Transcatheter prosthetic cusps for valvular regurgitation

Abstract

The present invention relates to an occlusion device, comprising a hollow tubular member including a proximal opening at its proximal end; b. a generally tubular surface extending distally from said proximal opening; c. a distal end. The occlusion device further comprises a grasping arm extending distally from said opening at said proximal end, wherein said distal end is either closed or comprises an aperture. The present invention relates to a method of delivering said device.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and more particularly to an artificial valve cusp for transcatheter treatment of valvular regurgitation. Background Art

[0002] Valvular regurgitation is the result of a leaky valve when the valve is in the closed position. The 4 types of valvular regurgitation are aortic regurgitation (AR), bicuspid regurgitation (MR), tricuspid regurgitation (TR), and pulmonary regurgitation (PR). When these lesions are at a level that causes symptoms or significant cardiac remodeling, the mainstay of treatment is valve replacement via heart shell surgery or, in some cases, catheter-based therapies. However, these treatments are limited to MR and TR in certain settings.

[0003] For example, the aortic valve is located between the left ventricle and the aorta. When the left ventricle contracts during each heartbeat (systole), the pressure in the left ventricle rises. When the pressure in the left ventricle rises above the pressure in the aorta, the aortic valve opens, allowing blood to leave the left ventricle and enter the aorta. The left ventricle actually pushes blood through the three flexible, cup-shaped leaflets that make up the aortic valve. When the left ventricle releases (when ventricular systole ends), the pressure in the left ventricle drops rapidly, and the pressure in the aorta forces the aortic valve to close. The aortic valve closes, preventing blood from flowing back into the left ventricle.

[0004] However, in the case of AR, valve leakage occurs when the aortic valve is in the closed state. In the closed state, the leaflets of the aortic valve are partially closed, leaving a portion of the aortic valve open (regurgitant orifice), which causes some blood to flow back into the left ventricle. This requires the heart to work harder, causing the patient's health to deteriorate. Figure 1A An example of a healthy normal heart is shown, where the aortic valve is completely closed. Figure 1B An example of AR is shown in which the abnormal aortic valve fails to close completely, allowing blood to flow back into the left ventricle.

[0005] Mutually, similar leaks were reported for the bicuspid, tricuspid, and pulmonary valves in the cases of MR, TR, and PR, respectively.

[0006] US 2015 / 0230919 A1 describes a method for lengthening bicuspid or tricuspid valve leaflets. The device is implanted around the leaflets, thereby extending the leaflets and possibly closing the malcoaptation gap.

[0007] However, prior art methods can be highly invasive and high risk procedures. The implant-based heart in prior art methods can be intolerant to the implant location. Furthermore, there remains a need for improved effective closure of the gap.

[0008] It is therefore an object of the present invention to provide a method and apparatus for preventing blood leakage in cases of AR, MR, TR and PR.

[0009] Another object of the present invention is to provide a device for preventing the above-mentioned blood leakage.

[0010] Another object of the present invention is to provide a method for delivering the same.

[0011] Other objects and advantages of the invention will become apparent as the description proceeds. Summary of the invention

[0012] The present invention relates to devices for alleviating valvular regurgitation. The present invention relates to treating valvular regurgitation by attaching artificial valve cusps to natural or artificial valve cusps or leaflets. By doing so, it improves heart function by preventing or reducing valve leakage. When the valve is in the open state, the artificial valve cusps are retractable to prevent valve stenosis.

[0013] The present invention relates to a blocking device, which includes a hollow tubular member having an opening and an elongated grasping arm extending from the opening so that a small gap is formed between the grasping arm and the hollow tubular member. The blocking device is installed at the heart valve cusp / leaflet of a heart valve with valvular insufficiency (having a regurgitant hole). The blocking device is installed in a manner such that the side / wall of the cusp / leaflet is positioned within the small gap. This is achieved by moving the grasping arm at an angle so that the gap is significantly increased, placing the gap on the corresponding cusp / leaflet side / wall, and returning the grasping arm at an angle so that the gap is reduced again, thereby effectively installing the device on the cusp / leaflet side / wall. When the heart valve is in a closed state, the relatively wide opening of the blocking device substantially closes the regurgitant hole, thereby preventing blood leakage.

[0014] The present invention relates to a blocking device, comprising:

[0015] A hollow tubular member comprising:

[0016] a. a proximal opening at its proximal end;

[0017] b. A generally tubular surface extending distally from the proximal opening;

[0018] c. distal end;

[0019] a grasping arm extending distally from said opening at said proximal end;

[0020] The distal end is either closed or includes a small hole.

[0021] Preferably, the hollow tubular member comprises a membrane.

[0022] Preferably, the membrane is self-expanding.

[0023] Preferably, the blocking device further comprises a frame, the frame comprising one or more metal wires;

[0024] wherein the membrane is mounted on the frame.

[0025] Preferably, the hollow tubular member tapers distally.

[0026] Preferably, a fine gap is formed between the gripping arm and the generally tubular surface.

[0027] Preferably, the gripping arm comprises a first set of connecting elements.

[0028] Preferably, said first set of connecting elements are selected from the group consisting of biocompatible needles, biocompatible pins and biocompatible staples.

[0029] Preferably, the first set of connecting elements are biocompatible needles extending proximally and obliquely.

[0030] Preferably, the generally tubular surface comprises a second set of connection elements.

[0031] Preferably, said second set of connecting elements are selected from the group consisting of biocompatible needles, biocompatible pins and biocompatible staples.

[0032] Preferably, the second set of connecting elements are biocompatible needles extending proximally and obliquely from the generally tubular surface.

[0033] Preferably, the blocking device further comprises a proximal ring attached to said proximal opening.

[0034] Preferably, the occlusion device further comprises a distal ring attached to the distal end portion of said hollow tubular member.

[0035] Preferably, the proximal ring and the distal ring face and are aligned with each other.

[0036] Preferably, the grasping arm comprises a loop at its distal end.

[0037] The present invention relates to a method for implanting an occluding device as described herein onto a heart valve cusp or leaflet, wherein the occluding device comprises a proximal ring attached to a proximal opening;

[0038] The method comprises:

[0039] Creates openings in blood vessels;

[0040] Insertion of the introducer sheath;

[0041] inserting a guide wire through the guide sheath and passing it through the blood vessel until it reaches the heart valve and through the heart valve to the corresponding heart chamber;

[0042] providing an inner sheath extending through the proximal ring of the occluding device, and

[0043] The inner sheath tube is configured to include a thickened portion disposed proximal to the proximal ring,

[0044] advancing the inner sheath over the guidewire until the device is placed in front of a corresponding heart valve;

[0045] providing a cord that is inserted through the guide sheath and passes through an opening in the inner sheath and through a loop of the grasping arm and returns to the guide sheath through the opening in the inner sheath so that both ends of the cord extend out of the guide sheath,

[0046] pulling the two ends of the rope proximally to open the grasping arms;

[0047] positioning the blocking device to a correct intended position;

[0048] pushing the blocking device distally;

[0049] releasing the two ends of the rope distally, thereby closing the grasping arms;

[0050] Retracting the inner sheath proximally;

[0051] retracting one end of the cord proximally until the cord clears the loop of the grasping arm, and continuing to retract the cord proximally until the cord is fully retracted;

[0052] retracting the guidewire proximally;

[0053] The introducer sheath is removed.

[0054] The present invention also relates to a blocking device, wherein the blocking device comprises a hollow tubular member, wherein the hollow tubular member comprises:

[0055] a. a distal opening at its distal end;

[0056] b. A generally tubular surface extending proximally from the distal opening;

[0057] c. proximal;

[0058] wherein the blocking device further comprises a grasping arm extending proximally from the opening at the distal end;

[0059] Wherein, the proximal end is either closed or includes a small hole.

[0060] Preferably, the grasping arm comprises a loop at its proximal end.

[0061] Preferably, the occluding means comprises a proximal ring attached to a proximal portion of the hollow tubular member.

[0062] The present invention relates to a method for implanting an occluding device into a heart valve cusp or leaflet,

[0063] Wherein, the blocking device comprises a hollow tubular member, and the hollow tubular member comprises:

[0064] a. a distal opening at its distal end;

[0065] b. A generally tubular surface extending proximally from the distal opening;

[0066] c. proximal;

[0067] wherein the blocking device further comprises a grasping arm extending proximally from the opening at the distal end;

[0068] wherein the proximal end is either closed or includes a small hole;

[0069] wherein the grasping arm comprises a loop at its proximal end; and

[0070] wherein the blocking device comprises a proximal ring attached to a proximal portion of the hollow tubular member;

[0071] The method comprises:

[0072] Creates openings in blood vessels;

[0073] Insertion of the introducer sheath;

[0074] inserting a guide wire through the guide sheath and passing it through the blood vessel until it reaches the heart valve and through the heart valve to the corresponding heart chamber;

[0075] providing an inner sheath passing through the proximal ring of the occluding device, and

[0076] The inner sheath tube is configured to include a thickened portion disposed proximal to the proximal ring,

[0077] advancing the inner sheath over the guidewire until the device is placed in the corresponding ventricle;

[0078] providing a cord that is inserted through the guide sheath and passed through an opening in the inner sheath distal to the distal ring and passed through the loop of the grasping arm and returned to the guide sheath through the opening in the inner sheath so that both ends of the cord extend out of the guide sheath,

[0079] pulling both ends of the rope proximally to open the grasping arms;

[0080] positioning the blocking device to a correct intended position;

[0081] pulling the blocking device proximally;

[0082] releasing the two ends of the rope distally, thereby closing the grasping arms;

[0083] retracting one end of the cord proximally until the cord clears the loop of the grasping arm, and continuing to retract the cord proximally until the cord is fully retracted;

[0084] Retracting the inner sheath proximally;

[0085] retracting the guidewire proximally;

[0086] The introducer sheath is removed. BRIEF DESCRIPTION OF THE DRAWINGS

[0087] The present invention is illustrated by way of example in the accompanying drawings, in which like reference numerals indicate like elements throughout, and in which:

[0088] - Figure 1A and Figure 1B A normally functioning aortic valve of the heart and an aortic valve of the heart with aortic regurgitation are shown respectively.

[0089] - Figure 2A and Figure 2B An embodiment of the present invention is shown.

[0090] - Figure 2C A hollow tubular member according to an embodiment of the present invention is shown.

[0091] - Figure 3A-3B The opening and closing of the aortic valve with aortic regurgitation are shown in the open state and the closed state, respectively.

[0092] - Figure 3C-3D They are shown respectively as Figure 3A-3B Opening and closing of the aortic valve with aortic regurgitation is shown in open and closed states, but the aortic valve is functioning with a device according to an embodiment of the present invention.

[0093] - Figures 4A-4C Schematic representations of an aortic valve with regurgitation only, with blood leakage and with the present invention are shown, respectively.

[0094] - Figure 5 A diagram of the present invention attached to a single cusp is shown.

[0095] - Fig. 6Aand Figure 6B An embodiment of the present invention is shown.

[0096] - Figure 7 Examples of embodiments of the invention are shown on bivalve and trivalve cusps.

[0097] - Figures 8A-8N An example of a delivery method step of the method of the present invention is shown.

[0098] - Fig. 9 A step of a delivery method according to an embodiment of the present invention is shown. DETAILED DESCRIPTION

[0099] The present invention relates to an artificial valve cusp. More specifically, the present invention relates to a blood leakage blocking device comprising a hollow tubular member that can be attached to the cusp / leaflet of one of the natural heart valves (aortic valve, bicuspid valve, pulmonary valve, tricuspid valve). When the blocking device is in its closed state, the blocking device effectively causes the natural heart valve to be completely closed. The hollow tubular member can be regarded as a support for the cusp / leaflet, which is an additional part that moves with the cusp / leaflet when it opens and closes the valve. The device of the present invention is also referred to as a "tip device" herein.

[0100] The device of the present invention will be described with reference to the aortic valve, but may similarly be attached mutatis mutandis to the cusps or leaflets of other natural or artificial heart valves.

[0101] In this specification, "proximal" refers to the end closest to the medical staff delivering the device. "Distal" refers to the end farthest from the medical staff during delivery of the device and closest to the target location in the patient's body. For embodiments of the device of the present invention inserted through the aorta (toward the left ventricle), the "distal direction" refers to the direction toward the left ventricle, while the "proximal direction" refers to the opposite direction, i.e., the direction toward the aorta, away from the left ventricle. Therefore, blood passing through the aortic valve flows from the distal end to the proximal direction.

[0102] In the case of a heart with aortic regurgitation, valve leakage occurs when the aortic valve is in a closed state. The leaflets / cusps are partially closed in the aortic valve closed state, causing a portion of the aortic valve to open, which causes a portion of the blood to flow back into the left ventricle. The structure of the present invention is such that when the aortic valve is in a closed state, the blocking device connected to one of the cusps is located in the regurgitant orifice of the aortic valve and effectively blocks the valvular regurgitation "opening" at the aortic valve regurgitant orifice. Therefore, blood from the aorta does not leak back into the left ventricle (but part of the blood only enters the interior of the hollow tubular member of the blocking device).

[0103] The blocking device of the present invention comprises a hollow tubular member that can be attached to the valve cusp. The hollow tubular member of the blocking device comprises a proximal open end, a lateral (side) tubular surface, and a closed (sealed) distal end or an end provided with a small hole / aperture (for wire passage, as will be described below with reference to the delivery of the device). More specifically, the hollow tubular member of the blocking device comprises a proximal opening at its proximal end, a generally tubular surface extending distally from the proximal opening, and a closed distal end (or an end provided with a small hole).

[0104] The device, when attached to the cusp, is configured as either:

[0105] 1. With the distal end completely closed, blood can enter the interior of the hollow tubular member only from the proximal opening and then flow out of the interior of the hollow tubular member (ie, the lateral (side) tubular surface is completely closed / sealed together with the distal end).

[0106] 2. In the case where the distal end includes a small hole, most of the blood can enter the interior of the hollow tubular member from the proximal opening and then flow out from the interior of the hollow tubular member, but a very small portion of the blood can flow out from the small hole at the distal end. However, this has minimal effect on cardiac function, and most of the potential leaking blood is blocked by the blocking device.

[0107] The proximal opening is located near the proximal end (at the edge) of the cusp, adjacent to the inner side of the cusp, so that when the aortic valve is in a closed state, the blocking device blocks the valvular regurgitation "opening" at the regurgitant orifice of the aortic valve.

[0108] The hollow tubular member of the blocking device is compressible and can expand so that the volume inside it can change. During systole, when the aortic valve is in its open state, blood flowing out of the left ventricle with a considerable current causes the blocking device to be partially compressed and its internal volume is thereby reduced. During diastole, when the aortic valve is in its closed state, blood from the aorta can enter the interior of the blocking device (potentially increasing its expansion and increasing the internal volume of the blocking device). In any case, during diastole, blood does not flow back into the left ventricle because it is blocked by the blocking device, which engages the inner side of the other cusps and effectively forms a seal that does not allow blood to pass through the engagement position between the blocking device and the inner side of the cusps (the side facing the center of the valve). The blocking device effectively causes the natural valve of the heart to be completely closed in its closed state, just like a healthy heart. In some embodiments, the blocking device of the present invention does not form a complete seal (at the regurgitant orifice), but reduces blood leakage, which also improves the health of the patient.

[0109] The opening of the hollow tubular member of the blocking device is attached (on its proximal side) near the inner side of the proximal end of the cusp. The blocking device extends distally near the cusp to which it is attached and along the cusp. Preferably, the blocking device tapers distally. In this way, the wide proximal end of the hollow tubular member of the blocking device engages the proximal end of the cusp of the aortic valve (the cusp to which it is attached and the other cusps whose ends tend to be close to engage with each other), thereby producing an effective seal. The distal portion of the hollow tubular member of the blocking device attached to the cusp can be narrower than the wide proximal opening because it is attached to the distal portion of the cusp and does not need to be widened to block. This configuration enables the blocking device to have the minimum mass for the most effective function. The proximal opening is configured to be wide enough to block.

[0110] According to one embodiment of the present invention, the hollow tubular member of the blocking device is in the form of a deformable membrane. The membrane (in the shape of the hollow tubular member) includes a proximal opening, a lateral tubular surface, and any of the following:

[0111] 1. Closed distal end (preferably tapering distally from the opening along the lateral tubular surface to the distal end). The interior of the membrane is completely closed / sealed (except for the proximal opening).

[0112] 2. A distal end comprising a small hole (preferably tapering distally from the opening along the lateral tubular surface to the distal end). The interior of the membrane is closed (except for the proximal opening and the distal hole).

[0113] During systole, the membrane may be partially compressed (by systolic blood flow), while during diastole, the membrane may expand as blood "leaks" into the interior of the hollow tubular member, thereby increasing its volume.

[0114] According to one embodiment, the membrane is self-expandable (e.g., elastic). During systole, the membrane is partially compressed (by systolic blood flow), and during diastole, the membrane expands. The membrane may include artificial sources, biocompatible materials (e.g., Dacron, Teflon, etc.), or biological sources (e.g., animal valve cusps, animal pericardium, etc.).

[0115] According to another embodiment of the present invention, the blocking device comprises a frame including one or more wires defining its general shape. The wires are configured so that they form a generally hollow tubular shape with a closed distal end. The frame wires are configured so that a film is attached thereto, thereby forming a reinforced hollow tubular member having a proximal open end, a lateral tubular surface extending distally from the proximal open end, and a closed distal end (optionally with an aperture). The film is actually mounted on the frame. Preferably, the frame shape tapers distally.

[0116] The blocking device of the present invention includes a grasping arm that extends distally from a proximal opening along the outer side of a lateral tubular surface of a hollow tubular member, wherein a fine gap is provided between the grasping arm and the outer side of the lateral tubular surface. When the blocking device is inserted, it is mounted on the cusp to which it is attached so that the cusp is located within the fine gap. The outer side of the lateral tubular surface engages with the inner side of the cusp, and the grasping arm engages with the outer side of the cusp. The grasping arm includes a connecting element that can be connected to the cusp.

[0117] Figure 2A One embodiment of the blocking device 10 of the present invention is shown. The blocking device 10 includes a membrane that forms a hollow tapered tubular member 5 with a proximal opening 12. The interior of the tapered tubular member 5 is completely closed / sealed by the membrane (except for the proximal opening 12). A lateral tubular surface 6 extends distally from the proximal opening 12, tapers distally and terminates in a closed distal end 7 (wherein in other embodiments (not shown) the distal end may include a very small hole).

[0118] Figure 2B An embodiment of a blocking device 10 of the present invention is shown, which includes a frame including one or more metal wires that define its general shape. The membrane (not shown) of the blocking device 10 is attached to the frame so that the frame and the membrane attached to the frame together form a hollow tapered tubular member 5 with a proximal opening 12 (wherein the interior of the tapered tubular member 5 is completely enclosed / sealed by the membrane except for the proximal opening 12). In one embodiment, the frame is outside the membrane layer. In another embodiment, the metal wires of the frame may be contained within the membrane layer.

[0119] The tapered tubular member 5 comprises an annular (preferably circular) wire portion at its proximal side forming a proximal opening 12. The tapered tubular member 5 comprises one or more longitudinal wire elements 13 along its length. The tapered tubular member 5 comprises one or more transverse wire elements surrounding one or more corresponding transverse portions of the tapered tubular member 5 disposed along its length. Figure 2B The embodiment of the embodiment shows three transversely encircling wire portions 14, 15, 16, each of which is in the form of a sine wave. Since the tapered tubular member 5 tapers distally, of every two adjacent transversely encircling wire portions, the more proximal transversely encircling wire portion is larger than the more distal transversely encircling wire portion (i.e., the more proximal transversely encircling wire portion surrounds a longer width portion). Here, wire portion 14 is larger than wire portion 15, and wire portion 15 is larger than wire portion 16.

[0120] The blocking device 10 of the present invention includes a gripping arm 20 (such as Figure 2A and 2BAs shown), the gripping arms 20 secure the device 10 to the cusp. Figure 2C Only the tapered hollow tubular member 5 is shown without the grasping arm 20. The grasping arm 20 is fixed to the proximal opening 12 and extends distally from the proximal opening 12 along the outer surface of the hollow tapered tubular member 5 (along the lateral tubular surface 6), with a fine gap 22 between the grasping arm 20 and the lateral tubular surface 6. When the occluding device 10 is inserted into the patient's body, it is mounted on the cusp so that the cusp is located within the fine gap 22 (between the lateral tubular surface 6 and the inner side of the grasping arm 20). The outer surface of the lateral tubular surface 6 of the tapered tubular member 5 engages the inner side of the cusp (the side facing the center of the valve), and the grasping arm 20 engages the outer side of the cusp (the side facing the vessel wall, i.e., the side facing the side wall of the ascending aorta).

[0121] The grasping arm 20 comprises a plurality of connecting elements 25 which can be connected to the cusps. Preferably, the plurality of connecting elements are located at the distal end portion of the grasping arm 20. Figure 2A-2B The multiple connecting elements 25 in the occlusion device 10 are biocompatible multiple needles that extend generally proximally (angled from the grasping arm 20) from the inner side of the grasping arm 20. In this way, when the cusp passes through the gap 22, the blocking device 10 can be inserted without damaging the cusp by the biocompatible multiple needles 25. When the blocking device 10 is fully inserted, the biocompatible multiple needles 25 pierce the outside of the cusp and thus permanently fix the blocking device 10 to the cusp.

[0122] Preferably, the outer surface portion of the lateral tubular surface 6 of the tapered tubular member 5 (generally the portion facing the grasping arm 20) includes a plurality of connection elements 26 connectable to the cusps. Preferably, the plurality of connection elements are located at the distal end portion of the outer surface portion of the lateral tubular surface 6 facing the grasping arm 20. Figure 2A-2B The multiple connecting elements 26 are biocompatible multiple needles that extend generally proximally (inclined from the lateral tubular surface 6) from the outer surface portion of the lateral tubular surface 6 that faces the grasping arm 20. In this way, the blocking device 10 can be inserted when the cusp passes through the gap 22 without the biocompatible multiple needles 26 damaging the cusp. When the blocking device 10 is fully inserted, the biocompatible multiple needles 26 pierce the inside of the cusp and thereby help secure the blocking device 10 to the cusp. Other types of connecting elements may be used, such as biocompatible multiple pins, biocompatible multiple nails, etc.

[0123] Figure 3A The aortic valve is shown in an open position with aortic regurgitation. Figure 3B The aortic valve is shown in the closed position with aortic regurgitation, where the leaking opening is visible. Figure 3CShown is an aortic valve in an open state with aortic regurgitation, with an occluding device 10 attached to the valve cusp. In this figure, the occluding device 10 is adjacent to the valve cusp as blood flows out of the left ventricle. Figure 3D The aortic valve is shown in a closed state with aortic regurgitation, wherein the leakage opening is blocked by the blocking device 10 .

[0124] Figure 4A A three-dimensional illustration of an aortic valve with regurgitation, three cusps 130 and a regurgitant orifice 140 is shown. Figure 4B Shows Figure 4A There is a blood leak 150. Figure 4C A three-dimensional illustration of the occlusion device 10 properly inserted within the aortic regurgitation orifice 140 is shown, the occlusion device 10 being configured to occlude blood leakage.

[0125] Figure 5 The occlusive device 10 is shown attached to a single native or prosthetic valve.

[0126] The frame wires, the gripping arms 20, the plurality of connecting elements 25, 26 may be made of a material selected from the group consisting of shape memory alloys, stainless steel, cobalt chromium alloys and nitinol. The frame is designed to withstand fatigue, be collapsible and / or self-expanding.

[0127] The overall length of the tapered tubular member 5 and the gripping arm 20 is typically between 4 mm and 8 mm (e.g. Fig. 6A 7mm as shown in the figure).

[0128] The diameter of the proximal opening 12 is usually between 6 mm and 8 mm (eg Fig. 6A shown).

[0129] The width of the gripping arm 20 is typically between 1 mm and 4 mm. The thickness of the gripping arm 20 is typically between 0.1 mm and 2 mm.

[0130] The diameter of the frame wire is usually between 0.1 mm and 1 mm.

[0131] The diameter of the connecting element biocompatible needles 25, 26 is typically between 0.1 mm and 0.4 mm. The length of the connecting element biocompatible needles 25, 26 is typically between 4 mm and 10 mm.

[0132] The thickness of the film is usually between 0.1 mm and 1 mm.

[0133] Figure 7 Examples of an occluding device 210 attached to a bicuspid valve leaflet and another occluding device 310 attached to a tricuspid valve leaflet are shown.

[0134] The present invention provides a device for closing a malcoaptation gap by filling the malcoaptation gap with an artificial cusp that adapts to the gap when filled with blood. The potential advantages of the present invention are that it provides better tolerance to the implantation site than the prior art leaflet lengthening method (in US 2015 / 0230919) and provides more effective gap closure. In addition, if necessary, a second device can be easily implanted next to the first device.

[0135] The present invention relates to a method for delivering a blocking device (e.g., a blocking device as defined herein) to an intended heart valve position via a delivery system, deploying and properly positioning the blocking device within the intended heart valve position so that it begins to function by improving the function of the heart valve. Figures 8A-8N A method of delivering the occluding device 10 of the present invention to its intended location at a heart valve cusp / leaflet is shown.

[0136] The delivery method of the present invention will be described with reference to the aortic valve, but delivery to the pulmonary artery (and many aspects of bicuspid and tripartite cusps) cusps / leaflets is similarly applicable mutatis mutandis.

[0137] According to an embodiment of the present invention, the delivery system includes an outer sheath 60 and an inner sheath 62 passing through the outer sheath. The delivery system includes a guide wire 63 that can slide through the inner sheath 62. Optionally, the guide wire is a particularly hard guide wire. Optionally, the guide wire 63 is a 035 type. The inner sheath 62 is configured so that the guide wire 63 can pass through the inner sheath 62.

[0138] Figure 6B An embodiment of an occluding device 10 is shown having a proximal ring 71 attached to the proximal opening 12 and a distal ring 72 attached to the distal portion of the tapered tubular member 5 (typically at the distal end of the tapered tubular member 5). Some embodiments may include only the proximal ring 71 and not the distal ring 72.

[0139] Preferably, the ring 71 and the ring 72 face each other and are aligned, and extend perpendicular to the surface (lateral tubular surface 6) of the tapered tubular member 5. The inner sheath 62 passes through the ring 71 and the ring 72. The inner sheath includes a thickened portion 62t, which is placed at the proximal end and adjacent to the proximal ring 71. In this way, when the sheath 62 moves distally, the thickened portion 62t pushes the proximal ring 71 distally and thus pushes the entire device 10 distally. Generally, the thickened portion 62t is located at the distal portion of the inner sheath 62, and the distance from the distal end is greater than the length of the tapered tubular member 5. During transportation, the blocking device 10 is located in the outer sheath 60 and is in a curled, compressed or shrunken state (e.g., curled to a small diameter less than 7 mm). The device is folded into a passive or compressed state (e.g., a preloaded state) in the delivery system.

[0140] The gripping arm 20 includes a loop 75 at its distal end. Figure 6B A loop 75 is shown attached to the distal end of the elongated portion of the grasping arm 20. The cord 66 extends through the guide sheath (at the proximal position where the medical staff operates the system), through the loop 75 and back into the guide sheath so that both ends of the cord 66 are accessible to the medical staff operating the system (so that both ends of the cord 66 extend out of the guide sheath). The grasping arm 20 tends to always be closed (i.e., tends to be adjacent to the outer surface of the tapered tubular member 5, leaving only a small gap 22). When the ends of the cord 66 are pulled proximally, the grasping arm 20 moves away from the outer surface of the tapered tubular member 5 (away from the lateral tubular surface 6). When the ends of the cord 66 are released, the grasping arm 20 returns toward the outer surface of the tapered tubular member 5 (towards the lateral tubular surface 6). The grasping arm 20 moves away from and toward the outer surface of the tubular member 5 (lateral tubular surface 6) in an angled manner because the proximal end of the grasping arm 20 is always attached to the proximal opening 12. The cord 66 may be passed through the inner sheath parallel to the guidewire or in a separate dedicated lumen and exit the inner sheath 62 at an appropriate opening near the location of the grasping arms 20 in order to pull and open the grasping arms 20 (to enlarge the gap 22).

[0141] The diameter of rings 71 and 72 is typically between 0.035" and 0.039".

[0142] The diameter of the ring 75 is typically between 0.5 mm and 2 mm.

[0143] The delivery system is such that the inner sheath 62 is placed in the delivery tube 64 and extends distally from the delivery tube 64, wherein the inner sheath 62 and the delivery tube 64 are connected so that they move distally together and move distally together. In the delivery system, the outer sheath 60 (in the initial stage, the inner sheath 62 is located in the outer sheath 64) is attached to the distal end of the delivery tube 64 and can pull the outer sheath 60 proximally so that the outer sheath 60 crosses the distal end of the delivery tube 64 in a coaxial manner. In any case, the outer sheath 60 and the delivery tube 64 are connected so that they move distally together and move proximally together (except when the outer sheath is moved separately in particular, as described below). The delivery system includes a proximal handle 65 for controlling the delivery system. The handle 65 is configured to control and move the delivery tube 64 proximally or distally accordingly (and therefore control and move the inner sheath 62 and the outer sheath 60). Another feature of the handle 65 is that it is configured to control and retract the outer sheath 60 proximally so that it passes over the distal end of the delivery tube 64 in a coaxial manner (for removal of the device 10 from the sheath). The outer sheath 60 can also be moved distally.

[0144] It should be noted that the guide wire 63 may be passed through a hole in the distal end of the hollow tubular member 5, which may aid in stability during the procedure.

[0145] The method for delivering the blocking device comprises the following steps:

[0146] Making a skin incision (for example, in the groin);

[0147] · Forming an opening in a blood vessel (e.g., femoral artery) and inserting an introducer sheath (e.g., 6Fr introducer sheath);

[0148] Optional insertion of a closure device;

[0149] Inserting a stiff guide wire 63 through the guide sheath and passing it through the femoral artery;

[0150] Optionally replace the 6Fr introducer sheath with a larger 11 to 16Fr introducer sheath;

[0151] Optionally, the stiff guidewire is replaced with a conventional guidewire and advanced all the way to the aorta and through the opening in the aortic valve into the left ventricle. Preferably, the guidewire is placed to conform to the luminal contour of the left ventricle all the way to the apex, preferably using a pigtail catheter. In some embodiments, the first guidewire is the only guidewire inserted during the entire delivery procedure;

[0152] Preferably, a hard guide wire 63 is used instead of a conventional (soft) guide wire;

[0153] The delivery catheter system is delivered to the distal side (which preferably includes a delivery tube 64, an outer sheath 60, an inner sheath 62 passing through the outer sheath 60, the blocking device 10 of the present invention (the proximal opening 12 is located proximally and the distal end 7 is located distally, wherein the inner sheath 62 passes through the rings 71 and 72), and the thickened portion 62t (the thickened portion 62t is arranged at the proximal end and adjacent to the proximal ring 71 of the device 10). The inner sheath 62 passes over the wire 63 (and the wire 63 passes through the inner sheath 62) in a "over the wire delivery" manner;

[0154] When the distal end of the inner sheath reaches the ascending aorta (eg Fig. 8A As shown), the outer sheath 60 is retracted proximally (the blocking device 10 is removed from the sheath), thereby starting to release the blocking device 10 ( Figure 8B ). At this stage, with the proximal ring 71 of the present invention adjacent to the thickened portion 62t, the inner sheath 62 is stationary, while the outer sheath 60 moves proximally. Once the outer sheath 60 is retracted proximally, the blocking device 10 of the present invention is completely released from the outer sheath 60 ( Figure 8C ). It should be noted that Fig. 8A Shown are a handle 65, a delivery tube 64, and an outer tube 60. The outer tube 60 and its contents are shown enlarged and even more enlarged;

[0155] Then pull both ends of the rope 66 proximally to open the gripping arms 20 ( Fig.8D );

[0156] The next step consists in positioning the occluding device 10 of the present invention in the correct intended position before attaching it to the cusp ( Figures 8E-8F ). The positioning includes rotating the occlusion device 10 based on the imaging device by manipulating the delivery system, such as clockwise or counterclockwise, so as to attach to the valve cusp. This is achieved by rotating the delivery tube 64 (via the handle 65), which in turn rotates the inner sheath 62, the outer sheath 60, and the device 10;

[0157] Once in the desired position (e.g., engaging the intended aortic valve cusp), the occlusion device 10 is pushed forward (by pushing the proximal ring 71 distally via the thickened portion 62t of the inner sheath 62) against the native aortic valve cusp in its vicinity ( Figure 8G );

[0158] Then, the ends of the rope 66 are released at the distal end, so that the gripping arms 20 are closed ( Figure 8H), because the grasping arms 20 always tend to close. The connecting element 25 is connected to the valve cusp, for example piercing the outside of the valve cusp. Thus, the occluding device 10 is fully deployed. Optionally, the connecting element 26 on the lateral tubular surface 6 also pierces the inside of the valve cusp to strengthen the connection. Optionally, once the final positioning is confirmed, a diathermy device is applied through the rope 66 to further fix the device to the valve cusp. The rope 66 may include nitinol and / or may include other conductive materials;

[0159] The delivery tube 64 including the inner sheath 62 therein and the outer sheath 60 thereon is retracted proximally in an "over the wire" manner ( Figure 8I );

[0160] Then, one end of the cord 66 is pulled proximally while the other end is moved distally until the cord 66 leaves the loop 75 and then also moves back proximally until the cord 66 is fully retracted ( Figure 8J );

[0161] Then, the guide wire 63 is withdrawn proximally (eg Figure 8K-8L );

[0162] The introducer sheath is then removed and the artery closed.

[0163] Figure 8M The device is shown functioning in the valve open state, Figure 8N The device is shown functioning in the valve closed state, preventing blood from leaking into the left ventricle.

[0164] It should be noted that some embodiments of the method may be performed mutatis mutandis without an outer sheath.

[0165] According to another aspect of the invention, in order to deliver to the bivalve cusps and the trivalve cusps, the blocking device 10 is installed in the delivery system in the opposite direction, that is, with an open portion at the distal end and a closed portion at the proximal end. According to this aspect of the invention, with necessary modifications, the terms "distal" and "proximal" defining the elements of the blocking device 10 are switched, for example, the opening (12) will be referred to as the distal opening, the grasping arm (20) extends proximally, the proximal ring (71) will be referred to as the distal ring, the distal ring (72) will be referred to as the proximal ring, etc. The blocking device will be labeled 110.

[0166] According to this aspect of the invention, the delivery system and insertion method are nearly identical, and the following section will primarily highlight the differences.

[0167] refer to Fig. 9, which shows a step of the insertion method (for delivery to the tricuspid cusp). The inner sheath passes through the proximal ring and the distal ring. The inner sheath includes a thickened portion 162t, which is placed at the proximal end and adjacent to the proximal ring (not shown). In this way, when the inner sheath 162 moves distally, the thickened portion 162t pushes the proximal ring distally, thereby pushing the entire device 110 distally.

[0168] The grasping arm 120 includes a loop connected to its proximal end. The rope 166 extends from the guide sheath (at the nearest position where medical personnel operate the system), passes through the grasping arm loop and returns to the guide sheath, so that both ends of the rope 166 are accessible to the medical personnel operating the system (so that both ends of the rope 166 extend from the guide sheath). The grasping arm always tends to be closed. When the two ends of the rope 166 are pulled proximally, the grasping arm moves away from the outer surface of the tapered tubular member (away from the lateral tubular surface). When the two ends of the rope 166 are released, the grasping arm returns toward the outer surface of the tapered tubular member (towards the lateral tubular surface). Since the distal end of the grasping arm is always attached to the distal opening of the blocking device 110, the grasping arm moves away from and toward the outer surface of the tubular member in an angled manner. For this function, the rope 166 is passed through an opening (the opening is adjacent to the distal ring of the blocking device 110 and at a position distal to the distal ring of the blocking device 110, for example, such as Fig. 9 The guidewire 66 may be threaded through the inner sheath 162 parallel to the guidewire or in a separate dedicated lumen.

[0169] The conveying method of the blocking device includes the following steps:.

[0170] Making a skin incision (for example, in the groin);

[0171] · Creating an opening in a blood vessel (e.g., femoral artery) and inserting an introducer sheath (e.g., 6FR introducer sheath);

[0172] Optional insertion of closure;

[0173] Inserting a stiff guide wire 163 through the guide sheath and passing it through the femoral artery;

[0174] Optionally replace the 6Fr introducer sheath with a larger 11 to 16Fr introducer sheath;

[0175] Optionally, the stiff guidewire is replaced with a conventional guidewire and advanced into the right atrium, through the tricuspid cusps, all the way to the right ventricle (or, with necessary modifications, through the left atrium, bicuspid cusps, left ventricle). Preferably, the guidewire is placed so that it conforms to the luminal contour of each ventricle, all the way to the apex, preferably using a pigtail catheter. In some embodiments, the first guidewire is the only guidewire inserted during the entire delivery process;

[0176] Preferably, a hard guide wire 163 is used instead of a conventional (soft) guide wire;

[0177] The delivery catheter system is delivered distally (preferably comprising a delivery tube 164, an outer sheath 160, an inner sheath 162 passing through the outer sheath 160, the blocking device 110 of the present invention (the distal opening is located at the distal end, the proximal end is located at the proximal side, wherein the inner sheath 162 passes through the blocking device 110 ring), and a thickened portion 162t (which is arranged at the proximal end and adjacent to the proximal ring of the blocking device 110). The inner sheath 162 passes over the wire 163 (and the wire 163 passes through the inner sheath 162) in a "over the wire delivery" manner;

[0178] When the distal end of the inner sheath 162 passes through the three-valve cusp (or two-valve cusp) and enters the right (or left) ventricle, the outer sheath 160 is retracted proximally (the blocking device 110 is moved out of the sheath), thereby starting to release the blocking device 10. At this stage, in the case of the proximal ring of the present invention adjacent to the thickened portion 162t, the inner sheath 162 is stationary, while the outer sheath 160 moves proximally. Once the outer sheath 160 is retracted proximally, the blocking device 110 of the present invention is completely released from the outer sheath 160 ( Figure 8C );

[0179] Then pull the ends of the rope 166 proximally to open the gripping arms 120 (eg Fig. 9 shown);

[0180] The next step includes positioning the occluding device 110 of the present invention in the correct intended position before attaching it to the valve cusp. This positioning includes rotating the occluding device 110 based on the imaging device by manipulating the delivery system, such as clockwise or counterclockwise, so as to attach to the valve cusp. This is achieved by rotating the delivery tube 164 (via the delivery system handle), which in turn rotates the inner sheath 162, the outer sheath 160, and the device 110;

[0181] Once in the desired position (e.g., engaging the intended cusps / leaflets), the occlusion device 110 is pulled proximally (the cord 166 emerges from the opening of the inner sheath 162 distal to the distal ring and thereby effectively hooks onto the distal ring, pushing the distal ring, and thus the entire device 110, proximally) until the cusps / leaflets are within the gap between the grasping arms 120 and the hollow tapered tubular member;

[0182] ·The ends of the rope 166 are then released at the distal end, causing the grasping arms 120 to close, as the grasping arms 120 always tend to close. The connecting element 25 is connected to the valve cusp, for example piercing the outside of the valve cusp. Thus, the blocking device 110 is fully deployed. Optionally, the connecting element on the lateral tubular surface also pierces the inside of the valve cusp, thereby strengthening the connection. Optionally, once the final positioning is confirmed, a diathermy device is applied through the rope 166 to further fix the device to the valve cusp. The rope 166 may include Nitinol and / or may include other conductive materials;

[0183] Then, one end of the cord 166 is pulled proximally while the other end moves distally until the cord 166 exits the grip arm loop, and then the cord 166 also returns proximally until the cord 166 is fully retracted. According to this aspect of the invention, the cord 166 is retracted before the inner sheath 162, so that the inner sheath 162 can leave the distal loop;

[0184] The delivery tube 164 including the inner sheath 162 therein and the outer sheath 160 thereon is proximally retracted in an "over the wire" manner;

[0185] The guidewire 163 is then withdrawn proximally;

[0186] The introducer sheath is then removed and the artery closed.

[0187] It should be noted that even according to this aspect of the invention, some embodiments of the method may be carried out mutatis mutandis without an outer sheath.

[0188] Although some embodiments of the present invention have been described by way of example, it will be apparent that the present invention may be implemented through numerous modifications, variations and adaptations, as well as using numerous equivalents or alternatives within the purview of those skilled in the art, without departing from the spirit of the invention or the scope of the claims.

Claims

1. An occlusive device configured to be deployed in an aortic valve, comprising: A compressible hollow tubular member comprising: a. a proximal opening at its proximal end, which is configured to face the aorta; b. A generally tubular surface extending distally from the proximal opening; c. distal end; wherein the hollow tubular member is configured to be partially compressed during systole and to expand during diastole by blood entering the interior of the occlusion device, a grasping arm extending distally from the opening at the proximal end, wherein the grasping arm is configured to attach to a single cusp; wherein the distal end is either closed or includes a small hole, wherein the blocking device is adjacent to the valve cusp and extends distally along the valve cusp, wherein the blocking device moves as the cusps open and close the valve, Wherein, the hollow tubular member tapers distally.

2. A blocking device according to claim 1, wherein the hollow tubular member comprises a membrane.

3. A blocking device according to claim 2, wherein the membrane is self-expanding.

4. The blocking device according to claim 2 or 3, further comprising a frame, the frame comprising one or more metal wires; wherein the membrane is mounted on the frame.

5. The blocking device according to claim 1, wherein: A fine gap is formed between the gripping arm and the generally tubular surface.

6. The blocking device according to claim 1, wherein: The gripping arm includes a first set of connecting elements.

7. The blocking device of claim 6, wherein the first set of connecting elements is selected from the group consisting of biocompatible needles, biocompatible pins, and biocompatible staples.

8. The blocking device according to claim 7, wherein: The first set of connecting elements are biocompatible needles extending proximally and obliquely.

9. A blocking device according to claim 1 or 6, wherein the generally tubular surface includes a second set of connecting elements.

10. The occlusion device of claim 9, wherein the second set of connecting elements is selected from the group consisting of biocompatible needles, biocompatible pins, and biocompatible staples.

11. The blocking device according to claim 10, wherein: The second set of connecting elements are biocompatible needles extending proximally and obliquely from the generally tubular surface.

12. The occlusion device of claim 1, further comprising a proximal ring attached to the proximal opening.

13. The blocking device according to claim 12 further includes a distal ring attached to the distal portion of the hollow tubular member.

14. The blocking device according to claim 13, wherein the proximal ring and the distal ring face and align with each other.

15. The blocking device according to claim 1 or 13, wherein: The grasping arm includes a loop at its distal end.

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