ITUB20155767A1 - ASSEMBLY OF CARDIAC VALVE PROSTHESIS, A CUSTOMIZED SET TOGETHER AND AN ANCHORING METHOD OF THE ASSEMBLY - Google Patents

Description

"Cardiac valve prosthesis assembly, kit comprising said assembly and method of anchoring said assembly".

DESCRIPTION

[0001]. Field of the invention

[0002]. The present invention relates to the technical domain of heart valve prostheses.

[0003]. The present invention relates to a cardiac valve prosthesis assembly, as well as a cardiac valve prosthesis kit comprising said assembly, as well as an anchoring method for cardiac valve prostheses.

[0004]. Furthermore, the present invention relates to a cardiac valve prosthesis assembly suitable for implantation according to a non-invasive technique.

[0005]. State of the art

[0006]. Heart valve prostheses are usually implanted using open heart surgery. The native valve is removed and replaced by the valve prosthesis. However, a highly invasive method can cause severe complications and is unsuitable for some types of patients at risk.

[0007]. There are four native heart valves: aortic, mitral or mitral or bicuspid, tricuspid and pulmonary, of which two are located in the wall of the left ventricle (aortic and mitral) and two in the part of the right ventricle (tricuspid and pulmonary). The left ventricle is the main pumping chamber of the human heart, therefore the aortic and mitral valves are subject to high pressure stresses.

[0008]. For example, the mitral valve, located between the left atrium and the left ventricle, opens during the atrial systole phase of the cardiac cycle, allowing blood to flow into the left ventricle, and then closing in order to prevent blood reflux towards the atrium. during the ventricular systole phase, in which the contracting ventricle causes the ejection of blood from the left ventricle to the aortic artery through the aortic valve. The closure of the two flaps of the mitral valve is favorably determined by the increase in pressure inside the ventricle, which can exceed 120 mmHg. In fact, the pressure gradient is in the opposite direction to the blood circulation direction. The mitral valve is connected to the mitral annulus, a saddle-shaped, predominantly fibrous, deformable ring that determines the attachment site of the valve leaflets. The mitral annulus changes its shape and size during the various phases of the cardiac cycle. For example, during the ventricular systole phase, the connection between the valve leaflets and the mitral annulus is therefore subject to high strains. The mitral annulus is surrounded at least partially by a portion of a coronary artery, the circumflex artery, as well as by the coronary sinus. A plurality of tendon cords act as tie rods between the valve flaps and papillary muscles of the ventricle to prevent the valve from opening in reverse during the systolic phase. Congenital wear and malformations can result in reduced valve function, sometimes requiring the restoration of valve function by implanting a heart valve prosthesis.

[0009]. Less invasive methods of implantation of valve prostheses do not involve the removal of the native valve, which is kept in the valve seat with the flaps open to allow the implantation of the valve prosthesis into the valve lumen of the native valve.

[0010]. Generally, the valve prosthesis is mounted on a catheter that delivers it to the implantation site: this type of implant is therefore known as a trans-catheter implant. Techniques of this type include, for example, transapioal implantation, in which a small incision is made in the patient's chest to allow access to the implantation site from an apical portion of the heart. As an alternative, for example, it is known to carry out the implant via the trans-vascular route, in which the catheter is inserted into a blood vessel, and by passing through it accesses the heart. Sometimes, the catheter passes through the atrial septum, the tissue that divides the two atrial chambers, by puncturing the atrial septum: this approach is known as trans-septal.

[0011]. The application of methods of this type for prosthetic valve implants, suitable for restoring the functionality, for example, of the aortic valve, is generally known, as shown for example in documents EP-A-2923665 and US-A-2012-203263. On the other hand, the mitral valve apparatus, including the tendon cords and papillary muscles in addition to the native mitral valve, is anatomically more complex than the aortic valve apparatus and makes it difficult to apply the non-invasive methods described above. Furthermore, the mitral annulus has a dynamically more unstable behavior during the cardiac cycle than the aortic annulus. Therefore, the need is felt to provide a cardiac valve prosthesis suitable for non-invasive implantation, also for restoring the functionality of the mitral valve.

[0012]. Valve prostheses for trans-catheter implantation are suitable for changing their shape, for example passing from a contracted state, of reduced radial size, to an expanded state, of increased radial size, suitable for adhering to the wall of the implantation site. Valve prostheses of this type comprise, for example, a frame comprising an expandable stent, for example mounted on an inflatable element of the catheter, or a self-expandable stent made of shape memory material, and may have a non-radial extension. symmetrical and suitable for fitting the implant site wall. In some known valve prostheses, said stent, when expanded, is suitable to press radially against the wall of the implantation site, in order to adhere to it and prevent the blood flow from filtering through a gap that could form between the valve prosthesis and the wall of the site. implant, when the valve prosthesis is closed. However, the radial pressure of the stent against the implant site wall is generally insufficient to ensure that the prosthesis remains in place, particularly in the case of a mitral valve prosthesis. In order to prevent displacement of the valve prosthesis from the implantation site, various anchoring strategies are known. As shown for example in U.S. Patent Application No. US-2013-0190861, a mitral valve prosthesis may include flap anchor whiskers or spurs, adapted to cling to the ventricular face of the native valve flaps.

[0013]. However, it is laborious for an operator to coordinate the insertion of the valve into the implantation site with the step of overturning the anchoring whiskers so that they firmly cling to the flaps of the native valve. Sometimes, anchoring to the native valve can even partially fail, resulting in reduced implant life or the need to repeat the implant procedure immediately. In addition, valve prostheses with anchors of this type create a high risk that at least one of the native valve flaps will interfere with the ejection systolic blood flow. In some cases, a portion of the flap subject to ejection flow is pushed into the ejection vessel, obstructing it at least partially.

[0014]. According to a further aspect shown in the aforementioned document US-A-2 013-0190861, a valve prosthesis can comprise an expandable crown, suitable to extend to surround the implantation site like a lifebuoy, substantially acting as a cap that blocks the displacement of the valve prosthesis.

[0015]. However, the mere provision of said expandable crown does not provide a satisfactory level of anchoring safety.

[0016]. The European patent application No. EP-A-2485795) shows, for example in Figures 84-85, some phases of a method of anchoring a mitral valve prosthesis called "screw method" (in English: "screw method"), wherein a substantially L-shaped anchoring device, comprising a knee portion and anchoring feet, of the valve prosthesis engages the tissue by means of a rotational movement.

[0017]. However, this method provides for the presence of anchors, for example anchoring feet or anchoring crowns, which protrude from the body of the valve prosthesis to hook against a wall of the ventricle substantially undercut with respect to the lumen of the native valve, for example risking to interfere with the tendon cords in order to determine a reduced anchoring and grip safety.

[0018]. As shown for example in international patent application No. WO-2009-134701, the stent of the support frame of the valve prosthesis can comprise at least a frusto-conical portion, suitable for fitting the profile of the implantation site, in which the opening of greater caliber faces towards the fluid inlet side, with reference to the physiological direction of blood circulation. The external wall of said frusto-conical portion rests on the flaps of the native valve which are advantageously maintained in a position such as to limit its interference with the ejection flow.

[0019]. However, the provision of said frusto-conical portion with the larger opening facing the fluid inlet side, does not provide a firm anchoring of the valve prosthesis to the implant site, since the systolic pressure gradient tends to push the valve prosthesis towards the atrial chamber. Therefore, a solution of this type in any case requires the provision of anchoring devices which cooperate with the effect of the radial pressure exerted by the expansion of the stent against the wall of the implantation site.

[0020]. For example, international patent application No. W0-2011-159779 shows a support and anchoring device for valve prosthesis comprising longitudinal rods which give the valve prosthesis a truncated conical shape having the smaller caliber opening facing towards the inlet side of fluid when the valve is open. Said frusto-conical shape is advantageously opposed to the systolic pressure gradient which tends to push the valve prosthesis towards the atrial chamber.

[0021]. However, the frusto-conical structure shown is rather deformable and in any case requires the provision of anchoring elements of the valve prosthesis, which extend around the opening of greater caliber, for example in the form of hooks, suitable for sticking into the tissue of the face of the mitral annulus facing the ventricle to oppose the systolic pressure thrust.

[0022]. Said anchoring elements which work on the tissue of the ventricular face of the mitral ring are invasive and cause damage to said tissue, strongly increasing the thrombogenic risk.

[0023]. Therefore, the need is strongly felt to provide an anchoring device for cardiac valve prosthesis, as well as a cardiac valve prosthesis assembly comprising said device, as well as an anchoring method, capable of overcoming the drawbacks of the prior art mentioned above.

[0024]. The need is also felt to provide an anchoring device for cardiac valve prosthesis, as well as a cardiac valve prosthesis assembly comprising said device, suitable for anchoring in a simple, firm and safe way to the implantation site, and of reduced invasiveness compared to solutions Note.

[0025]. Furthermore, the need is strongly felt to provide a less invasive anchoring method for a heart valve with respect to known solutions, without thereby imposing decreased anchoring efficacy or safety.

[0026]. Solution

[0027]. An object of the present invention is to obviate the aforementioned drawbacks of the known art and to provide a solution to the need to provide a cardiac valve prosthesis assembly, with improved simplicity of manufacture, with a smaller footprint and less invasive than known solutions without being less reliable and safe.

[0028]. A further particular object of the present invention is to provide a cardiac valve prosthesis kit comprising said cardiac valve prosthesis assembly, suitable for transapical and transfemoral implantation.

[0029]. A further particular object of the present invention is to provide an anchoring method which is simpler and less invasive than known solutions while ensuring a satisfactory degree of safety.

[0030]. This and other objects are achieved with a cardiac valve prosthesis assembly according to claim 1, as well as a cardiac valve prosthesis kit according to claim 9, as well as an anchoring method according to claim 10.

[0031]. Some advantageous embodiments are the subject of the dependent claims.

[0032]. According to an aspect of the invention, a cardiac valve prosthesis assembly, as well as a cardiac valve prosthesis kit comprising said assembly, as well as a method of anchoring said assembly, is suitable for implantation of a cardiac valve prosthesis in any of the four native valves.

[0033]. According to an aspect of the invention, a cardiac valve prosthesis assembly, as well as a cardiac valve prosthesis kit comprising said assembly, as well as a method of anchoring said assembly, is suitable for implantation of a cardiac valve prosthesis to replace the functionality of the native mitral valve. .

[0034]. According to an aspect of the invention, a cardiac valve prosthesis assembly, as well as a cardiac valve prosthesis kit comprising said assembly, is suitable for implantation according to a non-invasive technique, for example trans-femoral trans-vascular implant, or trans-apical implant. .

[0035]. Thanks to the provision of a cardiac valve prosthesis assembly, as well as a cardiac valve prosthesis kit comprising said assembly, as well as a method of anchoring said assembly, according to an aspect of the invention, it is possible to realize a cardiac valve prosthesis implant without providing sutures , as well as without removing the native valve.

[0036]. The provision of a cardiac valve prosthesis assembly, as well as a kit comprising said assembly, as well as a method of anchoring said assembly, in accordance with an aspect of the invention, allows to simplify the implantation procedure allowing the surgeon to focus more attention. on contingent and specific needs, such as the management of any emergencies or complications. On the other hand, a simplified implant procedure allows to reduce the intervention times, resulting in a better comfort for the patient, as well as a reduction in the costs related to the intervention, without reducing the safety or the reliability of the implant.

[0037]. Figures

[0038]. Further characteristics and advantages of the device, of the assembly and of the method according to the invention will appear from the following description of its preferred embodiment examples, given by way of non-limiting example, with reference to the attached figures, in which:

[0039]. Figure 1A is a schematic section showing a mitral cardiac valve prosthesis assembly, according to an aspect of the invention, operating under operating conditions;

[0040]. Figure 1B is a schematic section showing a mitral cardiac valve prosthesis assembly, according to an aspect of the invention, operating under operating conditions;

[0041]. Figure 1C is a schematic section showing an aortic cardiac valve prosthesis assembly, according to an embodiment of the invention, operating under operating conditions;

[0042]. Figure 1D is a schematic section showing a cardiac valve prosthesis assembly according to an embodiment of the invention, operating under operating conditions;

[0043]. Figures 2A and 2B are axonometric views illustrating a cardiac valve prosthesis assembly, according to some embodiments of the invention;

[0044]. - Figures 3A and 3B are schematic sectional views which illustrate some possible steps of a trans-apical anchoring method, in accordance with some possible ways of operating;

[0045]. - Figures 4A and 4B are schematic sectional views which illustrate some possible steps of a transseptal anchoring method, in accordance with some possible ways of operating;

[0046]. Figures 5A and 5B are axonometric views showing an anchoring device for a heart valve prosthesis assembly, in accordance with some embodiments of the invention;

[0047]. Figures 6A and 6B are partial section views showing an anchoring device of a heart valve prosthesis assembly, in accordance with some embodiments of the invention;

[0048]. Figure 7A is an axonometric view showing a cardiac valve prosthesis assembly in accordance with an embodiment of the invention;

[0049]. figure 7B is an axonometric view showing an anchoring device of a cardiac valve prosthesis assembly in accordance with an embodiment of the invention;

[0050]. Figure 7C is a sectional view showing a portion of an anchoring device of a heart valve prosthesis assembly, according to an embodiment of the invention;

[0051]. Figures 8A, 8B and 8C are schematic views in axonometry and with transparent parts showing a cardiac valve prosthesis assembly, in accordance with some embodiments of the invention;

[0052]. - Figures 9A, 9B and 9C are axonometric views showing an anchoring device for a heart valve prosthesis assembly, in accordance with some embodiments of the invention;

[0053]. Figures 10A and 10B are schematic sectional views showing an anchoring device of a cardiac valve prosthesis assembly, according to one embodiment, in a radially contracted state and in a radially expanded state, respectively;

[0054]. Figures H A and 11B are schematic sectional views showing an anchoring device of a cardiac valve prosthesis assembly, according to one embodiment, in a radially contracted state and in a radially expanded state, respectively.

[0055]. Description of some preferred embodiments

[0056]. With reference to the attached figures, a cardiac valve prosthesis assembly will be indicated as a whole with the reference numeral 100.

[0057]. In accordance with a general embodiment, a cardiac valve prosthesis assembly 100 comprises at least one anchoring device 10 and at least one valve element 20.

[0058]. Said anchoring device 10 comprises at least one main body 13 which defines at least one prosthesis lumen 25.

[0059]. Said main body 13 comprises at least a first edge 11 and at least a second edge 12, in which said first edge 11 is of smaller caliber than said second edge 12.

[0060]. The term "caliber" refers to the external caliber and not to the caliber of the prosthesis lumen 25.

[0061]. According to an embodiment, said main body 13 has a longitudinal extension and a radial extension, orthogonal to said longitudinal extension. According to an embodiment, said prosthesis lumen 25 passes through said anchoring device 10 along said longitudinal extension. In accordance with an embodiment, said gauge indicates the radial extension, evaluated on the radially outermost portions, of said first edge 11 and of said second edge 12.

[0062]. According to an embodiment, said main body 13 comprises an external face 14 connecting said first edge 11 and said second edge 12.

[0063]. In accordance with an embodiment, said external face 14 is unsuitable for facing said valve lumen 25.

[0064]. In accordance with an embodiment, said external face 14 faces opposite to said valve lumen 25.

[0065]. Said valve element 20 is connected directly or indirectly to said anchoring device 10. In other words, said valve element 20 can be connected to the surface of an internal face 17 of said anchoring device 10, facing towards the prosthesis lumen 25, or said valve element 2 0 can be connected to said anchoring device 10 by interposition of at least one further connection element. For example, said further connecting element can comprise a fastening ring.

[0066]. Said valve element 20 comprises a plurality of valve flaps 23.

[0067]. Said valve element 20 is suitable for opening by moving a free end 24 of at least one valve flap 23 towards said second edge 12 of said anchoring device 10.

[0068]. When in operating conditions, at least one valve flap 23 of said valve element 20 is suitable for opening said cardiac valve prosthesis 100 by moving said free end 24 towards said second edge 12.

[0069]. Advantageously, said plurality of valve flaps 23 opens and closes selectively by effect of the pressure gradient which develops inside said prosthesis lumen 25, under operating conditions.

[0070]. Advantageously, said free end 24 of said at least one valve flap 23 moves in opening towards the edge of greater caliber.

[0071]. In accordance with an embodiment, said anchoring device comprises at least one anchoring element 15 having a greater caliber than said first edge 11.

[0072]. Advantageously, the provision of an anchoring element 15 having a greater caliber than said first edge 11, allows to anchor said cardiac valve prosthesis assembly 100 to at least one seat wall 7 of said implant site 6.

[0073]. According to an embodiment, said anchoring element 15 locally increases the radial extension of said anchoring device 10.

[0074]. According to an embodiment, said at least one anchoring element 15 is located on said external face 14.

This results in a decreased invasiveness of the implant compared to known solutions.

[0075]. According to an embodiment, said at least one anchoring element 15 protrudes from said external face 14. According to an embodiment, said anchoring element 15 protrudes from said external face 14 so as to locally increase the gauge of said anchoring device 10.

[0076]. Advantageously, the provision of said at least one anchoring element 15 which protrudes from said external face 14, allows a coupling of improved effectiveness in the implantation site 6, since it allows to provide a firm anchoring of the valve prosthesis assembly 100, preventing it to move in the implantation site 6, when subjected to entrainment forces generated by the blood current that passes through the prosthesis lumen 25 during the atrial systole phase of the cardiac cycle, as well as when subjected to the pressure gradient that develops during the ventricular systole of the cardiac cycle.

[0077]. Advantageously, the provision of said at least one anchoring element 15 on said external face 14 allows to provide the valve prosthesis assembly 100 with a firm anchoring by acting exclusively on the seat walls 7 of the implantation site 6.

[0078]. Advantageously, in this way it is avoided to arrange said at least one anchoring element 15 on at least one of said first edge 11 or said second edge 12, thus avoiding to impose an anchoring on the anatomical surface on the sheaths, the implant site facing towards a ventricular chamber 9, or towards an atrial chamber 8, or towards the aorta or towards the pulmonary artery, according to the in vivo location of the cardiac valve prosthesis assembly 100. As is known, for example when said cardiac valve prosthesis assembly 100 is an assembly of mitral valve prostheses, said anatomical surface can be a surface of the native mitral annulus 5, therefore the provision of said anchoring element 15 on said external face 14, avoiding having said at least one anchoring element 15 on at least one between said first edge 11 or said second edge 12, avoids causing mechanical damage, such as incisions and scratches, to the surfaces of the an native mitral nulus 5 facing towards the atrial chamber and towards the ventricular chamber, respectively, when said cardiac valve prosthesis assembly 100 is in operating conditions.

[0079]. In accordance with an embodiment, said anchoring element 15 is made in a single piece with said main body 13.

[0080]. In accordance with an embodiment, said main body 13 is of a shape and material suitable for forming said anchoring element 15.

[0081]. In accordance with an embodiment, said main body 13 comprises a plurality of folds, and in which said plurality of folds have a greater radial extension than said first edge 11. In other words, said anchoring element 15 is made with a folded conformation of said main body 13.

[0082]. Thanks to the provision of integrating said anchoring element 15 and said main body 13 in a single structure, it allows to reduce the amount of material necessary to make said anchoring device 10.

[0083]. In accordance with an embodiment, said at least one valve flap 23 comprises an engagement portion 27, suitable for connecting directly or indirectly to a portion of the valve seat 26 obtained on said internal face 17 facing towards said prosthesis lumen 25.

[0084]. According to an embodiment, said valve element 20 of said cardiac valve prosthesis assembly 100 comprises two valve flaps 23. In this way, said cardiac valve prosthesis assembly 100 is for example suitable for replicating the structure of a native bicuspid valve. .

[0085]. According to an embodiment, said cardiac valve prosthesis assembly 100 is a mitral valve prosthesis assembly. For example, a mitral valve prosthesis assembly is shown in Figures 1A and 1B.

[0086]. According to an embodiment, said valve element 20 of said cardiac valve prosthesis assembly 100 comprises three valve flaps 23. In this way, said cardiac valve prosthesis assembly 100 is for example suitable for replicating the structure of a native tricuspid valve. .

[0087]. According to an embodiment, said cardiac valve prosthesis assembly 100 is an aortic valve prosthesis assembly. For example, an aortic valve prosthesis assembly is shown in Figure 1C.

[0088]. According to an embodiment, said cardiac valve prosthesis assembly 100 is a tricuspid valve prosthesis assembly. For example, a mitral valve prosthesis assembly is shown in Figure 1D.

[0089]. According to a variant embodiment, said cardiac valve prosthesis assembly 100 is a pulmonary valve prosthesis assembly.

[0090]. According to a variant embodiment, said cardiac valve prosthesis assembly 100 comprises at least four valve flaps 23.

[0091]. According to an embodiment, said valve element 20 comprises a biological prosthesis.

[0092]. According to an embodiment, said anchoring element 15 comprises at least one helical thread 151.

[0093]. According to an embodiment, said helical thread 151 is in the form of a helix, which wraps around said main body 13, like a mechanical screw thread wraps around the screw shank.

[0094]. Advantageously, said helical thread 151 is suitable for deforming a reciprocal portion thereof to provide a coupling or an anchor, like a self-tapping screw.

[0095]. According to an embodiment, said helical thread 151 winds at least partially around said external face 14 of said main body 13. In this way, said anchoring element 15 is suitable for forming a screwing path.

[0096]. In accordance with an embodiment, said helical thread 151 is made with a continuous relief that extends from said external face 14.

[0097]. According to an embodiment, said helical thread connects said first edge 11 with said second edge 12.

[0098]. In accordance with an embodiment, said helical thread 151 is made by means of a plurality of disjoint reliefs arranged so as to form a helical geometry.

[0099]. According to an embodiment, said anchoring element 15 comprises a plurality of helical threads.

[00100]. According to an embodiment, the thread pitch of said helical thread 151 is chosen in such a way that, under operating conditions, the blood pressure acts, with its component parallel to the longitudinal development direction of said valve lumen 25 , in the direction of the screwing of said cardiac valve prosthesis assembly 100 comprising said anchoring element 15 with helical thread 151.

[00101]. According to an embodiment, said anchoring element 15 comprises at least one rib.

[00102]. According to an embodiment, said anchoring element 15 comprises at least one circumferential ring 152.

[00103]. According to an embodiment, said circumferential ring 152 wraps at least partially around said external face 14 of said main body 13 of said anchoring device 10.

[00104]. According to an embodiment, by traveling along said circumferential ring 152 from a first point thereof, one returns periodically to said first point.

[00105]. In accordance with an embodiment, said circumferential ring 152 is made by means of a plurality of disjoint ridges arranged so as to form a circumferential geometry.

[00106]. According to an embodiment, said anchoring element 15 comprises a plurality of circumferential rings.

[00107]. According to an embodiment, each circumferential ring 152 of said plurality of circumferential rings is separated from the circumferential ring closest to itself, so as to expose at least a portion of said external face 14 between two successive circumferential rings.

[00108]. According to an embodiment, said anchoring element 15 comprises at least one beard.

[00109]. According to an embodiment, said anchoring element 15 comprises at least one hook.

[00110]. According to an embodiment, said anchoring element 15 is deformable. This feature is particularly advantageous when provided in combination with the provision of said anchoring element 15 comprising at least one barb, as well as in combination with the provision of said anchoring element comprising a circumferential ring 152.

[00111]. In accordance with an embodiment, said anchoring element 15 comprises a plurality of deformable barbs, to form a pine-like structure that extends from the external face of said main body.

[00112]. The provision of a deformable anchoring element 15 allows its shape to be changed, so as to make it suitable for each phase of the installation of said anchoring device 10.

[00113]. In accordance with an embodiment, during the step of inserting said anchoring device 10 into the implantation site 6, said anchoring element 15 can be configured in such a way as to extend as little as possible from said main body 13 or from said face external 14. For example, once the anchoring device 10 has been delivered to the implantation site 6, said anchoring element 15 can expand so as to protrude from said main body 13 or from said anchoring face 14 anchoring itself to the at least one seat wall 7 of the implantation site 6.

[00114]. According to an embodiment, said anchoring element 15 is suitable for changing its shape, passing from a radially contracted state, of reduced caliber or reduced radial extension, to a radially expanded state, of increased caliber or increased radial extension with respect to the radial extension of said radially contracted state.

[00115]. In accordance with an embodiment, said anchoring element 15 is deformed by means of the intervention of an operator who uses a suitable device for moving said anchoring element. In accordance with an embodiment, said special handling device can be mounted on a release device 101.

[00116]. According to an embodiment, said anchoring element 15 is self-expandable.

[00117]. According to an embodiment, said anchoring element 15 is at least partially made of shape memory material.

[00118]. The provision of a self-expanding anchoring element 15, as well as of an anchoring element 15 made of shape memory material, makes said anchoring element 15 suitable for selectively contracting and expanding during the insertion phases of the valve prosthesis assembly 100 at the implantation site. In accordance with an embodiment, the change in shape can occur in response to variations in environmental quantities that characterize the various steps of insertion of said valve prosthesis assembly 100.

[00119]. According to an embodiment, said anchoring element 15 comprises an aseptic coating. For example, said aseptic coating can be at least partially made of poly-tetra-fluoro-ethylene, or PTFE.

[00120]. According to an embodiment, said anchoring device 10 is at least partially made of metallic material. For non-limiting example, it may comprise carbon, pyrolytic carbon or graphite, or titanium or titanium alloys. According to an embodiment, said anchoring device 10 is made at least partially of polymeric material. For non-limiting example, it may comprise a nano-structured polymeric material.

[00121]. In accordance with an embodiment, said valve element 20 is made at least partially of synthetic material derived from processing on materials of biological origin, for example collagen. According to an embodiment, said valve element 20 comprises a frame made of metallic material or of radiopaque polymeric material (in a known way).

[00122]. According to an embodiment, said main body 13 is made at least partially of shape memory material.

[00123]. According to one embodiment, said shape memory material is Nitinol, or nitinol. In other words, according to an embodiment, said anchoring element 15 is made at least partially in Nitinol.

[00124]. According to an embodiment, said main body 13 comprises an expandable stent. For example, said stent can be expanded by expanding an inflatable element (in a known manner).

[00125]. According to an embodiment, said main body 13 comprises a self-expandable stent.

[00126]. According to an embodiment, the mesh of said stent can have a variety of shapes as well as dimensions.

[00127]. According to an embodiment, said main body 13 comprises an aseptic coating. For example, said aseptic coating can be at least partially made of poly-tetra-fluoro-ethylene, or PTFE.

[00128]. In accordance with an embodiment, at least a portion of said main body 13 measures increasing gauge by moving towards said second edge 12. For example, the increase in gauge of main body 13 is measured at said outer face 14.

[00129]. The provision of said at least one main body portion 13 of the anchoring device 10 which measures increasing caliber towards said second edge 12, advantageously allows said cardiac valve prosthesis assembly 100 to fit implant sites having different caliber, as well as implant sites having to at least one seat wall 7 of different compliance with the same caliber, simply by acting on what to insert said cardiac valve prosthesis assembly 100 into the implantation site. In other words, said characteristic cooperates to make said cardiac valve prosthesis assembly 100 versatile and suitable for application in implant sites of various sizes, as well as tolerances. In this way, the mass production of said cardiac valve prosthesis assembly 100 is favored.

[00130]. Furthermore, the provision of said at least one portion of the main body 13 of the anchoring device 10 which measures increasing caliber towards said second edge 12, allows to realize a cardiac valve prosthesis assembly 100 suitable for optimally fitting an implant site while without having to measure the compliance of the at least one seat wall 7 of the implantation site 6, making the implantation of said cardiac valve prosthesis assembly 100 faster, without thereby offering reduced implant reliability.

[00131]. In accordance with an embodiment, said external face 14 of said anchoring device 10 comprises an inlet portion 16 located adjacent to said second edge 12, in which said inlet portion 16 is unsuitable to include said at least one anchoring element 15 .

[00132]. According to an embodiment, said inlet portion 16 is unsuitable for anchoring to the implantation site. In other words, said inlet portion 16 is suitable for remaining outside the implantation site, under operating conditions.

[00133]. In accordance with an embodiment, said inlet portion 16 is suitable for forming an abutment abutment for at least a portion of the native valve apparatus. For example, when said cardiac valve prosthesis assembly 100 is a mitral valve prosthesis, said inlet portion 16 is suitable for forming an abutment abutment for at least a portion of the valve flaps 2 of the native valve 3, as well as for at least a portion of the cords tendon 4 connected to the valve flaps 2 of the native valve 3.

[00134]. According to an embodiment, said main body 13 measures an increasing gauge from said first edge 11 to said second edge 12.

[00135]. In this way the insertion of said anchoring device 10 in the implantation site is favored.

[00136]. According to an embodiment, said main body 13 comprises an at least partially frusto-conical portion.

[00137]. In accordance with an embodiment, said main body 13 is at least partially frustoconical with a flaring which increases the caliber of said main body 13, as one moves towards said second edge 12.

[00138]. With the term "truncated cone / a" referring to the conformation of said main body 13, we do not mean an exactly truncated conical shape, but rather a shape characterized by a constant increase in caliber, for example an increase in constant caliber from said first edge 11 towards said second edge 12.

[00139]. The provision of a portion of said main body 13 at least partially truncated cone is favorably opposed to the pressure gradient which, when in operating conditions, tends to move the cardiac valve prosthesis assembly 100 with respect to the implantation site 6.

[00140]. According to an embodiment, said anchoring face 14 and said anchoring element 15 are made in a single piece.

[00141]. According to an embodiment, said main body 13 comprises a plurality of frusto-conical portions. This feature is particularly advantageous when realized in combination with the provision of said anchoring element 15 comprising a plurality of circumferential rings 152.

[00142]. In accordance with an embodiment, each frusto-conical portion of said plurality of frusto-conical portions is suitable for forming a circumferential ring 152 with its radially outer edge 18.

[00143]. The provision of said main body 13 at least partially frusto-conical allows to optimize the insertion step of the anchoring device 10 in the implant site, in the glove it allows a more controlled insertion movement. For example, said cardiac valve prosthesis 100 comprising at least a truncated cone portion of said main body 13, performs an insertion step of each truncated conical portion which is predictable and in substantially linear relationship with the applied insertion force.

[00144]. In accordance with an embodiment, each frusto-conical portion of said plurality of frusto-conical portions is suitable for forming with said radially outer edge 18 said anchoring element 15.

[00145]. According to an embodiment, the main body 13 of said cardiac valve prosthesis 100 comprises exactly a truncated cone portion, to connect said first edge 11 to said second edge 12. The provision of this characteristic allows all said cardiac valve prosthesis assembly 100 to perform a predictable insertion step and in substantially linear relationship with the applied insertion force.

[00146]. For example, the applied insertion force can be a pushing action exerted on an abutment surface 19 of said second edge 12, or it can be a screwing action, or it can be a pulling or pulling action.

[00147]. According to an embodiment, said plurality of frusto-conical portions have a different degree of flaring. In other words, according to an embodiment, said plurality of frusto-conical portions have different taper angles.

[00148]. The provision of said main body 13 at least partially frustoconical allows to simplify the manufacturing process of said anchoring device 10, with respect to an irregular shape of said main body 13.

[00149]. According to an embodiment, said at least one anchoring element 15 extends at least partially towards said first edge 11. According to an embodiment, said at least one anchoring element 15 extends counter-inclined with respect to the profile of said main body 13.

[00150]. This feature is particularly advantageous when provided in combination with the provision of said at least one anchoring element 15 made deformable and / or made of shape memory material. In fact, a combination of this type allows to insert said cardiac valve prosthesis assembly 100 into the implantation site 1 when said anchoring element 15 is in a radially contracted form, reducing the risk of damaging the at least one seat wall 7 of the implantation site. 6 during the insertion phase of the cardiac valve prosthesis assembly 100.

[00151]. The provision of said at least one anchoring element 15 counter-inclined with respect to the flaring of the external gauge of said main body 13 allows a coupling of improved effectiveness in the implantation site 6, providing an even more firm anchoring of the valve prosthesis assembly 100 than to the entrainment forces generated by the blood current during the atrial systole phase of the cardiac cycle.

[00152]. According to an embodiment, said at least one anchoring element 15 extends at least partially towards said second edge 12. According to an embodiment, said at least one anchoring element 15 extends inclined in a direction concordant with respect to the said main body 13.

[00153]. This feature is particularly advantageous when provided in combination with the provision of said at least one anchoring element 15 made deformable and / or made of shape memory material. In fact, a combination of this type allows to insert said cardiac valve prosthesis assembly 100 into the implantation site 1 when said anchoring element 15 is in a radially contracted form, reducing the risk of damaging the at least one seat wall 7 of the implantation site 6. during the insertion phase.

[00154]. A method of anchoring a cardiac valve prosthesis will be described below.

[00155]. One method of anchoring a cardiac valve prosthesis includes the following steps:

[00156]. providing a cardiac valve prosthesis assembly 100 according to any of the embodiments described above;

[00157]. -inserting said cardiac valve prosthesis assembly 100 into the implantation site.

[00158]. In accordance with a possible way of operating, said cardiac valve prosthesis assembly 100 is inserted into the implantation site 6 by first inserting said first edge 11. In this way, the provision of at least a portion of said anchoring device 10 having an increasing caliber in works favorably for said cardiac valve prosthesis assembly 100 to be fitted into the implantation site 6.

[00159]. In accordance with a possible way of operating, a method comprises the further step of pre-assembling said at least one valve element 20 on said anchoring device 10 to form a cardiac valve prosthesis assembly 100. In other words, said cardiac valve prosthesis assembly 100 is assembled before insertion into the implant site. In still other words, said at least one valve element 20 is mounted on said anchoring device 10 to form a cardiac valve prosthesis assembly 100, before said step B).

[00160]. In accordance with a possible way of operating, a method comprises the further step of moving said cardiac valve prosthesis assembly 100 with rotational movement in the implantation site, so as to favor the anchoring of said at least one anchoring element 15 in the implantation site. plant.

[00161]. In accordance with a possible way of operating, a method comprises the further step of screwing said cardiac valve prosthesis assembly 100 into the implantation site 1. This way of operating is particularly advantageous when provided in combination with the provision of said at least one element of anchor 15 comprising at least one helical thread 151.

[00162]. In accordance with a possible mode of operation, a method comprises the further step of providing a release device 101, suitable for delivering said cardiac valve prosthesis assembly 100 to the implantation site.

[00163]. According to an embodiment, said release device 101 is suitable for trans-apical implantation.

[00164]. According to an embodiment, said cardiac valve prosthesis assembly 100 is a mitral valve prosthesis assembly, in which said cardiac valve prosthesis assembly 100 is inserted into the implantation site by trans-apical implantation. This simplifies the implantation process.

[00165]. For example, said screwing step can be operated by using a release device 101 comprising a maneuvering interface external to the patient's body and accessible by the surgeon.

[00166]. In accordance with a possible way of operating, a method comprises in step B) the further sub-step of inserting said cardiac valve prosthesis assembly 100 into the implantation site 1 by pushing it. This way of operating is particularly advantageous when said main body 13 of said anchoring device 10 measures increasing caliber by moving towards said second edge 12.

[00167]. In accordance with a possible way of operating, a method comprises in step B) the further sub-step of inserting, by pulling it, said cardiac valve prosthesis assembly 100 into the implantation site 6.

[00168]. In accordance with a possible way of operating, a method comprises the further step of inserting said valve prosthesis assembly 100 up to substantially abutment with the anatomical surface on which the implantation site 6 is made. For example, when said valve prosthesis assembly cardiac 100 is an assembly of mitral valve prostheses, said anatomical surface on which the implantation site 6 is made faces towards a ventricular chamber 9.

[00169]. According to a possible way of operating, said cardiac valve prosthesis assembly 100 is a mitral valve prosthesis assembly, and said implantation site comprises the mitral annulus 5, or native mitral annulus 5.

[00170]. According to an embodiment, said delivery device 101 is a catheter, suitable for transfemoral implantation.

[00171]. According to an embodiment, said delivery device 101 is a catheter, suitable for transseptal implantation.

[00172]. According to an embodiment, said cardiac valve prosthesis assembly 100 is a mitral valve prosthesis assembly, in which said cardiac valve prosthesis assembly 100 is delivered to the implantation site 6 mounted in a contracted form thereof on said release device 101, and wherein said cardiac valve prosthesis assembly 100 is adapted to expand to fit into the implantation site 6.

[00173]. In accordance with an embodiment, said at least one anchoring element 15 is made deformable or in shape memory material, and in which during the insertion of the cardiac valve prosthesis assembly 100 into the implantation site 1, said anchoring element 15 is in a contracted form, and in which said anchoring element is intended to expand when said cardiac valve prosthesis assembly 100 has been inserted into the implantation site 1. For example, the expansion of said anchoring element 15 is operated manually by operating on said release device 101, or is caused by the distinctive environmental conditions of the implantation site 6.

[00174]. In accordance with one embodiment, a heart valve prosthesis kit comprises said valve prosthesis assembly 100, as described in any of the previously reported embodiments, and a delivery device 101, as described in any of the embodiments. previously reported.

[00175]. In accordance with an embodiment, said release device 101 is exclusively suitable for delivering said cardiac valve prosthesis assembly 100.

[00176]. According to an embodiment, said delivery device 101 of said heart valve prosthesis kit is a surgical catheter.

[00177]. To the embodiments described above, a person skilled in the art, in order to meet contingent and specific needs, can make numerous modifications, adaptations and replace elements with other functionally equivalent ones, without however departing from the scope of the following claims.

LIST OF REFERENCES

Native valve flap

Native valve

Tendon cords

Native mitral annulus

Implantation site

Plant site headquarters wall

Atrial chamber

Ventricular chamber

Anchor device

First edge

Second board

Main body

External face

Anchor element

Portion of entrance

Inner face

Radially outer edge of frusto-conical portion Second edge abutment surface

Valve element

Valve flap

Free end of valve flap

Lumen of prostheses

Portion of valve seat

Portion of valve flap engagement

Cardiac valve prosthesis assembly, or valve prosthesis assembly

Release device

Helical thread

Circumferential ring

Claims (10)

CLAIMS A cardiac valve prosthesis assembly (100) comprising: at least one anchoring device (10), at least one valve element (20); wherein said anchoring device (10) comprises at least one main body (13) which defines at least one prosthesis lumen (25), and wherein said main body (13) comprises at least a first edge (11) and at least a second edge (12), wherein said first edge (11) is of smaller caliber than said second edge (12), and in which said main body (13) comprises an external face (14) connecting said first edge (11) and said second edge (12), said external face (14) being unsuitable for facing said valve lumen (25); wherein said valve element (20) is connected directly or indirectly to said anchoring device (10), and wherein said valve element (20) comprises a plurality of valve flaps (23); and in which said valve element (20) is adapted to open by moving a free end (24) of at least one valve flap (23) towards said second edge (12) of said anchoring device (10); and in which said anchoring device (10) comprises at least one anchoring element (15) having a greater caliber than said first edge (11). Cardiac valve prosthesis assembly (100) according to claim 1, wherein said anchoring element (15) comprises at least one of: at least one helical thread (151), at least one circumferential ring (152), at least one beard, at least one hook. Cardiac valve prosthesis assembly (100) according to claim 1 or 2, wherein said at least one anchoring element (15) is located on said outer face (14). Cardiac valve prosthesis assembly (100) according to any one of the preceding claims, wherein said anchoring element (15) is deformable; and / or in which said anchoring element (15) is suitable for changing its shape, passing from a radially contracted state, of reduced caliber or reduced radial extension, to a radially expanded state, of increased caliber or of increased radial extension, with respect to the radial extension of said radially contracted state; and / or in which said anchoring element (15) is self-expandable; and / or in which said anchoring element (15) is made at least partially of shape memory material; and / or in which said anchoring element (15) is made at least partially in Nitinol. Cardiac valve prosthesis assembly (100) according to any one of the preceding claims, wherein said anchoring element (15) is made in a single piece with said main body (13); and / or in which said main body (13) is of a shape and material suitable for forming said anchoring element (15); and / or in which said anchoring element (15) is formed by the folded shape of said main body (13); and / or in which said anchoring element (15) protrudes from said external face (14); and / or in which said anchoring face (14) and said anchoring element (15) are made in a single piece; and / or in which at least a portion of said main body (13) measures increasing caliber by moving towards said second edge (12). Cardiac valve prosthesis assembly (100) according to any one of the preceding claims, wherein said cardiac valve prosthesis assembly (100) is at least one of: an assembly of mitral valve prostheses, an assembly of aortic valve prostheses, - an assembly of tricuspid valve prostheses, a pulmonary valve prosthesis assembly. Cardiac valve prosthesis assembly (100) according to any one of the preceding claims, wherein said main body (13) comprises at least an at least partially frusto-conical portion; and / or in which said main body (13) comprises a plurality of frusto-conical portions. Cardiac valve prosthesis assembly (100) according to any one of the preceding claims, wherein said at least one anchoring element (15) extends counter-linked with respect to the profile of said main body (13) or inclined in a direction concordant with respect to the profile of said main body (13). 9. Cardiac valve prosthesis kit comprising: at least one valve prosthesis assembly (100), according to any one of the preceding claims, at least one release device (101). 10. Method of anchoring cardiac valve prosthesis comprising the following steps: A) providing a cardiac valve prosthesis assembly (100) according to any one of claims 1 to 8; B) insert said cardiac valve prosthesis assembly (100) into the implantation site.