Atrioventricular valve leaflet augmentation

Abstract

Apparatus and methods are provided for use with a delivery device (24) and a hole that has been pierced within a leaflet of an atrioventricular valve of a subject. A leaflet- augmentation device (20) is delivered to the hole by the delivery device (24) while being maintained in a radially-constrained configuration by the delivery device (24), before being deployed within the hole by the delivery device (24). The leaflet augmentation device (20) includes first and second sets (34A, 34B) of anchors (36) configured to self-expand on respective sides of the valve leaflet upon being released from the delivery device, a frame (38) configured to be radially expandable within the hole, to thereby radially expand the hole, and a self-sealing membrane (43) disposed within the frame. Other applications are also described.

Description

[0001] ATRIOVENTRICULAR VALVE LEAFLET AUGMENTATION

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims priority from U.S. Provisional Patent Application No.

[0003] 63 / 788,746 to Harari, filed April 14, 2025, entitled "Atrioventricular valve leaflet augmentation," and from U.S. Provisional Patent Application No. 63 / 928,117 to Harari, filed December 01, 2025, entitled "Atrioventricular valve leaflet augmentation.” The aforementioned applications are incorporated herein by reference.

[0004] TECHNICAL FIELD

[0005] The present disclosure generally relates to a medical implant, and specifically to an implant for implantation within an atrioventricular cardiac valve leaflet.

[0006] BACKGROUND

[0007] Heart valve dysfunction is a significant clinical concern that affects millions of individuals worldwide. The heart valves, including the mitral, aortic, tricuspid, and pulmonary valves, are responsible for directing the flow of blood in a unidirectional manner through the heart and circulatory system. Each valve consists of flexible, thin leaflets that open and close in response to the pressure gradients between the chambers of the heart, ensuring that blood flows efficiently without backward regurgitation. However, in certain heart valve diseases, these leaflets can become damaged, deformed, weakened, or distorted as a result of ventricular remodeling, impairing the proper function of the valve and leading to conditions such as valve insufficiency, stenosis, or regurgitation.

[0008] In particular, valve insufficiency or regurgitation occurs when the leaflets of the heart valve do not close properly during systole, allowing blood to leak backward through the valve. This backward flow of blood can lead to an overload of the heart chambers, increased cardiac workload, and ultimately, heart failure if left untreated. The causes of valve dysfunction can vary, including degenerative changes due to aging, congenital defects, infections, or damage from conditions such as rheumatic heart disease. The inability of the valve leaflets to achieve complete coaptation, or proper sealing, is often a key contributor to this dysfunction.

[0009] Functional regurgitation occurs when myocardial infraction causes remodeling of the heart and, in the case of mitral regurgitation, enlargement of the left ventricle. This causes the leaflets not to coapt, thereby leading to regurgitation via the valve.Current treatment strategies for heart valve dysfunction, particularly in cases of valve regurgitation or insufficiency, include medical management, surgical repair, and valve replacement. Valve repair (e.g., transcatheter edge-to-edge repair (TEER)), when possible, is generally preferred over valve replacement due to the benefits of preserving the native valve and avoiding the complications associated with prosthetic valve implantation. Surgical repair techniques for heart valve leaflets often involve re-shaping or reinforcing the valve tissue or using devices to assist in achieving proper leaflet coaptation. However, in certain cases, the structural integrity of the valve leaflets is so compromised that these repair techniques are insufficient, and more advanced interventions are required.

[0010] Traditional repair methods may not be effective for all patients, particularly when the valve leaflets are significantly weakened, or when there is a loss of leaflet tissue, such as in cases of severe annular dilation (it being noted that in cases of severe annular dilation there is a discrepancy between the surface area of the valve orifice and the surface area of the valve leaflets), calcification, or other degenerative or functional conditions. Additionally, some patients may have anatomically challenging valve configurations, which hinder the ability of conventional repair devices to restore proper valve function.

[0011] Transcatheter devices available in the market today are mainly designed to treat degenerative valve disease and not functional regurgitation. Such devices may require the patient to take blood diluting agents which entail mortality and morbidity risks, are challenging to be done and require skilled physicians, which limits the number of patients that can benefit from such procedures. Transcatheter edge-to-edge repair often requires the implantation of more than one device, thereby prolonging the operation time and procedure cost.

[0012] As a result, there is a growing need for innovative approaches to augment and repair the function of heart valve leaflets, especially in cases where conventional repair techniques are not sufficient.

[0013] SUMMARY

[0014] In accordance with some applications of the present disclosure, a hole is pierced within an atrioventricular valve leaflet, using a piercing device. A leaflet-augmentation device is delivered to the hole within the atrioventricular valve leaflet percutaneously, via a delivery device. For some applications, the delivery device has an outer diameter of less than 4.5 mm, e.g., less than 4.3 mm. For example, the delivery device may be a 12 French catheter (i.e., a catheter with an outer diameter of 4.06 mm).For some applications, the delivery device is delivered through the hole, such that a distal end of the delivery device is disposed within the subject’s ventricle. Typically, the distal end of the delivery device is guided through hole and into the ventricle, over a guidewire. Proximally to the distal end of the delivery device, the delivery device houses the leafletaugmentation device within a leaflet-augmentation device housing portion.

[0015] Typically, the leaflet-augmentation device is maintained in a radially constrained (i.e., crimped) configuration within leaflet-augmentation device housing portion during delivery of the leaflet-augmentation device to the hole. For some applications, the leaflet-augmentation device includes first and second sets of anchors, which are configured to be deployed on respective sides of the valve leaflet. When the leaflet-augmentation device housing portion is positioned within the hole, the first set of anchors are released from the leaflet-augmentation device housing portion. Typically, the first set of anchors are configured such that upon being released from the leaflet-augmentation device housing portion, the anchors radially expand and are biased toward the second set of anchors, as described in further detail hereinbelow.

[0016] In a subsequent step, a second set of anchors are released from leaflet-augmentation device housing portion of the delivery device. Typically, the second set of anchors are configured such that upon being released from the leaflet-augmentation device housing portion, the anchors radially expand and are biased toward the first set of anchors. Further typically, the first and second sets of anchors are configured such that when both sets of anchors are in their non-radially constrained configuration, tissue of the valve leaflet between is firmly held between the tips of the anchors belonging to the respective sets of anchors. For example, the sets of anchors may be configured such that (in their non-constrained configurations, i.e., if tissue is not disposed between the tips of the respective sets of anchors) the tips of anchors belonging to the respective sets of anchors overlap with each other, and / or such that the tips of anchors belonging to the respective sets of anchors touch each other, and / or such that an axial gap between the tips of anchors belonging to the respective sets of anchors is less than 3 mm, e.g., less than 2 mm.

[0017] Subsequently to both sets of anchors having been released (such that tissue of the valve leaflet between is firmly held between the tips of the anchors belonging to the respective sets of anchors), a frame of the leaflet-augmentation device is radially expanded in order to radially expand the hole within the valve leaflet. For some applications, a balloon is inflated within the frame, in order to expand the frame. The radial expansion of the frame typically expands thehole. For some applications, the frame and the two sets of anchors are formed as a single unitary structure.

[0018] Typically, by deploying the anchors prior to radially expanding the frame, the anchors hold onto a greater volume of tissue than if the anchors are only deployed after the frame has been radially expanded. This is because if the frame is first radially expanded the radial expansion of the frame stretches the tissue surrounding the hole, causing it to become thinner. Thus, by deploying the anchors prior to radially expanding the frame, the anchors typically anchor the frame within the valve leaflet with greater strength than if the anchors are only deployed after the frame has been radially expanded, ceteris paribus.

[0019] For some applications, the frame is initially radially expanded to a first diameter (e.g., by inflating a balloon within the frame, as described hereinabove). The efficacy of the leafletaugmentation device with the frame having been radially expanded to the first diameter is then measured. For example, the amount of mitral regurgitation subsequent to the deployment of the leaflet-augmentation device and the radial expansion of the frame to the first diameter may be measured (e.g., using Doppler echocardiography). For some applications, the determined amount of mitral regurgitation is compared to a baseline amount of mitral regurgitation that was measured prior to the deployment of the leaflet-augmentation device. For some applications, in response to determining that there is some remaining mitral regurgitation or that there has not been a great enough improvement in the mitral regurgitation as a result of the deployment of the leaflet-augmentation device, the frame is further radially expanded to a second diameter that is greater than the first diameter. Typically, the above-described procedure of incrementally radially expanding the frame and measuring the amount of mitral regurgitation subsequent to the radial expansion of the frame is repeated in an iterative manner, until a desired reduction in mitral regurgitation has been achieved, and / or until there is no or minimal mitral regurgitation.

[0020] Subsequent to the radial expansion of the frame, the distal end of the delivery device is retracted from the left ventricle via the frame. For some applications, a membrane is disposed within the frame and is configured to form a seal that prevents blood flow via the inside of the frame. For example, the membrane may be a self-sealing membrane as is described in further detail hereinbelow, the membrane being configured to facilitate tools such as a balloon and guidewire to be retracted (or reinserted) via the membrane and to subsequently self-seal. Typically, with the frame having been radially expanded and the membrane forming a seal thatprevents blood flow via the inside of frame, the deployed leaflet-augmentation device effectively increases the area of the valve leaflet.

[0021] There is therefore provided, in accordance with some applications of the present disclosure, apparatus for use with a delivery device and a hole that has been pierced within a leaflet of an atrioventricular valve of a subject, the apparatus including:

[0022] a leaflet-augmentation device configured to be delivered to the hole by the delivery device while being maintained in a radially-constrained configuration by the delivery device, before being deployed within the hole by the delivery device, the leaflet augmentation device including:

[0023] first and second sets of anchors configured to self-expand on respective sides of the valve leaflet upon being released from the delivery device, such that the first and second sets of anchors firmly hold tissue of the valve leaflet that surrounds the hole between tips of anchors belonging to the first and second sets of anchors;

[0024] a frame configured to be radially expandable within the hole, to thereby radially expand the hole; and

[0025] a membrane disposed within the frame, the membrane being non-porous with respect to blood and configured to prevent blood flow via the inside of the frame, and the membrane being self-sealing, such as to facilitate retraction of a distal end of the delivery device via the membrane.

[0026] For some applications, the first and second set of anchors are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors overlap with each other.

[0027] For some applications, the first and second set of anchors are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors touch each other.

[0028] For some applications, the first and second set of anchors are configured to self-expand such that in non-constrained configurations, an axial gap between the tips of anchors belonging to respective sets of anchors is less than 3 mm.

[0029] For some applications, the first and second set of anchors are configured to self-expand such that each of the anchors belonging to the first and second sets of anchors spans a radial distance from outside the frame of more than 1 mm.For some applications, the frame is configured to be incrementally expandable to a plurality of diameters of increasing magnitude.

[0030] For some applications, the frame is configured to be radially expandable to a maximum outer diameter of more than 5 mm.

[0031] For some applications, the frame is configured to be radially expandable to a maximum outer diameter of less than 20 mm.

[0032] For some applications, the apparatus is configured for use with a balloon, the frame is configured to be radially expanded by the balloon being expanded within the frame and the membrane is self-sealing, such as to form a seal after the balloon is deflated and retracted from inside the frame.

[0033] For some applications, the first and second sets of anchors are configured to be elastic at 37 C and the frame is configured to be plastic at 37 C.

[0034] For some applications, the first and second set of anchors are welded to the frame. For some applications, the first and second set of anchors are stitched to the frame. For some applications, the first and second set of anchors are made of a different material from that of the frame.

[0035] For some applications, the first and second set of anchors are made of a shape-memory alloy configured to have an austenite finish temperature of less than 25 C and the frame is made of the same shape-memory alloy configured to have an austenite finish temperature of more than 50 C.

[0036] For some applications, the first and second sets of anchors and the frame are formed from a unitary structure and are configured to be elastic at 37 C.

[0037] For some applications, the frame is continuous with the first and second sets of anchors. For some applications, the first and second sets of anchors and the frame are cut from a single tube of a shape-memory alloy, which is configured to have an austenite finish temperature of less than 25 C.

[0038] For some applications, the frame requires mechanical expansion in order to radially expand against mechanical forces that surrounding tissue of the valve leaflet exerts on the frame, and the frame is configured to maintain its radially expanded configuration after having been radially expanded within the tissue of the valve leaflet.For some applications, the membrane comprises a plurality of layers, each of the layers defining a respective slit therethrough, the layers being arranged with respect to each other such that the respective slits are angularly misaligned from each other and each of the slits does not overlap with any others of the slits.

[0039] For some applications, each of the slits does not cross any others of the slits.

[0040] For some applications, the membrane comprises at least three layers.

[0041] For some applications, a length of each of the slits is 4-20 mm.

[0042] For some applications, the membrane is elastic and is configured to facilitate insertion of a device through the membrane by the medical device being inserted through the slits and stretching the slits.

[0043] For some applications, the membrane is configured such that the slits return to their original sizes after the device is retracted from being inserted through the slits.

[0044] There is further provided, in accordance with some applications of the present disclosure, apparatus for use with a hole that has been pierced within a leaflet of an atrioventricular valve of a subject, the apparatus including:

[0045] a leaflet-augmentation device configured to be deployed within the hole, the leaflet augmentation device including a frame, a membrane disposed within the frame, and first and second set of anchors; and

[0046] a delivery device configured to:

[0047] deliver the leaflet-augmentation device to the hole, while maintaining the leafletaugmentation device in a radially-constrained configuration within the delivery device;

[0048] release first and second sets of anchors of the leaflet-augmentation device on respective sides of the valve leaflet, such that the first and second sets of anchors radially expand and firmly hold tissue of the valve leaflet that surrounds the hole between tips of anchors belonging to the first and second sets of anchors;

[0049] subsequently thereto, radially expand the frame of the leaflet-augmentation device, to thereby radially expand the hole; and

[0050] subsequently thereto, facilitate retraction of a distal end of the delivery device via the membrane, the membrane being configured to become sealed once the distal end of the delivery device has been retracted via the membrane, such as to prevent blood flow via the inside of the frame.For some applications, the first and second set of anchors are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors overlap with each other.

[0051] For some applications, the first and second set of anchors are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors touch each other.

[0052] For some applications, the first and second set of anchors are configured to self-expand such that in non-constrained configurations, an axial gap between the tips of anchors belonging to respective sets of anchors is less than 3 mm.

[0053] For some applications, the first and second set of anchors are configured to self-expand such that each of the anchors belonging to the first and second sets of anchors spans a radial distance from outside the frame of more than 1 mm.

[0054] For some applications, the delivery device is configured to radially expand the frame to a maximum outer diameter of more than 5 mm.

[0055] For some applications, the delivery device is configured to radially expand the frame to a maximum outer diameter of less than 20 mm.

[0056] For some applications, the apparatus is configured for use with a balloon, the delivery device is configured to radially expand the frame by radially expanding the balloon within the frame, and the membrane is configured to become sealed after the balloon is deflated and retracted from inside the frame.

[0057] For some applications, the first and second sets of anchors are configured to be elastic at 37 C and the frame is configured to be plastic at 37 C.

[0058] For some applications, the first and second set of anchors are welded to the frame. For some applications, the first and second set of anchors are stitched to the frame. For some applications, the first and second set of anchors are made of a different material from that of the frame.

[0059] For some applications, the first and second set of anchors are made of a shape-memory alloy configured to have an austenite finish temperature of less than 25 C and the frame is made of the same shape-memory alloy configured to have an austenite finish temperature of more than 50 C.For some applications, the first and second sets of anchors and the frame are formed from a unitary structure and are configured to be elastic at 37 C.

[0060] For some applications, the frame is continuous with the first and second sets of anchors. For some applications, the first and second sets of anchors and the frame are cut from a single tube of a shape-memory alloy, which is configured to have an austenite finish temperature of less than 25 C.

[0061] For some applications, the frame requires mechanical expansion in order to radially expand against mechanical forces that surrounding tissue of the valve leaflet exerts on the frame, and the frame is configured to maintain its radially expanded configuration after having been radially expanded within the tissue of the valve leaflet.

[0062] For some applications, the delivery device is configured to radially expand the frame incrementally to a plurality of diameters of increasing magnitude.

[0063] For some applications, the delivery device is configured to:

[0064] (a) radially expand the frame, to thereby radially expand the hole to a first diameter and maintain the hole at the first diameter for a period of time such as to facilitate measurement of regurgitation via the atrioventricular valve; and

[0065] (b) further radially expand the frame, to thereby radially expand the hole to a second diameter that is greater than the first diameter and maintain the hole at the second diameter for a period of time such as to facilitate measurement of regurgitation via the atrioventricular valve; and

[0066] perform steps (a) and (b) iteratively until regurgitation via the atrioventricular valve has been reduced to a desired level.

[0067] For some applications, the membrane comprises a plurality of layers, each of the layers defining a respective slit therethrough, the layers being arranged with respect to each other such that the respective slits are angularly misaligned from each other and each of the slits does not overlap with any others of the slits.

[0068] For some applications, each of the slits does not cross any others of the slits.

[0069] For some applications, the membrane comprises at least three layers.

[0070] For some applications, a length of each of the slits is 4-20 mm.For some applications, the membrane is elastic and is configured to facilitate insertion of a device through the membrane by the medical device being inserted through the slits and stretching the slits.

[0071] For some applications, the membrane is configured such that the slits return to their original sizes after the device is retracted from being inserted through the slits.

[0072] There is further provided, in accordance with some applications of the present disclosure, apparatus for use with a hole that has been pierced within a leaflet of an atrioventricular valve of a subject, the apparatus including:

[0073] a leaflet-augmentation device configured to be deployed within the hole, the leaflet augmentation device including a frame, a membrane disposed within the frame, and anchors; and

[0074] a delivery device configured to:

[0075] deliver the leaflet-augmentation device to the hole, while maintaining the leafletaugmentation device in a radially-constrained configuration within the delivery device;

[0076] anchor the leaflet-augmentation device to tissue of the leaflet that surround the hole via the anchors;

[0077] and subsequently thereto:

[0078] (a) radially expand a frame of the leaflet-augmentation device, to thereby radially expand the hole to a first diameter and maintaining the hole at the first diameter for a period of time such as to facilitate measurement of regurgitation via the atrioventricular valve; and

[0079] (b) further radially expand the frame of the leaflet-augmentation device, to thereby radially expand the hole to a second diameter that is greater than the first diameter and maintaining the hole at the second diameter for a period of time such as to facilitate measurement of regurgitation via the atrioventricular valve; and

[0080] perform steps (a) and (b) iteratively until regurgitation via the atrioventricular valve has been reduced to a desired level.

[0081] For some applications, the leaflet-augmentation device includes first and second set of anchors that are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors overlap with each other.For some applications, the leaflet-augmentation device includes first and second set of anchors that are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors touch each other.

[0082] For some applications, the leaflet-augmentation device includes first and second set of anchors that are configured to self-expand such that in non-constrained configurations, an axial gap between the tips of anchors belonging to respective sets of anchors is less than 3 mm.

[0083] For some applications, the leaflet-augmentation device includes first and second set of anchors that are configured to self-expand such that each of the anchors belonging to the first and second sets of anchors spans a radial distance from outside the frame of more than 1 mm.

[0084] For some applications, the delivery device is configured to radially expand the frame to a maximum outer diameter of more than 5 mm.

[0085] For some applications, the delivery device is configured to radially expand the frame to a maximum outer diameter of less than 20 mm.

[0086] For some applications, the anchors are configured to be elastic at 37 C and the frame is configured to be plastic at 37 C.

[0087] For some applications, the anchors are welded to the frame.

[0088] For some applications, the anchors are stitched to the frame.

[0089] For some applications, the anchors are made of a different material from that of the frame.

[0090] For some applications, the anchors are made of a shape-memory alloy configured to have an austenite finish temperature of less than 25 C and the frame is made of the same shapememory alloy configured to have an austenite finish temperature of more than 50 C.

[0091] For some applications, the anchors and the frame are formed from a single structure and are configured to be elastic at 37 C.

[0092] For some applications, the anchors and the frame are cut from a single tube of a shapememory alloy, which is configured to have an austenite finish temperature of less than 25 C.

[0093] For some applications, the frame requires mechanical expansion in order to radially expand against mechanical forces that surrounding tissue of the valve leaflet exerts on the frame, and the frame is configured to maintain its radially expanded configuration after having been radially expanded within the tissue of the valve leaflet.There is further provided, in accordance with some applications of the present disclosure, apparatus for use with a delivery device and a hole that has been pierced within a leaflet of an atrioventricular valve of a subject, the apparatus including:

[0094] a leaflet-augmentation device configured to be delivered to the hole by the delivery device while being maintained in a radially-constrained configuration by the delivery device, before being deployed within the hole by the delivery device, the leaflet augmentation device including:

[0095] first and second sets of anchors configured to self-expand on respective sides of the valve leaflet upon being released from the delivery device, such that the first and second sets of anchors firmly hold tissue of the valve leaflet that surrounds the hole between tips of anchors belonging to the first and second sets of anchors;

[0096] a frame configured to be radially expandable within the hole, to thereby radially expand the hole; and

[0097] a membrane disposed within the frame, the membrane including a plurality of layers, each of the layers defining a respective slit therethrough, the layers being arranged with respect to each other such that the respective slits are angularly misaligned from each other and each of the slits does not overlap with any others of the slits. For some applications, each of the slits does not cross any others of the slits.

[0098] For some applications, the membrane includes at least three layers.

[0099] For some applications, a length of each of the slits is 4-20 mm.

[0100] For some applications, the first and second set of anchors are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors overlap with each other.

[0101] For some applications, the first and second set of anchors are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors touch each other.

[0102] For some applications, the first and second set of anchors are configured to self-expand such that in non-constrained configurations, an axial gap between the tips of anchors belonging to respective sets of anchors is less than 3 mm.

[0103] For some applications, the first and second set of anchors are configured to self-expand such that each of the anchors belonging to the first and second sets of anchors spans a radial distance from outside the frame of more than 1 mm.For some applications, the frame is configured to be incrementally expandable to a plurality of diameters of increasing magnitude.

[0104] For some applications, the frame is configured to be radially expandable to a maximum outer diameter of more than 5 mm.

[0105] For some applications, the frame is configured to be radially expandable to a maximum outer diameter of less than 20 mm.

[0106] For some applications, the apparatus is configured for use with a balloon, the frame is configured to be radially expanded by the balloon being expanded within the frame and the membrane is self-sealing, such as to form a seal after the balloon is deflated and retracted from inside the frame.

[0107] For some applications, the membrane is elastic and is configured to facilitate insertion of a device through the membrane by the medical device being inserted through the slits and stretching the slits.

[0108] For some applications, the membrane is configured such that the slits return to their original sizes after the device is retracted from being inserted through the slits.

[0109] For some applications, the first and second sets of anchors and the frame are formed from a unitary structure and are configured to be elastic at 37 C.

[0110] For some applications, the frame is continuous with the first and second sets of anchors. For some applications, the first and second sets of anchors and the frame are cut from a single tube of a shape-memory alloy, which is configured to have an austenite finish temperature of less than 25 C.

[0111] For some applications, the frame requires mechanical expansion in order to radially expand against mechanical forces that surrounding tissue of the valve leaflet exerts on the frame, and the frame is configured to maintain its radially expanded configuration after having been radially expanded within the tissue of the valve leaflet.

[0112] For some applications, the leaflet-augmentation device includes a skirt disposed between the first and second sets of anchors, and around an outer ring of the membrane, the layers of the membrane are coupled to each other and the skirt, such that the membrane is sealed with respect to the frame.

[0113] For some applications:the skirt is disc shaped, the skirt having an inner diameter that defines a hole and an outer diameter;

[0114] a gap between the inner diameter and the outer diameter defines an annular width of the skirt; and

[0115] the annular width of the skirt is 1-5 mm.

[0116] For some applications, the hole defined by the inner diameter of the skirt has a diameter of 5-15 mm.

[0117] For some applications, the layers of the membrane are coupled to each other and the skirt such that within a region of the hole defined by the skirt the layers of the membrane are able to move with respect to each other and with respect to the skirt, and within the annular width of the skirt the layers of the membrane are sealed with respect to each other and with respect to the skirt.

[0118] There is further provided, in accordance with some embodiments of the present disclosure, the following examples, at least some of which are independent aspects of the present disclosure.

[0119] According to an independent aspect, the present disclosure includes Example 1:

[0120] Example 1. Apparatus for use with a delivery device and a hole that has been pierced within a leaflet of an atrioventricular valve of a subject, the apparatus comprising:

[0121] a leaflet-augmentation device configured to be delivered to the hole by the delivery device while being maintained in a radially-constrained configuration by the delivery device, before being deployed within the hole by the delivery device, the leaflet augmentation device comprising:

[0122] first and second sets of anchors configured to be elastic at 37 C and to selfexpand on respective sides of the valve leaflet upon being released from the delivery device, such that the first and second sets of anchors firmly hold tissue of the valve leaflet that surrounds the hole between tips of anchors belonging to the first and second sets of anchors;

[0123] a frame configured to be plastic at 37 C and to be radially expandable within the hole, to thereby radially expand the hole; and

[0124] a membrane disposed within the frame, the membrane being non-porous with respect to blood and configured to prevent blood flow via the inside of the frame.Example 2. The apparatus according to example 1, wherein the first and second set of anchors are welded to the frame.

[0125] Example 3. The apparatus according to any one of the preceding examples, wherein the first and second set of anchors are stitched to the frame.

[0126] Example 4. The apparatus according to any one of the preceding examples, wherein the membrane is self-sealing, such as to facilitate retraction of a distal end of the delivery device via the membrane.

[0127] Example 5. The apparatus according to any one of the preceding examples, wherein the apparatus is configured for use with a balloon, wherein the frame is configured to be radially expanded by the balloon being expanded within the frame and wherein the membrane is selfsealing, such as to form a seal after the balloon is deflated and retracted from inside the frame. Example 6. The apparatus according to any one of the preceding examples, wherein the first and second set of anchors are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors overlap with each other. Example 7. The apparatus according to any one of examples 1-5, wherein the first and second set of anchors are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors touch each other.

[0128] Example 8. The apparatus according to any one of examples 1-5, wherein the first and second set of anchors are configured to self-expand such that in non-constrained configurations, an axial gap between the tips of anchors belonging to respective sets of anchors is less than 3 mm.

[0129] Example 9. The apparatus according to any one of the preceding examples, wherein the first and second set of anchors are configured to self-expand such that each of the anchors belonging to the first and second sets of anchors spans a radial distance from outside the frame of more than 1 mm.

[0130] Example 10. The apparatus according to any one of the preceding examples, wherein the first and second set of anchors are made of a different material from that of the frame.

[0131] Example 11. The apparatus according to any one of the preceding examples, wherein the first and second set of anchors are made of a shape-memory alloy configured to have an austenite finish temperature of less than 25 C and wherein the frame is made of the same shape-memory alloy configured to have an austenite finish temperature of more than 50 C.Example 12. The apparatus according to any one of the preceding examples, wherein the frame is configured to be incrementally expanded to a plurality of diameters of increasing magnitude.

[0132] Example 13. The apparatus according to any one of the preceding examples, wherein the frame is configured to be radially expandable to a maximum outer diameter of more than 5 mm. Example 14. The apparatus according to any one of the preceding examples, wherein the frame is configured to be radially expandable to a maximum outer diameter of less than 20 mm. Example 15. The apparatus according to any one of the preceding examples, wherein the membrane comprises a plurality of layers, each of the layers defining a respective slit therethrough, the layers being arranged with respect to each other such that the respective slits are angularly misaligned from each other and each of the slits does not overlap with any others of the slits.

[0133] Example 16. The apparatus according to example 15, wherein each of the slits does not cross any others of the slits.

[0134] Example 17. The apparatus according to example 15, wherein the membrane comprises at least three layers.

[0135] Example 18. The apparatus according to example 15, wherein a length of each of the slits is 4-20 mm.

[0136] Example 19. The apparatus according to example 15, wherein the membrane is elastic and is configured to facilitate insertion of a device through the membrane by the medical device being inserted through the slits and stretching the slits.

[0137] Example 20. The apparatus according to example 19, wherein the membrane is configured such that the slits return to their original sizes after the device is retracted from being inserted through the slits.

[0138] According to a further independent aspect, the present disclosure includes Example 21 : Example 21. A method comprising:

[0139] piercing a hole within a leaflet of an atrioventricular valve of a subject; and deploying a leaflet-augmentation device within the leaflet by:

[0140] delivering the leaflet-augmentation device to the hole, while the leafletaugmentation device is in a radially-constrained configuration within a delivery device;anchoring the leaflet-augmentation device to tissue of the leaflet that surround the hole;

[0141] and subsequently thereto:

[0142] (a) radially expanding a frame of the leaflet-augmentation device, to thereby radially expand the hole to a first diameter and maintaining the hole at the first diameter for a period of time such as to facilitate measurement of regurgitation via the atrioventricular valve; and

[0143] (b) further radially expanding the frame of the leaflet-augmentation device, to thereby radially expand the hole to a second diameter that is greater than the first diameter and maintaining the hole at the second diameter for a period of time such as to facilitate measurement of regurgitation via the atrioventricular valve,

[0144] steps (a) and (b) being performed iteratively until regurgitation via the atrioventricular valve has been reduced to a desired level.

[0145] According to a further independent aspect, the present disclosure includes Example 22: Example 22. A method comprising:

[0146] piercing a hole within a leaflet of an atrioventricular valve of a subject; and deploying a leaflet-augmentation device within the leaflet by:

[0147] delivering the leaflet-augmentation device to the hole, while the leafletaugmentation device is in a radially-constrained configuration within a delivery device;

[0148] releasing first and second sets of anchors of the leaflet-augmentation device from the delivery device on respective sides of the valve leaflet, such that the first and second sets of anchors radially expand and firmly hold tissue of the valve leaflet that surrounds the hole between tips of anchors belonging to the first and second sets of anchors;

[0149] subsequently thereto, radially expanding a frame of the leaflet-augmentation device, to thereby radially expand the hole; and

[0150] subsequently thereto, retracting a distal end of the delivery device via a membrane disposed within the frame, the membrane being configured to become sealed once the distal end of the delivery device has been retracted via the membrane, such as to prevent blood flow via the inside of the frame.

[0151] The present disclosure will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:BRIEF DESCRIPTION OF THE DRAWINGS

[0152] Figs. 1A, IB, 1C, ID, IE, and IF are schematic illustrations of respective steps of the deployment of a leaflet-augmentation device within an anterior mitral valve leaflet of a subject, in accordance with some applications of the present disclosure;

[0153] Figs. 2A, 2B, 2C, and 2D are schematic illustrations of respective steps of the deployment of a leaflet-augmentation device from a delivery device, in accordance with some applications of the present disclosure, in the absence of any anatomy for illustrative purposes;

[0154] Figs. 3A, 3B, 3C, and 3D are schematic illustrations of respective steps of the deployment of a leaflet-augmentation device from a delivery device, in accordance with some applications of the present disclosure, in the absence of any anatomy or a delivery device for illustrative purposes;

[0155] Figs. 4A and 4B are schematic illustrations of leaflet-augmentation device or portions thereof, in accordance with some applications of the present disclosure;

[0156] Figs 5 A, 5B, 5C, and 5D are schematic illustrations of leaflet-augmentation device or portions thereof, in accordance with some additional applications of the present disclosure; and Figs. 6A, 6B, and 6C are schematic illustrations of a steerable delivery device for delivering a leaflet-augmentation device, in accordance with some applications of the present disclosure.

[0157] DETAILED DESCRIPTION OF EMBODIMENTS

[0158] Reference is now made to Figs. 1A, IB, 1C, ID, IE, and IF, which are schematic illustrations of respective steps of the deployment of a leaflet-augmentation device 20 within an anterior mitral valve leaflet 22 of a mitral valve 23 of a subject, in accordance with some applications of the present disclosure. It is noted that although some aspects of the present disclosure are described with reference to implanting the leaflet-augmentation device 20 within an anterior mitral valve leaflet, the scope of the disclosure includes implanting the leafletaugmentation device 20 within any leaflet of any atrioventricular heart valve, mutatis mutandis. For example, the leaflet-augmentation device may be deployed in the posterior mitral valve leaflet and / or a tricuspid valve leaflet (e.g., the anterior, septal and / or posterior leaflet).

[0159] Leaflet augmentation device 20 is typically delivered to the mitral valve percutaneously, via a delivery device 24. Figs. 1 A-F show the leaflet-augmentation device being delivered via a transeptal route (i.e., via the vena cava, the right atrium, and the interatrial septum). However,the scope of the present disclosure includes delivering the leaflet-augmentation device being delivered via an alternative route, e.g., transaortically or transapically. For some applications, the delivery device has an outer diameter of less than 4.5 mm, e.g., less than 4.3 mm. For example, the delivery device may be a catheter such as a 12 French catheter (i.e., a catheter with an outer diameter of 4.06 mm).

[0160] Typically, prior to the step shown in Fig. 1 A, a hole 26 is pierced within the anterior mitral valve leaflet 22, using a piercing device (not shown). For some applications (e.g., applications in which the device 20 is delivered via a transseptal approach), a transeptal needle is used to pierce both a transeptal hole and hole 26. For example, prior to delivery of the delivery device to hole 26, a transeptal needle is used to pierce both a transeptal hole (i.e., a hole in the interatrial septum) and hole 26 is the valve leaflet. For some applications, a diathermy needle is used to pierce a transeptal hole and / or hole 26.

[0161] For some applications, hole 26 is pierced approximately at the center of the valve leaflet, i.e., approximately equidistant from the valve annulus and the coaptation line. A potential advantage of piercing the hole approximately at the center of the valve leaflet is that leaflet flexibility is less affected than if regions at the annulus or at the coaptation line are cut. Typically, a leaflet portion that is not attached to any of the primary chordae is selected for cutting, to prevent damaging the primary chordae.

[0162] For some applications, delivery device is delivered through hole 26, such that the distal end 28 of the delivery device is disposed within the left ventricle 30, as shown in Fig. 1 A. For some applications, distal end 28 of the delivery device 24 includes an echogenic material (such as, a metal or an alloy (e.g., stainless steel) and / or a polymeric material) in order to facilitate ultrasonic imaging of the distal end 28 of the delivery device 24 in which the distal end 28 of the delivery device 24 is distinguishable from the surrounding tissue. Typically, the distal end 28 of the delivery device 24 is guided through hole 26 and into the left ventricle 30, over a guidewire (not shown). Proximally to distal end 28 of the delivery device 24, the delivery device 24 houses the leaflet-augmentation device 20 within a leaflet-augmentation device housing portion 32. For some applications, the distal end 28 of the delivery device 24 is configured as a dilator and is configured to the dilate hole 26, such that the leaflet-augmentation device housing portion 32 can be positioned within hole 26. Alternatively, a separate dilator is used to dilate hole 26, prior to guiding the distal end 28 of the delivery device 24 through the hole 26. For some applications (e.g., applications in which the device 20 is delivered via a transseptal approach), the same dilator is used to dilate both a transeptal hole and hole 26.Typically, the leaflet-augmentation device 20 is maintained in a radially-constrained (i.e., crimped) configuration within leaflet-augmentation device housing portion 32 during delivery of the leaflet-augmentation device 20 to hole 26. For some applications, the leafletaugmentation device 20 includes first and second sets 34A and 34B of anchors 36 (individual anchors 36 being clearly depicted in Fig. 2B, for example), which are configured to be deployed on respective sides of the valve leaflet. Referring now to Fig. IB, when the leafletaugmentation device housing portion 32 is positioned within the hole 26, the first set 34A of anchors 36 are released from the leaflet-augmentation device housing portion 32. In the example shown in Fig. IB, the first set 34A of anchors 36 are disposed on a ventricular side of the anterior mitral valve leaflet 22 and are released at this stage. Typically, first set 34A of anchors 36 are configured such that upon being released from the leaflet-augmentation device housing portion 32, the first set 34A of anchors 36 radially expand and are biased toward the second set 34B of anchors 36, as described in further detail hereinbelow.

[0163] Referring now to Figs. 1C and ID, in a subsequent step, first set 34A of anchors 36 are pulled up against the ventricular side of the leaflet (such that the first set 34A of anchors 36 are hidden from view in Figs. 1C-D by leaflet 22). Second set 34B of anchors 36 are then released from leaflet-augmentation device housing portion 32. In the example shown in Figs. 1C-D, the second set 34B of anchors 36 are disposed on an atrial side of the anterior mitral valve leaflet 22 and are released at this stage. However, the scope of the present disclosure includes first releasing the set of anchors 36 that are disposed on the atrial side of the anterior mitral valve leaflet 22 and subsequently releasing the set of anchors 36 that are disposed on the ventricular side of the anterior mitral valve leaflet 22.

[0164] Typically, the second set 34B of anchors 36 are configured such that upon being released from the leaflet-augmentation device housing portion 32, the second set 34B of anchors 36 radially expand and are biased toward the first set 34A of anchors 36. Further typically, the first and second sets 34A, 34B of anchors 36 are configured such that when both sets of anchors 36 are in their non-radially constrained configurations, tissue of the valve leaflet 22 between is firmly held between the tips of the anchors 36 belonging to the respective sets 34A, 34B of anchors 36. For example, the sets 34A, 34B of anchors 36 may be configured such that, in their non-constrained configurations (i.e., if tissue is not disposed between the tips of the respective sets 34A, 34B of anchors 36), the tips of anchors 36 belonging to the respective sets 34A, 34B of anchors 36 overlap with each other, and / or the tips of anchors 36 belonging to the respective sets 34A, 34B of anchors 36 touch each other, and / or an axial gap between the tips of anchors36 belonging to the respective sets 34A, 34B of anchors 36 is less than 3 mm, e.g., less than 2 mm.

[0165] Subsequently to both sets 34A, 34B of anchors 36 having been released (such that tissue of the valve leaflet between is firmly held between the tips of the anchors 36 belonging to the respective sets 34A, 34B of anchors 36), a frame 38 (shown in Fig. 3A, for example) of the leaflet-augmentation device 20 is radially expanded in order to radially expand hole 26 within the valve leaflet. This step is shown in Fig. IE, although the frame itself is not visible in this figure. For some applications, a balloon 42 is inflated within frame 38, in order to expand the frame. For some applications, balloon 42 is built into delivery device 24. Alternatively or additionally, a separate balloon and / or a different mechanical radial-expansion element is used to radially expand frame 38. The radial expansion of frame 38, typically expands hole 26. It is noted that, for some applications, the frame and the two sets 34A, 34B of anchors 36 are formed as a single unitary structure, for example, as shown in Figs. 4A-B and in Figs. 5A-D.

[0166] Subsequently, distal end 28 of delivery device 24 is retracted from the left ventricle 30 via frame 38, as shown in Fig. IF. For some applications, a membrane 43 (shown in Fig. 3D) is disposed within frame 38 and is configured to form a seal that prevents blood flow via the inside of frame 38. For example, the membrane 43 may be a self-sealing membrane as is described in further detail hereinbelow. Typically, with the frame having been radially expanded and the membrane forming a seal that prevents blood flow via the inside of frame, the deployed leaflet-augmentation device 20 effectively increases the area of the valve leaflet.

[0167] For some applications, the leaflet-augmentation device 20 is configured to improve the mechanical function of the atrioventricular valve by effectively increasing the area of the valve leaflet, for example, as described in US 8,758,431 to Orlov, which is incorporated herein by reference. Typically, by effectively increasing the area of the anterior mitral valve leaflet 22, the leaflet-augmentation device 20 enhances coaptation of the anterior and posterior leaflet, thereby reducing or preventing mitral regurgitation. Alternatively or additionally, by effectively increasing the area of the anterior mitral valve leaflet 22, the leaflet-augmentation device 20 treats a subject suffering from hypertrophic obstructive cardiomyopathy. The increase in the effective area of the anterior mitral valve leaflet 22 typically moves the depth at which the anterior and posterior leaflets coapt out of the systolic outflow. Alternatively or additionally, the leaflet-augmentation device 20 is radially expanded such as to straighten the anterior leaflet 22, such as to enhance coaptation of the anterior and posterior leaflet. In this regard, it is noted that the anterior mitral valve leaflet 22 is typically folded and in patients suffering fromfunctional mitral regurgitation, the anterior leaflet 22 is typically even more folded than in healthy subjects. Further alternatively or additionally, the stiffening of the anterior mitral valve leaflet 22 by the deployment of the leaflet-augmentation device 20 therein leads to a posterior shift of chordae attached to leaflet, thereby stretching the chordae and enhancing coaptation of the anterior and posterior leaflets of the mitral valve. For some applications, a plurality of holes are pierced within the valve leaflet and respective leaflet-augmentation devices 20 are placed into the holes, in order to achieve one or more of the above-described effects. Typically, the leaflet-augmentation device 20 is sized and positioned such that the device does not overlap with any secondary chords of the valve.

[0168] For some applications, frame 38 is initially radially expanded to a first diameter (e.g., by inflating a balloon within the frame, as described hereinabove). The efficacy of the leafletaugmentation device 20 with the frame 38 having been radially expanded to the first diameter is then measured. For example, the amount of mitral regurgitation subsequent to the deployment of the leaflet-augmentation device 20 and the radial expansion of frame 38 to the first diameter may be measured (e.g., using Doppler echocardiography). For some applications, the determined amount of mitral regurgitation is compared to a baseline amount of mitral regurgitation that was measured prior to the deployment of the leaflet-augmentation device 20. For some applications, in response to determining that there is some mitral regurgitation or that there has not been a great enough improvement in the mitral regurgitation as a result of the deployment of the leaflet-augmentation device 20, the frame 38 is further radially expanded to a second diameter that is greater than the first diameter.

[0169] Typically, the above-described procedure of incrementally radially expanding frame 38 and measuring the amount of mitral regurgitation subsequent to the radial expansion of frame 38 is repeated in an iterative manner, until a desired reduction in mitral regurgitation has been achieved, and / or until there is no mitral regurgitation. Typically, during the iterative repetition of the above-described steps, the delivery device 24 remains within the left atrium, such that it can be reinserted via the membrane 43 in the event that further radial expansion of the frame 38 by the balloon is required.

[0170] Typically, by deploying the anchors 36 prior to radially expanding the frame 38, the anchors 36 hold onto a greater volume of tissue than if the anchors 36 are only deployed after the frame 38 has been radially expanded. This is because if the frame 38 is first radially expanded the radial expansion of the frame 38 stretches the tissue surrounding the hole 26, causing it to become thinner. Thus, by deploying the anchors 36 prior to radially expandingthe frame 38, the anchors 36 typically anchor the frame 38 within the valve leaflet with greater strength than if the anchors 36 are only deployed after the frame 38 has been radially expanded, ceteris paribus.

[0171] Reference is now made to Figs. 2A, 2B, 2C, and 2D, which are schematic illustrations of respective steps of the deployment of leaflet-augmentation device 20 from delivery device 24, in accordance with some applications of the present disclosure. Figs. 2A-D show steps of the deployment of the leaflet-augmentation device 20 in the absence of any anatomy, for illustrative purposes.

[0172] As described hereinabove, typically, delivery device 24 houses the leaflet-augmentation device 20 within a leaflet-augmentation device housing portion 32, which is disposed proximally to distal end 28 of the delivery device 24. Typically, the leaflet-augmentation device 20 is maintained in a radially constrained (i.e., crimped) configuration within leafletaugmentation device housing portion 32 during delivery of the leaflet-augmentation device 20 to hole 26. As described hereinabove, when the leaflet-augmentation device housing portion 32 is positioned within the hole 26, the first set 34A of anchors 36 are released from the leafletaugmentation device housing portion 32. For some applications an overtube 40 of the delivery device 24 holds the anchors 36 in radially constrained configurations within the delivery device 24. As shown in the transition from Fig. 2A to Fig. 2B, in some embodiments, the first set 34A of anchors 36 are released from their radially-constrained configurations to their expanded configurations by retracting overtube 40. Typically, the first set 34A of anchors 36 are shape set such as to assume their expanded configurations upon being released from within the overtube 40, as is described in further detail hereinbelow.

[0173] As described hereinabove, in a subsequent step, second set 34B of anchors 36 are released from leaflet-augmentation device housing portion 32. As shown in the transition from Fig. 2B to Fig. 2C, in some embodiments, the second set 34B of anchors 36 are released from their radially-constrained configurations to their expanded configurations by further retracting overtube 40. Typically, the second set 34B of anchors 36 are shape set such as to assume their expanded configurations upon being released from within the overtube 40, as is described in further detail hereinbelow.

[0174] Subsequently to both sets 34A, 34B of anchors 36 having been released (such that tissue of the valve leaflet between is firmly held between the tips of the anchors 36 belonging to the respective sets 34A, 34B of anchors 36), frame 38 of the leaflet-augmentation device 20 is radially expanded in order to radially expand hole 26 within the valve leaflet, as describedhereinabove. For some applications, balloon 42 is disposed within frame 38 in a deflated state (as shown in Fig. 2C), during delivery of the frame to the hole in the valve leaflet. Once both sets 34A, 34B of anchors 36 have been released (such that tissue of the valve leaflet between is firmly held between the tips of the anchors 36 belonging to the respective sets 34A, 34B of anchors 36), balloon 42 is inflated within frame 38, in order to expand the frame 38. The radial expansion of frame 38, typically expands the hole 26 in the valve leaflet, as described hereinabove. For some applications, balloon 42 is built into delivery device 24. Typically, for such applications, the balloon 42 is disposed within delivery device 24 such that an axial center of the balloon 42 is disposed at an axial distance of more than 1 cm (e.g., more than 1.5 cm) and / or less than 4 cm (e.g., less than 3.5 cm), for example, 1-4 cm or 1.5-3.5 cm, from the tip of the delivery device 24. Alternatively or additionally, a separate balloon and / or a different mechanical radial-expansion element is used to radially expand frame 38.

[0175] Reference is now made to Figs. 3A, 3B, 3C, and 3D, which are schematic illustrations of respective steps of the deployment of leaflet-augmentation device 20, in accordance with some applications of the present disclosure. Figs. 3A-D show steps of the deployment of the leaflet-augmentation device 20 in the absence of any anatomy or delivery device 24, for illustrative purposes.

[0176] Fig. 3A shows leaflet-augmentation device 20 in its radially-constrained configuration (i.e., the configuration in which the leaflet-augmentation device is typically maintained during delivery of the leaflet-augmentation device 20 to the hole 26 in the valve leaflet). Typically, in this configuration, the diameter of frame 38 is at its minimum. In addition, first and second sets 34A and 34B of anchors 36 are straightened such that tips 44 of the anchors 36 of the respective sets 34A, 34B of anchors 36 are at opposite ends of the device 20. For some applications, in its radially-constrained configuration, the leaflet-augmentation device 20 has an outer diameter of less than 4 mm.

[0177] Fig. 3B shows leaflet-augmentation device 20 once the first set 34A of anchors 36 has been released. Typically, in this state, the anchors 36 extend radially outwardly from frame 38 and invert such that their tips 44 curve back toward the longitudinal center of the leafletaugmentation device 20.

[0178] Fig. 3C shows leaflet-augmentation device 20 once the second set 34B of anchors 36 has been released. Typically, in this state, the second set 34B of anchors 36 extend radially outwardly from frame 38 and invert such that their tips 44 curve back toward the longitudinal center of the leaflet-augmentation device 20.Typically, the anchors 36 include a shape-memory alloy, for example a nickel -titanium alloy, such as nitinol. Typically, the anchors 36 are shape-set in their expanded configurations and the shape-memory alloy is configured such that its austenite finish temperature (i.e., the temperature at which the shape-memory alloy completes its transformation from the martensite to the austenite phase upon heating, thereby allowing the material to recover the original shape to which it was shape set) is below the typical temperature of the subject’s blood. Thus, typically, the anchors 36 are elastic at typical blood temperature (i.e., at 37 C). For example, the shape-memory alloy may be configured to have an austenite finish temperature of less than 25 C, or less than 20 C. Thus, when the anchors 36 are released from overtube 40 (shown in Figs. 2A-D) within the subject’s heart, the anchors 36 are configured to automatically assume the expanded configuration to which they were shape set.

[0179] Typically, in their expanded configurations, the anchors 36 are configured such that each of the anchors 36 belonging to the first and second sets 34A, 34B of anchors 36 span a radial distance from the outside of frame 38 of more than 1 mm (e.g., more than 2 mm) and / or less than 5 mm (e.g., less than 4 mm), for example, 1-5 mm, or 2-4 mm. Once both sets 34A, 34B of anchors 36 have assumed their expanded configurations (and there is no tissue trapped between the tips), tips 44 of the first and second sets 34A, 34B of anchors 36 are configured such that the tips 44 of anchors 36 belonging to the respective sets 34A, 34B of anchors 36 overlap with each other, and / or the tips 44 of anchors 36 belonging to the respective sets 34A, 34B of anchors 36 touch each other, and / or an axial gap between the tips 44 of anchors 36 belonging to the respective sets 34A, 34B of anchors 36 is less than 3 mm, e.g., less than 2 mm.

[0180] Fig. 3D shows the leaflet-augmentation device 20 after frame 38 has been radially expanded and delivery device 24 has been retracted via frame 38. As described hereinabove, for some applications, membrane 43 is disposed within frame 38 and is configured to form a seal that prevents blood flow via the inside of frame 38 (i.e., the membrane is typically non-porous with respect to blood). For example, the membrane 43 may be a self-sealing membrane. Typically, the membrane 43 is made of an elastomeric material. For some applications, the membrane 43 includes a polymer such as polyurethane, silicone, and / or polytetrafluoroethylene. As described hereinabove, typically, the frame 38 is radially expanded by expanding a balloon (e.g., balloon 42) inside the frame 38. Typically, subsequent to the balloon 42 being deflated and retracted from within the frame 38, the membrane 43 self-seals. Further typically, the membrane 43 is configured to facilitate reinsertion of the distal end 28 of the delivery device 24 and the balloon 42 through the membrane 43 (for example, in the eventthat it is necessary to expand the frame 38 to a greater diameter after detecting that regurgitation via the valve has not been sufficiently reduced).

[0181] For some applications, the membrane 43 additionally forms a skirt which covers a portion of frame 38, to thereby form a seal between the frame 38 and the tissue of the valve leaflet that surrounds hole 26. For example, as shown, the membrane 43 may form a distal skirt 46 which forms a seal between a distal portion of the frame 38 (i.e., the portion of the frame 38 from which the first set 34A of anchors 36 extend) and the tissue of the valve leaflet that surrounds hole 26 and a proximal skirt 48, which forms a seal between a proximal portion of the frame 38 (i.e., the portion of the frame 38 from which the second set 34B of anchors 36 extend) and the tissue of the valve leaflet that surrounds hole 26. Alternatively, or additionally proximal skirt 48 and / or distal skirt 46 are formed of a different material from that of membrane 43. For some applications, a skirt is disposed between the first and second sets 34A, 34B of anchors 36, as shown in Figs. 5A-C.

[0182] As described hereinabove, in some embodiments, frame 38 is incrementally radially expanded and the amount of mitral regurgitation subsequent to each radial expansion of frame 38 is measured. For some applications, this process is repeated in an iterative manner, until a desired reduction in mitral regurgitation has been achieved, and / or until there is no mitral regurgitation. In some applications, in order to allow the incremental expansion of frame 38, the frame 38 is plastic at typical blood temperature (i.e., at 37 C). Typically, for such applications, frame 38 and sets 34A and 34B of anchors 36 are formed separately and are coupled to each other (e.g., by welding and / or stitching), such that the frame 38 is plastic and the anchors 36 are elastic at typical blood temperature. For example, the frame 38 may be made of a different material from that of the anchors 36, the different material being radially expandable. For example, the frame 38 may be made of a metal such as titanium and / or an alloy, such as cobalt-chrome. For some applications, the frame 38 is also made of a shapememory alloy, for example, a nickel -titanium alloy, such as nitinol. For some such applications, the frame 38 is made of the same shape-memory alloy as the anchors 36, however the portion of the shape-memory alloy that defines the frame 38 is configured such that its austenite finish temperature is above the typical temperature of the subject’s blood. For example, the shapememory alloy may be configured to have an austenite finish temperature of more than 50 C, or more than 60 C. Thus, when the frame 38 is released within the subject’s heart and the frame 38 is radially expanded, the frame 38 is in a plastic state. For some applications, the frame 38 is configured to be expanded up to a maximum outer diameter of more than 5 mm (e.g., morethan 8 mm), and / or less than 20 mm (e.g., less than 15 mm or less than 12 mm), for example, 5-20 mm, 8-15 mm, or 8-12 mm.

[0183] Reference is now made to Figs. 4A and 4B, which are schematic illustrations of leafletaugmentation device 20 or portions thereof, in accordance with some applications of the present disclosure. Both Figs. 4A and 4B show frame 38 and sets 34A and 34B of anchors 36 in their radially expanded states. Fig. 4A shows frame 38 and sets 34A and 34B of anchors 36 in the absence of membrane 43 and skirts 46 and 48, for illustrative purposes. As described in the above paragraph, in some applications frame 38 and sets 34A and 34B of anchors 36 are formed separately and are coupled to each other (e.g., by welding and / or stitching), such that the frame 38 is plastic and the anchors 36 are elastic at typical blood temperature. Alternatively, frame 38 and sets 34A and 34B of anchors 36 are formed from a unitary structure (for example, frame 38 and sets 34A and 34B of anchors 36 may be cut (e.g., laser cut) from a single tube of metal or alloy), as shown in Fig. 4A and 4B. Typically, for such applications both frame 38 and sets 34A and 34B of anchors 36 are configured to be elastic at typical blood temperature (i.e., at 37 C).

[0184] Typically, in such applications, frame 38 and sets 34A and 34B of anchors 36 are made of a shape-memory alloy, for example a nickel -titanium alloy, such as nitinol. Typically, the frame 38 is shape set such that cells of the frame 38 are arranged to define a generally expanded cylindrical shape and the anchors 36 are shape-set to radially expand from the frame 38 in their expanded configurations, as shown in Figs. 4A-B.

[0185] For some such applications, the shape-memory alloy from which frame 38 and sets 34A and 34B of anchors 36 are made is configured such that its austenite finish temperature (i.e., the temperature at which the shape-memory alloy completes its transformation from the martensite to the austenite phase upon heating, thereby allowing the material to recover the original shape to which it was shape set) is below the typical temperature of the subject’s blood. Thus, frame 38 and sets 34A and 34B of anchors 36 are elastic at typical blood temperature (i.e., at 37 C). For example, the shape-memory alloy may be configured to have an austenite finish temperature of less than 25 C, or less than 20 C.

[0186] In such applications, when the anchors 36 are released from overtube 40 (shown in Figs.

[0187] 2A-D) within the subject’s heart, the anchors 36 are configured to automatically assume the expanded configuration to which they were shape set, as described hereinabove.For some such applications, the frame 38 is shape set to have an outer diameter of more than 5 mm (e.g., more than 8 mm), and / or less than 20 mm (e.g., less than 15 mm or less than 12 mm), for example, 5-20 mm, 8-15 mm, or 8-12 mm, and the frame 38 is configured to be elastic at typical blood temperature. In some embodiments, even though the frame 38 has been shape set to radially expand, when the frame 38 is released within hole 26, the frame requires mechanical expansion (e.g., by balloon 42, a different balloon, and / or a different mechanical radial expansion element) in order to radially expand against the mechanical forces that the surrounding tissue of the valve leaflet exerts on the frame 38. In this regard it is noted that, in many patients, the valve tissue is highly calcified and stiff, such that the frame 38 is unable to self-expand against the tissue. Typically, once the frame 38 has been radially expanded to a given diameter (e.g., by balloon 42, a different balloon, and / or a different mechanical radial expansion element), the frame 38 is able to maintain its radially expanded configuration after having been radially expanded within the tissue of the valve leaflet (i.e., even after the element that was used to expand the frame 38 has been removed). For some such applications, frame 38 is incrementally radially expanded and the amount of mitral regurgitation subsequent to each radial expansion of frame 38 is measured, as described hereinabove.

[0188] Reference is now made to Figs 5A, 5B, 5C, and 5D, which are schematic illustrations of leaflet-augmentation device 20 or portions thereof, in accordance with some additional applications of the present disclosure. Fig. 5 A shows an exploded view of first and second sets 34A, 34B of anchors 36, a skirt 49, and membrane 43, the membrane including three layers 43A, 43B, and 43C. Fig. 5B shows a partially exploded view of portions of the leafletaugmentation device 20, in which skirt 49 is disposed between first and second sets 34A, 34B of anchors 36, but the three layers 43A, 43B, and 43C of membrane 43 are shown separated from the skirt 49 and first and second sets 34A, 34B of anchors 36. Figs. 5C and 5D show respective views of skirt 49 and three layers 43 A, 43B, and 43 C of membrane 43 in their assembled states with respect to first and second sets 34A, 34B of anchors 36.

[0189] As is described hereinabove with reference to Fig. 4A-B, frame 38 and sets 34A and 34B of anchors 36 as shown in Figs. 5A-E are formed from a unitary structure (for example, frame 38 and sets 34A and 34B of anchors 36 may be cut (e.g., laser cut) from a single tube of metal or alloy). The structure of frame 38 as shown in Figs. 5A-E differs from that shown in Figs. 4A-B in that the frame 38 as shown in Figs. 4A-B extends axially above and below sets 34A and 34B of anchors 36, whereas in Figs. 5A-E the frame is continuous with sets 34A and 34B of anchors 36 (i.e., the frame does not bifurcate from the first and second sets of anchors,but rather the frame comprises a central portion of the unitary structure which curves in respective directions to define the first and second sets of anchors).

[0190] Typically, for applications such as that shown in Figs. 5A-E, both frame 38 and sets 34A and 34B of anchors 36 are configured to be elastic at typical blood temperature (i.e., at 37 C). Typically, in such applications, frame 38 and sets 34A and 34B of anchors 36 are made of a shape-memory alloy, for example a nickel -titanium alloy, such as nitinol. Typically, the frame 38 is shape set such that cells of the frame 38 are arranged to define a generally expanded cylindrical shape and the anchors 36 are shape-set to radially expand from the frame 38 in their expanded configurations as shown in Figs. 5A-E.

[0191] For some such applications, the shape-memory alloy from which frame 38 and sets 34A and 34B of anchors 36 are made is configured such that its austenite finish temperature (i.e., the temperature at which the shape-memory alloy completes its transformation from the martensite to the austenite phase upon heating, thereby allowing the material to recover the original shape to which it was shape set) is below the typical temperature of the subject’s blood. Thus, frame 38 and sets 34A and 34B of anchors 36 are elastic at typical blood temperature (i.e., at 37 C). For example, the shape-memory alloy may be configured to have an austenite finish temperature of less than 25 C, or less than 20 C.

[0192] In such applications, when the anchors 36 are released from overtube 40 (shown in Figs.

[0193] 2A-D) within the subject’s heart, the anchors 36 are configured to automatically assume the expanded configuration to which they were shape set, as described hereinabove.

[0194] For some such applications, the frame 38 is shape set to have an outer diameter of more than 5 mm (e.g., more than 8 mm), and / or less than 20 mm (e.g., less than 15 mm or less than 12 mm), for example, 5-20 mm, 8-15 mm, or 8-12 mm, and the frame 38 is configured to be elastic at typical blood temperature. In some embodiments, even though the frame 38 has been shape set to radially expand, when the frame 38 is released within hole 26, the frame 38 requires mechanical expansion (e.g., by balloon 42, a different balloon, and / or a different mechanical radial expansion element) in order to radially expand against the mechanical forces that the surrounding tissue of the valve leaflet exerts on the frame 38. In this regard it is noted that, in many patients, the valve tissue is highly calcified and stiff, such that the frame 38 is unable to self-expand against the tissue. Typically, once the frame 38 has been radially expanded to a given diameter (e.g., by balloon 42, a different balloon, and / or a different mechanical radial expansion element), the frame 38 is able to maintain its radially expanded configuration after having been radially expanded within the tissue of the valve leaflet (i.e., even after the elementthat was used to expand the frame has been removed). For some such applications, frame 38 is incrementally radially expanded and the amount of mitral regurgitation subsequent to each radial expansion of frame 38 is measured, as described hereinabove.

[0195] Typically, skirt 49 is disc shaped. For some applications, the skirt has an inner diameter of more than 5 mm (e.g., more than 8 mm) and / or less than 15 mm (e.g., less than 12 mm), for example, 5-15 mm, or 8-12 mm. That is to say that the hole defined by the disc typically has a diameter of more than 5 mm (e.g., more than 8 mm) and / or less than 15 mm (e.g., less than 12 mm), for example, 5-15 mm, or 8-12 mm. Typically, the gap between the inner and outer diameter of the skirt (i.e., the annular width of the disc) is more than 1 mm (e.g., more than 2 mm) and / or less than 5 mm (e.g., less than 4 m), for example, 1-5 mm, or 2-4 mm.

[0196] For some applications, the membrane 43 includes a plurality of layers. In the example shown, the membrane includes 3 layers; layers 43 A, 43B, and 43C. However, the scope of the present disclosure includes the use of a different number of layers, for example, more than two and / or fewer than five (e.g., two to five) layers. Typically, the layers of the membrane 43 have the same outer diameter as the skirt 49 and the layers of the membrane 43 are coupled (e.g., laminated) to each other and to the skirt 49 within the annular width of the skirt 49, but the layers of the membrane 43 are not coupled to each other within the region of the hole defined by the skirt 49. As shown in Figs. 5C and 5D, around an outer ring 54 of membrane 43 (which largely corresponds to the annular width of the skirt), the layers of the membrane are coupled (e.g., laminated) to each other and the skirt. Thus, within the region of the hole defined by the skirt 49 the layers of the membrane 43 are able to move with respect to each other and with respect to the skirt 49, whereas within the annular width of the skirt 49 the layers of the membrane 43 are sealed with respect to each other and with respect to the skirt 49.

[0197] For some applications, skirt 49 is disposed between the first and second sets 34A and 34B of anchors 36. For some such applications, outer ring 54 of membrane 43 is disposed on the other side of one of the sets 34A, 34B of anchors 36. In the example shown in Figs. 5C and 5D, skirt 49 is disposed above set 34A of anchors 36 and outer ring 54 of membrane 43 is disposed below set 34A of anchors 36. As described hereinabove, around outer ring 54 of membrane 43 (which largely corresponds to the annular width of the skirt 49), the layers of the membrane 43 are coupled (e.g., laminated) to each other and the skirt. In this manner, the membrane 43 becomes sealed with respect to the frame 38. In addition, since the anchors 36 press against the tissue surrounding the hole 26 in the leaflet, the membrane 43 is sealingly coupled to the tissue surrounding the hole 26 in the leaflet.Typically, each of the layers of the membrane 43 defines a slit 50A, 50B, 50C therethrough. For example, as shown, layer 43A defines slit 50A, layer 43B defines slit 50B, and layer 43C defines slit 50C. Typically, the layers are arranged with respect to each other, such that the slits 50A, 50B, 50C are angularly misaligned with respect to each other and do not overlap with each other (i.e., each of the slits 50A, 50B, 50C doesn’t cross with any of the other slits 50A, 50B, 50C). For some applications, each of the slits 50A, 50B, 50C has a length of more than 4 mm (e.g., more than 6 mm) and / or less than 20 mm (e.g., less than 12 mm), e.g., 4-10 mm, or 6-12 mm. For some applications, the layers of the membrane 43 are arranged such that the slits 50A, 50B, 50C are approximately at a maximum angular misalignment with respect to each other. For example, as shown in Figs. 5A and 5B, the three slits 50A, 50B, 50C are arranged to be at approximately 120-degree angular misalignment with respect to each other. Thus, assuming that the membrane includes three layers (as shown), when the leafletaugmentation device 20 is in its deployed configuration, at any location within the area defined by the membrane 43 there are at least two layers of material blocking blood flow, since wherever one of the layers defines a slit 50A, 50B, 50C, the other two layers are unperforated. Similarly, assuming that the membrane 43 includes two layers, when the leaflet-augmentation device is in its deployed configuration, at any location within the area defined by the membrane 43 there is at least one layer of material blocking blood flow, since wherever one of the layers defines a slit 50A, 50B, 50C, the other layer is unperforated.

[0198] Typically, during delivery of the device 20, frame 38 is disposed on the delivery device 24 over balloon 42 (as shown in Fig. 2C). Typically, a device such as the balloon (and / or the portion of the delivery device 24 disposed inside the balloon and / or a guidewire that is used to guide the delivery device 24) is inserted through the membrane 43 by being advanced through the slits 50A, 50B, 50C in each of the layers of the membrane 43. Typically, the membrane 43 is sufficiently elastic that even after the slits 50A, 50B, 50C are stretched by virtue of the delivery device 24 being disposed inside the slits 50A, 50B, 50C, the slits 50A, 50B, 50C return to their original sizes after the delivery device 24 is retracted from within the membrane 43. For example, the layers of the membrane 43 may include a polymer such as polyurethane, silicone, and / or polytetrafluoroethylene.

[0199] Reference is now made to Figs. 6A, 6B, and 6C, which are schematic illustrations of delivery device 24 for delivering leaflet-augmentation device 20, the delivery device 24 being steerable, in accordance with some applications of the present disclosure. As described hereinabove, for example with reference to Figs. 1A-F, for some applications, the leaflet-augmentation device 20 is delivered via a transeptal route (i.e., via the vena cava, the right atrium, and the interatrial septum).

[0200] Referring first to Fig. 6A, for some applications, the distal end of the delivery device is steerable within a first plane such as to form a distal curved portion 60 between the distal tip 62 of the delivery device and a straight portion 64 of the delivery device, which is proximal to distal curved portion 60. For some applications, the distal end of the delivery device is steerable such that an angle alpha (a) between the distal tip 62 of the delivery device and straight portion 64 of the delivery device is less than 30 degrees (e.g., more than 20 degrees). Typically, the distal end of the delivery device is steered such as to form angle alpha (a) between the distal tip 62 of the delivery device and straight portion 64 of the delivery device subsequent to distal curved portion 60 having been advanced through the interatrial septum. Typically by forming angle alpha (a) between the distal tip 62 of the delivery device and straight portion 64 of the delivery device, the distal tip of the delivery device 24 is steered inferiorly toward the anterior mitral valve leaflet.

[0201] Referring now to Fig. 6B, for some applications, a distal portion of the delivery device is further steerable within the first plane such as to form a proximal curved portion 66 between straight portion 64 of the delivery device and a proximal straight portion 68 of the delivery device, which is proximal to proximal straight portion 68. Typically, the proximal curved portion 66 curves in the same plane as distal curved portion 60, but the proximal curved portion 66 curves in the opposite direction to distal curved portion 60. For some applications, the distal portion of the delivery device is further steerable such that an angle beta (P) between straight portion 64 of the delivery device and proximal straight portion 68 of the delivery device is more than 10 degrees (e.g., more than 20 degrees) and / or less than 50 degrees (e.g., less than 40 degrees), e.g., 10-50 degrees, or 20-40 degrees. Typically, the distal portion of the delivery device is steered such as to form angle beta (P) between straight portion 64 of the delivery device and proximal straight portion 68 of the delivery device subsequent to proximal curved portion 66 having been advanced through the interatrial septum. Typically, by forming angle beta (P) between straight portion 64 of the delivery device and proximal straight portion 68 of the delivery device, the delivery device is steered superiorly toward the roof of the left atrium to thereby provide maneuverability to steer the distal end of the delivery device inferiorly and anteriorly toward the anterior mitral valve leaflet. Typically, the distal portion of the delivery device is first steered such as to form angle beta (P) between straight portion 64 of the delivery device and proximal straight portion 68 of the delivery device to thereby providemaneuverability to steer the distal end of the delivery device inferiorly toward the anterior mitral valve leaflet (as shown in Fig. 6B), and only subsequently thereto is the distal end of the delivery device is steered such as to form angle alpha (a) between the distal tip 62 of the delivery device and straight portion 64 of the delivery device (as shown in Fig. 6A).

[0202] Referring now to Fig. 6C, for some applications, the distal end of the delivery device is steerable within a second plane such as to form a transverse distal curved portion 70 between the distal tip 62 of the delivery device and a straight portion 72 of the delivery device, which is proximal to distal curved portion 70. Typically, the second plane is perpendicular to the first plane and the direction of the curvature of transverse distal curved portion 70 is transverse to the direction of curvature of distal curved portion 60. For some applications, portions of the delivery device which are straight in the first plane are curved within the second plane and vice versa. (In other words, even a portion which is described as being a straight portion with respect to the first plane may be curved within the second plane and vice versa.) For some applications, the distal end of the delivery device is steerable such that an angle theta (9) between the distal tip 62 of the delivery device and straight portion 72 of the delivery device is more than 10 degrees (e.g., more than 15 degrees) and / or less than 40 degrees (e.g., less than 30 degrees), e.g., 10-40 degrees, or 15-30 degrees. Typically, the distal portion of the delivery device is steered such as to form angle theta (9) between the distal tip 62 of the delivery device and straight portion 72 of the delivery device, subsequent to distal curved portion 70 having been advanced through the interatrial septum. Typically, by forming angle theta (9) between the distal tip 62 of the delivery device and straight portion 72 of the delivery device, the delivery device is steered anteriorly toward the anterior mitral valve leaflet.

[0203] As noted hereinabove, although some aspects of the present disclosure are described with reference to implanting the leaflet-augmentation device within an anterior mitral valve leaflet, the scope of the disclosure includes implanting the leaflet-augmentation device within any leaflet of any atrioventricular heart valve, mutatis mutandis. For example, the leafletaugmentation device may be deployed in the posterior mitral valve leaflet and / or a tricuspid valve leaflet (e.g., the anterior, septal and / or posterior leaflet).

[0204] It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present disclosure includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

Claims

CLAIMS1. Apparatus for use with a delivery device and a hole that has been pierced within a leaflet of an atrioventricular valve of a subject, the apparatus comprising:a leaflet-augmentation device configured to be delivered to the hole by the delivery device while being maintained in a radially-constrained configuration by the delivery device, before being deployed within the hole by the delivery device, the leaflet augmentation device comprising:first and second sets of anchors configured to self-expand on respective sides of the valve leaflet upon being released from the delivery device, such that the first and second sets of anchors firmly hold tissue of the valve leaflet that surrounds the hole between tips of anchors belonging to the first and second sets of anchors;a frame configured to be radially expandable within the hole, to thereby radially expand the hole; anda membrane disposed within the frame, the membrane being non-porous with respect to blood and configured to prevent blood flow via the inside of the frame, and the membrane being self-sealing, such as to facilitate retraction of a distal end of the delivery device via the membrane.

2. The apparatus according to claim 1, wherein the first and second set of anchors are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors overlap with each other.

3. The apparatus according to claim 1 or 2, wherein the first and second set of anchors are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors touch each other.

4. The apparatus according to any one of claims 1-3, wherein the first and second set of anchors are configured to self-expand such that in non-constrained configurations, an axial gap between the tips of anchors belonging to respective sets of anchors is less than 3 mm.

5. The apparatus according to any one of claims 1-4, wherein the first and second set of anchors are configured to self-expand such that each of the anchors belonging to the first and second sets of anchors spans a radial distance from outside the frame of more than 1 mm.

6. The apparatus according to any one of claims 1-5, wherein the frame is configured to be incrementally expandable to a plurality of diameters of increasing magnitude.

7. The apparatus according to any one of claims 1-6, wherein the frame is configured to be radially expandable to a maximum outer diameter of more than 5 mm.

8. The apparatus according to any one of claims 1-7, wherein the frame is configured to be radially expandable to a maximum outer diameter of less than 20 mm.

9. The apparatus according to any one of claims 1-8, wherein the apparatus is configured for use with a balloon, wherein the frame is configured to be radially expanded by the balloon being expanded within the frame and wherein the membrane is self-sealing, such as to form a seal after the balloon is deflated and retracted from inside the frame.

10. The apparatus according to any one of claims 1-9, wherein the first and second sets of anchors are configured to be elastic at 37 C and the frame is configured to be plastic at 37 C.

11. The apparatus according to any one of claims 1-10, wherein the first and second set of anchors are welded to the frame.

12. The apparatus according to any one of claims 1-10, wherein the first and second set of anchors are stitched to the frame.

13. The apparatus according to any one of claims 1-12, wherein the first and second set of anchors are made of a different material from that of the frame.

14. The apparatus according to any one of claims 1-12, wherein the first and second set of anchors are made of a shape-memory alloy configured to have an austenite finish temperature of less than 25 C and wherein the frame is made of the same shape-memory alloy configured to have an austenite finish temperature of more than 50 C.

15. The apparatus according to any one of claims 1-9, wherein the first and second sets of anchors and the frame are formed from a unitary structure and are configured to be elastic at 37 C.

16. The apparatus according to claim 15, wherein the frame is continuous with the first and second sets of anchors.

17. The apparatus according to claim 15 or claim 16, wherein the first and second sets of anchors and the frame are cut from a single tube of a shape-memory alloy, which is configured to have an austenite finish temperature of less than 25 C.

18. The apparatus according to any one of claims 15-17, wherein the frame requires mechanical expansion in order to radially expand against mechanical forces that surrounding tissue of the valve leaflet exerts on the frame, and the frame is configured to maintain its radiallyexpanded configuration after having been radially expanded within the tissue of the valve leaflet.

19. The apparatus according to any one of claims 1-18, wherein the membrane comprises a plurality of layers, each of the layers defining a respective slit therethrough, the layers being arranged with respect to each other such that the respective slits are angularly misaligned from each other and each of the slits does not overlap with any others of the slits.

20. The apparatus according to claim 19, wherein each of the slits does not cross any others of the slits.

21. The apparatus according to claim 19 or 20, wherein the membrane comprises at least three layers.

22. The apparatus according to any one of claims 19-21, wherein a length of each of the slits is 4-20 mm.

23. The apparatus according to any one of claims 19-22, wherein the membrane is elastic and is configured to facilitate insertion of a device through the membrane by the medical device being inserted through the slits and stretching the slits.

24. The apparatus according to claim 23, wherein the membrane is configured such that the slits return to their original sizes after the device is retracted from being inserted through the slits.

25. Apparatus for use with a hole that has been pierced within a leaflet of an atrioventricular valve of a subject, the apparatus comprising:a leaflet-augmentation device configured to be deployed within the hole, the leaflet augmentation device comprising a frame, a membrane disposed within the frame, and first and second set of anchors; anda delivery device configured to:deliver the leaflet-augmentation device to the hole, while maintaining the leafletaugmentation device in a radially-constrained configuration within the delivery device;release first and second sets of anchors of the leaflet-augmentation device on respective sides of the valve leaflet, such that the first and second sets of anchors radially expand and firmly hold tissue of the valve leaflet that surrounds the hole between tips of anchors belonging to the first and second sets of anchors;subsequently thereto, radially expand the frame of the leaflet-augmentation device, to thereby radially expand the hole; andsubsequently thereto, facilitate retraction of a distal end of the delivery device via the membrane, the membrane being configured to become sealed once the distal end of the delivery device has been retracted via the membrane, such as to prevent blood flow via the inside of the frame.

26. The apparatus according to claim 25, wherein the first and second set of anchors are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors overlap with each other.

27. The apparatus according to claim 25 or 26, wherein the first and second set of anchors are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors touch each other.

28. The apparatus according to any one of claims 25-27, wherein the first and second set of anchors are configured to self-expand such that in non-constrained configurations, an axial gap between the tips of anchors belonging to respective sets of anchors is less than 3 mm.

29. The apparatus according to any one of claims 25-28, wherein the first and second set of anchors are configured to self-expand such that each of the anchors belonging to the first and second sets of anchors spans a radial distance from outside the frame of more than 1 mm.

30. The apparatus according to any one of claims 25-29, wherein the delivery device is configured to radially expand the frame to a maximum outer diameter of more than 5 mm.

31. The apparatus according to any one of claims 25-30, wherein the delivery device is configured to radially expand the frame to a maximum outer diameter of less than 20 mm.

32. The apparatus according to any one of claims 25-31, wherein the apparatus is configured for use with a balloon, wherein the delivery device is configured to radially expand the frame by radially expanding the balloon within the frame, and wherein the membrane is configured to become sealed after the balloon is deflated and retracted from inside the frame.

33. The apparatus according to any one of claims 25-32, wherein the first and second sets of anchors are configured to be elastic at 37 C and the frame is configured to be plastic at 37 C.

34. The apparatus according to any one of claims 25-33, wherein the first and second set of anchors are welded to the frame.

35. The apparatus according to any one of claims 25-33, wherein the first and second set of anchors are stitched to the frame.

36. The apparatus according to any one of claims 25-35, wherein the first and second set of anchors are made of a different material from that of the frame.

37. The apparatus according to any one of claims25-35, wherein the first and second set of anchors are made of a shape-memory alloy configured to have an austenite finish temperature of less than 25 C and wherein the frame is made of the same shape-memory alloy configured to have an austenite finish temperature of more than 50 C.

38. The apparatus according to any one of claims 25-32, wherein the first and second sets of anchors and the frame are formed from a unitary structure and are configured to be elastic at 37 C.

39. The apparatus according to claim 38, wherein the frame is continuous with the first and second sets of anchors.

40. The apparatus according to claim 38 or claim 39, wherein the first and second sets of anchors and the frame are cut from a single tube of a shape-memory alloy, which is configured to have an austenite finish temperature of less than 25 C.

41. The apparatus according to any one of claims 25-40, wherein the frame requires mechanical expansion in order to radially expand against mechanical forces that surrounding tissue of the valve leaflet exerts on the frame, and the frame is configured to maintain its radially expanded configuration after having been radially expanded within the tissue of the valve leaflet.

42. The apparatus according to any one of claims 25-41, wherein the delivery device is configured to radially expand the frame incrementally to a plurality of diameters of increasing magnitude.

43. The apparatus according to claim 42, wherein the delivery device is configured to:(a) radially expand the frame, to thereby radially expand the hole to a first diameter and maintain the hole at the first diameter for a period of time such as to facilitate measurement of regurgitation via the atrioventricular valve; and(b) further radially expand the frame, to thereby radially expand the hole to a second diameter that is greater than the first diameter and maintain the hole at the second diameter fora period of time such as to facilitate measurement of regurgitation via the atrioventricular valve; andperform steps (a) and (b) iteratively until regurgitation via the atrioventricular valve has been reduced to a desired level.

44. The apparatus according to any one of claims 25-43, wherein the membrane comprises a plurality of layers, each of the layers defining a respective slit therethrough, the layers being arranged with respect to each other such that the respective slits are angularly misaligned from each other and each of the slits does not overlap with any others of the slits.

45. The apparatus according to claim 44, wherein each of the slits does not cross any others of the slits.

46. The apparatus according to claim 44 or 45, wherein the membrane comprises at least three layers.

47. The apparatus according to any one of claims 44-46, wherein a length of each of the slits is 4-20 mm.

48. The apparatus according to any one of claims 44-47, wherein the membrane is elastic and is configured to facilitate insertion of the delivery device through the membrane by the delivery device being inserted through the slits and stretching the slits.

49. The apparatus according to claim 48, wherein the membrane is configured such that the slits return to their original sizes after the delivery device is retracted from being inserted through the slits.

50. Apparatus for use with a hole that has been pierced within a leaflet of an atrioventricular valve of a subject, the apparatus comprising:a leaflet-augmentation device configured to be deployed within the hole, the leaflet augmentation device comprising a frame, a membrane disposed within the frame, and anchors; anda delivery device configured to:deliver the leaflet-augmentation device to the hole, while maintaining the leafletaugmentation device in a radially-constrained configuration within the delivery device;anchor the leaflet-augmentation device to tissue of the leaflet that surround the hole via the anchors;and subsequently thereto:(a) radially expand a frame of the leaflet-augmentation device, to thereby radially expand the hole to a first diameter and maintaining the hole at the first diameter for a period of time such as to facilitate measurement of regurgitation via the atrioventricular valve; and(b) further radially expand the frame of the leaflet-augmentation device, to thereby radially expand the hole to a second diameter that is greater than the first diameter and maintaining the hole at the second diameter for a period of time such as to facilitate measurement of regurgitation via the atrioventricular valve; andperform steps (a) and (b) iteratively until regurgitation via the atrioventricular valve has been reduced to a desired level.

51. The apparatus according to claim 50, wherein the leaflet-augmentation device comprises first and second set of anchors that are configured to self-expand such that in nonconstrained configurations, tips of anchors belonging to respective sets of anchors overlap with each other.

52. The apparatus according to claim 50 or 51, wherein the leaflet-augmentation device comprises first and second set of anchors that are configured to self-expand such that in nonconstrained configurations, tips of anchors belonging to respective sets of anchors touch each other.

53. The apparatus according to any one of claims 50-52, wherein the leaflet-augmentation device comprises first and second set of anchors that are configured to self-expand such that in non-constrained configurations, an axial gap between the tips of anchors belonging to respective sets of anchors is less than 3 mm.

54. The apparatus according to any one of claims 50-53, wherein the leaflet-augmentation device comprises first and second set of anchors that are configured to self-expand such that each of the anchors belonging to the first and second sets of anchors spans a radial distance from outside the frame of more than 1 mm.

55. The apparatus according to any one of claims 50-54, wherein the delivery device is configured to radially expand the frame to a maximum outer diameter of more than 5 mm.

56. The apparatus according to any one of claims 50-55, wherein the delivery device is configured to radially expand the frame to a maximum outer diameter of less than 20 mm.

57. The apparatus according to any one of claims 50-56, wherein the anchors are configured to be elastic at 37 C and the frame is configured to be plastic at 37 C.

58. The apparatus according to any one of claims 50-57, wherein the anchors are welded to the frame.

59. The apparatus according to any one of claims 50-57, wherein the anchors are stitched to the frame.

60. The apparatus according to any one of claims 50-59, wherein the anchors are made of a different material from that of the frame.

61. The apparatus according to any one of claims 50-59, wherein the anchors are made of a shape-memory alloy configured to have an austenite finish temperature of less than 25 C and wherein the frame is made of the same shape-memory alloy configured to have an austenite finish temperature of more than 50 C.

62. The apparatus according to any one of claims 50-56, wherein the anchors and the frame are formed from a single structure and are configured to be elastic at 37 C.

63. The apparatus according to claim 62, wherein the anchors and the frame are cut from a single tube of a shape-memory alloy, which is configured to have an austenite finish temperature of less than 25 C.

64. The apparatus according to claim 62 or claim 63 , wherein the frame requires mechanical expansion in order to radially expand against mechanical forces that surrounding tissue of the valve leaflet exerts on the frame, and the frame is configured to maintain its radially expanded configuration after having been radially expanded within the tissue of the valve leaflet.

65. Apparatus for use with a delivery device and a hole that has been pierced within a leaflet of an atrioventricular valve of a subject, the apparatus comprising:a leaflet-augmentation device configured to be delivered to the hole by the delivery device while being maintained in a radially-constrained configuration by the delivery device, before being deployed within the hole by the delivery device, the leaflet augmentation device comprising:first and second sets of anchors configured to self-expand on respective sides of the valve leaflet upon being released from the delivery device, such that the first and second sets of anchors firmly hold tissue of the valve leaflet that surrounds the hole between tips of anchors belonging to the first and second sets of anchors;a frame configured to be radially expandable within the hole, to thereby radially expand the hole; anda membrane disposed within the frame, the membrane comprising a plurality of layers, each of the layers defining a respective slit therethrough, the layers being arranged with respect to each other such that the respective slits are angularly misaligned from each other and each of the slits does not overlap with any others of the slits.

66. The apparatus according to claim 65, wherein each of the slits does not cross any others of the slits.

67. The apparatus according to claim 65 or 66, wherein the membrane comprises at least three layers.

68. The apparatus according to any one of claims 65-67, wherein a length of each of the slits is 4-20 mm.

69. The apparatus according to any one of claims 65-68, wherein the first and second set of anchors are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors overlap with each other.

70. The apparatus according to any one of claims 65-69, wherein the first and second set of anchors are configured to self-expand such that in non-constrained configurations, tips of anchors belonging to respective sets of anchors touch each other.

71. The apparatus according to any one of claims 65-70, wherein the first and second set of anchors are configured to self-expand such that in non-constrained configurations, an axial gap between the tips of anchors belonging to respective sets of anchors is less than 3 mm.

72. The apparatus according to any one of claims 65-71, wherein the first and second set of anchors are configured to self-expand such that each of the anchors belonging to the first and second sets of anchors spans a radial distance from outside the frame of more than 1 mm.

73. The apparatus according to any one of claims 65-72, wherein the frame is configured to be incrementally expandable to a plurality of diameters of increasing magnitude.

74. The apparatus according to any one of claims 65-73, wherein the frame is configured to be radially expandable to a maximum outer diameter of more than 5 mm.

75. The apparatus according to any one of claims 65-74, wherein the frame is configured to be radially expandable to a maximum outer diameter of less than 20 mm.

76. The apparatus according to any one of claims 65-75, wherein the apparatus is configured for use with a balloon, wherein the frame is configured to be radially expanded by the balloon being expanded within the frame and wherein the membrane is self-sealing, such as to form a seal after the balloon is deflated and retracted from inside the frame.

77. The apparatus according to any one of claims 65-76, wherein the membrane is elastic and is configured to facilitate insertion of a device through the membrane by the medical device being inserted through the slits and stretching the slits.

78. The apparatus according to claim 77, wherein the membrane is configured such that the slits return to their original sizes after the device is retracted from being inserted through the slits.

79. The apparatus according to any one of claims 65-78, wherein the first and second sets of anchors and the frame are formed from a unitary structure and are configured to be elastic at 37 C.

80. The apparatus according to claim 79, wherein the frame is continuous with the first and second sets of anchors.

81. The apparatus according to claim 79 or claim 80, wherein the first and second sets of anchors and the frame are cut from a single tube of a shape-memory alloy, which is configured to have an austenite finish temperature of less than 25 C.

82. The apparatus according to any one of claims 65-81, wherein the frame requires mechanical expansion in order to radially expand against mechanical forces that surrounding tissue of the valve leaflet exerts on the frame, and the frame is configured to maintain its radially expanded configuration after having been radially expanded within the tissue of the valve leaflet.

83. The apparatus according to any one of claims 65-82, wherein the leaflet-augmentation device comprises a skirt disposed between the first and second sets of anchors, wherein around an outer ring of the membrane, the layers of the membrane are coupled to each other and the skirt, such that the membrane is sealed with respect to the frame.

84. The apparatus according to claim 83, wherein:the skirt is disc shaped, the skirt having an inner diameter that defines a hole and an outer diameter;a gap between the inner diameter and the outer diameter defines an annular width of the skirt; andthe annular width of the skirt is 1-5 mm.

85. The apparatus according to claim 84, wherein the hole defined by the inner diameter of the skirt has a diameter of 5-15 mm.

86. The apparatus according to claim 84 or 85, wherein the layers of the membrane are coupled to each other and the skirt such that within a region of the hole defined by the skirt the layers of the membrane are able to move with respect to each other and with respect to the skirt, and within the annular width of the skirt the layers of the membrane are sealed with respect to each other and with respect to the skirt.

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