replacement valve for use on a human body

专利摘要:
AORTIC BIOPROSTHESIS AND SYSTEMS FOR HER RELEASE. The present invention relates to the modality of the present description that are directed to stents, valve stents and associated methods and systems for their release by means of minimally invasive surgery.
公开号:BR112012010321B1
申请号:R112012010321-0
申请日:2010-09-10
公开日:2021-03-09
发明作者:Jacques Essinger；Youseff Biadillah；Stephane Delaloye；Jean-Luc Hefti；Luc Mantanus；Reynald Passerini
申请人:Symetis Sa；
IPC主号:

专利说明:

DESCRIPTION FIELD
[0001] The modalities of the present disclosure are directed to systems, methods, and devices for heart valve replacement in mammalian hearts. BACKGROUND OF THE DESCRIPTION
[0002] Conventional approaches to replacing a heart valve require cutting a relatively large opening in the patient's sternum ("sternotomy") or chest cavity ("thoracotomy") to allow the surgeon to access the patient's heart. In addition, these approaches require the patient's heart to be detained and a cardiopulmonary bypass (that is, the use of a heart and lung bypass machine to oxygenate and circulate the patient's blood). In recent years, efforts have been made to establish a less invasive heart valve replacement procedure by releasing and implanting a replacement heart valve through a catheter percutaneously (ie, through the skin) through or an approach transvascular - which releases the new valve through the femoral artery, or via the transapical route, where the replacement valve is released between the ribs and directly through the heart wall to the implantation site.
[0003] Although percutaneous heart valve replacement therapies (PHVT) are less invasive and arguably less complicated, they still have several shortcomings, including the inability of a surgeon to ensure proper positioning and stability of the replacement valve in the body of the patient. Specifically, if the replacement valve is not placed in the proper position with respect to the implantation site, it can lead to malfunction of the valve. For example, in an aortic valve replacement, if the replacement valve is placed too high, it can lead to valve regurgitation, instability, valve prolapse and / or coronary occlusion. If the valve is placed too low, it can also lead to regurgitation and interaction of the mitral valve.
[0004] To address such risks, recapture procedures and systems have been developed. For example, such a system is disclosed in U.S. publication No. 20050137688 and U.S. Patent No. 5,957,949, each disclosure of which is incorporated herein by reference. Although such systems can address the problem of improper placement, they are somewhat complicated, requiring the use of wires that are removably attached to one end of the stent to pull the stent back into the delivery catheter.
[0005] Throughout this description, which includes the previous description of the related technique, any and all publicly available documents described herein, which include any and all U.S. patents, are specifically incorporated by reference herein in their entirety. The foregoing description of the related technique is in no way intended as an admission that any of the documents described therein, including pending United States patent applications, are the prior art of the modalities in accordance with the present disclosure. Furthermore, the description in the present of any disadvantages associated with the products, methods, and / or apparatus described, is not intended to limit the inventions disclosed in the present. In fact, aspects of the disclosed modalities may include certain characteristics of the products, methods, and / or apparatus described without suffering from its described disadvantages. DESCRIPTION SUMMARY
[0006] In some embodiments, a replacement valve for use on a human body is provided, where the replacement valve includes a valve component and the stent component (the replacement valve is also referred to as a valve stent or a stent valve, and can be used interchangeably with the replacement valve for the entire development). The stent component defines a first end (for example, proximal) and a second end (for example, distal) and can include a plurality of sections of the stent.
[0007] The proximal end P of the stent component can be described as the end of the stent component / replacement valve that is ultimately positioned adjacent and / or in the left ventricle. The proximal end P of the stent component may comprise one or more anchoring or fixing elements for attachment to the delivery catheter (e.g., attachment end in a transapical delivery system). The distal end D of the stent component can be described as the end of the replacement valve / stent component that is finally positioned adjacent and / or close to the ascending aorta, when, for example, the delivery catheter is advanced in direction / to the ascending aorta in a transapical release system. The distal end is sometimes referred to as the aortic end and the proximal end is sometimes referred to as the ventricular end. According to the preferred disclosure modalities, the replacement valves according to at least some modalities are released in the distal to proximal direction, that is, the end of the stent (replacement valve) that is finally positioned in the / next the / adjacent to the aorta is released before the end of the stent (replacement valve), which is finally positioned at / next to / adjacent to the ventricle is finally released. Such release, according to preferred modalities, is through a transapical approach, or through the heart muscle (as opposed to being released in a transvascular manner). Although the preferred embodiments disclosed herein are described as being delivered using a direct heart access approach (for example, transapical approach using transapical / direct access delivery systems), some embodiments of the present invention can be distributed from transvascular (for example, transfemoral).
[0008] According to some modalities, a replacement valve is provided for use on a human body comprising: a valve component; and a stent component configured to house at least a part of the valve component comprising a proximal end and a distal end, the stent component further comprising: a lower anchoring crown comprising an at least partially tapered body, where the lower anchoring crown defines the proximal end of the stent component; an upper anchor crown in communication with the lower anchor crown and which comprises a body at least partially tapered, where the tapered body of the lower anchor crown leans out towards the proximal end, and the tapered body of the anchor crown upper leans out towards the distal end; being that the distal section of the stent comprises a body at least partially conical, where the distal section of the stent is in communication with the upper anchoring crown, preferably the distal section of the stent comprises a conical or cylindrical commissural post section and a section of stabilization arch, where the commissural pole section is in communication with the upper anchoring crown; and the stabilizing arch section is in communication with the commissural pole section and comprises a body at least partially tapered, and where the stabilizing arch section defines the distal end. In some embodiments, at least one partially cylindrical body of the commissural post section comprises the valve fixing elements. The stent component can be formed from a single tube or sheet of metal.
[0009] In this context, the term "partially conical body" must mean that the crown can have any divergent shape. The upper and / or lower anchor crown may include a plurality of subsequent tapered sections with different inclinations or may have a continuously increasing or decreasing divergence, for example, may have a trumpet mouth shape. The upper and / or lower anchoring crown may also include one or more cylindrical sections or sections that converge inwardly.
[00010] The upper and lower anchoring crowns can be found in a line where the stent has a minimum diameter.
[00011] In some embodiments, the commissural pole section meets the upper and / or lower anchoring crown on the same line, where the upper anchoring crown meets the lower anchoring crown.
[00012] The conical body of the lower anchor crown can tilt outward from an inner diameter D2 to an outer diameter D3 towards the proximal end, where the inner diameter D2 is between about 20 mm to about 30 mm, and the outer diameter D3 is between about 22 mm to about 40 mm. The axial distance between the planes of diameters D2 and D3 in the expanded configuration can be between about 3 to about 15 mm. The outward slope of the lower anchor crown can be defined by an angle α2, where α2 is between about 5 degrees to about 50 degrees.
[00013] The conical body of the upper anchor crown slopes outward from an inner diameter D2 to an outer diameter D1 towards the distal end, where the inner diameter D2 can be between about 20 mm to about 30 mm, and the outer diameter D1 is between about 22 mm to about 40 mm.
[00014] The axial distance between the planes of diameters D2 and D1 in the expanded configuration can be between about 3 to about 10 mm.
[00015] The outward slope of the upper anchor crown can be defined by an angle α1, where α1 is between about 10 degrees to about 80 degrees.
[00016] In some embodiments, the end of the upper anchor crown forms a point, where the tip is flexed inwardly towards the longitudinal axis at an angle α3 compared to the direction of the surface of the crown, and α3 is between about 0 degree to about 180 degrees. The length of the upper anchor crown and the commissural post section of the combined H3 stent component can be between about 3 to about 50 mm. The length of the stabilizing arches and the H4 stent component can be between about 5 to about 50 mm.
[00017] In some embodiments, the upper and / or lower crown may include a cylindrical or tilting section only slightly outward, thus there is a substantially cylindrical section between the part that in fact diverges from the upper conical crown and the part that in fact diverges from the lower conical crown. The substantially cylindrical section is sometimes referred to as the trunk section. The axial length of the trunk section can be greater than 3 mm. Additionally or alternatively, the length of the trunk section can be less than 7 mm. For example, the axial length of the trunk section can be between 4 and 6 mm.
[00018] In some embodiments the axial length of the substantially cylindrical section is at least 50% of the axial length of at least one of the lower or upper anchoring crown and / or where the axial length of the substantially cylindrical section is equal to or greater than the axial length of at least one of the first and second sections.
[00019] In the context of the present application, the substantially cylindrical or sloping sections only slightly outward are sections provided with an angle of inclination of less than 10 degrees with respect to the axis of the stent.
[00020] In some embodiments, the lower anchoring crown is configured to create a shape fit with an inlet flow from an aortic valve and then prevent the stent component and valve component from migrating towards the ascending aorta .
[00021] In some embodiments, the upper anchoring crown is configured to create a shape fit with an outflow tract and native aortic valve leaflets and then prevent the migration of the stent component and the valve component towards the left ventricle.
[00022] In some embodiments, the tips of the upper anchoring crown may extend into a final position in the native valve leaflets recessed or supported on them and then prevent migration of the stent component and the valve component towards the ascending aorta and / or towards the left ventricle.
[00023] In some embodiments, the commissural post section comprises a plurality of commissural posts configured for attachment to the valve component junction.
[00024] In one embodiment, the distal section of the stent comprises a plurality of stabilization arches to support against the ascending aorta for alignment of the stent component with respect to the ascending aorta, each stabilization arch comprises a divergent part that diverges away from the stent axis, in a direction towards the distal end; and an apex of the arc inclined at an angle (α5) measured from the divergent part in a direction towards the axis of the stent.
[00025] In some embodiments, the stabilization arcs or loops are configured to engage the ascending aorta to guide the stent component, the valve component and a longitudinally associated release system in an aortic annular aorta / column, then prevent tilting of the stent component and the valve component during the implantation procedure and / or when implanted.
[00026] In some embodiments, at least one member (or strut) of at least one arch comprises an asymmetric feature. Preferably, the member comprises a pattern, for example, one or more twists, such that the member is different from the other member of the arc and can be distinguished from the other member in a projected image. The asymmetric feature can provide information about rotational alignment during implantation, for example, when viewed in an X-ray projection.
[00027] Alternatively or additionally, there may be at least one asymmetric feature in an upper or lower crown cell.
[00028] In some embodiments, the lower anchoring crown comprises at least one fixing element for removable attachment to a release device.
[00029] In some embodiments, the (or at least one) fixation element is generally formed in the form of an opening that is capable of widening when the stent component expands radially. The opening is adapted to receive a pin arranged on the stent retainer.
[00030] In particular, the fastening element can be formed by an axial elongation of at least one cell of the lower crown. Preferably, three fasteners are formed by three such elongated cells, optionally equally spaced around the perimeter. Preferably, the or each elongated element is adapted to receive a respective pin that protrudes radially in the stent retainer.
[00031] In some embodiments, the fastening element can generally be formed in the shape of a hook. In particular, the fastening element is formed by an elongation of at least one cell of the lower crown which is angled inward and / or flexed. Preferably, three fasteners are formed by three such elongated cells, optionally equally spaced around the perimeter of the stent and flexed inward. The inclined fastening element or each element can be adapted to be received by a groove disposed in a stent retainer and / or to engage a respective pin that extends or protrudes axially in the stent retainer.
[00032] In some embodiments, the stent component comprises a plurality of commissural posts for attachment to a corresponding plurality of valve commissures.
[00033] In some embodiments of the present disclosure, a component of the stent may be provided which includes a central longitudinal axis and at least one fixing element for removable fixation to a release device. The at least one fastening member can generally be formed in the form of a hook that extends internally towards the central longitudinal axis. The release device may include a stent retainer comprising a groove for receiving the stent component fastener, where the release of the stent valve from the stent retainer can be facilitated by rotation of the stent retainer with respect to the stent retainer. fixation.
[00034] In yet other embodiments of the present disclosure, a replacement valve for use on a human body is provided that includes a valve component, a stent component for housing the valve component, and at least two valves (for example, polyester (PET) skirts). An inner skirt can be provided that covers at least part (for example, all) of an outer surface of the valve component, where the inner skirt can be sutured at least to the inlet flow of the valve component and to a surface internal stent. An external skirt can also be provided that is sutured to an external surface of the stent.
[00035] Some embodiments of the present disclosure provide a system for releasing the heart valve from the stent that includes an internal assembly and an external assembly. The internal assembly may include a guide wire lumen (for example, polymeric tubing) and a stent retainer for removable attachment to a stent valve. The external assembly may include a sheath. The inner member and the outer member can be positioned coaxially and slid with respect to each other in order to transition from a closed position to an open position, such that in the closed position the sheath covers surround the stent valve still attached to the retainer of the stent and then restricts the expansion of the stent valve. In the open position, the outer sheath may not restrict the expansion of the stent valve, so the stent valve can detach from the stent retainer and expand to a fully expanded configuration.
[00036] In some embodiments, the internal assembly of the delivery device may include a band of radiopaque marker or fluoroscopic marker attached to the distal guide wire lumen of the stent retainer.
[00037] In some embodiments, the diameter of the external assembly of the release device varies along its longitudinal axis.
[00038] In some embodiments of the present disclosure, a method is provided to replace an aortic valve in a human body. A stent valve can be covered with a sheath to keep the stent valve in a collapsed configuration. The stent valve can then be inserted in the collapsed configuration in the human body without making contact with the ascending aorta or aortic arch. The stent valve can be partially expanded by sliding the sheath towards the left ventricle of the heart. This sliding of the sheath towards the left ventricle can cause the distal end of the stent valve to expand while the proximal end of the stent valve remains restricted by the sheath. The sheath can additionally be slid towards the left ventricle of the heart in order to cause the full expansion of the stent valve. In some embodiments, the stent valve can be recaptured before it fully expands by sliding the sheath in the opposite direction.
[00039] In some embodiments, a method for heart valve replacement is provided that includes releasing a distal end of a stent valve from a sheath, where the distal end includes a radiopaque marker positioned on it (e.g., radiopaque marker band ). The stent valve is rotated, if necessary, to orient the stent valve appropriately with respect to the coronary arteries (for example, to prevent the commissures from turning to the coronary arteries). The stabilization arches or loops of the stent valve are released from the sheath in order to make at least one of the stabilization arches make contact with the aorta. The upper anchoring crown of the stent valve is released from the sheath and is brought into contact with the native leaflets of the valve. A lower anchor crown from the stent valve is released from the sheath and brought into contact with an annular tube / inlet flow tract. The lower anchor crown can be the proximal section of the stent valve, such that releasing the lower anchor crown causes the stent valve to be completely released from the sheath of the release device.
[00040] According to some modalities, a system is provided to replace a valve in a human body which comprises: a release device; and a replacement valve for use in a human body comprising: a valve component and a stent component configured to accommodate at least a part of the valve component comprising a proximal end and a distal end, the stent component being it further comprises: a lower anchoring crown that defines a body at least partially tapered, where the lower anchoring crown defines the proximal end of the stent component; an upper anchor crown in communication with the lower anchor crown and defining a body at least partially tapered, where the tapered body of the lower anchor crown leans out towards the proximal end, and the tapered body of the anchor crown upper leans out towards the distal end; the distal section of the stent defines a body at least partially conical, where the distal section of the stent comprises a conical post pole section and the stabilization arch section, where the commissural post section is in communication with the upper anchoring crown; and the stabilization arch section is in communication with the commissural pole section and defines a body at least partially tapered, where the stabilization arch section defines the distal end. The stabilization arc can tilt out of the commissural post and / or loop inwardly at its remote apex to the commissural post. The stent component may have a central longitudinal axis and that comprises at least one fixture for removable fixation to a release device, where the at least one fixture is located at a proximal end of the stent component, where the proximal end is defined as the end towards the left ventricle when released from a transapical approach.
[00041] In some embodiments, the (at least one) fixation element is generally formed in the form of an opening that is capable of widening when the stent component expands radially. The opening is adapted to receive a pin arranged on the stent retainer.
[00042] In particular, the fastening element can be formed by an axial elongation of at least one cell of the lower crown. Preferably, three fasteners are formed by three such elongated cells, optionally equally spaced around the perimeter. Preferably, the elongated element or each element is adapted to receive a respective pin, preferably radially arranged in the stent retainer.
[00043] In some embodiments, the (at least one) fixing element is generally formed in the shape of a hook.
[00044] In particular, the fastening element is formed by an elongation of at least one cell of the lower crown which is angled inward and / or flexed. Preferably, three fasteners are formed by three such elongated cells, optionally equally spaced around the perimeter of the stent and flexed inward. The inclined fastening element or each element can be adapted to be received by a groove disposed in a stent retainer and / or to engage a respective pin disposed in the stent retainer.
[00045] In some embodiments, the delivery device comprises: an internal member comprising a guide wire lumen and a stent retainer; and an outer member comprises a sheath; where the stent retainer comprises, for example, a groove for receiving the stent component retainer and / or at least one pin for engaging a stent element retainer in the form of an opening.
[00046] The pins can be arranged radially to engage the axial elongations of the stent element or the pins can subtend an angle less than 90 degrees with the axis of the stent retainer, preferably it can be arranged axially, to engage an element of stent inclined or flexed fixation internally with an opening.
[00047] The axial pins can be arranged in a circumferential groove of the stent retainer.
[00048] Each radial pin can be arranged in an axial groove separate from the stent retainer. Preferably, there are three slots equally spaced around the perimeter of the stent retainer for receiving the corresponding stent fasteners.
[00049] In some embodiments, the stent retainer comprises ramp surfaces to facilitate the release of the stent component after removing the stent sheath.
[00050] Preferably, each of the axial grooves comprises ramp surfaces, for example, facets on either side of the groove, to facilitate the lifting of the fasteners when the stent expands. Especially, when the stent component and the stent retainer do not remain in exact coaxial relationship after removing the stent sheath, the release of the stent component and the elevation of the fasteners are guaranteed.
[00051] The inner member and the outer member are coaxially positioned and slid with respect to each other in order to transition from a closed to an open position, such that in the closed position the sheath surrounds at least part of the valve stent still attached to the stent retainer which restricts the expansion of the stent valve, and such that in the open position the outer sheath does not restrict the expansion of the stent valve and the stent valve separates from the stent retainer and expands into a configuration expanded. The release of the stent valve from the stent retainer can optionally be facilitated by the slight rotation and / or axial movement of the stent retainer with respect to the fastener.
[00052] According to some modalities, a method is provided to replace an aortic valve in a human body, the method comprising: covering the replacement valves of the present invention with a sheath in order to keep the replacement valve in a collapsed configuration; transapically insert the replacement valve still in the configuration collapsed in the human body; partially expand the replacement valve by sliding the sheath towards the left ventricle of the heart, wherein said sliding of the sheath towards the left ventricle causes the expansion of a distal end of the replacement valve while the proximal end of the replacement valve remains restricted by the sheath; and further sliding the sheath towards the left ventricle of the heart in order to substantially release the entire replacement valve such that the replacement valve is allowed to expand into an expanded configuration.
[00053] In some embodiments, the method may comprise sliding the sheath in the opposite direction before said full expansion in order to recapture the replacement valve in the sheath.
[00054] According to some embodiments, a method for replacing a heart valve is provided which comprises: releasing a distal end of the replacement valves of the present invention from a sheath, wherein the distal end comprises a radiopaque marker; rotate the replacement valve, if necessary, to orient the replacement valve appropriately with respect to the coronary arteries; release the arches of the sheath replacement valve, in order to make at least one of the arches make contact with the aorta; release a first tapered crown from the sheath replacement valve in order to make the first tapered crown make contact with the native leaflets of the valve; and releasing a second crown from the sheath replacement valve, in order to make the second crown make contact with an annular tube / inlet flow tract, wherein the second crown comprises the proximal section of the replacement valve and said releasing the second crown comprises completely releasing the sheath replacement valve.
[00055] According to some embodiments, a method for replacing heart valve is provided which comprises: releasing a distal end of the replacement valves of the present invention from a sheath, wherein the distal end comprises a radiopaque marker and a plurality of bows; rotate the replacement valve, if necessary, to orient the replacement valve appropriately with respect to the coronary arteries; release the arcs from the sheath replacement valve in order to propel the arcs towards (and optionally make contact) to an area above a native valve; release a first part of the tapered crown from the sheath replacement valve, in order to make the first tapered crown make contact with the native leaflets of the valve; and releasing a second crown part from the sheath replacement valve to make the second crown make contact with an annular tube tract / native valve inlet flow, where the second crown is the proximal section of the valve of replacement and said release of the second crown comprises completely releasing the replacement valve from the sheath.
[00056] According to some embodiments, a method is provided to replace a worn or ill valve comprising: transapically implanting the replacement valves of the present invention, wherein the replacement valve comprises: a valve component; and a component of the stent to which the valve component is attached, the component of the stent comprising: a longitudinal axis; a lower anchoring crown which includes a substantially tapered shape provided with a narrow end, a wide end and a first predetermined height; and wherein an upper anchor crown includes a substantially tapered shape provided with a narrow end, a wide end and a second predetermined height, wherein: a central axis of each of the lower anchor crown and the upper anchor crown is arranged to align substantially with the longitudinal axis; the narrow ends of the lower anchor crown and the upper anchor crown are arranged to meet forming an annular groove to receive the annular tube of the worn or sick heart valve at a heart implantation site, the first height of the anchor crown lower is greater than the second height of the upper anchoring crown; and positioning the replacement valve so that the annular groove receives the annular tube from the worn or sick heart valve. BRIEF DESCRIPTION OF THE DRAWINGS
[00057] For a better understanding of the modalities of the present disclosure, reference is made to the following description, taken in conjunction with the accompanying drawings, in which the same reference characters refer to equal parts throughout the document, and in which are:
[00058] Figure 1 shows the placement of a double polyester fabric (PET) skirt 103 with respect to a component of the stent 101, as well as the placement of a valve component in the stent 102.
[00059] Figures 2A to 2I show the size and shape of the elements of the stent component in the expanded configuration and in the unexpanded configuration according to some disclosure modalities.
[00060] Figure 3 illustrates the anatomical compatibility between the stent and the aortic root.
[00061] Figure 4 illustrates the reach of the possible location for the coronary ostium (shaded area).
[00062] Figures 5A and 5B and figures 6A and 6B illustrate the process of selecting and suturing together the three non-coronary porcine cusps (figures 5 A and B). The biological conduit obtained in this way is trimmed, as trimmed above the insertion line of the leaflets. An internal PET tube is positioned on the outer surface of the biological porcine valve and trimmed according to the shape of the biological conduit. The two parts are then sutured together along the free margins (figures 6 A and B).
[00063] Figure 7 shows a bioprosthetic conduit mounted on the metallic stent, aligning the prosthetic commissures with the commissural totem 2 of the stent and maintaining the free flow margin of the prosthesis above the curvature out of the upper anchoring crown 3, in order to avoid reducing the prosthetic orifice area.
[00064] Figure 8 shows a strip of porcine pericardium that covers the free margin of the outflow tract valve.
[00065] Figure 9 illustrates a placement of a double polyester fabric (PET) skirt with respect to a component of the stent, according to some modalities of the present disclosure.
[00066] Figure 10 shows a release system for the distal to proximal expansion of a stent valve, according to some modalities of the present disclosure.
[00067] Figure 11 shows the elements of the release system for the distal to proximal expansion of a stent valve, according to some modalities of the present disclosure.
[00068] Figure 12 shows the elements of the release system for the distal to proximal expansion of a stent valve, according to some modalities of the present disclosure.
[00069] Figure 13 shows the partial release of an aortic bioprosthesis or replacement valve with a stent 100 according to some modalities.
[00070] Figure 14 shows the total release of an aortic bioprosthesis or replacement valve with a stent 100 according to some modalities.
[00071] Figure 15 shows an example of a recapture control handle 575 of the release device.
[00072] Figure 16 shows a release system for the distal to proximal expansion of a stent valve with a low profile 555 tip, according to some modalities of the present disclosure.
[00073] Figure 17 shows a stent retainer to be arranged in a delivery system. DETAILED DESCRIPTION
[00074] Some embodiments of the present disclosure are directed to systems, methods, and devices for replacing a heart valve. For example, such methods, systems and devices may be applicable to all variations of heart valve therapies that include, for example, replacement of weakened aortic, mitral, tricuspid and pulmonary valves. Some modalities may facilitate a surgical approach to a beating heart without the need for an open cavity in the chest and a deviation between heart and lung. This minimally invasive surgery approach can reduce the risks associated with replacing a weakened native valve on the first occasion, as well as the risks associated with secondary or subsequent surgeries to replace weakened artificial valves (for example, biological or synthetic). Stents, Stent valves / Stents with valve
[00075] Some embodiments of the present disclosure refer to stents and stent valves or valve stents. Valved stents in accordance with some embodiments of the present disclosure can include a valve component and at least one component of the stent (for example, a single stent valve or a double stent valve). The valve component may include a biological valve (for example, porcine or bovine valve provided), a synthetic valve (for example, synthetic valve leaflet made of biological tissue (for example, pericardium), and / or valve leaflet material and / or a mechanical valve assembly), any (any) other suitable material (s). The stent and valve components according to some modalities may be able to have at least two configurations: a collapsed or contracted configuration (for example, during release) and an expanded configuration (for example, after implantation).
[00076] According to some embodiments, the valve stent or the stent valves of the present disclosure can be used as replacement heart valves and can be used in methods to replace sick or damaged heart valves. Heart valves are passive structures that simply open and close in response to differential pressures on either side of the particular valve. The heart valve comprises mobile "leaflets" that open and close in response to differential pressures on either side of the valve leaflets. The mitral valve has two leaflets and the tricuspid valve has three. Aortic and pulmonary valves are referred to as "semilunar valves" due to the unique appearance of their leaflets or "cusps" and are shaped like a half moon. The aortic and pulmonary valves each have three cusps.
[00077] The valve component can be designed to be flexible, compressible, compatible with the host and non-thrombogenic. The valve component can be made of various materials, for example, allografts or new xenografts, cryopreserved or fixed by glutaraldehyde. Synthetic biocompatible materials, such as polytetrafluoroethylene, polyester, polyurethane, nitinol or other alloy / metal sheet material and the like can be used. The preferred material for the valve component is mammalian pericardium tissue, particularly young animal pericardium tissue.
[00078] The valve component can be any replacement heart valve known or used as replacement heart valves. Replacement heart valves are generally categorized into one of three categories: artificial mechanical valves; transplanted valves; and fabric valves. Mechanical valves are typically constructed from non-biological materials, such as plastic, metals and other artificial materials. Transplanted valves are natural valves taken from cadavers. These valves are typically removed and frozen in liquid nitrogen, and are stored for later use. They are typically fixed in glutaraldehyde to eliminate antigenicity. Artificial tissue valves are valves constructed from animal tissue, such as bovine or porcine tissue. Efforts have been made to use the patient's tissue for which the valve will be built. Such regenerative valves can also be used in combination with the components of the stent described herein. The choice of which type of heart replacement valves is generally based on the following considerations: hemodynamic performance, thrombogenicity, durability and ease of surgical implantation.
[00079] Most tissue valves are constructed by sewing the pig's aortic valve leaflets to a stent to secure the leaflets in the appropriate position, or by constructing the valve leaflets from the pericardial bag of cows or pigs and sewing. them to a stent. See, for example, U.S. Patent Publication No. 2005/0113910, the disclosure of which is incorporated herein by reference in its entirety. Methods of creating artificial tissue valves are described in U.S. Patent Nos. 5,163,955, 5,571,174 and 5,653,749, the disclosures of which are incorporated into the present by reference in their entirety.
[00080] According to some modalities, the valve component is attached to the internal channel (also referred to as the lumen) of the stent member. This can be achieved using any means known in the art. The valve component can be attached to the internal channel of the stent member by means of a suture or stitch, for example, by suturing the outer surface of the pericardium material from the valve component to the stent member, and, for example, securing the component valve to the commissural posts 2 of the stent member. The valve fixation position can be closer to the proximal end of the chosen stent with the understanding that the annular tube of the native valve that is replaced will preferably engage the external surface of the stent in the groove by the upper anchoring crown 3.
[00081] Figure 1 illustrates an aortic bioprosthesis or replacement valve with stent 100 according to some modalities. The stent component 101 supports a replacement biological valve prosthesis 102. In some embodiments, the stent valve comprises the following elements: a valve 102 (for example, biological porcine valve) that regulates blood flow between the left ventricle and the aorta; a self-expanding Nitinol stent 101 that acts as an anchoring structure in the native aortic annular tube for the biological valve in which it is sutured; and a double skirt 103 (e.g., double polyester (PET) skirts) sutured to the internal and external surfaces of the stent to reinforce the porcine biological valve and facilitate leak-proof sealing of the implant.
[00082] The stent 101 of the replacement valve can be self-expanding, being formed of a superelastic material or with a suitable shape memory or by the combination of materials (for example, nitinol). The stent is manufactured according to any method known in the art. In some embodiments, the stent is manufactured by laser cutting a tube or a single sheet of material (for example, nitinol). For example, the stent can be cut from a tube and then gradually expanded to its final diameter through cardiac treatment in a mandrel. In some embodiments, the stent is manufactured by laser cutting a tube of superelastic material or memory of a suitable shape or by combining materials (for example, nitinol). Heart-forming treatments can be applied, according to the state of the art, in order to repair the stent shape. As another example, the stent can be cut from a single sheet of material, and then subsequently rolled and welded to the desired diameter.
[00083] Figure 2 illustrates the stent component of an aortic bioprosthesis or replacement valve with stent 100 according to some modalities. The stent component 101 defines a first end (for example, proximal) and a second end (for example, distal) and can be described as having one or more of 5 predominant features or sections which include: stabilizing arcs 1; commissural posts 2; upper anchoring crown (first) 3; lower anchoring crown / part (second) 4; and inlet flow hooks 5.
[00084] Alternatively, the stent component 101 can be described as having one or more of: a distal section of the stent that defines the distal end; a proximal anchoring section that defines the proximal end; and an upper (first) crown section. The distal section of the stent can comprise the stabilization arch (section) 1 and the commissural post (section) 2. The proximal anchoring section can comprise the lower crown / anchoring part (second) 4. The upper crown section (first) it can comprise the upper anchoring crown 3. The upper crown section can comprise a first divergent part that diverges out in a direction towards the distal end. The first crown section can have a free end. The free end may be proximal to the distal end of the stent and / or distal to the proximal end of the stent.
[00085] Stabilization arcs 1 define the outflow section of the stent component (with respect to the direction of the main blood flow in the native valve), and include a generally divergent shape (for example, tapered), with the tapered curvature generally oriented in the same direction as the curvature of the upper anchoring crown 3. In some embodiments, the stabilizing arches 1 include a plurality of (e.g., 2, 3, 4, 5, 6, or more) generally larger arches in position referred to the arches in the commissural posts 2. In some embodiments, these larger arches are the first components of the stent to be used during the distal to proximal release of the aortic bioprosthesis or replacement valve with 100 stent from a first unexpanded configuration to a second expanded configuration (see, for example, figures 13 and 14).
[00086] In some embodiments, at least one of the arches employed 1 engages the ascending aorta, thereby orienting the stent release / valve system longitudinally into the aortic aorta / annular column, thus preventing any tilting of the implanted stent valve 100 . The stent 101 may also include a radiopaque marker at the distal end or close to that of one of the arches to help track stent placement during implantation.
[00087] The radial force of the stabilizing arcs 1 can be increased by adjusting the length and angle of the stabilizing arcs 1. In some embodiments, the tip of the elements forming the upper anchoring crown 3 and / or the stabilizing arcs 1 can be flexed towards the longitudinal axis of the stent, thus avoiding the potential damage to the vasalva sinus (see, for example, figure 2). The free area between the stabilizing arcs 1 can be adjusted (that is, increased or decreased) to improve blood flow to the coronary arteries. This section of the stent can be attached to the section of the anchor crown.
[00088] Commissural posts 2 are the part of the stent to which the valve 102 prosthesis is attached. In some embodiments, the commissural posts 2 include a plurality (for example, 2, 3, 4, 5, 6 or more) of arches (or other type of structure, for example, post) for fixing the prosthetic valve commissures. In some embodiments, the commissural posts 2 can be designed with an asymmetric shape (not shown), in order to easily identify under fluoroscopy, the three-dimensional position of each prosthetic commissure. In some embodiments, the commissural posts 2 can be designed with point marker bands to identify their respective position in relation to the coronary artery ostium.
[00089] The upper anchor crown section 3 may include a generally divergent part. The divergent part can have any suitable shape, such as tapered or widened with a non-uniform divergence angle with respect to the central axis (for example, dome type or trumpet mouth) giving a convex or concave divergence or a combination of any of these. The tapered / divergent angle or curvature can be oriented in the opposite direction to the angle or curvature of the lower anchor crown 4 or the proximal anchor stent section 4. Due to this geometry, the upper anchor crown 3 creates a fit with the device supravalvular and native aortic valve leaflets. Therefore, it prevents migration of the stent valve towards the left ventricle (migration of the implant during diastole). In addition, the upper anchoring crown 3 provides a radial force that creates additional friction fitted against the annular aortic tube plus native leaflets. In some embodiments, the tips of the crown elements 3 can be flexed to form a cylindrical surface, thereby reducing the risks of perforation of the sinus.
[00090] Due to this geometry, the section of the lower anchoring crown 4 creates a shape that fits with the inlet flow of an aortic valve (for example) and therefore prevents the migration of the prosthesis towards the ascending aorta ( migration of the implant towards the ascending aorta during systole). This section defines the proximal end P of the stent component (with respect to a native valve, or heart or ventricle). The section is generally tapered. In some embodiments, the inlet flow margin can be flexed inward to prevent damage to the level of the subvalvular apparatus. In addition, the lower anchoring crown 4 provides a radial force that creates additional friction fitted against the inlet flow / annular aortic tube tract.
[00091] Some modalities may additionally include the inlet flow margin hooks 5, which help in fixing the aortic bioprosthesis to the delivery system (through the stent retainer) during the release procedure.
[00092] In some modalities, the anchoring of the aortic bioprosthesis or the replacement valve with stent 100 in the native calcified aortic annular tube has two different aspects: fit by shape based on the shape and characteristics of the stent (for example, by the joined space section 3 and section 4); and friction fit based on the radial force applied by the self-expanding stent. The anatomical compatibility between the stent and the aortic root is illustrated in figure 3.
[00093] In some embodiments, the tips of the upper anchoring crown can rest in a final position between the sinutubular junction and the aortic annular tube according to figure 3 and press the native valve leaflets back.
[00094] The shaded box in figure 4 indicates the range of the possible location for the coronary ostium. The large entrances between the commissural totems 2 and the arches reduce the risk of damage to the coronary flow. In addition, the stent frame does not interfere with the possible need for coronary catheterization.
[00095] In some embodiments, the aortic bioprosthesis or replacement valve with stent 100 comprises a biological component, which can be obtained by selecting and suturing together the three non-coronary porcine cusps (see, for example, figures 5 A and B) . The biological conduit obtained is thus trimmed, just as trimmed above the insertion line of the leaflets (for example, removal of Valsava's breasts). An internal PET tube can be positioned on the external surface of the biological porcine valve and trimmed according to the shape of the biological conduit. The two parts can then be sutured together along the free margins (see figures 6 A and B). A manufacturing process related to the assembly of the biological component is disclosed in U.S. Provisional Order No. 61 / 109,310 and PCT related order WO 2010/049160, the total contents of which are incorporated into the present by reference in their entirety.
[00096] In some embodiments, the bioprosthetic conduit is mounted on the metallic stent, aligning the prosthetic commissures with the commissural totem 2 of the stent and maintaining the free flow margin of the prosthesis above the curvature out of the upper anchoring crown 3, the in order to avoid reducing the prosthesis orifice area (see figure 7).
[00097] In some embodiments, a strip of the additional porcine pericardium covers the free margin of the valve's outflow tract (figure 8). The internal PET skirt reinforces the biological tissue in the area where the points attach the valve to the stent struts. The pericardium strip protects the valve leaflets from direct contact with the finishing edge points on the distal valve cover.
[00098] In some modalities, the external PET skirt sutured in the lower anchoring crown contributes to mitigate the risk of paravalvular leakage from the implant. The skirt 103 (see figure 1) is designed to cover the truss structure or housing of the stent component. In some embodiments, the skirt follows the truss structure of the lower anchoring crown of the stent component and can be described as a specific atraumatic “flower” design (see, for example, figure 9). The design of the skirt 103 creates a geometric discontinuity at the edge of the inlet flow of the outer fabric skirt. Thus, when the stent is reduced in diameter, due to the excessive size of the prosthesis in relation to the diameter of the annular tube / LVOT, the shrinkage of the tissue does not create folds. In addition, the skirt reduces the risk of sharp margins in the stent carcass that can impair the integrity of the surrounding biological structures (eg, anterior mitral leaflet, left branch, etc.). The protruding “petals” of the skirt 103 act as soft cushioning elements when they flex over the tip of the element that forms the lower anchoring crown.
[00099] In some embodiments, the overall length of the stent may be small enough to avoid conflict with, for example, the mitral valve when the stent is being used for aortic valve replacement. Logically, it will be understood that these dimensions will vary depending, for example, on the type of valve used and the dimensions given above are included as examples only and other sizes / variations are available, which are in accordance with the present disclosure.
[000100] In yet other embodiments of the present disclosure, a replacement valve for use on a human body is provided that includes a valve component, a stent component for housing the valve component, and at least two skirts (for example, polyester (PET) skirts). An inner skirt can be provided that covers at least part (for example, all) of an outer surface of the valve component, where the inner skirt can be sutured at least to the inlet flow of the valve component and to a surface internal stent. An external skirt can also be provided that is sutured to an external surface of the stent.
[000101] An external PET fabric skirt can be provided in which the free margin of the stent is covered to prevent damage to the left ventricular wall and mitral valve (see, for example, figure 9).
[000102] In some embodiments, a stent is presented, which includes a section for fixing the commissural valve that is composed of a plurality (for example, two, three, four, five, six, eight, etc.) longitudinal elements connected on one side to a conical shaped section (for example) used for anchoring towards the left ventricle and on the other side to the conical shaped section (for example) used for stabilization.
[000103] According to some modalities, the stent is designed to be more compatible with the size and shape of a biological valve with narrow commissural posts 2 and, in some modalities, allow a more robust suture of the commissural posts from the valve to the stent. Narrow commissural posts 2 according to some modalities can improve the perforation of the coronary arteries through the vasalva sinus. To reduce the deflection of the longitudinal elements under diastolic pressure, an additional reinforcement crown can also be added in some embodiments.
[000104] According to some modalities, the stent design that allows the fixation of the commissural posts of valve 2, according to some modalities, provides an additional advantage, as the size and shape of such stents preferably do not change. substantially, and do not change during a crimping process required to load the stent (with valve, "valve stent") into a delivery device. In this way, this can reduce (and preferably reduces) the risk of damage to the suture and facilitates the curling and subsequently the release of the valve stent (for example).
[000105] Although numerous modalities are described in the present, other modifications are possible, and thus, the modalities noted are for illustrative purposes only.
[000106] Figures 2B to 2D are provided to illustrate the dimensions of the stent component. D3 represents the diameter of the most proximal margin of the stent component in the expanded configuration. D2 represents the diameter of the stent component at the joint between the upper and lower anchoring crowns. H2 represents the axial distance between the planes of diameters D2 and D3 in the expanded configuration. D1 represents the diameter of the most distal margin of the upper anchoring crown of the stent component in the expanded configuration. H1 represents the axial distance between the planes of diameters D1 and D2 in the expanded configuration.
[000107] The length of H2 can be between about 3 to about 15 mm (for example, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, and about 15 mm). The length of H2 can be adjusted depending on the intended application of the stent of the stent valve. For example, the length of H2 can vary from about 3 to about 5 mm, about 3 to about 7 mm, about 3 to about 12 mm, about 3 to about 15 mm, about 3 to about 20 mm, about 5 to about 10 mm, about 5 to about 12 mm, about 5 to about 15 mm, about 7 to about 10 mm, about 7 to about 12 mm, about 7 to about 15 mm, about 10 to about 13 mm, about 10 to about 15 mm, or about 7 to about 20 mm. For example, the length of this section may be at the lower end of the scale to avoid potential conflict with a heart valve, such as a mitral valve.
[000108] The diameter in D3 can be between about 22 mm to about 40 mm (for example, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, and about 40 mm). This D3 diameter can be adjusted depending on the intended application of the stent valve stent. Thus, the diameter D3 in the expanded configuration can be from about 15 mm to about 50 mm, from about 15 mm to about 40 mm, from about 20 mm to about 40 mm, from about 24 mm to about 40 mm, about 26 mm to about 40 mm, about 28 mm to about 40 mm, about 30 mm to about 40 mm, about 32 mm to about 40 mm, about from 34 mm to about 40 mm, from about 36 mm to about 40 mm, from about 38 mm to about 40 mm, from about 22 mm to about 38 mm, from about 22 mm to about 36 mm, from about 22 mm to about 34 mm, from about 22 mm to about 32 mm, from about 22 mm to about 30 mm, from about 22 mm to about 28 mm, about 24 mm to about 34 mm, from about 25 mm to about 35 mm, or from about 25 mm to about 30 mm.
[000109] The diameter of the D2 stent component can be between about 20 mm and about 30 mm (for example, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm , about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, and about 30 mm). This diameter of the D2 stent component can be adjusted depending on the intended application of the stent of the stent valve. For example, this diameter of the D2 stent component can be sized according to the shape of the annular tube of the heart valve. Thus, the diameter of the D2 stent component can be from about 15 mm to about 40 mm, from about 15 mm to about 30 mm, from about 18 mm to about 35 mm, from about 22 mm to about 30 mm, about 24 mm to about 30 mm, about 26 mm to about 30 mm, about 28 mm to about 30 mm, about 22 mm to about 28 mm, about 22 mm to about 26 mm, about 20 mm to about 24 mm, about 20 mm to about 26 mm, about 20 mm to about 28 mm, and about 22 mm to about 32 mm.
[000110] The diameter D1 can be between about 22 mm and about 40 mm (for example, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, 34 mm, 35 mm, 36 mm, 37 mm, about 38 mm, about 39 mm, and about 40 mm). This diameter D1 can be adjusted depending on the intended application of the stent of the stent valve. Thus, the diameter in the expanded configuration D1 can be from about 15 mm to about 50 mm, from about 15 mm to about 40 mm, from about 20 mm to about 40 mm, from about 24 mm to about 40 mm, about 26 mm to about 40 mm, about 28 mm to about 40 mm, about 30 mm to about 40 mm, about 32 mm to about 40 mm, about from 34 mm to about 40 mm, from about 36 mm to about 40 mm, from about 38 mm to about 40 mm, from about 22 mm to about 38 mm, from about 22 mm to about 36 mm, from about 22 mm to about 34 mm, from about 22 mm to about 32 mm, from about 22 mm to about 30 mm, from about 22 mm to about 28 mm, about 24 mm to about 34 mm, from about 25 mm to about 35 mm, or from about 25 mm to about 30 mm.
[000111] The length of H1 is between about 3 and about 10 mm (for example, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm , about 9 mm, and about 10 mm). The length of H1 can be adjusted depending on the intended application of the stent of the stent valve. For example, the length of H2 can vary from about 3 to about 5 mm, about 3 to about 15 mm, about 3 to about 20 mm, about 5 to about 10 mm, about 7 to about 10 mm, about 7 to about 12 mm, about 7 to about 15 mm, about 10 to about 13 mm, about 5 to about 15 mm, about 7 to about 20 mm. For example, the length of this section may be the least end of the scale to avoid the potential conflict with the breast of Valsalva.
[000112] Figure 2D is provided to illustrate the angles of the anchoring crowns. Angle α1 defines the angle of the upper anchor crown of the stent component in the expanded configuration. Angle α2 defines the angle of the lower anchor crown of the stent component in the expanded configuration. The angle α3 defines the flexion angle of the tip, which is done in order to prevent sinus damage.
[000113] The angle α1 can be from about 0 degrees to about 90 degrees (e.g., about 10 degrees, about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65 degrees, about 70 degrees, about 75 degrees, and about 80 degrees). The α1 angle can be from about 20 degrees to about 70 degrees, most preferably from about 30 degrees to about 60 degrees. According to some modalities, the angle α1 is about 20 degrees to about 80 degrees, about 20 degrees to about 60 degrees, about 20 degrees to about 50 degrees, about 20 degrees to about 45 degrees, about 40 degrees to about 60 degrees, about 45 degrees to about 60 degrees, about 30 degrees to about 50 degrees, about 30 degrees to about 45 degrees, about from 30 degrees to about 40 degrees, or from about 25 degrees to about 45 degrees.
[000114] The angle α can be from about 0 degrees to about 50 degrees (e.g., about 5 degrees, about 10 degrees, about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, and about 50 degrees). The α2 angle can be from about 10 degrees to about 40 degrees, most preferably from about 10 degrees to about 30 degrees. According to some modalities, the angle α2 is about 5 degrees to about 45 degrees, about 5 degrees to about 40 degrees, about 5 degrees to about 30 degrees, about 5 degrees to about 25 degrees, about 5 degrees to about 20 degrees, about 5 degrees to about 15 degrees, about 10 degrees to about 20 degrees, about 10 degrees to about 25 degrees, about from 10 degrees to about 30 degrees, from about 10 degrees to about 40 degrees, from about 10 degrees to about 45 degrees, from about 15 degrees to about 40 degrees, from about 15 degrees to about 30 degrees, about 15 degrees to about 25 degrees, about 20 degrees to about 45 degrees, about 20 degrees to about 40 degrees, or about 20 degrees to about 30 degrees.
[000115] The angle α3 can be from about 0 degrees to about 180 degrees (e.g., about 5 degrees, about 10 degrees, about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65 degrees, about 70 degrees, about 75 degrees, about 80 degrees, about 85 degrees, about 90 degrees, about 95 degrees, about 100 degrees, about 105 degrees, about 110 degrees, about 115 degrees, about 120 degrees, about 125 degrees, about 130 degrees, about 135 degrees, about 140 degrees, about 145 degrees, about 150 degrees, about 155 degrees, about 160 degrees, about 165 degrees, about 170 degrees, about 175 degrees, and about 180 degrees). According to some modalities, the angle α3 is about 45 degrees to about 90 degrees, about 45 degrees to about 180 degrees, about 60 degrees to about 90 degrees, about 45 degrees to about 120 degrees, about 60 degrees to about 120 degrees, about 90 degrees to about 120 degrees, about 90 degrees to about 180 degrees, or about 120 degrees to about 180 degrees.
[000116] The length of the upper anchor crown 3 and section of the commissural posts 2 of the H3 stent component is between about 3 to about 50 mm (for example, about 3 mm, about 4 mm, about 5 mm , about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm , about 20 mm, about 22 mm, about 24 mm, about 25 mm, about 26 mm, about 28 mm, about 30 mm, about 32 mm, about 32 mm, about 34 mm, about 36 mm , about 38 mm, about 40 mm, about 42 mm, about 44 mm, about 45 mm, about 46 mm, about 48 mm, and about 50 mm). The length of H3 can be adjusted depending on the intended application of the stent of the stent valve. For example, the length of H3 can vary from about 3 to about 40 mm, about 3 to about 30 mm, about 3 to about 20 mm, about 3 to about 10 mm, about 10 to about 50 mm, about 10 to about 40 mm, about 10 to about 30 mm, about 10 to about 20 mm, about 15 to about 50 mm, about 15 to about 40 mm, about 15 to about 30 mm, about 20 to about 50 mm, about 20 to about 40 mm, about 20 to about 30 mm, about 15 to about 50 mm, about 25 to about 50 mm, about 30 to about 50 mm, about 40 to about 50 mm, about 15 to about 40 mm, about 25 to about 40 mm, or about 30 to about 40 mm.
[000117] The length of the stabilizing arcs 1 of the H4 stent component is between about 5 and about 50 mm (for example, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 20 mm, about 22 mm, about 24 mm, about 25 mm, about 26 mm, about 28 mm, about 30 mm, about 32 mm, about 34 mm, about 36 mm, about 38 mm, about 38 mm, about 40 mm, about 42 mm, about 44 mm, about 45 mm, about 46 mm, about 48 mm, and about 50 mm). The length of H4 can be adjusted depending on the intended application of the stent of the stent valve. For example, the length of H4 can vary from about 5 to about 40 mm, about 5 to about 30 mm, about 5 to about 20 mm, about 5 to about 10 mm, about 10 to about 50 mm, about 10 to about 40 mm, about 10 to about 30 mm, about 10 to about 20 mm, about 15 to about 50 mm, about 15 to about 40 mm, about 15 to about 30 mm, about 20 to about 50 mm, about 20 to about 40 mm, about 20 to about 30 mm, about 15 to about 50 mm, about 25 to about 50 mm, about 30 to about 50 mm, about 40 to about 50 mm, about 15 to about 40 mm, about 25 to about 40 mm, or about 30 to about 40 mm.
[000118] Angles α4 and α5 (see also figure 2F) represent the angle of displacement of a longitudinal axis of the stent component 1 stabilization arcs in the expanded configuration. If the stabilizing arches are directed away from the center of the stent, angle α4 is used. If or where the stabilization arcs are directed towards the center of the stent, angle α5 is used.
[000119] The angle α4 is preferably from about 0 degrees to about 60 degrees (e.g., about 5 degrees, about 10 degrees, about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, and about 60 degrees). According to some modalities, the α4 angle is about 20 degrees to about 60 degrees, about 30 degrees to about 60 degrees, about 40 degrees to about 60 degrees, about 45 degrees to about 60 degrees, about 30 degrees to about 50 degrees, about 30 degrees to about 45 degrees, about 20 degrees to about 40 degrees, or about 15 degrees to about 45 degrees.
[000120] The α5 angle is preferably from about 0 degrees to about 20 degrees (e.g., about 5 degrees, about 10 degrees, about 15 degrees, and about 20 degrees). According to some embodiments, the α5 angle is about 5 degrees to about 20 degrees, about 10 degrees to about 20 degrees, about 15 degrees to about 20 degrees, about 0 degrees to about 15 degrees, about 0 degrees to about 10 degrees, about 5 degrees to about 15 degrees, about 10 degrees to about 15 degrees, or about 10 degrees to about 20 degrees.
[000121] Using the dimensions described above (that is, D1, D2, D3, H1, H2, H3, H4, α1, α2 and α3), the components of the stent of the stent valves according to some modalities of this revelation can be classified into different size categories, such as small, medium and large. thus, according to a first group of modalities, the components of the stent (or stent valves) can be dimensioned as small, medium and large, according to the following table. Table 1


[000122] In accordance with some embodiments, a replacement valve is provided comprising a valve component and a stent component, wherein the stent component comprises a lower anchoring crown, an upper anchoring crown, a section of commissural pole, and stabilization arches. The tapered body of the lower anchor crown can tilt outward from an inner diameter D2 to an outer diameter D3 towards the proximal end, where the inner diameter D2 can be between about 20 mm and about 27 mm, especially between 20 mm to about 25 mm and where the outside diameter D3 can be between about 26 mm to about 33 mm, especially between 26 mm and 32 mm. The axial distance between the planes of diameters D2 and D3 in the expanded configuration (H2) can be between about 7 and about 11 mm, where the outward slope of the lower anchor crown is defined by an angle α2, which can be from about 15 degrees to about 25 degrees. The tapered body of the upper anchor crown can tilt outward from an inner diameter D2 to an outer diameter D1 towards the distal end, where the inner diameter D2 can be between about 20 mm and about 27 mm, especially between 20 mm and 25 mm, and where the outside diameter D1 can be between about 26 mm and about 33 mm, especially between 26 mm and 31 mm. The axial distance between the planes of diameters D2 and D1 in the expanded configuration (H1) can be between about 4 and about 8 mm. The outward slope of the lower anchor crown can be defined by an angle α1, which can be from about 45 degrees to about 65 degrees. The end of the upper anchoring crown can form a point, where the point is flexed inwardly towards the longitudinal axis at an angle α3. The α3 angle can be from about 45 degrees to about 65 degrees. The length of the combined upper anchor crown and stent component (H3) commissural posts can be between about 11 and about 15 mm. The length of the stent component stabilization arcs (H4) can be between about 14 and about 30 mm (preferably up to about 22 mm); wherein the stent component stabilization arches expand outward at an α4 angle from a longitudinal axis towards the second distal end of the replacement valve. The angle α4 can be between about 5 degrees and about 15 degrees.
[000123] According to some modalities, a replacement valve is provided comprising a valve component and a stent component, wherein the stent component comprises a lower anchoring crown, an upper anchoring crown, a section of commissural pole, and stabilization arches. The conical body of the lower anchor crown can tilt outward from an inner diameter D2 to an outer diameter D3 towards the proximal end. The inner diameter D2 can be between about 21 mm and about 26 mm, and the outside diameter D3 can be between about 27 mm and about 33 mm. The axial distance between the planes of diameters D2 and D3 in the expanded configuration (H2) can be between about 8 and about 12 mm. The outward slope of the lower anchor crown can be defined by an angle α2, which can be from about 15 degrees to about 25 degrees. The conical body of the upper anchor crown can tilt outward from an inner diameter D2 to an outer diameter D1 towards the distal end. The inner diameter D2 can be between about 21 mm and about 26 mm, and the outside diameter D1 can be between about 27 mm and about 32 mm. The axial distance between the planes of diameters D2 and D1 in the expanded configuration (H1) can be between about 4 and about 8 mm. The outward slope of the lower anchor crown is defined by an angle α1, which can be from about 45 degrees to about 65 degrees. In some embodiments, the end of the upper anchor crown forms a point, the point of which is flexed inwardly towards the longitudinal axis at an angle α3, which can be from about 45 degrees to about 65 degrees. The length of the upper anchor crown and section of the stent component (H3) commissural posts can be between about 13 and about 17 mm. The length of the stabilizing arches and the stent component (H4) can be between about 15 and about 23 mm. In some embodiments, the stent component stabilization arches expand outward at an α4 angle from a longitudinal axis toward the second distal end of the replacement valve. The angle α4 is between about 5 degrees and about 15 degrees.
[000124] According to some embodiments, a replacement valve is provided comprising a valve component and a stent component, wherein the stent component comprises a lower anchoring crown, an upper anchoring crown, a section of commissural pole, and stabilization arches. The conical body of the lower anchor crown can tilt outward from an inner diameter D2 to an outer diameter D3 towards the proximal end. The inner diameter D2 can be between about 22 mm to about 27 mm, the outer diameter D3 can be between about 28 mm and about 34 mm, and the axial distance between the planes of diameters D2 and D3 in the expanded configuration ( H2) can be between about 9 and about 13 mm. The outward slope of the lower anchor crown can be defined by an angle α2, where α2 is about 15 degrees to about 25 degrees. The conical body of the upper anchor crown slopes outward from an inner diameter D2 to an outer diameter D1 towards the distal end, where the inner diameter D2 can be between about 22 mm and about 27 mm, and where the outer diameter D1 can be between about 28 mm and about 33 mm. The axial distance between the planes of diameters D2 and D1 in the expanded configuration (H1) can be between about 4 and about 8 mm; wherein the outward slope of the lower anchor crown is defined by an angle α1, which can be from about 45 degrees to about 65 degrees. The end of the upper anchor crown can form a point, the point being flexed inwardly towards the longitudinal axis at an angle α3, which can be from about 45 degrees to about 65 degrees. The length of the upper anchor crown and commissural post section of the stent component (H3) combined can be between about 15 and about 19 mm. The length of the stabilizing arches and stent component (H4) can be between about 16 and about 24 mm. The stent component stabilization arcs expand outward at an angle α4 from a longitudinal axis towards the second distal end of the replacement valve, where α4 is between about 5 degrees and about 15 degrees.
[000125] In some embodiments, multiple fixing elements (for example, 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more , 11 or more, 12 or more, 13 or more, 14 or more, 15 or more, 16 or more, 17 or more, 18 or more, 19 or more, 20 or more, etc. or 2 to 5, 2 to 10, 2 to 20, 2 to 30, 2 to 40, etc.) can be provided to retain the stent in a catheter while a compatible / complementary element (for example, pinned stent retainer) can be attached to the delivery device . The design of the multiple fixation elements (for example, forming "holes") may allow the stent to be attached to the catheter only when the stent is curled. The fixation may automatically release when the stent begins to expand. That is, the stent shape in the unexpanded state is designed to have holes or free area that can be used to couple the stent with a stent retainer. When the stent is expanded, the expanded configuration is missing such holes or free spaces, and thus the stent automatically becomes decoupled or frees itself from the stent retainer in the expansion.
[000126] The stent component may additionally include one or a plurality (for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, etc.) of fastening elements at the proximal end of the stent, in that the fasteners are capable of being compatible with a stent retainer 560 of a release device 500 (see figures 10 and 12). The fasteners may include a crochet-like configuration that engages, for example, a groove or other opening in the 560 stent retainer. Such fasteners may be formed in the form of a flexion, or curved angled member (for example, a curved angled member). "L" or "J" format). See figure 2D. In some embodiments, such fasteners may be a hook (for example, a "J" shape). in the modality illustrated in figure 2D, the fixation element can be supplied in an angled shape, for example, which extends from the body of the stent internally towards a central longitudinal axis of the stent. Opening in the 560 stent retainer (for example, groove) may allow safe release of the stent in the rotation of the delivery system (for example, part, all, or members of it - for example, the rotation of the stent retainer). For example, when the stent release / retainer system rotates, the end of the fastener slides on a surface (for example, a ramp that extends in the circumferential direction) and is thus forced, according to some modalities , to disengage the stent retainer when it reaches a margin (for example, radially outermost end of the ramp).
[000127] As shown in figure 2E, in some embodiments there is a cylindrical section 16 between the upper conical crown 13 and the lower conical crown 14. The cylindrical section 16 can further extend to form commissural posts, such that the axial profile shows a additional cylindrical section 17 between the upper tapered crown 13 and the stabilizing arches 11.
[000128] The distal part 18 of the stabilization arches 11 is angled inward, such that the arms of the stabilization arches 11 are detached to allow the distal section of the stent to adapt to the inside of the aorta.
[000129] Using the dimensions as referenced in figure 2E, the stent components of the stent valves according to the alternative preferred embodiments of the present disclosure can be classified into different size categories, such as small, medium and large. thus, according to some modalities, the components of the stent (or stent valves) can be sized as small, medium and large according to the table below. Table 2


[000130] D1 represents the diameter of the stent component at the distal margin of the upper conical crown that tilts externally in the expanded configuration.
[000131] D3 represents the diameter of the most proximal margin of the stent component in the expanded configuration.
[000132] D2 represents the diameter of the stent component in the cylindrical section between the upper and lower anchoring crowns in the expanded configuration.
[000133] D4 represents the diameter of the stent component at the junction between the external and internal flexed sections of the stabilization arcs in the expanded configuration,
[000134] D5 represents the diameter of the stent component at the most distal margin of the stent in the expanded configuration.
[000135] L1 represents the axial length of the internally flexed part of the stabilization arcs.
[000136] L2 represents the axial length of the part that tilts externally of the stabilization arcs.
[000137] L3 represents the axial length of the cylindrical section between the upper anchoring crown and the stabilizing arches.
[000138] L4 represents the axial length of the conical part of the upper anchoring crown in the expanded configuration.
[000139] L5 represents the axial length of the trunk section between the conical part of the upper anchoring crown and the conical part of the lower anchoring crown.
[000140] L6 represents the axial length of the tapered part that slopes outwardly from the lower anchoring crown in the expanded configuration.
[000141] L7 represents the axial length of the proximal cylindrical part of the lower conical crown.
[000142] L8 represents the axial length of the axial extensions that form the fastening elements.
[000143] L9 represents the axial length of the cylindrical section between the stabilizing arches and the lower tapered crown.
[000144] The total length L10 of the stent then results in a range from 41 mm to 49 mm.
[000145] As compared with Table 1, the dimensions have been further improved as explained below, for example, the diameter D1 has been reduced by about 2 to 3 mm. Figure 2F shows, in comparison, a first embodiment according to Table 1 (in dashed lines) and a second preferred embodiment according to Table 2 in flat lines.
[000146] When the final position of the stent is determined by a friction fit between the upper crown and the leaflets of the native valve it can be seen that a stent according to the second preferred modality can be seated further down in the native valve in comparison with the first modality and then, the commissural posts that include the valve of the second preferred modality extend closer to the native annular tube.
[000147] It was observed in vivo that some modalities of the stent component may allow the self-positioning of the replacement valve under diastolic pressure. Once released slightly above the aortic annular tube, the stent valve migrates towards the left ventricle due to the forces caused by the diastolic pressure until it reaches a stable position given by the radial shape / strength of the anchoring crowns, the conformity of the annular tube aortic valve, and the presence of any calcification.
[000148] In some other embodiments, the presence of calcification deposits on the native valve can limit or prevent the valve from sliding from one release position to a different stable position. In this case, the stable position can be the same as the release position.
[000149] In some embodiments, a stent valve suitable for implantation in a place of the calcified native valve comprises an upper (first) crown section comprising at least one part that diverges out in a direction towards an aortic end of the stent valve. The upper crown section may have a free end (for example, proximal to the distal end of the stent component). The upper crown / divergent part may have an angle of divergence (or inclination or taper angle) with respect to the stent axis of less than 60 degrees (preferably 50 degrees or less, preferably 45 degrees or less, for example, 43 to 45 degrees) and / or have an axial length of less than 10mm (preferably less than 8mm, preferably less than 6mm, preferably less than 5mm, for example, 3 to 4mm). Such dimensions (see, for example, the modality in figure 2H shown in continuous line compared to the modality in dashed lines) can be related as less sculpted than in some other drawings. The dimensions can, nevertheless, provide a reliable support surface to resist the migration of the stent valve towards the ventricle during ventricular diastole, without the upper crown being so large and / or having an aggressive angle of inclination that the positioning it is probably adversely affected by calcified deposits.
[000150] Additionally or alternatively, a stent valve suitable for implantation in a calcified valve site comprises an upper (first) crown that comprises at least a part that diverges out in one direction towards an aortic end of the valve stent. A substantially non-divergent region 16 (see, for example, figure 2E) that communicates with the narrow end of the divergent part can extend from it in a direction towards the ventricular end of the stent valve. The term "substantially non-divergent" may mean a divergence of not more than 10 degrees, preferably less than 8 degrees, preferably less than 6 degrees, preferably less than 5 degrees, preferably less than 4 degrees, and preferably zero degrees. The substantially divergent region may have an axial length L5 (see figure 2E) of at least 1mm, preferably at least 2mm, preferably at least 3mm, preferably at least 4mm, for example, 4.5 to 5.5mm. The provision of such a substantially divergent region may make the stent valve better accommodate calcified deposits where the stent valve passes through the native valve and / or the native annular tube. The substantially divergent region can separate (at least a part) the upper (first) crown from the (at least a part) lower (second) crown. The substantially non-diverging section may form a part of the upper crown section and / or the lower crown section.
[000151] Additionally or alternatively, a stent valve suitable for implantation in a calcified valve site comprises a section of the lower crown. The section of the lower crown may comprise at least one part that diverges outwardly in a direction towards the ventricular end of the valve stent. The lower crown and / or the diverging part may be provided in a part of the stent valve intended to be received in the ventricle, to engage native tissue to resist migration of the stent valve in a direction outside the ventricle. The diverging part of the lower crown section can have an angle of divergence with respect to the valve on the stent axis between 10 degrees and 20 degrees (preferably 10 to 16 degrees, more preferably 10 to 15 degrees, more preferably 10 to 14 degrees, plus preferably 10 to 13 degrees). Such an angle of divergence can be related as less sculpted than some other drawings (see, for example, the modality in figure 2H shown in continuous line compared to the modality in dashed lines). However, the angle allows the lower crown to function to resist migration, while it is versatile in accommodating a wide range of calcifications without affecting function.
[000152] In a proposal, an upper crown of a stent valve is provided that is not very large (see, for example, the modality in figure 2H shown in continuous line compared to the dashed line modality that has a larger crown ), with the axial length L4 being between 3 and 4 mm and the angle α1 of the upper crown being between 43 ° and 45 °, as well as the length of the cylindrical part 16 which is not very small, with the length L5 being between 4.5 to 5.5 mm. Stents of this type do not block the coronary arteries or make contact with the Vasalva sinus, they reduce the risk of coronary occlusion and they then fit into a calcified annular tube.
[000153] In a preferred embodiment, the lower crown comprises a relatively small tapered angle of about 10 ° to about 13 ° and a proximal cylindrical section with an axial length of about 1 to 2 mm. Stents of this type allow a homogeneous settlement towards a calcified annular tube and less turbulence in the valve inlet flow.
[000154] In an additional preferred embodiment, the stent 11 stabilization arches are flexed inward with a relatively large radius of curvature to prevent injuries to the ascending aorta.
[000155] Figure 2F shows a comparison of different modalities in a side view. The side view represented in dashed lines represents a first modality that corresponds to Table 1 and figures 2A to 2D. The side view shown in a continuous line represents a second preferred embodiment that corresponds to Table 2 and figure 2E.
[000156] As seen in figure 2F in the preferred embodiments, the external inclination angles of the upper conical crown 13 and the lower conical crown 14 have been reduced, while the external inclination angle of the stabilization arches 11 is slightly greater in the preferred modalities. The total length of the upper conical crown 13 was shortened by shortening the axially extending tip. The distance between the upper and lower conical crowns in the preferred modalities according to Table 2 is greater than in the first modalities according to Table 1.
[000157] In the example shown in figure 2F, the lower anchoring crown 14 can have axial extensions 19, each forming a respective fastening element. Preferably, the fastening member comprises an opening for receiving a pin disposed on the stent retainer of the delivery system.
[000158] Preferably, the lower anchoring crown comprises cells 20 and the extension is formed by an elongation 21 of at least one cell 22 as shown in figure 2G.
[000159] The upper part of figure 2G shows a side view of cells in the lower anchoring crown in an unexpanded configuration. Elongation 21 of cell 22 defines an opening 23 for engagement with a pin 82. When the sheath has been removed from the stent and the stent expands radially, the size of the opening (for example, diameter O) of opening 23 widens as shown at the bottom of figure 2G.
[000160] Stretch 21 can be received by an axial groove arranged in the stent retainer of the delivery system.
[000161] Figure 2H shows a side view of a stabilization arch 111 of a specific modality. In this embodiment, an arm 126 of arc 111 comprises a pattern 125, in this case, two threads, such that arm 126 is different from the other arm 127 of arc 111 and can be distinguished from the other arm 127 in a projected image, such as a x-ray image.
[000162] In some embodiments, a valve stent delivery system, and the method for releasing the valve stent to an implantation site are provided in which the valve stent is expanded at the implantation site in a gradual manner (eg example) from its distal end towards its proximal end. For example, a release procedure that causes expansion of a valve stent may involve retracting a sheath element in a catheter release device. The sheath element, in such modality, restricts the valve stent towards a section of the heart (for example, the left ventricle of the heart). According to a procedure, there may be no interaction of the delivery system with the anatomy of the ascending aorta / aortic arch. For example, the sheath that restricts the valve stent and tip of the delivery system may not be required to enter the aortic arch during the delivery procedure, which is beneficial since such entry can potentially cause a bending moment that acts on the valve stent and results in inaccurate positioning of the valve stent (for example, tilt).
[000163] According to some modalities, a heart replacement valve is provided which comprises: a valve component; and a component of the stent to which the valve component is attached, the component of the stent comprising: a longitudinal axis; a lower anchoring crown which includes a substantially tapered shape provided with a narrow end, a wide end and a first predetermined height; and an upper anchor crown which includes a substantially tapered shape provided with a narrow end, a wide end and a second predetermined height, in which: a center of each of the lower anchor crown and the upper anchor crown are arranged to meet each other. substantially align with the longitudinal axis; the narrow ends of the lower and upper anchoring crowns are arranged to meet to form an annular groove to receive the annular tube from a failed heart valve at a heart implantation site, and the first height of the lower anchoring crown is greater than than the second height of the upper anchor crown.
[000164] Figure 2I illustrates two examples of aortic bioprosthesis or replacement valves with stent 100 and 100 'according to some modalities.
[000165] According to these modalities, the upper anchoring crown 3, 13 and the lower anchoring crown 4, 14 are in a line L, from where the commissural posts 2, 12 extend.
[000166] The curvature 31 between two adjacent stabilizing arches 11 corresponds to a radius that is much smaller than the curvature 32 at the tip of the stabilizing arches 11. Thus, the arches 11 extend further upwards than out of the posts. commissural 12 and the risk of making contact with the tissue in this region is reduced.
[000167] Additionally, the thickness 33 of the stabilization arch material on this base close to the section where it communicates with the commissural posts 12 is less than the thickness of the material 34 at the tip 23. Thus, the surfaces of the stabilization arches 11 that are directed against the internal wall of the aorta are relatively wide, such that the risk of cutting the arterial tissue is reduced, whereby the stabilization arches 11 at its base are not very rigid.
[000168] The points 23 of the stabilization arcs 11 turn at least partially towards the central axis of the stent. The stabilization arch 11 in its total length can be divergent, but with reduced divergence in the part of the tip 23. Thus, the stabilization arches 11 have a paddle-shaped envelope, which, on the one hand, supports the positioning of the stent and, on the other hand, reduces the risk of damaging the surrounding tissue. Cardiac Stent Valve Release System
[000169] The present invention additionally provides a delivery system for releasing the stent valves of the present invention. Some embodiments of the present disclosure provide a heart valve release system from the stent that includes an internal assembly and an external assembly. The internal assembly may include a guide wire lumen (for example, polymeric tubing) and a stent retainer for removable attachment to a stent valve. The external assembly may include a sheath. The inner member and the outer member can be coaxially positioned and slid with respect to each other in order to transition from a closed to an open position, such that in the closed position the sheath surrounds the stent valve still attached to the retainer. stent and thus restricts the expansion of the stent valve. In the open position, the outer sheath may not restrict the expansion of the stent valve, so the stent valve can detach from the stent retainer and expand to a fully expanded configuration.
[000170] Figures 10 to 14 illustrate the release device 500 according to some modalities. The delivery system allows for a minimally invasive surgical approach whereby valve replacement surgery is performed on a beating heart without the need for an open cavity in the chest and a deviation between heart and lung. In some modalities, the heart is penetrated transapically through a relatively small opening in the patient's chest (for example, an intercostal space - a region between two ribs). From this access point, the left ventricle is penetrated at the apex of the heart.
[000171] The release device 500 is used to position and release the aortic bioprosthesis or the replacement valve with stent 100 at the desired location on the patient's native calcified aortic valve through transapical access. In some embodiments, the delivery system comprises the following components: a flexible internal member 552; flexible external member 554; and a 501 release handle.
[000172] In some embodiments, the flexible inner member 552 restricts a lumen of the guidewire proximally connected to a female luer lock and distally to an atraumatic tip of the radiopaque 556. In some embodiments, the flexible inner member 552 may comprise additionally a stent retainer, which can be added to prevent premature release of the aortic bioprosthesis during the release procedure. In some embodiments, the flexible inner member 552 may additionally comprise a radiopaque marker band for precise positioning of the implant. The internal member is fixed proximally to the release handle.
[000173] In some modalities, the flexible external member 554 distally restricts the compressed aortic bioprosthesis and is fixed proximally to the trigger of the release handle. Both flexible members can be coaxially arranged and longitudinally slidable.
[000174] In some embodiments, the release device 500 comprises a release handle 501, which provides an ergonomic fit for the physician's hand to facilitate the disposition of the aortic bioprosthesis 100. In some embodiments, the release device 500 may comprise a or more of the following characteristics (see figure 11): the check valve 520 to embed the annular space between the internal and the external member; safety button 510 to prevent premature implant release; release button 505 to allow partial / total release of the implant; and trigger 520 to release the aortic bioprosthesis from the delivery system.
[000175] In some embodiments, the release system has a through profile of 33F, a usable length of min. 330mm, and is compatible with 0.889 mm (.035 ") guidewires. The delivery system accepts all sizes other than the aortic bioprosthesis or the 100-stent replacement valve.
[000176] The preparation of the device before use can comprise one or more of the following optional preparation steps: rinse the stent valve 100 in 4 different baths containing 500ml of sterile saline solution for a minimum of 3min in each bath (min. total rinse duration of 12 minutes) to remove the residues from the sterilizing solution; curling the stent valve 100 into the transapical delivery system using a press (for example, MSI HV200- 104-40 press); and scanning the release system.
[000177] At this stage, the delivery system can be inserted through the wire in the left ventricle. An introducer sheath can optionally be used through which the release device is inserted. However, in the illustrated example, the outer member 554 (figure 12) of the release device can have a generally uniform diameter over at least part of its intended length to be inserted. Such a uniform diameter can allow the delivery device to be inserted into the left ventricle without the need for an additional introducer sheath. Avoiding an introducer sheath may allow for a smaller puncture opening in the ventricle wall, because the puncture does not need to accommodate a wall thickness of an introducer sheath in addition to the release device. The following exemplary steps can be performed in order to release the stent valve 100: unscrewing and removing the safety button; fluoroscopic positioning of the crimped stent valve 100 at the desired location by means of the radiopaque marker strip located on the inner member (for example, at the level of the D2 groove); partial release of the stent valve 100 under fluoroscopic control when pulling the trigger with the release button 505 in the "partial release" position (figure 13). At this stage, the stabilization arcs are completely arranged and the upper anchor crown partially or totally arranged. Pulling trigger 520 causes a backward movement of the outer member with respect to the inner member and then partial implant release; final release of stent valve 100 partially disposed under fluoroscopic control in the appropriate position when pulling the trigger with the release button in the "full release" position (figure 14).
[000178] When arranged, the stent valve 100 automatically separates from the stent retainer due to the self-expanding properties of the stent, thereby leaving the upper and lower crown extending completely over the native leaflets respectively in the outflow tract of the ventricle left. Careful removal of the tip of the 556 release system through the functional bioprosthesis and completely disposed under fluoroscopic control to avoid any valve displacement. The release system can be closed by pushing the trigger forward and removing the release system through the sheath introducer.
[000179] Figures 10 to 12 show a release system 500 for the distal to proximal expansion of a stent valve 100, according to some embodiments of the present disclosure. In some embodiments of the delivery system, system 500 may include an inner member 552 and an outer member 554 (e.g., sheath) that are coaxially positioned and slidable against each other. The inner member 552 can comprise the tubing (for example, polymeric tubing) that serves as a guide wire lumen and in which at least one of (and preferably several or all) a tip 556, a fluoroscopic marker 568 (for example, band radiopaque marker), and a 560 stent retainer are attached (for example, attached). The polymeric piping can be reinforced proximally with a rigid rod (for example, stainless steel). A luer connector can be attached to a stainless steel rod to allow scanning of the lumen of the guidewire with saline solution (for example). The outer member 554 may comprise a distally disposed sheath that can be used to restrict the stent in a closed / restricted configuration (for example, substantially unexpanded). Proximally, the sheath can be attached to a hemostatic valve to allow the annular space to be embedded between the inner and outer limbs with saline solution (for example). As illustrated, the diameter of the outer member 505 can be substantially uniform at least over a portion of its intended length to be inserted through the ventricle wall. In some other embodiments, the diameter of the outer limb may vary in its longitudinal direction (for example, a smaller diameter proximally to decrease the flexion stiffness of the release system). As explained above, the placement of the stent valve can be controlled by pulling a trigger on the release device handle or the handle. In some other embodiments, placement of the stent valve can occur by keeping the inner member at the level of the stainless steel stem with one hand and the outer member at the level of the hemostatic valve with the other hand. Then, when positioning the replacement valve (for example, under fluoroscopic control), the external member is retracted with the internal member that is kept in its original position, until the stent is completely placed.
[000180] In some embodiments, at any time during the placement procedure, up to the configuration described in figure 13 (for example, just before the final release of the valve retainer device), the movement of the external member 554 (that is, the valve sheath) can be inverted, allowing the "recapture" of the device within the release system. The recapture mechanism of the release device can be activated by turning the recapture control handle 575, which can be placed on the proximal end of the release system. The bioprosthesis 100 is held in place by inlet flow hooks (see hooks 5 in figure 2A) and / or one or more bioprosthesis fixing elements that engage the stent retainer 560, while the handle 575, which advances in a thread, slides behind the valve sheath to close the prosthesis again. This feature allows for either the repositioning or total recovery of the prosthesis on the implant side at any time during the procedure before the final release.
[000181] In some embodiments, the tip of the release system can be in two parts, which can be easily disconnected. The inner part 557 can optionally be of metallic material, while the distal conical part 558 can optionally be of a polymeric material. The distal conical part 558 forms the actual tip of the delivery system. With this arrangement, the large tip of the delivery system can be removed whenever necessary or desired, for example, during the curling of the stent valve 100 and / or the loading of the curled stent valve 100 in the release device.
[000182] In some embodiments, a release system is provided with a temporary low profile tip 555 (see figure 16). This stem configuration of the delivery system allows the prosthesis 100 to easily pass over the tip during the aforementioned crimping and / or assembly procedure. Once the prosthesis is assembled, the tip can be quickly changed with a 558 tapered tip, which can be used for the release process. During the assembly procedure, the low-profile tip 555 allows the introduction of the nail through the prosthesis 100, even when the prosthesis 100 is in a partially collapsed shape. The advantages of crossing the valve through the tip when the prosthesis 100 is already partially collapsed include, but are not limited to: better control and direct view of the prosthetic cusp arrangement during the curling (since the valve orifice is not occluded by any component), preventing folds or tissue entrapment within the stent frames. Finally, the introduction of the soft low-profile tip additionally proves the proper leveling of the cusps, and can cancel the effect of the remaining part of the curl.
[000183] In some embodiments, the internal assembly of the release device may include a fluoroscopic marker attached to the distal guidewire lumen of the stent retainer. In some embodiments, the diameter of the external assembly of the release device varies along its longitudinal axis. In still other embodiments, the delivery system comprises a rigid rod (for example, stainless steel) in communication with a proximal end of the guidewire lumen. In some embodiments, the release system comprises a luer connector in communication with the rigid rod.
[000184] In some embodiments, a system for releasing the heart valve from the stent is provided, comprising: an internal assembly comprising a guide wire lumen and a stent retainer for removable fixation to a stent valve, in which the The stent valve comprises at least one fixture for removable fixation to the stent retainer, wherein the at least one fixture is located at a proximal end of the stent valve, where the proximal end is defined as the end in towards the left ventricle when released from a transapical approach; and an external assembly comprising a sheath; where the inner and outer members are coaxially positioned and slid with respect to each other in order to transition from a closed to an open position, such that in the closed position the sheath surrounds the stent valve still attached to the retainer stent valve that restricts the expansion of the stent valve, and such that in the open position the outer sheath does not restrict the expansion of the stent valve allowing the stent valve to separate from the stent retainer and expand into an expanded configuration.
[000185] In some embodiments, the guidewire lumen comprises the polymeric tubing. In some embodiments, the stent retainer may be attached (directly or indirectly) to the guidewire lumen. A fluoroscopic marker can be attached to the distal guide wire lumen to the stent retainer. In some embodiments, a rigid rod may be in communication with a proximal end of the guidewire lumen. A luer connector can be in communication with the rigid rod. In some embodiments, the diameter of the external assembly varies along its longitudinal axis.
[000186] According to some modalities, a method is provided to replace an aortic valve in a human body, the method comprising: covering a stent valve according to the present invention with a sheath in order to maintain the valve stent in a collapsed configuration; transapically insert the stent valve still in the collapsed configuration in the human body; partially expand the stent valve by sliding the sheath towards the left ventricle of the heart, where said sliding of the sheath towards the left ventricle causes the expansion of a distal end of the stent valve while the proximal end of the stent valve remains restricted by the sheath; and further sliding the sheath towards the left ventricle of the heart in order to release substantially all of the stent valve, such that the stent valve is allowed to expand into an expanded configuration. The method may further comprise sliding the sheath in the opposite direction before said full expansion in order to recapture the stent valve in the sheath.
[000187] According to some embodiments, a method for replacing a heart valve is provided which comprises: releasing a distal end of a stent valve according to the present invention from a sheath, wherein the distal end comprises a marker radiopaque; rotate the stent valve, if necessary, to orient the stent valve appropriately with respect to the coronary arteries; release the stabilization arches from the sheath stent valve in order to make at least one of the stabilization arches make contact with the aorta; releasing an upper anchor crown 3 from the sheath stent valve in order to make the lower anchor crown make contact with the native leaflets of the valve; and releasing a lower anchor crown 4 from the sheath stent valve in order to make the lower anchor crown 4 make contact with an annular tube / inlet flow tract, wherein the lower anchor crown 4 comprises the proximal section of the stent valve and said release of the lower anchoring crown 4 comprises the total release of the stent valve from the sheath.
[000188] In some embodiments, the method for replacing a heart valve comprises: releasing a distal end of a valve stent according to the present invention from a sheath, wherein the distal end comprises a radiopaque marker and a plurality of arcs stabilization; optionally rotate the valve stent, if necessary, to orient the stent valve appropriately with respect to the coronary arteries; release the stent stabilization arches with the sheath valve, in order to make at least one of the stabilization arches make contact with an area above a native valve; releasing a part of the upper anchor crown 3 from the sheath valve stent, in order to make the upper anchor crown make contact with the native leaflets of the valve; and releasing a portion of the lower anchor crown 4 from the sheath valve stent in order to make the lower anchor crown 4 make contact with an annular tube tract / native valve inlet flow, in which the crown of the stent lower anchor 4 is the proximal section of the stent valve and said release of the lower anchor crown 4 comprises fully releasing the stent valve from the sheath. If used, the step of rotating the valve stent can be performed before the step of releasing the distal end of the valve stent, or after the step of releasing the distal end of the valve stent.
[000189] In some embodiments, the method for replacing a heart valve comprises: releasing a distal end of a valve stent according to the present invention from a sheath before the proximal end is released. The distal end of the stent may not be the first part of the stent that is released from the sheath. An intermediate part can be released first from a sheath.
[000190] In accordance with some embodiments, a replacement valve is provided for use on a human body comprising: the replacement valve of the present embodiments comprising a valve component, a stent component comprising a lower anchoring crown , and the upper anchor crown, a section of commissural pole, and stabilizing arches; wherein the stent component comprises at least one fixture configured for removable attachment to a groove of a stent retainer 560 of a release device 500. The commissural post section can optionally be generally cylindrical in shape, or generally tapered , or in some other way.
[000191] According to some embodiments, a method of implanting a replacement valve according to the present invention in a mammalian heart is provided which comprises: releasing a replacement valve to a mammalian heart implantation site, where: the implantation site comprises a release location and a final location; and the release location is spaced from the final location in an upward blood flow direction; and releasing the replacement valve at the release location, where: the replacement valve slides into the final location at least one heartbeat subsequent to the replacement valve that is released at the release location.
[000192] According to some embodiments, a method of implanting a replacement valve according to the present invention in a mammalian heart is provided which comprises: releasing a replacement valve to a mammalian heart implantation site, where: the implantation site comprises a release location and a final location; and the release location is spaced from the final location by a predetermined distance in an upward blood flow direction; and releasing the replacement valve at the release location, where: the replacement valve slides to the final location, preferably in at least one heartbeat, subsequent to the replacement valve that is released at the release location.
[000193] In some embodiments, the predetermined distance comprises a range between about 3 mm and about 20 mm; between about 7 mm and about 11 mm; between about 8 mm and about 12 mm; between about 9 mm and about 13 mm.
[000194] According to some embodiments, a method of implanting a replacement valve according to the present invention in a mammalian heart is provided which comprises: releasing a replacement valve to a mammalian heart implantation site, where: the stent is released with the stent axis being substantially aligned with the catheter axis, but not being aligned with the main axis of the ascending aorta; and the main direction of the catheter axis is different from the main direction of the axis of the ascending aorta; and releasing the replacement valve, wherein: the replacement valve moves to the final orientation, thereby, at least partially tilting, such that the stent axis substantially aligns with or at least is closer to the main axis the ascending aorta or the root of the ascending aorta, subsequent to the replacement valve that is released. The stabilization arches support alignment.
[000195] Preferably, the stent is released at a release location. Subsequent to the replacement valve that is released at the release location, the stent slides to its final location and / or tilts for its final orientation.
[000196] In some embodiments, one or more 565 fixing elements may serve to retain the stent valve in the delivery system until the full release of the stent during release / implantation, thus allowing, in some embodiments, the recapture of the stent partial release. The 565 fasteners can also prevent the stent from "popping out" of the delivery system well before it is fully released - such an outward jump can result in improper implant placement.
[000197] Figure 17 shows a 580 stent retainer to be arranged in a delivery system not shown in the figure. Stent retainer 580 comprises axial grooves 581 for receiving axial stent fasteners not explicitly shown in this figure, for example, elongated cells. Within each groove 581 there is a pin 582, which protrudes from the base of the groove 581. Each pin can be generally extending radially, or it can be projected at an inclined angle (inclined with respect to the radius and / or axis).
[000198] The pins can be tilted in the direction of a radial direction perpendicular to the axial direction by an angle between 0 and 30 degrees, preferably between 0 and 20 degrees or between 0 and 15 degrees, more preferably, between 0 and 10 degrees, where the value of 0 degrees corresponds to an extending radial pin. Preferably, the pins are angled away from the side of the aorta towards the ventricular side. Tilting the pins provides an additional degree of precaution against protections against unintentionally bouncing the stent with respect to the stent retainer during disassembly or during recapture.
[000199] Instead of pins that are inclined or protrude radially, pins that protrude axially can be used instead.
[000200] The pins 582 can be embraced by the fastening elements that comprise entries.
[000201] Slots 581 comprise ramp surfaces 583 to facilitate the release of the stent component after removing the sheath from the stent. The ramp surfaces 583 are formed by facets on either side of the groove 581, to facilitate the lifting of the fasteners and to prevent eventual blocking of the fasteners by the walls 584 of the groove 581 when the stent expands. Ramp surfaces 583 can generate a self-raising effect when contacted by an expanding part of the stent. Additionally or alternatively, the ramp surfaces 583 can assist in separation by means of small manual manipulation of the stent retainer, for example, rotation and / or axial movement. Medical uses
[000202] According to some modalities, cardiac stent valves are provided as replacement heart valves. There are four valves in the heart that serve to direct the flow of blood through the two sides of the heart in a forward direction. On the left (systemic) side of the heart are: 1) the mitral valve, located between the left atrium and the left ventricle, and 2) the aortic valve, located between the left ventricle and the aorta. These two valves direct the oxygenated blood that comes from the lungs through the left side of the heart to the aorta for the distribution of blood. On the right (pulmonary) side of the heart are: 1) the tricuspid valve, located between the right atrium and the right ventricle, and 2) the pulmonary valve, located between the right ventricle and the pulmonary artery. These two valves direct deoxygenated blood that comes from the body through the right side of the heart to the pulmonary artery for delivery to the lungs, where it again becomes reoxygenated to start a circuit once again.
[000203] Problems that can develop with heart valves consist of stenosis, in which a valve does not open properly, and / or insufficiency, also called regurgitation, in which a valve does not close properly. In addition to stenosis and insufficiency of the heart valves, the heart valves may need repair or surgical replacement due to certain types of bacterial or fungal infections, in which the valve can continue to function normally, but nevertheless nourishes an overgrowth of bacteria in the valve leaflets that can embolize and lodge downstream in a vital artery. In such cases, surgical replacement of any of the mitral or aortic valves (valves on the left side of the heart) may be necessary. likewise, bacterial or fungal growth in the tricuspid valve can embolize the lungs resulting in an abscess of the lung. In such cases, the tricuspid valve is replaced even though no stenosis or insufficiency of the tricuspid valve is present.
[000204] According to some modalities, a method is provided to replace a worn or sick valve that transapically comprises implanting a replacement valve, wherein the replacement valve is a stent valve of the present disclosure. In this way, the replacement valve comprises a valve component and a stent component, in which the valve component is connected to the stent component. On implantation, the replacement valve is positioned so that the annular groove receives the annular tube from the worn or sick heart valve.
[000205] In such cases, the stent valves of the present disclosure can be designed to be self-positioned under diastolic pressure (i.e., permissible in vivo migration). The placement of the stent valve can be upstream of the annular tube, where the stent valve will be locked in position once the annular groove of the stent component receives the annular tube. thus, according to some embodiments, methods are provided for implanting a replacement valve in a mammalian heart that comprises releasing a replacement valve for a mammalian heart implantation site. The implantation site can comprise a release location and a final location; and the release location is spaced from the final location (and according to some modalities, the spacing comprises a predetermined distance) in an upward blood flow direction. Releasing the replacement valve at the release location, the replacement valve is able to slide to the final location, usually in at least one heartbeat subsequent to the replacement valve that is released at the release location.
[000206] According to some modalities, the methods establish that when the replacement valve slides to the final location, the replacement valve is substantially positioned to the final location.
[000207] In some embodiments of the present disclosure, a method is provided to replace an aortic valve in a human body. A stent valve can be covered with a sheath to keep the stent valve in a collapsed configuration. The stent valve can then be inserted in the collapsed configuration in the human body without making contact with the ascending aorta or aortic arch. The stent valve can be partially expanded by sliding the sheath towards the left ventricle of the heart. This sliding of the sheath towards the left ventricle can cause the distal end of the stent valve to expand while the proximal end of the stent valve remains restricted by the sheath. The sheath can additionally be slid towards the left ventricle of the heart in order to cause the full expansion of the stent valve. In some embodiments, the stent valve can be recaptured before it fully expands by sliding the sheath in the opposite direction.
[000208] In some embodiments, a method for heart valve replacement is provided that includes releasing a distal end of a sheath stent valve, where the distal end includes a radiopaque marker positioned on it. The stent valve is rotated, if necessary, to orient the stent valve appropriately with respect to the coronary arteries (for example, to prevent the commissures from turning to the coronary arteries). The stabilization arches 1 of the stent valve are released from the sheath in order to make the stabilization arches 1 make contact with the aorta. An upper anchor crown 3 of the stent valve is released from the sheath in order to make the upper anchor crown 3 make contact with the native leaflets of the valve. A lower anchor crown 4 of the stent valve is released from the sheath in order to make the lower anchor crown 4 make contact with an annular tube / inlet flow. The lower anchor crown 4 can be the proximal section of the stent valve such that releasing the lower anchor crown 4 causes the stent valve to be completely released from the sheath.
[000209] According to some modalities, a replacement valve for use on a human body is provided, where the replacement valve includes a valve component and a stent component. The stent component can also be used without a valve attached as a stent. The stent devices of the present disclosure can be used to mechanically enlarge a narrowed or totally blocked blood vessel; typically as a result of atherosclerosis. In this way, the stent devices of the present disclosure can be used in angioplasty procedures. These include: percutaneous coronary intervention (PCI), commonly known as coronary angioplasty, to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease; peripheral angioplasty, performed to mechanically enlarge the opening of blood vessels beyond the coronary arteries.
[000210] Thus, it is seen that stent valves (e.g., single stent valves and double stent valves) and associated methods and systems for surgery are provided. Although the modalities in particular have been revealed in detail in the present, this was done by way of example for purposes of illustration only, and is not intended to be limiting with respect to the scope of the appended claims, which follow. In particular, the depositor contemplates that various substitutions, alterations and modifications can be made without departing from the spirit and scope of the invention, as defined by the claims. Other aspects, advantages and modifications are considered to be within the scope of the following claims. The claims presented are representative of the inventions disclosed herein. Other unclaimed inventions are also contemplated. The depositor preserves the right to pursue such inventions in claims later.
[000211] In some embodiments, a replacement valve for use on a human body is provided that comprises a valve component, and a stent component configured to accommodate at least a part of the valve component comprising a proximal end and an end distal, the stent component additionally comprising a lower anchoring crown which defines a body at least partially tapered, wherein the lower anchoring crown defines the proximal end of the stent component, an upper anchoring crown in communication with the crown lower anchor and defining a body at least partially tapered, in which the tapered body of the lower anchor crown tilts out towards the proximal end, and in which the tapered body of the upper anchor crown tilts out in the direction of the distal end, with the distal section of the stent defining a body at least partially conical, in which the distal section of the st ent comprises a tapered commissural pole section and the stabilizing arch section, in which the commissural pole section is in communication with the upper anchoring crown, and in which the stabilizing arch section is in communication with the pole section commissural and defines a body at least partially conical, and in which the stabilizing arc section defines the distal end.
[000212] Preferably, a replacement valve is provided in which the at least one partially cylindrical body of the commissural post section comprises valve fixing elements.
[000213] Preferably, a replacement valve is provided in which the tapered body of the lower anchor crown tilts outward from an inner diameter D2 to an outer diameter D3 towards the proximal end, where the inner diameter D2 is between about 20 mm and about 30 mm, and where the outer diameter D3 is between about 22 mm and about 40 mm.
[000214] Preferably, a replacement valve is provided, in which the axial distance between the planes of diameters D2 and D3 in the expanded configuration is between about 3 and about 15 mm.
[000215] Preferably, a replacement valve is provided, in which the outward slope of the lower anchoring crown is defined by an angle α2, and in which α2 is about 5 degrees to about 50 degrees.
[000216] Preferably, a replacement valve is provided, in which the conical body of the upper anchor crown tilts outward from an inner diameter D2 to an outer diameter D1 towards the distal end, where the inner diameter D2 is between about 20 mm and about 30 mm, and where the outside diameter D1 is between about 22 mm and about 40 mm.
[000217] Preferably, a replacement valve is provided, wherein the axial distance between the planes of diameters D2 and D1 in the expanded configuration is between about 3 and about 10 mm.
[000218] Preferably, a replacement valve is provided, in which the outward slope of the lower anchoring crown is defined by an angle α1, and in which α1 is about 10 degrees to about 80 degrees.
[000219] Preferably, a replacement valve is provided, in which the end of the upper anchoring crown forms a point, and in which the point is flexed internally towards the longitudinal axis at an angle α3, and where α3 is about from 0 degrees to about 180 degrees.
[000220] Preferably, a replacement valve is provided, wherein the length of the upper anchoring crown and the commissural post section of the combined H3 stent component is between about 3 to about 50 mm.
[000221] Preferably, a replacement valve is provided, wherein the length of the stabilizing arches and the H4 stent component is between about 5 to about 50 mm.
[000222] Preferably, a replacement valve is provided, in which the lower anchoring crown is configured to create a shaped fit with an inlet flow from an aortic valve and then prevent the migration of the stent component and the component valve towards the ascending aorta.
[000223] Preferably, a replacement valve is provided, in which the upper anchoring crown is configured to create a shaped fit with an outflow tract and native leaflets from an aortic valve and then prevent component migration of the stent and the valve component towards the left ventricle.
[000224] Preferably, a replacement valve is provided, wherein the section of the commissural post comprises a plurality of commissural posts configured for attachment to the commissures of the valve component.
[000225] Preferably, a replacement valve is provided, in which the stabilizing arches are configured to engage the ascending aorta to guide the stent component, the valve component, and a longitudinally associated release system in an annular aorta / column aortic valve, thus preventing the stent component and valve component from tilting when implanted.
[000226] Preferably, a replacement valve is provided, in which the stent component is formed from a single tube or sheet of metal.
[000227] Preferably, a replacement valve is provided, wherein the lower anchoring crown comprises at least one fixing element for removable attachment to a release device.
[000228] Preferably, a replacement valve is provided, wherein the stent component comprises a plurality of commissural posts for attachment to a corresponding plurality of valve commissures.
[000229] Preferably, a replacement valve is provided, in which the tapered body of the lower anchor crown tilts outward from an inner diameter D2 to an outer diameter D3 towards the proximal end, where the inner diameter D2 is between about 20 mm and about 25 mm, and where the outside diameter D3 is between about 26 mm and about 32 mm; wherein the axial distance between the planes of diameters D2 and D3 in the expanded configuration (H2) is between about 7 and about 11 mm; wherein the outward slope of the lower anchor crown is defined by an angle α2, and where α2 is about 15 degrees to about 25 degrees; wherein the conical body of the upper anchor crown tilts outward from an inner diameter D2 to an outer diameter D1 towards the distal end, where the inner diameter D2 is between about 20 mm and about 25 mm, and whereas the outer diameter D1 is between about 26 mm and about 31 mm; wherein the axial distance between the planes of diameters D2 and D1 in the expanded configuration (H1) is between about 4 and about 8 mm; wherein the outward slope of the lower anchor crown is defined by an angle α1, and where α1 is about 45 degrees to about 65 degrees; wherein the end of the upper anchor crown forms a point, and the point is flexed internally towards the longitudinal axis at an angle α3, and where α3 is about 45 degrees to about 65 degrees; wherein the length of the upper anchor crown and the stent component (H3) commissural posts is between about 11 and about 15 mm; wherein the length of the stent component stabilization arcs (H4) is between about 14 and about 22 mm; and where the stent component stabilization arcs expand externally at an angle α4 of a longitudinal axis towards the second distal end of the replacement valve, where α4 is between about 5 degrees and about 15 degrees.
[000230] Preferably, a replacement valve is provided, in which the tapered body of the lower anchor crown tilts outward from an inner diameter D2 to an outer diameter D3 towards the proximal end, where the inner diameter D2 is between about 21 mm and about 26 mm, and where the outside diameter D3 is between about 27 mm and about 33 mm; wherein the axial distance between the planes of diameters D2 and D3 in the expanded configuration (H2) is between about 8 and about 12 mm; wherein the outward slope of the lower anchor crown is defined by an angle α2, and where α2 is about 15 degrees to about 25 degrees; wherein the conical body of the upper anchor crown tilts outward from an inner diameter D2 to an outer diameter D1 towards the distal end, where the inner diameter D2 is between about 21 mm and about 26 mm, and whereas the outer diameter D1 is between about 27 mm and about 32 mm; wherein the axial distance between the planes of diameters D2 and D1 in the expanded configuration (H1) is between about 4 and about 8 mm; wherein the outward slope of the lower anchor crown is defined by an angle α1, and where α1 is about 45 degrees to about 65 degrees; wherein the end of the upper anchor crown forms a point, and the point is flexed inwardly towards the longitudinal axis at an angle α3, and where α3 is about 45 degrees to about 65 degrees; wherein the length of the upper anchor crown and the section of the stent component (H3) commissural posts is between about 13 and about 17 mm; wherein the length of the stabilizing arches and the stent component (H4) is between about 15 and about 23 mm; and where the stent component stabilization arcs expand externally at an angle α4 of a longitudinal axis towards the second distal end of the replacement valve, where α4 is between about 5 degrees and about 15 degrees.
[000231] Preferably, a replacement valve is provided, in which the tapered body of the lower anchor crown leans out from an inner diameter D2 to an outer diameter D3 towards the proximal end, where the inner diameter D2 is between about 22 mm and about 27 mm, and where the outside diameter D3 is between about 28 mm and about 34 mm; wherein the axial distance between the planes of diameters D2 and D3 in the expanded configuration (H2) is between about 9 and about 13 mm; wherein the outward slope of the lower anchor crown is defined by an angle α2, and where α2 is about 15 degrees to about 25 degrees; wherein the conical body of the upper anchor crown tilts outward from an inner diameter D2 to an outer diameter D1 towards the distal end, where the inner diameter D2 is between about 22 mm and about 27 mm, and in whereas the outer diameter D1 is between about 28 mm and about 33 mm; wherein the axial distance between the planes of diameters D2 and D1 in the expanded configuration (H1) is between about 4 and about 8 mm; wherein the outward slope of the lower anchor crown is defined by an angle α1, and where α1 is about 45 degrees to about 65 degrees; where the end of the upper anchor crown forms a point, and where the point is flexed internally towards the longitudinal axis at an angle α3, and where α3 is about 45 degrees to about 65 degrees; wherein the length of the upper anchor crown and the commissural pole section of the stent component (H3) combined is between about 15 and about 19 mm; wherein the length of the stabilizing arches and the stent component (H4) is between about 16 and about 24 mm; and wherein the stent component stabilization arcs expand externally at an angle α4 from a longitudinal axis towards the second distal end of the replacement valve, where α4 is between about 5 degrees and about 15 degrees.
[000232] In some embodiments, a system for replacing a valve in a human body is provided that comprises a release device and a replacement valve for use in a human body that comprises a valve component, and a stent component configured for housing at least a part of the valve component comprising a proximal end and a distal end, the stent component additionally comprising a lower anchoring crown defining a body at least partially tapered, wherein the lower anchoring crown defines the proximal end of the stent component, an upper anchoring crown communicating with the lower anchoring crown and defining a body at least partially tapered, in which the tapered body of the lower anchoring crown leans outwardly towards the proximal end, and where the tapered body of the upper anchor crown leans outwardly towards the distal end, being that a distal section of the stent defines a body at least partially conical, in which the distal section of the stent comprises a conical post section and stabilization arch section, in which the section of the commissural post is in communication with the crown of upper anchorage; and where the stabilization arch section is in communication with the commissural pole section and defines a body at least partially tapered, and where the stabilization arch section defines the distal end, the stent component having an axis central longitudinal and comprises at least one fixture for removable fixation to a release device, wherein the at least one fixture is located at a proximal end of the stent component, where the proximal end is defined as the end towards the left ventricle when released from a transapical approach.
[000233] Preferably, a system is provided, wherein the at least one fastening element is generally formed in the shape of a hook.
[000234] Preferably, a system for replacing a valve in a human body comprising a release device and a replacement valve is provided, wherein the release device comprises: an inner member comprising a guide wire lumen and a retainer stent; and an outer member comprising a sheath; where the stent retainer comprises a groove for receiving the stent component fastener, and where the inner and outer members are coaxially positioned and slidable with respect to each other in order to transition from a closed position to an open position, such that in the closed position the sheath surrounds at least part of the stent valve still attached to the stent retainer which restricts the expansion of the stent valve, and such that in the open position the outer sheath does not restrict the expansion of the stent stent valve and stent valve separates from the stent retainer and expands to an expanded configuration.
[000235] Preferably, a system for replacing a valve in a human body comprising a release device and a replacement valve is provided, wherein the release of the stent valve from the stent retainer is facilitated by the slight rotation of the stent retainer with respect to the fixing element.
[000236] In some embodiments, a method for replacing an aortic valve in a human body is provided, the method comprising: covering the replacement valve as described above with a sheath in order to keep the replacement valve in a collapsed configuration , transapically inserting the replacement valve still in the configuration collapsed in the human body, partially expanding the replacement valve by sliding the sheath towards the left ventricle of the heart, in which the said sheath inclination towards the left ventricle causes the expansion of a distal end of the replacement valve while the proximal end of the replacement valve remains constrained by the sheath, and additionally slide the sheath towards the left ventricle of the heart in order to substantially release the entire replacement valve such that the valve is allowed to replacement option expands to an expanded configuration.
[000237] In some embodiments, a method is provided which further comprises sliding the sheath in the opposite direction before said full expansion in order to recapture the replacement valve in the sheath.
[000238] In some embodiments, a method is provided, the method comprising releasing a distal end of the replacement valve, as described above, from a sheath, where the distal end comprises a radiopaque marker, rotating the replacement valve, if necessary, to orient the replacement valve appropriately with respect to the coronary arteries, release the arches from the sheath replacement valve in order to make the arches make contact with the aorta, release a first tapered crown from the replacement valve on the sheath, in order to make the first tapered crown to make contact with the native leaflets of the valve, and to release a second crown from the sheath replacement valve, in order to make the second crown make contact with a pipe tract annular / inlet flow, wherein the second crown comprises the proximal section of the replacement valve and said release of the second crown comprises completely releasing the s valve replacement of the sheath.
[000239] In some embodiments, a method for replacing a heart valve is provided, the method comprising releasing a distal end of the replacement valve, as described above, from a sheath, wherein the distal end comprises a radiopaque marker and a plurality of arcs, rotate the replacement valve, if necessary, to orient the replacement valve appropriately with respect to the coronary arteries, release the arcs from the sheath replacement valve to make the arcs make contact with an area above a native valve, release a first part of the tapered crown from the sheath replacement valve to make the first tapered crown make contact with the native leaflets of the valve, and release a second part of the replacement valve crown of the sheath, in order to make the second crown make contact with an annular tube tract / native valve inlet flow, in which the second crown is the section pr oximal of the replacement valve and said release of the second crown comprises completely releasing the replacement valve from the sheath.
[000240] In some embodiments, a method for replacing a heart valve is provided, the method comprising transapically implanting the replacement valve as described above, wherein the replacement valve comprises a valve component and a component of the stent to which the valve component is attached, the stent component comprising a longitudinal axis, a lower anchoring crown includes a substantially tapered shape that has a narrow end, a wide end and a first predetermined height, and one upper anchor crown includes a substantially tapered shape provided with a narrow end, a wide end and a second predetermined height, wherein a center of each of the lower anchor crown and the upper anchor crown is arranged to substantially align with the axis longitudinal, the narrow ends of the lower anchor crown and the anchor crown are uperior are arranged to meet forming an annular groove to receive the annular tube of the worn or sick heart valve at a site of implantation of the heart, the first height of the lower anchoring crown is greater than the second height of the upper anchoring crown , and position the replacement valve so that the annular groove receives the annular tube from the worn or sick heart valve.

权利要求:
Claims (14)
[0001]
1. Replacement valve (100) for use on a human body comprising: a valve component (102); and a stent component (101) configured to house at least a part of the valve component (102) comprising a proximal end (P) and a distal end (D), the stent component (101) further comprises: a section distal stent that defines the distal end (D) and that comprises a stabilizing arch section and a commissural pole section that communicates with the stabilizing arch section, the commissural pole section defining the supports for the valve component (102); a proximal anchoring section that defines the proximal end (P); and a first crown section that communicates with the distal stent section and with the proximal anchoring section, the first crown section comprising a divergent first part that diverges out in a direction towards the distal end (D), the first crown section having a free end, characterized by the fact that the stabilization arch section comprises a plurality of stabilization arches (1, 11) to support against the ascending aorta for the alignment of the stent component (101) with respect to to the ascending aorta, each stabilization arch (1, 11) comprising: a divergent part that diverges away from the stent axis, in a direction towards the distal end (D); and an apex of the arch (23 ') inclined at an angle (α5) measured from the divergent part in a direction towards the stent axis.
[0002]
2. Replacement valve (100) according to claim 1, characterized by the fact that the first divergent part comprises a narrow end that communicates with the proximal anchoring section.
[0003]
3. Replacement valve (100) according to claim 1, characterized by the fact that the free end of the first crown section is close to the distal end (D).
[0004]
4. Replacement valve (100) according to claim 1, characterized by the fact that (i) the divergence angle of the first divergent part with respect to a valve axis (100) is less than 60 degrees, and / or (ii) the axial length between the free end of the first crown section and the narrow end of the first divergent part is less than 10 mm.
[0005]
5. Replacement valve (100) according to claim 1, characterized by the fact that the stent still comprises a tubular part (16) that extends proximally to the narrow end of the first divergent part, the tubular part (16 ) having a divergence in an inclusive range of 0 degrees (no divergence) to 10 degrees with respect to the valve axis (100).
[0006]
6. Replacement valve (100) according to claim 5, characterized in that the tubular part (16) is generally cylindrical with a deviation of 0 degrees.
[0007]
Replacement valve (100) according to claim 5, characterized in that the axial length of said tubular part (16) is at least 1 mm.
[0008]
Replacement valve (100) according to claim 1, characterized in that the proximal anchor part comprises a second crown section comprising a divergent second part that diverges out in a direction towards the proximal end (P), the second crown part has a free end.
[0009]
Replacement valve (100) according to claim 8, characterized in that the free end of the second crown section defines the proximal end (P).
[0010]
10. Replacement valve (100), according to claim 8, characterized by the fact that the second divergent part has an angle of divergence with respect to the axis in a range of 10 to 20 degrees.
[0011]
11. Replacement valve (100) according to claim 8, characterized by the fact that it still comprises at least one fixing element for securing the valve (100) to a stent retainer (560) of a delivery system ( 500).
[0012]
Replacement valve (100) according to claim 1, characterized by the fact that a lower anchoring crown (4) comprising an at least partially tapered body, in which the lower anchoring crown (4) defines the proximal end (P) of the stent component (101); an upper anchor crown (3) in communication with the lower anchor crown (4) and comprising an at least partially tapered body, wherein the tapered body of the lower anchor crown (4) tilts out towards the end proximal (P), and in which the conical body of the upper anchoring crown (3) tilts out towards the distal end (D); a distal section of the stent that comprises a body at least partially conical, in which the distal section of the stent is in communication with the upper anchoring crown (3).
[0013]
Replacement valve (100) according to claim 12, characterized in that the valve (100) comprises a fixture for removable fixation to a release device (500), preferably arranged in the lower anchoring crown ( 4), wherein the valve (100) preferably has an interconnected open cell truss structure (20), the truss structure including peripheral cells that define one end of the stent component (101), a first plurality of peripheral cells ( 22) being axially extended compared to a second plurality of peripheral cells, to define a plurality of fastening elements that project with respect to the second plurality of peripheral cells, each fastening element including an open part (23) defined by the extension of the respective peripheral cell (22).
[0014]
Replacement valve (100) according to claim 13, characterized in that the at least one fixing element is generally formed in the form of an opening (23) which is capable of widening when the stent component ( 101) expands.

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法律状态:
2020-09-29| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-10-06| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2021-01-05| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-03-09| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 09/03/2021, OBSERVADAS AS CONDICOES LEGAIS. |

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2021-06-22| B16C| Correction of notification of the grant|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 10/09/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO |

优先权:

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申请号 | 申请日 | 专利标题

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US25723009P| true| 2009-11-02|2009-11-02|

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US61/257,230|2009-11-02|

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US35387510P| true| 2010-06-11|2010-06-11|

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US61/353,875|2010-06-11|

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PCT/EP2010/063306|WO2011051043A1|2009-11-02|2010-09-10|Aortic bioprosthesis and systems for delivery thereof|

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