Transcatheter artificial cusp for valve insufficiency

Abstract

An obstructing device mountable on a heart valve cusp or leaflet, in a valve lumen having a flow axis between an upstream direction and a downstream direction, comprising: a hollow tubular member, comprising: a proximal end comprises a proximal opening, configured to be faced toward the direction of a regurgitation leakage; and a substantially tubular surface extending distally from said proximal opening to a distal end with the direction of the regurgitation leakage and a leaflet anchor, comprising: a peripheral frame having a distal end, a proximal end, and at least two side arms; an arm extending distally from said proximal end, located between said side arms and which traps said cusp or leaflet in a space defined therebetween and which space varies along a longitudinal axis of the leaflet anchor, defined between said distal end and said proximal end.

Description

[0001] TRANSCATHETER ARTIFICIAL CUSP FOR VALVE INSUFFICIENCY

[0002] RELATED APPLICATION

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 644,150, filed on May 8, 2024, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD OF THE INVENTION:

[0005] The present invention relates to the field of medical devices. More particularly, the present invention, in some embodiments thereof, relates to an artificial cusp for trans-catheter treatment of valve insufficiency.

[0006] BACKGROUND OF THE INVENTION:

[0007] Valvular insufficiency is a result of valve leakage when the valve is in a closed state. Four main valvular insufficiencies are Aortic regurgitation (AR) also known as aortic insufficiency, mitral regurgitation (MR), tricuspid regurgitation (TR), and pulmonary regurgitation (PR). The main treatment for these pathologies, when they are in a state causing symptoms or significant cardiac remodeling, is valve replacement through open heart surgery, or in some cases catheter-based therapy. However, these treatments are limited to MR only, and TR, under specific conditions.

[0008] For example, the aortic valve lies between the left ventricle and the aorta. When the left ventricle contracts during each heartbeat (systole), pressure rises in the left ventricle. When the pressure in the left ventricle rises above the pressure in the aorta, the aortic valve opens, allowing blood to exit the left ventricle into the aorta. The left ventricle actually pushes blood through three flexible cuplike leaflets which make up the aortic valve. When the left ventricle relaxes (when ventricular systole ends) pressure in the left ventricle rapidly drops and the aortic pressure forces the aortic valve to close. The aortic valve closes and prevents blood from flowing back to the left ventricle.

[0009] However, in the case of AR, valve leakage occurs when the aortic valve is in a closed state. The leaflets partially close in the aortic valve in the close state, leaving a portion of the aortic valve opened (regurgitant orifice), what causes a portion of the blood to flow back into the left ventricle. This necessitates the heart to work harder, causing a deterioration to the health of a patient. Fig. 1A shows an example of a healthy normal heart where the aortic valve is fully closed. Fig. IB shows an example of AR with an abnormal aortic valve which fails to fully close allowing the blood to leak backwards into the left ventricle.

[0010] Similar leakages occur to the mitral (bicuspid) valve, the tricuspid valve and the pulmonary valve in cases of MR, TR and PR, respectively, mutatis mutandis.

[0011] The current standard of care treatment is valve replacement performed by invasive open heart surgery accompanied by severe trauma to the patient and long rehabilitation time.

[0012] US 2015 / 0230919 Al Describes a method for leaflet prolongation of the mitral or tricuspid valve. The device is implanted around the leaflet therefore extending it and potentially closing the malcoaptation gap.

[0013] However, such prior art approaches may be highly invasive and risky procedures. The heart, in prior art approaches based on implantations, may be non-tolerant to the implantation positions. An improved efficient closure of the gap may be useful.

[0014] WO 2020026234 relates to an obstructing device comprising a hollow tubular member comprising: a. a proximal opening at its proximal end; b. a substantially tubular surface extending distally from said proximal opening; c. a distal end. The obstructing device further comprises a grasping arm extending distally from said opening at the proximal end; wherein the distal end is either closed or comprises a small orifice. This publication also relates to a method of delivery of the device.

[0015] US 9,414,918 relates to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices.

[0016] An improved and efficient means for closing the gap and a structure for its easy attachment and implantation may be useful. Optionally or additionally, an improved easy method for its delivery, attachment and / or implantation may be useful.

[0017] SUMMARY OF THE INVENTION:

[0018] It is an object of some embodiments of the present invention to provide a method and means for preventing or reducing blood leakages in cases of AR, MR, TR and PR.

[0019] It is an object of some embodiments of the present invention to provide an easily attachable device that prevents the aforementioned blood leakages.

[0020] It is an object of some embodiments of the present invention to provide an easy method of delivery thereof.

[0021] Other objects and advantages of the present invention may become apparent as the description proceeds. Aortic regurgitation also known as aortic insufficiency is a condition where the aortic valve fails, allowing backflow of blood from the aorta into the left ventricle of the heart. The present invention, in some embodiments thereof, relates to an obstructing device mountable on to one of the native aortic cusps which reduces the back flow to a minimum. An exemplary delivery method is a minimally invasive transcatheter procedure through the groin whereby a crimped device is provided inside a delivery system and is advanced over a guidewire into the left ventricle. As it is placed near the native valve, the device is deployed out of the delivery system and mounted on the desired cusp. With the assistance of fluoroscopy and ultrasound imaging (and / or a two-way steering mechanism) the delivery system is advanced towards the native cusp and the device deployed and mounted on the native cusp. The device "clips on" to the native cusp for perfect attachment. After deployment and retraction of the delivery system the device remains attached to the native cusp and the regurgitation is significantly reduced. A potential advantage of the present invention, is that patients can look forward to a shorter recovery time regaining quality of life.

[0022] The present invention obstructing device, in some embodiments thereof, enables grasping the native cusp in its center, in a secure, yet relatively atraumatic attachment. Thus, potentially preserving normal cusp motion. The present invention artificial cusp, in some embodiments thereof, being at the aortic valve expands during diastole and collapses during systole, significantly reducing backflow while minimally interfering with forward flow.

[0023] The present invention, in some embodiments thereof, relates to a device for alleviating valvular insufficiency. The present invention, in some embodiments thereof, relates to the treatment of valvular insufficiency by attaching an artificial valve cusp to a native or artificial cusp or leaflet. By doing this it improves heart function by preventing or reducing valve leakage. The artificial cusp is collapsible to prevent valve stenosis when the valve is in an open state.

[0024] The present invention, in some embodiments thereof, relates to an obstructing device comprising a hollow tubular member for sealing the regurgitant orifice when the respective heart valve is closed and an attachment element attached to said hollow tubular member. A relatively wide opening / dimension of the hollow tubular member substantially fills and blocks the regurgitant orifice when the heart valve is in a closed state thus reducing or preventing blood leakage. The hollow tubular member opening faces the "leaking blood" such that the leaking blood enters the hollow tubular member via said opening.

[0025] The attachment element, in some embodiments thereof, is attachable to the respective native cusp / leaflet. Optionally, the attachment element comprises material having a shape memory effect. It is manufactured by shape setting to have an arc shape when undeformed (in room temperature). The attachment element comprises two main portions which enable it to function as a clip and attach itself to a native cusp like a clip. The first main portion is a peripheral frame with a hollow interior and optionally forms a closed loop. The second main portion is a central arm extending from one edge of the peripheral frame and having a free end. Both the peripheral frame and the central arm optionally curve similarly in the same direction and have an arc shape when undeformed. The attachment element is mounted on the native cusp by initially having the peripheral frame in a "deformed" straightened position while the central arm has an arc shape when undeformed. The native cusp / leaflet is placed within a gap formed between the curved central arm and the surface of the straightened peripheral frame. Thereafter, the peripheral frame is released to return to its arc shape when undeformed, thereby closing the "clip" and being mounted on the cusp / leaflet. The central arm and peripheral frame each curve engaging an opposite side of the cusp / leaflet thereby providing a robust attachment. The central arm engages one side of the cusp / leaflet while the peripheral frame engages its opposite side.

[0026] The present invention, in some embodiments thereof, also relates to a delivery system and to a method of insertion using the delivery system. In some embodiments of the invention, a full evaluation of the aortic valve is performed using a CT scan ("Multiphase evaluation of the aortic valve" protocol) and Transthoracic Echocardiography. Also in the deployment stage, the obstructing device is deployed under fluoroscopy and Transesophageal Echocardiography guidance.

[0027] The present invention, in some embodiments thereof, relates to an obstructing device mountable on a heart valve cusp or leaflet comprising: a hollow tubular member comprising:

[0028] • a proximal opening at its proximal end;

[0029] • a substantially tubular surface extending distally from said proximal opening;

[0030] • a distal end, being either closed or comprising a small orifice; an attachment element comprising:

[0031] • a peripheral frame having a distal end, a proximal end and two side arms, each of said side arms being attached to said distal end and proximal end;

[0032] • a central clipping arm extending distally from said proximal end and having a free end; wherein said hollow tubular member is attached to said peripheral frame; and wherein said peripheral frame and central clipping arm are both curved and have an arc shape when undeformed.

[0033] Preferably, the peripheral frame comprises a hollow interior. Preferably, the hollow tubular member is attached to the peripheral frame at the exterior side of the arc shape.

[0034] Preferably, the distance between the proximal opening and the attachment element proximal end is between 0.1 and 0.5 mm; and wherein the distance between the hollow tubular member distal end and the attachment element distal end is between 0.1 and 0.5 mm.

[0035] Preferably, the central clipping arm comprises a plurality of sharp edges at its sides.

[0036] Preferably, each one of the side arms comprises a plurality of sharp edges at its inner side.

[0037] Preferably, the sharp edges curve backwards or forwards.

[0038] Preferably, the peripheral frame distal end and peripheral frame proximal end are each placed at the edges of the arc shape of the peripheral frame; and wherein the central clipping arm free end and the proximal end of the central clipping arm are each placed at the edges of the arc shape of the central clipping arm.

[0039] Preferably, the hollow tubular member comprises a membrane.

[0040] Preferably, the membrane is self-expandable.

[0041] Preferably, the obstructing device further comprising a frame comprising one or more wires; wherein the membrane is mounted on said frame.

[0042] Preferably, the hollow tubular member tappers distally.

[0043] Preferably, the peripheral frame comprises one or more apertures.

[0044] Preferably, the attachment element comprises material selected from the group consisting of metal alloy and shape memory alloy.

[0045] Preferably, the attachment element comprises material selected from the group consisting of nitinol, stainless steel, and cobalt chromium.

[0046] Preferably, the attachment element comprises connecting elements.

[0047] Preferably, the connecting elements are selected from the group consisting of biocompatible needles, biocompatible pins and biocompatible spikes.

[0048] Preferably, the connecting elements slant from the attachment element.

[0049] The present invention, in some embodiments thereof, relates to a delivery system for delivering an obstructing device for being mounted on a native cusp or leaflet, said delivery system comprising: a distal holder comprising:

[0050] • a distal front member • a ring-shaped element extending proximally from said distal front member;

[0051] • a top (preferably flat) surface; a proximal holder comprising:

[0052] • a distal surface;

[0053] • a lock spring element comprising a spring mechanism configured to push the distal portion of said lock spring element away from the central axis of the proximal holder, and wherein a gap is formed between the distal portion of said lock spring element and a portion of said distal surface; a wire lumen connected to a handle and distally and proximally movable by said handle; a proximal lumen connected to said handle; an outer sheath distally and proximally movable by said handle, configured to cover the proximal holder and part of the distal holder and engageable with the distal holder ring-shaped element; wherein said wire lumen passes through said proximal lumen; wherein said wire lumen is fixedly connected to said distal holder; and wherein said proximal lumen is fixedly connected to said proximal holder.

[0054] Preferably, the delivery system comprises a distal holder internal bore passing through the distal holder and a proximal holder internal bore passing through the proximal holder; wherein the wire lumen passes through said distal holder internal bore and through said proximal holder internal bore.

[0055] Preferably, the lock spring element comprises one or more teeth elements extending downwards from the distal portion of the lock spring element.

[0056] Preferably, the system further comprises an obstructing device mountable on a heart valve cusp or leaflet comprising: a hollow tubular member comprising:

[0057] • a proximal opening at its proximal end;

[0058] • a substantially tubular surface extending distally from said proximal opening;

[0059] • a distal end, being either closed or comprising a small orifice; an attachment element comprising:

[0060] • a peripheral frame having a distal end, a proximal end and two side arms, each of said side arms being attached to said distal end and proximal end;

[0061] • a central clipping arm extending distally from said proximal end and having a free end; wherein said hollow tubular member is attached to said peripheral frame; and wherein said peripheral frame and central clipping arm are both curved and have an arc shape when undeformed; wherein the peripheral frame distal end is placed within the ring shaped element; and wherein the peripheral frame proximal end is placed within the gap.

[0062] The present invention, in some embodiments thereof, relates to a method for implanting an obstructing device on a heart valve cusp or leaflet, comprising: creating an opening in a blood vessel; inserting an introducer sheath; inserting a guide wire through the introducer sheath and passing it through the blood vessel all the way to the heart valve and therethrough to the respective heart chamber; providing a delivery system comprising:

[0063] • the obstructing device as explained herein;

[0064] • a distal holder retaining the peripheral frame distal end;

[0065] • a proximal holder retaining the peripheral frame proximal end;

[0066] • a wire lumen connected to a handle and distally and proximally movable by said handle, and fixedly attached to said distal holder;

[0067] • a proximal lumen connected to said handle and fixedly attached to said proximal holder; wherein said wire lumen passes through said proximal lumen;

[0068] • an outer sheath distally and proximally movable by said handle, configured to cover the proximal holder and part of the distal holder, wherein the central clipping arm is deformed by being at least partially straightened by the outer sheath restricting it; passing the delivery catheter system distally by passing the wire lumen over the guidewire until the distal portion of the outer sheath arrives near the respective heart valve cusp or leaflet; retrieving the outer sheath proximally to an extent where the central clipping arm curves to its arc shape when undeformed; positioning the obstructing device in the correct intended position to be attached to the native cusp or leaflet; forwarding the wire lumen distally while the proximal lumen remains stationary thereby releasing the peripheral frame distal end from being retained by the distal holder, and thereby having the peripheral frame curve to its arc shape when undeformed and thereby having the central clipping arm placed tightly engaging the belly of the cusp while the peripheral frame tightly engages the cusp flow facing side; retrieving the outer sheath proximally to an extent where the peripheral frame proximal end is released from being retained by the proximal holder, thereby releasing the obstructing device to be completely deployed; proximally retrieving the outer sheath, the distal holder and proximal holder; proximally retrieving the guide wire; removing the introducer sheath; closing the blood vessel.

[0069] Preferably, the retrieving of the outer sheath proximally to an extent where the peripheral frame proximal end is released from being retained by the proximal holder, comprises retrieving the outer sheath to an extent such that a lock spring element is released thereby releasing the peripheral frame proximal end from being retained by the proximal holder.

[0070] The present invention, in some embodiments thereof, relates to a method for implanting an obstructing device on a heart valve cusp or leaflet, comprising: creating an opening in a blood vessel; inserting an introducer sheath; inserting a guide wire through the introducer sheath and passing it through the blood vessel all the way to the heart valve and therethrough to the respective heart chamber; providing a delivery system comprising:

[0071] • an obstructing device comprising: a hollow tubular member comprising:

[0072] - a distal opening at its distal end;

[0073] - a substantially tubular surface extending proximally from said distal opening;

[0074] - a proximal end, being either closed or comprising a small orifice; an attachment element comprising:

[0075] - a peripheral frame having a distal end, a proximal end and two side arms, each of said side arms being attached to said distal end and proximal end;

[0076] - a central clipping arm extending proximally from said distal end and having a free end; wherein said hollow tubular member is attached to said peripheral frame; and wherein said peripheral frame and central clipping arm are both curved and have an arc shape when undeformed; a distal holder retaining the peripheral frame distal end; a proximal holder retaining the peripheral frame proximal end; • a wire lumen connected to a handle and distally and proximally movable by said handle, and fixedly attached to said distal holder;

[0077] • a proximal lumen connected to said handle and fixedly attached to said proximal holder; wherein said wire lumen passes through said proximal lumen;

[0078] • an outer sheath distally and proximally movable by said handle, configured to cover the proximal holder and part of the distal holder, wherein the central clipping arm is deformed by being at least partially straightened by the outer sheath restricting it; passing the delivery catheter system distally by passing the wire lumen over the guidewire until passing the respective heart valve cusp or leaflet; retrieving the outer sheath proximally to an extent where the central clipping arm curves to its arc shape when undeformed; positioning the obstructing device in the correct intended position to be attached to the native cusp or leaflet; forwarding the wire lumen distally while the proximal lumen remains stationary thereby releasing the peripheral frame distal end from being retained by the distal holder, and thereby having the peripheral frame curve to its arc shape when undeformed and thereby having the central clipping arm placed tightly engaging the belly of the cusp while the peripheral frame tightly engages the cusp flow facing side; retrieving the outer sheath proximally to an extent where the peripheral frame proximal end is released from being retained by the proximal holder, thereby releasing the obstructing device to be completely deployed; proximally retrieving the outer sheath, the distal holder and proximal holder; proximally retrieving the guide wire; removing the introducer sheath; closing the blood vessel.

[0079] Following is a non-exclusive list including some examples of embodiments of the invention. The invention also includes embodiments which include fewer than all the features in an example and embodiments using features from multiple examples, also if not expressly listed below.

[0080] Example 1. An obstructing device mountable on a heart valve cusp or leaflet, in a valve lumen having a flow axis between an upstream direction and a downstream direction, comprising: an hollow tubular member, comprising: an attachment element configured to trap said leaflet or cusp comprising: a peripheral frame having a distal end, a proximal end and at least one and optionally two or more side arms; a clipping arm extending distally from said proximal end, located between said side arms and / or adjecnt to and / or along said at least one side arm, and having a free end, so that said cusp or leaflet can be trapped between said frame and said clipping arm; wherein said hollow tubular member is attached to said peripheral frame; wherein said peripheral frame and said central arm are each elastically deformable and have a preferred bending plane to apply clamping force towards said leaflet or cusp when said leaflet or cusp is trapped therebetween; and wherein said peripheral frame and said central arm are each curved in their respective preferred bending plane.

[0081] Example 2. An obstructing device according to example 1, wherein said peripheral frame and said central arm are curved in an arc shape in a resting state thereof.

[0082] Example 3. An obstructing device according to example 1, wherein the hollow tubular member is attached to the peripheral frame at the exterior side of the arc shape thereof.

[0083] Example 4. An obstructing device according to example 2 or example 3, wherein said arc shape of said frame extends from said proximal end to said distal end thereof and wherein said arc shape of said clipping arm extends from a proximal end to a distal end.

[0084] Example 5. An obstructing device according to any of the preceding examples, wherein said tubular member is elongate and has an axis and wherein said attachment element is elongate and has an axis and wherein said elongate hollow tubular member is attached to said peripheral frame such that when said elongate attachment element is mounted on a cusp so that said axis points in a downstream direction, said elongate hollow tubular member also points in a downstream direction.

[0085] Example 6. An obstructing device according to any of the preceding examples, wherein said hollow tubular member comprises: a proximal opening at its proximal end; a substantially tubular surface extending distally from said proximal opening; a distal end, being either closed or comprising a small orifice;

[0086] Example 7. An obstructing device according to any of the preceding examples, wherein in said peripheral frame, each of said side arms being attached to said distal end and proximal end and said clipping arm does not extend to said distal end. Example 8. The obstructing device according to any of the preceding examples, wherein the peripheral frame comprises a hollow interior through which said clipping arm can pass absent said leaflet or cusp.

[0087] Example 9. The obstructing device according to any of the preceding examples, wherein the distance between the proximal opening and the attachment element proximal end is between 0.1 and 0.5 mm; and wherein the distance between the hollow tubular member distal end and the attachment element distal end is between 0.1 and 0.5 mm.

[0088] Example 10. The obstructing device according to any of the preceding examples, wherein the clipping arm comprises a plurality of protrusions adapted to engage cusp tissue and extending in a direction away from said preferred bending plane.

[0089] Example 11. The obstructing device according to any of the preceding examples, wherein each one of the side arms comprises a plurality of protrusions adapted to engage cusp tissue and extending in a direction towards the other side arm.

[0090] Example 12. The obstructing device according to any one of examples 10 or 11, wherein the sharp edges curve in a proximal or a distal direction.

[0091] Example 13. The obstructing device according to any of the preceding examples, wherein the hollow tubular member comprises a membrane.

[0092] Example 14. The obstructing device according to example 13, wherein the membrane is self-expandable.

[0093] Example 15. The obstructing device according to any one of examples 13 or 14, further comprising a frame comprising one or more wires; wherein the membrane is mounted on said frame.

[0094] Example 16. The obstructing device according to any of the preceding examples, wherein the hollow tubular member tappers distally in a downstream direction.

[0095] Example 17. The obstructing device according to any of the preceding examples, wherein the peripheral frame comprises one or more apertures.

[0096] Example 18. The obstructing device according to any of the preceding examples, wherein the attachment element is made of a super-elastic or shape memory material.

[0097] Example 19. The obstructing device according to any of the preceding examples, wherein the attachment element comprises connecting elements configured to engage cusp material.

[0098] Example 20. The obstructing device according to example 19, wherein the connecting elements slant from the attachment element. Example 21. The obstructing device according to any of the preceding examples, wherein the clipping arm includes at least one cusp engaging needle extending in a preferred bending plane thereof.

[0099] Example 22. The obstructing device according to any of the preceding examples, wherein in said resting state, a gap is defined between the frame and clipping arm, said gap having an opening greater than 6 mm.

[0100] Example 23. A delivery system for delivering an obstructing device for being mounted on a native cusp or leaflet, said delivery system comprising: a body; a capsule at a distal end of said body, the capsule comprising: a recess for receiving an obstructing device; a distal holder for holding a distal part of said obstructing device; a proximal holder for holding a proximal side of said obstructing device; wherein said one of said proximal and said distal holders is movable to two positions, a first position where a section of said obstructing device is exposed, allowing part of said obstructing device to elastically extend away from said capsule and a second position where the proximal or distal end of the obstructing device is released from being held.

[0101] Example 24. A delivery system according to example 23, comprising a spring configured to push said obstructing device away from said capsule when said obstructing device is released at both a distal end and a proximal end thereof.

[0102] Example 25. A delivery system according to example 23 or example 24, comprising an obstructing device in said recess, wherein said obstructing device comprises a curved frame with a curved resting state, wherein said capsule holds said frame to prevent said curved frame from being at said curved resting state.

[0103] Example 26. A method for implanting an obstructing device on a heart valve cusp or leaflet, comprising: advancing passing a delivery catheter system having an obstructing device mounted therein, until the distal portion of the catheter arrives near a target heart valve cusp or leaflet; releasing a clipping arm of said obstructing device to extend radially away from said delivery catheter system and define a gap therebetween; positioning said cusp or leaflet within said gap; and further releasing at least a further part of said obstructing device to elastically extend away from said delivery catheter system so that said gap is closed and said cusp or leaflet is trapped by said clipping arm against said obstructing device. Example 27. A method according to example 26, further comprising releasing said obstructing device entirely from said delivery catheter system using an elastic recoil.

[0104] Example 28. A method according to example 26 or example 27, wherein said further releasing an elastically deformable frame and said clipping arm, wherein said cusp or leaflet prevents said clipping arm from reaching a resting position on an opposite side of said cusp or leaflet.

[0105] Example 29. An obstructing device mountable on a heart valve cusp or leaflet, in a valve lumen having a flow axis between an upstream direction and a downstream direction, comprising: a hollow tubular member, comprising: a proximal end comprises a proximal opening, configured to be faced toward the direction of a regurgitation leakage; and a substantially tubular surface extending distally from said proximal opening to a distal end with the direction of the regurgitation leakage and a leaflet anchor, comprising: a peripheral frame having a distal end, a proximal end, and at least two side arms; an arm extending distally from said proximal end, located between said side arms and having a free end, so that said cusp or leaflet can be trapped between said frame and said grasping arm; wherein said peripheral frame and said grasping arm define a space therebetweenwhen flattened, and wherein said space varies along a longitudinal axis of the leaflet anchor, defined between said distal end and said proximal end; wherein said hollow tubular member is attached to said peripheral frame, such that said proximal opening is adjacent to said proximal end of said peripheral frame.

[0106] Example 30. The obstructing device according to example 29, wherein said space is widest at the the proximal end of the frame and narrows toward the distal end of the frame.

[0107] Example 31. The obstructing device according to examples 29 or 30, wherein the grasping arm comprises a plurality of protrusions on each one of the side arms adapted to engage cusp tissue and extend in a direction towards the other side arm.

[0108] Example 32. The obstructing device according to example 31, wherein at least one protrusion of said plurality of protrusions comprises a rounded tip.

[0109] Example 33. The obstructing device according to any of the preceding examples, wherein the arm comprises a plurality of protrusions in a direction towards the frame. Example 34. The obstructing device according to example 33, wherein at least one protrusion of said plurality of protrusions comprises a rounded tip.

[0110] Example 35. The obstructing device according to examples 33 or 34, wherein the plurality of protrusions of the grasping arms fits within the plurality of protrusions of the frame, and wherein said space is defined by a space between the plurality of protrusions of the grasping arms and the plurality of protrusions of the frame.

[0111] Example 36. The obstructing device according to any of the preceding examples, wherein the leaflet anchor comprises at least one sharp protrusion, perpendicular to the frame and directed toward the cusp tissue, wherein said at least one sharp protrusion is placed on one or both of said frame and said grasping arm.

[0112] Example 37. The obstructing device according to example 36, wherein the frame comprises an enlarged space near its said distal end, defined by a margin between a distal end of said arm and said distal end of said frame.

[0113] Example 38. The obstructing device according to any of the preceding examples, wherein said frame comprises a connection location near its proximal end, wherein said connection area is configured to connect to a delivery system.

[0114] Example 39. The obstructing device according to example 38, wherein said connection area comprises a geometry shaped and sized to interact with a corresponding geometry on the delivery system.

[0115] Example 40. The obstructing device according to example 39, wherein said geometry comprises one or both of: a protrusion shaped and sized to fit within a depression on the delivery system; and a recess shaped and sized to receive a protrusion from the delivery system.

[0116] Example 41. The obstructing device according to any of the preceding examples, wherein one or both of said hollow tubular member and said proximal opening thereof is shaped and sized to conform with a regurgitant orifice of the heart valve.

[0117] Example 42. The obstructing device according to example 41, wherein one or both of said hollow tubular member and said proximal opening thereof are pre-shaped to have a triangular or substantially triangular cross-section.

[0118] Example 43. The obstructing device according to examples 41 or 42, wherein one or both of said hollow tubular member and said proximal opening thereof are pre- shaped according to a patient- specific regurgitant orifice shape. Example 44. The obstructing device according to any of examples 41 to 43, wherein the hollow tubular member is sufficiently soft for conforming to the regurgitant orifice when the heart valve is closed.

[0119] Example 45. The obstructing device according to example 44, wherein said tubular member is sufficiently pliable to change a shape thereof during a cardiac cycle.

[0120] Example 46. The obstructing device according to any of the preceding examples, wherein said peripheral frame and said grasping arm are each elastically deformable and have a preferred bending plane to apply clamping force towards said leaflet or cusp when said leaflet or cusp is trapped therebetween; and wherein said peripheral frame and said grasping arm are each curved in their respective preferred bending plane.

[0121] Example 47. The obstructing device according to any of the preceding examples, wherein said peripheral frame and said grasping arm are curved in an arc shape in a resting state thereof.

[0122] Example 48. The obstructing device according to example 47, wherein the hollow tubular member is attached to the peripheral frame at the exterior side of the arc shape thereof.

[0123] Example 49. The obstructing device according to any of the preceding examples, wherein the hollow tubular member is formed of a membrane.

[0124] Example 50. The obstructing device according to to any of the preceding examples, wherein the tubular member is self-expandable.

[0125] Example 51. The obstructing device according to any of the preceding examples, wherein the hollow tubular member tappers distally in a downstream direction.

[0126] Example 52. The obstructing device according to any of the preceding examples, wherein the hollow tubular member is curved, extending adjacent to and along the leaflet

[0127] Example 53. The obstructing device according to any of the preceding examples, wherein the leaflet anchor is made of a super-elastic or shape memory material.

[0128] Example 54. An obstructing device mountable on a heart valve cusp or leaflet, in a valve lumen having a flow axis between an upstream direction and a downstream direction, comprising: a hollow tubular member, comprising: a proximal end comprises a proximal opening; and a substantially tubular surface extending distally from said proximal opening to a distal end, wherein one or both of said hollow tubular member and said proximal opening comprises a pre-selected shape configured to conform to a regurgitant orifice of the heart valve; and a leaflet anchor, comprising: a peripheral frame having a distal end, a proximal end, and two side arms; a grasping arm extending distally from said proximal end, located between said side arms and having a free end, so that said cusp or leaflet can be trapped between said frame and said grasping arm; wherein said hollow tubular member is attached to said peripheral frame.

[0129] Example 55. The obstructing device according to example 54, wherein one or both of said hollow tubular member and said proximal opening thereof is shaped and sized according to a shape of the regurgitant orifice.

[0130] Example 56. The obstructing device according to examples 54 or 55, wherein one or both of said hollow tubular member and said proximal opening are pre-shaped to have a triangular or substantially triangular shape.

[0131] Example 57. The obstructing device according to any of examples 54 to 56, wherein one or both of said hollow tubular member and said proximal opening are pre-shaped according to a patient- specific regurgitant orifice shape to have an un-rounded shape.

[0132] Example 58. The obstructing device according to any of examples 54 to 57, wherein the hollow tubular member is sufficiently soft to be shaped as the regurgitant orifice when the heart valve is closed.

[0133] Example 59. The obstructing device according to example 58, wherein said tubular member is sufficiently pliable to change a shape thereof during a cardiac cycle.

[0134] Example 60. The obstructing device according to example 59, wherein said tubular member is sufficiently deformable to maintain the regurgitant orifice shape when the heart valve opens.

[0135] Example 61. The obstructing device according to example 60, wherein said tubular member is configured to encourage tissue ingrowth thereon.

[0136] Example 62. The obstructing device according to any of examples 54 to 61, wherein said tubular member comprises a pericardium tissue.

[0137] Example 63. A delivery system for delivering an obstructing device for being mounted on a native cusp or leaflet, said delivery system comprising: a body; a capsule defined by a movable proximal outer sheath and a movable distal outer sheath; a distal holder for receiving a distal part of said obstructing device and a proximal holder for receiving a proximal side of said obstructing device, wherein the proximal holder and the distal holder are mounted on said body and covered by said capsule

[0138] Example 64. The delivery system according to example 63, comprising an obstructing device held by said distal holder and said proximal holder, wherein said obstructing device comprises a curved frame with a curved resting state wherein said distal holder and said proximal holder hold said frame to prevent said curved frame from being at said curved resting state

[0139] Example 65. The delivery system according to example 64, wherein the obstructing device comprises a curved grasping arm with a curved resting state and, wherein said capsule holds said grasping arm to prevent said curved grasping arm from being at said curved resting state.

[0140] Example 66. The delivery system according to any of examples 64 or 65, wherein the proximal holder comprises at least one geometry configured to have geometric interferabce with a corresponding geometry on a proximal portion of said frame.

[0141] Example 67. The delivery system according to example 66, wherein said at least one geometry comprises one or both of: a protrusion shaped and sized to fit within a depression on said frame; and a depression shaped and sized to receive a protrusion from said frame.

[0142] Example 68. The delivery system according to any of examples 66 to 67, wherein the proximal holder comprises a fixator configured to attach the proximal portion of said frame to said proximal holder.

[0143] Example 69. The delivery system according to example 68, wherein said fixator is configured to press said proximal portion of said frame onto said proximal holder.

[0144] Example 70. The delivery system according to any of examples 66 to 69, wherein the distal holder comprises at least one recess defined by said distal outer sheath partially covers said distal holder, configured to receive a distal portion of said frame.

[0145] Example 71. The delivery system according to any of examples 65 to 69, wherein said proximal sheath is configured to be partially retracted in the proximal direction and said distal sheath is configured to be partially retracted in the distal direction, revealing the grasping arm.

[0146] Example 72. The delivery system according to any of examples 64 to 71, wherein said proximal sheath is configured to be fully retracted in the proximal direction to release said proximal portion. Example 73. The delivery system according to any of examples 68 to 71, wherein said fixator comprises an elastic mechanism, and wherein the fixator is configured to radially bent away when said proximal sheath is fully retracted.

[0147] Example 74. The delivery system according to any of examples 70 to 73, wherein said distal sheath is configured to be fully retracted to release said distal portion from said recess.

[0148] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0149] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS:

[0150] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings and images. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0151] The present invention, in some embodiments thereof, is illustrated by way of example in the accompanying drawings, in which similar references consistently indicate similar elements and in which:

[0152] - Figs. 1A and IB illustrate a normal functioning heart aortic valve and an Aortic Regurgitation functioning heart aortic valve respectively.

[0153] - Figs. 2A-2D illustrate embodiments of the present invention obstructing device.

[0154] - Figs. 2E-2F illustrate embodiments of the present invention obstructing device hollow tubular member.

[0155] - Fig. 2G illustrates an embodiment of the present invention obstructing device attachment element.

[0156] - Fig. 2H illustrates an embodiment of the obstructing device with the frame and central clipping arm straightened. - Fig. 21 is an image of a frame including a central arm of an embodiment of the obstructing device mounted on a cusp.

[0157] - Fig. 2J is an image of a frame including a central arm of an embodiment of the obstructing device in a relaxed state.

[0158] - Figs. 3A-3K illustrate an embodiment of the present invention delivery system or portions thereof.

[0159] - Figs. 4A-4C illustrate an embodiment of the present invention delivery system at different stages.

[0160] - Figs. 5A-5D illustrate different stages of a method according to an embodiment of the present invention.

[0161] - Figs. 6A and 6B illustrate an embodiment of the present invention device functioning in different valve states.

[0162] - Figs. 7A-7B show an example of heart leakages before and after the implanting of an embodiment of the present invention.

[0163] - Fig. 8 illustrates an embodiment of the present invention delivery system.

[0164] - Fig. 9A illustrates embodiments of a leaflet anchor of an obstruction device, in accordance with exemplary embodiments of the invention.

[0165] - Fig. 9B shows a side view of a leaflet anchor connected to a tubular member, in accordance with exemplary embodiments of the invention.

[0166] - Figs. 9C-E show perspective views of a leaflet anchor connected to a tubular member, in accordance with exemplary embodiments of the invention.

[0167] - Fig. 10 illustrates embodiments an obstructing device, in accordance with exemplary embodiments of the invention.

[0168] - Fig. 11 shows an obstructing device deployed on a leaflet, in accordance with exemplary embodiments of the invention.

[0169] - Fig. 12 shows a perspective view of a delivery system comprising an obstruction device, in accordance with exemplary embodiments of the invention.

[0170] - Fig. 13, shows a deployed shape-fitted obstructing device, in accordance with exemplary embodiments of the invention.

[0171] - Fig. 14, shows a shape-fitted obstructing device, in accordance with exemplary embodiments of the invention.

[0172] - Figs. 15A-C, show a flowchart of a method for deploying an obstructing device, in accordance with exemplary embodiments of the invention. - Figs. 16A-B, 17A-B, and 18A-B, show exemplary dimensions and views of an obstructing device, in accordance with exemplary embodiments of the invention.

[0173] DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION:

[0174] The present invention, in accordance with some embodiments thereof relates to an artificial cusp attachment. More particularly, the present invention, in some embodimenst thereof, relates to a blood leakage obstructing device comprising a hollow tubular member, attachable to one of the heart native valves' (aortic valve, mitral valve, pulmonary valve, tricuspid valve) cusps / leaflets. Potentially, the obstructing device effectively causes the heart native valve to be fully closed when in its closed state. The hollow tubular member, in some embodiments, acts as a scaffold to the cusps / leaflets, an add-on portion that moves with the cusp / leaflet as it opens and closes the valve.

[0175] The device of some embodiments of the present invention will be explained mostly in relation to the aortic valve, but may similarly be attached to the other heart native or artificial valves' cusps or leaflets, mutatis mutandis, noting that the direction of flow and / or of regurgitation may change the relative orientation of an anchor section and the hollow tublar section.

[0176] In the present specification the “proximal end” refers to the end closest to the medical personnel delivering the device. The “distal end” refers to the end furthest from the medical personnel and closest to the target location in the patient’s body during delivery of the device. In relation to the embodiment which inserts the device of the present invention via the aorta (towards the left ventricle), the "distal direction" refers to the direction towards the left ventricle and the ’’proximal direction” refers to the opposite direction, i.e. the direction towards the aorta away from the left ventricle. Thus, the normal blood through the aortic valve flows from the distal to the proximal direction.

[0177] In cases with hearts having aortic valvular insufficiency, valve leakage occurs when the aortic valve is in a closed state. The leaflets / cusps partially close in the aortic valve in its closed state, leaving a portion of the aortic valve opened, which causes a portion of the blood to flow back into the left ventricle. In accordance with some embodiments of the present invention, the obstructing device which is attached to one of the cusps is situated in the regurgitant orifice of the aortic valve when the aortic valve is in a closed state and effectively obstructs the valvular insufficiency "opening" at the regurgitant orifice of the aortic valve. Thus, the blood from the aorta does not leak back to the left ventricle (but part of the blood only enters the interior of the hollow tubular member of the obstructing device). The obstructing device of some embodiments of the present invention comprises a hollow tubular member, attachable to the valve cusp. The hollow tubular member of the obstructing device comprises a proximal opened end, a lateral (side) tubular surface and a closed (sealed) distal end or an end provided with a small hole / orifice. More specifically, the obstructing device hollow tubular member comprises a proximal opening at its proximal end, the substantially tubular surface extending distally from the proximal opening and a closed distal end (or an end provided with a small orifice).

[0178] The device is such that when attached to the cusp, either:

[0179] 1. in case where the distal end is completely closed, blood may enter and thereafter exit the interior of the hollow tubular member from the proximal opening only (i.e. the lateral (side) tubular surface along with the distal side is all closed / sealed).

[0180] 2. in case where the distal end includes a small orifice, blood may enter and thereafter exit the interior of the hollow tubular member mainly from the proximal opening but a very small portion may exit the distal small orifice. However, this minimally affects the function of the heart and most of the potential leakage blood is obstructed by the obstructing device.

[0181] The embodiment with the distal end small orifice is potentially advantageous as this configuration prevents clotting of blood within the hollow tubular member by allowing minimal blood flow through the orifice and / or allows opening of the hollow tubular member by blood flow therethrough.

[0182] The proximal opening may be placed near the proximal end (at the edge) of the cusp, adjacent to its inner side such that when the aortic valve is in a closed state, the obstructing device obstructs the valvular insufficiency "opening" at the regurgitation orifice of the aortic valve. The hollow tubular member is preferably, but not necessarily, positioned such that it extends up to 3mm proximally above the proximal edge of the native cusp (the nodule of Ar antius).

[0183] In some embodiments of the invention, the obstructing device hollow tubular member is compressible and may be expanded such that the volume of its interior may vary. During systole, when the aortic valve is in its open state, the blood exiting the left ventricle at a substantial current flow causes the obstructing device to partially be compressed and its interior volume to thus decrease. During diastole, when the aortic valve is in its closed state, blood from the aorta may enter the obstructing device interior (possibly adding to its expansion thereof and an increase in the obstructing device interior volume). In any case, during diastole, the blood in the aorta does not flow back to the left ventricle as it is blocked by the obstructing device which engages the other cusps flow facing sides (i.e. the sides facing the center of the valve) and effectively forms a seal not allowing (or reducing the ability of) the blood to pass through the engaging locations between the obstructing device and the cusps flow facing sides. The obstructing device effectively causes the heart native valve to be more closed (in some cases - fully closed) when in its closed state, as in the function of a healthy heart. In some embodiments, the present invention obstructing device does not form a total seal (at the regurgitation orifice), but decreases the blood leakage, which also improves the health of a patient.

[0184] In some embodiments of the invention, the opening of the hollow tubular member of the obstructing device (at its proximal side) is attached near the cusp proximal end. The obstructing device hollow tubular member engages the cusp flow facing side and extends distally adjacent to and along the cusp that it is attached to (along the cusp flow facing side). Optionally, the obstructing device hollow tubular member tappers distally. In this manner the wide proximal end of the obstructing device hollow tubular member engages the proximal ends of the cusps of the aortic valve (the cusp that it is attached to and the other cusps that their ends tend to close to engage each other) causing the effective seal. The distal part of the obstructing device hollow tubular member attached to the cusp may be narrower than the wide proximal opening, as it is attached to the distal portion of the cusp but does not need to be wide in order to obstruct. This configuration enables the obstructing device to have a minimal mass for a most effective function. The proximal opening is configured to be wide enough to obstruct.

[0185] According to an embodiment of the present invention, the obstructing device hollow tubular member is in the form of a deformable membrane. The membrane (in the form of the hollow tubular member) comprises a proximal opening, a lateral tubular surface and either:

[0186] 1. a 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).

[0187] 2. a distal end comprising a small orifice, (the membrane 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 end orifice).

[0188] During systole the membrane may be partially compressed (by the systole blood flow) and during diastole the membrane may expand as the "leakage" blood enters the interior of the hollow tubular member enlarging its volume.

[0189] According to one embodiment the membrane is self-expandable (e.g. elastic). During systole the membrane is partially compressed (by the systole blood flow) and during diastole the membrane expands. The membrane may comprise an artificial source, a biocompatible material (e.g. Dacron, PTFE, etc.) or a biologic source (e.g. animal valve cusp, animal pericard, porcine pericardium, bovine pericardium etc.). The membrane may also comprise autologous tissue.

[0190] According to another embodiment of the present invention, the obstructing device comprises a frame comprising one or more wires that define its general shape. The wires are structured such that they form a general hollow tubular shape with a closed distal end. The frame wires are structured such that the membrane is attached thereto forming a strengthened hollow tubular member with a proximal opened end, the lateral tubular surface extending distally from the proximal opened end and a closed distal end (optionally with a small orifice). The membrane is actually mounted on the frame (either from within or from without). Preferably the frame shape tappers distally. The present invention may include embodiments with a self expandable hollow tubular member mounted on the wires frame (which may also be self expanding).

[0191] In some embodiments of the invention, the obstructing device comprises a clip-like element attached to the hollow tubular member, configured to attach and mount the hollow tubular member to a respective cusp of the heart valve.

[0192] An aspect of some embodiments of the invention relates to a cusp-mounted cardiac implant including a frame and one or more arm and in which the frame and / or the arm bend to engage a cusp therebetween. In some embodiments of the invention, the frame has two stable states, each with a different curvature state and wherein in one state, a gap is defined between the arm and the frame and in another state the gap is smaller or negative (the arm goes past the frame. Optionally, the arm is prevented from going past the frame not by the arm extending to or past an edge of the frame, but by the cusp. Some, in some embodiments, one stable state is defined by the existence of a cusp trapped between the arm and the frame. In some embodiments of the invention, the gaps and geometry of the frame and arm and forces applied thereby are selected to avoid or reduce damage to the cusp, other than, for example, penetration of one or more needles into the cusp.

[0193] In some embodiments, the frame has a single stable state, when it is curved and the arm is placed within. In some embodiments, deployment is performed when the frame is deformed to an unstable state, and them released on the cusp. The frame strives to return to a stable state while encountering the leaflet and exerting force thereon, optionally, enough force to hold the leaflet between the frame and the arm. This force potentially prevents dislodgment of the device while preventing cusp perforation.

[0194] An aspect of some embodiments of the invention relates to a frame for engaging a cusp of a cardiac valve in which the frame is curved. In some embodiments of the invention, the frame extends laterally and axially along a cusp, when engaging the cusp and the curvature is a plane perpendicular to the cusp surface. In some embodiments of the invention, the frame is elastic and is formed of multiple elongate elements, for example, an elongate frame and a clipping arm extending from one side of the frame towards the other side of the frame, with the cusp to be trapped between the frame and the arm. Optionally, one or more or all of the elongate elements define a preferred bending plane, within which resistance to bending is lower. For example, the elongate elements may be laterally flat with a thin and a thick dimension and have a preferable bending plane which extends along the length of such elongate element and in a direction of the thin dimension. All the elongate elements optionally share a same preferred bending plane which is optionally perpendicular to the cusp, when trapped. It is noted that the term “plane” also includes slightly curved surfaces, as the elongate elements may not bend exactly in a flat plane.

[0195] A potential advantage of having a curved shape, especially an arc shape, for the frame is that such shape may more closely conform to the shape of a cusp in a closed state of the cardiac valve. This may reduce deformation of the cusp, preventing damage thereto and / or avoiding regurgitation caused by such deformation. Optionally, the curvature is not too great, to prevent pathological blocking of the valve by the cusp in an open state of the valve. For example, the curvature in a deployed state may be, for example between 20 and 200 mm or more, for example, between 30 and 100 mm. Optionally or additionally, the arc size in angle of the frame is between 10 and 60 degrees, for example, between 15 and 30 degrees. It is noted that in a resting state, the frame may be considerably more deformed and / or have a smaller radius of curvature, for example, a radius of curvature which is a factor of 0.5 or 0.25 or more of said radii.

[0196] In an obstructing device configuration, according to some embodiments of the invention, the frame has attached thereto a hollow obstructing member, which can be compressed by cardiac flow and expanded to block the valve in a closed state of the valve. In some embodiments of the invention, the member is constrained to be curved by the shape of the frame. Optionally or additionally, the frame is not attached to the member over the entire length of the member, which may allow, for example, for a distal part of the member to extend radially away from the cusp and the frame. A gap defined thin may be, for example, between 1 and 10 mm, for example, between 2 and 6 mm. Optionally or additionally, the member may be curved, at least in part, to conform to a cusp shape.

[0197] It is noted that a natural cusp may be flatter at a coapting section thereof where two cusps meet. Optionally, the frame is designed to be flatter at such section than in a more downstream section. An aspect of some embodiments of the invention relates to a method for engaging a cusp of a cardiac valve using at least three elongate elements on alternating sides of a cusp, where at least one of the elements, optionally all the elements, include one or more projections, optionally a row of projections which lie generally I a plane of the cusp and the elements. In some embodiments of the invention, the elements are arranged into a frame with a central arm and the frame includes serrations projecting towards the arm and the arm includes serrations projecting towards the frame.

[0198] In some embodiments of the invention, an additional anchoring is provided using one or more needles (used as a term for penetrating elements) which penetrate into the cusp. Optionally or additionally, non-penetrating elements may be provided, e.g., projections pointed perpendicular form the plane of the cusp and / or the elements.

[0199] In some embodiments of the invention, the elements are formed by cutting a sheet, for example, using laser cutting. Alternative, one or more of the elements are formed by a bent wire.

[0200] An aspect of some embodiments of the invention relates to a method of delivering a clasping anchoring element to a cardiac cusp. In some embodiments of the invention, the element includes a frame and a central arm, which central arm is optionally attached to the frame on one side thereof but optionally does not reach to the opposite side of the frame.

[0201] In some embodiments of the invention, the method includes releasing the central arm to elastically extend away form a delivery system and the frame, thereby defining a gap into which a cusp portion may be positioned.

[0202] Optionally, thereafter, a part of the frame is released to close the gap and engage the cusp between the frame and the arm.

[0203] Optionally, a remaining portion of the frame is help until final deployment. This potentially allows the anchoring element to be removed from the cusp. Optionally or additionally, the frame has a reduced locking force against the arm until the remaining portion is release and allowed to bend. Optionally, the remaining portion comprises a base which elastically (including via shape memory and super-elastically) interconnects the arm and the frame.

[0204] In some embodiments of the invention, a delivery system is used which includes an optional bending ability (e.g., to help align the gap with the cusp). Optionally or additionally, the delivery system provided an ability to move just the tip a short distance, for example, between 0.5 and 3 cm, for example, between 1 and 2 cm, thereby allowing the frame (or a containing capsule) to be moved without repositioning the delivery system as a whole. Optionally or additionally, the delivery system includes a capsule to hold the frame and a tab to selectively release the arm (e.g., retract a sheath or tab from a side of the frame enough so the arm is released, but not far enough so that the frame is released) and / or the frame (e.g., by further retraction).

[0205] Optionally or additionally, the delivery system includes a tab to selectively release the remaining part of the frame when delivery is completed. Optionally, such release is assisted by an elastic element which pushes the frame away from the capsule. Optionally or additionally, such elastic release is provided by the frame itself.

[0206] An aspect of some embodiments of the invention relates to a cusp connector (e.g., a leaflet anchor) for connecting to the cusp with sufficient strength and / or geometrical engagement to potentially prevent disengagement of the obstructing device from the cusp while avoiding cusp perforation.

[0207] In some embodiments, the cusp connector comprises a grasping arm and a frame, wherein the frame and / or the grasping arm comprises roughness to potentially increase friction and restrict the movement of a leaflet caught between the arm and the frame. In some embodiments, the frame comprises lateral protrusions on the inner edge thereof, optionally facing the grasping arm. Alternatively or additionally, the arm comprises lateral protrusions facing the inner edge of the frame. The frame protrusions and the arm protrusions define a margin (e.g., a space) therebetween. Alternatively or additionally, the frame protrusions and / or the arm protrusions may connect to the cusp by piercing thereof. In some embodiments, the frame protrusions and / or the arm protrusions are sufficiently sharp and / or pointy for penetrating the cusp while maintaining a degree of bluntness to potentially prevent cusp perforation.

[0208] In some embodiments, the size of the margin along the longitudinal axis of the cusp connector is non-uniform, optionally decreasing in size from the proximal end to the distal end.

[0209] In some embodiments, the varying margin allows the cusp connector to anchor to leaflets of different thicknesses and / or leaflets having portions of different thicknesses, by potentially ensuring that some spacing (e.g., space sizes) matches cusp thickness. In some embodiments, the size varies according to a thickness gradient of the leaflet, for potentially clinging to the cusp at a uniform and / or substantial uniform force, along the longitudinal axis of the cusp connector.

[0210] In some embodiments, the cusp connector comprises one or more protrusions, located on the frame and / or arm, and directed toward the cusp tissue, optionally perpendicular to the frame, optionally, configured for penetrating the cusp tissue. The direction toward the cusp potentially reduces the risk of cusp tearing. This one or more protrusions potentially reduces and / or prevents lateral and / or rotational movement of the obstructing device relative to the cusp surface, having the potential advantage of reducing device dislodgment and / or cusp perforation.

[0211] In some embodiments, the cusp connector is designed to reduce focal force, optionally by providing spaces where it might otherwise pinch. For example, at the distal and / or proximal end of the farem. In some embodiments, the cusp connector comprises a space at the distal portion of the frame, defined by the frame and lack of grasping arm and / or protrusions for potentially reducing focal force on the cusp near the distal end of the cusp connector. Alternatively or additionally, the cusp connector comprises such a space at the proximal thereof, for potentially reducing focal force on the cusp near the proximal opening of the obstructing device.

[0212] An aspect of some embodiments of the invention relates to the deployment of an obstructing device having a curved cusp connector (e.g., a leaflet anchor). In some embodiments, the curved cusp connector comprises a curved frame and a curved grasping arm (at a relaxed and undeformed state), optionally, the frame and the arm are aligned and / or curved to the same level.

[0213] In some embodiments, delivering an obstructing device having a curved cusp connector comprises maintaining the frame and the arm in a straightened form while navigating toward the implantation site. Upon reaching a target site, the arm is released to curve and protrude away from the straightened frame, optionally, in the concave side of the frame (when unstraightened). In some embodiments, the deployment of the obstructing device on a cusp is performed by placing the device on said cusp, optionally, positioning the device such that the cusp is between the arm and the frame between the curved released arm and the straightened frame and then releasing the frame to curve and align with the arm.

[0214] In some embodiments, the cusp connector comprises a margin between the arm and the frame, optionally defined by lateral protrusions on the inner edge of the frame, facing lateral protrusions of the grasping arm. In some embodiments, the size of the margin along the longitudinal axis of the cusp connector optionally decreases in size from the proximal end to the distal end, such that the margin is wider than the cusp at the proximal end thereof and narrower from the cusp at the distal end thereof, for potentially preventing the arm from crossing to the other side of the frame, optionally the convex side of the frame, which might result in significant cusp deformation and / or perforation.

[0215] In some embodiments, the frame of the cusp connection comprises a geometry at the proximal end thereof for interacting with a delivery system. In some embodiments, this interaction is a geometric interference to the relative movement (e.g., lateral and / or rotational) between the geometry of the frame and a corresponding geometry on the delivery system. For example, the frame comprises at least one protrusion that fits within a corresponding recess on the delivery system. Alternatively or additionally, the delivery system comprises at least one protrusion that fits within a corresponding recess on the frame. In some embodiments, the delivery system comprises a fixator for fixing the frame and / or the proximal portion thereof in proximity to the delivery system, to potentially enable the interaction between the frame geometry and the corresponding geometry on the delivery system. This interaction geometrically interferes with the movement of the frame relative to the delivery system. In some embodiments, the fixator presses the proximal portion of the frame onto the delivery system until the release of the obstructing device, when this press is released. In some embodiments, the fixator presses are released by the fixator rotating away from the device and / or delivery system, optionally by activating a spring mechanism. This release potentially simplifies and / or expedites the emergence of the device from the delivery system. The fixator potentially holds the proximal end of the frame relatively stable and allows to release thereof in a relatively sudden manner, having the potential advantage of reducing and / or avoiding contact between the device and the delivery system when the device is released.

[0216] An aspect of some embodiments of the invention relates to an obstruction device that conforms to the shape of the regurgitant orifice. This conformation potentially improves the sealing of the regurgitant orifice.

[0217] In some embodiments, the tubular member and / or the proximal opening thereof is preshape according to the shape of the regurgitant orifice. In some embodiments, the tubular member and / or the proximal is shaped based on a typical shape of a regurgitant orifice, such as a triangular. In some embodiments, the tubular member and / or the proximal opening thereof is shaped according to a patient-specific regurgitant orifice shape, optionally as imaged by known in the art imaging modalities.

[0218] In some embodiments, the tubular member is formed from a material sufficiently soft that can be deformed by the pressure exerted thereon by the cusps when the heart valve is closed, shaping the tubular member and / or the proximal opening as the regurgitant orifice. In some embodiments, the material is elastic so that the tubular member and / or the proximal opening returns to its original shape when the pressure is removed (when the heart valve opens). In other embodiments, the material is deformable so that the tubular member and / or the proximal opening preserve the shape of the regurgitant orifice. In some embodiments, the level of softness and / or deformability of the material is adjusted to the cusp conditions. For example, if the cusps are relatively thin and / or weak, the tubular member comprises a material of enhanced softness and / or deformability for enabling thereof to be shaped by the cusps. In some embodiments, the tubular member is formed from a material sufficiently stiff to potentially cause the cusps to conform to it.

[0219] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0220] Fig. 2A shows an embodiment of the present invention obstructing device 10. The obstructing device 10 comprises a membrane that forms a hollow tapering tubular member 5 with a proximal opening 12. The interior of tapering 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, tappers distally and terminates at the closed distal end 7 (wherein in other embodiments (not shown) the distal end may comprise an orifice / hole). The hollow tubular member 5 is attached to an attachment element 20 (also referred to herein as "attaching element" interchangeably).

[0221] Fig. 2F shows an exemplary embodiment of the present invention hollow tubular member 5 comprising a frame comprising one or more wires that define its general shape. The membrane of the obstructing device 10 (not shown) is attached to the frame, such that the frame and membrane attached thereto form together a hollow tapering tubular member 5 with a proximal opening 12 (wherein the interior of tapering tubular member 5 is completely closed / sealed by the membrane except for the proximal opening 12 and optionally a distal orifice, as explained herein). In one embodiment the frame is external to the membrane layer (inside or outside the member). In another embodiment, the wires of the frame may be contained within the layer of the membrane. The frame is designed to withstand fatigue, and may be collapsible and / or selfexpanding.

[0222] According to an embodiment of the present invention, the tapering tubular member 5 comprises a round (preferably circular) wire portion on its proximal side forming the proximal opening 12. The tapering tubular member 5 comprises one or more longitudinal wire elements 13 along its length. The tapering tubular member 5 comprises one or more transverse wire elements (e.g. circular) surrounding one or more respective transverse portions of the tapering tubular member 5 placed along its length.

[0223] The embodiment of Fig. 2F shows, for example, three transverse surrounding wire portions 14, 15, 16, each in the form of a sinusoidal wave. Since the tapering tubular member 5 tappers distally, in case of each two adjacent transverse surrounding wire portions, the more proximal one of the two is larger (i.e. it surrounds a longer width portion) than the more distal one of the two. In this case, wire portion 14 is optionally greater that wire portion 15, which is optionally greater than wire portion 16.

[0224] In some embodiments the tapering tubular member 5 may comprise one or more longitudinal wire elements along its length and one or more transverse wire elements surrounding one or more respective transverse portions of the tapering tubular member 5 placed along its length.

[0225] The obstructing device 10 further optionally comprises an attaching element 20. The attaching element alone is shown in Fig. 2G. The attaching element 20 may be in the form of a snap clip, bendy, snap barrette, contour clip. The attaching element 20 comprises a metal alloy (e.g., nitinol) that tends to bend / curve thereby forming an arc. The attaching element 20 comprises two elongated (typically thin) side arms 20a. The attaching element 20 comprises a proximal end 20p, the two side arms 20a extending distally from said proximal end 20p, and a central clipping arm 20c extending distally from said proximal end 20p. The attaching element 20 comprises a distal end 20d attached to the distal portions of the side arms 20a. While the side arms 20a are optionally connected to both the proximal end 20p and the distal end 20d, the central clipping arm 20c is connected only to the proximal end 20p and has a distal free end 20f (i.e., the free end is not connected to the frame distal end 20d). The proximal end 20p, distal end 20d and side arms 20a form a peripheral frame 20m having a hollow interior with the central clipping arm 20c extending distally from the proximal end 20p within the hollow interior.

[0226] In Fig. 2G the frame 20m is flat and the central clipping arm 20c is in the form of an arc. This is the situation at a certain stage of the insertion process as explained herein (where the frame is retained in a flat manner and the central clipping arm 20c is released thereby curving into an arc form). It should be bom in mind that when the frame 20m is released from being retained, it also curves into an arc typically to the same extent as that of the central clipping arm 20c. The distal end 20d and proximal end 20p are each placed at the edges of the arc shape of peripheral frame 20m. Also, the free end 20f and the attachment point of the central clipping arm 20c to the proximal end 20p are each placed at the edges of the arc shape of the central clipping arm 20c.

[0227] According to an embodiment of the present invention, the central clipping arm 20c comprises a plurality of sharp edges 20s on its sides. For example, each side of the central clipping arm 20c may comprise a plurality of circular adjacent arcs which form the sharp edges 20s at the connection points of each two adjacent arcs. Optionally or alternatively, the side arms 20a also comprise sharp edges 20as along their sides (preferably along their inner sides), e.g. a plurality of circular adjacent arcs which form the sharp edges 20as at connection points of each two adjacent arcs. These sharp edges 20s, 20as assist in providing a firm attachment of the attaching element 20 to the native cusp. Optionally or additionally, non-sharp serrations or other protrusions designs may be provided. A potential advantage of such serrations or protrusions is that they better engage the cusp and may assist in resisting blood flow, preventing device migration. Optionally or additionally, the central and / or side arms include one or more apertures or a coating or other treatment which optionally encourages tissue ingrowth and / or adhesion to the cusp.

[0228] According to an embodiment of the present invention, the sharp edges 20s, 20as are curved (or bend) backwards or forwards (in relation to the general longitudinal axis of the attachment element 20) to engage the cusp tissue in a firmer manner. For example, the sharp edges 20s may curve (or bend) towards the outer side of the central clipping arm 20c curve to firmly engage the tissue in the belly of the cusp. Also, the sharp edges 20as may curve (or bend) towards the inner side of the frame 20m curve, to firmly engage the tissue in the cusp flow facing side. The direction of the edges may be selected to better resist pressure caused by blood flow in a matching direction.

[0229] In some embodiments of the invention, the attaching element 20 always tends to bend, thereby forming an arc, i.e., both the peripheral frame 20m (mainly the side arms 20a) and the central clipping arm 20c tend to bend to a similar extent (each of which forms an arc shape). The attaching element 20 comprises a shape memory alloy (e.g., nitinol). This potentially enables a most advantageous function. In some embodiments of the invention, attaching element 20 is manufactured by shape setting. The attaching element 20 is bent / curved (during its manufacture) and put in high temperature (as known in the art). This produces an attaching element 20 having an arc shape at room temperature, wherein the arc shape remains constant. Thereafter, if the attaching element 20 arc shape is deformed (i.e., either further bent or straitened), it will always tend to return to its arc shape state that it had in the heating process. An element of the present invention having this constant arc shape state (after being shape set to have the constant arc shape) will be referred to herein as an element having "an arc shape when undeformed". Therefore, the attaching element 20 comprises an arc shape when undeformed. The central clipping arm 20c comprises an arc shape when undeformed, etc. It is noted that “arc shape” includes other monotonic curves as well, for example, where the radius of curvature increases or decreases along the arm. In some embodiments of the invention, a non-monotonic curve is provided and one or more arms may increase and decrease in curvature along its length. Also, it is noted that the curvature of the arms is optionally not identical between the arms. It is noted that other materials, for example, elastic materials, such as stainless steel may be used. A potential advantage of shape memory and super elastic materials such as nitinol is that the device may be crimped or otherwise deformed during delivery to a greater extent without affecting its function after deployment.

[0230] According to a preferred embodiment, the peripheral frame 20m is substantially symmetrical. Preferably, the peripheral frame 20m comprises a longitudinal axis larger than its transverse axis (i.e. they are not equal). The central clipping arm 20c extends along the frame 20m longitudinal axis. Preferably, the frame 20m is elliptic. The frame may also comprise other shapes, e.g. oval, rectangular, etc. In some embodiments of the invention, the frame is not symmetrical (e.g., frame 20m and / or central arm 20c are not symmetrical and / or not symmetrically aligned). This may be useful if the frame is implanted in an asymmetrical part of the heart, for example, not in the plane including the mitral and aortic valves.

[0231] In some embodiments of the invention, the hollow tubular member 5 is attached to the peripheral frame 20m with the hollow tubular member proximal opening 12 near the attaching element proximal end 20p and the hollow tubular member closed distal end 7 near the attaching element distal end 20d. The distance range between the proximal opening 12 and the proximal end 20p is usually between 0.1 and 0.5 mm, e.g., preferably 0.15mm (wherein the proximal end 20p is usually placed more proximal than the proximal opening 12). The distance range between the closed distal end 7 and the distal end 20d is usually between 0.1 and 0.5 mm (wherein the distal end 20d is usually placed more distal than the closed distal end 7). The attachment between the frame 20m and the hollow tubular member 5 may be implemented by sewing. The attachment element 20 may comprise a plurality of orifices / apertures or depressions for use of the sewing. Figs. 2A and 2G show examples of depressions 4 at the arms 20a where the depression 4 openings face outwards. The sewing "strings" may be non absorbable surgical sutures and comprise material selected from the group consisting of nylon, polyester, PVDF and polypropylene. Their thickness is usually between 10-0 and 2-0.

[0232] In some embodiments of the invention, the curve of the attaching element 20 (both the peripheral frame 20m and the central clipping arm 20c) is curved away from the hollow tubular member 5. In other words, the hollow tubular member 5 engages the external part of the convex curve of the arc portion, i.e., the hollow tubular member 5 engages (and is attached at) the curved side which is the exterior of the arc portion.

[0233] Nevertheless, other embodiments may include the curve of the attaching element 20 (both the peripheral frame 20m and the central clipping arm 20c) curved towards the hollow tubular member 5 (engaging the internal part of the convex curve of the arc portion; i.e., the hollow tubular member 5 engages (and is attached at) the curved interior side of the arc portion), mutatis mutandis.

[0234] Fig. 2B shows a side view of the obstructing device 10. Fig. 2C shows a "top" view of the obstructing device 10, with the central clipping arm 20c curving towards the top (having an arc shape). Fig. 2D shows a side view example of the present invention obstructing device 10 about to be attached to a native cusp. Whereas Fig. 2A shows the device 10 with the frame 20m and central clipping arm 20c being in their undeformed curved arc shape, Fig. 2H shows an embodiment with the frame 20m and central clipping arm 20c being in a deformed manner - straightened.

[0235] Fig. 2D shows an option for delivery where hollow member 5 (and optionally frame 20)is mounted on a guidewire / delivery catheter, potentially allowing the cusp to be engaged or device positioned while also allowing the efficacy of member 5 in preventing regurgitation, to be estimated, by allowing member 5 to expand in blood flow. In other embodiments of the invention, member 5 is folded in a delivery capsule and the guidewire (if any) passes to the side of it, while central clipping arm 20C is positioned as shown in Fig. 2D. This may make deployment easier, but interfere with estimation of device efficacy.

[0236] The attachment element 20 may comprise connecting elements (e.g., 20q, see Fig. 2J, for example showing two such needles) connectable to the cusp. For example, the connecting elements may be biocompatible needles that slant therefrom. The connecting elements are placed on the attachment element 20 surfaces that engage the cusp, as explained herein. The biocompatible needles may pierce the cusp portions that engage the attachment element 20 and thereby enhance a firm connection of the obstructing device 10 to the cusp. Other types of connecting elements may be used, such as biocompatible pins, biocompatible spikes, etc.

[0237] According to an embodiment of the present invention, the connecting elements slant backwards or forwards (in relation to the general longitudinal axis of the attachment element 20) to engage the cusp tissue in a firmer manner. For example, the connecting elements on the central clipping arm 20c may face the outer side of the central clipping arm 20c curve to firmly engage the tissue in the belly of the cusp. Also, the connecting elements may face the inner side of the frame 20m curve, to firmly engage the tissue in the cusp flow facing side.

[0238] Fig. 21 is an image of a frame 20a including a central arm 20c of an embodiment of the attaching element 20 mounted on a cusp 21, viewed from the location of cusp cooptation towards a vessel wall. In this embodiment, both serrations (or other tissue engaging geometries) 20as, on arms 20a and serrations (or other geometries) 20s are shown. In some embodiments of the invention, such serrations are sharp enough to engage tissue but blunt enough to avoid or reduce trauma to cusp tissue, especially trauma which might cause calcification or tearing of a cusp.

[0239] For example, such serrations may be between 0. And 2 mm apart, for example, 1 mm. Optionally or additionally, such serrations are between 0.3 and 0.7 mm long, for example, 0.5mm. a distance between arm2c and arms 2a, while generally not constant, can be, for example, related to a cusp thickness, for example, be between 60% and 200% of a cusp thickness, for example, be between 90% and 150%, for example, be between 105% and 130%. In an example of a 0.4 mm thick cusp, the distance may be, for example, 0.5 mm on the average. In other embodiments, a distance of, for example, between 0.2 and 1.5 mm may be provided. Optionally, the distance is selected so that the cusp is not pinched hard enough to be damaged. Also, the distance may be selected so that arm 20c and arms 20a can sit in a same (curved) plane of the cusp with reduced deformation of the cusp, while still providing anchoring even under conditions of aortic outflow. This may reduce stress on the cusp and / or reduce regurgitation.

[0240] In the embodiment shown there are multiple mechanisms holding frame 20m to cusp 21, including, sideways crimp provided by the arms, serrations which both enhance the crimp (e.g., by increasing friction) and provide axial (along the frame length) anchoring and also optional needles 20q.

[0241] Fig. 2J is an image of a frame including a central arm portion of an embodiment of the attaching element 20 in a relaxed state and in a lateral view corresponding to a view along the plane of cusp 21. Also visible is a ruler (in mm), showing typical dimensions of some embodiments of the invention. Optional pins 20q are visible on a tip 20f of central arm 20c.

[0242] It is noted that the curve of arm 20c and of arms 20a is optionally not the same, with arm 20c being overcurved, e.g., to ensure snug clasping of cusp 21 therebetween. Optionally or additionally, even if the curve is the same, base 20 selectively (and elastically) aims arms 20a and arm 20c in different directions. Optionally or additionally, it is noted that the baseline stiffness of arms 20a can be set to be greater than that of arm 20c, e.g., due to their greater combined cross-section, which causes arm 20c to bend more in response to deployment.

[0243] It is also noted that when engaging a cusp 21, cusp 21 would be above arms 20a as shown in Fig. 2J with arm 20c above cusp 21 and needles 20q pointing down into the cusp.

[0244] The present invention, in some embodiments thereof, provides a device that closes the malcoaptation gap by filling it with an artificial cusp that self-fits the gap when filled with blood and / or causes the cusps to adapt to the device geometry. A potential advantage of some embodiments of the present invention is providing a better tolerance to the implantation position than in the prior art leaflet prolongation method (in US 2015 / 0230919), and a more efficient closure of the gap, both or either of which may be provided by a potentially more stable anchoring of the instant design, which may prevent movement axially and / or radially along the cusp, especially movement within a cardiac cycle and / or movement between cardiac cycles. Furthermore, a second device can be implanted next to the first one if needed. Furthermore, the method of attachment to the native cusp can be more efficient and less complicated than that of the method of WO 2020026234 (e.g., by potentially avoiding string manipulation during insertion and / or not using connecting elements biocompatible pins).

[0245] The present invention, in some embodiments thereof, relates to a method for delivering an obstructing device (e.g. the obstructing device as defined herein) via a delivery system to the intended heart valve location, deploying and correctly positioning the obstructing device within the heart valve intended location such that it begins to function by improving the function of the heart valve. The present invention attachment element 20 curving feature is optionally utilized to attach the obstructing device 10 to a respective native cusp in. The obstructing device 10 is delivered through a delivery system 300 where its attachment to a respective native cusp is carried out.

[0246] The present invention delivery system, in some embodiments thereof, comprises movable elements (e.g., as will be explained herein) in order to safely hold, control and mount the present invention device on a native cusp. Figs. 3A-3K show various portions of the present invention delivery system, according to some embodiments. The delivery system 300 comprises a guide wire (not shown in Figs. 3A-3K) and a wire lumen 50 (e.g. catheter) configured to pass over the guide wire, for example, in an "over the wire delivery" manner. The guide wire may optionally be an extra stiff guide wire. For example, the guide wire is of type 035 inch. The delivery system further comprises an outer sheath 60 a distal holder 70 (e.g., in the form of distal cone 70) and a proximal holder 80. The obstructing device 10 is configured to rest on and be retained by the distal cone 70 and proximal holder 80. The attaching element 20 of the obstructing device 10, without the tubular member 5, is shown in most of these figures for the purpose of simplicity. However, it would be understood that the present invention system and method would include the entire obstructing device 10 with the tubular member 5 in a crimped / folded / compressed / collapsed configuration (e.g. a pre-load state) attached to the attaching element 20 for example as explained herein.

[0247] The delivery system comprises a proximal lumen 90 (e.g. as part of a catheter) fixedly connected to the proximal holder 80. The proximal lumen remains stationary during one or more of the method stages, as will be explained herein. The distal end of proximal lumen 90 (not shown) terminates within the proximal holder 80. The wire lumen 50 passes through the proximal lumen 90. The proximal holder 80 comprises an inner bore which the proximal lumen 90 passes through. Preferably, the proximal lumen 90 is fixedly connected to a portion of the inner bore and the wire lumen 50 continues distally (from within the distal end of the proximal lumen 90) along the inner bore to the distal cone 70. The wire lumen 50 passes through a second bore within the distal cone 70. The wire lumen 50 is fixedly attached to the distal cone 70 (typically to a portion of the distal cone 70 inner bore).

[0248] The delivery system optionally comprises a proximal handle (not shown) for controlling the delivery system (e.g. pushing / pulling the handle forwards / retracts the wire lumen 50 and thereby the holders sheath and proximal lumen 90). The handle comprises appropriate knobs (as known in the art) to control the movements of the wire lumen 50, the proximal lumen 90 and the outer sheath 60. The movement control of these elements potentially enable for a most efficient retaining of the obstructing device 10 and its gradually deployment as will be explained.

[0249] Fig. 3A shows the distal cone 70 and proximal holder 80 retaining the attaching element 20. The distal cone 70 and proximal holder 80 are distanced from one another such that the attaching element 20 is tightly retained (the distal cone 70 retaining distal end 20d and the proximal holder 80 retaining proximal end 20p.

[0250] The distal cone 70 comprises a distal front member 71. The distal front member 71 may be in the form of a disc or in the form of a "front cone" tapering distally with a proximal circular disc shape. The wire lumen 50 passes through the distal front member 71 (preferably via its center). The distal cone 70 (according to this embodiment) comprises a "sliced" cone shaped element 70c attached at its distal end to the distal front member 71. The cone shaped element 70c has a flat surface 70f. It could be considered that the cone shaped element 70c has a bottom partial cone shape tapering proximally and has a top flat surface 70f. The distal cone 70 comprises a ring-shaped element 75 extending proximally from the distal front member 71. Optionally, the distal portion of flat surface 70f has a diagonal flat surface 70d that may assist in retaining the distal portion of attaching element 20. The distal cone 70 comprises a proximal spacer 78 (preferably tubular). The proximal side of the spacer 78 is engageable with the distal end of proximal holder 80. The spacer 78 length is such that when it engages the distal end of proximal holder 80 the attaching element 20 is secured in a good manner. The wire lumen 50 passes through the spacer 78. In other embodiments the distal holder can have other shapes than the distal cone 70 (e.g. tubular), but still may comprise one or more of a top flat surface, a distal front member, a ring, spacer, inner bore, being fixedly connected to wire lumen 50, etc., mutatis mutandis. Fig. 3B shows another angle of Fig. 3A. Fig. 3C shows the elements of Figs. 3A and 3B without the attaching element 20. Fig. 3D shows the elements of Figs. 3A and 3B in a position where the interior of ring 75 and the diagonal flat surface 70d may be seen. Fig. 3E shows the elements of Figs. 3A and 3B in an "upside-down" manner. Fig. 3F shows the distal cone 70 and the wire lumen 50 only. Fig. 3G shows the outer sheath 60 partially covering the attaching element 20. Fig. 3H shows the proximal holder 80 retaining the attaching element 20 (without showing the distal cone 70).

[0251] The proximal holder 80 comprises a distal surface 81 and a lock spring element 85, such that the attaching element 20 proximal end 20p is retained between the distal surface 81 and an optional lock spring element 85. The lock spring element 85 comprises a distal portion 82 such that at least a distal portion of distal portion 82 is placed above a proximal portion of the distal surface 81. Thus, a gap is formed between a portion of the distal portion 82 and the distal surface 81, wherein the attaching element 20 proximal end 20p is retained within said gap. The lock spring element 85 further comprises a proximal portion 87.

[0252] The lock spring element 85 comprises a spring mechanism (not shown), for example in the form of an elastic tab (or other spring shape, such as a loop) that pushes the distal portion 82 of the lock spring element 85 away from the central axis of the proximal holder 80 (e.g., when not retained by the sheath 60 as will be explained). The central axis of the proximal holder 80 is the center of its inner bore (along the proximal-distal direction). For example, the spring mechanism may comprise a spring anchored between a portion of the proximal holder 80 and a portion of the lock spring proximal portion 87. The distal surface 81 may be split into two portions by the proximal holder 80 bore, partially "overlapping" from beneath (as can be seen in Fig. 3K).

[0253] Fig. 31 shows the proximal holder 80, the wire lumen 50 and the proximal lumen 90. Fig. 3K shows the elements of Fig. 31 without the lock spring element 85. Fig. 3J shows the lock spring element 85. The lock spring element 85 preferably comprises two teeth elements 85t (protrusions) extending downwards from distal portion 82 of the lock spring element 85, for assisting in retaining the attaching element 20 proximal end 20p. When retaining the attaching element 20, the teeth elements 85t are placed preferably such that each of the teeth elements 85t is positioned in a respective open space between the central clipping arm 20c and a respective side arm 20a.

[0254] The delivery of the obstructing device 10 is carried out as follows. First the attaching element 20 is positioned such that it rests on the distal cone 70 top flat surface 70f and on the distal surface 81 of the proximal holder 80. The attaching element 20 is retained at its distal end 20d by the inner surface of the ring-shaped element 75 which engages distal end 20d from above and / or from the side. The diagonal flat surface 70d may also contribute to its tight fixation. The attaching element 20 is retained at its proximal end 20p by the lock spring element 85 distal portion 82 and teeth 85t. The outer sheath 60 pushes the distal portion 82 towards the proximal holder 80 central axis thereby retaining the proximal end 20p.

[0255] Fig. 4A shows the initial configuration with the outer sheath 60 fully covering the obstructing device 10. The distal end of the outer sheath 60 engages the proximal end of ring 75. In this configuration the distal front member 71 is in the shape of a front cone tapering distally with the wire lumen 50 passing therethrough. In other embodiments the wire lumen 50 terminates at a distal section of the distal holder 70 (e.g. at the most distal portion of the distal front member 71), wherein the guidewire continues distally out of the distal holder 70.

[0256] In this figure, the attachment element 20 frame 20m is initially placed in a flat position and the central clipping arm 20c (not shown) is not fully curved, only curved until engaging the outer sheath 60. The obstructing device 10 is advanced to the target location during which the outer sheath 60 continuously covers it and engages ring 75. The distal cone 70 proximal spacer 78 engages with the distal end of proximal holder 80 during this advancement, thereby securing the obstructing device 10.

[0257] According to a preferred embodiment, the delivery system is such that the handle may advance the wire lumen 50 and thereby the distal and proximal holders and outer sheath 60 connected thereon which move together when wire lumen 50 is advanced / retracted. The handle comprises abilities to move the outer sheath 60 and / or the proximal sheath 90 distally or proximally in relation to the wire lumen 50, as known in the art. This enables the gradual deployment of the obstructing device 10.

[0258] When arriving at the target location, the sheath 60 is proximally retracted (by the handle), gradually unsheathing the obstructing device 10. Fig. 4B shows the sheath 60 partially retracted. Part of the ring 75 is shown in a transparent form in Figs. 4B-4C for a better understanding. When the sheath proximally passes the central clipping arm 20c distal portion, the central clipping arm 20c curves and a gap 200 is formed between the central clipping arm 20c and the frame 20m surface (the common surface containing the side arms 20a). The distal free end 20f extends beyond the imaginary line where the sheath 60 has restrained it up until now.

[0259] With the optional assistance of fluoroscopy and / or ultrasound imaging the attaching element 20 (with arm 20c defining a gap 200 from arms 20a) is moved relative to the native cusp so the native cusp is placed within the gap 200 such that the native cusp is positioned between the central clipping arm 20c and the frame 20m. One manner for such placement is to advance the gapped device 10 forward when the cusp is not in contact with other cusps along is free edge and thereby capture the cusp in the gap. The attaching element 20 is positioned such that the central clipping arm 20c is placed engageable with the belly of the cusp, while the peripheral frame 20m is engageable with the cusp flow facing side. Other delivery embodiments may include a two- way steering mechanism.

[0260] In some embodiments of the invention, rapid pacing or other cardiac immobilization methods are used to reduce the movement of the cusp. Failure to capture is optionally remedied by retracting element 10 and advancing it again. Rapid pacing is optionally stopped once the cusp is in the gap, optionally, before the gap is closed.

[0261] Thereafter, the wire lumen 50 is moved distally by the handle and the proximal lumen 90 is maintained in place (by the handle). This causes the distal cone 70 to move distally while the attachment element 20 is retained at its proximal end 20p by teeth 85t. The distal end 20d is released from the ring 75 and surface 70f retainment and curves accordingly with the central clipping arm 20c thereby closing the gap 200 and thereby "clipping" onto the native cusp and being firmly mounted thereon (wherein the central clipping arm 20c tightly engages the belly of the cusp and the peripheral frame 20m tightly engages the cusp flow facing side).

[0262] Thereafter, the sheath 60 is further retracted proximally beyond the distal portion 82 of the lock spring element 85 thereby releasing the lock spring element 85 pushing it away from the central axis of proximal holder 80 and thereby the teeth elements 85t move away from the central axis of proximal holder 80 and release the attachment element 20 proximal end 20p. This lock spring safety feature is aimed to prevent early implant release prior to optimal positioning on the selected cusp. After its release, the obstructing device is fully deployed and mounted on the native cusp where the tubular member 5 is positioned in the regurgitant orifice (the malcoaptation gap) when the heart valve is in a closed state thus preventing blood leakage. The delivery system is thereafter retracted.

[0263] In some embodiments of the invention, even after frame 20m is closed, as long as base 20p is being help, element 20 may be pulled off the cusp by retraction this may cause some damage to the cusp.

[0264] An embodiment of the present invention delivery method will be explained in relation to the aortic valve, but may similarly be delivered to the pulmonary valve (and with many aspects to the mitral and tricuspid valves) cusps / leaflets, mutatis mutandis.

[0265] The present invention, in some embodiments thereof, relates to a method for implanting the obstructing device as explained herein. The method is partially shown in Figs 5A-5D. Portions of the method are also taught in the description relating to the present invention device and system as explained herein. The method comprises the following steps: creating an opening in a blood vessel; inserting an introducer sheath; inserting a guide wire 63 through the introducer sheath and passing it through the blood vessel all the way to the heart valve and therethrough to the respective heart chamber; other manners of providing access to the valve may be used as well. providing a delivery catheter system, for example as explained herein, for example, allowing selective release of the central arm and moving device 10 with the central arm selectively released and then releasing the frame. One example comprises:

[0266] • The obstructing device as explained herein;

[0267] • a distal holder 70 retaining the peripheral frame distal end 20d;

[0268] • a proximal holder 90 retaining the peripheral frame proximal end 20p;

[0269] • a wire lumen 50 connected to a handle and distally and proximally movable by said handle, and fixedly attached to said distal holder 70;

[0270] • a proximal lumen 90 connected to said handle and fixedly attached to said proximal holder; wherein said wire lumen 50 passes through said proximal lumen 90;

[0271] • an outer sheath 60 distally and proximally movable by said handle, configured to cover the proximal holder 80 and part of the distal holder 70, wherein the central clipping arm 20c is deformed by being at least partially straightened by the outer sheath 60 restricting it; passing the delivery catheter system distally (Fig. 5A), by passing the wire lumen 50 over the guidewire 63 until the distal portion of the outer sheath 60 arrives at the ascending aorta (e.g. approximately 5 mm above the aortic valve) as shown in Fig. 5B; Optionally, the positioning of the guidewire helps align the device with the cusps in a radial direction with respect to the aorta, retrieving the outer sheath 60 proximally (unsheathing the obstructing device 10 thereby beginning to release the obstructing device 10, wherein during this stage the proximal lumen 90 and wire lumen 50 remain stationary while the outer sheath 60 moves proximally) to an extent where the central clipping arm 20c curves to its arc shape when undeformed; positioning the obstructing device 10 in the correct intended position to be attached to the native cusp or leaflet (this positioning comprises rotating the obstructing device 10 such that the native cusp is positioned between the central clipping arm 20c and the frame 20m, and forwarding the obstructing device distally to the desired extent for attachment); forwarding the wire lumen 50 distally while the proximal lumen 90 remains stationary (by means of the handle), thereby releasing the peripheral frame distal end 20d from being retained by the distal holder 70, and thereby having the frame 20m curve to its arc shape when undeformed (and thereby the central clipping arm 20c is placed tightly engaging the belly of the cusp, while the peripheral frame 20m tightly engages the cusp flow facing side); retrieving the outer sheath 60 proximally to an extent where the peripheral frame proximal end 20p is released from being retained by the proximal holder 80 (thereby releasing the obstructing device 10 to be completely deployed); the procedure may now be completed and the delivery system retrieved, for example by: proximally retrieving the outer sheath 60, the distal holder 70 and proximal holder 80; proximally retrieving the guide wire 63; removing the introducer sheath; closing the blood vessel.

[0272] Preferably, the retrieving of the outer sheath proximally to an extent where the peripheral frame proximal end 20p is released from being retained by the proximal holder 80, comprises retrieving the outer sheath to an extent such that a lock spring element is released thereby releasing the peripheral frame proximal end 20p from being retained by the proximal holder 80.

[0273] An expanded aspect of the method (which may be understood in conjunction with the method description hereinabove) is described below. The method comprises:

[0274] • Making a skin incision (e.g. in the groin).

[0275] • Creating an opening in a blood vessel (e.g. the femoral artery) and inserting an introducer sheath (e.g. a 6Fr introducer sheath).

[0276] • Optionally inserting a closure device.

[0277] • Inserting a stiff guide wire 63 (e.g. a stiff 0.35’ wire) through the introducer sheath and passing it through the femoral artery.

[0278] • Optionally replacing the 6Fr introducer sheath with a large 11 to 16Fr introducer sheath.

[0279] • Optionally replacing the stiff guide wire with a regular guide wire and advancing it all the way up to the aorta and through the opening in the aortic valve and into the left ventricle. Preferably, the guide wire is placed such that it contours to the inner cavity of the left ventricle all the way to the apex, preferably using a pigtail catheter. In some embodiments the first guide wire is the only guide wire inserted (advancing it all the way up to the aorta and through the opening in the aortic valve and into the left ventricle, etc.) for the whole delivery procedure. • It should be noted that the insertions of the guide wire(s) explained herein may be according to the basilica method.

[0280] • Optionally, replacing the regular (soft) guide wire with a stiff guide wire 63. Such replacement may assist in supporting the device maneuvering acts. A different appropriate guidewire may be used.

[0281] • Passing a delivery catheter system distally (Fig. 5A), the delivery system is as explained herein, preferably comprising: a distal holder 70 comprising:

[0282] • a distal front member 71;

[0283] • a ring-shaped element 75 extending proximally from said distal front member 71;

[0284] • a top (preferably) flat surface 70t; a proximal holder 80 comprising:

[0285] • a distal surface 81;

[0286] • a lock spring element 85 comprising a spring mechanism configured to push the distal portion 82 of said lock spring element 85 away from the central axis of the proximal holder 80, and wherein a gap is formed between the distal portion 82 of said lock spring element 85 and a portion of said distal surface 81; a wire lumen 50 connected to a handle and distally and proximally movable by said handle; a proximal lumen 90 connected to said handle; an outer sheath 60 distally and proximally movable by said handle, configured to cover the proximal holder 80 and part of the distal holder 70 and engageable with the distal holder ring-shaped element 75 (such that when engaged, the engagement forms a closed / sealed closure); wherein said wire lumen 50 passes through said proximal lumen 90; wherein said wire lumen 50 is fixedly connected to said distal holder 70; and wherein said proximal lumen 90 is fixedly connected to said proximal holder 80; the obstructing device 10 as explained herein, wherein the peripheral frame distal end 20d is placed within the ring-shaped element 75; and wherein the peripheral frame proximal end 20p is placed within the gap. In this system, the guide wire may pass through the wire lumen 50. The wire lumen 50 can pass in an "over the wire delivery" manner over wire 63 (while wire 63 passes through wire lumen 50).

[0287] • When the distal portion of the inner sheath arrives at the ascending aorta (e.g. approximately 5 mm above the aortic valve) as shown in Fig. 5B, retrieving the outer sheath 60 proximally (unsheathing the obstructing device 10) thus beginning to release the obstructing device 10. During this stage the proximal lumen 90 and wire lumen 50 remain stationary while the outer sheath 60 moves proximally. The outer sheath 60 is proximally retrieved to an extent where the central clipping arm 20c curves (but still covering the lock spring element 85 distal portion 82).

[0288] The next step comprises positioning the present invention obstructing device 10 in the correct intended position prior to attaching it to the cusp. This positioning comprises rotating the obstructing device 10 such that the native cusp is positioned between the central clipping arm 20c and the frame 20m (the central clipping arm 20c is placed engageable with the belly of the cusp, while the peripheral frame 20m is engageable with the cusp flow facing side. This may be carried out based on imaging modality (e.g. a fluoroscopy and ultrasound imaging) by manipulating the delivery system such as clock or counter-clock rotation. This is carried out by rotating the wire lumen 50 (by means of the system handle) which in turn rotates the distal cone 70 and proximal holder 80 and thus the device 10 which is retained thereon them. The wire 63 may be pushed or pulled to maneuver the catheter as known in the art for correct placement of the obstructing device 10.

[0289] • Once at the required rotated position (e.g. to engage the predetermined aortic cusp) the distal cone 70 and proximal holder 80 are pushed forward (distally) by the wire lumen 50 advanced distally (along with the proximal lumen 90) such that the native aortic cusp is within the gap 200 (between the central clipping arm 20c and the frame 20m) as shown in Fig. 5C.

[0290] • Then, the wire lumen 50 is moved distally and the proximal lumen 90 remains stationary (by means of the handle), thereby the front end of the attachment element 20 is released from the distal cone 70 ring 75 and curves accordingly with the central clipping arm 20c. Thereby, the central clipping arm 20c is placed tightly engaging the belly of the cusp, while the peripheral frame 20m tightly engages the cusp flow facing side.

[0291] • Once position on the cusp is verified by the imaging modalities, the outer sheath is proximally retrieved to an extent proximal to the lock spring element 85 distal portion 82, thereby causing the lock spring element 85 to move away from the proximal holder 80 central axis, thereby releasing the obstructing device 10 to be completely deployed (the attachment element 20 forms a "clip" on the native cusp (locking it in place) with the hollow tubular member 5 attached to the frame 20m and being placed at the regurgitant orifice (the malcoaptation gap) when the native valve closes).

[0292] • Thereafter, the outer sheath 60, the distal cone 70 and proximal holder 80 are proximally retrieved by the handle in an "over the wire" manner.

[0293] • The guide wire 63 is then proximally retrieved. The obstructing device 10 is mounted on the native cusp and working (Fig. 5D). While some gaps are shown, this need not be the case. Even if some gaps remain, regurgitation is expected to be substantially reduced (e.g., between 50% and 70%, between 70% and 90% or more) by obstructing device 10.

[0294] • Then the introducer sheath is removed and the artery is closed.

[0295] The obstructing device implant can be withdrawn back into the delivery system prior to full deployment, when readjustment for optimal positioning or a bailout is required. At any stage before the final deployment (by the lock spring element 85) there is an option to reposition or retrieve the obstructing device 10, allowing the personnel cardiologist multiple attempts at effectively reducing regurgitation with feedback from the imaging modalities. For example, before the final deployment step (retracting outer sheath 60 and releasing the lock spring 85) the obstructing device 10 can still be repositioned / retrieved by re-sheathing the outer sheath 60 (i.e., advancing it distally), etc.

[0296] Fig. 6A shows the device functioning in a valve open state and Fig. 6B shows the device functioning in a valve closed state preventing blood leakage into the left ventricle. The remaining gaps shown in this computer generated image would typically be closed, at least in most part in the body due to the compliance of the cusps. Some amount of regurgitation may remain. Optionally, regurgitation is reduced by at least 50%, 70%, 80% or more or intermediate amounts. Fig. 7A shows the heart valve before implanting the present invention obstructing device. It can be shown that due to the blood leakage, a considerable amount of blood flows back through the valve. Fig. 7B shows the present invention obstructing device 10 preventing blood leakage.

[0297] According to another aspect of the present invention, e.g., for delivery to the mitral and tricuspid valves, the obstructing device 10 is mounted in the opposite direction within the delivery system i.e. with the hollow tubular member opened portion distally and the hollow tubular member closed portion proximally. According to this aspect of the present invention the terms "distal" and "proximal" defining the elements of the obstructing device 10 are switched, e.g. the opening (12) will be referred to as the distal opening, the distal / proximal portions of the attachment element are switched, etc. mutatis mutandis.

[0298] According to this aspect of the present invention the delivery system and method of insertion are almost the same, and the following portion will mainly emphasize on the differences. The attachment element according to this embodiment will be referenced 120.

[0299] Reference is made to Fig. 8 that shows the attachment element 120 placed in the opposite direction than that of Figs. 3A-3K and Figs 4A-4C. In this embodiment the central clipping arm 120c extends proximally from the frame 120m distal side. Therefore, during delivery, the outer sheath 60 moves proximally until it passes the proximal free end 120f and the central clipping arm 120c curves to an arc shape.

[0300] According to one embodiment of the present invention, the main differences between the method for delivering the obstructing device to the mitral or tricuspid cusps / leaflets and the method for delivery to the aortic and pulmonary cusps / leaflets comprise:

[0301] • Providing an obstructing device with the central clipping arm 120c extending proximally from the frame 120m distal side 120d (and not distally from the frame 120m proximal side 120p). The device itself may be larger than for the aorta - the frame and / or expanding member. The access is optionally through the atria which may assist in avoiding damage to the chordea. Access from the ventricle is possible as well, in which case the device orientation during delivery may be similar to that of an aortic device.

[0302] • Passing the delivery catheter system distally, by passing the wire lumen 50 over the guidewire 63 until the distal portion of the outer sheath 60 passes the respective tricuspid or mitral valve (and not stopping before arriving at the aorta or pulmonary valve).

[0303] • retrieving the outer sheath 60 until it completely passes the central clipping arm 120c.

[0304] • The positioning of the obstructing device 110 in the correct intended position to be attached to the native cusp or leaflet mainly comprises retrieving proximally (and not forwarding distally) the obstructing device to the desired extent for attachment.

[0305] This aspect of the present invention method comprises: creating an opening in a blood vessel; inserting an introducer sheath; inserting a guide wire through the introducer sheath and passing it through the blood vessel all the way to the heart valve and therethrough to the respective heart chamber; providing a delivery system comprising: an obstructing device comprising: a hollow tubular member comprising: - a distal opening at its distal end;

[0306] - a substantially tubular surface extending proximally from said distal opening;

[0307] - a proximal end, being either closed or comprising a small orifice; an attachment element comprising:

[0308] - a peripheral frame having a distal end, a proximal end and two side arms, each of said side arms being attached to said distal end and proximal end;

[0309] - a central clipping arm extending proximally from said distal end and having a free end; wherein said hollow tubular member is attached to said peripheral frame; and wherein said peripheral frame and central clipping arm are both curved and have an arc shape when undeformed;

[0310] • a distal holder retaining the peripheral frame distal end;

[0311] • a proximal holder retaining the peripheral frame proximal end;

[0312] • a wire lumen connected to a handle and distally and proximally movable by said handle, and fixedly attached to said distal holder;

[0313] • a proximal lumen connected to said handle and fixedly attached to said proximal holder; wherein said wire lumen passes through said proximal lumen;

[0314] • an outer sheath distally and proximally movable by said handle, configured to cover the proximal holder and part of the distal holder, wherein the central clipping arm is deformed by being at least partially straightened by the outer sheath restricting it; passing the delivery catheter system distally by passing the wire lumen over the guidewire until passing the respective heart valve cusp or leaflet; retrieving the outer sheath proximally to an extent where the central clipping arm curves to its arc shape when undeformed; positioning the obstructing device in the correct intended position to be attached to the native cusp or leaflet (including pulling proximally to mount on the native cusp); forwarding the wire lumen distally while the proximal lumen remains stationary thereby releasing the peripheral frame distal end from being retained by the distal holder, and thereby having the peripheral frame curve to its arc shape when undeformed and thereby having the central clipping arm placed tightly engaging the belly of the cusp while the peripheral frame tightly engages the cusp flow facing side; retrieving the outer sheath proximally to an extent where the peripheral frame proximal end is released from being retained by the proximal holder, thereby releasing the obstructing device to be completely deployed; proximally retrieving the outer sheath, the distal holder and proximal holder; proximally retrieving the guide wire; removing the introducer sheath; closing the blood vessel.

[0315] The attachment element (both the side arms 20a and the central clipping arm 20c) tend to curve forming an arc of a circle with a radius angle usually between 10 and 20 degrees.

[0316] The total length of the frame 20m is preferably between 15 and 25 mm. The total width of the frame 20m is preferably between 3mm and 5 mm. The thickness of the frame 20m (any one of its portions) is preferably between 0.1mm and 1mm. The width of each of the arms 20a is preferably between 0.2 and 0.8 mm.

[0317] The length of the central clipping arm 20c is preferably between 5 and 15 mm. Its width is preferably between 0.2 and 1.5 mm. Its thickness is preferably between 0.1 and 0.8 mm.

[0318] The general length of the tapering tubular member 5 is usually between 10 and 25 mm. The diameter of the proximal opening 12 is usually between 4 and 8 mm. Fig. 2D shows an example of the proximal opening 12 having a 6mm diameter and the distal end having a 2mm diameter.

[0319] The diameter of the tubular member 5 frame wires (e.g. elements 12, 13, 14, 15, 16) is usually between 0.1 and 1 mm. The thickness of the membrane of the tubular member 5 is usually between 0.1 and 1 mm.

[0320] The delivery system wire lumen 50 has a diameter preferably between 0.5 and 2.5 mm. The delivery system proximal lumen 90 has a diameter preferably between 1 and 4 mm.

[0321] The proximal holder 80 has a general diameter preferably between 1 and 4 mm. Its length is preferably between 10 and 50 mm.

[0322] The lock spring element 85 distal portion 82 has a height preferably between 0.1 and 3 mm. The length of the proximal holder 80 distal surface 81 is preferably between 3 and 20 mm.

[0323] The length of each tooth 85t is usually between 0.1 and 0.8 mm. Its width is usually between 0.1 and 0.8 mm. Its thickness (height) is usually between 0.1 and 0.8 mm.

[0324] The distal cone 70 has a length preferably between 10 and 50 mm. The distal front member 71 has a diameter preferably between 2 and 7 mm.

[0325] The ring 75 has a diameter preferably between 2 and 7 mm. Its length (along the delivery system longitudinal axis) is preferably between 1 and 20 mm. Its thickness is preferably between 0.2 and 1.5 mm.

[0326] The attachment element 20, frame wires, the connecting elements may comprise material selected from the group consisting of metal alloy and shape memory alloy. The attachment element 20, frame wires, the connecting elements may comprise material selected from the group consisting of nitinol, stainless steel, and cobalt chromium.

[0327] The lumens 50, 90, and the outer sheath 60 may be made of a material selected from the group consisting of a metal alloy and Pebax. Preferably, each of these lumens comprises several layers of polymer materials.

[0328] According to an embodiment of the present invention, the proximal holder 80 and distal holder 70 may comprise stainless steel and / or durable polymers.

[0329] The distal front member 71 may comprise a soft tip (comprising soft material). The delivery system outer sheath 60 comprises an outer diameter preferably between 12 and 18 Fr. (e.g., preferably 14 Fr.). The outer diameter of sheath 60 and soft tip of distal front member 71 may allow for low friction advancement through the main vessels, minimizing the risk of damage to the vessels.

[0330] Leaflet anchor variants

[0331] Referring now to Fig. 9A, showing a leaflet anchor 900 of an obstruction device, in accordance with exemplary embodiments of the invention.

[0332] Referring also to Fig. 9B showing a side view of a leaflet anchor 900 connected to a tubular member, in accordance with exemplary embodiments of the invention. Referring also to Figs. 9C-E showing perspective views of a leaflet anchor connected to a tubular member, in accordance with some exemplary embodiments of the invention.

[0333] Leaflet anchor 900 may be considered a variant of attachment element 20, (shown for example in Fig. 2G), having the same general functional elements. Various optional variations are shown in the Figure and not all need to be provided in every alternative embodiment. For example, only one or two of the varying features may be provided in some embodiments.

[0334] In some embodiments, leaflet anchor 900 comprises a frame 902 (which generally corresponds to frame 20m), and an arm 904 (which generally corresponds to clipping arm 20C). In some embodiments, frame 902 comprises a proximal end 906 (which generally corresponds to proximal end 20p), a distal end 908 (which generally corresponds to distal end 20d), and sides 909, defining a shape, optionally a closed shape, for example, a closed loop such as an elliptical ring. The closed shape has the potential advantage of enhancing frame 904 structure stability. It is noted that the anchor designs described herein may also be used to anchor structures other than tubular elements. A potential particular advantage of anchor designs as described herein in accordance with some embodiments of the invention relates to stable alignment of the tubular element so it functions to reduce regurgitation, while reducing effects on other parts of the valve. In some embodiments, arm 904 is optionally, positioned within a hollow interior defined by frame 902, when leaflet anchor 900 is flattened, optionally at the center of the hollow interior. A proximal end of arm 904 is connected to the proximal end of frame 92, while the distal end of arm 904 and optionally the rest of the arm is free, and extending distally within said interior.

[0335] In some embodiments, arm 904 comprises a connection area 910 for engaging a delivery system (e.g., delivery system 1200), optionally located near proximal end 906 of frame 902. In some embodiments, a proximal portion 911 of frame 902 which includes connection area 910 is intended to be positioned outside the cusp, as shown for example in Fig. 11, for potentially simplifying the positioning and / or deployment of the obstructing device.

[0336] In some embodiments, connection area 910 comprises at least one geometry that interacts with the delivery system, optionally with a corresponding geometry on the delivery system. In some embodiments, the at least one geometry comprises two or more geometries, optionally, at least one located on each side 909 of frame 904. In some embodiments, the at least one geometry is in the form of at least one recess 912 corresponding to a shape of a respective protrusion on the delivery system (as shown for example in Fig. 12). Alternatively or additionally, the at least one geometry optionally comprises at least one protrusion, optionally protruding vertically from connection, corresponding to a shape of a respective recess on the delivery system. In some embodiments, the at least one geometry is defined by two or more protrusions 914 facing toward the center of frame 902 (e.g. toward arm 904) forming a slot therebetween, optionally, a slot having a partially open shape (as shown for example in Figs. 9A- B), alternatively or additionally a slot having a closed shape.

[0337] In some embodiments, frame 902 comprises anchoring elements 916 (which generally corresponds to anchoring elements 20as), located on sides 909 and optionally facing toward arm 904. In some embodiments, arm 904 comprises anchoring elements 918 (which generally corresponds to sharp edges 20s), optionally, facing anchoring elements 916. In some embodiments, anchoring elements, 916 and / or 918 potentially occupy about 50% of the length of frame 902, for example, about 45%-60%, or about 30%-45%, or about 20%-80%, or lower or higher or intermediate ranges of percentage.

[0338] Anchoring elements 916 and / or 918 potentially engage the leaflet placed between frame 902 and arm 904, when leaflet anchor 900 is in a closed state. This potentially reduces and / or prevents movement of the leaflet by increasing geometric interference to movement of the leaflet between frame 902 and arm 904. In addition, anchoring elements 916 and 918 potentially increases the friction to this movement. Increasing geometric interference and / or friction has the potential advantage of anchoring leaflet anchor 900 to the cusp while reducing and / or avoiding the risk of cusp perforation and / or tearing. Optionally, when the leaflet is trapped between frame 902 and arm 904, anchoring elements 916 and / or 918 are perpendicular to the leaflet, having the potential advantage of reducing and / or preventing slippage of the leaflet out of leaflet anchor 900. Alternatively or additionally, Anchoring elements 916 and / or 918 are sufficiently sharp to cling onto the leaflet, optionally by piercing thereof. In some embodiments, anchoring elements 916 and / or 918 are sufficiently sharp for piercing the leaflet but have some degree of smoothness for potentially avoiding tearing the leaflet. In some embodiments, anchoring elements 916 and / or 918 comprise a sharp tip that is rounded to some level, optionally by electropolishing. In some embodiments, anchoring elements 916 and / or 918 comprise a sharp tip mounted on a stopper, (such as a radially protruding step), for preventing over-penetration of the tip. Alternatively or additionally, anchoring elements 916 and / or 918 comprise a sharp tip and smooth edges for potentially reducing the risk of tearing the cusp.

[0339] In some embodiments, anchoring elements 916 and / or 918 are a plurality of protrusions and / or spikes, optionally, defining a jagged and / or sharp edge at the inner rim of frame 902 and / or at the sides of arm 904. In some embodiments, anchoring elements 916 and / or 918 anchoring elements 916 and / or 918 have a triangle shape, for example, having a width of about 1 mm and a height of about 1mm, or a width of about 1-1.5 mm and a height of about 1-1.5 mm, or a width of about 0.5-1.5 mm and a height of about 0.5-1.5 mm, or a width of about 0.2-1.8 mm and a height of about 0.2- 1.8 mm, or lower or higher or intermediate ranges or widths and heights.

[0340] In some embodiments, a space 920 is defined between arm 904 and sides 909, referred to herein as the distance between two points on a latitude line. In some embodiments, anchoring elements 918 (of arm 904), which face anchoring elements 916 (of frame 902) define space 920 therebetween.

[0341] In some embodiments, anchoring elements 918 matches the shape of anchoring elements 916, allowing space 920 therebetween to be narrow and / or uniform. For example, anchoring elements 916, in the form of a plurality of protrusions, mesh with anchoring elements 918, in the form of a plurality of protrusions, and space 920 is defined by a space between the plurality of protrusions 916 and the plurality of protrusions 918. In some embodiments, space 920 is sized according to the leaflet’s thickness, such that space 920 is sufficiently narrow to grasp the leaflet therebetween while potentially avoiding perforating the leaflet.

[0342] In some embodiments, space 920 varies along the longitudinal axis of leaflet anchor 900.

[0343] The varying space potentially enables attachment element 90 to grip leaflets of different thicknesses. The thickness of an aortic leaflet can vary depending on factors such as age, health, and / or medical history. Generally, aortic leaflets can range from about 0.5 to 1.5 millimeters in thickness and may be uniformly thick along their length.

[0344] In some embodiments, the varying space 920 potentially enables a gradient of grip force along the leaflet, optionally, according to the leaflet flexibility and / or thickness. The force gradient has the potential advantage of reducing cusp distortion and / or tearing.

[0345] In some embodiments, space 920 narrows from proximal end 906 to distal end 908, such that space 920 is widest at proximal end 906 narrowing toward distal end 908, and narrowest at the distal end 908. In some embodiments space 920 at proximal end 906 is about 0.1-0.5 mm, or 0.2-0.8 mm or 0.3-1 mm, or lower or higher or intermediate ranges or space sizes. In some embodiments space 920 at distal end 908 is about 0.05-0.2 mm, or 0.03-0.1 mm or 0.9-0.3 mm, or lower or higher or intermediate ranges or space sizes.

[0346] In some embodiments, the size of space 920 varies according to the thickness variation of the leaflet which may thin from locations near the valve opening when advancing towards and along the leaflet. Adjusting the dimensions of space 920 to the leaflet anatomy potentially reduces undesired pulling of the leaflet tissue, having the potential advantage of reducing and / or avoiding leaflet distortion and / or tearing.

[0347] In some embodiments, space 920 changes gradually along the frame, alternatively or additionally, space 920 comprises portions of different sizes.

[0348] In other embodiments, space 920 widens from proximal end 906 to distal end 908, such that space 920 is narrowest at proximal end 906 and widest at the distal end 908, and / or comprises portions of differing sizes.

[0349] In some embodiments, leaflet anchor 900 comprises a material having a shape memory effect, as described herein. In some embodiments, the material comprises an elastic and / or superelastic material such as Nitinol, as described in this document.

[0350] In some embodiments, leaflet anchor 900 is curved, optionally shaped to have an arc profile (at a relaxed undeformed state). In some embodiments, the arc has a curvature radius that varies along the profile. In some embodiments, the curvature radius where arm 904 and frame 902 overlap is for example about 10-15 mm, or about 2-25 mm, or 8-30 mm, or lower or higher or intermediate ranges or curvature radius. In some embodiments, beyond the overlap portion, the curvature radius of frame 902 is smaller, for example about 5-10 mm, or 3-12 mm, or 2-15 mm, or lower or higher or intermediate ranges or curvature radius.

[0351] In some embodiments, during deployment, frame 902 is deformed (e.g., straightened) while arm 904 remains curved, defining a gap between straightened frame 902 and curved arm 904. Upon placing a leaflet between frame 902 and arm 904 (e.g., at said gap) the straightening force applied on frame 904 is released to allow frame 904 to return to its curved undeformed shape, and to a position at the center of frame 902, optionally within the curved plane defined by frame 902.

[0352] In some embodiments, space 920, increases from distal end 908 to proximal end 906, optionally being generally thinner than the leaflet at distal end 908 and wider than the leaflet at proximal end 906. This space configuration potentially prevents arm 904 from crossing over to the opposite side of frame 902 (e.g., the other side of the curved plane defined by the frame), having the potential advantage of reducing and / or avoiding the risk of deforming and / or perforating the leaflet as a result of this arm crossover.

[0353] Alternatively or additionally, leaflet anchor 900 may comprise a stopper (not shown) for preventing arm 904 from crossing to the other side of frame 902. Optionally alternatively or additionally, arm 904 is designed to expand laterally, such that at least a portion thereof is and / or becomes wider than the distance between sides 909 of frame 904. For example, arm 904 may comprise a deformable material potentially allowing it to be flattened, for example, by applying pressure, optionally during deployment. In another example, arm 904 may comprise extensions that can be extended, for example, extended to the sides.

[0354] In some embodiments, leaflet anchor 900 comprises at least one connecting element 922, directed toward the cusp tissue, optionally perpendicular to frame 902, shown for example in Fig. 9A from a rear view and in Fig. 9B from a side view.

[0355] The at least one perpendicular connecting element 922 may be placed on frame 902 and / or arm 904. In some embodiments, the at least one connecting element 922 is in the form of a biocompatible needle, biocompatible pin, and / or biocompatible spikes. In some embodiments, at least one connecting element 922 is sufficiently sharp to pierce the leaflet for clinging thereto. In some embodiments, the dimensions of at least one connecting element 922 are sufficient for attaching to the cusp yet are small enough to potentially reduce the risk of cusp perforation. In addition, connecting element 922, directed toward the cusp tissue potentially enables lateral anchoring to the leaflet which potentially reduces and / or prevents movements of leaflet anchor that would otherwise might cause leaflet tearing.

[0356] The at least one connecting element 922 potentially increases the gripping force of the leaflet anchor 900 onto the cusp, having the potential advantage of reducing and / or avoiding the risk of obstructing device dislodgment from the cusp.

[0357] In some embodiments, at least one connecting element 922 is manufactured separately from anchor leaflet 900 and welded to the frame at defined locations, alternatively or additionally, at least one connecting element 922 is manufactured together with anchor leaflet

[0358] 900.

[0359] In some embodiments, frame 902 comprises an enlarged area 924 near its distal end 908 for potentially reducing focal force (e.g., by pinching) on the cusp at this location, having the potential advantage of reducing and / or preventing the risk for cusp perforation. In some embodiments, enlarged area 924 is defined by a portion of frame 900, which lacks arm 904 and / or anchoring elements 916. In some embodiments, enlarged area 924 is defined by the space between the distal end of arm 904 and distal end 908 of frame 902. In some embodiments, the length of this space is about 1-3 mm, or 0.5-2, mm, or 2-4 mm, or lower or higher or intermediate ranges or lengths.

[0360] In some embodiments, enlarged area 924 is configured to be held by a delivery system, while allowing arm 904 to be open (e.g. allowing the arm 904 to be free).

[0361] In some embodiments, frame 902 may comprise a plurality of geometries (such as openings and / or depressions) for sewing a tubular member (e.g., tubular member 5) to frame 902 therethrough, having the potential advantage of preventing suture slippage. For example, depression 4 as shown for example in Figs. 2A and 2G, and / or openings 1401, shown for example in Fig. 14.

[0362] In some embodiments, leaflet anchor 90 comprises one or more radio-opaque markers, for monitoring the obstructing device position during and / or after deployment.

[0363] In some embodiments, at least one connecting element 922 is formed of and / or comprises radio-opaque material, optionally, manufactured separately from frame 902 and later added thereto.

[0364] Alternatively or additionally, the sutures connecting the tubular member to frame 902 are formed of and / or comprise radio-opaque material.

[0365] Referring now to Fig. 10, showing an obstructing device 1000, in accordance with exemplary embodiments of the invention.

[0366] Referring also to Fig. 11, showing obstructing device 1000 deployed on a leaflet, in accordance with exemplary embodiments of the invention.

[0367] In some embodiments, obstructing device 1000 is a variant of obstructing device 10, having the same general functional elements.

[0368] In some embodiments, obstructing device 1000 comprises leaflet anchor 900 and a hollow tubular member 1002 (which generally corresponds to hollow tubular member 5).

[0369] In some embodiments, leaflet anchor 900 is curved, optionally having a profile shaped as an arc (at a relaxed undeformed state). The curved shape potentially allows leaflet anchor 900 to conform to the shape of the leaflet (as shown for example in Fig. 11). This conformation has the potential advantage of reducing and / or avoiding leaflet shape deformation (such as straightening and / or other distortion) which might interfere with the cusp function. In some embodiments, frame 902 and arm 904 are aligned (e.g., having the same curvature). In some embodiments, in a relaxed state, arm 904 is positioned within the curved plane defined by frame 902 (e.g., between sides 909). In other embodiments, arm 904 may protrude from the plane defined by frame 902, and / or have a greater curvature than frame 902, for potentially altering the compressive force applied on the tissue by leaflet anchor 900, relative to frame 902 and arm 904 having the same curvature and / or aligned within the same curved plane.

[0370] In some embodiments, hollow tubular member 1002 is attached to frame 902, optionally by more than one connection point (e.g., sutures) along the longitudinal axis thereof, such that tubular member 1002 is adjacent to leaflet anchor 904. This adjacency potentially reduces and / or avoids a gap formation between tubular member 1002 and leaflet anchor 904. The lack and / or reduction of said gap has the potential advantage of reducing the risk of tubular member 1002 detaching from leaflet anchor 904 as a result of pressure exerted by blood flow within said gap. In some embodiments, tubular member 1002 is curved and / or aligned with the curved shape of leaflet anchor 904, potentially increasing the contact between tubular member 1002 and the leaflet anchor 904, having the potential advantage of reducing said gap.

[0371] In some embodiments, tubular member 1002 has a conical shape, as shown for example in Figs. 10 and 11.

[0372] In some embodiments, tubular member 1002 is curved (as shown for example in Fig. 2E and / or 14) and potentially conforms to the shape of the leaflet (e.g., extending along the curvature of the leaflet), having the potential advantage of reducing and / or avoiding a gap formation between obstruction device 1200 (e.g, tubular member 1002) and the leaflet. The lack and / or reduction of said gap has the potential advantage of reducing the risk of obstruction device 1200 detaching from the leaflet as a result of pressure exerted by blood flow within said gap-

[0373] In some embodiments, frame 902 is connected to the exterior of the tubular member, as shown for example in Fig. 2A. In other embodiments, frame 902 is connected to tubular member 1002 from within the tubular member. This interior connection potentially strengthens the connection between frame 902 and tubular member 1002. The interior connection allows leaflet anchor 904 to compress both a portion of tubular member 1006 and the leaflet, having the potential advantage of further reducing the risk of the obstruction device detaching from the leaflet. In some embodiments, tubular member 1002 comprises and / or is formed of a membrane, optionally, comprising pericardium tissue, optionally alternatively or additionally, comprising non-biological materials such as polyurethane, as previously described herein. In some embodiments, tubular member 1002 is formed by shaping the membrane to have a hollow tubular shape, optionally, by sewing and / or gluing the membrane to itself. In some embodiments, tubular member 1002 is formed by a line of sutures and / or glue 1004 extending along the longitudinal axis thereof, positioned to be against the target cusp, optionally, extending along frame 902 and laterally within frame 902, optionally, located next to leaflet anchor 900. In other embodiments, a line of sutures and / or glue 1004 is positioned at a circumferential distance from the target cusp and / or leaflet anchor 900, for example, if the tubular member has a non-circular shape.

[0374] In some embodiments, tubular membrane 1002 comprises a proximal opening 1006 (which generally corresponds to proximal opening 12) and a distal end 1008 (which generally corresponds to distal end 7). In some embodiments, distal end 1008 is either closed or comprises a small orifice. This small orifice allows a very small portion of blood entering tubular member 1002 to exit through distal end 1008, having the potential advantage of reducing and / or avoiding the risk of blood stagnation and / or thrombus formation within tubular member 1002. In some embodiments, the orifice diameter is about 2 mm, for example, 0.1-2.5mm, or 0.5-1.5 mm, or 1- 2.5 mm, or about 1.5mm, or about 1.9mm or lower or higher or intermediate ranges or diameters.

[0375] In some embodiments, the small orifice has a diameter small enough such that the small portion of blood exiting therethrough minimally affects the function of the heart and most of the potential leakage blood is obstructed by the obstructing device. In other embodiments, the small orifice has a diameter smaller than proximal opening 1006 for potentially obstructing the majority of the leakage, and sufficiently large for potentially avoid being clogged, for example, l-2mm, or 2.5-3 mm, or 0.5-3.5 mm or about 2mm, or about 2.8mm or lower or higher or intermediate ranges or diameters.

[0376] In some embodiments, tubular member 1002 is compressible and / or self-expandable. Optionally, tubular member 1002 configured to radially collapse during systole, when blood flows outside and / or along a tubular surface thereof from the distal end towards the proximal end and wherein said tubular member reduces regurgitation through the aortic valve when the aortic valve closes on tubular member 1002, during diastole, optionally tubular member 1002 expanded as blood enters the interior of the hollow tubular member, as described in this document. Alternatives holding mechanism for delivery systems

[0377] Referring now to Fig. 12, showing a perspective view of a delivery system 1200 comprises an obstruction device 1208, in accordance with exemplary embodiments of the invention.

[0378] In some embodiments, delivery system 1200 is a variant of delivery system 300.

[0379] In some embodiments, delivery system 1200 comprises a wire lumen 1202 (which generally corresponds to wire lumen 50), a proximal holder 1204 (which generally corresponds to proximal holder 80), and a distal holder 1206. In some embodiments, both holders are mounted over wire lumen 1202 and shaped and / or sized for holding obstructing device 1208 (which can generally correspond to obstructing device 10 and / or 1000), optionally, at a compressed configuration. In some embodiments, delivery system 1200 further comprises a proximal outer sheath 1210, (which generally corresponds to outer sheath 60) and a distal outer sheath 1212, mounted on said holders 1204, and 1206. In some embodiments, proximal outer sheath 1210 and / or distal outer sheath 1212 are movable and can be moved axially, optionally separately, back and / or forth along the longitudinal axis of the delivery system 1200.

[0380] At an extended position of both proximal outer sheath 1210 and distal outer sheath 1212, distal outer sheath 1212 is extended proximally, and proximal outer sheath 1210 is extended distally such that distal outer sheath 1212 and proximal outer sheath 1210 are contacting, defining a capsule which fully covers and / or substantially covers the obstructing device. In this configuration, the grasping arm of the device is compressed and retained within the capsule, allowing the insertion of delivery system 1200 toward the deployment site.

[0381] In some embodiments, one or both of proximal holder 1204 and / or distal holder 1206 is partially retracted (e.g., proximal holder 1204 is moved proximally and / or distal holder 1206 is moved distally to reveal (e.g., uncover) the grasping arm. This revealing allows the arm to open and extend away from the device’s frame (e.g., forming a gap between the frame and the arm), while frame 902 is still held by proximal holder 1210 and / or distal holder 1212.

[0382] In some embodiments, proximal holder 1210 comprises one or more geometries 1214 that can interact with corresponding geometries on a proximal portion of frame 902. In some embodiments, proximal holder 1210 comprises one or more protrusions 1214 that fit within recess 912 of the obstructing device’s frame (e.g. frame 902). Alternatively or additionally, proximal holder 1210 comprises at least one recess that can receive a protrusion of the obstructing device’s frame. In some embodiments, this fit geometrically interferes with the movement of the obstructing device relative to proximal holder 1204, potentially preventing undesired disconnection and / or in-plane rotation of the obstructing device from proximal holder 1204. In some embodiments, proximal holder 1204 comprises a fixator 1216 (which generally corresponds to fixator spring element 85). In some embodiments, when proximal outer sheath 1210 is extended (e.g., to cover the obstruction device) and / or partially extended (e.g., to reveal the grasping arm while still retaining the obstruction device) a portion of fixator 1216, optionally a distal portion thereof, presses a portion of the obstructing device’s frame against proximal holder 1204. This pressing potentially causes and / or maintainsan engagement between protrusions 1214 of proximal holder 1210 and slot 912 of the obstructing device’s frame, providing geometric interference to movements therebetween. In some embodiments, fixator 1216 presses on a proximal end of the obstructing device’s frame, as shown for example in the figure, alternatively or additionally, fixator 1216 presses on protrusions 1214. Applying said pressure allows the interaction of one or more geometries 1214 of proximal holder 1210 (e.g., protrusions 1214) with the corresponding geometries on a proximal portion of frame 902 (e.g., recesses 912). This interaction potentially geometrically interferes with the movement of frame 902 relative to proximal holder 1210, potentially fixing frame 902 on proximal holder 1210. In some embodiments, fixator 1216 comprises a flat surface, for potentially applying uniform press.

[0383] In some embodiments, fixator 1216 comprises a spring mechanism (not shown), optionally, located between fixator 1216 and proximal holder 1210). For example, fixator 1216 can be a shape memory strip predefined with a bend, which, when revealed, bends elastically so that the fixator 1216 moves away from frame 902. In some embodiments, when proximal outer sheath 1210 is fully retracted (e.g., withdrawn proximally), the distal end of fixator 1216 radially bent away from the longitudinal axis of delivery system 1200, releasing the press on the proximal portion of the obstructing device’s frame. This press release potentially allows for the disconnection of the proximal portion of the obstructing device’s frame from proximal holder 1204. In other embodiments, fixator 1216 is axially movable, and said press release is achieved by moving fixator 1216 in the proximal direction.

[0384] In some embodiments, distal holder 1206 comprises a recess 1218, shape and / or sized to tarp the distal end of the obstructing device’s frame (e.g., enlarged space 924), optionally, without engaging arm 904. In some embodiments, recess 1218 is defined by distal outer sheath 1212 covering and / or partially covering distal holder 1206.

[0385] In some embodiments, distal outer sheath 1212 is movable with respect to distal holder 1206, such that retracting distal outer sheath 1212 (e.g., moving in the distal direction) and / or may uncover, retracts, and / or eliminates the recess 1218, and allowing the distal end of the obstructing device’s frame to release from distal holder 1206. In some embodiments, distal outer sheath 1212 is movable with respect to distal holder 1206, such that both move as a single unit, and form a fixed recess 1218. Retracting distal outer sheath 1212 (together with distal holder 1206) from recess 1218, allows the distal end of the obstructing device’s frame to egress from recess 1218 and to disconnect from distal holder 1206.

[0386] In some embodiments, after positioning a leaflet within and / or aligning the device at a desired angle and / or orientation relative to the leaflet the gap between the open grasping arm and the obstructing device’s arm, the device is deployed on the cusp by releasing thereof from the delivery system. In some embodiments, the release may be performed by first releasing the distal end of the obstruction device’s leaflet anchor (e.g., by first fully retracting distal outer sheath 1212) and then the proximal end of the obstruction device’s frame (e.g., by fully retracting proximal outer sheath 1210), by first releasing the proximal end of the obstruction device’s frame (e.g., by first fully retracting proximal outer sheath 1210) and then releasing the distal end of the obstruction device’s frame (e.g., by fully retracting distal outer sheath 1212), and / or by retracting both retracting distal outer sheath 1212 and / or proximal outer sheath 1210, simultaneously and / or intermittently. In some embodiments, said first and / or second release is performed after evaluation of the device positioning on the cusp, optionally using imaging, such as ultrasound, such as TEE ultrasound, and / or fluoroscopy.

[0387] In some embodiments the leaflet anchor (e.g., leaflet anchor 900), of the obstructing device is curved. When the obstructing device is held by proximal holder 1204 and distal holder 1206 the device’s frame is straightened. Upon releasing one or both of the frame ends from delivery system 1200 the frame is allowed to re-curve, aligning with the grasping arm, and trapping the cusp therebetween.

[0388] In some embodiments, delivery system 1200 comprises a proximal handle (not shown) for controlling the movement of proximal outer sheath 1210, distal outer sheath 1212, wire lumen 1202 and a bendable tip (not shown and generally corresponds to front member 71). The handle comprises appropriate knobs (e.g., as known in the art) to operate (e.g., move) proximal outer sheath 1210 and / or distal outer sheath 1212 axially back and / or forth.

[0389] In some embodiments, proximal outer sheath 1210 and / or distal outer sheath 1212 can be moved continuously axially back and / or forth. Alternatively or additionally, the movement of proximal outer sheath 1210 and / or distal outer sheath 1212 is stepped, optionally comprising three steps for each and / or one or both sheaths, which defines three stages of the delivery device:

[0390] (i) a fully extended stage of the sheaths, where proximal outer sheath 1210 is fully extended (e.g., moved) distally, and / or distal outer sheath 1212 is fully extended (e.g., moved) proximally. In some embodiments, when both proximal outer sheath 1210 and distal outer sheath 1212 are fully extended, the obstructing device is covered and the arm is pressed against the frame.

[0391] (ii) a fully retracted stage, where, proximal outer sheath 1210 is fully retracted (e.g., moved) proximally to release the proximal end of the frame, and / or distal outer sheath 1212 is fully retracted (e.g., moved) distally, to release the distal end of the frame. In some embodiments, when both proximal outer sheath 1210 and distal outer sheath 1212 are fully retracted, the obstructing device is released from the delivery system.

[0392] (iii) a partially extended (e.g., partially retracted) stage of the sheaths, where proximal outer sheath 1210 is partially extended (e.g., moved) distally, and / or distal outer sheath 1212 is partially extended (e.g., moved) proximally to reveal arm 904, while proximal outer sheath 1210 and / or distal outer sheath 1212 still holds frame 900 (e.g., proximal outer sheath 1210 still holds the proximal portion of frame 902, and / or distal outer sheath 1212 still holds the distal portion of frame 902).

[0393] Shape fitting obstructing device

[0394] Referring now to Fig. 13, showing a deployed shape-fitted obstructing device 1300, in accordance with exemplary embodiments of the invention.

[0395] Referring also to Fig. 14, showing a shape-fitted obstructing device 1300, in accordance with exemplary embodiments of the invention.

[0396] In some embodiments, obstructing device 1300 is a variant of obstructing device 10 and / or 1000.

[0397] In some embodiments, obstructing device 1300 comprises a proximal opening 1306 (which generally corresponds to proximal opening 12 and / or 1006) sized and / or shaped to conform and / or match (e.g., selected) the shape of a regurgitant orifice, which by nature is not necessarily round. Herein conforming refers to matching the shape of the regurgitant orifice to sealing to reduce leakage by 5% or more.

[0398] In some embodiments, the pre- shape is selected during the manufacture of the device, and / or shaped by the heart valve.

[0399] This match potentially increases the extent to which the obstruction device occupies the regurgitant orifice, having the potential advantage of improving the sealing of the regurgitant orifice by the obstructing device and / or further reducing valve leakage.

[0400] In some embodiments, proximal opening 1306 comprises a triangular and / or substantially triangular shape, as shown for example in Figs. 13 and 14. Additionally, in some embodiments, tubular member 1302 (which generally corresponds to tubular member 5 and / or 1002) is shaped according to the shape of a regurgitant orifice, optionally, by the pressure exerted thereon by the leaflets when the valve is closed, for potentially improving the contact between the leaflets and the obstructing device (e.g., tubular member). For example, tubular member 1302 is shaped to have a triangular cross-section along the length thereof, as shown for example in Fig. 14. In some embodiments, tubular member 1302 is further curved, optionally tapering from proximal opening 1306 to a distal end 1308 (which generally corresponds to distal end 1008) as described in this document, as shown for example in Fig 14.

[0401] It is noted, that the shape of proximal opening 1306 and / or tubular member 1302 corresponds to the shape of a regurgitant orifice, and is not limited to a triangular and / or substantially triangular shape, optionally defined by the three leaflets for example of an aortic, tricuspid, and / or pulmonary valve. For example, an obstructing device intended for the mitral valve may comprise a hemisphere and / or crescent shape, to fit the shape of a mitral regurgitant orifice defined by the two leaflets of the mitral valve. In another example, a congenital abnormal aortic valve may only have two leaflets instead of three, that may not open and close fully, defining, for example, a hemisphere and / or crescent shape regurgitant orifice.

[0402] In some embodiments, proximal opening 1306 and / or tubular member 1302 is preshaped to match an expected shape (e.g., a typical shape) of the regurgitant orifice. Optionally alternatively or additionally, the proximal opening 1306 and / or tubular member 1302 is preshaped according to the specific shape of the patient’s regurgitant orifice, optionally based on imaging of the regurgitant orifice.

[0403] In some embodiments, tubular member 1302 is sufficiently soft and / or deformable such that the pressure exerted thereon by the leaflets when the valve is closed, deforms proximal opening 1306 and / or tubular member 1302 to conform to the shape of the regurgitant orifice. This potentially allows proximal opening 1306 and / or tubular member 1302 to potentially conform to a patient-specific regurgitant orifice shape. In addition, this allows proximal opening 1306 and / or tubular member 1302 to potentially conform to a changing regurgitant orifice shape. For example, the shape of the regurgitant orifice may change over time and / or depending on the medical conditions of the patient. For example, expansion of the aorta may cause expansion of the leaflets, which may result in changing the shape of the regurgitant orifice.

[0404] In some embodiments, tubular member 1302 is sufficiently pliable to change shape during a cardiac cycle. In some embodiments, tubular member 1302 is sufficiently elastic, such that upon pressure release, tubular member 1302 returns to a non-deformed shape. In some embodiments, the non-deformed shape of proximal opening 1306 and / or the cross-section of tubular member 1302 is round and / or substantially round. In other embodiments, the non-deformed shape corresponds to a typical shape of a regurgitant orifice, such as a triangular. In some embodiments, tubular member 1302 is sufficiently deformable, such that upon pressure release, tubular member 1302 maintains the deformed configuration.

[0405] Exemplary deployment methods

[0406] Referring now to Figs. 15A-C, showing a flowchart of a method for deploying an obstructing device, in accordance with exemplary embodiments of the invention.

[0407] At 1502, a patient is selected. In some embodiments, the patient is diagnosed with valve regurgitation, (e.g., aortic regurgitation), or Aortic regurgitation (AR) mixed with Aortic stenosis (AS).

[0408] In some embodiments, the patient is diagnosed with AR and / or AS and does not meet the requirements for TAVI (transcatheter aortic valve implantation) also known as TAVR (transcatheter aortic valve replacement) and / or the patient’s health condition interferes with a desire to perform the TAVI surgical procedure. In some embodiments, the obstructing device (e.g., obstructing device 10 and or 1000) can be implanted in patients diagnosed with AR and / or AS at a level of severity that does not justify TAVI, for example, having relatively functioning leaflets.

[0409] In some embodiments, the obstruction device may be implanted in a patient having a replacement valve, optionally, for potentially repairing a leaking valve.

[0410] At 1504, a leaflet for deploying the obstruction device thereon is selected (e.g., a single leaflet). In some embodiments, the selection is based on a pre-evaluation of the aortic valve, optionally performed using (e.g., known in the art) imaging modalities. In some embodiments, the leaflet is selected according to the size, thickness, and / or length thereof. For example, a selected leaflet should be thick enough for the obstructing device to be attached to, without causing cusp perforation, yet not too thick as to prevent fitting within the frame and the arm of the obstructing device. Alternatively or additionally, the selected cusp exhibits normal motion, and / or lack of tissue irregularity and / or coronary artery ostia. In some embodiments, the device properties are selected and / or adjusted according to the size, thickness, and / or length of the patient’s leaflet(s). At 1506, a delivery system (e.g., delivery system 1200), optionally comprising an obstruction device, is inserted into the patient’s body, optionally, through the groin.

[0411] At 1508, the delivery system is advanced toward a native heart valve, such as the aortic valve. In some embodiments, an introducer sheath is inserted through the groin and the delivery system and is advanced through the femoral artery to the descending aorta up to, for example, approximately 2-20 mm above the aortic valve. In some embodiments, during the navigation to the deployment site, the device is compressed and / or covered (e.g., sheathed) by one or more movable sheaths of the delivery system.

[0412] At 1510, an arm (e.g., arm 904) of the obstructing device is revealed. In some embodiments, the obstructing device is partially unsheathed, optionally by retracting (e.g., moving) one or more movable sheaths, optionally under imaging modalities guidance, for revealing the grasping arm of the device.

[0413] At 1512, optionally, the arm is allowed to open (e.g., to protrude from the obstructing device as a result of unsheathed thereof).

[0414] At 1514, The delivery system reaches the selected native leaflet. In some embodiments, while the arm is open, the obstructing device is advanced towards the aortic valve and directed at the selected native cusp for device positioning. Reaching the desired cusp might include articulation of the delivery system in one or more planes and rotation of the delivery catheter.

[0415] At 1516, the obstructing device, positioned within the delivery system, is aligned with respect to the selected leaflet. In some embodiments, positioning the device at the correct position is based on a pre-planned fluoroscopy viewing angles based on a CT scan, using a three cusp view where the target cusp is in the center and a second view showing an overlap of the two adjacent cusps.

[0416] Optionally, a pigtail catheter is advanced and placed at the target cusp, optionally, from a second access artery, optionally, in order to inject a contrast agent for fluoroscopy.

[0417] At 1518, the device is oriented with respect to the leaflet. When the correct (e.g., desired) orientation of the device is achieved, the device is further advanced towards the aortic valve. Optionally, at this stage, the heart is overpaced to potentially reduce aortic outflow.

[0418] At 1520, optionally, the obstruction device positioning on the leafet is adjusted. In some embodiments, in this stage, prior to the release of the obstructing device frame, the device can be retrieved, re-sheathed, and / or repositioned at any stage of the implantation procedure with potentially minimal and / or no damage to the native cusps. For example, in some embodiments, as long as the proximal end of the frame is unreleased, the proximal outer sheath can be moved distally for recovering and / or compressing the arm, At 1522, the obstruction device is released from the delivery system. In some embodiments, once a desired position of the device on the cusp is verified optionally, by the imaging modalities, the obstructing device is released from the delivery system, locking it in place. Releasing the device from the delivery system might include a one step release procedure and / or a multi-step procedure, as described in this document.

[0419] At 1524, the delivery system is withdrawn and removed from the patient's body.

[0420] At 1526, follow-uping the patient is performed. In some embodiments, the device is monitored for detecting disconnection thereof from the cusp. In some embodiments, the obstructing device comprises radio-opaque markers (e.g., as described herein), which can be monitored by viewing thereof by imaging modalities, such as X-ray imaging, CT scanning, and / or other radiographic imaging techniques.

[0421] At 1628, additional procedures optionally, aortic valve surgical and / or percutaneous interventions procedures can be performed, for example, days, weeks, and / or years later, optionally while the obstructing device remains deployed on the cusp. For example, balloon valvuloplasty, any coronary procedure performed surgically and / or percutaneously and / or any surgical aortic valve repair technique performed on cusps that the obstructing device is not attached to.

[0422] In some embodiments, at least one additional obstruction device can be implanted on another leaflet (e.g., another single leaflet), having the potential advantage of improving the sealing of the regurgitant orifice. In some embodiments, TAVR can be performed for implanting balloon expandable and / or self-expandable valves, optionally, while the obstructing device remains deployed. The obstructing device may be deployed on any of the cusps, optionally, on the non-coronary cusp, having the potential advantage of reducing and / or avoiding the risk of the obstructing device being pushed against certain heart tissue upon deployment of the replacement valve. Optionally alternatively or additionally, the replacement valve is implanted after removing the obstructing device. In some embodiments, obstructing device removal can be performed while avoiding and / or minimizing cusp damage. Optionally, the removal is performed by straightening the frame (e.g., frame 902) of the leaflet anchor (e.g., leaflet anchor 900), allowing a gap to be formed between the arm (e.g., 904), and then removing the device.

[0423] Example

[0424] Reference is now made to the following examples of experimental results, which together with the above descriptions illustrate some embodiments of the disclosure in a non-limiting fashion. In a proof of concept study on 3 pigs Aortic regurgitation (AR) was induced by pulling the aortic root, and then the present invention obstructing device was implanted followed by reinduction of AR. Transcatheter implantation procedure of the device was developed based on CT planning and demonstrated in healthy pigs. The results - In all 3 pigs moderate- severe AR was successfully induced by pulling on the aortic root. Following the obstructing device implantation induction of AR was reduced to none or trivial (e.g., reduced by 80% or more) based on epicardial echocardiography doppler. Transcatheter implantation of the obstructing device (e.g., using a design similar to that shown in Figs. 2I-2J, but with an expanding member) in healthy pigs was repeatedly demonstrated using a dedicated delivery system.

[0425] In another proof-of-concept study on three pigs, AR was induced by pulling the aortic root, and then an obstructing device was implanted, followed by re-induction of AR.

[0426] A transcatheter implantation procedure of the obstructing device was developed based on CT planning and demonstrated in healthy pigs.

[0427] An obstructing device made of a nitinol leaflet anchor and a pericardial tubular member attached to the leaflet anchor was used . The obstructing device was crimped in a dedicated delivery catheter. The device is introduced through the femoral artery over a stiff 0.35’ wire. Once above the aortic valve the device is uncovered and positioned on one of the native cusps. Once positioning is confirmed the device is released. The obstructing device is potentially designed to fill the aortic regurgitant orifice.

[0428] Long-term in vivo up to 3 -month follow-up were performed.

[0429] In all three pigs moderate- severe AR was successfully induced by pulling on the aortic root. Following obstructing device implantation induction of AR was reduced to none or trivial based on epicardial echocardiography doppler.

[0430] Transcatheter implantation of the obstructing device in healthy pigs was repeatedly demonstrated using a dedicated delivery system.

[0431] Initial long term safety durability tests up to 90 days follow-up demonstrated the feasibility of long-term leaflet augmentation using the obstructing device.

[0432] Exemplary obstructing device dimensions

[0433] Referring now to Figs. 16A-B, 17A-B and 18A-B, showing exemplary dimensions of an obstructing device, in accordance with exemplary embodiments of the invention.

[0434] Figures 16A and 16B show exemplary dimensions of leaflet and / or cusp anchor 900a (which corresponds to anchor 900) its components. In some embodiments, the total length from proximal end 906 to the distal end 908 is exemplified as approximately between 15 mm to 19 mm, for example, about 15, about 16, about 17, about 18 or about 19 mm or intermediate values, while the transverse width of anchor 900a is between 3 mm to 4 mm for example, about 3, about 3.1, about 3.4, about 3.7, about 3.95 mm or intermediate values. In some embodiments, the width of anchor 900a is uniform along its length, while in other embodiments the width may vary along the longitudinal axis. In some embodiments, the dimension of between 3mm to 4mm corresponds to the widest portion of the anchor in a variable-width configuration and / or to the width measured near the proximal end 906. As can be appreciated, the sizes in this and other embodiments in this and / or other specification sections can vary. For example, the entire anchor can be increased in size by 10%, 20%, 30%, 50% or intermediate or larger percentages, or shrunken by the same percentage. This will have a pro-rata effect on the measurements herein. In addition, each one of the measurements can be individually modified, for example, increased or decreased by these percentages. Unless noted otherwise, the sizes in this section are in millimeters (mm).

[0435] In some embodiments, the total length of the leaflet and / or cusp anchor 900a includes a portion aligned with the line along which the tubular member (e.g., 1002 and / or 1002a) connects to itself (e.g., line 1004). In some embodiments, this portion is intended to engage, contact, abut, and / or overlap with the hollow tubular member. In some embodiments, the length of this portion is approximately between 11 mm to 13 mm, for example, about 11, about 12, about 13 mm or intermediate values. In some embodiments, the tubular member is formed and / or connected to the anchor by suturing, this portion of anchor 900a is aligned with a “cone to clip stitch line” (e.g., the line where the stitches of the tubular cone are optionally located) of the obstructing device.

[0436] In some embodiments, the anchor comprises a proximal portion 911, which extends proximally beyond the tubular member and is located proximally to the portion intended to engage with the tubular member. In some embodiments, the length of this potion is approximately between 2 mm to 4 mm for example, about 2, about 2.5, about 3, about 3.5, about 4 mm or intermediate values. Portion 911 may be used for holding the device during delivery and / or removal. In some embodiments of the invention, portion 911 serves to offset the pivot point of arm 904 from arms 909 which may, for example, provide more uniform pressure along the length of arm 904 and / or reduce the risk of pinching at the pivot point and / or allow the tubular member to be start at a location lower than the edge of the leaflet.

[0437] In some embodiments, the thickness of the frame (e.g., frame 902) at the proximal portion thereof (e.g., adjacent to proximal end 906) is approximately between 0.35 to 0.7 mm, for example, about 0.35, about 0.42, about 0.5, about 0.6, about 07 mm or intermediate values., and the thickness of the arm (e.g., arm 904) at this region, where no connecting elements are provided, is approximately between 0.4 to 0.7 mm for example, about 0.4, about 0.45 about 0.5, about 0.55, about 0.6, about 0.7 mm or intermediate values. In some embodiments of the invention, the thicknesses are the same. A potential advantage of different thicknesses is assisting in balancing the expected degree of deformation of each of arms 904 and 909, where thicker arms may deform less for a same width. Balancing may be used, for example, to obtain similar deformations or to encourage more deformation in arm 904 and / or arms 909, for example, 10% more, 20% more, 30% more or intermediate of larger amounts.

[0438] In some embodiments, anchor 900a (e.g., frame 902) comprises one or more bases for the connection of perpendicular connecting elements 922. In some embodiments, each base has a width of approximately between 0.35 mm to 0.55 mm , for example, about 0.35, about 0.42, about 0.49, about 0.55 mm or intermediate valuesand / or a length of approximately between 0.45 mm to 0.65 mm , for example, about 0.45, about 0.53, about 0.61, about 0.65 mm or intermediate values. In some embodiments, the perpendicular connecting element 922, optionally welded to this base, has a width of approximately between 0.2 mm to 0.6 mm, for example, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6 mm or intermediate values and / or an overall length of approximately between 1.0 mm to 1.4mm, for example, about 1.0, about 1.1, about 1.2, about 1.3, about 1.4 mm or intermediate values , wherein the proximally extending sharpened portion thereof has, for example, a length of approximately between 0.4 mm to 0.8 mm, for example, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8 mm or intermediate values. In some embodiments, this base is in the form of a port and / or recess into which the perpendicular connecting element 922 is inserted and is optionally welded and / or is frictionally and elastically engaged in place. In some embodiments of the invention, the sizes of elemenst 922 (e.g., of a shaft thereof) is designed for elasticly and frictionally fitting into said recesses / ports, in at least one dimension, or is smaller. In some embodiments, connecting element 922 is welded to anchor 900a (e.g., frame 902) from the side opposite to the sharpened protrusion of connecting element 922. In some embodiments, the welding is performed circumferentially around the entire perimeter of perpendicular connecting element 922, optionally, at the interface where it enters the base in frame 902. Fig. 16B shows an example where connecting elements 922 are cut from a same sheet as frame 902.

[0439] Figures 17 A and 17B show exemplary dimensions of a hollow tubular member 1002a (which generally corresponds to tubular member 1002), according to some embodiments of the invention. Figure 17A shows a flat (unfolded) layout of the tubular member prior to shaping, having a generally trapezoidal or conical profile (when folded). The shape and dimensions may depend on the desired final shape of the tubular element and / or may depend on limitations due to attachment and / or suturing. In this example, the flat sheet has a height of approximately between 11 mm to 13 mm, for example, about 11, about 11.5, about 12, about 12.5, about 13 mm or intermediate values, a base width of approximately between 18 mm to 22 mm, for example, about 18, about 19, about 20, about 21, about 22 mm or intermediate values , and / or a top width (after tapering) of approximately between 6 mm to 9 mm, for example, about 6, about 7, about 7.5, about 8, about 8.5, about 9 mm or intermediate values. In some embodiments of the invention, this layout is used to form the conical geometry of the tubular member by folding and connecting (e.g., by suturing or bonding) opposing edges.

[0440] Figure 17B shows a side view of the same tubular member in its formed conical shape, having a proximal opening 1006 and a distal end 1008, in this example, in the form of a distal orifice. In this example, the height of the cone is approximately between 10 mm to 14 mm, for example, about 10, about 11, about 12, about 13, about 14 mm or intermediate values, the diameter of the proximal opening is approximately between 5 mm to 7 mm for example, about 5, about 5.5, about 6, about 6.5, about 7 mm or intermediate values, and / or the diameter of the distal orifice is approximately between 1 mm to 4 mm or smaller, for example, about 1, about 1.5, about 2, about 2.5, about 3, about 4 mm or intermediate values. These exemplary dimensions illustrate one possible size configuration of the tubular member and are optionally selected to fit within anatomical constraints and device requirements.

[0441] Figures 18A-B show exemplary curvature of anchor 900a of obstructing device 1000a.

[0442] In some embodiments, tubular member 1002a (e.g., shown in its conical configuration) is connected to anchor 900a. A radius of curvature of for example approximately between 11 mm to 14 mm, for example, about 11, about 11.5, about 12, about 12.5, about 13 mm or intermediate values.is exemplified in Figure 18A, corresponding to the curvature of anchor 900a (e.g., the frame thereof). This curvature is optionally pre-defined to conform to the anatomical contour of the target leaflet and / or cusp, optionally after engaging with leaflet tissue thereof.

[0443] In some embodiments, the tubular member has a generally conical shape. In other embodiments, the shape of the tubular member is asymmetrical and tends to conform to the curvature of the anchor, optionally enhancing anatomical compatibility and sealing performance.

[0444] In some embodiments, a portion of anchor 900a, referred to as proximal portion 911, extends proximally beyond the edge of the tubular member 1002a, for example, approximately between 2mm to 4.5mm, for example, about 2, about 2.5, about 3, about 3.5, about 4, about 4.5 mm or intermediate values. This proximal extension is optionally used to facilitate engagement with a delivery system, provide positioning control, or define a reference point for deployment.

[0445] In some embodiments, anchor 900a is connected to tubular member 1002a along at least a portion of line 1400. In some embodiments, line 1400 represents the location where tubular member 1002a is connected to itself (e.g., to form its conical or tubular shape). Optionally additionally or alternatively, line 1400 may represent an optional the suture line or attachment zone where the tubular member 1002a is closed into a tube and / or secured to the anchor structure.

[0446] It is noted that the dimensions shown in figures 16A-18B are provided for illustrative purposes only and may vary across different embodiments, for example, depending on patientspecific anatomy, deployment technique, and / or functional performance needs.

[0447] General

[0448] It is expected that during the life of a patent maturing from this application many relevant frames will be developed; the scope of the term frames is intended to include all such new technologies a priori.

[0449] As used herein with reference to quantity or value, the term “about” means “within ± 10 % of’.

[0450] The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

[0451] The term “consisting of’ means “including and limited to”.

[0452] The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0453] As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

[0454] Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0455] Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

[0456] Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

[0457] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[0458] As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

[0459] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0460] While some of the embodiments of the invention have been described by way of illustration, it will be apparent that the invention can be carried into practice with many modifications, variations and adaptations, and with the use of numerous equivalents or alternative solutions that are within the scope of a person skilled in the art, without departing from the spirit of the invention, or the scope of the claims.

[0461] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. An obstructing device mountable on a heart valve cusp or leaflet, in a valve lumen having a flow axis between an upstream direction and a downstream direction, comprising: a hollow tubular member, comprising: a proximal end comprises a proximal opening, configured to be faced toward the direction of a regurgitation leakage; and a substantially tubular surface extending distally from said proximal opening to a distal end with the direction of the regurgitation leakage and a leaflet anchor, comprising: a peripheral frame having a distal end, a proximal end, and at least two side arms; a grasping arm extending distally from said proximal end, located between said at least two side arms and having a free end, so that said cusp or leaflet can be trapped between said frame and at least one of said grasping arms; wherein said peripheral frame and said grasping arm define a space therebetween when flattened, and wherein said space varies along a longitudinal axis of the leaflet anchor, defined between said distal end and said proximal end; wherein said hollow tubular member is attached to said peripheral frame, such that said proximal opening is adjacent to said proximal end of said peripheral frame.

2. The obstructing device according to claim 1, wherein said space is widest at the the proximal end of the frame and narrows toward the distal end of the frame.

3. The obstructing device according to claims 1 or 2, wherein the grasping arm comprises a plurality of protrusions on each one of the side arms, adapted to engage cusp tissue and extend in a direction towards the other side arm.

4. The obstructing device according to claim 3, wherein at least one protrusion of said plurality of protrusions comprises a rounded tip.

5. The obstructing device according to any of the preceding claims, wherein the grasping arm comprises a plurality of protrusions in a direction towards the frame.

6. The obstructing device according to claim 5, wherein at least one protrusion of said plurality of protrusions comprises a rounded tip.

7. The obstructing device according to claims 5 or 6, wherein the plurality of protrusions of the grasping arm fits within the plurality of protrusions of the frame, and wherein said space is defined by a space between the plurality of protrusions of the grasping arms and the plurality of protrusions of the frame.

8. The obstructing device according to any of the preceding claims, wherein the leaflet anchor comprises at least one sharp protrusion, perpendicular to the frame and directed toward the cusp tissue, wherein said at least one sharp protrusion is placed on one or both of said frame and said grasping arm.

9. The obstructing device according to claim 8, wherein the frame comprises an enlarged space near its said distal end, defined by a margin between a distal end of said arm and said distal end of said frame.

10. The obstructing device according to any of the preceding claims, wherein said frame comprises a connection location near its proximal end, wherein said connection area is configured to connect to a delivery system.

11. The obstructing device according to claim 10, wherein said connection area comprises a geometry shaped and sized to interact with a corresponding geometry on the delivery system.

12. The obstructing device according to claim 11, wherein said geometry comprises one or both of: a protrusion shaped and sized to fit within a depression on the delivery system; and a recess shaped and sized to receive a protrusion from the delivery system.

13. The obstructing device according to any of the preceding claims, wherein one or both of said hollow tubular member and said proximal opening thereof is shaped and sized to conform with a regurgitant orifice of the heart valve.

14. The obstructing device according to claim 13, wherein one or both of said hollow tubular member and said proximal opening thereof are pre- shaped to have a triangular or substantially triangular cross-section.

15. The obstructing device according to claims 13 or 14, wherein one or both of said hollow tubular member and said proximal opening thereof are pre-shaped according to a patientspecific regurgitant orifice shape.

16. The obstructing device according to any of claims 13 to 15, wherein the hollow tubular member is sufficiently soft for conforming to the regurgitant orifice when the heart valve is closed.

17. The obstructing device according to claim 16, wherein said tubular member is sufficiently pliable to change a shape thereof during a cardiac cycle.

18. The obstructing device according to any of the preceding claims, wherein said peripheral frame and said grasping arm are each elastically deformable and have a preferred bending plane to apply clamping force towards said leaflet or cusp when said leaflet or cusp is trapped therebetween; and wherein said peripheral frame and said grasping arm are each curved in their respective preferred bending plane.

19. The obstructing device according to any of the preceding claims, wherein said peripheral frame and said grasping arm are curved in an arc shape in a resting state thereof.

20. The obstructing device according to claim 19, wherein the hollow tubular member is attached to the peripheral frame at the exterior side of the arc shape thereof.

21. The obstructing device according to any of the preceding claims, wherein the hollow tubular member is formed of a membrane.

22. The obstructing device according to to any of the preceding claims, wherein the tubular member is self-expandable.

23. The obstructing device according to any of the preceding claims, wherein the hollow tubular member tappers distally in a downstream direction.

24. The obstructing device according to any of the preceding claims, wherein the hollow tubular member is curved, extending adjacent to and along the leaflet.

25. The obstructing device according to any of the preceding claims, wherein the leaflet anchor is made of a super-elastic or shape memory material.

26. An obstructing device mountable on a heart valve cusp or leaflet, in a valve lumen having a flow axis between an upstream direction and a downstream direction, comprising: a hollow tubular member, comprising: a proximal end comprises a proximal opening; and a substantially tubular surface extending distally from said proximal opening to a distal end, wherein one or both of said hollow tubular member and said proximal opening comprises a pre-selected shape configured to conform to a regurgitant orifice of the heart valve; and a leaflet anchor, comprising: a peripheral frame having a distal end, a proximal end, and two side arms; a grasping arm extending distally from said proximal end, located between said side arms and having a free end, so that said cusp or leaflet can be trapped between said frame and said grasping arm; wherein said hollow tubular member is attached to said peripheral frame.

27. The obstructing device according to claim 26, wherein one or both of said hollow tubular member and said proximal opening thereof is shaped and sized according to a shape of the regurgitant orifice.

28. The obstructing device according to claims 26 or 27, wherein one or both of said hollow tubular member and said proximal opening are pre-shaped to have a triangular or substantially triangular shape.

29. The obstructing device according to any of claims 26 to 28, wherein one or both of said hollow tubular member and said proximal opening are pre-shaped according to a patientspecific regurgitant orifice shape to have an un-rounded shape.

30. The obstructing device according to any of claims 26 to 29, wherein the hollow tubular member is sufficiently soft to be shaped as the regurgitant orifice when the heart valve is closed.

31. The obstructing device according to claim 30, wherein said tubular member is sufficiently pliable to change a shape thereof during a cardiac cycle.

32. The obstructing device according to claim 31, wherein said tubular member is sufficiently deformable to maintain the regurgitant orifice shape when the heart valve opens.

33. The obstructing device according to claim 32, wherein said tubular member is configured to encourage tissue ingrowth thereon.

34. The obstructing device according to any of claims 26 to 33, wherein said tubular member comprises a pericardium tissue.

35. A delivery system for delivering an obstructing device for being mounted on a native cusp or leaflet, said delivery system comprising: a body; a capsule defined by a movable proximal outer sheath and a movable distal outer sheath; a distal holder for receiving a distal part of said obstructing device and a proximal holder for receiving a proximal side of said obstructing device, wherein the proximal holder and the distal holder are mounted on said body and covered by said capsule.

36. The delivery system according to claim 35, comprising an obstructing device held by said distal holder and said proximal holder, wherein said obstructing device comprises a curved frame with a curved resting state wherein said distal holder and said proximal holder hold said frame to prevent said curved frame from being at said curved resting state.

37. The delivery system according to claim 36, wherein the obstructing device comprises a curved grasping arm with a curved resting state and, wherein said capsule holds said grasping arm to prevent said curved grasping arm from being at said curved resting state.

38. The delivery system according to any of claims 36 or 37, wherein the proximal holder comprises at least one geometry configured to have geometric interference with a corresponding geometry on a proximal portion of said frame.

39. The delivery system according to claim 38, wherein said at least one geometry comprises one or both of: a protrusion shaped and sized to fit within a depression on said frame; and a depression shaped and sized to receive a protrusion from said frame.

40. The delivery system according to any of claims 38 to 39, wherein the proximal holder comprises a fixator configured to hold the proximal portion of said frame to said proximal holder.

41. The delivery system according to claim 40, wherein said fixator is configured to press said proximal portion of said frame onto said proximal holder.

42. The delivery system according to any of claims 36 to 41, wherein the distal holder comprises at least one recess defined by said distal outer sheath partially covers said distal holder, configured to receive a distal portion of said frame.

43. The delivery system according to any of claims 37 to 41, wherein said proximal sheath is configured to be partially retracted in the proximal direction and said distal sheath is configured to be partially retracted in the distal direction, revealing the grasping arm.

44. The delivery system according to any of claims 36 to 43, wherein said proximal sheath is configured to be fully retracted in the proximal direction to release said proximal portion.

45. The delivery system according to any of claims 40 to 43, wherein said fixator comprises an elastic mechanism, and wherein the fixator is configured to radially bent away when said proximal sheath is fully retracted.

46. The delivery system according to any of claims 42 to 45, wherein said distal sheath is configured to be fully retracted to release said distal portion from said recess.

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