolic phase .
[0003] To optimize the efficiency of the action of pumping blood, the structure of the heart consists of two different compartments, namely, the right and left compartments, each of which is in turn subdivided into two chambers, the atrium and the ventricle. The right compartment of the heart, which consists of the right atrium and ventricle, receives blood from the peripheral circulation and sends it to the pulmonary circulation for oxygenation. The left compartment, similarly subdivided into the left atrium and ventricle, provides the peripheral circulation, receiving oxygenated blood from the pulmonary circulation and pumping it to the systemic circulation.
[0004] In order to make the blood flow within the heart unidirectional, a valve is positioned at the outlet of each chamber. The valves located at the outlet of the atrium are called atrioventricular, as they connect the atrial chamber to the ventricular chamber on each side of the heart. On the right side of the heart this valve is also called the tricuspid; on the left side, it is just referred to as the mitral valve. Finally, the valve positioned at the outlet of the right ventricle is called the pulmonary valve, while the valve at the outlet of the left ventricle is called the aortic valve.
[0005] Diseases that negatively affect the functioning of a heart valve are among the most serious of cardiovascular disorders. Of these, mitral valve failure, or its inability to close completely, is a very disabling valve disease because it reduces the efficiency of the pumping action of the left side of the heart, which is responsible for the entire body's blood supply.
[0006] In the current state of the art, the standard therapy for the treatment of severe valve dysfunctions is to replace the valve with an implantable prosthesis. In other cases, especially in the case of mitral valve dysfunction, it is repaired. In both cases this is achieved through an open heart surgical procedure that gives direct access to the malfunctioning valve. This procedure requires the heart to be temporarily stopped and the creation, using suitable pumps and oxygen exchangers, of an extracorporeal artificial blood circuit. Despite the refinement of the techniques used to manage cardiac arrest and the improvement in cardiopulmonary bypass systems, open heart treatment presents risks due to its invasiveness and the time required for the procedure. In fact, implantable prostheses, both for repair and replacement, normally used in traditional surgeries usually require a long operation in order to be fixed at the implantation site using specific suturing techniques. In fact, in some cases, it is not possible to perform surgery because of the patient's general condition, for example, old age or the presence of concomitant illnesses.
[0007] In order to overcome these limitations, procedures have been developed recently that are much less invasive, called transcatheter procedures. For this purpose, radially foldable and self-anchoring prostheses are used at the implantation site. The prostheses can be implanted through catheters capable of navigating within the vascular system and releasing the prosthetic device reaching the implantation site by remote access performed, for example, in a peripheral vessel, such as a vena cava, the femoral artery, etc. Valve dysfunctions can therefore be corrected with a beating heart and with limited use of surgical practice. To date, transcatheter techniques are currently being used clinically for the treatment of the aortic valve.
[0008] The situation regarding the treatment of atrioventricular valve disorders is different, especially the treatment of mitral regurgitation. The complex anatomical configuration of the valve and surrounding structures, the variability of diseases, which in turn differ greatly from each other, which affect the valve directly or indirectly, make it extremely difficult to meet the requirements for an implant safe and effective in the mitral valve via the transcatheter route.
[0009] Even in the variety of individual models, the main technologies developed for transcatheter prostheses for atrioventricular valves differ primarily based on the solution used for the anchorage mechanism for the implant site.
[0010] A number of known prostheses for atrioventricular valves include devices that are fixed to the implantation site using various types of hooks, stitches, clips or other mechanical elements capable of directly connecting with, sometimes even physically penetrating, one or more elements of the valve or adjacent anatomical structures, for example, the valve ring or cusps. Examples of such prostheses are described in applications WO 2010/037141 and WO 2011/002996, in which two circumferential crowns are described, with hooks and loops, respectively, which allow hooking on the mitral valve ring. In WO 2008/103722 a prosthesis is described with stitches and hooks that hook into both the ring and the cusps of the native valve.
[0011] Other known cardiac prostheses have a support structure provided, at the end facing the ventricle, with loops designed to employ the native cusps or their free margins. At the atrium-facing end, similar loops or a burnout of the supporting structure are provided, which creates an interference on the atrial side of the valve. The prosthesis is therefore fixed to both sides of the native valve. Examples of this anchoring solution are described in WO 2011/106533, WO 2011/069048, WO 2011/137531 and WO 2012/011108.
[0012] Other known cardiac prostheses comprise two separate components that are implanted according to a well-defined sequence. In general, the process provides for a first substantially annular component to be implanted separately and independently into the native atrioventricular valve, generally flush with the annulus. The second component of the cardiac prosthesis is implanted after a period of time that can vary from a few minutes to several days. The second component comprises the functional prosthetic cusps and uses the first component as an anchoring element, through direct mechanical coupling, which does not directly involve the native valve. Examples of this model solution are described in US 6,730,121, US 2012/016464, FR 2,874,813, US 2008/077235 and US 2005/137691. Even though the model of specific modalities is very different, these patent documents describe solutions that can be brought back to the same anchoring principle.
[0013] Other known cardiac prostheses comprise separate components, separate from each other in the pre-implantation phases, but the final anchorage necessarily requires the direct involvement of both all components and the native valve. An example is described in WO 2011/109813, where a linear element, for example a wire or a band, is released around the mitral valve and then closed back on itself so as to surround the cusps of the valve. The linear element acts as a retaining ring of a valved component, generally described in WO 2011/109813 as a cylindrical structure equipped with functional prosthetic cusps, which is expanded into the native mitral valve. The native valve cusps therefore remain trapped between the linear element and the valved component, creating, due to friction between the various components, the anchorage of the prosthesis system to the implantation site. In WO 2012/063228 another example of a prosthesis comprising an annular element that is implanted to correspond to the native mitral valve is described. The position of this device can be sub-ring, in which case the structure is subdivided into several parts so as to have the double open and closed configuration, or supra-ring, in which case it is a simpler single structure with the closed configuration. In both, the annular element is positioned so as to completely surround the native valve cusps close to its insertion into the annulus, without, however, independently anchoring itself. A second implantable element, comprising the prosthetic cusps, is expanded into the mitral valve and the first annular element, which mechanically engages with the latter. The solid coupling that results between the various components is capable of blocking the native valve cusps between the two elements, ensuring a secure and long-lasting anchorage and effective tightness against backflow.
[0014] The aforementioned known prostheses do not adequately meet a number of essential requirements for the proper replacement of malfunctioning atrioventricular valves by a transcatheter-type prosthesis. Many of them are not able to guarantee contact with the implantation site anatomy, which is continuous along the entire periphery of the prosthesis and stable over time. This requirement is essential in order to obtain both secure and balanced anchorage and to avoid the possibility that retrograde flow pathways are created around the prosthesis.
[0015] Another aspect that most known prostheses do not take into account is the fact that peripheral tightness against retrograde flow must be achieved without the prosthesis by applying a radial force on the native valve ring. In fact, diseases that interfere with the functioning of the atrioventricular valve are often associated with dilatory phenomena, sometimes only in the ring, at other times the heart chambers are also involved. Therefore, a radial force applied to an anatomical structure that already pathologically tends to dilate not only aggravates the disease itself, but does not provide any guarantee as to the long-term behavior of the prosthesis. The prostheses described in WO 2011/109813 and WO 2012/063228 deal with this aspect, but have the problem that they consist of several components that are independent of each other. This complicates the prosthesis implantation procedure and does not guarantee that it is correctly mounted in the final position necessary for its functioning, ideally as planned. Furthermore, these prostheses run the risk of being less stable and durable over time. BRIEF DESCRIPTION OF THE INVENTION
[0016] The present invention relates to a prosthetic device for a malfunctioning atrioventricular heart valve, which allows the use of minimally or fully invasive transcatheter implantation techniques and significantly reduces the time required for its implantation, solving the problems of the prior art.
[0017] The invention is directed to a prosthetic device for a heart valve, comprising: a valve part with prosthetic cusps capable of reproducing the function of the valve cusps of a native heart valve, expandable from a collapsed configuration to the deployment to an expanded working configuration. a containment part which surrounds the valve part in order to contain its expansion in the expanded working configuration, a connecting part which stably connects the valve part to the containment part.
[0018] More specifically, the valve part comprises a dedicated central support element to support all of the prosthetic cusps, while creating a suitable channel for the flow of blood to fill the ventricle. The connecting part preferably comprises a set of flexible molded elements which ensure the physical connection and the structural union between the central support element and the containment part. Below these elements of the prosthetic device will generally be referred to as connecting elements.
[0019] According to a first aspect, the prosthetic device has a single and continuous structure, but it is functionally differentiated, capable of anchoring and sealing to an atrioventricular valve without exerting any radial force on the latter or on the environment surrounding anatomical. On the contrary, the prosthetic device is suitable to integrate intimately with the native valve as it does not merely replace it in the function of making the blood flow unidirectional, but also stabilizes its shape and dimensions, preventing successive dilations. and prolapses caused by the disease.
[0020] The described prosthetic device implantation techniques comprise minimally invasive implantation techniques, such as transcatheter or endoscopic techniques, or more generally implantation techniques allowing the heart to continue to beat without the need for extracorporeal circulation. The prosthetic device can also be implanted using surgical techniques with direct access, but reduced dimensions, to the implantation site.
[0021] With specific reference to endoscopic or transcatheter implantation procedures and generally minimally invasive, the structure of the present prosthetic device may lead to, in whole or in part, a selectively expandable smaller radial space. This characteristic is obtained through the use of a material with superelastic properties, or which allows great deformations of any element of the structure while remaining in the elastic domain, that is, without suffering permanent distortions. For example, the equiatomic alloy of nickel and titanium, known commercially by the name Nitinol, has this type of superelastic properties.
[0022] According to one aspect of the prosthetic device, the containment portion is positioned at the back of the atrioventricular valve cusps so as to completely surround them. Expansion of the central support element within the native valve until it contacts the containment portion, therefore, achieves the effect of trapping and locking the valve cusps securely in the prosthesis structure. If the implementation of the containment part occurs at the immediately subannular level, very close to the ring, this interaction between the prosthetic device and the native valve provides the functions of anchoring at the implantation site and produces the fluid squeeze necessary for the correct functioning of the device prosthetic. Furthermore, immobilizing the native cusps in the vicinity of their insertion line in the valve annulus, this also results in the stabilization of the anatomical structure, avoiding the risk of successive pathological dilations that affect the long-term performance of the prosthetic device, as well as constituting an aggravation of the patient's clinical condition. Since the prosthetic device is in a single body at the time of implantation, the mechanical continuity between the central support element and the containment part makes their mutual positioning and the method of integration of the prosthetic device with the natural valve cusps clear and independent of the operator or the implantation procedure.
[0023] According to another aspect of the prosthetic device, the containment part is obtained with a structure having a substantially annular geometry when viewed from above, capable of continuously surrounding the entire native valve. The substantially annular geometry can be molded beforehand according to profiles that best fit the anatomy of the atrioventricular valve ring, e.g. oval, oblong, beam-shaped, etc. In addition, the substantially annular geometry can be two-dimensional, which is flat, or three-dimensional, molding, for example, to the anatomical saddle shape of the native ring. The geometry creates a continuous coupling with the native valve throughout its peripheral development, in such a way as to provide balanced anchorage and avoid creating pathways through which retrograde blood flow can pass.
[0024] According to another aspect of the prosthetic device, the containment portion is substantially inextensible longitudinally, that is, in terms of the length of the peripheral extension, although it is deformable to reduce the space it occupies during the implantation procedure. The requirement for an inextensible structure results from the need to have an effective retaining element for the expansion of the central support element. In this mode, the radial force exerted by the central element, which is also necessary to anchor to the stable native cusps, is supported entirely by the containment part, thus avoiding any radial stress on the surrounding anatomy. The requirement for deformation capacity in terms of shape results from the need for compatibility with minimally invasive implantation procedures, both surgical and possibly transcatheter.
[0025] Atrioventricular valves are characterized by a subvalvular apparatus, which comprises tendinous cords and papillary muscles, which creates physical continuity between the so-called free margin of the valvular cusps and the wall of the ventricle. The valve cusps are such, therefore, connected to the ventricular structure on both sides: on the one hand through the ring, while on the opposite margin, the free margin, through the tendinous cords. According to another aspect of the prosthetic device, the containment part is mountable from an open configuration such that it can be inserted into the back of the cusps, in the space between the inner wall of the ventricle and the cusps themselves, for the substantially annular closed configuration. In other words, the containment part must be able to configure itself into an initial and temporary open geometry to allow its positioning behind the native atrioventricular valve, and a substantially closed working geometry at the beginning of the implantation procedure. real, suitable to completely surround the native valve and provide the desired contrast for the expansion of the central support element.
[0026] According to a particular aspect of the prosthetic device, the open configuration of the containment part can be obtained by breaking the annular structure according to a predetermined position.
[0027] According to another particular aspect of the prosthetic device, the open configuration of the containment part can be obtained by subdivision of the containment part into two or more, and not necessarily symmetrical, segments or subcomponents. The physical continuity of the containing part can be reconstituted by connecting each segment directly to its adjacent ones, or through the system of connecting elements, for example, in the case where these attach more than one segment at a time to the central element. In this last solution, the connecting elements themselves act as a bridge and link between the various segments of the containment part.
[0028] By way of practical example, without intending in any way to limit the general nature of the invention, reference may be made to the implantation of the mitral valve prosthetic device. According to a first solution, the containment part comprises two segments obtained by separating the annular structure in line with the two commissural regions. In this case, one segment of the containment parts substantially coincides with the posterior arch of the valve, which coincides with the line of insertion of the posterior cusp into the annulus, while the other segment coincides with the anterior arch, that is, with the line of insertion of the anterior cusp over the valve ring. It proves to be advantageous, in this configuration, to have the connecting elements close to the middle section of each segment. This solution makes the positioning of the containment part surround the simple native valve. In fact, early in the deployment process, each segment can be deformed into a configuration that takes up little radial space. Then, when the device has been introduced into the ventricle, each segment, still in the space-saving configuration, can be easily inserted into the back of the corresponding valve cusp and then released, each independently, possibly maintaining the central support structure in collapsed configuration. Simple locking mechanisms positioned at the ends of the segments, such as, for example, mechanical fasteners, make it possible to restore a closed structure for the containment part, which is deformable but not extensible.
[0029] According to another aspect of the prosthetic device, the segments of the containment part, regardless of the number and shapes in which they are subdivided, are temporarily separable from the rest of the structure of the prosthesis, in particular from the part of the valve equipped with the cusps of the prosthetic valve. In this way, the segments of the containment part can be introduced into the ventricular chamber and positioned partially or entirely around the native valve at different times relative to the central support element. Then, the central support structure, together with all the connecting elements, is introduced into the ventricular chamber, close to the implantation site. In this case too, the physical continuity of the containment part, as well as the entire structure of the prosthesis, can be reconstituted before the implantation procedure, directly connecting each of the segments to those adjacent to it, or connecting more segments to the same system of elements of link, or through a combination of the two methods.
[0030] In order to reduce the risk of damaging the native cusps in the area where coupling with the valve prosthesis occurs, all or part of the containment part may be covered with tissue, of a biological nature, for example, animal pericardium or of an artificial nature, for example fabric made from PET or PTFE, or a polymer material, for example silicones or polyurethanes, or a combination of the two, for example polymer material internally, covered by a fabric film . The presence of an outer tissue lining of the containment part, as well as the central support element, also has the additional advantage of promoting endothelialization of the same by the surrounding cell structures, increasing the ability of the prosthetic device to integrate with the surrounding physiological environment. .
[0031] According to another aspect of the prosthetic device, the containment part described above may, at the same time, prove to be flexible compared to the deformations that occur in the plane identified by the containment part itself, but substantially rigid compared to direct deformations outside this plane. This property favors the maintenance of the correct spatial reference between the containment part and the central support element, which means, therefore, that they are substantially in line contact with a predetermined section of the central element, regardless of the implantation process, of the specific anatomy of the patient and the method of positioning the prosthesis itself. Therefore, it is possible to properly mold the coupling region on the central support element in such a way that it can accommodate the geometry of the section of the containment part properly and in a non-traumatic way. For example, a suitably molded groove can be provided or truncated cone-shaped parts can be positioned in the profile of the central element, or small circumferential pads can be made with additional material, either of a biological nature, such as an animal pericardium, or a artificial nature, such as fabrics made from PET or PTFE, silicone polymers, etc. By improving the coupling between the supporting element and the containment part, or increasing the extension of the contact surface, it is possible to achieve a strong anchorage of the native cusps between the two elements while keeping the applied pressure low. This last aspect significantly reduces the risk of damage and injury to the native cusps, which is beneficial for the long-term reliability of the prosthetic device.
[0032] According to another aspect, the prosthetic device comprises a mechanism suitable for stably connecting the part of the valve comprising the central support element to the containment part. In fact, the need to position the containment portion separately from the central body of the prosthesis, in order to be able to fully deploy behind the native atrioventricular valve cusps, involves the presence of a mechanism capable of connecting the two main parts of the device prosthetic before final implantation. The operation of the locking mechanism of the two parts, that is, the restoration of the structural integrity of the prosthesis, occurs using methods compatible with transcatheter procedures, which is through remote control of the components, in accordance with the current state of the art of the techniques of intervention. The locking mechanism is based on the use of guide wires to which the structural elements participating in the binding mechanism are limited. In detail, the locking mechanism includes one or more structures belonging to the containment part and one or more structures belonging to the central valve element. Due to the action of the guide wires, these structures are aligned and connected to each other in a stable manner, thus restoring the structural unity of the prosthesis.
[0033] According to a particular aspect of the invention, the segments into which the containment part is subdivided are limited to one or more guide wires through the presence of hollow structures that allow them to pass through. With this solution, the same guidewire system previously positioned around the native valve can be used initially to guide the correct placement of the containment portion on the back of the native valve cusps and then also to operate the valve mechanism. block.
[0034] According to another particular aspect of the invention, the central support element has, on its periphery, hollow structures suitable for the passage of one or more guide wires, according to the configurations that allow the stable, mechanical connection with structures corresponding hollows on the containment part of the prosthetic device.
[0035] According to another particular aspect of the invention, each segment of the containment part has common mechanisms that allow it to be elastically deformed until it assumes a straight configuration occupying minimal radial space. Thus, the introduction and implantation of the segments of the containment part at the implant site can occur inside small diameter catheters, which make the procedure safer and minimally invasive. BRIEF DESCRIPTION OF THE DRAWINGS
[0036] The solution according to one or more embodiments of the invention, as well as the subsequent features and relative advantages, will be better understood with reference to the following detailed description, given purely by way of indication and not limitation, to be read together with the attached figures in which, for the sake of simplicity, the corresponding elements are indicated with the same or similar references and their explanation will not be repeated. To this end, it is expressly understood that the figures are not necessarily to scale, with a number of details that may be exaggerated and/or simplified, and that, unless otherwise indicated, are used simply to conceptually illustrate the structures and the procedures described. In particular:
[0037] According to different points of view, figure 1A and figure 1B show a general schematic representation of a prosthetic device for the treatment of heart valves, according to an embodiment of the invention;
[0038] Figure 2 is a cross-sectional view of the left side of the heart, with particular attention to the anatomy of the atrioventricular valve. This view will be used to illustrate specific applications of the prosthetic device in accordance with various embodiments of the invention;
[0039] Figure 3 shows an example of the application of the prosthetic device for the replacement of the atrioventricular valve on the left side of the heart;
[0040] Figure 4 shows a different modality of the prosthetic device for the treatment of heart valves, characterized by an oblong geometry of the containment part;
[0041] Figure 5A and Figure 5B show a different embodiment of the containment part of the structure of the prosthesis, according to an embodiment of the invention;
[0042] Figure 6 shows a posterior embodiment of the containment part of the structure of the prosthesis, according to an embodiment of the invention;
[0043] Figure 7 shows an example of a prosthetic device for the treatment of heart valves, according to an embodiment of the invention, characterized by having the containment part of the structure of the prosthesis incorporated in such a way as to present two distinct configurations: one open configuration, temporary, and a closed configuration, which corresponds to the working configuration;
[0044] Figure 8A and Figure 8B show a different modality of a prosthetic device for the treatment of heart valves, according to an embodiment of the invention, characterized by a different configuration of the containment part of the structure of the prosthesis;
[0045] Figure 9A and Figure 9B show, according to different views, a general schematic representation of a prosthetic device for the treatment of heart valves, according to an embodiment of the invention, characterized by having one or more parts of the part. containment of the structure of the prosthesis, which are temporarily separable from the remaining part of the structure of the prosthesis, it being necessary, however, to re-establish the single body of the structure before implantation of the device;
[0046] Figures 10A to Figure 10C show an example of an embodiment of a prosthetic device for the treatment of heart valves, according to an embodiment of the invention, characterized in that the containment part of the structure of the prosthesis subdivided into two parts that are temporarily separable from the remaining part of the prosthesis structure;
[0047] Figures 11A to Figure 11G show an example of an implantation procedure using a minimally invasive surgical procedure of the prosthetic device for the treatment of heart valves described in Figure 10A to Figure 10C,
[0048] Figure 12A and Figure 12E show, according to different views, a general schematic representation of a prosthetic device for the treatment of heart valves, in accordance with an embodiment of the invention, characterized in that it is equipped with a mechanism to lock the containment part for the valve part of the prosthetic device, compatible with an implantation procedure based on transcatheter techniques,
[0049] Figures 13A to Figure 13E show an example of an embodiment the segments in which the containment part is subdivided, according to an embodiment of the invention, comprising sections with a unidirectional elastic joint that allow the segments of the containment part to recover a linear configuration, taking up little radial space, particularly suitable for use in transcatheter implantation procedures,
[0050] Figures 14A to Figure 14G show an example of an implantation procedure based on transcatheter techniques of the prosthetic device for the treatment of heart valves having the connection mechanism shown in Figures 12A to Figure 12E and the segments of the part of containment as shown in Figures 13A to Figure 13E. DETAILED DESCRIPTION OF THE PREFERRED MODALITIES
[0051] Figure 1A and Figure 1B show, according to two different perspectives for a better understanding of the drawing, a general schematic representation of an implantable prosthesis device 10 used to replace the function of an atrioventricular valve, according to a modality of the invention.
[0052] The prosthetic device 10, as illustrated in figure 1A and figure 1B, is formed by a prosthetic structure 12, forming a support and an interface with the native valve and by a set of flexible prosthetic cusps 14 fixed to its interior. The structure of prosthesis 12 is made into a single entity, but three conceptually identifiable parts can be seen in them that are different from each other in functional terms. In fact, it is possible to identify: - a central support element 16, - a containment part 18, - a set of connecting elements 20 for joining the central support element 16 and the containment part 18.
[0053] The prosthetic structure 12, as well as each of its elements, is designed to be dismountable without repercussions on the safety and functionality of the prosthetic device. Therefore, it is possible to temporarily reduce the radial size of the prosthesis, in order to allow it to be introduced into the heart cavities through small opening access holes, compatible with minimally invasive surgery techniques, or even with the techniques of known transcatheters for positioning and implanting cardiac prostheses. In other words, it is possible to insert the prosthetic device 10, inside a catheter, with a small radial profile, capable of driving the prosthesis into the heart cavity, close to the implantation site, through direct minimally invasive access routes, for example, via transapical, or via transluminal, and carry out its implementation and implantation there, functionally replacing the native valve.
[0054] Below is a detailed description of the various parts that make up the structure of the prosthesis.
[0055] The central support element 16 is the part of the prosthesis structure, which delimits the channel for the passage of blood through the device. Within the central support element 16 the flexible prosthetic cusps that make blood flow within the unidirectional channel are fixed. Each prosthetic cusp 14 actually has a sealed edge on the inner surface of the central support element 16, while the opposite edge is free to arrange itself according to the flow pattern within the prosthetic device 10. Under flow conditions Directly, and therefore in the open valve configuration, the cusp of the prosthesis 14 flexes substantially in the direction of flow, with the free edge moving away from the axis of the central support element 16, minimizing obstruction to flow. In contrast, in the closed valve configuration, the prosthetic cusps 14 are positioned transversely to the flow direction, with the free edge of each prosthetic cusp 14 in contact with the free edge of the adjoining prosthetic cusps to fully occlude the orifice of the channel. In this way, the main function of the valve is activated, that is, to make the flow within it unidirectional, preventing reverse flow and minimizing interference with direct flow.
[0056] In the modality illustrated in figure 1A and figure 1B there are three cusps of the prosthetic valve 14, with three being the ideal number of cusps in a cylinder orifice. However, the working principle does not change substantially even if there are a smaller number of cusps, for example two, or a number greater than three. The central support element 16 is a radially foldable elastic structure, which tends, due to its elastic recovery, to expand even to a diameter greater than the maximum diameter that maintains the coaptation, which is the contact, between the free margins of the closed prosthetic cusps 14.
[0057] The containment part 18 is the part of the structure of the prosthesis, which contrasts and limits the free expansion of the central support element 16, preventing it from exceeding the maximum diameter compatible with the preservation of coaptation between the prosthetic cusps 14. The containment portion 18 has a substantially annular geometry and is longitudinally inextensible, i.e. it does not significantly change its peripheral extent, even when the central bearing element 16 expands within it, applying an outwardly radial force. During the implantation process, when the prosthetic device 10 is positioned for final release in accordance with the implantation site, the containment portion 18 is placed outside the native atrioventricular valve, around the valve cusps completely, while the element center bearing 16 is within the cusps of native valves, substantially on the axis of the atrioventricular valve orifice. Upon final release, the central support element 16 expands until it meets the containment part 18, with which it engages on the outer surface. As a consequence of the design of the structure of the prosthesis, the natural valve cusps remain trapped within the coupling between the two parts of the prosthetic device 10. In addition, the containment part 18 also has the function of stabilizing the native valve ring, preventing that the radial force exerted by the central support element 16, although necessary to ensure the effective anchorage of the prosthesis, is transferred to the surrounding anatomical structure, which is normally affected by degenerative and dilatory processes associated with the disease, which causes the malfunction of the atrioventricular valve.
[0058] Finally, the set of connecting elements 20 is that part of the structure of the prosthesis 12 that physically connects the central support element 16 and the containment part 18, making the structure of the prosthesis 12 a single and continuous entity. The monolithic structure allows for a safer and more effective functioning of the prosthesis, making the anchoring mechanism of the prosthesis stable and durable, as well as simplifying and speeding up the implantation process, with immediate and reproducible positioning of the prosthesis, as can be seen from the examples described in the figures below.
[0059] In order to make the explanations clearer, in the outlines of Figure 1A and 1B, as well as in the following figures, the outer diameter of the central support element 16 is shown with dimensions smaller than the inner dimensions of the part of containment 18. In other words, the figures show that these two components of the structure of the prosthesis 12 are not in contact with each other in the fully expanded configuration. It is possible to have the oversizing of the central support element 16, compared to the dimensions of the containment part 18. In this case, there is interference between the two parts of the structure of the prosthesis 12 and, in fact, the central support element 16 applies radial pressure on the containment part 18 when it exerts its restricting expansion action, regardless of the thickness of the tissue that is trapped between the two parts of the prosthesis structure 12. This radial pressure increases the anchoring stability for the valve cusps natives.
[0060] In order to better illustrate the modality of the invention described in figure 1A and figure 1B, a practical example of this is described below as a prosthesis to replace the mitral valve, the heart valve to be positioned between the left atrium and the ventricle left. For this purpose the anatomical cross-section diagram of the left side of the heart is given in figure 2. It is shown a cross-section in the longitudinal axis of the left side of the heart, as it would appear if the posterior wall of the left ventricle and atrium had been removed. Therefore, it is possible to visualize the mitral valve in the projection of the posterior arch, with the posterior cusp in the foreground and the anterior cusp opposite the orifice. The cusp insertion line in the plane of the valve identifies the mitral valve ring. The zones of the ring that pass between the anterior and posterior cusps are denoted as commissural zones. The chosen anatomical section also clearly shows the subvalvular apparatus, which consists of tendinous cords and papillary muscles. This subvalvular apparatus creates continuity between the free margins of the valve cusps and the walls of the ventricle.
[0061] Figure 3 shows an example of the application of the prosthetic device 10 described in Figure 1, according to a specific embodiment of the invention. The illustrative diagram shown in Figure 3 shows the central support element 16 of the device expanded within the mitral valve to create the intraprosthetic passage for blood flow. The prosthetic cusps 14 are within this passage, with the function of making the flow unidirectional. Although the central support element 16 is within the native mitral valve, the containment portion 18 of the prosthesis is positioned at the back of the native cusps, to surround the mitral valve externally, as a limiting restriction on the expansion of the central support element 16 It is clear how the design of the structure of the prosthesis 12 is such that the implanted prosthesis does not apply any tension to the mitral annulus. The two sets of connecting elements 20 of the prosthesis structure pass over the mitral valve in the subvalvular space near the midline of each native cusp, avoiding any interference with the tendinous chord bundles that tend to open in such regions. Due to the specific anatomical view, Figure 3 shows only one of the groups of linkage arms 20, that is, one that passes along the posterior cusp. A similar arrangement is also created symmetrically in the middle part of the anterior cusp, remaining hidden in perspective in Figure 3. It should be noted that, anatomically, over the middle part of each valve cusp an opening is actually created in the chordae tendinous bundles that away from the free margins, as shown in figure 2 for the posterior cusp. Each valve cusp is actually connected, through the chordae tendinae, to both papillary muscles, which lie in positions almost in front of the ventricular cavity. This opening in the combs of the tendinous chords constitutes an excellent passage for the connecting elements 20 of the structure of the prosthesis.
[0062] From Figure 3 it is equally clear how the connecting elements 20 contribute to the anchorage of the prosthesis, especially during the critical systolic phase, when the atrioventricular valve is closed and the ventricular pressure, at its maximum, pushes the prosthesis for the atrium. In fact, it is clear how the connecting elements 20, being one with the containment part 18 segregated at the back of the native cusps, operate as a structure, which securely fastens the central support element 16 to the valve ring, which effectively integrates the anchoring action due to the capture and imprisonment of native cusps within the structure of the prosthesis itself.
[0063] Figure 4 shows another version of the structure of the prosthesis 22, according to a different embodiment of the invention. In this embodiment the containment portion 24 of the prosthesis structure maintains an annular and inextensible shape, but has an oval geometry elongated about an axis, an alternative to the substantially circular geometry of the containment portion 18 depicted in Figure 1. To simplify the diagram , the cusps of the prosthetic valves are not shown, being superfluous for the purposes of the description, and, in addition, the central support element 16 is shown in a compressed configuration, such as an example of the geometry assumed during the implantation procedure before the final release.
[0064] It should be noted, with reference to the configuration depicted in Figure 4, how appropriate it is to provide the connecting elements 20 with arms, the cross section of which has a relatively small thickness (by way of indication and not limited to the range of 0.25mm to 0.75mm) and a significantly larger transverse dimension (eg not yet limiting, in the range 0.5m to 3mm). Due to this dimensioning, and the particular loop design, the connecting elements 20 prove to be radially flexible, but rigid if loaded tangentially or axially. They are therefore suitable for compensating for any variation in radial distance that is created between the containment part 24 (or 18) and the central support element 16, for example when the former is deployed while it is still in a compressed configuration. as shown in figure 4. At the same time, however, they are suitable for maintaining clear reference between the two elements during the implantation procedure, avoiding, for example, a displacement of the containment component in relation to the central element during the positioning the prosthesis in contact with the mitral valve ring.
[0065] The containment part 24, which has an elongated, oval or bundle-shaped, symmetrical or asymmetrical shape, is often more suitable for coupling to the anatomical shape of the atrioventricular valve ring, even in the presence of pathological conditions . In fact, during the early stages of the implantation procedure the containment portion 24 of the prosthetic device, already implanted in the ventricular chamber, has to substantially conform to the ventricular aspect of the native valve ring. In fact, the positioning of the containment portion 24 in close proximity to the insertion line of the valve cusps to the ring ensures both anchoring life, being the thickest and most robust zone of the cusp, and full tightening to counter flow , in which there is continuity of the cusps along the entire periphery of the valve. With regard to this last point, the fact that the extension of the valve cusps significantly reduces in the commissural zones, where there is a transition between the two valve cusps, has to be taken into account. Therefore, if the prosthesis is placed too low in the ventricle, this increases the risk of continuity of the cusps trapped inside the coupling between the containment part and the central element will be interrupted at the level of the commissural areas, thus being limited to the main arches.
[0066] This lack of continuity in the sealing ring creates leakage outside the prosthetic channel, and therefore a loss of grip of the prosthesis to reverse the flow. Choosing the geometry of the annular part of the prosthesis, according to the anatomy and pathology to be treated, makes it easier and more effective to position the structure itself close to the native ring, on the back of the native cusps, positioning facilitated by geometric matching of the parties. Based on the simple pathophysiological considerations known in the prior art, the ideal geometry of the annular part can be selected both in a two-dimensional and in a three-dimensional way, for example, according to a saddle shape in space.
[0067] It is useful to point out that the geometry adopted by the annular part during the initial phase of coupling with the native valve ring may not affect the final geometry of the expanded prosthesis structure, in particular the shape of the prosthesis hole, which guarantees the best operating conditions for the prosthetic cusps. In fact, it is possible, according to the various embodiments of the invention, to vary, with a considerable degree of freedom, the flexural rigidity of the containment part, also creating cross sections with anisotropic elastic characteristics, while still fulfilling the essential requirement of no longitudinal extensibility of the part itself. It is possible to design the annular part in such a way that it is substantially flexible according to the deformations that remain in the plane identified by the element itself, while being substantially rigid in all direct deformations outside this plane. With a design of this type, the containment part cannot be deformed, in the direction of the axis of the prosthesis, during the positioning of the device in the best position for implantation, preventing it from being misaligned in relation to the coupling region on the external surface of the device. central support. At the same time, its in-plane deformation capacity allows it to adapt perfectly to the expanded geometry of the central support element, thus promoting the permanent coupling between the two structures, without, on the other hand, interfering with the correct functioning of the prosthetic cusps, which require a predefined working geometry of the supporting element, which contains them. As an example of the above, it is therefore possible to design the containment part with any oblong geometry suitable for coupling with the native ring, at the moment it is positioned in the sub-ring groove of the native valve, holding said part of planar containment during all phases of positioning, due to its rigidity to out-of-plane deformation, and ultimately, when it is deployed, to make it conform to the definitive cylindrical geometry of the support element, due to its capacity of deformation in the plane.
[0068] Purely by way of example, without limiting the general nature of the invention, an embodiment of a containment part 26, which satisfies the characteristics of an anisotropic elastic response described above is shown in Figure 5A, as an integral part of the structure of the prosthesis. , and in Figure 5B, where it is shown in isolated form, for clarity. The containment portion 26 is formed of a substantially tubular structure, the flexibility of which is regulated by a series of openings 28 having selected dimensions and position. In the example shown in Figures 5A and 5B, the openings 28 are aligned along two main generators, one on the inner face and one on the outer face of the containment part 26. This creates two continuous bands 30a, 30b, one on the upper side and one on the underside, which makes the annular part particularly rigid for out-of-plane deformations. This stiffness capacity is in accordance with the bandwidth. The dimensions of the single opening and the distance between adjacent openings, on the other hand, determine the elastic characteristics for in-plane flexion.
[0069] Another example of an embodiment of a containment part 32 is described in Figure 6. This figure also shows the containment part 32, isolated from the rest of the structure of the prosthesis, for clarity. In this example, which does not limit the general nature of the invention, the containment portion 32 is in tubular form with openings 34 positioned according to a cyclic sequence that reduces the anisotropy of the elastic response of the annular portion, which results in the openings being more uniformly distributed over the surface. With this geometry it is also possible to modulate the elastic response according to the bending direction. For example, by reducing the size of the openings 34 positioned on the upper and lower sides, compared to the dimensions of the openings 34 positioned on the inner and outer sides of the containment part 32, a greater rigidity capacity to out-of-plane deformations is achieved. compared to the coplanar deformations with the structure. Still by way of example, without intending to limit the general nature of the invention, figure 6 also shows the modulation of the dimension of the openings 34 according to their angular position in the annular part, in order to obtain a structure with elastic properties that vary to the along the periphery according to predetermined requirements. With the geometry shown in figure 6, for example, there is a containment part 32, the flexural flexibility of which, while still being anisotropic in each cross section, increases away from the parts of continuity with the connecting elements 20 to let it be at its maximum near the mid-range.
[0070] The modalities shown in figure 5 and figure 6 refer conceptually to the structural component of the containment part. To reduce the risk of injury to the anatomical structures of the implantation site, such a structural component can be covered with polymeric material, eg silicone or polyurethane, and/or tissue, in order to recreate a continuous, non-traumatic external surface. The use of tissue, both artificial and biological, for the outer surface of the containment component also enhances its ability to be endothelyzed and therefore physiologically integrated into the implantation site.
[0071] As previously described, the subvalvular structure of the atrioventricular valves creates anatomical and functional continuity between the heart valve and the ventricular wall. Each valve cusp is therefore continuous with the heart structure, on the one hand through the ring and on the other through the chords and papillary muscles. This continuity is important for the stability of the ventricular chamber and is desirable for the treatment of valve dysfunction, to avoid any interference with it. Due to this limitation, the requirement to encircle the atrioventricular valve externally with the containment portion of the prosthesis structure can be satisfied by providing it with an open transitional configuration, such as to allow it to be positioned in the space between the portion of behind the native cusps and the ventricle wall, without the need to interrupt the continuity between the ventricle and the valve. The subsequent requirements for flexural malleability and longitudinal non-extensibility of the containment portion suggest that the open configuration represents a temporary condition associated with its pre-implantation positioning behind the native valve, while for the actual deployment phase and under operating conditions the containment portion has a closed and substantially continuous configuration.
[0072] Figure 7 shows a version of the structure of the prosthesis, according to various embodiments of the invention, which provides a containment part 36 having a configuration that can go from temporarily open to closed. In the example given in the figure, which does not limit the general nature of the invention, the containment part 36 is separated into two curved segments 37, 38, each segment 37, 38 being equipped with a mechanism for closing the annular geometry in one phase. subsequent to its placement on the back of the native valve cusps. In the example shown, this mechanism comprises a molded pin 39, for example with a saw tooth, facing a cavity 40 which has the design and dimensions to prevent the molded pin 39 from coming out once it has been inserted into cavity 40 The cavity 40 can be designed to be radially elastic. In this way, it is possible to have slight interference between the molded pin 39 and the cavity 40, increasing the solidification capacity and reliability of the closing mechanism. Obviously, the closing mechanism can take equivalent alternative forms. For example, cavity 40 itself may have a sawtooth profile internally, produced by elastic lamellas (not shown) that project into cavity 40. In general, the use of superelastic material to create the denture structure makes make it easier to create deformable structures that improve coupling effectiveness.
[0073] Figure 8A and Figure 8B show another version of the structure of the prosthesis, which is again in accordance with various embodiments of the invention. The solution depicted in Figure 8A has a geometry that can prove particularly advantageous for mitral valve implantation. In this version, the subdivision of the containment part 36 is made asymmetrically, replicating, for example, the anatomy of the native valve, where the posterior annular arch 37', which is the one on which the posterior cusp rests, is longer than the anterior annular arch 38', on which the anterior cusp rests. In this case, once inserted into the back of the posterior cusp, the larger segment surrounds the commissural regions with the terminal parts of this segment, molded with a suitable curvature, the closing mechanisms on both sides are positioned in the subaortic space of the ventricle , known as the TSVE (left ventricular outflow tract) (LVOT). In this region of the ventricle, which is substantially free of the elements of the mitral subvalvular apparatus, it may be simpler to trigger the mechanism of re-closure of the containment part, directly in the case of an open heart surgical intervention, using interventional techniques during a procedure of transcatheter. Figure 8A also shows an alternative design for the closing mechanism, given in more detail in Figure 8B. In this drawing, the ends of a segment are equipped with an axially projecting molded element 41. In the example in Figure 8B, although this does not limit the general nature of the invention, this molded element 41 is in the form of a sphere 42 connected to the end of the segment by a pin 43 of a smaller diameter than the sphere 42. from the corresponding end of the other segment there is a blind cavity 44, which negatively reproduces the modulation described above and which is therefore suitable for accommodating and blocking the molded element 41. The position of this blind cavity 44, on the outer face of the segment, means that the radial force exerted on the containment part 36 by the central support element 16, after its expansion, contributes to the stability of the coupling, preventing the molded element 41 from leaving the corresponding cavity 44 in which it is accommodated.
[0074] It should be noted that the flexibility of the segments of the containment part facilitates its placement in the back of the native cusps. In fact, it is possible to considerably amplify the openings present between the segments of the containment part, compared to what is indicated in figure 7 and figure 8 purely by way of example, so as to surround the native valve with all the segments.
[0075] In Figure 9A and Figure 9B a different modality is described for the implantable prosthetic device, developed to replace the function of the atrioventricular valve, according to an embodiment of the invention. In this modality the containment part 50, which can have any of the two-dimensional or three-dimensional shapes described above, is subdivided into two or more segments or subcomponents 51, which are separated from each other and which are obtained by separating the containment part according to the connecting elements 20. Furthermore, each sub-component is temporarily detachable, using any modality of a reversible closing mechanism, from those connecting elements which, however, it is involved in the final configuration of the implant.
[0076] The subdivision of the containment part into two or more subcomponents combined with the possibility of releasing one or more of said subcomponents of the connecting elements on the central support structure makes the immediate positioning of the containment part on the back of the valve native fold-out as possible during the first stages of the implantation procedure. Then, the restoration of the unity of the prosthesis structure, with the recovery of all functional properties, allows the final implantation. The structural continuity of the containment part, which also guarantees its longitudinal inextensibility and its ability to contrast and limit the radial expansion of the central body, can therefore also be obtained with the contribution of the connecting elements present in the prosthesis. structure.
[0077] Purely by way of example, without limiting the general nature of the invention, an embodiment of the implantable prosthetic device according to the above-described embodiment is illustrated in detail in Figures 10A to Figure 10C.
[0078] Figure 10A shows the containment part 50, in a substantially circular shape, for simplicity of representation, subdivided into two subcomponents 51, which are not necessarily symmetrical. The continuity of the containment part 50 is interrupted in line with the connecting elements 20 to the central support element 16. Each end 52 of each sub-component 51 is equipped with a pin 53 preferably oriented outside the annular plane. Figure 10A shows an embodiment in which the pin is oriented substantially perpendicular to the annular plane. In turn, the connecting elements 20 are equipped with cylindrical cavities 55 each suitable to accommodate each of these pins. A pair of cylindrical seats 55is present in each of the two groups of connecting elements 22, substantially arranged in angular positions diametrically opposite the central support element 16. These cylindrical cavities 55, like the pins 53 present at the ends of the segments 51 of the part of containment 50, may be provided with lamellae, teeth or other surface discontinuities designed to increase friction in the bore-pin coupling, improving the stability of the connection between the subcomponents 51 of the containment part 50 and the connecting elements 20. cylindrical seats 55 are oriented in a manner consistent with the orientation of the pins 53 present on the subcomponents 51 of the containment part 50, such that the pin-hole coupling maintains said part in a plane geometrically consistent with the valve ring native.
[0079] Figure 10B shows how, once positioned at the back of the native cusps, the subcomponents 51 of the containment part 50 can be brought behind the central element 16 of the prosthesis structure, such that each pin 53 can be substantially aligned with the corresponding cylindrical cavity 55 present in the connecting elements 20 between the two parts.
[0080] Figure 10C shows the segments 51 of the containment part 50 restored to the central element 16 of the prosthesis structure through the hole-pin couplings created with the connecting elements 20. It can be seen how, in the modality described in figure 10, at the end of the process for reconstituting the prosthesis structure unit, the containment part 50 is continuous throughout the periphery of the device and longitudinally inextensible, due to the presence of short transverse structures 56, an integral part of the connecting elements 20, which join each pair of cylindrical cavities 55. Only after the prosthesis frame unit has been reconstituted, as shown in Figure 10C, is it possible to proceed with the final positioning of the valve prosthesis and its implantation. Only in the original configuration, in fact, is it possible at the same time to carry out the correct positioning of the prosthesis in relation to the native valve, the ideal mutual positioning of the containment part 50 and the central support element 16, ensuring the perfect tightness of the prosthesis to contain the flow, the effective anchorage of the prosthesis to the implantation site, with the stability contributed by the connecting elements as described above.
[0081] It is clear that the pin-hole connecting mechanism as described in Figures 10A to Figure 10C is given purely by way of example, without any intention of limiting the general nature of the invention. Various solutions for creating a reversible coupling between the segments of the element and containing the connecting elements are known in the prior art and are usable in the simple embodiments of the invention described herein.
[0082] Figures 11A to Figure 11G illustrate, by way of example only, an implantation procedure of the implantable prosthetic device modality described in Figure 10. The sequence shown in Figure 11 assumes a minimally invasive surgical procedure intended to replace the mitral valve, operated without removing the native valve. Access to the implant site is through the left atrium with an anterograde approach to the mitral valve, as per normal practice, followed by surgical procedures. It is assumed that the left ventricle is empty and therefore accessible, either directly or through endoscopic techniques known in the prior art, but not necessarily with the heart imprisoned. The treatment technology and philosophy remain substantially valid and usable even using retrograde access, for example, apical, and a transcatheter-type process, based on intervention techniques that allow the process to be carried out, even with the heart closed and in complete absence cardiopulmonary bypass.
[0083] To describe the implantation procedure, the same anatomical design of the left side of the heart as described in Figure 2 is used.
[0084] Figure 11A shows the first step in the procedure, which consists of the positioning, within the ventricle cavity, of two semi-arched segments that form the subcomponents 51 of the containment part 50 of the structure of the prosthesis. From what has been said about the procedure adopted here, subcomponents 51 are introduced into the left ventricle through the mitral valve, with direct manipulation compatible with the surgical approach. Each is positioned at the back of a commissural region of the mitral valve, covering the entire bundle of chordae tendinae that surrounds the corresponding half of the valve. The orientation of the subcomponents 51 is such that the connector pins 53 are directed towards the apex of the ventricle, which is distal to the operator. Surgical access makes it possible to have a direct view, possibly with the support of endoscopic instrumentation, of the implantation site and, in particular, of the interior of the left ventricle. It is therefore possible to accurately verify the placement of the two subcomponents 51, for example, with regard to their misconfiguration on the outside of the entire mitral subvalvular apparatus, before proceeding to the next stage.
[0085] Figure 11B shows the introduction into the ventricular cavity of the remaining part of the prosthesis structure, with the central support part 16 inserted collapsing to its radial diameter of a smaller size and maintained in this configuration using a containment sheath of a release system. The connecting elements 20 can be left free outside the sheath of the delivery system, or they can also be compressed into the sheath during the introduction operation into the ventricle cavity, in order to have a non-traumatic introduction profile and a small profile, then selectively released once inside the ventricle. For simplicity of representation, figure 11B shows the free connecting elements 20, in a position at a distance from the subcomponents 51 of the containment part.
[0086] Figure 11C shows a first subcomponent 51 of the containment part 50 reconnected to the central support element 16 through the connecting elements 51, using the pre-arranged hole-pin couplings in both parts. This operation can be easily completed under direct or endoscopic vision during an open-heart surgical procedure, while interventional techniques are required in the case of closed-heart transcatheter procedures.
[0087] Figure 11D shows the same operation performed by another subcomponent 51 of the containment part. The prosthetic frame unit is therefore completely reconstituted, and the prosthetic device is ready to be implanted. The mitral valve, including its subvalvular apparatus, is fully contained between the central support element 16, still in its collapsed configuration to a minimal radial area, and the annular containment portion 50, fully implanted in the ventricular cavity outside the valve. Said parts of the structure of the prosthesis are connected and integrated with each other through the connecting elements 20, in accordance with the main dictates of the present invention and in accordance with the embodiment illustrated in figure 1.
[0088] Figure 11E and Figure 11F show how, the unit of the prosthesis structure having been reconstituted, the repositioning of the central support element 16, obtained by the implantation device through the release system, involves the automatic repositioning of the element of containment 50 as well. The delivery system is therefore displaced proximally in order to reach the correct implant position. The correct implantation position is when the containment portion 50 is in contact with the ventricular aspect of the mitral valve ring, allocated to the so-called subannel groove, while the central element 16 of the prosthetic device is, still in the collapsed configuration, mounted in the native valve. The configuration illustrated in Figure 11F, immediately before the final implant, makes it possible to appreciate how the prosthetic device, conceptually described in Figure 1, regardless of the various modalities of the invention, is a device capable of positioning itself in the best way without special skill being required of the operator. In fact, the structural unit existing between the containment part 50 and the central support element 16 prevents the prosthesis from being disposed in a very distal position (which is too deep into the ventricle) or in a very proximal position (i.e. very displaced towards the atrium) in relation to the ideal plane of the native ring. It is, in fact, sufficient for the implantation device to apply a slight traction in a proximal direction over the release system to make sure that the containment element 50 is exactly in contact with the valve ring and that the release position is correct. has been achieved. The impossibility of the containment part 50 being able to migrate into the atrium, said part being segregated on the ventricular side of the ring of the same native mitral valve, which, in fact, prevents the traction exerted on the release system from generating a positioning very proximal to the prosthetic device.
[0089] Figure 11G shows the last phase of the implantation process, with the launch of the central support element 16 and its expansion until it arrives and contacts the containment part 50. The native mitral valve cusps, trapped between the two elements of the structure of the prosthesis provide and ensure stable anchorage of the prosthesis and effective tightening for the counterflow of blood.
[0090] A different modality of implanted prosthetic device fully compatible with the use of transcatheter intervention procedures is illustrated in Figures 12A to Figure 12E.
[0091] Figure 12A and Figure 12B, according to two different perspectives for a better understanding of the description, show the valve prosthetic device in a particularly advantageous modality for implantation in an atrioventricular valve using transcatheter techniques. Also in this case, similarly to the previous modalities, a containment part 60 can, in its entirety, have any two-dimensional or three-dimensional shape, according to the anatomy of the healthy or pathological atrioventricular valve, such as it can be subdivided into two or more separate segments or subcomponents 61. Each subcomponent 61 is temporarily detachable, using a reversible locking mechanism 62, from those connecting elements 64 to which it is otherwise coupled in the final implant configuration.
[0092] Figure 12C shows the prosthetic device with the subcomponents 61 making the containment part 60 separated from the central part 63, in order to make the structure of the reversible locking mechanism 62 of the parts of the prosthesis more visible.
[0093] Figure 12D and 12E illustrate an enlarged detail of the locking mechanism 62.
[0094] In the solution described here, without limiting the general nature of the invention, the connecting elements 64, which are an integral part of the central part 63 and protrude externally on its periphery, are each equipped with a pair of hollow pins 64a, 64b, which are parallel and suitably spaced apart and are substantially aligned with the axis of the prosthetic device itself. The number of connecting elements 64 is equivalent to the number of subcomponents 61 into which the containment portion 60 of the prosthesis is divided in such a way as to allow continuity of the containment portion 60 to be reconstituted through the connector elements 64. As shown in Figure 12D, each pin 64a, 64b of the same subcomponent 61 is hollow and therefore allows a guide wire to pass freely within it, as will be more clearly described below. Likewise, each end 61a, 61b of each subcomponent 61 of the containment portion 60 is also composed of a preferably, but not restricted to, hollow substantially cylindrical structure, as shown in Figure 12E, suitable not only for free passage. of a guide wire, but also having dimensions such as to allow stable engagement with the corresponding pin 64a, 64b present in the connector 64. The hollow ends 61a, 61b of each subcomponent 61 of the containment portion 64 are substantially oriented perpendicular to a principal plane of the subcomponent itself. Thus, the containment portion 60, in its entirety, is parallel to the plane of the native valve ring once the structural unit of the valve prosthetic device has been reconstituted.
[0095] Both cylindrical cavities present at the ends 61a, 61b of the subcomponents 61 of the containment part 60 and the pins 64a, 64b present on the connecting elements 64 can be provided with lamellae or teeth or other suitable surface discontinuities to increase the friction in the hole-pin coupling, improving the stability of the mutual link.
[0096] Finally, the entire structure of each subcomponent 61 of the containment part 60 can provide a passage for a guide wire 65', 65" along all or at least most of its length. In this way, it will be easier of positioning subcomponent 61 within the ventricle cavity at the back of the native valve cusps. It is, in fact, sufficient to provide the 65', 65" guide wires, using well-known interventional techniques currently used in clinical use, by along the path that identifies the desired positioning of subcomponent 61 and introduces said subcomponent so that it runs along guide wires 65', 65" itself.
[0097] Figures 13A to Figure 13E show a possible embodiment of the subcomponent 61, in which the containment part 60 is subdivided, which is particularly suitable for an implantation procedure performed by means of transcatheter techniques.
[0098] Figure 13A shows for simplicity of representation, only the structural part of the subcomponents 61 that make up the containment part 60 of the prosthetic device. As already described above, the structural part is obtained substantially from a tubular element 66 in the wall whose openings 67 have been made and are appropriately sized and positioned and suitable to provide the structure with the desired elastic behavior, which may be anisotropic and variable from section to section, according to the configuration along the path of subcomponent 61. Then, the structure of subcomponent 61 has the shape, as shown schematically in Figure 13A: center section 61c is curved consistent with the geometry chosen for the containment portion 60, while the ends 61a, 61b are substantially offset at right angles to the central section 61c of subcomponent 61. The final shape of subcomponent 61, such as the shape shown in Figure 13A, can be assigned to it in the production phase, using appropriate heat treatments, applied to the part held within a mold.
[0099] In Figure 13A, the two ends 61a, 61b of a preferably cylindrical shape, are clearly identifiable, substantially offset at right angles to the main plane of the structure of the central section 61c. These ends 61a, 61b comprise the elements of the subcomponent 61 which form part of the connecting mechanism with the central part 63 of the prosthetic device. These ends 61a, 61b are connected to the central section 61c of the structure of subcomponent 61 through a transition zone 68 which acts as a unidirectional hinge, allowing in a way the realignment of the ends in the same plane as the remaining part of the subcomponent 61, but, in the opposite direction, preventing a greater 90° deflection between the main plane of the subcomponent 61 and the axis of the prosthetic device, since the subcomponent 61 has been connected to the central part 63 of the prosthetic device. This functional requirement avoids the risk of a deformation of the subcomponents 61 of the containment part 60 into the ventricular chamber. In this way, both the continuity of contact of the containment part 60 on the native valve ring, and the correct mutual alignment between the containment part 60 and the central part 63 are guaranteed at the moment of the final release of the prosthetic device.
[0100] Figure 13B and Figure 13C illustrate by way of example, without limiting the general nature of the invention, in doing so, an embodiment of said unilateral joint 68. In which, the end 61a, 61b of the subcomponent 61 is connected to the rest of the frame 61c by a pair of coils 69, created directly in the wall of the tubular body 66, shaped to act as an angle spring. This solution is compatible with the work processes of subcomponent 61 described above.
[0101] In greater detail, Figure 13B shows the flexed configuration, which is operative, of the hinge section 68. In order to create an angular stop point, the lower surfaces 70a, 70b of the two sections of the tubular body adjacent to the hinge 68 are cut at an angle such that in the configuration offset to 90° they come into contact with each other and, at the same time, the elastic coil 69 is closed like a package. The two aspects combined prevent deformation of the end 61a, 61b when compared to the central section 61c of the structure of the subcomponent 61. Figure 13C shows the straightened configuration of the common part 68. The surfaces of the two sections 70a, 70b previously in contact are separated, and the elastic coils that join 69 are open. The geometry of the elastic coil 69 is such that the deformation is substantially uniformly distributed, avoiding stress concentrations in the material.
[0102] Figure 13D and Figure 13E show how the combined effect of the mesh design of the frame 66 and the elastic hinge 68 introduced near the ends 61a, 61b allows the subcomponent 61 to assume a substantially straight shape, particularly suitable for its deployment using transcatheter techniques. In particular, figure 13D shows the smoothing of the ends 61a, 61b, made possible by the elastic hinge 68, a possible embodiment of which is illustrated in figure 13B and figure 13C. Figure 13E shows the linear configuration of subcomponent 61 made possible by the mesh design of the center section 61c of subcomponent 61.
[0103] It is clear to anyone skilled in the art that other alternative embodiments of the invention than those described in Figure 13 can provide either a different design than the elastic coils 69, or solutions having the center section 61c and the ends 61a, 61b of the frame created as separate parts, joined together by elastic joints, in the form of additional components made of metallic material or polymeric material.
[0104] Purely by way of example, without limiting the general nature of the invention in any way, Figures 14A to Figure 14E illustrate a possible transcatheter implantation procedure of the implantable prosthetic device modality described in Figure 12, including the connection of the part of containment 60 to the central part of prosthesis 63, in a manner compatible with a fully interventional transcatheter procedure. To make the drawings clearer, in this group of figures the representation of the native atrioventricular valve is omitted. Furthermore, the case is shown of a prosthesis having the containment part 60 subdivided into two segments or subcomponents 61. Obviously, an entirely analogous process can also be performed, in the case where the containment part is subdivided into a larger number of subcomponents.
[0105] Figure 14A shows the positioning, in outline, using catheters 70 with a low radial profile, of the subcomponents 61 of the containment portion 60 of the prosthesis in the back of the native atrioventricular valve cusps. To facilitate and ensure a good result for this operation, 65', 65" guide wires are used, one for each 61 subcomponent, which have been pre-marked in accordance with the final position required for the 61 subcomponents themselves. a technique well known in the current state of the art of cardiac interventional procedures of navigating a guidewire within the chambers of the heart. Each subcomponent 61, previously stretched as shown in Figure 13E and mounted within a catheter 70 with a low profile, it is therefore guided by the corresponding guide wire 65', 65" until it reaches the desired final position. This operation is made possible by the presence of a passage for a wire within the structure 66 of subcomponent 61.
[0106] Figure 14B shows how, once the subcomponent 61 has been brought to its ideal position for the implant, the catheter 70, which has been manifesting it, will be removed, however, leaving the guide wires 65 ', 65" in situ, i.e. through structure 66 of subcomponent 61 and with both ends accessible to the operator. Released from the sheath of catheter 70, subcomponent 61 resumes its original configuration with the curvature of central section 61c itself and its ends 61a, 61b offset with respect to the plane of the central section 61c.
[0107] Figure 14C shows the central part 63 of the prosthesis, collapsed to its smallest radial diameter, being maintained in this configuration within a release system 71, with the free ends of the guide wires 65', 65" inserted into the passages for the wires present inside each pin 64a, 64b of each subcomponent 61 of the link mechanism 64. In this way, each guide wire 65', 65" connects a pair of pins 64a, 64b, which are essential for the central body 63 of the prosthesis and positioned on two separate and adjacent connecting elements 64 to the two ends 61a, 61b of the corresponding subcomponent 61 of the containment portion 60.
[0108] Figure 14D shows the central part 63 of the prosthesis, still in the collapsed configuration inside the release system 71, introduced into the heart cavity, in order to reach the implant position.
[0109] Figure 14E shows how the tension of the guide wires 65', 65" brings the ends 61a, 61b of the subcomponents 61 of the containment part 60 together and aligns them with that of the corresponding pins 64a, 64b that are an integral part of the connecting elements 64.
[0110] Figure 14F shows how the additional tensioning of the guide wires 65', 65" works the mechanical connection between the ends 61a, 61b of the subcomponents 61 of the containment part 60 and the pins 64a, 64b that are an integral part of the elements of connection 64. In this configuration, both the structural continuity of the containment portion 60 and the uniqueness of the prosthetic device are reconstituted.
[0111] Figure 14G finally shows the release of the central part 63 and its expansion to the point where it approaches and comes into contact with the containment part 60. This being the final phase of the implantation procedure of the valve prosthesis , both guidewires 65', 65" and the release system 71 of the central part 63 of the prosthesis can be removed from the cardiac chambers.
[0112] Naturally, without prejudice to the principle of the invention, the modalities and characteristics of the same may vary considerably from those described and illustrated, without departing from the scope of the present invention.

权利要求:
Claims (17)
[0001]
1. Prosthetic device for a heart valve, characterized in that it comprises: a valve part (16, 63) with prosthetic cusps (14) capable of reproducing the function of the valve cusps of a native heart valve, expandable from a collapsed configuration for deployment to an expanded working configuration, a containment portion (18, 24, 32, 36, 51, 61) that surrounds the valve portion (16, 63) to contain and restrict its expansion in the configuration working, wherein the containment portion is substantially inextensible longitudinally, a connecting portion (20) stably connects the valve portion (16) to the containment portion (18, 24, 32, 36, 51, 61) through connecting elements (53, 55, 64) when the valve part (16) is in the collapsed configuration.
[0002]
2. Prosthetic device according to claim 1, characterized in that the valve part (16, 63) comprises a support element designed to support all the prosthetic cusps (14), the connecting elements (53, 55 , 64) of the connecting part (20) comprising flexible elements for the physical connection and structural unit between the supporting element of the valve part (16, 63) and the containment part (18, 24, 32, 36, 51 , 61).
[0003]
3. Prosthetic device according to claim 1 or 2, characterized in that the containment part (18, 24, 32, 36, 51, 61) is a structure with a two-dimensional or three-dimensional geometry, which is substantially annular when viewed from above.
[0004]
4. Prosthetic device according to claim 3, characterized in that the containment part (18, 24, 32, 36, 51, 61) is selectively mountable from an open configuration, suitable to make its insertion into the back of the native valve cusps, for the substantially annular closed configuration.
[0005]
5. Prosthetic device according to claim 4, characterized in that the containment part (18, 24, 32, 36, 51, 61) comprises a plurality of segments (51, 61), each comprising means of connection (53, 61a, 61b) for the assembled reconstruction of the annular continuity of the containment part (18, 24, 32, 36, 51, 61).
[0006]
6. Prosthetic device according to claim 4 or 5, characterized in that the connecting means comprise one or more connecting elements (53, 55, 64) of the connecting part (20).
[0007]
7. Prosthetic device according to claim 5 or 6, characterized in that some or all of the segments (51, 61) are temporarily separable from the valve part (16, 63).
[0008]
8. Prosthetic device, according to any one of the preceding claims, characterized in that the containment part (18, 24, 32, 36, 51, 61) is at the same time flexible in relation to deformations that occur in the identified plane by the containment part (18, 24, 32, 36, 51,61) itself, and substantially rigid with respect to direct deformation out of that plane.
[0009]
9. Prosthetic device, according to any one of the preceding claims, characterized in that at least part of the containment part (18, 24, 32, 36, 51, 61) is covered by tissue of a biological or artificial nature or with polymeric material, or a combination thereof.
[0010]
10. Prosthetic device according to any one of the preceding claims, characterized in that it comprises a locking mechanism compatible with transcatheter technologies, in which the containment part (18,24,32,36,51,61) is subdivided into subcomponents (51, 61) to allow it to be positioned at the back of the native atrioventricular valve cusps, the blocking mechanism comprising one or more structures (61a, 61b) of the containment part (18, 24, 32 , 36, 51, 61) which can be aligned and stably coupled to one or more structures (64a, 64b) of the valve portion (16, 63, using a guide wire (65', 65".
[0011]
11. Prosthetic device according to claim 10, characterized in that the guide wires (65', 65”) are connected to each of one or more structures (61a, 61b) of the containment part (18, 24 , 32, 36) and to each of one or more structures (64a, 64b) of the valve portion (16, 63).
[0012]
12. Prosthetic device according to claim 11, characterized in that one or more structures of the containment part (18, 24, 32, 36, 51, 61) and one or more structures of the valve part (16, 63) comprise hollow members (61a, 61b; 64a, 64b) suitable for allowing the guide wires (65', 65”) to pass through.
[0013]
13. Prosthetic device according to any one of claims 10 to 12, characterized in that the valve part (16, 63) has, on its periphery, hollow structures (64a, 64b) suitable for the passage of one or more guide wires (65', 65” suitable for the realization of stable mechanical coupling with corresponding hollow structures (61a, 61b) present in the containment part(18, 24, 32, 36).
[0014]
14. Prosthetic device according to any one of claims 10 to 13, characterized in that each subcomponent of the containment part (18, 24, 32, 36) has articulation mechanisms that allow them to be elastically deformed, until they assume a configuration taking the radial space reduced in relation to an expanded working configuration.
[0015]
15. Method for assembling a prosthetic device for a heart valve, characterized in that it comprises the steps of: - providing a valve part (16, 63) in a collapsed configuration, the valve part (16, 63) having prosthetic cusps (14) capable of reproducing the function of the valve cusps of a native heart valve, the valve part (16, 63) being expandable from a collapsed configuration for implantation to an expanded working configuration, - provide a containment portion (18, 24, 32, 36, 51, 61) surrounding the valve portion (16, 63) to contain and restrict its expansion in the expanded working configuration, wherein the containment portion is substantially not. longitudinally extensible, - stably connecting the valve part (16, 63) to the containment part (18, 24, 32, 36, 51, 61) by means of a connecting part (20) via connecting elements ( 53, 55.64), when the valve part (16, 63) is in configuration c olapsed.
[0016]
16. Method for mounting a prosthetic device according to claim 15, characterized in that the containment part (18, 24, 32, 36, 51, 61) is selectively mountable from an open configuration for a substantially closed annular configuration.
[0017]
17. Method for assembling a prosthetic device according to claim 16, characterized in that the containment part (18, 24, 32, 36, 51, 61) comprises a plurality of segments each comprising means of connection for assembled reconstruction of the annular continuity of the containment part (18,24, 32, 36, 51, 61.

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法律状态:
2020-03-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-03-09| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-05-04| 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 04/02/2015, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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ITBO20140050|2014-02-04|

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ITBO2014A000050|2014-02-04|

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