ATTACHMENT DEVICE FOR ATTACHING A PROSTHETIC VALVE AND SYSTEM FOR IMPLANTING A PROSTHETIC VALVE

专利摘要:
Anchoring or mooring devices configured to be positioned on a valve that is native to a human heart and to provide structural support to dock a prosthetic valve on them. The mooring devices can have spiral structures that define an internal space in which the prosthetic valve can be maintained. The mooring devices may have enlarged end regions with circular or non-circular shapes, for example, to facilitate the implantation of the mooring device or to improve the retention of the mooring device in position once developed. Docking devices can be laser cut tubes with locking wires to assist in better maintaining a mooring shape. The mooring devices may include various accessories to promote friction, such as layers of friction cover. Such mooring devices may have ends configured to securely secure the cover layers to the mooring device cores.
公开号:BR112019003222B1
申请号:R112019003222-3
申请日:2017-08-25
公开日:2021-01-12
发明作者:Darshin S. Patel；Boaz Manash；Khen Perlmutter；Eyal Leiba；Yoav Rozen；Dinesh L.Sirimanne；Noa Axelrod；Zohar Kiblitski
申请人:Edwards Lifesciences Corporation；
IPC主号:

专利说明:

Field of the Invention
[0001] The present invention generally relates to medical devices and procedures pertaining to prosthetic heart valves. More specifically, the invention relates to the replacement of heart valves that can present malformation and / or dysfunction. The modalities of the invention refer to an anchor or mooring device that can maintain the positioning of a prosthetic heart valve to replace the function of a native heart valve, for example, for a mitral or tricuspid valve replacement procedure, in addition to procedures of deployment associated with the implantation of such an anchor or mooring device and / or an assembly including the anchor or mooring device and a prosthetic heart valve. Related Orders
[0002] This application claims priority for US provisional patent application No. 62 / 395,940, filed on September 16, 2016. This application also claims priority for US provisional patent application No. 62/380117, filed on September 26, 2016. August 2016. These two applications, in addition to US patent application No. 14 / 372,953, entitled "Mitral Valve Docking Devices, Systems and Methods," filed on July 17, 2014, are all incorporated herein by reference in their entirety. Background
[0003] Referring primarily to figures 1 and 2, the mitral valve 50 controls the flow of blood between the left atrium 52 and left ventricle 54 of the human heart. After the left atrium 52 receives oxygenated blood from the lungs through the pulmonary veins, the mitral valve 50 allows oxygenated blood to flow from the left atrium 52 into the left ventricle 54. When the left ventricle 54 contracts, the oxygenated blood that has been maintained in the left ventricle 54 it is distributed through the aortic valve 56 and the aorta 58 to the rest of the body. Meanwhile, the mitral valve closes during ventricular contraction to prevent any blood from flowing back into the left atrium.
[0004] When the left ventricle contracts, blood pressure in the left ventricle increases substantially, which serves to force the mitral valve to close. Due to the large differential pressure between the left ventricle and the left atrium during this time, a large amount of pressure is applied to the mitral valve, resulting in a possibility of prolapse, or eversion of the mitral valve cusps back into the atrium. A series of tendon cords 62, therefore, connects the mitral valve cusps to the papillary muscles located in the walls of the left ventricle, where both the tendon cord and the papillary muscles are tensioned during ventricular contraction to keep the cusps in the closed position and to avoid that they extend back towards the left atrium. This helps to prevent the flow of oxygenated blood back into the left atrium. Tendinous cords 62 are schematically illustrated both in the cardiac cross section of figure 1 and in the top view of the mitral valve in figure 2.
[0005] A general shape of the mitral valve and its cusps as seen from the left atrium, is illustrated in figure 2. Commissures 64 are located at the ends of the mitral valve 50 where the anterior cusps 66 and the posterior cusp 68 join. Various complications of the mitral valve can potentially cause fatal heart failure. One form of valvular heart disease is mitral valve leak or mitral regurgitation, characterized by the fact that abnormal blood leakage occurs from the left ventricle, through the mitral valve, back into the left atrium. This can be caused, for example, by dilation of the left ventricle, causing the native mitral cusps to not fully co-exist, resulting in a leak, damage to the native cusps or weakening (or damage to) tendinous cords and / or papillary muscles . In these circumstances, it may be desirable to repair the mitral valve or replace the functionality of the mitral valve with a prosthetic heart valve.
[0006] With regard to valve replacement, while open surgical procedure options are more readily available, there has been much less development in terms of commercially available ways to replace a mitral valve through catheter implantation and / or other procedures minimally or less invasive. Replacing a mitral valve is more difficult than replacing the aortic valve in many ways, for example, due to the non-circular physical structure of the mitral valve, its subanular anatomy, and more difficult access to the valve.
[0007] It may be beneficial if you use prosthetic aortic valves or similar circular or cylindrical valve prostheses for mitral valve replacements. However, one of the most prominent obstacles to mitral valve replacement is the efficient anchoring or retention of the valve in the mitral position, due to the fact that the valve is subjected to a large cyclic load. As noted above, another problem with mitral valve replacement is the size and shape of the native mitral ring, as can be seen in figure 2. Aortic valves are more circular or cylindrical in shape than mitral valves. In addition, the mitral and tricuspid valves are both larger than the aortic valve and more elongated in shape, making them more difficult and unconventional sites for implanting a replacement valve with a generally circular or cylindrical valve structure. A circular prosthetic valve that is so small can result in leakage around the implant (ie, paravalvular leakage) if a good seal is not established around the valve, while a circular prosthetic valve that is too large can stretch and damage parts narrows of the native mitral ring. Additionally, in many cases, the need to perform aortic valve replacement arises due, for example, to aortic valve stenosis, where the aortic valve narrows, due to calcification or other hardening of native cusps. Therefore, the aortic ring generally forms a more compact, rigid and stable anchorage site for a prosthetic valve than the mitral ring, which is larger than the aortic and non-circular ring. Cases of mitral valve regurgitation hardly provide such a good anchorage location. In addition, the presence of tendon cords and other anatomy in the mitral position can form obstructions that make anchoring a device in the mitral position much more challenging.
[0008] Other obstacles to the efficient replacement of the mitral valve can arise from large cyclical loads that the mitral valve undergoes and the need to establish a sufficiently strong and stable anchorage and retention. In addition, even a slight change in valve alignment can still result in blood flow through the valve or other parts of the heart that are obstructed or otherwise negatively impacted. summary
[0009] One way to apply the existing circular or cylindrical transcatheter valve technology to replace the non-circular valve (for example, mitral valve replacement, tricuspid valve replacement, etc.) would be to use an anchor (for example, an mitral anchor) or docking station that forms or otherwise provides a more circular docking location in the native valve position (for example, mitral valve position) to hold such prosthetic valves. In this way, the existing expandable transcatheter valves developed for the aortic position, or similar valves that have been slightly modified to more efficiently replicate the function of the mitral valve, can be implanted with greater safety in such mooring positions positioned in the native valve ring. (e.g., native mitral ring). The docking station can first be positioned on the native valve ring, and after that, the valve implant or the transcatheter heart valve can be advanced and positioned through the docking station, while in a disassembled position, and can then be expanded, for example, through automatic expansion (for example, in the case of valves that are constructed with NiTi or other shaped memory material), balloon expansion, or mechanical expansion, so that the prosthetic valve structure pushes radially against the docking station and / or fabric between the two to keep the valve in place. Preferably, the docking station can also be distributed minimally or less invasively, for example, through the same or similar transcatheter approaches as used to deliver a transcatheter heart valve, so that a completely separate procedure is not necessary for implantation the docking station before dispensing the prosthetic valve.
[0010] It would therefore be desirable to provide devices and methods that can be used to facilitate the mooring or anchoring of such valves. The embodiments of the invention provide a stable docking station or docking device for retaining a prosthetic valve (for example, a prosthetic mitral valve). Other features are provided to improve the development, positioning, stability and / or integration of such docking stations and / or replacement prostheses that must be maintained. These devices and methods will more safely maintain prosthetic valves, and can also greatly prevent or reduce regurgitation or blood leakage around prosthetic valves. Such mooring devices and methods can be used for various valve replacement procedures, for example, for mitral, tricuspid, pulmonary or aortic valve replacements, to provide safer and more robust anchorage and retention of native ring valve implants in these positions.
[0011] Docking devices for mooring a prosthetic valve to a native valve (eg, mitral valve, tricuspid valve, etc.) of a heart may include various accessories, components and features. For example, such mooring devices may include a spiral anchor that has at least one center turn (for example, a full turn or a partial turn center turn) defining a center turn diameter. At least one central loop can be one or more functional loops / spirals. The spiral anchor may also include a lower loop extending from at least one central loop defining a diameter that is greater than the central loop diameter. The bottom loop can be a front loop / spiral. The spiral anchor can also include an upper loop connected to the central loop. The upper arm can be one or more stabilizing turns / spirals. The upper loop can be shaped to have a first diameter along a first geometry axis and a second diameter along a second geometry axis. The diameter of the first geometry of the upper revolution may be greater than the diameter of the central revolution, and the second diameter of the geometric axis may be greater than the diameter of the central revolution and less than the diameter of the lower revolution. The various spiral anchors described here can be configured to be implanted in the native valve (for example, native mitral valve, tricuspid valve, etc.) with at least part of the at least one central loop of the spiral anchor positioned in a chamber (for example , a left ventricle) of the heart and around the valve cusps of the native valve.
[0012] Any of the spiral anchors described here can also include an extension having a length extending from an upper end of the at least one central loop to an upper loop / spiral or stabilizing loop / spiral. The extension may have a smaller or reduced thickness compared to other parts of the spiral anchor, for example, at least one central turn, upper turn, lower turn, etc. The extension can extend vertically at an angle between 60 and 120 degrees, 70 to 110 degrees, 80 to 100 degrees, 90 degrees with respect to at least one central loop
[0013] The various mooring devices for mooring a prosthetic valve to a native heart valve may have a spiral anchor (for example, which may be the same as or similar to other spiral anchors described in this description) that have a proximal tip and a distal tip. The spiral anchor can include at least one central loop (for example, a total or partial central loop, which can be the same or similar to other central or functional loops described in that description). The at least one central loop can have a first thickness and define a central loop diameter. Any of the spiral anchors described here can also include an extension having a length extending from an upper end of the at least one central loop. The spiral anchor may also include an upper loop (for example, which may be equal to or similar to other upper loops or stabilizing loops / loops described in this description) extending from an upper end of the extension. The extension may have a second thickness that is less than the first thickness. The upper lap may have a third thickness that is greater than the second thickness. As discussed above, the spiral anchor can be configured to be implanted in the native valve (for example, native mitral valve, tricuspid valve, etc.) with at least part of the at least one full or partial central loop of the spiral anchor positioned on a chamber (eg, left ventricle) of the heart and around the valve cusps (eg, mitral valve cusps) of the native heart valve.
[0014] The various mooring devices, for mooring a prosthetic valve to a native heart valve, may also have a spiral anchor (for example, which may be the same as or similar to other spiral anchors described in this description) that have a proximal tip and a distal tip and at least one central loop (for example, a total or partial central loop, which can be equal to or similar to other central loops / loops or functional loops / loops described in this description) that defines a diameter. The spiral anchor can also have an upper loop that is connected to at least one central loop. A cover layer can surround the spiral anchor along all or at least part of the at least one central loop. The cover layer can be connected to the spiral anchor. At least one friction enhancement layer can be arranged on the spiral anchor and / or the cover layer. The at least one friction enhancement layer can be arranged over at least part of the at least one central loop. The spiral anchor can be configured so that no part of the upper loop is covered by the friction enhancement layer. The spiral anchor can also be configured to be implanted in a native valve (for example, a native mitral valve, etc.) with at least part of at least one central loop of the spiral anchor positioned in a chamber (for example, left ventricle ) of the heart and around the valve cusps of the native valve.
[0015] Any of the spiral anchors of any of the mooring devices described here, may include one or more layers of cover that surround all or at least part of the spiral anchor or a core of the spiral anchor. For example, a cover layer may surround all or at least part of at least one central loop (or all central loops / loops or functional loops / loops of the spiral anchor) and / or other parts of the spiral anchor. The cover layer can be connected to the spiral anchor in several ways. The cover layer can be a high friction cover layer, a low friction cover layer, or both, a low friction cover layer and a high friction cover layer, used together. The low friction cover layer can be configured to surround a core of the spiral anchor (for example, the total length of the spiral anchor) and extends beyond the proximal tip and / or the distal tip. The low friction covering layer may form a tapered or rounded tip at its distal end and / or at its proximal end. A high friction cover layer or higher friction cover layer (for example, higher than the low friction cover layer) can surround a part of the low friction cover layer and / or a part of the spiral anchor (for example, all or part of at least one central loop).
[0016] Any of the spiral anchors described here can include at least one friction improvement element or multiple friction improvement elements. The at least one friction enhancement element or friction enhancement elements can be positioned over all or part of the spiral anchor or a cover / layer on the spiral anchor. The at least one friction-enhancing element may include a plurality of protuberances on the surface of the spiral anchor or on the surface of the cover. The lumps can be made of PET, polymer, fabric or other material. The protrusions may extend along a length of the spiral anchor or cover along at least part of the central turns / spirals. Optionally, the at least one friction enhancement element may be or include a plurality of locking and key cutouts on an outer surface of the spiral anchor. The locking cutouts can be grooves formed on the outer surface of the spiral anchor, and the key cutouts can be protrusions extending outward from the spiral anchor, which can be sized and shaped to fit into locking cutouts.
[0017] Systems for implanting a mooring device into a native heart valve may include a mooring device (for example, any mooring device described above or elsewhere in that description). The mooring device may include an opening or hole, and the system may include a structure threaded through the opening or hole. The system may also include a delivery catheter, and a delivery device arranged on the delivery catheter. The impulse device may include a central lumen that accepts the suture or through which the suture passes. The impulse and suture device can be arranged so that the retraction of the suture pulls the spiral anchor against the impulse device, and retracts the impulse device into the delivery catheter and retracts the spiral anchor into the delivery catheter. The suture can be arranged in the central lumen so that the retraction of the suture and / or the impulse device proximally with respect to the delivery catheter retracts the spiral anchor or delivery device into the delivery catheter.
[0018] A mooring device for attaching a prosthetic valve to a valve native to a heart may have a spiral anchor that includes a hollow tube. The hollow tube can have a proximal locking accessory and a distal locking accessory. There may be a plurality of cutouts through a part of the tube. The cuts can have a pattern and shape that incorporate both longitudinal and transverse cuts, they can form teeth and grooves in the hollow tube. The mooring device can also have a wire, and the distal end of the wire can be attached to the distal locking accessory. A wire length (for example, the total length or a part of it) can extend through the hollow tube and apply a radially internal tension to the hollow tube. The hollow tube is configured to at least partially surround the cusps of a native mitral valve and provide a mooring surface for an expandable prosthetic valve.
[0019] Methods used to implant a mooring device for a prosthetic valve into a native heart valve can include a variety of steps (for example, any of the steps described throughout this description). The docking device deployed with these methods can be any of the docking devices described here. For example, an implantable mooring device with these steps may have a spiral anchor having at least one full or partial turn defining a central diameter, an extension having a length extending from an upper end of at least one central turn, and an upper loop extending from an upper end of the extension. Thus, the distal end of a delivery catheter can be positioned within a first chamber (for example, a left atrium) of a heart. Optionally, the delivery catheter can be advanced and positioned through a previously implanted guide sheath. The delivery catheter can contain the mooring device in a first configuration. A distal end of a mooring device can be advanced from the delivery catheter, so that the mooring device adopts a second configuration as it is advanced and / or when it is implanted. The mooring device is advanced through a valve ring (for example, a native mitral valve ring) and into a second chamber of the heart (for example, the left ventricle), so that a distal tip circles around looses any native chordae and cusps from the native valve (for example, from a mitral valve). The extension of the mooring device can be advanced, so that its upper end is positioned in the first chamber (for example, the left atrium). The upper part of the mooring device can be advanced into the first chamber (for example, the left atrium) and released, so that the upper part is in contact with the first chamber wall (for example, the left atrium wall ). A replacement prosthetic valve can be implanted in the mooring device. For example, a replacement valve can be inserted into an internal space defined by the mooring device in the second configuration. The replacement valve can be radially expanded until there is a holding force between the replacement valve and the mooring device to keep the replacement valve in a stable position. Native cusps or other tissue can be trapped between the delivery device and the prosthetic valve.
[0020] Valve replacement can be accomplished through the use of an anchor or spiral mooring device at the native valve location for mooring an expandable transcatheter heart valve. Spiral anchors or mooring devices provide a more stable base or location, where prosthetic valves can be expanded. The modalities of the invention, therefore, provide a more robust way of implanting a replacement heart valve, even in places such as a native mitral ring, where the ring itself may be non-circular or otherwise variable. Brief Description of Drawings
[0021] Additional features and advantages of the invention will become apparent from the description of the modalities using the attached drawings. In the drawings:
[0022] Figure 1 illustrates a schematic cross-sectional view of a human heart;
[0023] Figure 2 illustrates a schematic top view of a mitral valve ring of a heart;
[0024] Figure 3 illustrates a perspective view of a spiral anchor, according to a first embodiment of the invention;
[0025] Figure 4 shows a side view of the spiral anchor in figure 3;
[0026] Figure 5 shows a top view of the spiral anchor of figures 3 and 4;
[0027] Figure 6 illustrates a cross-sectional view of part of a heart, during a distribution step of the spiral anchor, of figures 3 to 5, for the native mitral ring;
[0028] Figure 7 illustrates a cross-sectional view of part of a heart, during an additional stage of distribution of the spiral anchor, of figures 3 to 5, to the native mitral ring;
[0029] Figure 8 illustrates a cross-sectional view of a part of a heart with the spiral anchor, of figures 3 to 5, positioned in the native mitral ring;
[0030] Figure 9 illustrates a cross-sectional view of part of a heart with the spiral anchor, figures 3 to 5, and a prosthetic mitral valve implanted in the native mitral ring;
[0031] Figure 10 illustrates a perspective view of a modified version of the spiral anchor of figures 3 to 5;
[0032] Figure 11 schematically illustrates an open view of a laser cutting tube to be used as a spiral anchor, according to an embodiment of the invention;
[0033] Figure 11A schematically illustrates an open view of a laser cutting tube to be used as a spiral anchor and a tensioning wire according to an embodiment of the invention;
[0034] Figure 12 illustrates a top view of the spiral cut laser anchor of figure 11 in an assembled state;
[0035] Figure 13 illustrates a perspective view of the laser cut spiral anchor of figure 11 in an assembled and driven state, and with the structure of a prosthetic valve kept there;
[0036] Figure 14 shows a top view of a modified spiral anchor with the end hooks;
[0037] Figure 15 illustrates a schematic view of another modified spiral anchor with a high friction covering layer;
[0038] Figure 16 illustrates a schematic view of another spiral anchor modified with the friction elements;
[0039] Figure 16A illustrates a cross-sectional view of the embodiment illustrated in figure 16;
[0040] Figure 17 illustrates a schematic view of a spiral anchor incorporating both a friction element and a high friction cover;
[0041] Figure 18 illustrates another modified spiral anchor with surface characteristics to facilitate interlocking or retaining position between adjacent spirals;
[0042] Figure 19 illustrates an illustrative spiral anchor which is a variation of the spiral anchor of figure 10;
[0043] Figure 19A illustrates a cross-sectional view of a spiral anchor modality;
[0044] Figure 20 schematically illustrates a top view of a modality of a spiral anchor implanted and arranged in a desired position in the native mitral ring;
[0045] Figure 21 illustrates the spiral anchor of figure 19 additionally including marker bands;
[0046] Figure 22 illustrates a cross section of a proximal end of the spiral anchor of figure 19;
[0047] Figure 22A illustrates a modality of a suture wrapped through a spiral anchor;
[0048] Figure 22B illustrates another modality of a suture wrapped through a spiral anchor;
[0049] Figure 22C illustrates a modality of a suture wrapped through a spiral anchor;
[0050] Figure 23 illustrates a distal end of a spiral skeleton or core of a mooring device, according to an embodiment of the invention;
[0051] Figure 24 illustrates a distal end of a spiral skeleton or core of a mooring device, according to another embodiment of the invention;
[0052] Figure 25 illustrates a proximal end of a spiral skeleton or core of a mooring device, according to an embodiment of the invention; and
[0053] Figure 26 illustrates a proximal end of the anchoring device of figure 25, with a covering layer fixed on the spiral skeleton or core. Detailed Description
[0054] Various spiral mooring or anchoring devices are described here, which can be used in conjunction with expandable transcatheter heart valves (THV) in a native valve ring (for example, mitral or tricuspid valve ring) in order to implant safer way and keep the prosthetic valve at the implant site. Anchoring / mooring devices, according to the modalities of the invention, provide or form a more circular and / or stable ring at the implantation site, where the prosthetic valves have cylindrical shaped valve structures or stents can be expanded or otherwise implanted. In addition to providing an anchorage for the prosthetic valve, the anchoring / mooring devices can be dimensioned and shaped to tighten or pull the anatomy of the native valve (for example, mitral, tricuspid, etc.), radially, inside. Thus, one of the main causes of valve regurgitation (for example, functional mitral regurgitation), specifically the enlargement of the heart (for example, left ventricle) and / or valve ring, and the consequent stretching of the native valve ring (for example, example, mitral), can be at least partially diverted or reacted. Some modalities of the anchoring or mooring devices additionally include accessories that, for example, are shaped and / or modified to better maintain a position or shape of the mooring device during and / or after the expansion of a prosthetic valve. By providing such anchoring or mooring devices, replacement valves can be more easily implanted and maintained in various valve rings, including the mitral ring that does not have a naturally circular cross section.
[0055] A spiral anchoring / mooring device, according to an illustrative embodiment of the invention, is illustrated in figures 3 to 5. Figure 3 illustrates a perspective view of the anchor or mooring device 1, figure 4 illustrates a side view of the anchoring / mooring device 1 and figure 5 illustrates a top view of the anchoring / mooring device 1.
[0056] The mooring device 1 includes a spiral with a plurality of turns extending along a central geometric axis of the mooring device 1. The spiral can be continuous and can generally extend helically, with several sized sections and formatted differently, as described in more detail below. The mooring device 1 illustrated in figures 3 to 5 is configured to better fit in the mitral position, but it can be shaped similarly or differently in other modalities for better accommodation in other native valve positions, too.
[0057] The mooring device 1 includes a central region 10 with approximately three fully spiral turns having substantially equal internal diameters. The centralized region 10 of the mooring device 1 serves as the main landing region or retention region for retaining the expandable prosthetic valve or THV when the mooring device 1 and the valve prosthesis are implanted in a patient's body. Other modalities of the mooring device 1 may have a central region 10 with more or less than three spiral turns, depending, for example, on the patient's anatomy, the amount of vertical contact desired between the mooring device 1 and the valve prosthesis (e.g., THV) and / or other factors. Spirals in the central region 10 can also be referred to as "functional spirals", since the properties of these spirals contribute the most to the amount of holding force generated between the valve prosthesis, the mooring device 1, and the native mitral cusps and / or other anatomical structures.
[0058] Several factors can contribute to the total holding force between the mooring device 1 and the prosthetic valve held there. A major factor is the number of turns included in the functional spirals, while other factors include, for example, an inner diameter of the functional spirals, a frictional force between the spirals and the prosthetic valve, and the resistance of the prosthetic valve and the radial force of the valve are applied to the spiral. A mooring device can have a variety of numbers of spiral turns. The number of functional laps can be in the ranges of just a little more than a half lap up to 5 laps, or an entire lap up to 5 laps, or more. In a mode with three full turns, an additional half turn is included in the ventricular part of the docking device. In another mode, there may be three full turns on the mooring device. In one embodiment, in the atrial part of the mooring device, there can be a half turn up to three quarters of a turn or half to three quarters of a circle. While a range of turns is provided, as the number of turns on a mooring device is reduced, the dimensions and / or materials of the spiral and / or the wire from which the spiral is made can also change to maintain a strength of adequate retention. For example, the diameter of the wire may be larger and / or the diameter of the function spiral turns in a mooring device with fewer spirals. There may be a plurality of spirals in the atrium and ventricle.
[0059] A size of the functional spirals or spirals of the central region 10 is generally selected based on the size of the desired THV to be implanted within the patient. Generally, the inner diameter of the coils / functional turns (for example, the coils / turns of the central region 10 of the mooring device 1) will be smaller than the outer diameter of the expandable heart valve, so that when the prosthetic valve is expanded in the mooring device, a radial tension or additional holding force will act between the mooring device and the prosthetic valve to hold the prosthetic valve in place. The holding force required for the proper implantation of a prosthetic valve varies based on the size of the prosthetic valve and on the ability of the assembly to handle mitral pressures of approximately 180 mm Hg. For example, based on bench studies using a prosthetic valve with an expanded outer diameter of 29 mm, a holding force of at least 18.5 N is required between the mooring device and the prosthetic valve in order to maintain shape hold the prosthetic valve on the mooring device and resist or prevent mitral regurgitation or leakage. However, under this example, to meet this 18.5 N holding force requirement with statistical reliability, a target average holding force must be substantially greater, for example, approximately 30 N.
[0060] In many modalities, the holding force between the mooring device and the valve prosthesis drastically reduces when a difference between the outer diameter of the prosthetic valve in its expanded state and the inner diameter of the functional spirals is less than about 5 mm , since the small size differential would be too small to create sufficient holding force between components. For example, when, as in a modality, a prosthetic valve with an expanded outer diameter of 29 mm is expanded into a set of coils with an inner diameter of 24 mm, the observed holding force is about 30 N, but when the same prosthetic valve is expanded into a set of coils with an internal diameter of 25 mm (for example, only 1 mm larger), the observed holding force drops significantly to just 20 N. Therefore, for valves and mooring devices of this type, in order to create sufficient holding force between the mooring device and a 29 mm prosthetic valve, the inner diameter of the functional spirals (for example, central region 10 coils of the mooring device 1) must be 24 mm or less. Generally, the inner diameter of the functional spirals (for example, central region 10 of the tracking device 1) should be selected so that it is at least about 5 mm less than the prosthetic valve that is selected for implant, despite other accessories and / or features (for example, friction enhancing accessories, material features, etc.) can be used to provide better retention if other sizes or size ranges are used, as the various factors can affect the retention force . In addition, a size of the inner diameter of the functional spirals or central region 10 can be selected to join the mitral anatomy in order to deflect, at least partially, or react to mitral regurgitation that is caused by the stretching of the native valve ring as a result, for example. example, left ventricular enlargement.
[0061] It is noted that the desired retention forces, discussed above, are applicable to the modalities for mitral valve replacements. Therefore, other modalities of the mooring device that are used to replace other valves may have different size ratios based on the desired holding forces for replacing the valve in those respective positions. In addition, the size differentials may also vary, for example, based on the materials used for the valve and / or the mooring device, where there are other accessories to prevent the expansion of the functional spirals or to improve friction / locking, and / or based on several other factors.
[0062] In the modalities where the mooring device 1 is used in the mitral position, the mooring device can be first advanced and distributed to the native mitral valve ring, and then configured in a desired position, before implantation of the THV . Preferably, the mooring device 1 is flexible and / or made of a memory effect material, so that the spirals of the mooring device 1 can be straightened for distribution via a transcatheter approach as well. In another embodiment, the spiral can be made of another biocompatible material, such as stainless steel. Some of the other catheters and other delivery tools can be used to deliver the mooring device 1 and the prosthetic valve, without having to perform separate preparatory steps, simplifying the implantation procedure for the end user.
[0063] The mooring device 1 can be distributed to the mitral position transatrially, from the left atrium, in a transeptal way through the atrial septum, or it can be distributed to the mitral position through one of several other access points or known procedures. Figures 6 and 7 illustrate some steps during the delivery of a mooring device 1 to the mitral position using a transeptal approach, where a guide sheath 1000 is advanced through the vasculature into the right atrium and through the atrial septum from the heart to the atrium left, and a 1010 delivery catheter is advanced through the guide sheath 1000 through the vasculature, right atrium, and septum into the left atrium. As can be seen better in figure 6, the mooring device 1 can be advanced through a distal end of the delivery catheter 1010 positioned in the left atrium (for example, positioned in a commissure), through the native mitral ring, for example , at a commissure of the native mitral valve, and into the left ventricle. The distal end of the mooring device 1 then circulates the mitral anatomy (for example, native mitral cusps and / or tendinous cords) located in the left ventricle, so that all or at least some of the native cusps and / or tendinous cords are cornered or grouped and kept (for example, surrounded by) by the mooring device spirals 1.
However, since the functional coils / turns or coils / turns of the central region 10 of the mooring device 1 are kept relatively small in terms of diameter (for example, the central region 10 in one embodiment may have an internal diameter approximately 24 mm (for example, +/- 2 mm) or other diameter smaller than THV and / or the native ring) in order to increase the holding force with the prosthetic valve, it may be difficult to advance the mooring device 1 around the existing cusps and / or chordae to a desired position with respect to the native mitral ring. This is especially true if the entire mooring device 1 is made so that it has the same small diameter as the central region 10. Therefore, with reference again to figures 3 to 5, the mooring device 1 may have a distal or lower region. 20 that creates a front spiral / turn (or front ventricular spiral / turn) of the mooring device 1, which has a diameter that is larger than the diameter of the spirals / turns of the spirals / turns of the central region 10.
[0065] Accessories of the mitral anatomy in the left ventricle have variable dimensions, and can have a width greater than approximately 35 to 45 mm in a long geometric axis. The diameter or width of the front spiral / turn (eg, ventricular spiral / turn) of the lower region 20 can therefore be selected to be larger so that a distal or front end 21 of the mooring device 1 can be easily navigated in around, and surround, the accessories of mitral anatomy (for example, cusps and / or tendinous cords). Various sizes and shapes are possible, for example, in one embodiment, the diameter can be any size from 25 mm to 75 mm. The term "diameter" as used in this description does not require a spiral / loop to be a complete or perfect circle, but is generally used to refer to a larger width through opposite points of the spiral / loop. For example, with respect to the front spiral / lap, the diameter can be measured from the distal tip 21 to the opposite side, as if the lower region 20 or the front spiral / lap forms a complete rotation, or the diameter can be considered double the radius of curvature of the front spiral / turn. In one embodiment, the lower region 20 of the mooring device 1 (for example, spiral / front turn) has a diameter (for example,) of approximately 43 mm (for example, +/- 2 mm), in other words, the radius of curvature in the front spiral / turn can be approximately 21.5 mm. Having the front spiral / lap larger than the functional spirals can help to orient the spirals around and / or through the chordae geometry more easily, and, most importantly, properly around native mitral valve cusps . Once the distal tip 21 is navigated around the desired mitral anatomy, the remaining spirals of the docking device 1 can also be oriented around the same accessories, where the reduced size of the other spirals can cause cornered anatomical accessories to be pulled slightly radially inward. Meanwhile, the length of the enlarged lower region 20 is generally kept relatively short, to avoid obstruction or interference of blood flow along the left ventricular outflow tract through the lower region 20. For example, in one embodiment, the enlarged lower region 20 spans only about half a loop or rotation. With a lower region 20 having this relatively short length, when a prosthetic valve is expanded into the mooring device 1 and the spirals of the mooring device 1 begin to unwind slightly due to the size differential between the mooring device and the prosthetic valve , the lower region 20 can also be pulled in and changed slightly. Under this example, after expansion of the prosthetic valve, the lower region 20 may be similar in size and substantially aligned with the functional spirals of the mooring device 1, instead of continuing to protrude away from the functional spirals, thereby reducing any potential flow disturbances. Other mooring arrangements may have lower regions that are longer or shorter, depending on the particular application.
[0066] The mooring device 1 in figures 3 to 5 also includes an enlarged proximal or upper region 30 that creates a stabilizing spiral / turn (for example, which may be an atrial spiral / turn) of the mooring device 1. When the mooring device 1 has been placed in a desired position and in orientation on the native mitral ring, the entire mooring device 1 is released from the 1010 delivery catheter, and thereafter a prosthetic valve (for example, a THV) is distributed to the docking device 1. During a transient or intermediate stage of the implantation procedure, that is, during the time between the deployment and release of the docking device 1 and the final distribution of the prosthetic valve, there is a possibility that the spiral it can be changed and / or dislodged from its desired position or orientation, for example, by regular cardiac function. Alteration of the mooring device 1 can potentially lead to less secure implantation, lack of alignment and / or positioning problems for the prosthetic valve. A stabilizing or spiral accessory can be used to help stabilize the docking device in the desired position. For example, the mooring device 1 may include the upper region 30 with an increased stabilization spiral / loop (eg, increased atrial spiral / loop) that must be positioned in the circulatory system (for example, in the left atrium), so that can stabilize the mooring device. For example, the upper region 30 or spiral / stabilization loop can be configured to support or push the walls of the circulatory system (for example, against the walls of the left atrium) in order to improve the ability of the mooring device 1 in remain in your desired position before implantation of the prosthetic valve.
[0067] The stabilizing spiral / loop (eg, atrial spiral / loop) in the upper region 30 of the mooring device 1 in the illustrated mode extends for about or almost an entire turn or rotation, and ends at a proximal end 31. In other modalities, the stabilizing spiral / turn (for example, atrial spiral) can extend for more or less than one turn or rotation, depending, for example, on the amount of contact desired between the mooring device and the circulatory system (for example, with the walls of the left atrium) in each particular application. The radial size of the stabilizing spiral / loop (eg, atrial spiral) in the upper region 30 can also be significantly larger than the size of the functional spirals in the central region 10, so that the stabilizing spiral / loop (for example, atrial spiral) to widen or extend sufficiently outward to make contact with the walls of the circulatory system (for example, the walls of the left atrium). For example, in one embodiment, a main diameter 32 or width of the upper region 30 is approximately 50 mm (for example, +/- 2 mm), or about twice the size of the spirals in the central region 10. A lower region of the left atrium usually narrows towards the native mitral ring. Therefore, when the mooring device 1 is properly developed in the mitral position, the stabilizing spiral / loop (eg, atrial spiral) of the upper region 30 rests and pushes the walls of the left atrium to help maintain the mooring device 1 in a relatively high desired position and orientation and preventing or reducing the change of the mooring device 1 in the direction of the left ventricle, until THV is advanced to and expanded in the mooring device 1. Once the prosthetic valve (for example, THV ) is expanded within the mooring device, the force generated between the functional spirals and the prosthetic valve (for example, with tissue, cusps, etc. between them) is sufficient to secure and stabilize the mooring device and the prosthetic valve without need the stabilizing spiral / turn.
[0068] Optionally, the stabilizing spiral / loop (for example, atrial spiral) of the upper region 30 may be non-circular in shape and, in the illustrated mode, is oriented and arranged in an elliptical or ovoid shape. As illustrated in figure 5, an elliptical-shaped stabilizing spiral / loop or other non-circular shape (for example, atrial spiral) can have a major geometrical axis diameter 32, D1 (i.e., a greater width of the spiral loop) and a smaller geometric axis diameter 33, D2 (i.e., an end-to-end width). The widths / diameters can be chosen based on the size of the anatomy of a part of a circulatory system (for example, based on the size of the human left atrium). The diameter of the main geometric axis (or greater width), D1, can vary from 40 to 100 mm, or can be from 40 to 80 mm, or from 40 to 75 mm. The diameter of the smaller geometric axis (or smaller width) D2 can vary from 20 to 80 mm, or from 20 to 75 mm. While a larger diameter / width D1 of the stabilizing spiral / loop (eg, atrial spiral) can be approximately 50 mm, a diameter / width D2 along a smaller geometric axis of the stabilizing spiral / loop (for example, spiral atrial) may be much smaller, for example, only slightly larger than the diameter of the central region 10 of the mooring device 1, as can be better seen in the top view of the mooring device 1 in figure 5. In other embodiments, the orientation of the upper region of the mooring device can be done in other ways. For example, the stabilizing spiral / loop (e.g., atrial spiral) of the upper region 30 can still be substantially circular, and / or the stabilizing spiral / loop can be oriented in one direction, so that a center of the upper region be diverted from the center of other parts of the mooring device. This shape orientation of the upper region 30 of the docking device 1 can, for example, increase the contact between the docking device 1 and the left atrial wall or other anatomy in the radial direction, in which the upper region 30 extends further to away from the other parts of the mooring device 1. The stabilizing spiral / turn (eg, atrial spiral) can be oriented so that when viewed from a top view (figure 20), the stabilizing spiral / turn (for example, atrial spiral) has a center that is deviated from the center of the functional spirals by about 50 to 75% of the diameter of the functional loops. The stabilizing loop (eg, atrial loop) of the spiral can be flexible and flex inward. This accommodates the anatomy (eg, left atrium anatomy) where the stabilizing spiral / turn (eg, atrial spiral) may have a larger or smaller geometric axis diameter that is larger than the atrium or other anatomy itself.
[0069] Importantly, the mooring device 1 can be rotated or otherwise oriented so that the narrowest part of the upper region 30, or the part that extends at least radially outward, is ideally directed. For example, when implanted in a native mitral valve, towards the left atrial wall that opposes or pushes the left ventricular outflow tract, so that the amount of pressure applied by the mooring device 1 against that part of the wall atrial pressure is reduced. In this way, an amount of displacement of that part of the wall into the left ventricular outflow tract will also be reduced, and the enlarged upper region 30 can therefore avoid obscuring, interfering with, or otherwise affecting blood flow through the left ventricular outflow tract.
[0070] With the upper region enlarged 30, the mooring device 1 can be maintained or retained more securely in proper positioning and orientation in the native valve ring (eg native mitral ring) before THV is implanted and expanded . Such self-retention of the mooring device 1 will more efficiently prevent the undesirable alteration or inclination of the mooring device 1 before the prosthetic valve is completely implanted, thus improving the performance of the implant as a whole.
[0071] Figures 6 to 9 illustrate some of the steps that can be used to distribute and deploy a mooring device (for example, mooring device 1 or other mooring devices described elsewhere here) and a THV in position mitral. While focusing on the mitral position, similar steps can be used in other valve locations, for example, the position of the tricuspid valve. The mooring device can be the mooring device 1 described above with respect to figures 3 to 5 or another similar mooring device (for example, other mooring devices), and THV is generally an automatic expansion THV, mechanical expansion or balloon expansion (or a combination thereof) with a circular or cylindrical valve structure or stent that is sized to be expanded and maintained in the mooring device.
[0072] Figures 6 and 7 illustrate a transeptal procedure for distributing the mooring device 1 to the patient's mitral position, where a guide / introducer sheath 1000 is advanced through the atrial septum of the heart and a distal end of a delivery catheter 1010 is advanced through the guide sheath 1000 and positioned with a distal opening of the delivery catheter positioned in the left atrium to deliver the mooring device 1. Optionally, a delivery catheter can be advanced in a similar way through anatomy (eg, vasculature , chambers of the heart, septum, etc.) and similarly positioned without first inserting or using a guide sheath. In an illustrative procedure, the guide sheath 1000 (and / or the delivery catheter 1010) is introduced into the patient's venous system by percutaneous perforation or by a small surgical cut, for example, in the patient's groin, and then the sheath guide 1000 (and / or catheter 1010) is advanced through the patient's vasculature to the left atrium as illustrated in figures 6 and 7. It is noted that the illustrated transeptal procedure is just an example, and several alternative procedures and / or access sites they can instead be used to deliver the mooring device 1 and / or a prosthetic valve suitable for the mitral position or other positions of the heart. However, a transatrial or transeptal procedure may be preferable, since such procedures provide a cleaner entrance to the left side of the heart when compared, for example, with a transapical procedure or another procedure where access to the mitral valve is through the ventricle left, so the doctor can avoid direct interference with tendon cords and other ventricular obstacles.
[0073] As illustrated in figure 6, the delivery catheter 1010 is advanced to a position in the left atrium where the distal end of the delivery catheter 1010 is above a plane of the native valve (for example, the mitral plane) and can be positioned, for example, near a commissure of the native valve. The delivery catheter can be steerable in multiple dimensions (for example, more than two dimensions) to allow for more accurate positioning. The positioning of the distal opening of the delivery catheter defines an access point for implanting the mooring device 1 in the mitral position. The access site is usually close to one of the two commissures of the native mitral valve, so that the front end 21 of the mooring device 1 can be advanced through the native valve commissure into the left ventricle in order to unfold the spiral / front turn (for example, ventricular spiral) of the lower region 20, plus at least part of the functional spirals (for example, spirals of the central region 10), into the left ventricle. In an unfolding method, the front end 21 of the mooring device 1 is first passed through the A3P3 commissure of the native mitral valve, and then more of the mooring device 1 is advanced out of the delivery catheter through the A3P3 commissure.
[0074] While the mooring device 1 is held in the delivery catheter 1010, the mooring device 1 can be straightened to be more easily maneuvered through the delivery catheter 1010. Thereafter, the mooring device 1 is rotated, pushed or otherwise advanced out of the delivery catheter 1010, the mooring device 1 can return to its original spiral or curved shape, and an additional advance of the mooring device 1 out of the delivery catheter causes a clockwise advance or counterclockwise (that is, visualizing the ring in the direction of the outflow of blood) from the front tip 21 around (for example, to surround) various accessories of the mitral anatomy, based on the direction of curvature of the mooring device 1 when it comes out of the delivery catheter. The increased front spiral / lap (e.g., ventricular spiral / lap) in the lower region 20 of the docking device 1 makes navigation of the front end 21 of the docking device 1 around the mitral anatomy in the left ventricle easier. In the example above, when the front end 21 of the mooring device 1 enters the left ventricle through the commissure A3P3 and is advanced clockwise by observing the ring in the direction of outflow (for example, from the atrium to the ventricle), the device mooring 1 can first bypass and corner the posterior cusp of the native mitral valve. Alternative methods are also available to corner the posterior cusp first, for example, by inserting the front end 21 through the A1P1 commissure and then advancing the mooring device counterclockwise.
[0075] In some situations, cornering the posterior cusp of the native mitral valve may, first, be easier than cornering the anterior cusp first, since the posterior cusp is positioned closer to a ventricular wall that provides a more confined space to the over which the front end 21 can advance. The front end 21 of the mooring device 1 can therefore use the ventricular wall near the posterior cusp as a path or guide for advancing around the posterior cusp. Conversely, when trying to advance the front tip 21 of the mooring device 1 around and to capture the anterior cusp of the native mitral valve first, there is no nearby ventricular wall that can facilitate or guide the advance of the front tip 21 in that direction. Therefore, in some situations, it may be more difficult to adequately start encompassing the mitral anatomy when navigating the front tip 21 to try to capture the anterior cusp first instead of the posterior cusp.
[0076] Having said that, it may still be preferable or necessary, in some procedures, to corner the anterior cusp first. In addition, in many situations, it can also be simpler to bend the distal end of the 1010 delivery catheter in a counterclockwise direction in preparation for the delivery of the mooring device. As such, the distribution method of the mooring device can be adjusted accordingly. For example, a mooring device can be configured with spiral turns in an opposite counterclockwise direction (for example, as seen in figure 10 below), where the 1010 delivery catheter also winds in a counterclockwise direction. In this way, such a mooring device can be advanced, for example, through the A3P3 commissure and into the left ventricle in a counterclockwise direction by observing the ring in an outflow direction (for example, atrium to ventricle) instead in the clockwise direction described above.
[0077] An amount of mooring device to be advanced into the left ventricle depends on the particular application or procedure. In one embodiment, the spirals of the lower region 20, and most of the spirals of the central region 10 (even if not all) are advanced and positioned in the left ventricle. In one embodiment, the mooring device 1 is advanced to a position in which the front end 21 rests behind the anterior medial papillary muscle. This position provides a more secure anchoring of the front end 21, and, consequently, of the mooring device 1 as a whole, since the front end 21 rests and is maintained between the tendon cord and the ventricular wall in that area. Meanwhile, since any part of the mitral anatomy is cornered and / or captured by the front end 21, the further advance of the mooring device 1 serves to collect the captured chordae and / or cusps within the spirals of the mooring device 1. Both the safe positioning of the front tip 21 and the retention of the native mitral anatomy by the mooring device 1 can serve to prevent obstruction of the left ventricular outflow tract (for example, the aortic valve) before the THV implantation.
[0078] After a desired amount of mooring device 1 has been advanced into the left ventricle, the rest of the mooring device 1 is then unfolded or released into the left atrium. Figure 7 illustrates a method of releasing the atrial part of the locking device 1 into the left atrium. In figure 7, the distal end of the delivery catheter 1010 is rotated backwards or retracted, while the mooring device 1 remains in substantially the same position and orientation, until the entire mooring device 1 is released from the delivery catheter 1010. For example, when the mooring device 1 is advanced clockwise through the commissure A3P3, the distal end of the delivery catheter 1010 can thereafter be rotated counterclockwise or retracted to release the atrial part of the mooring device. 1. This way, a ventricular position of the mooring device 1 does not need to be adjusted or readjusted during or after releasing the atrial part of the mooring device 1 from the 1010 delivery catheter. Various other methods of releasing the atrial part of the device berthing 1 can also be used. Before the release of the stabilizing spiral / loop (eg, atrial spiral) from the delivery catheter, it can be held in place and / or retracted / retrieved by a maintenance / anchor device (for example, hooked to a suture) release, connected by a burr, a Velcro hook, a lock, a lock, an anchor that can be screwed into the distribution device, etc.). Once released, the mooring device is not justly engaged with the native mitral valve (that is, it is only loosely positioned around the native mitral valve cusps).
[0079] After the mooring device 1 is fully developed and adjusted to a desired position and orientation, the delivery catheter 1010 can be removed to make room for a separate delivery catheter to deliver THV, or in some embodiments, the catheter delivery valve 1010 can be adjusted and / or repositioned if the prosthetic valve is delivered through the same 1010 catheter. Optionally, the guide sheath 1000 can be left in place and the prosthetic valve or THV delivery catheter can be inserted and advanced through it guide sheath 1000 after delivery catheter 1010 is removed. Figure 8 illustrates a cross-sectional view of a part of a patient's heart with the docking device 1 of Figures 3 to 5 positioned in the mitral position and before THV delivery. Here, the enlarged upper region 30 of the mooring device 1 can push against the atrial walls to help retain the mooring device 1 in the desired orientation, and as described above, the orientation of the upper region 30 can be arranged so that the region upper 30 do not push against any walls that could potentially result in obstructions in the left ventricular outflow tract.
[0080] Additionally, it should be noted that in at least some procedures, once the mooring device 1 is distributed to the mitral position as described above, and before implantation of the prosthetic valve, the native mitral valve can still continue to operate in a substantially normal manner, and the patient can remain stable, since the valve cusps are not substantially restricted by the docking station. Therefore, the procedure can be performed on a beating heart without the need for a heart-lung machine. Additionally, this allows the physician to have more time flexibility to implant the valve prosthesis, without the risk of the patient being or entering a position of hemodynamic impairment if a long time elapses between implantation of the mooring device 1 and implantation of the rear valve.
[0081] Figure 9 illustrates a cross-sectional view of a part of the heart with both the mooring device 1 and a prosthetic valve 40 (for example, THV) finally implanted in the mitral position. Generally, the prosthetic valve 40 will have an expandable frame structure 41 that houses a plurality of valve cusps 42. The expandable frame 41 of the prosthetic valve 40 can be balloon expandable, or can be expanded in other ways, for example, the frame it can be expanded automatically, mechanically or in a combination of shapes. The prosthetic valve 40 can be delivered through the same catheter 1010 used to deliver the mooring device 1, or it can be introduced through a separate catheter, generally while the valve 40 is disassembled radially to facilitate navigation through the delivery catheter. Optionally, the guiding sheath can be left in place when catheter 1010 is removed, and a new prosthetic valve or THV delivery catheter can be advanced through guiding sheath 1000. Prosthetic valve 40 is then advanced out of the guiding catheter. distribution and positioned through the mooring device 1 while still in the dismounted configuration, and can then be expanded in the mooring device 1, so that the radial pressure or tension between the components safely holds the entire assembly in place in the mitral position . The mitral valve cusps (or a part of the mitral valve cusps) can be interspersed between the functional turns of the mooring spiral and the frame 41 of the prosthetic valve. After the docking device and prosthetic valve are safely deployed / deployed, the rest of the delivery tools can be removed from the patient.
[0082] Figure 10 illustrates a perspective view of a modified version of the spiral anchor or mooring device 1 of figures 3 to 5. The mooring device 100 in figure 10 has a central region 110, a lower region 120, and an upper region 130 which can be equal to or similar to the respective central, lower and upper regions 10, 20, 30 in the docking device described previously 1. The docking device 100 may include accessories and features that are the same as or similar to the accessories and characteristics described in relation to the mooring device 1, and can also be implanted using the same or similar steps. However, the mooring device 100 includes an additional extension 140 substantially positioned between the central region 110 and the upper region 130. In some embodiments, the extension 140 can optionally be positioned, for example, entirely in the central region 110 (e.g. in an upper part of the central region 110) or totally in the upper region 130. In figure 10, the extension 140 is made of or includes a vertical part of the spiral that extends substantially parallel to a central geometric axis of the mooring device 100 In some embodiments, the extension 140 can be angled with respect to the central geometric axis of the mooring device 100, but it will generally serve as a vertical or axial spacer that spaces the adjacent connected parts of the mooring device 100 in a vertical or axial direction. so that a vertical or axial space is formed between the spiral parts on either side of the extension 140 (for example, a po space formed between an upper or atrial side and a lower or ventricular side of the mooring device 100).
[0083] The extension 140 of the mooring device 100 must be positioned through (for example, crossing) or close to the native valve ring, in order to reduce the amount of mooring device 100 that crosses or pushes or supports against the native ring when the mooring device 100 is implanted. This can potentially reduce the tension applied by the mooring device 100 to the native mitral valve. In one arrangement, extension 140 is positioned at and crosses or crosses one of the commissures of the native mitral valve. In this way, extension 140 can space the upper region 130 of the native mitral cusps to prevent the upper region 130 from interacting with or engaging the native cusps on the atrial side. The extension 140 also elevates a position of the upper region 130, so that the contact that the upper region 130 creates against the atrial wall can be raised or further spaced from the native valve, which can, for example, also reduce the stresses in and around the native valve, in addition to providing a more secure retention of the position of the mooring device 100. The extension 140 can have a length ranging from 5 to 100 mm, and in one embodiment, it is 15 mm.
[0084] The mooring device 100 can additionally include one or more hollowed holes 150 at or near one or both proximal and distal ends of the mooring device 100. The hollowed holes 150 can serve, for example, as suture holes for fix a cover layer over the coil of the mooring device 100 and / or, for example, as a fixation place for distribution tools, such as a retraction / suture was for a booster, a retention / anchor device (for example example, to retain the mooring device and / or allow the device to retract and recover after being fully or partially developed from the delivery catheter), or other advancing device or holding device. In some embodiments, the width or thickness of the spiral of the mooring device 100 can also vary over the length of the mooring device 100. For example, a central region of the mooring device 100 can be created slightly thinner than the end regions of the mooring device 100 (not shown), so that, for example, the central regions exhibit greater flexibility, the end regions are stronger or more robust, and / or the end regions provide more surface area for suturing or otherwise fixing a covering layer to the spiral of the mooring device 100, among other reasons. In one embodiment, all or a part of the extension 140 may have a thickness that is less than the thickness in other regions of the mooring device, for example, the extension 140 may be thinner than the front spiral / turn or lower region 120, thinner than the spiral / functional turns or central region 110, and / or thinner than the stabilizing spiral / turn or upper region 130, for example, as illustrated, for example, in figure 19.
[0085] In figure 10 (and similarly, figure 19), the spirals of the docking device 100 are shown as turning in a direction opposite to the spirals in the docking device 1 described above. Therefore, the mooring device 100, as shown, is configured to be inserted through the native valve ring in a counterclockwise direction while observing the ring in the direction of outflow of blood (for example, from the atrium to the ventricle). This advance can be made through the A3P3 commissure, A1P1 commissure, or through another part of the native mitral valve. The arrangement of the docking device 100 in a counterclockwise direction also allows the distal end of the delivery catheter to be bent in a similar counterclockwise direction, which in many cases is easier to reach than the bending of the delivery catheter. clockwise distribution. The various modalities of spiral mooring devices described here (including mooring devices 1, 100, 200, 300, 400, 500, 600 and 1100) can be configured to advance clockwise or counterclockwise through one of the several access points (for example, any commissure).
[0086] In most situations and patients, the mooring device must be located elevated in relation to the native mitral valve (for example, further into the left atrium). When considering mitral anatomy, the combination of mooring device and finally implanted valve must be located high in the native valve, in some cases as high as possible, to anchor the valve in a clean area of the native mitral cusps. Additionally, in a healthy human heart, the native mitral cusps are generally softer above the coaptation line (for example, above where the cusps join when the mitral valve is closed) and rougher below the coaptation line. The softer area or area of the native cusps is much more collagenous and stronger, thus providing a safer anchorage surface for the prosthetic valve than the rougher area or area. Therefore, in most cases, the mooring device must be located as high as possible on the native valve during insertion, while also having sufficient holding force to anchor the prosthetic valve or THV. For example, the length of the spiral in the mooring device located in the ventricle generally depends on the number of turns in the ventricle and the thickness of the wire used. Generally, the thinner the wire used, the more length it will need in the ventricle to provide sufficient retention force. For example, if a mooring spiral is 370 mm long, then about 280 mm (for example, +/- 2 mm) would be located in the ventricle. About 70 to 90 mm would be located in the atrium and about 10 to 15 would be used in the transition or extension length to move the mooring device spirals from the mitral valve plane on the atrial side of the mooring device.
[0087] The average mitral valve in humans measures approximately 50 mm in length along its long geometric axis and 38 mm along its short geometric axis. Due to the size and shape of the native valve and typically the reduced size of the replacement valves, an inverse relationship is formed with respect to the spiral diameter of the mooring device between how high the mooring device can be located in the mitral position and the force that the mooring device can provide for THV to be deployed there. Docking devices with larger diameters can capture more chordae and, consequently, have the ability to be deployed in a higher position in relation to the native valve, but will provide a lower amount of holding force for valves that are moored to them. Conversely, mooring devices with smaller diameters may provide greater holding forces for moored valves, but may not be able to circumvent and capture the maximum chordae during positioning, which may result in the mooring device being placed in the lower ring. native valve. Meanwhile, larger mooring devices can be modified so that they have increased coil diameters or thicknesses and / or can be constructed using materials with a high modulus of elasticity.
[0088] Figures 11 to 13 illustrate a mooring device, according to another embodiment of the invention. The mooring device 200 (see figures 12 and 13) is formed with a laser cut tube 210 and a tensioning wire 219. The wire 219 can be used to adjust the curvature and / or size of the mooring device 200. For example , the mooring device 200 can take on a larger or wider configuration when it is positioned on the native valve ring, and can thereafter be adjusted with wire 219 to assume a smaller or narrower configuration to prepare for mooring a valve prosthetic.
[0089] Figure 11 schematically illustrates an open laminated view of a laser cut tube 210, for example, the ends of the sheet can be connected to form a tubular structure, or a similar tube can be formed as a tube and cut like a tube, that is, without a joint. The tube 210 can be made from memory effect material or not (for example, NiTi, stainless steel, other materials, or a combination of materials). The tube 210 can be laser cut with the pattern shown in figure 11, or with a similar pattern, where the cut pattern dictates the shape of the docking device 200 when the docking device 200 is operated. The standardized cuts in Figure 11 include a plurality of separate cuts 2211 that extend transversely to a longitudinal geometric axis of the tube 210, and which separate the tube 210 into a plurality of interconnected links 212. Each of the cuts 211 can form, in addition, one or more teeth 213 and one or more corresponding grooves 214 at adjacent links 212, where teeth 213 can extend into adjacent grooves 214, including when tube 210 is bent or curved. The teeth 213 and grooves 214 formed by each cut 211 can extend in the same direction along the tube 210, or some can be configured to extend in the opposite direction, depending on the desired shape of the mooring device 200. The cuts 211 are also fully contained in the sheet or tube, in other words, the cuts 211 do not extend to any of the edges of the tubular sheet or tube, so that the links 212 remain interconnected to each other at least in one region. In other embodiments, some or all of the cuts may extend to the edges of the sheet or tube, as needed. In the embodiment of figure 11, each of the cuts 211 additionally includes end regions 215 at any end of the cuts 211 which extend parallel to the longitudinal geometric axis of the tube 210. The end regions 215 provide space for adjacent links 212 to articulate with respect to each other while remaining interconnected.
[0090] The laser cut patterning can also be modified or varied along the length of tube 210, with cuts having different sizes, shapes and positioning in the sheet or tube, in order to make different shapes and curvatures in the mooring device 200 when the mooring device 200 is tensioned or actuated. For example, as seen in figure 11, a left end of the sheet or tube includes other cuts 216 that are larger than the cuts 211 that are found in the central and right parts of the sheet or tube (as illustrated). The left end of tube 210 may have such laser cutting patterns increased in order to make a more mobile or flexible distal tip of the mooring device 200, as described in greater detail below.
[0091] Additionally, the laser-cut sheet or tube may include one or more distal wire locking accessories, for example, cut 217 at a distal or left end of the sheet or tube as illustrated, and / or one or more accessories of proximal wire locking, for example, cuts 218 at the proximal or right end of the sheet or tube, as illustrated. Using one or both of the 217 or proximal 218 wire locking accessories, a locking wire 219, shown in Figure 11A, can be attached to the distal or proximal end of the tube 210 and can then be tensioned through the tube 210 and locked at the opposite end of the tube 210 in order to achieve a desired driven shape of the docking device 200. With the laser cutting patterns positioned over a large part of or along the entire length of the tube 210, when locking wire 219 is attached to one end of tube 210 and is then driven and locked at the other end of tube 210, tube 210 is forced into a desired final spiral shape or shape by virtue of the arrangement of cuts 211 and 216. The tension in the tensioning wire has the ability to control the radial external and internal forces applied to the mooring device 200, and by the mooring device 200 to other accessories, for example, in a sub valve stitution 40 kept there. The locking wire can assist in controlling the forces applied by the mooring device, but in other embodiments, a locking wire is not required. The locking wire may be in a laser-cut hypotube, or the locking wire may be in a tube that is not laser cut. The locking thread can be a suture, tie, thread, strip, etc. and the locking wire can be made of a variety of materials, for example, metal, steel, NiTi, polymer, fiber, Dyneema, other biocompatible materials, etc.
[0092] In some modalities, for example, the modalities where a memory effect material, such as NiTi, is used to build the mooring device 200, the tube 210 can be located around a round mandrel defining a spiral diameter desired during fabrication and shape configuration at that specific diameter. The determined shape diameter may, in some embodiments, be larger than the desired final diameter of the mooring device 200, so that the tube 210 takes on the larger diameter determined when it is extruded from a delivery catheter and before the locking or tensioning wire is triggered. During this time, the larger diameter of the mooring device 200 can help to assist the mooring device 200 in easier navigation around and surrounding the anatomical geometry of the native valve.
[0093] Additionally, in some embodiments, the distal end 222 of the tube 210 may be shaped differently, so that, instead of following the same spiral shape as the rest of the mooring device 200, the distal end 222 flexes or articulates slightly radially outwardly compared to other parts of the mooring device 200, for example, as seen in Figure 12, in order to further assist in surrounding the mitral or other valve anatomy. In addition to or in place of a different shape configuration, as mentioned above, the distal end 222 of the tube 210 can include different cuts 216 in order to make the distal end 222 more flexible or mobile, which can also assist in navigation of the distal end 222 of the mooring device 200 around the anatomical geometry.
[0094] After the mooring device 200 has been maneuvered around mitral anatomy or other anatomical geometry and has reached a desired position with respect to the native valve, the locking wire can be tensioned or otherwise acted in order to reduce the size of the mooring device (for example, to reduce the diameter of spiral turns), in preparation for a fairer or safer mooring of a prosthetic replacement valve 40. Meanwhile, in some modalities where the distal end 222 of the mooring device mooring 200 is shaped to flex outward, the tensioning of the locking wire may, in some cases, retract or pull distal tip 222 further in so that distal tip 222 conforms more closely to the rest of the shape. mooring device 200, to contribute more efficiently to the mooring of the replacement valve 40.
[0095] Henceforth, the replacement valve 40 can be positioned and expanded in the mooring device 200. Figure 13 is an example of the mooring device 200 after having been actuated by the locking wire, and also after the replacement valve 40 has been expanded. The tension in the locking wire helps to more efficiently maintain a desired shape and size of the locking device 200 and to maintain a greater holding force between the locking device 200 and valve 40. The external radial pressure provided by valve 40 in the mooring device 200 it is reacted by the internal radial pressure provided by the tensioning or locking wire and mooring device 200 in the valve 40, forming a stronger and safer retention between the parts. As can be seen in figure 13, since the mooring device 200 can maintain its shape and size more efficiently, the internal radial pressure of the mooring device 200 on valve 40 can cause a widening effect at the ends of the valve 40, thereby providing an even safer retention between locking device 200 and valve 40.
[0096] The mooring device 200 can be modified in various ways in other modalities. For example, the mooring device can be made from or include memory effect materials in addition to NiTi, or in some embodiments, it can be made from non-memory materials, such as stainless steel, from other biocompatible materials and / or combination thereof. In addition, while the mooring device 200 has been described above for use on the mitral valve, in other applications, a slightly modified or similar mooring device can also be used to dock replacement valves at other native valve locations, for example, on the valve tricuspid, pulmonary valve, or aortic valve.
[0097] The mooring device 200 described above, and similar devices using a tensioning or locking wire, can provide many advantages over other mooring devices, such as devices where a locking wire is not used. For example, the locking wire provides the user with the ability to control an amount of external and internal radial forces applied to and by the mooring device by performing and adjusting the tension on the locking wire, without compromising a desired mooring device profile or the ability to distribute the mooring device through a catheter or through minimally invasive techniques. Fig. 11A illustrates a tensioning wire 219 that is retained below teeth 218 or wrapped around teeth 218, then pulled through opening 217 and tightened into opening 217 to configure the shape of the mooring device. In addition, laser cuts on the tube make the mooring device more flexible, allowing the mooring device to be introduced through catheters that can have relatively small bend radii in certain locations.
[0098] In the modalities where a memory effect material is used, the mooring device can have its shape configured for a spiral having a larger diameter to allow the spiral to more easily circulate the anatomical accessories during the distribution of the mooring device and before the locking wire is tensioned. In addition, the distal end of the mooring device can be additionally shaped or slightly oriented outward to help further circulate the anatomical geometry during the advancement and positioning of the mooring device. Additionally, in some embodiments, the distal end of the mooring device can be further modified, for example, with more material removed to form larger cuts, making the distal part of the mooring device even more flexible, so that the tip can be more easily triggered and manipulated to more efficiently navigate around and circulate different cardiovascular anatomies. A pattern can be laser cut to reduce forces more in one area than in another. The tube can be ovalized, that is, the cross-sectional area of the tube can be ovalized, so that forces allow the tube to curve in a desired direction. The tensioning wire can also be attached to both a proximal end and a distal end of the tube, to provide tensioning force. Illustrative cut patterns are illustrated, but other cut patterns are also possible.
[0099] Various mechanisms can be additionally incorporated or added to one or more of the mooring devices described here (for example, mooring devices here 1, 100, 200, 300, 400, 500, 600 and 1100), for example, in order to increase the holding force between the mooring device and a replacement valve which is expanded here. Spiral mooring devices will generally have two open or free ends after implantation. When THV or another replacement valve is expanded in the spiral. The spiral can unwind and partially increase in diameter due to the external pressure applied by the expansion valve to the spiral, which in turn reduces the holding force applied by the spiral to the valve. The mechanisms or other accessories can therefore be incorporated into the mooring devices to prevent or reduce the spiral from unfolding when the replacement valve is expanded on them, resulting in an increase in radial forces and holding forces between the mooring device and the valve. Such mechanisms can be incorporated in place of modifying the size and shape of the mooring device, for example, without making the spiral thicker or reducing the diameter of the internal space formed by the spiral, both of which can negatively affect performance or facilitate distribution of the locking device. For example, when the spiral of the mooring device itself is thickened, the increased thickness results in a more rigid spiral, making it difficult for the mooring device to pass through a delivery catheter. Meanwhile, when the diameter of the internal space formed by the spiral is greatly reduced, the reduced space can prevent the expandable valve from fully expanding.
[0100] An alternative first modification to ensure sufficient holding force between a mooring device and a valve that is expanded in the mooring device is illustrated in figure 14. The mooring device 300 in figure 14 includes a main spiral 310 (which may be similar in size and shape to one of the mooring devices described above) and anchors 320 extending from two free ends of the spiral 310. Anchors 320 are dimensioned, shaped and otherwise configured to embed them in the surrounding tissue (eg, the atrial and / or ventricular walls), for example, when a replacement valve is expanded on the mooring device 300. Anchors 320 can be barbed to promote internal growth once anchors 320 are embedded on the walls of the heart or other tissue. Anchors can have any of many different shapes and sizes. Anchors can extend from the end or from any area near the end. Optionally, anchors or burrs can also be positioned at various locations along the length and another surface of the mooring device.
[0101] During operation, when the mooring device 300 is deployed in the mitral anatomy, since the mooring device 300 is positioned through the mitral valve, one end of the mooring device 300 is positioned in the left atrium while the other end mooring device 300 is positioned in the left ventricle. The shape and size of the spiral 310 of the mooring device 300 can be selected and optimized to ensure that the ends of the spiral 310 rest against the atrial and ventricular walls, respectively, when the mooring device 300 is advanced to the desired position . The anchors 320 at the ends of the spiral 310 can therefore anchor themselves to the respective cardiac walls. When the replacement valve is expanded in spiral 310, the free ends of spiral 310 are held in position by anchors 320 being housed in the walls of the heart. The inability of the free ends of the spiral 310 to move when the replacement valve is expanded in the mooring device 300 prevents the spiral 310 from unwinding, thereby increasing the radial forces applied between the mooring device 300 and the expanded valve and perfecting the retaining force between components.
[0102] Figure 15 illustrates a schematic view of a portion of another mooring device modified to improve the holding forces between the mooring device and a replacement valve. Three-turn parts of a mooring device 400 are illustrated in figure 15. The mooring device 400 includes a main spiral or core 410, which can, for example, be a NiTi spiral / core or a spiral / core that is made of or includes one or more of several other biocompatible materials. The mooring device 400 additionally includes a cover 420 that covers the spiral / core 410. The cover 420 can be made of or include a high friction material, so that when the expandable valve is expanded in the mooring device 400, a quantity increased friction is generated between the valve and the cover 420 to maintain a shape of the mooring device 400 and prevent or inhibit / resist the unfolding of the mooring device 400. The cover can also or can alternatively increase the amount of friction between the device mooring and native cusps and / or prosthetic valve to help retain the relative positions of the mooring device, cusps and / or prosthetic valve.
[0103] The cover 420 is made of one or more high friction materials that is located on the spiral wire 410. In one embodiment, the cover 420 is made of or includes a PET braid over an ePTFE tube, the last of which serves as a core for the cover 420. The ePTFE tube core is porous, providing a padded layer for stringers or other parts of an expandable valve frame to penetrate, perfecting the engagement between the valve and the mooring device 400. Meanwhile , the PET layer provides additional friction against the native valve cusps when the prosthetic valve is expanded and the stringers or other parts of the valve frame apply pressure outward on the mooring device 400. These accessories can work well together to increase forces between the mooring device 400 and the native cusps and / or prosthetic valve, also increasing the increase in holding forces and preventing the mooring device 400 from developing scroll.
[0104] In other embodiments, the cover 420 can be made from one or more other high-friction materials that cover the spiral 410 in a similar way. The material or materials selected to make the cover 420 can also promote rapid internal tissue growth. In addition, in some embodiments, an external surface of a replacement valve frame can also be covered in a fabric material or other high friction material to further increase the frictional force between the mooring device and the valve, thereby reducing in this way, further or preventing the mooring device from unrolling. The friction provided by the cover can provide a coefficient of friction greater than 1. The cover can be made of ePTFE and can be a tube that covers the spiral, and can be smooth or can have pores (or be braided or have other structural accessories that provide a larger accessible surface area as pores do) to encourage internal tissue growth. The cover can also have a PET braid over the ePTFE tube when the ePTFE tube is smooth. The outermost surface of the cover or braid over the cover can be any biocompatible material that provides friction, such as a biocompatible metal, silicone tubing or PET. The pore size on the cover can vary from 30 to 100 microns. In the modalities in which there is a PET cover over ePTFE, the PET layer is only attached to the ePTFE cover, and not directly to the mooring device's spiral. The ePTFE tube cover can be attached to the mooring device's spiral at the proximal and distal ends of the covers. It can be subsequently welded to the spiral, or radiopaque markers can be replaced on the outside of the ePTFE tube cover or PET braid and riveted on the materials to keep them in place for the spiral.
[0105] Meanwhile, in some embodiments, the mooring device 400 may also include anchors similar to anchors 320 discussed above to further increase the holding forces, but other modalities of the mooring device may incorporate cover 420 without additionally including such additional end anchors. Once the replacement valve is expanded in the mooring device 400 and the resulting assembly begins to function as a combined functional unit, any internal tissue growth can also serve to reduce the load on the combined mooring and valve assembly.
[0106] Cover 420 can be added to any of the docking devices described here (for example, docking devices 1, 100, 200, 300, 400, 500, 600 and 1100) and can cover all or part of the device mooring. For example, the cover can be configured to cover only the functional coils, the front coil, the stabilizing coil or just a part of one or more of them (for example, only a part of the functional coils).
[0107] Figures 16 and 16A schematically illustrate a part of another modified mooring device that improves the holding forces between the mooring device and a replacement valve. As illustrated in the sectional view of figure 16A, the fabric of the valve cusp 42 undulates to conform to the variable cross section between the areas of the spiral 510 with friction elements 510 and without friction elements. This undulation of the cusp fabric 42 results in a more secure trapping of the fabric 42 between the mooring device 1 and the valve frame 41. The mooring device 500 in figure 16 includes a main spiral 510 and one or more discrete friction elements 520 that are spaced along a length of the spiral 510. The friction elements 520 can be made from a fabric material or other high-friction material, such as PET, and can be formed as small volumes on the surface of the spiral 510 or another layer that is located in the spiral 510. In some embodiments, the cover 420 can be considered itself a friction element or it can be considered to form one or more friction elements 520. In some embodiments, the friction elements 520 are added in addition to adding a high friction cover 530 which is similar to cover 420 discussed above. As an example of a mooring device 500 with both a high friction cover 530 and friction elements 520 applied over a main spiral 510 is illustrated schematically in figure 17.
[0108] When an expandable valve is expanded on the mooring device 500, friction is formed between the valve frame and the friction elements 520 and / or between the valve frame, the native valve cusps and the mooring device that prevents or inhibits / resists the unwinding of the spiral 510 of the mooring device 500. For example, the friction elements 520 may engage or otherwise extend into the cells defined by the expandable valve frame and / or cusp tissue force valve into the cells of the expandable valve. In addition, when the valve is expanded on the mooring device 500, each of the friction elements 520 can engage with adjacent turns of the mooring device 500 above and / or below the friction element 520 and / or with one or more friction elements 520 on adjacent turns of the mooring device 500. Any or all of these couplings will cause the mooring device 500 to inhibit or resist unwinding, thereby increasing the holding force between the mooring device 500 and the expanded valve.
[0109] Figure 18 schematically illustrates parts of the three loops of another modified mooring device 600 which helps to improve the holding forces between the mooring device and a replacement valve. The mooring device 600 includes a spiral 610 that is modified with one or more lock patterns and interlocking keys spaced along the length of the spiral 610. The lock and key patterns can be simple, for example, a rectangular groove or cutout 618 and a complementary rectangular projection 622, as generally illustrated in figure 18, can either be made of or include different shapes and / or more complex patterns in other embodiments. In addition, grooves 618 and projections 622 can all be arranged in the same axial direction or in different axial directions in various modalities. Lock and key patterns or other friction elements can be replaced in functional turns of the mooring device.
[0110] When an expandable valve is expanded on the mooring device 600, the locking and key mechanism is based on adjacent turns of spiral 610 supporting each other at each turn interlock with adjacent turns of spiral 610 located above and / or below it when one or more of the projections 622 engage the corresponding grooves 618. The interlocking of the grooves 618 and the projections 622 prevents the relative movement between the respective characteristics, consequently also preventing the spiral 610 of the mooring device 600 from physically unfolding. Therefore, this arrangement also serves to increase the radial forces and the final holding force between the mooring device 600 and a replacement valve which is expanded in the mooring device 600.
[0111] Figure 19 illustrates a perspective view of an illustrative spiral anchor or mooring device. The mooring device 1100 in figure 19 can be the same or similar in structure to the mooring device 100 in figure 10, described above, and can include any of the accessories and features described with respect to the mooring device 100. The mooring device 1100 can also include a central region 1110, a lower region 1120, an upper region 1130 and an extension region 1140. The lower and upper region 1120, 1130 can form larger spiral diameters than the central region 1110, and the region of extension 1140 can space the upper region 1130 from the central region 1110 in a vertical direction, also in a similar manner to that previously described. The mooring device 1100 is also arranged or rolled up so that the advancement of the mooring device 1100 in the left ventricle can be performed counterclockwise by looking at the ring in the direction of outflow (for example, from the atrium to the ventricle ). Other modalities can facilitate the advance and placement of the docking device clockwise.
[0112] In the embodiment of figure 19, the central spirals / turns 1110 of the mooring device 1100 also serve as functional spirals / turns and provide a main docking point for a prosthetic valve or THV that is expanded there. The central loops 1110 will generally be positioned in the left ventricle, while a small, if any, distal part will extend through the native valve ring and into the left atrium, described in greater detail below. In the examples where a THV has an outer diameter of 29 mm expanded, the central loops 1110 can have an internal diameter ranging from 20 mm to 30 mm, and in an illustrative embodiment, it can be approximately 23 mm (for example, +/- 2 mm) in order to provide about 16 N of holding force between the parts, which is sufficient to steadily maintain expanded THV in the mooring device 1100, and preventing THV from dislodging the mooring device 1100, even for several mitral pressures.
[0113] Meanwhile, the lower region 1120 of the mooring device 1100 serves as a forward spiral / loop (for example, a ventricular circulation loop). The lower region 1120 includes the distal tip of the mooring device 1100, and extends radially outward from the central loops 1100 in order to capture the native valve cusps, and some or all of the chordae and / or other mitral anatomy, when the mooring device 1100 is advanced into the left atrium. Native mitral valves exhibiting mitral regurgitation typically measure about an A2P2 distance of 35 mm and a distance of 45 mm from commissure to commissure. Therefore, when a 29 mm THV is used, the reduced THV size and, consequently, the size of the central loops 1110, are smaller than the long geometric axis of mitral anatomy. As such, the lower region 1120 is formed to have an increased size or profile compared to the central loops 1110, in order to initially orient the mooring device 1100 more easily around both native valve cusps. In one example, the diameter of the lower region 1120 can be constructed to be almost the same distance, measured between the commissures of the native valve (for example, 45 mm), so that the distal tip extends approximately that distance away the delivery catheter outlet during the delivery of the 1100 mooring device.
[0114] The upper region 1130 of the mooring device 1100 serves as the stabilizing spiral / loop (eg, atrial spiral / loop) that provides the mooring device 1100 with an automatic retention mechanism during the transition phase after the mooring device 1100 is deployed on the native valve and before THV delivery. The left atrium usually widens outward from the mitral annulus, forming a tunnel shape that extends away from the annulus. The diameter of the upper region 1130 is selected to allow the upper region 1130 to fit at least an approximate desired height in the left atrium, and to prevent the upper region 1130 from sliding or falling further towards the native mitral ring after the position desired is achieved. In one example, the upper region 1130 is formed to have a diameter of 40 to 60 mm, such as a diameter of about 53 mm.
[0115] Additionally, the shape and placement of the upper region 1130 are selected so that after the THV is expanded in the mooring device 1100, the upper region 1130 applies minimal pressure or no pressure to the part of the atrial wall that is adjacent to the wall aortic. Figure 20 is a schematic top view of a part of a heart, illustrating an approximation of the left atrium 1800, and the mitral valve 1810 positioned in a central region. In addition, an approximate position of the 1840 aorta is also schematically illustrated. Meanwhile, a mooring device 1100 has been distributed to the native mitral valve 1810 at the A3P3 commissure 1820. Importantly here, the upper region 1130 of the mooring device 1100 is positioned away from a wall 1830 of the left atrium 1800 which is adjacent to the aorta 1840 In addition, when the THV is expanded in the mooring device, the central region 1110 of the mooring device 1100 will tend to expand slightly and unwind, which can further pull the upper region 1130 away from the atrial wall 1830 (for example, counterclockwise and descending as illustrated in figure 20). Additional details on the positioning of the mooring device 1100 in relation to the mitral valve 1810, with additional reference to figure 20, will be discussed in greater detail below.
[0116] The extension region 1140 provides a vertical extension and spacing between the central region 1110 and the upper region 1130 of the mooring device 1100. In some embodiments, the extension region 1140 of the mooring device 1100 (and extension 140 of the mooring device mooring 100) can therefore be referred to as an ascending lap. The location at which the 1100 mooring device crosses the mitral plane is important in preserving the integrity of the native valve anatomy, and specifically the valve cusps and commissures, to serve as a suitable mooring site for the final THV implant. . In mooring devices without such an extension or ascending region 1140, more of the mooring device will sit on or against the mitral plane and squeeze against the native cusps, and the relative movement or friction of the mooring device against the native cusps could potentially damage the cusps native to the atrial side. Having an extension region 1140 allows the part of the mooring device 1100, which is positioned in the left atrium, to rise away from and be spaced from the mitral plane.
[0117] In addition, the extension region 1140 of the mooring device 1100 may also have a smaller diameter cross section. In the illustrated embodiment, the core of the wire or other regions of the mooring device 1100 may have a diameter, for example, of 0.825 mm, while the core of the extension region 1140 may have a diameter of 0.6 mm. In another embodiment, the wire core from other regions of the mooring device has a transversal diameter of 0.85 mm, and the extension region has a transversal diameter of 0.6 mm. When other regions of the mooring spiral have a cross-sectional diameter of 0.825 mm or less, or a cross-sectional diameter of 0.85 mm or greater, extension region 1140 may have a cross-sectional diameter of 0.4 to 0.8 mm . Thicknesses can also be chosen based on a ratio of one to the other. The extension region can have a transverse diameter that is 50% to 75% of the transverse diameter of the rest of the wire parts. A region of extension 1140 with a smaller cross section can allow a precise angle of ascension of the region of extension 1140 from the mitral plane. The radius of curvature and the wire cross section of the extension region 1140 can be additionally selected, for example, to provide a sufficient connection point between the central region 1110 and the upper region 1130 on the mooring device 1100, and / or for allow the 1140 extension region to be unfolded and retrieved more easily with less force during distribution, since a thinner wire core is generally easier to straighten and fold. Additionally, in the modalities in which a memory effect such as NiTi is used for the wire core, the thicknesses of both the extension region 1140 and the rest of the mooring device 1100 must be chosen so as not to exceed any voltage limits, based on the material properties of the material or selected materials.
[0118] While as noted above, a wire core of the 1100 mooring device may be made of NiTi, another memory effect material or other biocompatible metal or other material, the wire core may be covered with one or more additional materials. These cover or layer materials can be attached in a variety of ways including, for example, adhesion, melting, molding, etc. around the core or otherwise suturing, tying or attaching the cover / layer to the wire core. Briefly referring to figure 22, a cross section of a distal part of the mooring device 1100 includes a wire core 1160 and a cover layer 1170. The wire core 1160, for example, can provide resistance to the device mooring 1100. Meanwhile, a base material of cover layer 1170 covering the core of wire 1160 can be, for example, ePTFE or another polymer. The cover layer 1170 can be more compressive than the wire core 1160, so that the wire frame and / or THV stringers can partially penetrate or otherwise anchor in the cover layer 1170 to obtain additional stability when THV is expanded in the mooring device 1100. A more compressible material will also allow the tightening or compression of native valve cusps and other anatomy between the mooring device 1100 and THV to be less traumatic, resulting in less wear and / or damage for native anatomy. In the case of ePTFE, the material is also not permeable to water or blood, but will allow ethylene oxide gas to pass or penetrate, thus providing a layer through which the underlying 1160 wire core can be more easily sterilized. Meanwhile, while not permeable to blood, an ePTFE 1170 cover layer can be constructed with, for example, a pore size of 30 microns, to facilitate the anchoring of blood cells in and against the outer surface of the cover layer 1170 , for example, to promote internal tissue growth after implantation. In addition, ePTFE is also a very low friction material. An 1100 mooring device with an ePTFE 1170 cover layer will provide stability and promote internal growth.
[0119] While a low friction 1170 ePTFE cover layer can assist with interactions between the ends of the 1100 mooring device and the native heart anatomy, additional friction may be more desirable in the central region 1110, which provides the functional spirals of the mooring device 1100 for mooring THV. Therefore, as seen in figure 19, an additional cover 1180 (which can optionally be equal to or similar to cover 420 and / or friction elements 520) can be added to the central region 1110 of the mooring device 1100, above the ePTFE 1170 layer. Figure 19A illustrates a cross-sectional view of the layers. The 1180 cover (presented as a braided layer) or another layer of high friction provides additional friction between adjacent spirals and against native cusps and / or THV when THV is expanded in the 1100 mooring device. The friction that is formed at the interfaces between the spirals and between the inner surface of the central region 1110 of the mooring device 1100, the native mitral cusps, and / or the outer surface of THV creates a safer locking mechanism to anchor more strongly THV and the mooring device 1100 to the valve native. Since the spirals / functional turns or central region 1110 of the mooring device 1100, that is, the mooring region that interacts with THV, is generally the only region in which a high friction cover / layer is desired, as noted in figure 19, the braided layer or cover / high friction layer 1180 does not extend into the lower region 1120 or extension region 1140, so that these regions of the mooring device 1100, together with the upper region 1130, remain in low friction to facilitate less traumatic interactions with the native valve and other anatomy of the heart. Additional friction elements and thus improved retention forces between the mooring device and a replacement valve can also be added to the device via any 1180 high friction cover / layer combination and high friction elements or others accessories described here and illustrated in figures 15 to 18.
[0120] Figure 20 illustrates a top view of a possible placement of the mooring device 1100 on the native mitral valve 1810 before the expansion of a THV. In this modality, the mooring device 1100 is advanced in a counterclockwise direction through the commissure A3P3 1820 of the mitral valve 1810 and into the left ventricle. When a desired amount of mooring device 1100 (for example, the lower region 1120 and much of the central region 1110) has been advanced into the left ventricle, the remaining loops of the mooring device 1100, for example, any remaining part of the central region 1110 (if any), extension region 1140 (or a part of it), and upper region 1130, is then released from the delivery catheter, for example, by a clockwise or opposite rotation of the delivery catheter, so that these parts of the mooring device 1100 can be sheathed or otherwise released while a position of the central region 1110 and the lower region 1120 of the mooring device 1100 remain stationary or substantially in position with respect to the surrounding anatomy. In figure 20, the parts of device 1100 below the native valve are shown with dotted lines.
[0121] Correct placement of the mooring device 1100 can be very important. In one embodiment, the mooring device 1100 must be positioned in relation to the native valve 1810 so that a desired part of the mooring device 1100 extends through the native valve 1810 at or near the A3P3 commissure, and contact the side of the native cusps. As can be seen, for example, in figure 19, a proximal part of the central region 1110 of the mooring device 1100 extends between the proximal end of the cover or braided layer 1180 and the extension region 1140, where the ePTFE or low layer friction 1170 remains exposed. Preferably, this ePTFE or low friction region is the part of the 1100 mooring device that crosses the mitral plane and comes into contact with the atrial side of the native cusps. Meanwhile, the part of the mooring device 1100 that passes through the mitral valve can be, for example, the part of the exposed central region 1110 proximal to the end of the cover layer or braided 1180, or it can also include part of the proximal end of the layer of cover or braided 1180 as well.
[0122] The advance of the lower spirals or ventricular spirals of the mooring device 1100 into the left ventricle, must be accurate. To facilitate this, one or more marker bands or other display accessories can be included in any of the mooring devices described here. Figure 21 illustrates a top view of a modified embodiment of the mooring device 1100, where two marker bands 1182, 1184 have been added to the mooring device 1100. Marker bands 1182, 1184 are positioned close to each other. While the marker bands and / or display accessories can be located in various locations, in figure 20, a first marker band 1182 is positioned at the proximal end of the high friction layer 1180, while a second marker band 1184 is positioned at a shorter distance from the proximal end of the high friction layer 1180. One marker band 1182 can be made thicker than the other marker band 1184, so that the two can be easily distinguished. Marker bands 1182, 1184 or other visualization accessories provide landmarks to easily identify the position of the proximal end of the high friction layer 1180 with respect to both the delivery catheter and the native mitral anatomy. Therefore, a physician can use marker bands 1182, 1184 or other visualization accessories to determine when to stop the 1100 mooring device from advancing into the left ventricle (for example, when marker bands are in a commissure close to orientation A3P3), and to initiate the release or exposure of the remaining proximal part of the mooring device 1100 into the left atrium. In one embodiment, the marker bands 1182, 1184 are viewed under fluoroscopy or another 2D imaging modality, but the invention should not be limited to that. In some embodiments, one or both of the marker bands are positioned on the low friction layer 1170 near the end of the braided layer 1180, or on other parts of the mooring device 1100 based on user preference. In other embodiments, less or more marker bands can be used. The braided layer 1180 can extend through the part of the mooring device coils that engages the replacement heart valve.
[0123] Any of the mooring devices shown here can be further modified, for example, to facilitate or assist in the advancement of the mooring device to a suitable position with respect to the native valve. Modifications can also be made, for example, to help protect the native valve and other native heart tissue from damage caused by the docking device during implantation or positioning of the docking device. For mitral applications, when a front or distal tip of a spiral-shaped docking device, similar to the previously described, is introduced and rotated into position in the left ventricle, the distal tip can be sized, shaped and / or otherwise configured to more easily navigate around and encircle the tendon cord. On the other hand, the distal tip must also be created in a non-traumatic way so that advancing the distal tip around and / or through the mitral valve or other valve anatomy does not damage the anatomy.
[0124] Meanwhile, in some embodiments, the proximal end of the mooring device is attached to an impeller in the delivery catheter, which pushes the mooring device out of a distal opening of the catheter. The terms impeller, impeller, and impeller rod are used interchangeably here and can be substituted for each other. While attached to the mooring device, the impeller can assist in pushing or retracting or retrieving the mooring device with respect to the delivery catheter, in order to allow the mooring device to be repositioned at any stage throughout the distribution process. The methods described here can include several steps related to retrieving and repositioning the mooring device, for example, retracting a push / suture / lashing rod or other accessory to pull / retract the mooring device back into the catheter. distribution, then repositioning and redeploying the docking device in a different position / orientation or location. For mooring devices that have a cover layer, such a fabric layer, which covers a spiral skeleton of the mooring device, adjustments of the mooring device by the impeller can result in friction forces applied against the cover layer, particularly in parts located at the proximal and distal ends of the mooring device, for example, by the cardiac anatomy and / or by the impeller / impulse rod / impulsion device itself. Therefore, the structure at the spiral ends of the mooring device and the connection techniques (for example, adhesion or suture techniques) to connect the tissue layer to the spiral can both be important to handle and deal with such frictional forces. and to prevent tearing of the tissue layer from the spiral or the ends of the spiral.
[0125] In view of the above considerations, the 1100 mooring device may include non-traumatic distal and proximal tips. Figure 22 illustrates a cross section of the proximal end of the mooring device 1100, illustrating the respective geometries of the wire core 1160, for example, which can be made of NiTi and a low friction covering layer 1170, for example, which can be made of ePTFE or other polymer. The low friction cover layer 1170, for example, can extend slightly in front of the end of the wire core 1160 and taper downwardly to a rounded tip. The rounded extension region provides space for the low-friction covering layer 1170 to anchor in and around the 1160 wire core, while also forming a non-traumatic tip. The distal end of the mooring device here (for example, mooring device 1100) can be constructed or arranged to have a similar structure.
[0126] With reference to figures 19 and 22, the mooring device 1100 may optionally include additional fixing holes 1164 near each proximal tip and distal tip. The fixing holes 1164 can be used to additionally fix the cover layer 1170 to the wire core 1160, for example, through a suture or other tie. This and / or similar fastening measures can additionally prevent sliding or movement between the core 1160 and the cover layer 1170 during the unfolding and / or recovery of the mooring device 1100. Optionally, the cover layer 1170 can be adhered , cast, molded, etc. around the nucleus without suture.
[0127] In some embodiments, the distal end of the mooring device 1100 can be tapered slightly and radially inward, for example, so that it is tangential to the circular shape formed by the spirals of the central region 1110. Similarly, the spiral / stabilization loop or the upper region 1130 of the mooring device 1100 can also taper slightly and radially inward, for example, so that it is tangential (or has a part that is tangential) to the circular shape formed by the spirals of the central region 1110, and it can also, for example, be pointed slightly upwards towards the atrial roof and away from the other spirals of the mooring device 1100. The upper region 1130 of the mooring device 1100 can be configured in this way as a precautionary measure, for example example, if the 1100 mooring device is not located in the desired position discussed above and slides in the direction of the left ventricle , where the upper 1130 region can potentially come into contact with the mitral plane, or if the 1100 mooring device is being implanted into the heart with an abnormal anatomy.
[0128] With regard to facilitating the attachment of the mooring device 1100 to a pusher / impeller or other advance or recovery mechanism in the delivery catheter, the proximal end of the mooring device 1100 may additionally include a second hole or hole 1162. As illustrated in figure 22A, hole or hole 1162 can be dimensioned so that a holding device, such as a long release suture 1163, can be wound through it to connect or attach the mooring device 1100 to the distal end of the impeller or other delivery catheter accessory. Hole 1162 can be rounded or smooth to avoid unintentional cutting of the release suture. The release suture provides a more secure attachment of the mooring device 1100 to the delivery catheter, and may also allow retraction by retraction of the mooring device 1100 when the mooring device 1100 position retracts, partial recovery, or full recovery, if desired. Figure 22C illustrates a closer view of the release suture 163 wrapped through hole 1162 of the mooring device 1100, where the exterior of the delivery catheter 1010 has been removed. A pusher device 1165 is configured as a pusher tube with a lumen extending through it, for example, from end to end. The suture in this mode runs through a longitudinal hole through the device / pusher tube 1165 kept inside the delivery catheter 1010. In the meantime, once the desired positioning of the mooring device 1100 has been achieved, the doctor or another user can simply cut a proximal part of the release suture and pull the release suture proximally to pass the cut end of the suture through hole 1162, thereby releasing the mooring device 1100 from the delivery catheter. In one embodiment, the suture can be rolled up and extended so that the suture extends from orifice 1162 through the 1165 thrust device / tube to an external loop or hub for the patient (the loop can be closed or opened with two attached ends handle or hub). When cut, a portion of the suture may remain attached to the loop or cube (or otherwise maintained by the healthcare provider), which may allow the suture to be pulled proximally until the cut end comes out of hole 1162 to release the distribution device. Figure 22B illustrates another embodiment of suture 1163 at the proximal end of the spiral, through orifice 1162.
[0129] Several additional modifications can be made to the distal tip or the proximal tip of either of the mooring devices described here, or both ends, which can make the mooring device more robust. Figure 23 illustrates a distal end of a spiral skeleton or core of a mooring device, according to another embodiment of the invention. The distal end of the spiral / core 710 can be made of or include Nitinol, another metal or memory material, and / or non-memory material. The distal end of the spiral / core 710 has a substantially flat or rectangular cross section, with a distal ring-shaped tip 712. The illustrated rectangular cross section can be formed in such a way only at one distal end of the spiral 710, or can be extend over the length of the spiral 710, while in other embodiments, the entire spiral 710, including the distal end region, may have a rounder cross-section or a cross-section of another shape. The ring-shaped tip 712 has an increased or expanded width compared to other parts of the spiral / core 710, and defines a hollow hole 714 to facilitate the passage of one or more sutures. A free end 716 of the ring-shaped tip 712 can be arranged as a circular or otherwise curved arc, while an opposite proximal end 718 of the tip 712 can be formed as a rounded or tapered transition portion between the tip 712 and a adjacent region of spiral 710. Near distal tip 712, spiral 710 may additionally include one or more anchor holes 720 to further assist in anchoring a cover layer that is located on and attached to spiral 710.
[0130] A covering layer covering the spiral / core skeleton 710 of the mooring device can be, for example, one or more of the covers or layers (for example, low friction and / or high friction covers), previously described . The cover layer can be made of or include, for example, an ePTFE core tube that is wrapped with a woven PET fabric, or it can be made of or include any other fabric or other biocompatible material. Such a cover layer can be used to cover most of the mooring device, for example, from a main body of the spiral / core skeleton 710 up to or slightly above the end 718 of the distal tip 712. The cover layer can , then, be connected to the distal ring-shaped tip 712, for example, through sutures that are passed through the hollow hole 714 and that are placed on top and cover the arched free end region 716. The sutures serve to anchor the cover layer on the spiral / core skeleton 710, and also serve to soften the edges of the ring-shaped distal tip 712. Additional sutures can also be passed through one or more cover anchor holes 720 near the distal tip 712 , to provide additional anchoring of the cover layer to the 710 spiral / core skeleton.
[0131] Figure 24 illustrates a distal end of a spiral skeleton or core of a mooring device that can be used with any of the mooring devices described here. The distal end of the spiral / core 810 can also be made of or include Nitinol, another metal or memory material and / or other non-memory material. The distal end of the spiral / core 810 has a spherical-shaped distal tip 812. The spherical-shaped tip 812 can be made with the rest of the spiral / core skeleton 810, or it can have a separate spherical shape or short rod shape with a rounded end that is welded to or otherwise fixed to the distal end of the spiral / core 810. Meanwhile, a small space 814 is formed or left between the spherical shaped tip 812 and the rest of the spiral / core 810. The space 814 can be approximately 0.6 mm or any other size that is sufficient to facilitate passage through and / or crossing over one or more sutures to anchor or otherwise connect a covering layer to the distal end of the spiral / core 810.
[0132] One or more cover layers or covers that cover the 810 spiral / core skeleton of the mooring device may be similar to the previously described cover layers or covers. The cover / cover layers can be made of or include, for example, an ePTFE core tube that is wrapped with a woven PET fabric, or can be made of or include any other fabric or other biocompatible material. In a fixation method, such a cover / cover layer covers a main body of the spiral skeleton 810, over the space 814, and up to or slightly above the 812 ball-shaped tip, while leaving a free end of the ball-shaped tip 812 sphere exposed. The cover / cover layer is then connected to the distal end of the spiral 810, for example, through sutures that are passed through the space 814. In a second fixation method, the entire ball-shaped tip 812 is wrapped with and fully covered by the cover layer, and sutures are then passed through and / or crossed over the space 814 to anchor the entire cover layer over the tip of the ball-shaped tip 812.
[0133] The distal tips 712, 812 as illustrated and described with reference to figures 23 and 24 provide their respective docking devices with distal ends that are rounded with compact noses that allow easier and more convenient navigation of their respective docking devices. inside the left ventricle. In addition, since each of the tips 712, 812 is curved or rounded, the tips 712, 812 form ends with soft edges. The shapes and structures at the distal ends of the respective spiral skeletons 710, 810, the type, texture and construction of the cover layer, and the suture techniques for attaching the cover layer to the spiral skeletons 710, 810 also allow tight connections between the distal tips 718, 812 and the respective covering layers, without using glue or any other adhesive. In addition, the construction and tip arrangements prevent the exposure of any sharp edges, and also prevent the surfaces of the spiral skeletons 710, 810 from cutting and / or protruding out of the cover layers as a result of any frictional forces that they are applied to the cover layers of the mooring devices during or after distribution.
[0134] As discussed above, in some modalities, the mooring device can be fixed to an impeller which can facilitate the thrust and retraction of the mooring device for distribution and readjustment purposes. Figure 25 illustrates a proximal end of a spiral / core skeleton 910 of a mooring device 900 (which can be the same as or similar to other mooring devices described here), and Figure 26 illustrates the proximal end of the mooring device 900 with a cover layer 920 over the spiral / core skeleton 910, and sutures 930 securing the cover layer 920 to the spiral / core skeleton 910.
[0135] Referring first to Figure 25, the spiral / core skeleton 910 of the mooring device 900 has a proximal end region that has a substantially flat or rectangular cross section, similar to the cross section of the distal end of the spiral / core 710 discussed above. The illustrated rectangular cross section can be shaped in such a way only in the region of the proximal end of the spiral / core 910, or can extend over the length of the spiral / core 910, while in other modalities, the entire spiral / core 910, including the proximal end region, it may have a rounder cross-section or cross-section of another shape. An elongated or oval cut hole 912 extends through the proximal end region of the spiral / core 910, where two flanks 914, 916 of the spiral / core 910 extend along each side of the cut hole 912 to connect the proximal free end 918 from the spiral / core 910 to the rest of the spiral / core 910. The cut hole 912 has a width that is sufficient to cross or cross a needle and / or one or more sutures 930.
[0136] As shown in figure 26, the cover / cover layer 920 can be, for example, a cover, layer of fabric, or another layer equal or similar in construction to that discussed above, with respect to the previous modalities of the mooring device . The cover / cover layer 920 is wrapped around the spiral / core skeleton 910, and is anchored or otherwise attached to the spiral / core 910 by sutures 930 that run along and cross the cut spindle 912. The sutures 930 can cross cut hole 912 in an "8" shape, as shown in figure 26, where a suture 930 crosses cut hole 912 at least twice and is wrapped around opposite sides 914, 916 of the adjacent spiral / core 910 to the cut hole 912 at least once each. In the illustrated embodiment, suture 930 is passed through cut hole 912 at least twice each. Sutures 930 are positioned on or moved towards a proximal part of cut hole 912, close to the free end 918 of the spiral / core skeleton 910, so that a distal end of cut hole 912 remains exposed and accessible to a user, and remains open and large enough, for example for a 940 retraction cord (for example, release suture) from a delivery catheter impeller to pass or cross, thus establishing a safety connection between the 900 mooring device and the impeller. The retraction thread 940 can be a suture.
[0137] When the mooring device 900 is connected to the impeller via the retraction wire 940, a distal end of the impeller (not shown) rests against the proximal free end of the mooring device 900 or the retraction wire 940 rests against the distal end of the cut hole 912, in order to advance the mooring device 900 out of the delivery catheter. Meanwhile, when it is desirable for the docking device 900 to be pulled back or retracted, for example, to readjust a position of the locking device 900 at the implantation site, the retraction cord 940 can be pulled proximally to retract the mooring device 900 proximally, too. Similar steps can be used with other mooring devices. When the retraction thread 940 is pulled back, the retraction thread rests against the sutures 930 that extend through the cut hole 912, which, due to the "8" suture, forms a region of cross suture that it serves to provide a padded landing region against which the 940 retraction cord can rest. Therefore, sutures 930 serve to anchor and secure cover layer 920 to the spiral / core skeleton 910, while also masking or covering the sharp edges of cut hole 912, to protect retraction wire 940 from damage or breakage caused by the device mooring 900, and conversely, to protect the mooring device 900 from damage by the 940 retraction cord, during recovery or other retraction of the mooring device 900.
[0138] Like the distal end provisions discussed with respect to figures 23 and 24, the shape and structure at the proximal end of the 910 spiral / core skeleton, the type, texture and construction of the 920 covering layer, and the technique connection points (eg suture technique) to fix the cover / cover layer 920 to the spiral / core skeleton 910 each contribute to a tight connection between the proximal end of the spiral 910 and the cover / cover layer 920 , and can be performed without the use of glue or any other adhesives (for example, the suture technique does not require them). In addition, the cutting edge construction and arrangement prevents the exposure of any sharp edges, and also prevents the surfaces of the 910 spiral / core skeleton from cutting and / or projecting out of the 920 cover / layer as a result of any friction that are applied to the cover / cover layer 920 of the docking device 900 during or after distribution.
[0139] In several other modalities, all or any of the different accessories of different modalities discussed above can be combined or modified, based on the needs of each individual patient. For example, different accessories associated with several different issues (for example, flexibility, increased friction, protection) can be incorporated into the mooring devices as needed for each individual application, based on specific characteristics or requirements of the particular patient.
[0140] Modalities of the mooring devices presented here have generally been discussed above to assist the anchor replacement valves in the mitral position. However, as also mentioned above, mooring devices, as described or slightly modified versions, can also be applied in ways similar to valve replacements in other valve locations as well, for example, in tricuspid, pulmonary or aortic positions. Patients who are diagnosed with insufficiencies in any position may exhibit enlarged rings that prevent native cusps from coapping properly and may also cause the rings to become too large, too soft or otherwise sick to maintain an expandable valve safely . Therefore, the use of a rigid or semi-rigid mooring device can also be beneficial to anchor a replacement valve such as these valve locations as well, for example, to prevent replacement valves from dislodging during normal cardiac function.
[0141] The mooring devices shown here can be additionally covered with one or more covers or layers of cover, in a similar way to the one discussed above. In addition, cover layers for any of these applications can also be made of or include a material that promotes faster internal tissue growth. The cover layer can be additionally constructed to have a greater amount of surface area, for example, with a velvety film, porous surface, braided surface, etc., for internal growth of additional reinforcement fabric.
[0142] Mooring devices similar to those discussed above, when applied to valves in addition to the mitral valve, can also provide a safer landing zone in these locations as well. The mooring devices and associated replacement valves can be applied in a similar manner as discussed with respect to implantation in the mitral valve. A possible access point for tricuspid replacement can be, for example, transeptal access, while a possible access point for aortic replacement can be, for example, transfemoral access, although access to respective valve sites is not. limited to that. The use of spiral-shaped mooring devices, as described above, in other valve locations can also serve to tighten or circumferentially tighten the native cusps after the development of the replacement valve on the native ring, for example, by virtue of the cusps and other fabric being interposed between the coils of the mooring device and held in place by a spring force of the mooring device, which additionally prevents the sliding or other movement of the mooring device and the interleaved fabric in relation to the mooring device, and prevents unwanted growth or expansion of the native ring over time.
[0143] For the purposes of this description, certain aspects, advantages and novelty of the modalities of that description are described here. The above methods, apparatus and systems should not be considered as limiting. Instead, the present description is directed to all the new and non-obvious features and aspects of the various modalities described, alone and in various combinations and subcombination with each other. The methods, apparatus and systems are not limited to any specific aspect or feature or combination of them and can be combined, nor do the described modalities require that any one or more of the specific advantages be present or problems are solved.
[0144] Although the operations of some of the described modalities are described in a particular sequential order for convenient presentation, it should be understood that this form of description encompasses the new provision, unless a particular order is required by the specific language presented bellow. For example, the operations or steps described sequentially may, in some cases, have a new disposition or can be carried out simultaneously. Furthermore, for the sake of simplicity, the attached figures may not illustrate the various ways in which the methods described can be used in conjunction with other methods. In addition, the description sometimes uses the terms "provide" or "achieve" to describe the methods described. These terms are high-level abstractions from the actual transactions that are carried out. Actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one skilled in the art.
[0145] In view of the many possible modalities to which the principles of description can be applied, it must be recognized that the illustrated modalities are only preferred examples and should not be considered as limiting the scope of the description. Instead, the scope of the description is defined by the following claims.

权利要求:
Claims (30)
[0001]
1. Mooring device for mooring a prosthetic valve to a heart valve, characterized by the fact that the mooring device (1100) comprises: a spiral anchor comprising: a proximal tip and a distal tip; at least one central loop (1110) having a first thickness and defining a central loop diameter; an extension (1140) having a length extending from an upper end of at least one central loop (1110), the extension (1140) having a second thickness which is less than the first thickness; an upper loop (1130) extending from an upper end of the extension (1140), the upper loop (1130) having a third thickness which is greater than the second thickness; and wherein the spiral anchor is configured to be implanted in the native valve with at least part of the at least one central loop (1110) of the spiral anchor positioned in a heart chamber and around the valve cusps of the native valve.
[0002]
2. Device according to claim 1, characterized in that the first thickness is at least 0.8 mm and the second thickness is between 0.4 to 0.8 mm.
[0003]
3. Device according to claim 1, characterized in that the spiral has a rectangular cross-sectional shape, and the first thickness and the second thickness are widths.
[0004]
4. Device according to claim 1, characterized in that the spiral has a circular or elliptical cross shape, and the first thickness and the second thickness are diameters.
[0005]
5. Device according to claim 1, characterized in that the length of the extension is between 5 to 100 mm, and creates a vertical separation between at least one central loop (1110) and the upper loop (1130).
[0006]
6. Device according to claim 1, characterized in that the diameter of the at least one central loop (1110) is between 20 and 30 mm. 6. Device according to claim 1, characterized in that it additionally comprises a lower loop (1120) extending from at least one central loop (1110), the lower loop (1120) having the first thickness and defining a bottom turn diameter that is larger than the center turn diameter.
[0007]
Device according to claim 7, characterized in that the third thickness is equal to the first thickness and in which the upper turn (1130) comprises a first diameter along a first geometry axis and a second diameter along a second geometric axis; wherein the first diameter of the axis is greater than the diameter of the center turn, and where the second diameter of the second axis is greater than the diameter of the center turn and less than the diameter of the lower turn.
[0008]
8. Device according to claim 8, characterized in that the first geometry axis diameter is between 40 to 80 mm, and the second geometry axis diameter is between 20 to 80 mm.
[0009]
Device according to claim 1, characterized in that the at least one central loop (1110) comprises between half and 5 turns, and the upper loop comprises between half and one turn.
[0010]
10. Device according to claim 8, characterized in that it additionally comprises a covering layer (1170) consisting of a biocompatible material, where the covering layer (1170) surrounds the spiral anchor.
[0011]
11. Device according to claim 11, characterized in that the cover layer (1170) extends at least along the part of the spiral anchor that is configured to be in contact with a replacement valve.
[0012]
Device according to claim 12, characterized in that it additionally comprises at least one friction-improving element comprising a plurality of protuberances on the surface of the spiral anchor or on the surface of the cover layer.
[0013]
13. Device according to claim 11, characterized in that the spiral anchor additionally comprises fixing holes near each proximal and distal end.
[0014]
14. Device according to claim 14, characterized in that the cover layer (1170) is attached to the spiral anchor with sutures extending through the spiral anchor fixing holes and through the cover layer.
[0015]
Device according to claim 11, characterized in that it further comprises a friction enhancement element comprising a second covering layer (1180) surrounding and extending over at least one length of the part of the length of the layer of cover (1170), where the second cover layer (1180) is connected to the first cover layer (1170) by sutures and provides a friction coefficient of at least 1.
[0016]
16. Device according to claim 16, characterized in that the second covering layer (1180) is a braided material.
[0017]
17. Device according to claim 16, characterized in that the second covering layer (1180) is a woven material.
[0018]
18. Device according to claim 16, characterized in that the second covering layer (1180) comprises pores having a diameter ranging in size from 30 to 100 microns.
[0019]
19. Device according to claim 1, characterized in that it additionally comprises at least one friction-enhancing element comprising a plurality of lock and key cutouts on the outer surface of the spiral anchor.
[0020]
20. Device according to claim 20, characterized in that the locking cutouts are grooves formed on the outer surface of the spiral anchor, and the keys are protrusions that extend outwards from the spiral anchor, dimensioned and shaped to fit in the locking cutouts.
[0021]
21. Device according to claim 1, characterized in that it additionally comprises a suture (1163) which is removably screwed through a hole (1162) in the proximal end and configured to be connected to an impeller device (1165) within a delivery catheter to retrieve the mooring device (1100).
[0022]
22. Device according to claim 22, characterized in that the suture (1163) is removably screwed through the hole (1162) at a location along a length of the suture (1163) and then the ends of the suture are threaded through a space between a central point of the suture and the proximal end of the spiral anchor.
[0023]
23. Device according to claim 1, characterized in that it additionally comprises a low friction covering layer, the low friction covering layer having a distal end and a proximal end, surrounding the spiral anchor and extending along of a length of the spiral anchor, in addition to the distal tip, and in addition to the proximal tip, the low friction cover layer having a rounded or tapered tip at its distal end and at its proximal end.
[0024]
24. Device according to claim 1, characterized in that the distal end of the spiral anchor is tapered slightly and radially inward in a direction tangential to a circular shape formed by the central loop (1110).
[0025]
25. Device according to claim 1, characterized in that the proximal end of the spiral anchor is tapered slightly and radially inward and is pointed in an upward direction.
[0026]
26. System for implanting the mooring device, as defined in claim 1, in the native valve, the system characterized by the fact that it comprises: a delivery catheter; a suture (1163) threaded through a hole (1162) at a proximal end of the mooring device; and a pusher device (1165) disposed in the delivery catheter; wherein the pusher device (1165) includes a central lumen; where the suture (1163) is arranged in the central lumen, so that the retraction of the suture (1163) and / or the pusher device (1165) proximally with respect to the delivery catheter retracts the spiral anchor into the delivery catheter .
[0027]
27. System according to claim 27, characterized in that the suture (1163) is threaded through the hole at a location along a length of the suture (1163) and then the ends of the suture are threaded through a space between the central point of the suture and the proximal end of the spiral anchor.
[0028]
28. Device according to claim 1, characterized by the fact that the mooring device (1100) is configured to be implanted in the native mitral valve with at least a portion of the mooring device (1100) positioned in and around the left ventricle of mitral valve cusps of the native mitral valve.
[0029]
29. System for implanting a prosthetic valve in a native valve, the system characterized by the fact that it comprises: a mooring device (1100) comprising: a spiral anchor comprising: a first loop comprising a first thickness and defining a diameter of the first loop , an extension (1140) having a length extending between a first end and a second end, the first end extending from the first loop in a direction not parallel to the first loop, and the extension (1140) having a second thickness which is less at the first thickness, a second loop extending from the second end of the extension (1140), the second loop having a third thickness that is greater than the second thickness and a hole at a proximal end, and
[0030]
30. System for implanting a prosthetic valve in a native valve, the system characterized by the fact that it comprises: a mooring device (1100) comprising: a spiral anchor comprising: a first loop comprising a first thickness and defining a diameter of the first loop , an extension (1140) having a length extending between a first end and a second end, the first end extending from the first loop in a direction not parallel to the first loop, and the extension (1140) having a second thickness which is less at the first thickness, a second loop extending from the second end of the extension (1140), the second loop having a third thickness that is greater than the second thickness and a hole at a proximal end, and in which the spiral anchor is configured to be implanted in the native valve with at least part of the first loop of the spiral anchor positioned in a chamber the heart and around valve cusps of the native valve, a delivery catheter, a suture (1163) threaded through the orifice, and an impeller device (1165) arranged on the delivery catheter, in which the impeller device (1165) includes a central lumen, in which the suture (1163) is arranged in the central lumen so that the retraction of the suture (1163) and / or the pusher device (1165) proximally with respect to the delivery catheter can retract the spiral anchor into the delivery catheter.

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法律状态:
2020-11-17| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-01-12| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 25/08/2017, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201662380117P| true| 2016-08-26|2016-08-26|

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US62/380,117|2016-08-26|

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US201662395940P| true| 2016-09-16|2016-09-16|

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US62/395,940|2016-09-16|

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US15/682,287|US10463479B2|2016-08-26|2017-08-21|Heart valve docking coils and systems|

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US15/682,287|2017-08-21|

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US15/684,836|US10687938B2|2016-08-26|2017-08-23|Heart valve docking system|

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US15/684,836|2017-08-23|

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PCT/US2017/048659|WO2018039589A1|2016-08-26|2017-08-25|Heart valve docking coils and systems|BR122020019883-4A| BR122020019883B1|2016-08-26|2017-08-25|mooring device for mooring a prosthetic valve|

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BR122020019887-7A| BR122020019887B1|2016-08-26|2017-08-25|SYSTEM FOR IMPLEMENTING A MOUNTING DEVICE|

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BR122020019881-8A| BR122020019881B1|2016-08-26|2017-08-25|mooring device for mooring a prosthetic valve|