Heart valve repair device and delivery device therefor

Abstract

The present invention provides an implantable device or implant configured to be positioned inside a natural heart valve so that the natural heart valve can form a more effective seal. [Solution] In some implementations, the implantable device or implant, or one or more parts thereof, can be configured to expand and / or contract. For example, the implantable device or implant can be narrowed upon delivery and expanded upon implantation on a natural heart valve.

Description

Background Art

[0001] Cross - reference to related applications This application claims priority to both U.S. Provisional Patent Application No. 63 / 215,977, filed Jun. 28, 2021, and U.S. Provisional Patent Application No. 63 / 130,364, filed Dec. 23, 2020, the entire contents of which are hereby incorporated by reference for all purposes.

[0002] Natural heart valves (i.e., aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play an important role in ensuring forward flow with respect to adequate blood supply through the cardiovascular system. These heart valves can be damaged, for example, by congenital malformations, inflammatory processes, infectious conditions, diseases, etc., and thus their effectiveness may be reduced. Such damage to the valve can lead to severe cardiovascular disorders or death. A damaged valve can be surgically repaired or replaced during open - heart surgery. However, open - heart surgery is highly invasive and complications can occur. By using transvascular techniques, an artificial device can be introduced and implanted in a much less invasive manner than open - heart surgery. As an example, a transvascular technique that can be used to access the natural mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting the catheter into the right femoral vein, advancing it up the inferior vena cava, and into the right atrium). Then, the septum is punctured and the catheter is passed into the left atrium. By using a similar transvascular technique, an artificial device can be implanted inside the tricuspid valve. In that case, it starts in the same way as the transseptal technique but instead of puncturing the septum, the delivery catheter is guided in the right atrium towards the tricuspid valve.

[0003] A healthy heart has an overall conical shape, tapering towards the apex and base. The heart is a four-chambered structure, containing the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The natural mitral valve in the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure from other natural heart valves. The mitral valve includes an annulus, which is the ring portion of the natural valve tissue surrounding the mitral valve opening, and a pair of leaflets or lobes that extend downward from the annulus into the left ventricle. The mitral annulus can form a "D" shape, an ellipse shape, or other non-circular cross-sectional shape with a long axis and a short axis. Because the anterior leaflet is larger than the posterior leaflet, a roughly "C" shaped boundary can be formed between the abutting free edges of the lobes when they are closed together.

[0004] When functioning correctly, the anterior and posterior leaflets work together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. As the muscles of the left atrium contract and the left ventricle relaxes (also called "ventricular diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. As the muscles of the left atrium relax and the muscles of the left ventricle contract (also called "ventricular systole" or "systole"), the blood pressure in the left ventricle rises, biasing the two valve leaflets to press together laterally. This closes the one-way mitral valve, preventing blood from flowing back into the left atrium, and instead expelling it from the left ventricle through the aortic valve. To prevent the two valve leaflets from dislocating due to pressure or folding back towards the left atrium through the mitral annulus, several fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0005] Valve regurgitation involves a valve improperly allowing some blood to flow through the valve in the wrong direction. For example, mitral regurgitation occurs when the natural mitral valve fails to properly close during systole, allowing blood to flow from the left ventricle into the left atrium. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, including valve leaflet prolapse, papillary muscle dysfunction, stretching of the mitral annulus due to left ventricular dilation, or a combination of these. Mitral regurgitation in the central part of the valve leaflet can be called central jet mitral regurgitation, while mitral regurgitation closer to one of the valve leaflets (i.e., the point where the leaflets meet) can be called eccentric jet mitral regurgitation. Central jet regurgitation occurs when the valve does not close properly because the edges of the valve leaflets do not meet in the middle, resulting in regurgitation. Tricuspid valve regurgitation, while similar, can occur on the right side of the heart. [Overview of the project]

[0006] This abstract is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, no feature included in the examples in this abstract is a requirement of the claims unless the claims expressly enumerate such features. Also, the features, components, steps, concepts, etc., described in this abstract and the examples elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples summarized herein.

[0007] The implantable device or implant (e.g., implantable device, etc.) is configured to be positioned inside a natural heart valve so that the natural heart valve can form a more effective seal.

[0008] In some implementations, the implantable device or implant includes an anchor portion. Each anchor includes multiple paddles, each movable between an open position and an closed position.

[0009] In some implementations, the implantable device or implant includes a spacer, a cap, and an anchor portion. The cap is movable relative to the spacer. Each anchor includes multiple paddle members. The paddle members are configured to move between an open position and a closed position by driving the cap relative to the spacer.

[0010] In some implementations, the implantable device or implant includes an anchor containing a paddle frame. The paddle frame has a thickness greater than its own width. When the anchor is in the occluded position, the paddle frame is in an expanded position with its expanded full width, and when the anchor is in the open position, the paddle frame is in a constricted position with its constricted full width.

[0011] In some implementations, the implantable device or implant includes an anchor with a paddle frame. The paddle frame has a torsioned transition portion. In this case, the torsion causes the paddle frame to be in an expanded position with its extended full width when the anchor is in the closed position. The torsion also causes the paddle frame to be in a constricted position with its narrowed full width when the anchor is in the open position.

[0012] In some implementations, the implantable device or implant includes an anchor containing a paddle frame. The paddle frame has an inner portion and an outer portion. The inner and outer portions of the paddle frame are configured such that driving the anchor to the open position generates tension in the inner portion of the paddle frame, and this tension drives the outer portion of the paddle frame to the constricted position, thereby giving the paddle frame a constricted overall width.

[0013] In some implementations, the implantable device or implant includes an anchor containing a paddle frame. The paddle frame includes a rigid inner portion and a flexible outer portion.

[0014] In some implementations, the implantable device or implant includes an anchor comprising a paddle frame and a cam member, a spacer, and a drive member having the cam member. One or more anchors are configured to be attached to one or more leaflets of a natural heart valve. Each anchor includes an inner paddle and an outer paddle connected to a flexible portion of the spacer. The paddle frame is connected to the connecting portion between the inner and outer paddles. The cam member engages with the flexible portion, generating tension in the paddle frame, which drives the paddle frame from an expanded position to a constricted position.

[0015] In some implementations, the portable device or implant includes an anchor containing a paddle frame. The paddle frame is movable between a folded position and a normal position. A retaining device holds the paddle frame in the folded position. By removing the retaining device, the paddle frame is driven to the normal position.

[0016] In some implementations, the implantable device or implant includes an anchor containing a paddle frame. One or more drive lines are connected to the paddle frame. By applying tension to the drive lines, the paddle frame is driven from an expanded position to a constricted position.

[0017] In some implementations, the implantable device or implant includes an anchor comprising a paddle frame. The paddle frame has at least two arms connected to each other at a distal connection point. One or more drive lines are connected to the paddle frame, and by applying tension to the drive lines, at least two arms of the paddle frame rotate, flex, and / or articulate inward around the distal connection point, thereby driving the paddle frame from an expanded position to a constricted position.

[0018] In some implementations, the implantable device or implant includes an anchor comprising a paddle frame. The paddle frame has at least two arms positioned within a sleeve member. The proximal ends of at least two arms are made movable within the sleeve member, allowing the paddle frame to move between an expanded position and a constricted position.

[0019] In some implementations, the implantable device or implant includes an anchor comprising a paddle frame. The paddle frame has an inner portion and an outer portion. The outer portion of the paddle frame has at least two arms extending from the inner portion. The at least two arms are biased inward, so that when the anchor is in the closed position, the at least two arms extend across the centerline of the spacer.

[0020] In some implementations, the implantable device or implant includes an anchor and a spacer. The spacer has a frame that is movable from a constricted position to an expanded position.

[0021] In some implementations, the implantable device or implant includes an anchor containing a paddle frame. The paddle frame is movable between an expanded position and a constricted position. The paddle frame has a concave shape when in the expanded position and a constricted shape when in the constricted position.

[0022] In some implementations, the implantable device or implant includes a spacer and one or more extension members connected to the spacer. The spacer extension members are configured to allow tissue engraftment after implantation onto the natural valve. The spacer extension members are positioned to prevent or inhibit expansion of the valve annulus after tissue engraftment.

[0023] In some implementations, the implantable device or implant includes an inner member, an inner paddle, and an outer paddle. The inner paddle is movably connected to the inner member via a first connecting portion. The outer paddle is movably connected to the inner paddle via a second connecting portion. The device is configured to fix a valve leaf between the inner paddle and the inner member at a first engagement region, and to fix a valve leaf between the inner paddle and the inner member at a second engagement region separate from and spaced apart from the first engagement region.

[0024] In some implementations, the implantable device or implant includes a frame configured to support an anchor portion. The frame is movable between an expanded position and a constricted position. The frame includes a pair of outer frame members and a pair of inner frame members. A movable member is operably mounted to the outer frame members. The pair of inner frame members define a first retaining portion and a second retaining portion configured to receive the movable member. By driving the movable member toward its distal portion, the outer frame members are driven toward the constricted position.

[0025] In some implementations, the portable device or implant includes a frame member comprising a post and a drive member. The drive member is configured to engage with the post and further to drive the post. By driving the post, the width of the frame member is adjusted.

[0026] In some implementations, the implantable device or implant includes a clasp. The clasp includes a fixed arm, a movable arm, and one or more fixing members. The one or more fixing members include friction-enhancing members configured to generate sufficient friction between the valve leaf and the movable arm to secure the valve leaf inside the clasp without puncturing the valve leaf.

[0027] In some implementations, the implantable device or implant includes a paddle frame, a width adjustment control line, and a line retention portion. The width adjustment control line enables a user to drive the paddle frame from an expanded position to a constricted position by applying tension to a drive line. The retention portion includes a first retention member and a first elastic member. The first retention member is configured to move between a first retention position and a first non-retention position. In the first retention position, the first retention member contacts a first portion of the width adjustment control line and provides sufficient friction against the first portion of the width adjustment control line to retard movement of the first drive line. In the first non-retention position, the first retention member does not contact the first portion of the drive line. The first elastic member is configured to apply an elastic force sufficient to drive the first retention member from the first non-retention position to the first retention position.

[0028] In some implementations, the implantable device or implant includes a cap having a hole that traverses the cap from a proximal end to a distal end. The width of the hole at the distal end is greater than the width of the hole at the proximal end. The paddle frame is driven from the expanded position to the constricted position by being drawn into the cap.

[0029] In some implementations, the implantable device or implant includes a paddle frame and a rotating paddle frame control member. The rotating paddle control member enables the paddle frame to expand or constrict depending on the direction of rotation when a user applies a rotational driving force.

[0030] In some implementations, the implantable device or implant includes an anchor configured to attach to one or more valve leaflets in a native heart valve. Each of the anchors includes an inner paddle and an outer paddle. The inner paddle and the outer paddle are formed from a single strip of material.

[0031] In some implementations, the portable device or implant includes a paddle frame that has sufficient flexibility to deflect laterally when it encounters a faulty material.

[0032] In some implementations, the implantable device or implant includes a paddle frame and a biasing member. The biasing member, by bending, allows the paddle frame to deflect laterally and provides a restorative force to return the paddle frame to its original position.

[0033] In some implementations, the implantable device or implant comprises a spacer, an anchor portion, and gap-filling material. The anchor is configured to attach to one or more leaflets of a natural heart valve. The gap-filling material is positioned to reduce blood flow through one or more gaps between the spacer and the natural heart valve when the natural heart valve is blocked.

[0034] In some implementations, the implantable device or implant includes at least one anchor having a paddle frame which includes a movable member attached to a rotatable shaft of a drive unit. By rotationally driving the rotatable shaft, the movable member is driven relative to the rotatable shaft within the conduit of the drive unit, thereby driving the paddle frame between a constricted position and an expanded position.

[0035] In some implementations, the implantable device or implant includes at least one anchor having a paddle frame containing a movable member having one or more flexible projections. The implantable device or implant further includes a drive portion having a column or lumen, the column or lumen containing a plurality of slots or recesses configured to fix the movable member in a desired position within the column or lumen by receiving the flexible projections of the movable member. The device or implant is configured such that the paddle frame is driven between a constricted position and an expanded position by driving the movable member relative to the column or lumen.

[0036] In some implementations, the device or implant includes a connection opening for detachable connection to a conduit of a delivery device. The connection opening includes a proximal and a distal portion, in which case the width of the distal portion is greater than the width of the proximal portion. The conduit is coupled to the implantable device when at least one arm of the conduit is in its normal position and is positioned within the distal portion of the connection opening. The conduit is detached from the implantable device when the user moves the conduit away from the implantable device, thereby driving at least one arm of the conduit through the proximal portion of the connection opening to a compressed position.

[0037] In some implementations, the device or implant includes at least one anchor having a paddle frame with a retaining feature including a flexible arm. The implantable device or implant further includes a drive member having a connecting feature for detachably connecting to the retaining feature of the paddle frame. The device or implant (e.g., the drive member and the paddle frame) is configured to drive the paddle frame between a constricted position and an expanded position by driving the drive member relative to the conduit of the implantable device or implant.

[0038] In some implementations, the device or implant includes at least one anchor having a paddle frame with a movable member. The implantable device or implant further includes a drive portion having a drive member with a protruding sidewall that is movable between a normal position and a compressed position, the drive member being detachably connected to the movable member of the paddle frame. The drive portion may include a column or lumen, the column or lumen having a plurality of holes or recesses configured to fix the movable member in a desired position inside the column or lumen by receiving the protruding sidewall of the drive member. The device or implant (e.g., drive member, column, and paddle frame) is configured such that the paddle frame is driven between a constricted position and an expanded position by driving the drive member against the column or lumen, thereby driving the movable member against a conduit and further against the paddle frame.

[0039] A further understanding of the properties and advantages of the present invention is provided in the following description and claims, in particular when considered in conjunction with the accompanying drawings in which similar components have similar reference numerals. [Brief explanation of the drawing]

[0040] To further clarify the various aspects of implementation of this disclosure, a more detailed description of specific examples and implementations will be provided by reference to various aspects of the accompanying drawings. These drawings illustrate only exemplary implementations of this disclosure and are therefore not intended to limit the scope of this disclosure. Furthermore, while some examples may be drawn to scale, not all examples are drawn to scale. Examples of this disclosure and other features and advantages will be described and explained with additional specificity and detail through the use of the accompanying drawings.

[0041] [Figure 1] Figure 1 shows a cross-sectional view of the human heart during diastole. [Figure 2]Figure 2 shows a cross-sectional view of the human heart during systole. [Figure 3] Figure 3 shows a cross-section of the human heart during systole, illustrating mitral valve regurgitation. [Figure 4] Figure 4 is a cross-sectional view of Figure 3, with annotations to illustrate the natural shape of the mitral lobe during systole. [Figure 5] Figure 5 illustrates a healthy mitral valve in a state where the valve lobes are obstructed when viewed from the atrial side. [Figure 6] Figure 6 illustrates a dysfunctional mitral valve, showing a visible gap between the valve lobes when viewed from the atrial side. [Figure 7] Figure 7 shows the tricuspid valve as viewed from the atrial side. [Figure 8] Figures 8 to 14 show examples of implantable devices or implants at various stages of development. [Figure 9] Same as above. [Figure 10] Same as above. [Figure 11] Same as above. [Figure 12] Same as above. [Figure 13] Same as above. [Figure 14] Same as above. [Figure 15] Figure 15 shows an example of an implantable device or implant similar to those illustrated in Figures 8 to 14, but with independently controllable paddles. [Figure 16] Figures 16 to 21 illustrate the implantable devices or implants shown in Figures 8 to 14, illustrating how they are delivered and implanted into the interior of the natural valve. [Figure 17] Same as above. [Figure 18] Same as above. [Figure 19] Same as above. [Figure 20] Same as above. [Figure 21] Same as above. [Figure 22]Figure 22 shows a perspective view of an exemplary implantable device or implant in an occluded position. [Figure 23] Figure 23 shows a front view of the implantable device or implant shown in Figure 22. [Figure 24] Figure 24 shows a side view of the implantable device or implant shown in Figure 22. [Figure 25] Figure 25 shows a front view of the implantable device or implant shown in Figure 22, with the cover covering the paddle and the connecting member or spacer. [Figure 26] Figure 26 shows a top-down perspective view of the implantable device or implant shown in Figure 22 in an open position. [Figure 27] Figure 27 shows a perspective view from below of the implantable device or implant shown in Figure 22 in an open position. [Figure 28A] Figure 28A shows a clasp for use in an implantable device or implant. [Figure 28B] Figure 28B shows a perspective view of an exemplary clasp in an exemplary implantable device or implant in an occluded position. [Figure 29] Figure 29 shows a portion of the natural flap tissue held by the clasp. [Figure 30] Figure 30 shows a side view of an exemplary implantable device or implant in a partially open position with the clasp in an occluded position. [Figure 31] Figure 31 shows a side view of an exemplary implantable device or implant in a partially open position with the clasp in the open position. [Figure 32] Figure 32 shows a side view of an exemplary implantable device or implant in a semi-open position with the clasp in the occluded position. [Figure 33]Figure 33 shows a side view of an exemplary implantable device or implant with the clasp in the open position and in a semi-open position. [Figure 34] Figure 34 shows a side view of an exemplary implantable device or implant in a three-quarters open position with the clasp in the occluded position. [Figure 35] Figure 35 shows a side view of an exemplary implantable device or implant in a three-quarters open position with the clasp in the open position. [Figure 36] Figure 36 shows a side view of an exemplary implantable device in the fully open or fully bailed-out position with the clasp in the closed position. [Figure 37] Figure 37 shows a side view of an exemplary implantable device in the fully open or fully bailed-out position with the clasp in the open position. [Figure 38] Figures 38 to 49 illustrate the exemplary implantable devices or implants shown in Figures 30 to 38, including the cover, and depict how they are delivered and implanted into the interior of a natural valve. [Figure 39] Same as above. [Figure 40] Same as above. [Figure 41] Same as above. [Figure 42] Same as above. [Figure 43] Same as above. [Figure 44] Same as above. [Figure 45] Same as above. [Figure 46] Same as above. [Figure 47] Same as above. [Figure 48] Same as above. [Figure 49] Same as above. [Figure 50] Figure 50 is a schematic diagram illustrating the path of a natural valve leaf along each side of a connecting member or spacer in an exemplary valve restoration device or implant. [Figure 51]Figure 51 is a schematic overhead view illustrating the path of a natural valve leaf around a connecting member or spacer in an exemplary valve restoration device or implant. [Figure 52] Figure 52 illustrates a connecting member or spacer located within the gap of the natural valve, as viewed from the atrial side of the natural valve. [Figure 53] Figure 53 illustrates a valve repair device or implant attached to a natural valve leaflet, with the connecting member or spacer positioned within the gap of the natural valve when viewed from the ventricular side of the natural valve. [Figure 54] Figure 54 is a perspective view of a valve repair device or implant attached to a valve leaflet of a natural valve, with the connecting member or spacer positioned within the gap of the natural valve when viewed from the ventricular side of the natural valve. [Figure 55] Figure 55 shows a perspective view of an exemplary implantable device or implant in an occluded position. [Figure 56A] Figure 56A illustrates an exemplary valve repair device with the paddle in the open position. [Figure 56B] Figure 56B illustrates the valve repair device shown in Figure 56A, in which the paddle is in the open position, and a wider gap is formed between the gripping member and the paddle by driving the gripping member. [Figure 56C] Figure 56C is a diagram illustrating the valve repair device shown in Figure 56A, where the valve tissue is positioned between the gripping member and the paddle, as shown in Figure 56A. [Figure 56D] Figure 56D illustrates the valve repair device shown in Figure 56A, where the gap between the gripping member and the paddle is reduced by driving the gripping member. [Figure 56E] Figures 56E to 56F illustrate how the paddle in the valve repair device shown in Figure 56A moves from the open position to the closed position. [Figure 56F] Same as above. [Figure 56G]Figure 56G shows the valve repair device of Figure 56A in the closed position, with the gripping member engaged with the valve tissue. [Figure 56H] Figure 56H shows the valve repair device of Figure 56A after it has been detached from the delivery device and attached to the valve tissue, with the valve repair device in an closed and locked state. [Figure 57] Figure 57 is a plan view of an exemplary implantable device or implant having multiple anchors, each anchor comprising multiple paddles and multiple clasps, each clasp corresponding to an associated paddle. [Figure 58] Figure 58 shows a front view of the exemplary implantable device or implant shown in Figure 57. [Figure 59] Figure 59 shows a side view of the exemplary implantable device or implant shown in Figure 57. [Figure 60] Figure 60 shows a plan view of an exemplary implantable device or implant, similar to the exemplary implantable device in Figure 57, except that only a portion of the paddles of each anchor contain the corresponding clasp. [Figure 61] Figure 61 shows a front view of the exemplary implantable device or implant shown in Figure 60. [Figure 62] Figure 62 shows a side view of the exemplary implantable device or implant shown in Figure 60. [Figure 63] Figure 63 shows a plan view of an exemplary implantable device or implant, similar to the exemplary implantable device in Figure 60, except that the inner paddles of each anchor are longer in length than the outer paddles of the anchor. [Figure 64] Figure 64 shows a front view of the exemplary implantable device or implant shown in Figure 63. [Figure 65] Figure 65 shows a side view of the exemplary implantable device or implant shown in Figure 63. [Figure 66]Figure 66 shows a plan view of an exemplary implantable device or implant, similar to the exemplary implantable device in Figure 60, except that the inner paddles of each anchor are shorter in length compared to the outer paddles of the anchor. [Figure 67] Figure 67 shows a front view relating to the exemplary implantable device or implant shown in Figure 66. [Figure 68] Figure 68 shows a side view of the exemplary implantable device or implant shown in Figure 66. [Figure 69] Figures 69–73 show the exemplary implantable device or implant of Figure 57 at various stages of deployment. [Figure 70] Same as above. [Figure 71] Same as above. [Figure 72] Same as above. [Figure 73] Figure 74 is a plan view of an exemplary implantable device or implant having multiple anchors, each anchor comprising multiple paddle members and multiple clasps, each clasp corresponding to an associated paddle member. [Figure 74] Figure 75 shows a front view of the exemplary implantable device or implant shown in Figure 74. [Figure 75] Figure 76 shows a side view of the exemplary implantable device or implant shown in Figure 74. [Figure 76] Figure 77 shows a plan view of an exemplary implantable device or implant, similar to the exemplary implantable device in Figure 74, except that only a portion of the paddle members of each anchor include the corresponding clasp. [Figure 77] Figure 78 shows a front view of the exemplary implantable device or implant shown in Figure 77. [Figure 78] Figure 79 shows a side view of the exemplary implantable device or implant shown in Figure 77. [Figure 79]Figure 80 shows a plan view of an exemplary implantable device or implant, similar to the exemplary implantable device in Figure 77, except that the inner paddle members of each anchor are longer in length than the outer paddle members of the anchor. [Figure 80] Figure 81 shows a front view of the exemplary implantable device or implant shown in Figure 80. [Figure 81] Figure 82 shows a side view of the exemplary implantable device or implant shown in Figure 80. [Figure 82] Figure 83 shows a plan view of an exemplary implantable device or implant, similar to the exemplary implantable device in Figure 77, except that the inner paddle members of each anchor are shorter in length compared to the outer paddle members of the anchor. [Figure 83] Figure 84 shows a front view of the exemplary implantable device or implant shown in Figure 83. [Figure 84] Figure 85 shows a side view of the exemplary implantable device or implant shown in Figure 83. [Figure 85] Figures 86A, 87A, and 88–90 show the exemplary implantable device or implant of Figure 57 at various stages of deployment. [Figure 86A] Same as above. [Figure 86B] Same as above. [Figure 87A] Same as above. [Figure 87B] Same as above. [Figure 88] Same as above. [Figure 89] Same as above. [Figure 90] Figures 86B and 87B illustrate an example similar to the one shown in Figures 86A and 87A, with the paddle portion in the extended position. [Figure 91] Figure 91 shows a perspective view of an exemplary paddle frame for an implantable device or implant. [Figure 92]Figure 92 shows a partial view of the paddle frame in Figure 91 when the paddle frame is in a constricted position. [Figure 93] Figure 93 shows the paddle frame of Figure 91, which is positioned inside the delivery system. [Figure 94] Figure 94 shows an exemplary implantable device or implant, including the paddle frame of Figure 91, when the implantable device or implant is in an open position. [Figure 95] Figure 95 shows the paddle frame from Figure 91 when the paddle frame is in a constricted position. [Figure 96] Figure 96 shows a perspective view of an exemplary paddle frame for an implantable device or implant. [Figure 97] Figure 97 shows a partial view of the paddle frame in Figure 96. [Figure 98] Figure 98 shows a partial front view of an exemplary implantable device, including an exemplary paddle frame, when the implantable device or implant is in an occluded position. [Figure 99] Figure 99 shows a partial front view of an exemplary implantable device, including an exemplary paddle frame, when the implantable device or implant is in an occluded position. [Figure 100] Figure 100 shows a partial front view of an exemplary implantable device, including an exemplary paddle frame, when the implantable device or implant is in an occluded position. [Figure 101] Figure 101 shows a partial front view of the implantable device or implant shown in Figure 98 when the implantable device or implant is in an open position. [Figure 102] Figure 102 shows a partial front view of the implantable device or implant shown in Figure 99 when the implantable device or implant is in an open position. [Figure 103]Figure 103 shows a partial front view of the implantable device or implant shown in Figure 100, with the implantable device or implant in an open position. [Figure 104] Figure 104 shows a partial side view of the implantable device or implant shown in Figure 98 when the implantable device or implant is in an open position. [Figure 105] Figure 105 shows a partial side view of the implantable device or implant shown in Figure 99 when the implantable device or implant is in an open position. [Figure 106] Figure 106 shows a partial side view of the implantable device or implant shown in Figure 100 when the implantable device or implant is in an open position. [Figure 107] Figure 107 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 108] Figure 108 shows a front view of the exemplary paddle frame shown in Figure 107 when the paddle frame is in a constricted position. [Figure 109] Figure 109 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 110] Figure 110 shows a front view of the exemplary paddle frame shown in Figure 109 when the paddle frame is in a constricted position. [Figure 111] Figure 111 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 112] Figure 112 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 113] Figure 113 shows a front view of an exemplary configuration relating to the exemplary paddle frame of Figure 112. [Figure 114] Figure 114 shows a front view of an exemplary configuration relating to the exemplary paddle frame of Figure 112. [Figure 115] Figure 115 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 116] Figure 116 shows a plan view of the paddle frame that exemplifies the one in Figure 115. [Figure 117] Figure 117 shows a perspective view of an exemplary implantable device or implant, including an exemplary paddle frame, when the implantable device or implant is in an open position. [Figure 118] Figure 118 shows a bottom view of the implantable device or implant shown in Figure 117. [Figure 119] Figure 119 shows a front view of the implantable device or implant shown in Figure 117 when the implantable device or implant is in an occluded position. [Figure 120] Figure 120 shows a side view of the implantable device or implant shown in Figure 117, attached to a natural heart valve. [Figure 121] Figure 121 shows a bottom view of the implantable device or implant shown in Figure 117, attached to a natural heart valve. [Figure 122] Figure 122 shows a front view of an exemplary implantable device or implant when it is in an occluded position. [Figure 123] Figure 123 shows an example of the implantable device or implant from Figure 122 in an open position. [Figure 124] Figure 124 shows an exemplary paddle frame of the implantable device or implant shown in Figure 122 when the implantable device or implant is in an open position. [Figure 125] Figure 125 shows a front view of an exemplary paddle frame of an implantable device or implant when the paddle frame is positioned in a constricted location. [Figure 126]Figure 126 shows an example of the paddle frame from Figure 125 when the paddle frame is in the extended position. [Figure 127] Figure 127 shows a perspective view of an implantable device or implant including an exemplary paddle frame, where the device includes exemplary means for driving the paddle frame from a normal position to a constricted position. [Figure 128] Figure 128 shows the paddle frame in Figure 127, which was designated as the constricted position. [Figure 129] Figure 129 shows a perspective view of the exemplary implantable device or implant of Figure 127, except that the device includes exemplary means for driving the paddle from a normal position to a constricted position. [Figure 130] Figure 130 shows a perspective view of the exemplary implantable device or implant of Figure 127, except that the device includes exemplary means for driving the paddle from a normal position to a constricted position. [Figure 131] Figure 131 shows a perspective view of an exemplary implantable device or implant, including an exemplary paddle frame. [Figure 132] Figure 132 shows the implantable device or implant of Figure 131 having exemplary means for driving the paddle frame from a normal position to a constricted position. [Figure 133] Figure 133 shows the implantable device or implant of Figure 131 having exemplary means for driving the paddle frame from a normal position to a constricted position. [Figure 134] Figure 134 shows the implantable device or implant of Figure 131 having exemplary means for driving the paddle frame from a normal position to a constricted position. [Figure 135] Figure 135 shows the implantable device or implant of Figure 131 having exemplary means for driving the paddle frame from a normal position to a constricted position. [Figure 136]Figure 136 shows the implantable device or implant of Figure 131 having exemplary means for driving the paddle frame from a normal position to a constricted position. [Figure 137] Figure 137 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 138] Figure 138 shows an exemplary pair of paddle frames from Figure 137 positioned adjacent to each other. [Figure 139] Figure 139 shows a side view of an example of an implantable device or implant including the paddle frame shown in Figure 137, with the paddle frame positioned in a stenotic location. [Figure 140] Figure 140 shows a side view of the implantable device or implant shown in Figure 139 when the paddle frame is in the expanded position. [Figure 141] Figure 141 shows a partial side view of the implantable device or implant shown in Figure 139 when the paddle frame is in a constricted position. [Figure 142] Figure 142 shows a partial side view of the implantable device or implant shown in Figure 139, with the paddle frame in the expanded position. [Figure 143] Figure 143 shows a perspective view of the implantable device or implant of Figure 139, which has the paddle frame of Figure 137. [Figure 144] Figure 144 shows a front view of the implantable device or implant of Figure 139, which has the paddle frame of Figure 137. [Figure 145] Figure 145 shows a perspective view of an example of an internal and external paddle for the implantable device or implant shown in Figure 139. [Figure 146] Figure 146 shows a side view of the inner and outer paddles in Figure 145. [Figure 147] Figure 147 shows a plan view of the inner and outer paddles in Figure 145. [Figure 148]Figure 148 shows a perspective view illustrating an exemplary connection between the paddle in Figure 146 and the paddle frame in Figure 137. [Figure 149] Figure 149 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 150] Figure 150 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 151] Figure 151 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 152] Figure 152 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 153] Figures 153–155 show front views of various configurations of exemplary paddle frames for implantable devices or implants. [Figure 154] Same as above. [Figure 155] Same as above. [Figure 156] Figure 156 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 157] Figure 157 is a front view relating to an exemplary paddle frame for an implantable device or implant, the paddle frame being shown in an extended position. [Figure 158] Figure 158 is a front view relating to the exemplary paddle frame of Figure 157, where the paddle frame is shown in a constricted position. [Figure 159] Figure 159 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 160] Figure 160 shows a left side view of the paddle frame shown in Figure 159. [Figure 161] Figure 161 shows a plan view of the paddle frame shown in Figure 159. [Figure 162]Figure 162 shows a perspective view of an example of an implantable device or implant including the paddle frame shown in Figure 159. [Figure 163] Figure 163 shows a front view of the implantable device or implant shown in Figure 162, including the paddle frame shown in Figure 159. [Figure 164] Figures 164–168 show the implantable device or implant of Figure 162 having exemplary means for driving the paddle frame of Figure 159 between an expanded position and a constricted position. [Figure 165] Same as above. [Figure 166] Same as above. [Figure 167] Same as above. [Figure 168] Same as above. [Figure 169] Figure 169 shows a perspective view of an example assembly consisting of a paddle and a connecting member frame for an implantable device or implant. [Figure 170] Figure 170 shows a rear view of the assembly consisting of the paddle and the connecting member frame shown in Figure 169. [Figure 171] Figure 171 is a perspective view of an example of an implantable device or implant including an assembly consisting of the paddle and connecting member frame shown in Figure 171, wherein the connecting member frame is in a constricted position. [Figure 172] Figure 172 is a perspective view of the implantable device or implant shown in Figure 171, with the connecting member frame in the extended position. [Figure 173] Figure 173 shows a plan view of the implantable device or implant shown in Figure 171, with the connecting member frame in a constricted position. [Figure 174] Figure 174 shows a plan view of the implantable device or implant shown in Figure 172, with the connecting member frame in the extended position. [Figure 175]Figure 175 is a rear view of the assembly consisting of the paddle and connecting member frame shown in Figure 169 when it is in a constricted position, and the assembly consisting of the paddle and connecting member frame is attached to the inner and outer paddles of the anchor portion of the implantable device or implant. [Figure 176] Figure 176 is a rear view of the assembly consisting of the paddle and connecting member frame shown in Figure 169 when in the extended position, and the assembly consisting of the paddle and connecting member frame is attached to the inner and outer paddles of the anchor portion of the implantable device or implant. [Figure 177] Figure 177 is a perspective view of the assembly consisting of the paddle and connecting member frame shown in Figure 169 when it is in a stenotic position, and the assembly consisting of the paddle and connecting member frame is attached to the inner and outer paddles of the anchor portion of the implantable device or implant. [Figure 178] Figure 178 is a plan view of the assembly consisting of the paddle and connecting member frame shown in Figure 169 when in the extended position, and the assembly consisting of the paddle and connecting member frame is attached to the inner and outer paddles of the anchor portion of the implantable device or implant. [Figure 179] Figure 179 shows a perspective view of the assembly consisting of the paddle and connecting member frame from Figure 169, when it is in the extended position. [Figure 180] Figure 180 is a perspective view of the joint member frame in the assembly consisting of the paddle and joint member frame of Figure 169, the joint member frame being attached to the inner paddle of the anchor portion of the implantable device or implant. [Figure 181] Figure 181 shows a front view of the frame in the assembly consisting of the paddle and connecting member shown in Figure 169, when it is in a constricted position. [Figure 182] Figure 182 shows a side view of the connecting member frame shown in Figure 181. [Figure 183]Figure 183 shows a plan view of the connecting member frame shown in Figure 181. [Figure 184] Figure 184 shows a perspective view of the connecting member frame of Figure 181. [Figure 185] Figure 185 shows a front view of the connecting member frame of Figure 181 when it is in the extended position. [Figure 186] Figure 186 shows a side view of the connecting member frame shown in Figure 185. [Figure 187] Figure 187 shows a plan view of the connecting member frame shown in Figure 185. [Figure 188] Figure 188 shows a perspective view of the connecting member frame shown in Figure 185. [Figure 189] Figure 189 shows a perspective view of an exemplary pair of paddle frames for a pair of anchors in an implantable device or implant. [Figure 190] Figure 190 shows a front view of the paddle frame shown in Figure 189. [Figure 191] Figure 191 shows a plan view of the paddle frame shown in Figure 189. [Figure 192] Figure 192 shows a side view of the paddle frame in Figure 189. [Figure 193] Figure 193 is a plan view of an example of an implantable device or implant including one of the paddle frames from Figure 189, with the paddle frame in an extended position. [Figure 194] Figure 194 is a plan view of the implantable device or implant shown in Figure 193, with the paddle frame positioned in a constricted location. [Figure 195] Figure 195 shows a ventricular view of the natural valve with the implantable device or implant from Figure 193 positioned to connect to the natural valve. [Figure 196] Figure 196 shows an atrial view of an exemplary implantable device or implant attached to a natural heart valve. [Figure 197] Figure 197 is an atrial view of the implantable device or implant shown in Figure 196 attached to a natural valve, with tissue engraftment covering the device. [Figure 198] Figure 198 is a front view of the implantable device or implant shown in Figure 196, attached to a natural flap, with tissue engraftment covering the device. [Figure 199] Figure 199 is an atrial view of an exemplary implantable device or implant attached to a natural valve of the heart, the device including an exemplary connecting extension member. [Figure 200] Figure 200 is an atrial view of the implantable device or implant shown in Figure 199 attached to a natural valve, with tissue engraftment covering the device. [Figure 201] Figure 201 is an atrial view relating to an exemplary implantable device or implant attached to a natural valve of the heart, the device including an exemplary connecting extension member. [Figure 202] Figure 202 is an atrial view of the implantable device or implant shown in Figure 201, attached to a natural valve, with tissue engraftment covering the device. [Figure 203] Figure 203 is a front view of an exemplary implantable device or implant attached to a natural heart valve, the device including an exemplary connecting extension member. [Figure 204] Figure 204 is a front view of the implantable device or implant shown in Figure 203, attached to a natural flap, with tissue engraftment covering the device. [Figure 205] Figure 205 is a front view of an exemplary implantable device or implant attached to a natural heart valve, the device including an exemplary connecting extension member. [Figure 206] Figure 206 is a front view of the implantable device or implant shown in Figure 205, attached to a natural flap, with tissue engraftment covering the device. [Figure 207] Figure 207 is an atrial view of an exemplary implantable device or implant attached to a natural heart valve, the device including an exemplary connecting extension member. [Figure 208] Figure 208 is a front view of an exemplary implantable device or implant attached to a natural heart valve, the device including an exemplary connecting extension member. [Figure 209] Figure 209 is a front view of an exemplary implantable device or implant attached to a natural heart valve, the device including an exemplary connecting extension member. [Figure 210] Figures 210 to 214 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 211] Same as above. [Figure 212] Same as above. [Figure 213] Same as above. [Figure 214] Same as above. [Figure 215] Figures 215 to 218 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 216] Same as above. [Figure 217] Same as above. [Figure 218] Same as above. [Figure 219] Figures 219 to 222 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 220] Same as above. [Figure 221] Same as above. [Figure 222] Same as above. [Figure 223] Figures 223-224 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 224] Same as above. [Figure 225]Figures 225 to 227 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 226] Same as above. [Figure 227] Same as above. [Figure 228] Figures 228 to 230 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 229] Same as above. [Figure 230] Same as above. [Figure 231] Figures 231-232 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 232] Same as above. [Figure 233] Figure 233 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 234] Figure 234 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 235] Figure 235 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 236] Figure 236 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 237] Figure 237 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 238] Figure 238 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 239] Figure 239 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 240]Figure 240 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 241] Figure 241 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 242] Figure 242 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 243] Figure 243 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 244] Figure 244 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 245] Figures 245 to 250 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 246] Same as above. [Figure 247] Same as above. [Figure 248] Same as above. [Figure 249] Same as above. [Figure 250] Same as above. [Figure 251] Same as above. [Figure 252] Figures 251-252 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 253] Same as above. Figure 253 illustrates an example of coupling between a drive member and a component of a device or implant. [Figure 254] Figures 254-255 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 255] Same as above. [Figure 256] Figure 256 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 257] Figure 257 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 258] Figures 258-259 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 259] Same as above. [Figure 260] Figures 260-261 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 261] Same as above. [Figure 262] Figure 262 illustrates an example of a coupling between a drive member and a component of a device or implant. [Figure 263] Figures 263-264 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 264] Same as above. [Figure 265] Figures 265-266 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 266] Same as above. [Figure 267] Figures 267-268 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 268] Same as above. [Figure 269] Figures 269 to 270 illustrate an example of coupling between a drive member and a component of a device or implant. [Figure 270] Same as above. [Figure 271] Figure 271 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 272]Figure 272 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 273] Figure 273 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 274] Figure 274 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 275] Figure 275 illustrates an example of a connection between a drive member and a component of a device or implant. [Figure 276] Figure 276 illustrates an example of a drive device or control device. [Figure 277] Figure 277 illustrates an example of a drive device or control device. [Figure 278] Figure 278 illustrates an example of a pulley configuration. [Figure 279] Figure 279 is a plan view relating to the drive device or control device shown in Figure 277. [Figure 280] Figure 280 is a bottom view of the drive device or control device shown in Figure 277. [Figure 281] Figures 281 and 282 illustrate an example of a drive device or control device. [Figure 282] Same as above. [Figure 283] Figures 283 to 285 illustrate an example of a drive device or control device. [Figure 284] Same as above. [Figure 285] Same as above. [Figure 286] Figure 286 illustrates an example of a paddle frame. [Figure 287] Figure 287 illustrates an example of a drive or control device coupled to a paddle frame. [Figure 288]Figure 288 illustrates an example of a drive or control device coupled to a paddle frame. [Figure 289] Figure 289 illustrates an example of an adjustable paddle frame assembly. [Figure 290] Figure 290 illustrates an example of an adjustment mechanism for the adjustable paddle assembly shown in Figure 289. [Figure 291] Figure 291 illustrates an example of an adjustable paddle frame assembly. [Figure 292] Figure 292 illustrates an example of a drive device or control device. [Figure 293] Figure 293 illustrates an example of an adjustable paddle frame assembly. [Figure 294] Figure 294 illustrates an example of an adjustable paddle frame assembly. [Figure 295] Figure 295 illustrates an example of an adjustable paddle frame assembly. [Figure 296] Figure 296 illustrates an example of an adjustment member in the adjustable paddle frame assembly shown in Figures 294 and 295. [Figure 297] Figure 297 illustrates an example of an adjustable paddle frame assembly. [Figure 298] Figures 298 to 300 illustrate an example of a drive device or control device. [Figure 299] Same as above. [Figure 300] Same as above. [Figure 301] Figure 301 shows a frontal cross-sectional view of an implantable device or implant. [Figure 302] Figure 302 shows a perspective cross-sectional view of the device / implant shown in Figure 301. [Figure 303] Figure 303 shows a perspective view of the device / implant shown in Figure 301. [Figure 304]Figure 304 shows a side view of the device / implant shown in Figure 301. [Figure 305] Figure 305 shows a plan view of the device / implant shown in Figure 301. [Figure 306] Figures 306 to 311 show partial diagrams of the device / implant from Figure 301 at various stages of assembly. [Figure 307] Same as above. [Figure 308] Same as above. [Figure 309] Same as above. [Figure 310] Same as above. [Figure 311] Same as above. [Figure 312] Figure 312 shows a front view of device / implant 301 in the expanded position. [Figure 313] Figure 313 shows a side view of device / implant 301, which was designated as the expansion position. [Figure 314] Figure 314 shows a plan view of device / implant 301, which was designated as the expansion position. [Figure 315] Figure 315 shows a front view of device / implant 301, which was identified as the stenotic location. [Figure 316] Figure 316 shows a side view of device / implant 301, which was identified as the location of the stenosis. [Figure 317] Figure 317 shows a plan view of device / implant 301, which was identified as the location of the stenosis. [Figure 318] Figure 318 shows a frontal cross-sectional view of an example of an implantable device or implant. [Figure 319] Figure 319 shows a side view of the device / implant shown in Figure 318. [Figure 320] Figures 320 to 323 show front views of the device / implant from Figure 318 at various positions as it moves from an expanded position to a constricted position. [Figure 321] Same as above. [Figure 322] Same as above. [Figure 323] Same as above. [Figure 324] Figure 324 shows a front view of an example of a part of a paddle frame for an implantable device or implant. [Figure 325] Figure 325 shows a perspective view of the frame in Figure 324. [Figure 326] Figure 326 shows a plan view of the frame in Figure 324. [Figure 327] Figure 327 shows a side view of the frame in Figure 324. [Figure 328] Figures 328 to 331 show front views of the device / implant from Figure 324 at various positions as it moves from an expanded position to a constricted position. [Figure 329] Same as above. [Figure 330] Same as above. [Figure 331] Same as above. [Figure 332] Figure 332 shows a perspective view of an example of a part of a paddle frame for an implantable device or implant. [Figure 333] Figure 333 shows a front view of the frame of Figure 332 attached to the anchor. [Figure 334] Figure 334 shows a front view including a partial cross-section of the frame of Figure 332 as part of an implantable device or implant. [Figure 335] Figure 335 shows the frame of Figure 332 attached to the drive unit of an implantable device or implant. [Figure 336] Figure 336 shows a perspective view of an implantable device or implant using the frame of Figure 332. [Figure 337] Figure 337 shows a front view of the device in Figure 332 in its extended position. [Figure 338]Figure 338 shows a front view of the device in Figure 332, which is in a constricted position. [Figure 339] Figure 339 shows a side view of the device in Figure 332, which is in an extended position. [Figure 340] Figure 340 shows a side view of the device in Figure 332, which was identified as being in a constricted position. [Figure 341] Figure 341 shows a plan view of the device in Figure 332, which is in an expanded position. [Figure 342] Figure 342 shows a plan view of the device in Figure 332, which is considered to be in a constricted position. [Figure 343] Figure 343 is a front view relating to an implantable device or implant, illustrating two examples relating to a paddle frame for the device. [Figure 344] Figure 344 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 345] Figures 345 to 347 show front views of the frame of Figure 332 at various positions, from the expanded position to the constricted position. [Figure 346] Same as above. [Figure 347] Same as above. [Figure 348] Figure 348 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 349] Figure 349 shows a perspective view of the frame of Figure 348 as part of an implantable device or implant. [Figure 350] Figure 350 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 351] Figure 351 shows a perspective view of the frame in Figure 350. [Figure 352] Figure 352 shows a plan view of the frame in Figure 350. [Figure 353] Figure 353 shows a side view of the frame in Figure 350. [Figure 354] Figure 354 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 355] Figure 355 shows a perspective view of the frame in Figure 354. [Figure 356] Figure 356 shows a plan view of the frame in Figure 355. [Figure 357] Figure 357 shows a side view of the frame in Figure 356. [Figure 358] Figure 358 shows a perspective view of an exemplary paddle frame for an implantable device or implant. [Figure 359] Figure 359 shows a front cross-sectional view of the frame shown in Figure 358. [Figure 360] Figure 360 ​​shows a front cross-sectional view of an exemplary paddle frame for an implantable device or implant. [Figure 361] Figure 361 shows a plan view of the frame in Figure 360. [Figure 362] Figure 362 shows a frontal cross-sectional view of an exemplary paddle frame for an implantable device or implant. [Figure 363] Figure 363 shows a perspective view of the paddle frame attached to the elongated cap. [Figure 364] Figure 364 shows a partial front view of the frame and elongated cap in Figure 363. [Figure 365] Figure 365 shows a front view of an example of a connection mechanism between the rigid inner portion and the flexible outer portion of the paddle frame. [Figure 366] Figure 366 shows a perspective view of the paddle frame assembly shown in Figure 365. [Figure 367] Figure 367 shows a plan view of the paddle frame assembly shown in Figure 365. [Figure 368]Figure 368 shows a side view of the paddle frame assembly of Figure 365. [Figure 369] Figure 369 shows a rear view of the paddle frame assembly of Figure 365. [Figure 370] Figure 370 shows a front view of an example of a connection mechanism between the rigid inner portion and the flexible outer portion of the paddle frame. [Figure 371] Figure 371 shows a side view of the paddle frame assembly of Figure 370. [Figure 372] Figure 372 shows a rear view of the paddle frame assembly of Figure 370. [Figure 373] Figure 373 shows a front view of an example of a connection between the rigid inner portion and the flexible outer portion of the paddle frame. [Figure 374] Figure 374 shows a side view of the paddle frame of Figure 373. [Figure 375] Figure 375 shows a perspective view of the paddle frame of Figure 373. [Figure 376] Figure 376 shows a front view of an example of a connection between the rigid inner portion and the flexible outer portion of the paddle frame. [Figure 377] Figure 377 shows a perspective view of the paddle frame assembly of Figure 376. [Figure 378] Figure 378 shows a schematic view of an anchor portion in a transplantable device or implant in a closed position. [Figure 379] Figure 379 is a schematic view of the anchor portion of Figure 378 in a closed position, showing the natural valve leaf fixed by the anchor portion. [Figure 380] Figure 380 shows a schematic view of an exemplary anchor portion in a closed position for a transplantable device or implant. [Figure 381] Figure 381 is a schematic view of the anchor portion of Figure 380, showing the natural valve leaf fixed by the anchor portion. [Figure 382] Figure 382 shows a schematic diagram of the anchor portion in Figure 380, which is in a partially open position. [Figure 383] Figure 383 shows a schematic diagram of the anchor portion in Figure 380, which is in the open position. [Figure 384] Figure 384 is a plan view of the anchor in the anchor portion of Figure 380, showing the anchor in a flattened state. [Figure 385] Figure 385 is a schematic diagram of the anchor in the anchor portion of Figure 380, where the anchor is in the closed position and a clasp is attached to the anchor. [Figure 386] Figure 386 is a schematic diagram of the anchor and clasp in Figure 385, which are considered to be in the occluded position, showing how the valve leaf of the natural valve is fixed by the anchor and clasp. [Figure 387] Figure 387 is a schematic diagram of the anchor and clasp shown in Figure 385, where the anchor is in the open position and the clasp is in the closed position. [Figure 388] Figure 388 is a schematic diagram of the anchor portion and clasp in an implantable device or implant in an occluded position, showing the inward biasing force of the outer paddle of the anchor portion. [Figure 389] Figure 389 is a schematic diagram of one side of the anchor portion in Figure 388, which is in the closed position, and shows the inward biasing force on the outer paddle. [Figure 390] Figure 390 is a plan view of an example of a clasp for an implantable device or implant, wherein the clasp is flat. [Figure 391] Figure 391 shows an example of a clasp for a portable device or implant. [Figure 392] Figure 392 is a plan view of an example of a clasp for an implantable device or implant, showing the clasp in a flattened state. [Figure 393]Figure 393 is a side view of an example of a clasp for an implantable device or implant, with the clasp in an occluded position. [Figure 394] Figure 394 shows the anchor portion of Figure 388 positioned within a jig for shape memory alloys. [Figure 395] Figure 395 shows a perspective view of an example of an anchor portion for an implantable device or implant. [Figure 396] Figure 396 shows a plan view of an example of the inner member and inner paddle portion in the anchor portion of Figure 395. [Figure 397] Figure 397 shows a left-side perspective view of an example of an implantable device or implant. [Figure 398] Figure 398 shows a right-side perspective view of the device shown in Figure 397. [Figure 399] Figure 399 shows a front view of the device shown in Figure 397. [Figure 400] Figure 400 is a partial perspective view of the distal portion of the device shown in Figure 397, illustrating how the anchor portion is attached to the cap at the distal end of the device. [Figure 401] Figure 401 shows a perspective view of an example of a clasp for an implantable device or implant. [Figure 402] Figure 402 shows a perspective view of an example of a clasp for an implantable device or implant. [Figure 403] Figure 403 shows a perspective view of an example of a clasp for an implantable device or implant. [Figure 404] Figure 404 shows a perspective view of an example of a clasp for an implantable device or implant. [Figure 405] Figure 405 shows a perspective view of an example of a clasp for an implantable device or implant. [Figure 406]Figure 406 shows a perspective view of an example of a clasp for a transplantable device or implant. [Figure 407A] Figure 407A shows an example of a holding mechanism or locking mechanism. [Figure 407B] Figure 407B shows an example of the holding mechanism or locking mechanism of Figure 407A deployed within a housing. [Figure 407C] Figure 407C is a cross-sectional view of Figure 407B, showing the holding mechanism or locking mechanism within the housing. [Figure 408A] Figure 408A shows an example of a cap engaged with a paddle. [Figure 408B] Figure 408B shows an enlarged view of the cap of Figure 408A in the case where there is no paddle. [Figure 408C] Figure 408C is a perspective view of the cap and paddle shown in Figure 408A. [Figure 408D] Figure 408D is a cross-sectional view showing the deflection of the paddle caused when the paddle is drawn into the cap to various degrees. [Figure 408E] Figure 408E is a perspective view showing the degree of deflection of Figure 408D. [Figure 408F] Figure 408F is a schematic view showing a configuration in which the paddle is simultaneously deflected by the combined draw into the cap. [Figure 408G] Figure 408G is a perspective view of the cap and paddle assembly. <于 <于 [Figure 409A] Figure 409A is a top perspective view of an assembly consisting of a cap and two adjustable independent paddles. <于 <于 [Figure 409B] Figure 409B is a bottom perspective view of the assembly of Figure 409A. <于 <于 [Figure 409C] Figure 409C is a cross-sectional view illustrating independent control of the paddles of Figures 409A and 409B. <于 <于 [Figure 410A] Figure 410A is a partial cross-sectional view of an adjustable paddle assembly. It should be noted that the content of tags <于 and <于 [Figure 409A] you provided seems to be incorrect format. I translated them as <于 and <于 [Figure 409A] according to the rules, but you may need to check if there are any errors in these tags. [Figure 410B] Figure 410B is a perspective view of the adjustable paddle assembly shown in Figure 410A. [Figure 410C] Figure 410C is a cross-sectional view relating to the adjustable paddle assembly shown in Figure 410B. [Figure 410D] Figure 410D is a cross-sectional view relating to the adjustable paddle assembly shown in Figure 410B. [Figure 410E] Figure 410E is a side view of the adjustable paddle assembly shown in Figure 410B. [Figure 410F] Figure 410F is a side view of an adjustable paddle assembly, showing the paddle in the first drive position. [Figure 410G] Figure 410G is a side view of an adjustable paddle assembly, showing the paddle in the second drive position. [Figure 410H] Figure 410H is a side view of an adjustable paddle assembly, showing the paddle in the third drive position. [Figure 411A] Figure 411A is a side view of the adjustable paddle assembly. [Figure 411B] Figure 411B is a side view of the adjustable paddle assembly shown in Figure 411A. [Figure 411C] Figure 411C is a front view relating to the adjustable paddle assembly shown in Figure 411A. [Figure 411D] Figure 411D shows the use of the adjustable paddle assembly shown in Figure 411A within a valve restoration device or implant. [Figure 411E] Figure 411E shows the use of the adjustable paddle assembly shown in Figure 411A within a valve restoration device or implant. [Figure 412A] Figure 412A shows an example of a paddle structure formed from a sheet material. [Figure 412B] Figure 412B is a side view of the paddle structure shown in Figure 412A. [Figure 412C]Figure 412C is a plan view of the paddle structure shown in Figure 412A. [Figure 412D] Figure 412D is a bottom view of the paddle structure shown in Figure 412A. [Figure 412E] Figure 412E is another side view of the paddle structure shown in Figure 412A. [Figure 412F] Figure 412F shows details of an example of an eyelet in the paddle structure shown in Figure 412A. [Figure 412G] Figure 412G is a plan view of the flat material used to form the paddle structure in Figure 412A. [Figure 412H] Figure 412H shows an example of a valve restoration device or implant including the paddle structure of Figure 412A in the fully retracted position. [Figure 412I] Figure 412I shows the valve restoration device or implant of Figure 412H with the paddle structure in a partially open position. [Figure 412J] Figure 412J shows the valve repair device or implant of Figure 412H with the paddle structure in the lateral extension or lateral open position. [Figure 412K] Figure 412K is a perspective view relating to a die that may be used to form the paddle structure shown in Figure 412A. [Figure 412L] Figure 412L is a perspective view of the die shown in Figure 412K. [Figure 413A] Figure 413A shows an example of a valve restoration device or implant having a compressible outer paddle portion. [Figure 413B] Figure 413B shows an example of a valve restoration device or implant having a compressible outer paddle portion. [Figure 414A] Figure 414A is a perspective view of an example of a valve restoration device or implant having a compressible outer paddle portion. [Figure 414B] Figure 414B is a perspective view showing the paddle in the valve restoration device or implant illustrated in Figure 414A. [Figure 415A] Figure 415A is a side view of an example of a valve repair device or implant, which is in an open state and has gap-filling material. [Figure 415B] Figure 415B is a diagram showing the valve repair device or implant shown in Figure 415A attached to the valve leaf of the natural valve, as viewed from the ventricular side of the natural valve. [Figure 415C] Figure 415C is a side view of the valve repair device or implant shown in Figure 415A in an occluded state. [Figure 415D] Figure 415D is a front view of the valve repair device or implant shown in Figure 415A in an occluded state. [Figure 416A] Figure 416A is a side view of an example of a valve repair device or implant, which is in an open state and has gap-filling material. [Figure 416B] Figure 416B shows the valve repair device or implant shown in Figure 416A attached to the valve leaf of the natural valve, as viewed from the ventricular side of the natural valve. [Figure 416C] Figure 416C is a side view of the valve repair device or implant shown in Figure 416A in an occluded state. [Figure 416D] Figure 416D is a front view of the valve repair device or implant shown in Figure 416A in an occluded state. [Figure 417] Figure 417 shows a perspective view of an example of a paddle frame and drive device for a portable device. [Figure 418] Figure 418 shows a perspective cross-sectional view of a portion of the paddle frame and drive device shown in Figure 417. [Figure 419] Figure 419 shows a front cross-sectional view of part of the paddle frame and drive device shown in Figure 417. [Figure 420] Figure 420 shows a bottom view of part of the paddle frame and drive device shown in Figure 417. [Figure 421]Figure 421 shows a front cross-sectional view of an example of a paddle frame and drive device for a portable device. [Figure 422] Figure 422 is a front cross-sectional view of a portion of the paddle frame and the drive device shown in Figure 421, in which the conduit of the delivery device is attached to the drive device, and the drive member is attached to the paddle frame. [Figure 423] Figure 423 shows a perspective cross-sectional view of a portion of the paddle frame shown in Figure 421. [Figure 424] Figure 424 shows a plan view of the drive device shown in Figure 421. [Figure 425] Figure 425 shows a front cross-sectional view of a portion of the paddle frame and drive device from Figure 421, without the conduit and drive member from Figure 422. [Figure 426] Figure 426 shows a front cross-sectional view of a portion of the paddle frame and drive device of Figure 421, when it has the conduit and drive member of Figure 422. [Figure 427] Figures 427–429 show various diagrams illustrating examples of connections between the conduit of an implantable device and the components of the implantable device. [Figure 428] Same as above. [Figure 429] Same as above. [Figure 430] Figures 430 to 432 are various diagrams relating to the connection between the conduit and the components of the implantable device in Figures 427 to 429, where the conduit is moving proximal to the implantable device. [Figure 431] Same as above. [Figure 432] Same as above. [Figure 433] Figures 433 to 435 are various diagrams relating to the coupling between the conduit and the components of the implantable device in Figures 427 to 429, where the conduit is detached from the implantable device. [Figure 434] Same as above. [Figure 435] Same as above. [Figure 436] Figure 436 is a front view illustrating an exemplary coupling between a conduit and components of an implantable device, where the drive member extends into the implantable device through the conduit. [Figure 437] Figure 437 shows the coupling between the conduit and the components of the implantable device in Figure 436, where the drive member is moving proximal to the conduit. [Figure 438] Figure 438 shows the connection between the conduit and the components of the implantable device in Figure 436, where the conduit is moving proximal to the implantable device. [Figure 439] Figure 439 shows the connection between the conduit and the components of the implantable device in Figure 436, where the conduit is detached from the implantable device. [Figure 440] Figure 440 shows a perspective view of an example of coupling between the paddle frame and the drive member of a portable device. [Figure 441] Figure 441 shows a front view of an example of a coupling portion for the drive member in Figure 440. [Figure 442] Figure 442 shows a side view of an example of a coupling portion for the drive member in Figure 440. [Figure 443] Figure 443 shows a partial front view of the paddle frame in Figure 440. [Figure 444] Figure 444 shows a front cross-sectional view of an example of a paddle frame and drive device for a portable device. [Figure 445] Figure 445 shows an example relating to the distal portion of an exemplary drive shaft for the drive device of Figure 444. [Figure 446] Figure 446 is a cross-sectional view of an example of a conduit for the drive device shown in Figure 444, where the distal portion of the drive shaft in Figure 445 moves through the conduit. [Modes for carrying out the invention]

[0042] The following description refers to accompanying drawings illustrating exemplary implementations of the disclosure. Several implementations having different structures and operations do not deviate from the scope of the disclosure.

[0043] The exemplary implementations of this disclosure relate to systems, devices, methods, etc., for repairing defective heart valves. For example, various implementations relating to implantable devices, valve repair devices, implants, and systems (including systems for delivering them) are disclosed herein, and unless otherwise specified, any combination of these options is possible. In other words, the individual components of the disclosed devices and systems can be combined as long as they are not mutually exclusive or not physically impossible. Furthermore, the techniques and methods herein can be performed on living animals or on simulations, such as on cadavers, cadaver hearts, simulators (in which parts of a body, heart, tissue, etc., are simulated), etc.

[0044] As described herein, when one or more components are described as being connected, joined, fixed, coupled, attached, or otherwise interconnected, such interconnections may be direct, such as between components themselves, or indirect, such as through the use of one or more intermediate components. Also as described herein, references to “member,” “component,” or “part” are not limited to a single structural member, component, or element, but may include assemblies of components, members, or elements. Also as described herein, the terms “substantially” and “about” are defined as at least close to (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0045] Figures 1 and 2 are cross-sectional views of the human heart H in diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, respectively, i.e., the atrioventricular valves. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible lobes (e.g., lobes 20, 22 shown in Figures 3-6, and lobes 30, 32, 34 shown in Figure 7), which extend inward across their respective valve openings and, by joining together or "joining" in the flow, form a unidirectional fluid-occluded surface. The natural valve repair system of this application has been frequently described and / or illustrated with respect to the mitral valve MV. Therefore, the anatomical structures of the left atrium LA and left ventricle LV will be described in more detail. However, the device described herein can also be used in the repair of other natural valves, for example, the device can be used in the repair of the tricuspid valve (TV), aortic valve (AV), and pulmonary valve (PV).

[0046] The left atrium (LA) receives oxygen-rich blood from the lungs. During the diastolic phase, as shown in Figure 1, the blood already collected in the left atrium (LA) (during the systolic phase) moves into the left ventricular LV through the mitral valve (MV) as the left ventricle (LV) expands. During the systolic phase, as shown in Figure 2, the left ventricle (LV) contracts, pumping blood into the body through the aortic valve (AV) and ascending aorta (AA). During systole, the mitral valve (MV) lobes close, preventing blood from flowing back from the left ventricle (LV) into the left atrium (LA), and blood is collected into the left atrium from the pulmonary veins. In some implementations, the device described in this application is used to repair the function of a defective mitral valve (MV). Specifically, the device is configured to assist in the closure of the mitral valve lobes to prevent blood from flowing back from the left ventricle (LV) into the left atrium (LA). Many of the devices described in this application are designed to easily grip and secure natural valve leaves around a joint member or spacer that acts beneficially as a filler in the backflow opening to prevent or block backflow during systole, but this is not essential.

[0047] Referring to Figures 1-7, the mitral valve MV contains two leaflets, the anterior leaflet 20 and the posterior leaflet 22. The mitral valve MV also contains an annulus 24, which is a variablely dense, fibrous annular tissue surrounding the leaflets 20 and 22. Referring to Figures 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle (LV) by chordae tendineae (CT). Chordae tendineae are cord-like tendons that connect the papillary muscles (PM) (i.e., muscles located at the base of the chordae tendineae and within the wall of the left ventricle LV) to the leaflets 20 and 22 of the mitral valve MV. The papillary muscles (PM) function to restrict the movement of the leaflets 20 and 22 of the mitral valve MV and to prevent the mitral valve MV from inverting. The mitral valve MV opens and closes in response to pressure changes within the left atrium (LA) and the left ventricle (LV). The papillary muscles (PM) do not open or close the mitral valve MV. Rather, the papillary muscles (PM) support and stabilize lobes 20 and 22 against the high pressure necessary to circulate blood throughout the body. The papillary muscles (PM) and chordae tendineae (CT) together are known as subvalvular tissue, which functions to prevent the mitral valve (MV) from protruding into the left atrium (LA) when the mitral valve (MV) is obstructed. As can be seen from the left ventricular outflow tract (LVOT) diagram shown in Figure 3, the anatomical structure of lobes 20 and 22 is such that the medial surfaces of the lobes join at their free ends, and lobes 20 and 22 begin to move away from each other, retracting and spreading apart. Lobes 20 and 22 spread apart towards the atrium until each lobe contacts the mitral annulus.

[0048] Various disease processes can impair the proper function of one or more natural valves in the heart. These disease processes include degenerative processes (e.g., Barlow's disease, elastic fiber defect, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricular LV or right ventricular RV due to a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy, etc.) can distort the shape of the natural valve, which can lead to natural valve dysfunction. However, the majority of patients undergoing valve surgery, such as mitral valve MV surgery, suffer from degenerative diseases that cause dysfunction in the lobes (e.g., lobes 20, 22) of the natural valve (e.g., mitral valve MV), resulting in prolapse and regurgitation.

[0049] Generally, natural valves can malfunction in different ways, including (1) stenosis and (2) regurgitation. Stenosis occurs when the natural valve does not open completely, causing impaired blood flow. Typically, stenosis is caused by the accumulation of calcification on the valve lobes, which thickens the lobes and impairs the valve's ability to open completely and allow forward blood flow. Regurgitation occurs when the valve lobes do not completely close, causing blood to leak back into the previous chamber (for example, blood leaking from the left ventricle into the left atrium).

[0050] There are three main mechanisms by which the natural valve becomes regurgitant or inoperable, and these mechanisms include Carpentier type I, type II, and type III dysfunctions. Carpentier type I dysfunction involves annular dilation, which causes normally functioning leaflets to separate from each other and fail to form a tight seal (i.e., the leaflets do not properly join). Dysfunctions that constitute the type I mechanism include leaflet perforation, such as that found in endocarditis. Carpentier type II dysfunction involves one or more leaflets of the natural valve protruding above the plane of joining. Carpentier type III dysfunction involves restricted movement of one or more leaflets of the natural valve, resulting in abnormal restriction of the leaflets below the plane of the annular dilation. Leaflet restriction can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0051] Referring to Figure 5, when a healthy mitral valve (MV) is in an occluded position, the anterior leaflet 20 and posterior leaflet 22 join together, thereby preventing blood from leaking from the left ventricle (LV) to the left atrium (LA). Referring to Figures 3 and 6, mitral regurgitation (MR) occurs when the anterior leaflet 20 and / or posterior leaflet 22 of the mitral valve (MV) are displaced into the left atrium (LA) during systole, causing the edges of the leaflets 20 and 22 to no longer contact each other. When joining does not occur in this way, a gap 26 is created between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow back from the left ventricle (LV) to the left atrium (LA) during systole, as illustrated by the mitral regurgitation (MR) pathway shown in Figure 3. Referring to Figure 6, the gap 26 can have a width W of approximately 2.5 mm to 17.5 mm, 5 mm to 15 mm, 7.5 mm to 12.5 mm, or 10 mm. In some situations, the gap 26 can have a width W greater than 15 mm. As mentioned above, there are several different embodiments in which valve regurgitation can be caused by dysfunction of the valve lobes (e.g., valve lobes 20, 22 of the mitral valve MV).

[0052] In any of the situations described above, a valve repair device or implant capable of closing the gap 26 by engaging the anterior leaflet 20 and posterior leaflet 22 to prevent regurgitation of blood through the mitral valve MV is desirable. As can be seen from Figure 4, an abstract representation of an implantable device, valve repair device, or implant 10 is shown implanted between the valve leaves 20 and 22 to prevent regurgitation during systole (compare Figure 3 with Figure 4). In some implementations, the connecting members of the device 10 (e.g., spacers, connectors, gap fillers, etc.) have an overall tapered or triangular shape to naturally adapt to the shape of the natural valve and to the nature of its expanded valve leaves (towards the annulus). In this application, the terms spacer, joining member, coupling member, and gap filler are used interchangeably and refer to a member that fills a portion of the space between the leaves of a natural valve, and / or a member configured such that the leaves of a natural valve engage or "join" each other (for example, so that the leaves of a natural valve join not only to each other but also to joining members, coupling members, spacers, etc.).

[0053] While stenosis or regurgitation can affect any valve, stenosis has been found to primarily affect either the aortic valve (AV) or the pulmonary valve (PV), and regurgitation has been found to primarily affect either the mitral valve (MV) or the tricuspid valve (TV). Both valve stenosis and regurgitation increase the burden on the heart and, if left untreated, can lead to very serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. The left side of the heart (i.e., the left atrium (LA), left ventricle (LV), mitral valve (MV), and aortic valve (AV)) is primarily responsible for circulating blood throughout the body. Therefore, because the pressure is substantially higher on the left side of the heart, mitral valve (MV) or aortic valve (AV) dysfunction is particularly problematic and often life-threatening.

[0054] For malfunctioning natural heart valves, either repair or replacement may be performed. Repair typically involves preserving and modifying the patient's natural valve. Replacement typically involves replacing the patient's natural valve with a biological or mechanical substitute. Typically, the aortic valve (AV) and pulmonary valve (PV) are more prone to stenosis. Because stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic or pulmonary valve can involve removing the valve and replacing it with a surgically implanted valve, or replacing it with a transcatheter valve. The mitral valve (MV) and tricuspid valve (TV) are more prone to deformation of the valve leaflets and / or surrounding tissues, which, as mentioned above, can prevent proper occlusion of the mitral valve (MV) or tricuspid valve (TV), allowing for regurgitation or backflow of blood from the ventricle to the atrium (for example, deformation of the mitral valve (MV) can allow for regurgitation or backflow from the left ventricle (LV) to the left atrium (LA), as shown in Figure 3). Backflow of blood from the ventricle to the atrium results in valve insufficiency. Deformities in the structure or shape of the mitral valve (MV) or tricuspid valve (TV) are often repairable. In addition, backflow can occur due to dysfunction of the chordae tendineae (CT) (for example, the CT can become stretched or ruptured), which allows the anterior leaflet 20 and posterior leaflet 22 to invert, causing blood to flow back into the left atrium (LA). Problems caused by dysfunction of the chordae tendineae can be repaired by repairing the chordae tendineae or by repairing the structure of the mitral valve (MV) (for example, by fixing the leaflets 20 and 22 at the affected area of ​​the mitral valve).

[0055] The devices and procedures disclosed herein often refer to the repair of mitral valve structures. However, it will be understood that the devices and concepts provided herein may be used to repair any natural valve, as well as any component of a natural valve. Such devices can be used between the lobes 20 and 22 of the mitral valve MV to prevent or block the regurgitation of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (Figure 7), any device and concept herein can be used between any two of the anterior lobe 30, septal lobe 32, and posterior lobe 34 to prevent or block the regurgitation of blood from the right ventricle into the right atrium. In addition, any device and concept provided herein can be used together with all three lobes 30, 32, and 34 to prevent or block the regurgitation of blood from the right ventricle into the right atrium. That is, the valve repair devices or implants provided herein can be centrally positioned between the three lobes 30, 32, and 34.

[0056] An exemplary implantable device (e.g., an implantable device, etc.) or implant may optionally include a connecting member (e.g., a spacer, a connector, a gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, the implantable device or implant may have any combination or any partial combination of the features disclosed herein without having a connecting member. When included, the connecting member (e.g., a connector, a spacer, etc.) is configured to be positioned inside the opening of the natural heart valve, thereby assisting in filling the space between the valve leaves and forming a more effective seal, thereby reducing or preventing the regurgitation described above. The connecting member may have a structure that is impermeable to blood (or resists blood flow through it) and may have a structure that blocks the return of blood from the left ventricle to the left atrium and from the right ventricle to the right atrium by allowing the natural valve leaves to occlude around the connecting member during ventricular systole. The device or implant may be configured to seal to two or three natural valve lobes; that is, the device may be used in a natural mitral valve (biscuspid valve) and in a natural tricuspid valve. The jointing member is sometimes referred to herein as a spacer because it can fill the space between natural valve lobes that do not completely close and are not functioning properly (e.g., mitral valve lobes 20, 22, or tricuspid valve lobes 30, 32, 34).

[0057] Optional connecting members (e.g., spacers, connectors, etc.) can have a variety of shapes. In some implementations, the connecting member can have an elongated cylindrical shape with a circular cross-section. In some implementations, the connecting member can have an elliptical, oval, crescent, rectangular, or various other non-cylindrical shapes. In some implementations, the connecting member can have an atrial portion positioned within or adjacent to the atrium, a ventricular portion or lower portion positioned within or adjacent to the ventricle, and a side surface extending between the natural valve lobes. In some implementations configured for use in tricuspid valves, the atrial portion or upper portion is positioned within or adjacent to the right atrium, the ventricular portion or lower portion is positioned within or adjacent to the right ventricle, and the side surface extends between the natural tricuspid valve lobes.

[0058] In some implementations, the anchor can be configured to fix the device to one or both of the natural valve leaves so that the connecting member is positioned between the two natural valve leaves. In some implementations configured for use in tricuspid valves, the anchor can be configured to fix the device to one, two, or three of the tricuspid valve leaves so that the connecting member is positioned between the three natural valve leaves. In some implementations, the anchor can be attached to the connecting member in a position adjacent to the ventricular portion of the connecting member. In some implementations, the anchor can be attached to a drive member such as a shaft or drive wire, to which the connecting member is also attached. In some implementations, the anchor and the connecting member can be positioned independently of each other by moving each of them separately along the longitudinal axis of the drive member (e.g., drive shaft, drive rod, drive tube, drive wire, etc.). In some implementations, the anchor and the connecting member can be positioned simultaneously by moving the anchor and the connecting member together along the longitudinal axis of the drive member (e.g., shaft, drive wire, etc.). The anchor can be configured to be positioned behind the natural petal leaf when transplanted, so that the petal leaf is grasped by the anchor.

[0059] The device or implant may be configured to be implanted via a delivery system or other delivery means. The delivery system may include one or more of the following: a guide / delivery sheath, a delivery catheter, a maneuverable catheter, an implant catheter, a tube, or a combination thereof. The joint member and anchor may be compressible into a radially compressed state and self-expandable into a radially expanded state when the compressive pressure is released. The device may be configured such that the anchor expands radially away from the joint member, which is initially still compressed, to form a gap between the joint member and the anchor. The natural valve leaf can then be positioned within this gap. By expanding radially, the joint member can close the gap between the joint member and the anchor, thereby trapping the valve leaf between the joint member and the anchor. In some implementations, the anchor and joint member are optionally configured to self-expand. The implantation methods for various implementations may differ and are described in more detail below for each implementation. Further information regarding these delivery methods and other delivery methods can be found in U.S. Patent No. 8,449,599, U.S. Patent Application Publication No. 2014 / 022136, U.S. Patent Application Publication No. 2014 / 0067052, U.S. Patent Application Publication No. 2016 / 0331523, and PCT Patent Application Publication No. WO2020 / 076898, which are incorporated herein by reference in their entirety for all purposes. These methods can be carried out on living animals with necessary modifications, or on simulations such as cadavers, cadaver hearts, simulators (e.g., parts of a body, heart, tissue, etc. are simulated), etc.

[0060] The disclosed device or implant can be configured such that an anchor is connected to a valve leaflet and can resist large systolic pressures that bias the device toward the left atrium by utilizing tension from natural chordae tendineae. During diastole, the device can rely on compressive and retaining forces applied to the valve leaflet grasped by the anchor.

[0061] Referring here to Figures 8 to 15, a schematicly illustrated implantable device or implant 100 (e.g., an artificial spacer device, a valve restoration device, etc.) is shown at various stages of development. The device or implant 100, as well as other similar devices / implants, are described in more detail in PCT Patent Application Publication WO2018 / 195215, PCT Patent Application Publication WO2020 / 076898, and PCT Patent Application Publication WO2019 / 139904, which are incorporated herein by reference in their entirety. The device 100 may include any other features relating to an implantable device or implant described in this application or the applications cited above, and the device 100 may be positioned to engage with valve tissue (e.g., valve lobes 20, 22, 30, 32, 34) as part of any suitable valve restoration system (e.g., any valve restoration system disclosed in this application or the applications cited above).

[0062] The device or implant 100 is deployed from a delivery system or other delivery means 102. The delivery system 102 may include one or more of the following: catheters, sheaths, guide catheters / sheaths, delivery catheters / sheaths, maneuverable catheters, implant catheters, tubes, channels, pathways, combinations thereof, etc. The device or implant 100 includes a joint or connecting portion 104 and an anchor portion 106.

[0063] In some implementations, the joint portion 104 of the device or implant 100 is configured to be implanted between the leaflets of a natural valve (e.g., a natural mitral valve, a natural tricuspid valve, etc.) and includes a joint member or joining means 110 (e.g., a spacer, plug, filler, foam, sheet, membrane, connecting member, etc.) slidably attached to a drive member 112 (e.g., a drive wire, drive shaft, drive tube, etc.). The anchor portion 106 includes one or more anchors 108, which are drivable between an open state and a closed state and can take a wide variety of forms, such as a paddle, gripping member, or the like. The drive means or drive member 112 opens and closes the anchor portion 106 of the device 100, thereby gripping the leaflets of the natural valve during implantation. The drive means or drive member 112 (and other drive means and drive members as described herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), be made of a wide variety of different materials, and can have a wide variety of configurations. For example, the drive member may be threaded so as to rotate the drive member to move the anchor portion 106 relative to the joint portion 104. Alternatively, the drive member may not be threaded so as to push or pull the drive member 112 to move the anchor portion 106 relative to the joint portion 104.

[0064] The anchor portion 106 and / or anchor of device 100 includes an outer paddle 120 and an inner paddle 122, connected between the cap 114 and the joining means or joining member 110 by portions 124, 126, and 128 in some implementations. Portions 124, 126, and 128 can be articulated and / or flexible to move between all the positions described below. The interconnection of the outer paddle 120, the inner paddle 122, the joining member 110, and the cap 114 by portions 124, 126, and 128 can restrict the device to the positions and movements illustrated herein.

[0065] In some implementations, the delivery system 102 includes a maneuverable catheter, an implantable catheter, and a drive means or drive member 112 (e.g., a drive wire, a drive shaft, etc.). These can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the drive means or drive member 112 extends through the delivery catheter and further through a connecting means or connecting member 110 to the distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). The extension and retraction of the drive member 112 increase and decrease the distance between the connecting member 110 and the distal end of the device (e.g., a cap 114 or other attachment portion), respectively. In some implementations, a collar or other mounting member directly or indirectly attaches the connecting member 110 to the delivery system 102 so that a drive means or drive member 112 slides through the collar or other mounting member, and in some implementations, through the connecting means or connecting member 110 when driven, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0066] In some implementations, the anchor portion 106 and / or anchor 108 may include a mounting portion or gripping member. The illustrated gripping member may include a clasp 130 including a base or fixed arm 132, a movable arm 134, an optional return, a friction-enhancing member, or other fastening means 136 (e.g., projection, ridge, groove, textured surface, adhesive, etc.), and a joint portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 such that the joint portion 138 is positioned in close proximity to the fastening means or fastening member 110. In some implementations, the clasp (e.g., a clasp with a return, etc.) has a flat surface and does not fit into a recess in the inner paddle. Rather, the flat portion of the clasp is positioned relative to the surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the clasp 130. The joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or a similar joint. In some implementations, the joint portion 138 is a flexible member made of a material integrally formed with the fixed arm 132 and the movable arm 134. The fixed arm 132 is attached to the inner paddle 122 and remains stationary or substantially stationary with respect to the inner paddle 122 when the movable arm 134 opens, releasing the clasp 130 and exposing the return, friction-enhancing member, or fixing means 136.

[0067] In some implementations, the clasp 130 is released by applying tension to a drive line 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, flex, or rotate on the joint portion 138. The drive line 116 extends through a delivery system 102 (e.g., through a maneuverable catheter and / or implant catheter). Other drive mechanisms are also possible.

[0068] The drive line 116 can take on a wide variety of forms, such as a line, suture, wire, rod, catheter, or similar. The clasp 130 may be equipped with a spring force so that it continues to provide a clamping force to the grasped natural valve leaf in the occluded position. This clamping force remains constant regardless of the position of the inner paddle 122. Optional return, friction-enhancing member, or other fixing means 136 of the clasp 130 may grasp, clamp, and / or puncture the natural valve leaf to further secure it.

[0069] During transplantation, the paddles 120 and 122 open and close to grip, for example, between the paddles 120 and 122 and / or between the paddles 120 and 122 and the joining means or joining member 110. By using the clasp 130, the natural valve leaf can be gripped and / or further secured by engaging with the valve leaf by a return, friction-enhancing member, or fixing means 136 and by clamping the valve leaf between the movable arm 134 and the fixed arm 132. The return, friction-enhancing member, or other fixing means 136 (e.g., return, projection, ridge, groove, textured surface, adhesive, etc.) in the clasp or clasp with return 130 can increase friction with respect to the valve leaf or partially or completely puncture the valve leaf. The drive line 116 can be driven individually so that each clasp 130 can be opened and closed individually. By driving them individually, it becomes possible to grip one valve leaf at a time, or to reposition the clasp 130 on a valve leaf that was not adequately gripped without altering the good grip on other valve leaves. The clasp 130 can open and close relative to the position of the inner paddle 122 (as long as the inner paddle is in the open position or at least partially open position), thereby enabling the gripping of valve leaves in various positions required by specific situations.

[0070] Referring here to Figure 8, the device 100 is shown in an extended or fully open state for deployment from the implant delivery catheter of the delivery system 102. In the fully open position, the device 100 is positioned at the end of the catheter in the delivery system 102 because it occupies the least space in the fully open position and also allows the use of the smallest catheter (or the largest device 100 for a given catheter size). In the extended state, the cap 114 is separated from the connecting means or connecting member 110 so that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the insides of the outer paddle 120 and the inner paddle 122 is approximately 180 degrees. The clasp 130 is kept closed during deployment through the delivery system 102 to prevent the return, friction-enhancing member, or other fastening means 136 (Figure 9) from snagging or damaging the delivery system 102 or tissue in the patient's heart. The drive line 116 can extend to and be attached to the movable arm 134.

[0071] Referring to Figure 9, although the device 100 is shown in the same stretched and relaxed state as in Figure 8, the clasp 130 is in a fully open position between the fixed portion 132 and the movable portion 134 of the clasp 130, ranging from approximately 140 to 200 degrees, from approximately 170 to 190 degrees, or from approximately 180 degrees. It has been found that the full opening of the paddles 120, 122 and the clasp 130 improves the ease of detaching or attaching the device 100 to the patient's anatomical structures, such as chordae tendineae CT, during implantation.

[0072] Referring here to Figure 10, the device 100 is shown in a shortened or fully closed state. The compact size of the device 100 in the shortened state makes it easier to operate and position within the heart. To move the device 100 from the extended state to the shortened state, the drive means or drive member 112 is retracted, pulling the cap 114 toward the connecting means or connecting member 110. The connection portion 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained to move such that a compressive force acting from the cap 114 onto the outer paddle 120 pulls the paddle or gripping member toward the connecting means or connecting member 110, moving radially outward. When moving from the open position to the closed position, the outer paddle 120 maintains an acute angle with respect to the drive means or drive member 112. The outer paddle 120 can optionally be biased toward the closed position. The inner paddle 122 moves over a fairly large angle to orient itself away from the open joining means or joining member 110 during the same operation, and further to fold along the closed side of the joining means or joining member 110. In some implementations, the inner paddle 122 is made thinner and / or narrower than the outer paddle 120, and the connecting portions 126, 128 (e.g., joints, flexible connectors, etc.) connected to the inner paddle 122 can be made thinner and / or more flexible. For example, this enhanced flexibility can allow for greater movement compared to the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some implementations, the outer paddle 120 is made narrower than the inner paddle 122. The connecting portions 126 and 128 connected to the inner paddle 122 can be made more flexible to allow for greater movement compared to, for example, the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some implementations, the inner paddle 122 can be the same width as or substantially the same width as the outer paddle.

[0073] Referring here to Figures 11-13, device 100 is shown in a partially open and gripping-ready state. To transition from a fully closed state to a partially open state, the drive means or drive member (e.g., drive wire, drive shaft, etc.) is extended, pushing the cap 114 away from the joining means or joining member 110, thereby pulling the outer paddle 120 and the inner paddle 122, and partially widening the anchor or anchor portion 106. The drive line 116 is also retracted, thereby opening the clasp 130 so that it can grip the valve leaf. In some implementations, the pair of inner and outer paddles 122, 120 are driven integrally, rather than individually, by a single drive means or a single drive member 112. Also, the position of the clasp 130 depends on the position of the paddles 122, 120. For example, referring to Figure 10, closing the paddles 122 and 120 also means closing the clasp. In some implementations, the paddles 120 and 122 can be controlled independently. For example, device 100 may have two drive members and two independent caps (or other mounting parts), so that one paddle can be controlled using one independent drive member (e.g., a wire, shaft, etc.) and cap (or other mounting part), and the other paddle can be controlled using the other independent drive member and cap (or other mounting part).

[0074] Referring to Figure 12, extending one drive line 116 can close one clasp 130. Referring to Figure 13, extending another drive line 116 can close another clasp 130. By repeatedly driving one or both of the drive lines 116, the clasps 130 can be repeatedly opened and closed.

[0075] Referring here to Figure 14, device 100 is shown in both a fully closed and deployed state. The delivery system or delivery means 102 and the drive means or drive member 112 are retracted, and the paddles 120, 122 and clasp 130 remain in the fully closed position. After being deployed, device 100 can be held in the fully closed position by a mechanical latch, or it can be biased to remain closed by using a spring material such as steel, other metals, plastics, composite materials, etc., or by using a shape memory alloy such as Nitinol. For example, the connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from a metal such as steel, or from a shape memory alloy such as Nitinol, which can be manufactured from wire, sheet, tube, or laser-sintered powder, and are further biased to hold the outer paddle 120 in an enclosed state around the joining means or joining member 110, and to clamp the clasp 130 around the natural valve leaf. Similarly, the fixed arm 132 and movable arm 134 of the clasp 130 are biased to clamp the valve leaf. In some implementations, the mounting or connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from any other suitable elastic material such as metal or polymer material to maintain the device 100 in an enclosed state after implantation.

[0076] Figure 15 illustrates an example in which the paddles 120 and 122 are independently controllable. The device 101 shown in Figure 15 is similar to the device shown in Figure 11, except that the device 100 in Figure 15 includes drive members configured as two independent drive members or drive wires 111 and 113 coupled to two independent caps 115 and 117. To move the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, the drive means or drive member 111 is extended, pushing the cap 115 away from the joining means or joining member 110, thereby pulling the outer paddle 120 and the inner paddle 122, and partially widening the first anchor 108. To move the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, the drive means or drive member 113 is extended, pushing the cap 115 away from the connecting means or connecting member 110, thereby pulling the outer paddle 120 and the inner paddle 122, and partially widening the second anchor 108. The independent paddle control shown in Figure 15 can be implemented in any device disclosed in this application. For comparison, in the example shown in Figure 11, the pair of inner and outer paddles 122, 120 are driven collectively, rather than individually, by a single drive means or a single drive member 112.

[0077] Referring to Figures 16 to 21, the implantable device 100 shown in Figures 8 to 14 is delivered and implanted inside the natural mitral valve MV of heart H. Referring to Figure 16, the delivery sheath / catheter is inserted through the septum into the left atrium LA, and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state as shown in Figure 16. Subsequently, the implant / device is moved to a fully occluded state as shown in Figure 17 by retracting the drive means or drive member 112.

[0078] As can be seen from Figure 18, the implant / device is driven to a position within the mitral valve MV and further into the ventricular LV, and is partially open to grasp the valve lobes 20 and 22. For example, the maneuverable catheter can be advanced and steered or bent, thereby allowing it to be positioned as shown in Figure 18. The implant catheter connected to the implant / device can be advanced from inside the maneuverable catheter, thereby allowing the implant to be positioned as shown in Figure 18.

[0079] Referring to Figure 19, the implant catheter can be retracted into the maneuverable catheter to position the mitral valve lobes 20 and 22 within the clasp 130. By extending the drive line 116, one of the clasps 130 is occluded, capturing the lobe 20. Figure 20 shows that by subsequently extending the other drive line 116, the other clasp 130 is occluded, capturing the remaining lobe 22. Furthermore, as can be understood from Figure 21, the delivery system 102 (e.g., maneuverable catheter, implant catheter, etc.), the drive means or drive member 112, and the drive lines 116 are then retracted to completely occlude the device or implant 100 and deploy it within the natural mitral valve MV.

[0080] Referring here to Figures 22–27, an example relating to an implantable device or implant or implant 200 is shown. The implantable device 200 is one of many different configurations that device 100 schematically shown in Figures 8–14 can take. Device 200 may include any other features relating to the implantable device or implant described herein, and device 200 may be positioned to engage with valve tissue 20, 22 as part of any suitable valve restoration system (e.g., any valve restoration system disclosed herein). Device / implant 200 may be an artificial spacer device, a valve restoration device, or another type of implant that attaches to the leaflets of a natural valve.

[0081] In some implementations, the implantable device or implant 200 includes a joint or connecting portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some implementations, the joint or connecting portion 204 of the device optionally includes a connecting member 210 (e.g., a spacer, connecting member, plug, membrane, sheet, etc.) for implantation between the leaflets of a natural valve. In some implementations, the anchor portion 206 includes a plurality of anchors 208. The anchors can be configured in various ways. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clasp 230. In some implementations, the mounting portion 205 includes a first collar or proximal collar 211 (or other mounting member) for engaging with the capture mechanism 213 (Figures 43-49) of the delivery system 202 (Figures 38-42 and 49). The delivery system 202 may be identical or similar to the delivery system 102 described elsewhere and may include one or more of the following: catheters, sheaths, guide catheters / sheaths, delivery catheters / sheaths, maneuverable catheters, implant catheters, tubes, channels, pathways, combinations thereof, etc.

[0082] In some implementations, the joining members 210 and paddles 220, 222 can be formed from a metal cloth such as mesh, a woven fabric, a braid, or any other suitable form, or from a flexible material cut by laser cutting or other means. The material can be cloth, a shape memory alloy wire such as Nitinol to provide shape-setting ability, or any other flexible material suitable for implantation in the human body.

[0083] The drive member 212 (e.g., drive shaft, drive rod, drive tube, drive wire, drive line, etc.) extends from the delivery system 202 and engages with the implantable device or implant 200 to enable the drive of the implantable device or implant 200. In some implementations, the drive member 212 extends through the capture mechanism 213, the proximal collar 211, and the connecting member 210 to engage with the cap 214 of the distal portion 207. The drive member 212 can be configured to engage the cap 214 detachably by a screw connection or a similar connection, so that the drive member 212 can be disengaged and removed from the device 200 after implantation.

[0084] The connecting member 210 extends from the proximal collar 211 (or other mounting member) to the inner paddle 222. In some implementations, the connecting member 210 has an overall elongated and circular shape, but other shapes and configurations are possible. In some implementations, the connecting member 210 has an elliptical shape or cross-section when viewed from above (e.g., Figure 51), a tapered shape or cross-section when viewed from the front (e.g., Figure 23), and a circular shape or cross-section when viewed from the side (e.g., Figure 24). A mixture of these three geometric shapes can result in a three-dimensional shape relating to the illustrated connecting member 210 that achieves the advantages described herein. It can also be understood that the circular shape of the connecting member 210 substantially follows or approximates the shape of the paddle frame 224 when viewed from above.

[0085] The size and / or shape of the connecting member 210 can be selected to minimize the number of implants (preferably one) required for a single patient, while simultaneously maintaining a low transflap gradient. In some implementations, the anterior-posterior distance at the top of the connecting member is approximately 5 mm, and the medial-to-lateral distance at the widest point of the connecting member is approximately 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and the overall shape strategy described above. It will be readily apparent that using other anterior-posterior and medial-to-lateral distances as a starting point for the device will result in a device with different dimensions. Furthermore, using other dimensions and shape strategies described above will also result in a device with different dimensions.

[0086] In some implementations, the outer paddle 220 is articulately attached to the cap 214 of the distal portion 207 by a connecting portion 221 and to the inner paddle 222 by a connecting portion 223. The inner paddle 222 is articulately attached to the joint member by a connecting portion 225. Thus, the anchor 208 is configured similarly to a leg, with the inner paddle 222 resembling the upper portion of the leg, the outer paddle 220 resembling the lower portion of the leg, and the connecting portion 223 resembling the knee portion of the leg.

[0087] In some implementations, the inner paddle 222 has a rigid portion that is hard, relatively hard, or rigid, and / or is hardened by a reinforcing member or fixing portion 232 of the clasp 230. The hardening of the inner paddle allows the device to be driven to various different positions as illustrated and described herein. The inner paddle 222, the outer paddle 220, and the joint can all be interconnected as described herein, thereby restricting the device 200 to the movement and position as illustrated and described herein.

[0088] In some implementations, the paddle frame 224 is attached to the cap 214 at its distal portion 207 and extends to a connecting portion 223 between the inner paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is formed from a more rigid and harder material compared to the material forming the paddles 222, 220, so that the paddle frame 224 provides support for the paddles 222, 220.

[0089] As can be seen from Figure 51, the paddle frame 224 provides additional clamping force between the inner paddle 222 and the joint member 210, and assists in wrapping the valve leaf around the sides of the joint member 210 for better sealing between the joint member 210 and the valve leaf. That is, the paddle frame 224 can be configured having a rounded three-dimensional shape extending from the cap 214 to the connecting portion 223 of the anchor 208. The connections between the paddle frame 224, the outer paddle 220 and the inner paddle 222, the cap 214, and the joint member 210 can restrict each of these members to the movement and position described herein. In particular, the connecting portion 223 is restricted by its connection between the outer paddle 220 and the inner paddle 222, and by its connection to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connecting portion 223 (and thus to the inner paddle 222 and the outer paddle 220) and by its attachment to the cap 214.

[0090] By configuring the paddle frame 224 in this way, the surface area is increased compared to the outer paddle 220 alone. This makes it easier, for example, to grasp and fix the natural valve leaf. The increased surface area also allows the clamping force of the paddle 220 and paddle frame 224 on the natural valve leaf to be distributed over a relatively large surface area of ​​the natural valve leaf, further protecting the natural valve leaf tissue. Referring again to Figure 51, the increased surface area of ​​the paddle frame 224 also allows the natural valve leaf to be clamped against the implantable device or implant 200 so that the natural valve leaf is joined to the entire periphery of the bonding member or connecting member 210. This can improve the sealing of the natural valve leaves 20, 22, for example, and thus prevent or further reduce mitral valve regurgitation.

[0091] In some implementations, the clasp includes a movable arm coupled to the anchor. In some implementations, the clasp 230 includes a base or fixed arm 232, a movable arm 234, a return 236, and a joint portion 238. The fixed arm 232 is attached to the inner paddle 222 with the joint portion 238 positioned in close proximity to the connecting member 210. The joint portion 238 is provided with a spring force so that when the clasp 230 is closed, the fixed arm 232 and the movable arm 234 are biased toward each other. In some implementations, the clasp 230 includes friction-enhancing members or fastening means such as a return, projection, ridge, groove, textured surface, or adhesive.

[0092] In some implementations, the fixed arm 232 is attached to the inner paddle 222 through a hole or slot 231 using sutures (not shown). The fixed arm 232 can be attached to the inner paddle 222 using any suitable means such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, clamps, latches, or similar. The fixed arm 232 remains substantially stationary relative to the inner paddle 222 when the movable arm 234 is released, thereby releasing the clasp 230 and exposing the return or other friction-enhancing member 236. The clasp 230 is released by applying tension to a drive line 216 (e.g., as shown in Figures 43-48) attached to a hole 235 in the movable arm 234, thereby causing the movable arm 234 to articulate, rotate, and / or bend on the joint portion 238.

[0093] Referring here to Figure 29, an enlarged view of one of the valve leaves 20, 22 grasped by a clasp such as clasp 230 is shown. The valve leaves 20, 22 are grasped between the movable arm 234 and the fixed arm of clasp 230. Although the tissue of the valve leaves 20, 22 is not punctured by the barb or friction-enhancing member 236, in some implementations the barb 236 may partially or completely puncture the valve leaves 20, 22. The angle and height of the barb or friction-enhancing member 236 relative to the movable arm 234 helps to secure the valve leaves 20, 22 inside the clasp 230. In particular, the force pulling the implant away from the natural valve leaves 20, 22 promotes further engagement of the barb or friction-enhancing member 236 with the tissue, thereby ensuring better retention. The retention of the valve leaves 20 and 22 within the clasp 230 is further improved by the position of the fixed arm 232, which is located near the return / friction-enhancing member 236 when the clasp 230 is closed. In this configuration, the tissue is shaped into an S-shaped curved path by the fixed arm 232, the movable arm 234, and the return / friction-enhancing member 236. Thus, the force pulling the valve leaves 20 and 22 away from the clasp 230 promotes further engagement of the tissue with the return / friction-enhancing member 236 before the valve leaves 20 and 22 can escape. For example, the tension of the valve leaves during expansion can promote pulling the return 236 toward the ends of the valve leaves 20 and 22. Thus, the S-shaped path, by utilizing the tension of the valve leaves during expansion, can more tightly engage the valve leaves 20 and 22 with the return / friction-enhancing member 236.

[0094] Referring to Figure 25, the artificial device or implant 200 may also include a cover 240. In some implementations, the cover 240 may be positioned on the joint member 210, on the outer paddles 220 and inner paddles 222, and / or on the paddle frame 224. The cover 240 may be configured to prevent or reduce blood flow through the artificial device or implant 200, and / or to promote the engraftment of natural tissue. In some implementations, the cover 240 may be cloth or fabric, such as PET, velour, or other suitable fabric. In some implementations, instead of cloth, or in addition to cloth, the cover 240 may include a coating (e.g., polymer) applied to the implantable device or implant 200.

[0095] During transplantation, the paddles 220 and 222 of the anchor 208 are opened and closed, allowing the natural valve leaves 20 and 22 to be gripped between the paddles 220 and 222 and the connecting member 210. The anchor 208 is driven between a closed position (Figures 22 to 25) and various open positions (Figures 26 to 37) by extending and retracting the drive member 212. Extending and retracting the drive member 212 increases and decreases the distance between the connecting member 210 and the cap 214, respectively. The proximal collar 211 (or other mounting member) and the connecting member 210 slide along the drive member 212 during driving, resulting in a change in the distance between the connecting member 210 and the cap 214, which drives the paddles 220 and 222 between different positions, thereby gripping the mitral valve leaves 20 and 22 during transplantation.

[0096] When opening and closing device 200, the pair of inner and outer paddles 222 and 220 are driven together, rather than individually, by a single drive member 212. The position of the clasp 230 depends on the positions of the paddles 222 and 220. For example, the clasp 230 is configured such that closing the anchor 208 simultaneously closes the clasp 230. In some implementations, device 200 can be configured to have paddles 220 and 222 that are independently controllable in the same manner (e.g., device 100 shown in Figure 15).

[0097] In some implementations, the clasp 230 further secures the natural valve leaves 20, 22 by engaging them with a barb and / or other friction-enhancing member 236, and further by sandwiching the valve leaves 20, 22 between the movable arm 234 and the fixed arm 232. In some implementations, the clasp 230 is a barb clasp, including a barb that increases friction with the valve leaves 20, 22 and / or can partially or completely puncture the valve leaves 20, 22. The drive line 216 (Figures 43-48) can be driven individually so that each clasp 230 can be opened and closed individually. By driving individually, it is possible to grip one valve leaf 20, 22 at a time, or to reposition the clasp 230 on a valve leaf 20, 22 that is not sufficiently gripped without altering the good grip on other valve leaves 20, 22. The clasp 230 can be fully opened and closed when the inner paddle 222 is not closed, thereby allowing the valve leaves 20, 22 to be grasped in various positions as required by specific circumstances.

[0098] Referring here to Figures 22-25, the device 200 is shown in the closed position. When closed, the inner paddle 222 is positioned between the outer paddle 220 and the joining member 210. The clasp 230 is positioned between the inner paddle 222 and the joining member 210. Once the natural petal leaves 20, 22 have been successfully captured, the device 200 is driven to the closed position and held in that position so that the petal leaves 20, 22 are secured within the device 200 by the clasp 230 and pressed against the joining member 210 by the paddles 220, 222. The outer paddle 220 may have a broad curved shape that conforms to the curved shape of the joining member 210 to more securely grip the petal leaves 20, 22 when the device 200 is closed (as can be seen, for example, from Figure 51). The curved shape and rounded edge of the outer paddle 220 also prevent or prevent tearing of the petal leaf tissue.

[0099] Referring here to Figures 30 to 37, the implantable device or implant 200 described above is shown in various positions and configurations ranging from partially open to fully open. The paddles 220 and 222 of the device 200 transition between the positions shown in Figures 30 to 37, from the closed position shown in Figures 22 to 25, to the upward extension of the drive member 212 from the fully retracted position to the fully extended position.

[0100] Referring here to Figures 30-31, the device 200 is shown in a partially open position. The device 200 is driven to the partially open position by extending the drive member 212. The extension of the drive member 212 pulls down the bottom of the outer paddle 220 and the paddle frame 224. The outer paddle 220 and the paddle frame 224 pull down the inner paddle 222, in which case the inner paddle 222 is connected to the outer paddle 220 and the paddle frame 224. Because the proximal collar 211 (or other mounting member) and the connecting member 210 are held in place by the capture mechanism 213, the inner paddle 222 is articulated, rotated, and / or bent toward the opening. The inner paddle 222, the outer paddle 220, and the paddle frame all bend to the positions shown in Figures 30-31. By opening the paddles 222, 220 and frame 224, a gap is formed between the joining member 210 and the inner paddle 222 that can receive and grip the natural petal leaves 20, 22. This movement also exposes the clasp 230, which can move between a closed position (Figure 30) and an open position (Figure 31), thereby forming a second gap for gripping the natural petal leaves 20, 22. The range of the gap between the fixed arm 232 and the movable arm 234 of the clasp 230 is limited to the range in which the inner paddle 222 extends away from the joining member 210.

[0101] Referring here to Figures 32 and 33, the device 200 is shown in the laterally extended or laterally open position. The device 200 is driven to the laterally extended or laterally open position by continuing the extension of the drive member 212 described above, thereby increasing the distance between the joining member 210 and the cap 214 of the distal portion 207. Continuing the extension of the drive member 212 pulls down the outer paddle 220 and paddle frame 224, thereby spreading the inner paddle 222 further away from the joining member 210. In the laterally extended or laterally open position, the inner paddle 222 is more horizontally extended compared to other positions of the device 200 and forms an angle of approximately 90 degrees with respect to the joining member 210. Similarly, the paddle frames 224 are in their maximally extended position when the device 200 is in the laterally extended or laterally open position. The increased gap formed between the connecting member 210 and the inner paddle 222 in the lateral extension or lateral open position allows the clasp 230 to open further before engaging with the connecting member 210 (Figure 33), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0102] Referring here to Figures 34-35, the exemplary device 200 is shown in the three-quarters extended position. The device 200 is driven to the three-quarters extended position by continuing the extension of the drive member 212 as described above, thereby increasing the distance between the joining member 210 and the cap 214 of the distal portion 207. Continuing the extension of the drive member 212 pulls down the outer paddle 220 and paddle frame 224, thereby spreading the inner paddle 222 further away from the joining member 210. In the three-quarters extended position, the inner paddle 222 is open to the joining member 210 at an angle of more than 90 degrees, approximately 135 degrees. The paddle frame 224 is less spread compared to the lateral extended position or lateral open position and begins to move inward toward the drive member 212 as the drive member 212 is further extended. The outer paddle 220 also bends backward toward the drive member 212. Similar to the lateral extension position or lateral open position, the increased gap formed between the connecting member 210 and the inner paddle 222 in the lateral extension position or lateral open position allows the clasp 230 to open further (Figure 35), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0103] Referring here to Figures 36-37, the exemplary device 200 is shown in the fully extended position. The device 200 is driven to the fully extended position by continuing to extend the drive member 212 as described above, thereby increasing the distance between the joining member 210 and the cap 214 of the distal portion 207 to the maximum distance allowed by the device 200. Continuing to extend the drive member 212 pulls down the outer paddle 220 and paddle frame 224, thereby spreading the inner paddle 222 further away from the joining member 210. The outer paddle 220 and paddle frame 224 are driven to a position where they are closer to the drive member. In the fully extended position, the inner paddle 222 is open to the joining member 210 at an angle of approximately 180 degrees. The inner and outer paddles 222 and 220, in their fully extended position, are straightened to form an angle of approximately 180 degrees between them. The fully extended position of device 200 provides the maximum size of the gap between the connecting member 210 and the inner paddle 222, and in some implementations, also allows the clasp 230 to be fully opened to approximately 180 degrees between the fixed arm 232 and the movable arm 234 of the clasp 230 (Figure 37). The position of device 200 is the longest and narrowest configuration. Thus, the fully extended position of device 200 may be a desirable position for rescuing device 200 from an attempted implant, or a desirable position for positioning the device within a delivery catheter, or similar.

[0104] Configuring the artificial device or implant 200 so that the anchor 208 can extend in a linear or nearly linear configuration (e.g., at approximately 120 to 180 degrees relative to the connecting member 210) can offer several advantages. For example, this configuration can reduce the radial waveform profile of the artificial device or implant 200. It can also make it easier to grasp the natural valve leaves 20, 22 by providing a larger opening between the connecting member 210 and the internal paddle 222 for grasping the natural valve leaves 20, 22. In addition, a relatively narrow and linear configuration can prevent or reduce the possibility of the artificial device or implant 200 becoming entangled in natural anatomical structures (e.g., chordae tendineae CT shown in Figures 3 and 4) when positioning and / or retrieving the artificial device or implant 200 within the delivery system 202.

[0105] Referring here to Figures 38–49, an exemplary implantable device 200 is shown being delivered and implanted within the natural mitral valve MV of heart H. As described above, the device 200 shown in Figures 38–49 includes an optional cover 240 (e.g., Figure 25) over a connecting member 210, a clasp 230, and an inner paddle 222 and / or an outer paddle 220. The device 200 is deployed from a delivery system 202 (e.g., which may include a maneuverable catheter and / or an implantable catheter extendable from a guide sheath) and held by a capture mechanism 213 (see, e.g., Figures 43 and 48), and further driven by extending and retracting a drive member 212. The fingers of the capture mechanism 213 detachably attach the collar 211 to the delivery system 202. In some implementations, the capture mechanism 213 is held in a closed position around the collar 211 by a drive member 212, so that after the device 200 is successfully implanted, the fingers of the capture mechanism 213 can be released from the collar 211 by removing the drive member 212, thereby releasing the collar 211 and thus detaching the capture mechanism 213 from the device 200.

[0106] Referring to Figure 38, the delivery system 202 (e.g., its delivery catheter / sheath) is inserted through the septum into the left atrium (LA), and the device / implant 200 is deployed from the delivery system 202 in a fully open state for the reasons described above with respect to the device 100 (for example, an implant catheter holding the device / implant can be expanded to deploy the device / implant from the maneuverable catheter). Subsequently, by retracting the drive member 212, the device 200 is driven through a partially occluded state (Figure 39) to the fully occluded state shown in Figures 40-41. The delivery system or catheter then maneuvers the device / implant 200 toward the mitral valve (MV), as shown in Figure 41. Referring to Figure 42, when the device 200 is aligned with the mitral valve MV, the drive member 212 extends, opening the paddles 220 and 222 to a partially open position, and the drive line 216 (Figures 43 to 48) is retracted, opening the clasp 230 and putting it in a waiting state for gripping the valve leaflets. Next, as shown in Figures 43 to 44, the partially open device 200 is inserted through the natural valve (for example, by advancing the implant catheter from the maneuverable catheter) until the valve leaflets 20 and 22 are properly positioned between the inner paddle 222 and the connecting member 210, and further inside the open clasp 230.

[0107] Figure 45 shows the device 200, in which both clasps 230 are in an occluded state, but the return 236 of one clasp 230 is not engaged with one of the valve lobes 22. As can be seen from Figures 45 to 47, the misaligned clasp 230 is opened and closed again to properly grasp the released valve lobe 22. When both valve lobes 20 and 22 are properly grasped, the device 200 is driven to the fully occluded position shown in Figure 48 by retracting the drive member 212. When the device 200 is fully occluded and implanted in the natural valve, the capture mechanism 213 can be released from the proximal collar 211 (or other mounting member) by disengaging and withdrawing the drive member 212 from the cap 214, thereby allowing the capture mechanism 213 to be withdrawn into the delivery system 202 (e.g., into the catheter / sheath), as shown in Figure 49. After deployment, the device 200 can be maintained in a fully closed position by mechanical means such as a latch, or it may be biased to remain closed through the use of a spring material such as steel and / or through the use of a shape memory alloy such as Nitinol. For example, the paddles 220, 222 can be formed from steel or Nitinol shape memory alloy, which can be manufactured from wire, sheet, tube or laser sintered powder, and further bias the outer paddle 220 to remain closed around the inner paddle 222, the joining member 210 and / or clasp 230, which sandwich the natural valve leaves 20, 22 around it.

[0108] Referring to Figures 50 to 54, after the device 200 has been implanted in the natural valve, the connecting member 210 functions as a gap filler in the valve regurgitation opening, such as the gap 26 in the mitral valve MV shown in Figure 6, or a gap in another natural valve. In some implementations, when the device 200 is deployed between two opposing valve leaves 20, 22, the valve leaves 20, 22 no longer join to each other in the area of ​​the connecting member 210, but instead join to the connecting member 210. This reduces the distance that the valve leaves 20, 22 need to approach to close the mitral valve MV during systole, thereby facilitating the repair of functional valve diseases that can cause mitral regurgitation. The reduction in the valve leaf approach distance can also result in several other advantages. For example, the reduced approach distance required of the valve leaves 20, 22 reduces or minimizes the stress experienced by the natural valve. A shorter approach distance to the valve leaves 20 and 22 also requires less approach force, which can reduce the tension experienced by the valve leaves 20 and 22 and reduce the diameter reduction of the valve ring. A smaller or no reduction in the diameter of the valve ring can result in a smaller reduction in the valve opening area compared to a device without a connecting member or spacer. In this way, the connecting member 210 can reduce the transvalvular gradient.

[0109] To adequately fill the gap 26 between the valve leaves 20 and 22, the device 200 and its components can have a wide variety of different shapes and sizes. For example, the outer paddles 220 and paddle frames 224 can be configured to fit the shape or geometry of the joining member 210, as shown in Figures 50 to 54. As a result, the outer paddles 220 and paddle frames 224 can engage with both the joining member 210 and the natural valve leaves 20 and 22. In some implementations, when the valve leaves 20 and 22 are joined to the joining member 210, the valve leaves 20 and 22 can prevent small leaks on the outer and inner surfaces 201 and 203 of the joining member 210 by completely surrounding or "embracing" the joining member 210. The interaction between the valve lobes 20, 22 and the device 200 is evident in Figure 51, which shows a schematic atrial or surgeon's view diagram illustrating a paddle frame 224 (which would not actually be visible from a true atrial diagram, e.g., Figure 52) conforming to the geometry of the connecting member 210. The opposing valve lobes 20, 22 (whose ends would also not be visible from a true atrial diagram, e.g., Figure 52) are driven to approach the connecting member 210 by the paddle frame 224, thereby completely surrounding or "embracing" it.

[0110] This connection of the valve leaves 20 and 22 to the outer and inner surfaces 201 and 203 of the connecting member 210 (shown from the atrial side in Figure 52 and from the ventricular side in Figure 53) seems to contradict the above statement that the presence of the connecting member 210 minimizes the distance at which the valve leaves need to be close together. However, the distance at which the valve leaves 20 and 22 need to be close together is still minimized if the connecting member 210 is precisely positioned in the regurgitation gap 26, and even more so if the regurgitation gap 26 is smaller than the width (inside-outside) of the connecting member 210.

[0111] Figure 50 illustrates the geometric shapes of the joint member 210 and paddle frame 224 from the perspective of the LVOT. As can be seen from this figure, the joint member 210 has a tapered shape, with smaller dimensions in the region close to where the inner surfaces of the valve lobes 20 and 22 are required to be joined, and increasing in dimensions as the joint member 210 extends toward the atrium. Thus, the problem of the geometric shape of the illustrated natural valve is addressed by the tapered shape of the joint member. Referring again to Figure 50, the tapered shape of the joint member, in combination with the shape of the extended paddle frame 224 (towards the annulus) as shown, can help achieve capture at the lower end of the valve lobe, reduce stress, and minimize transvalvular gradient.

[0112] Referring to Figure 54, the shapes of the joint member 210 and the paddle frame 224 can be defined based on the internal commissure diagram of the natural valve and the device 200. Two factors relating to these shapes are the joining of the valve leaves to the joint member 210 and the reduction of stress on the valve leaves resulting from the joining. Referring to Figures 54 and 24, for both joining the valve leaves 20, 22 to the joint member 210 and reducing the stress that the joint member 210 and / or the paddle frame 224 apply to the valve leaves 20, 22, the joint member 210 can have a circular or rounded shape, and the paddle frame 224 can have a full radius that extends almost the entire length of the paddle frame 224. The rounded shape of the joint member 210 and / or the illustrated fully rounded shape of the paddle frame 224 distribute the stress on the valve leaves 20, 22 across the greatly curved engagement region 209. For example, in Figure 54, the force exerted on the valve leaves 20 and 22 by the paddle frame spreads along the entire round length of the paddle frame 224 because the valve leaf 20 tries to open during the expansion phase.

[0113] Referring here to Figure 55, an example of an implantable device or implant 300 is shown. The implantable device 300 is one of many different configurations that the device 100 schematically illustrated in Figures 8 to 14 can take. The device 300 may include any other features relating to the implantable device or implant described herein, and the device 300 may be positioned to engage with valve tissue 20, 22 as part of any suitable valve restoration system (e.g., any valve restoration system disclosed herein).

[0114] The implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 includes a joint portion 304, which optionally includes a joint member 310 (e.g., a spacer, plug, membrane, sheet, etc.) for implantation between the lobes 20, 22 of a natural valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 may include one or more paddles, for example, an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchors may also include and / or be coupled to a clasp 330. In some implementations, the mounting portion 305 includes a first collar or proximal collar 311 (or other mounting member) for engaging with a capture mechanism (e.g., a capture mechanism 213 shown in Figures 43 to 49) of a delivery system (e.g., a delivery system such as the systems shown in Figures 38 to 42 and 49).

[0115] The anchor 308 can be attached to other parts of the device and / or to each other in various different ways (e.g., directly, indirectly, by welding, stitching, adhesive, linking, latching, integral molding, or a combination of some or all of these). In some implementations, the anchor 308 is attached to the joining member or joining element 310 by a connecting portion 325 and to the cap 314 by a connecting portion 321.

[0116] The anchor 308 may include a first part or outer paddle 320 and a second part or inner paddle 322, separated by a connecting portion 323. The connecting portion 323 can be attached to a paddle frame 324 that is hinged to a cap 314 or other mounting portion. Thus, the anchor 308 is configured similarly to a leg, with the inner paddle 322 resembling the upper part of a leg, the outer paddle 320 resembling the lower part of a leg, and the connecting portion 323 resembling the knee portion of a leg.

[0117] In an implementation having a joining member or joining element 310, the joining member or joining element 310 and the anchor 308 can be joined to each other in various ways. For example, as shown in the illustrated example, the joining member 310 and the anchor 308 can be joined to each other by integrally forming the joining member 310 and the anchor 308 as a single integrated component. This can be achieved, for example, by forming the joining member 310 and the anchor 308 from a continuous strip 301 made of a braided or woven material such as braided or woven Nitinol wire. In the illustrated example, the joining member 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, and 325 are formed from a continuous strip of fabric 301.

[0118] Similar to the anchor 208 in the implantable device or implant 200 described above, the anchor 308 can be configured to move between various configurations by moving the distal end of the device (e.g., cap 314, etc.) axially relative to the proximal end of the device (e.g., proximal collar 311 or other mounting member, etc.), thereby moving the anchor 308 relative to the midpoint of the device. This movement can be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other mounting member, etc.) of the device. For example, the anchor 308 can be positioned in a fully extended configuration or a linear configuration (e.g., similar to the configuration of device 200 shown in Figure 36) by moving the distal end (e.g., cap 314, etc.) away from the proximal end of the device.

[0119] In some implementations, in the linear configuration, the paddle portions 320, 322 are aligned with or linear to the orientation of the longitudinal axis of the device. In some implementations, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the joining member 310 (for example, similar to the configuration of device 200 shown in Figure 36). From the linear configuration, the anchor 308 can be driven to a fully folded configuration (e.g., Figure 55) by, for example, driving the proximal and distal ends toward each other and / or toward the midpoint or center of the device. Initially, as the distal end (e.g., cap 314, etc.) moves toward the proximal end and / or toward the midpoint or center of the device, the anchor 308 bends at the connecting portions 321, 323, and 325, and the connecting portion 323 moves radially outward with respect to the longitudinal axis of the device 300 and axially toward the midpoint and / or proximal end of the device (for example, similar to the configuration of device 200 shown in Figure 34). As the cap 314 continues to move toward the midpoint and / or proximal end of the device, the connecting portion 323 moves radially inward with respect to the longitudinal axis of the device 300 and axially toward the proximal end of the device (for example, similar to the configuration of device 200 shown in Figure 30).

[0120] In some implementations, the clasp includes a movable arm coupled to the anchor. In some implementations, the clasp 330 (as shown in detail in Figure 28B) includes a base or fixed arm 332, a movable arm 334, an optional return / friction-enhancing member 336, and a joint portion 338. The fixed arm 332 is attached to the inner paddle 322 with the joint portion 338 positioned in close proximity to the connecting member 310. The joint portion 338 is equipped with a spring force such that the fixed arm 332 and the movable arm 334 are biased toward each other when the clasp 330 is closed.

[0121] The fixed arm 332 is attached to the inner paddle 322 through a hole or slot 331 using sutures (not shown). The fixed arm 332 may be attached to the inner paddle 322 by any suitable means, such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesive, or similar. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is released, thereby releasing the clasp 330 and exposing the return 336. The clasp 330 is released by applying tension to a drive line (e.g., drive line 216 shown in Figures 43-48) attached to a hole 335 in the movable arm 334, thereby causing the movable arm 334 to articulate, rotate, and / or bend on the joint portion 338.

[0122] In summary, the implantable device or implant 300 is similar in structure and operation to the implantable device or implant 200 described above, except that the bonding member 310, the outer paddle 320, the inner paddle 322, and the connecting portions 321, 323, and 325 are formed from a single strip 301 of material. In some implementations, the strip 301 of material is attached to the proximal collar 311, the cap 314, and the paddle frame 324 by being woven or inserted through openings configured to receive a continuous strip 301 of material, in the proximal collar 311, the cap 314, and the paddle frame 324. The continuous strip 301 may be a single layer of material or may include two or more layers. In some implementations, part of the device 300 has a single layer of material strip 301, and other parts are formed from multiple overlapping or overlapping layers of material strip 301.

[0123] For example, Figure 55 shows a joint member 310 and an inner paddle 322 formed from multiple overlapping layers consisting of strips of material 301. A single continuous strip of material 301 can start and end at various locations on the device 300. The ends of the material strip 301 can be located at the same or different locations on the device 300. For example, in the example shown in Figure 55, the material strip 301 starts and ends at the location of the inner paddle 322.

[0124] Similar to the implantable device or implant 200 described above, the size of the connecting member 310 can be selected to minimize the number of implants (preferably one) required for a single patient, while simultaneously maintaining a low transflap gradient. In particular, forming many of the components of the device 300 from strips 301 made of material makes it possible to make the device 300 smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the connecting member 310 is less than 2 mm, and the inward-outward distance at the widest point of the device 300 (i.e., the width of the paddle frame 324 wider than the connecting member 310) is about 5 mm.

[0125] The concepts disclosed in this application can be used with a wide variety of different valve repair devices. Figures 56A to 56H illustrate another example relating to one valve repair system 40056 to which the concepts of this application can be applied, among many valve repair systems for repairing a patient's natural valve. Valve repair system 40056 includes a delivery device 40156 and a valve repair device 40256.

[0126] The valve repair device 40256 includes a base assembly 40456, a pair of paddles 40656, and a pair of gripping members 40856. In one example, the paddles 40656 can be formed integrally with the base assembly. For example, the paddles 40656 can be formed as an extension of a link in the base assembly. In the illustrated example, the base assembly 40456 of the valve repair device 40256 has a shaft 40356, a coupler 40556 configured to move along the shaft, and a lock 40756 configured to lock the coupler in a stationary position on the shaft. The coupler 40556 is mechanically connected to the paddles 40656 such that the movement of the coupler 40556 along the shaft 40356 drives the paddles between an open position and a closed position. Thus, the coupler 40556 functions as a means for mechanically coupling the paddle 40656 to the shaft 40356, and when driven along the shaft 40356, drives the paddle 40656 between their open and closed positions.

[0127] In some implementations, the gripping member 40856 is rotatably connected to the base assembly 40456 so that the width of the opening 41456 between the paddle 40656 and the gripping member 40856 can be adjusted by driving the gripping member (for example, the gripping member 40856 can be rotatably connected to the shaft 40356 or to any other suitable member in the base assembly). The gripping member 40856 may include a return portion 40956 for attaching the gripping member to the valve tissue when the valve repair device 40256 is attached to the valve tissue. The gripping member 40856 forms means for gripping the valve tissue (particularly the tissue of the valve leaf) using fastening means or fastening portions such as the return portion 40956. When the paddle 40656 is in the closed position, the paddle engages with the gripping member 40856, and when the valve tissue is attached to the return portion 40956 of the gripping member, the paddle acts as a retaining or fixing means, holding the valve tissue at the gripping member and fixing the valve repair device 40256 to the valve tissue. In some implementations, the gripping member 40856 is configured to engage with the paddle 40656 such that the return portion 40956 engages with the valve tissue member and the paddle 40656, for the purpose of fixing the valve repair device 40256 to the valve tissue member. For example, in certain situations, it may be advantageous for the paddle 40656 to maintain the open position and for the gripping member 40856 to move outward toward the paddle 40656 to engage the valve tissue with the paddle 40656.

[0128] Although the examples shown in Figures 56A to 56H illustrate a pair of paddles 40656 and a pair of gripping members 40856, it will be understood that the valve repair device 40256 may include any appropriate number of paddles and gripping members.

[0129] In some implementations, the valve repair system 40056 includes an placement shaft 41356 that is detachably attached to the shaft 40356 of the base assembly 40456 in the valve repair device 40256. After the valve repair device 40256 is fixed to the valve tissue, the placement shaft 41356 can be removed from the shaft 40356, thereby removing the valve repair device 40256 from the rest of the valve repair system 40056, which allows the valve repair device 40256 to remain attached to the valve tissue and the delivery device 40156 to be removed from the patient's body.

[0130] The valve repair system 40056 may also include a paddle control mechanism 41056, a gripping member control mechanism 41156, and a lock control mechanism 41256. The paddle control mechanism 41056 is mechanically attached to the coupler 40556 and drives the paddle 40656 between the open and closed positions by driving the coupler along the shaft. The paddle control mechanism 41056 can take any suitable form, such as a shaft or rod. For example, the paddle control mechanism may include a hollow shaft, a catheter tube, or a sleeve fitted on the placement shaft 41356 and on the shaft 40356 and connected to the coupler 40556.

[0131] The gripping member control mechanism 41156 is configured to drive the gripping member 40856 so that the width of the opening 41456 between the gripping member and the paddle 40656 can be changed. The gripping member control mechanism 41156 can take any suitable form, such as a line, suture or wire, rod, catheter, etc.

[0132] The lock control mechanism 41256 is configured to lock and unlock the lock. The lock 40756 functions as a locking means for locking the coupler 40556 in a stationary position relative to the shaft 40356 and can take on a wide variety of different forms, and the type of lock control mechanism 41256 can be indicated by the type of lock used. In one example, the lock 40756 takes the form of a lock often used in caulking guns. That is, the lock 40756 includes a rotatable plate having a hole, and the shaft 40356 of the valve repair device 40256 is positioned inside the hole in the rotatable plate. In this example, when the rotatable plate is in an inclined position, the rotatable plate maintains its position on the shaft 40356 by engaging with the shaft 40356, but when the rotatable plate is in a substantially non-inclined position, the rotatable plate can move along the shaft (this allows the coupler 40556 to move along the shaft 40356). In other words, when the rotatable plate of the lock 40756 is in the tilted position (or locked position), the coupler 40556 is prevented from moving along the shaft 40356 in direction Y (as shown in Figure 56E), while when the rotatable plate is in the substantially non-tilted position (or unlocked position), the coupler is allowed to move along the shaft 40356 in direction Y. In the example where the lock 40756 includes a rotatable plate, the lock control mechanism 41256 is configured to engage with the rotatable plate, thereby driving the plate between the tilted position and the substantially non-tilted position. The lock control mechanism 41256 can be, for example, a rod, suture, wire, or any other member capable of driving the rotatable plate of the lock 40756 between the tilted position and the substantially non-tilted position. In some implementations, the rotatable plate of lock 40756 is biased to an inclined position (or locked position), and the plate can be driven from the inclined position to a substantially non-inclined position (or unlocked position) by using the lock control mechanism 41256.In some implementations, the rotatable plate of lock 40756 is biased to a substantially non-tilted position (or unlocked position), and the plate can be driven from the substantially non-tilted position to the tilted position (or locked position) by using the lock control mechanism 41256.

[0133] Figures 56E to 56F illustrate a valve repair device 40256 driven from an open position (shown in Figure 56E) to a closed position (shown in Figure 56F). The base assembly 40456 includes a first link 102156 extending from point A to point B, a second link 102256 extending from point A to point C, a third link 102356 extending from point B to point D, a fourth link 102456 extending from point C to point E, and a fifth link 102556 extending from point D to point E. A coupler 40556 is movably mounted on a shaft 40356, and the shaft 40356 is fixed to the fifth link 102556. The first link 102156 and the second link 102256 are rotatably mounted to the coupler 40556 at point A, so that the movement of the coupler 40556 along the shaft 40356 drives the position at point A, and consequently drives the first link 102156 and the second link 102256. The first link 102156 and the third link 102356 are rotatably mounted to each other at point B, and the second link 102256 and the fourth link 102456 are rotatably mounted to each other at point C. One paddle 40656a is mounted to the first link 102156 such that the movement of the first link 102156 drives the paddle 40656a, and the other paddle 40656b is mounted to the second link 102256 such that the movement of the second link 102256 drives the paddle 40656b. Alternatively, paddles 40656a and 40656b can be connected to links 102356 and 102456, or they can be extensions of links 102356 and 102456.

[0134] To drive the valve repair device from the open position (shown in Figure 56E) to the closed position (shown in Figure 56F), the coupler 40556 is driven in direction Y along the shaft 40356, thereby driving the pivot point A of the first link 102156 and the second link 102256 to a new position. By driving the coupler 40556 (and pivot point A) in direction Y, the portion of the first link 102156 located near point A is driven in direction H, and the portion of the first link 102156 located near point B is driven in direction J. The paddle 40656a is attached to the first link 102156 such that when the coupler 40556 is driven in direction Y, the paddle 40656a is driven in direction Z. In addition, the third link 102356 is rotatably attached to the first link 102156 at point B, thereby driving the coupler 40556 in direction Y, which drives the third link 102356 in direction K. Similarly, driving the coupler 405 (and the pivot point A) in direction Y drives the portion of the second link 102256 located near point A in direction L, and drives the portion of the second link 102256 located near point C in direction M. The paddle 40656b is attached to the second link 102256 such that driving the coupler 40556 in direction Y drives the paddle 40656b in direction V. In addition, the fourth link 102456 is rotatably attached to the second link 102256 at point C, thereby driving the coupler 40556 in direction Y, which drives the fourth link 102456 in direction N. Figure 56F illustrates the final position of the valve repair device 40256 after the coupler 40556 has been driven as shown in Figure 56E.

[0135] Referring to Figure 56B, the valve repair device 40256 is shown in the open position (similar to the position shown in Figure 56E), and the gripping member control mechanism 41156 is shown in a state where it drives the gripping member 40856 to provide a wider gap at the opening 41456 between the gripping member and the paddle 40656. In the illustrated example, the gripping member control mechanism 41156 includes a line, such as a suture or wire, which is fitted through an opening in the end of the gripping member 40856. Both ends of the line extend through the delivery opening 51656 of the delivery device 40156. When the line is pulled in direction Y through the delivery opening 51656, the gripping member 40856 is driven inward in direction X, thereby widening the opening 41456 between the gripping member and the paddle 40656.

[0136] Referring to Figure 56C, the valve repair device 40256 is shown with the valve tissues 20 and 22 positioned within the opening 41456 between the gripping member 40856 and the paddle 40656. Referring to Figure 56D, after the valve tissues 20 and 22 are positioned between the gripping member 40856 and the paddle 40656, the width of the opening 41456 between the gripping member and the paddle is narrowed by using the gripping member control mechanism 41156. That is, in the illustrated example, the gripping member 40856 is made able to move in direction D by releasing or pushing out the line of the gripping member control mechanism 41156 from the opening 51656 of the delivery member in direction H, thereby narrowing the width of the opening 41456. Although the gripping member control mechanism 41156 is shown to widen the opening 41456 between the gripping member and the paddle 40656 by driving the gripping member 40856 (Figure 56C), it will be understood that there may be cases where it is not necessary to drive the gripping member when positioning valve tissue within the opening 41456. However, in certain situations, it may be necessary to widen the opening 41456 between the paddle 40656 and the gripping member 40856 when receiving valve tissue.

[0137] Referring to Figure 56G, the valve repair device 40256 is in the closed position and fixed to the valve tissues 20 and 22. The valve repair device 40256 is fixed to the valve tissues 20 by paddles 40656a and 40656b and gripping members 40856a and 40856b. In particular, the valve tissues 20 and 22 are attached to the valve repair device 40256 by the return portions 40956 of the gripping members 40856a and 40856b, and the valve repair device 40256 is fixed to the valve tissues 20 and 22 by the engagement of the paddles 40656a and 40656b with the gripping member 40856.

[0138] To drive the valve repair device 40256 from the open position to the closed position, the lock 40756 is driven to the unlocked state by the lock control mechanism 41256 (as shown in Figure 56G). After the lock 40756 is unlocked, the coupler 40556 can be driven along the shaft 40356 by the paddle control mechanism 41056. In the illustrated example, the paddle control mechanism 41056 drives the coupler 40556 along the shaft in direction Y, thereby driving one paddle 40656a in direction X and the other paddle 40656b in direction Z. By driving paddle 40656a in direction X and paddle 40656b in direction Z, the paddles are engaged with the gripping members 40856a and 40856b, and the valve repair device 40256 is fixed to the valve tissues 20 and 22.

[0139] Referring to Figure 56H, after the valve repair device 40256 is fixed to the valve tissues 20 and 22 by driving the paddle 40656 to the closed position (as shown in Figure 56G), the lock 40756 is driven to the locked state by the lock control mechanism 41256 (Figure 56G) to maintain the valve repair device 40256 in the closed position. After the valve repair device 40256 is maintained in the locked state by the lock 40756, the valve repair device 40256 is removed from the delivery device 40156 by detaching the shaft 40356 from the placement shaft 41356 (Figure 56G). In addition, the valve repair device 40256 is detached from the paddle control mechanism 41056 (Figure 56G), the gripping member control mechanism 41156 (Figure 56G), and the lock control mechanism 41256. By removing the valve repair device 40256 from the delivery device 40156, it is possible to keep the valve repair device fixed to the valve tissues 20 and 22 while the delivery device 40156 is being removed from the patient.

[0140] When implantable devices or implants are placed within a natural heart valve, the drive of the device to the implantation site may be hindered or obstructed by the natural heart structure. For example, the articular portion of the implantable device or implant (such as the paddle portion of the anchor used to secure the device to the natural heart valve tissue) may be rubbed, temporarily caught, or temporarily blocked by chordal CTs (shown in Figures 3 and 4) extending into the valve lobe. Exemplary implantable devices or implants can be configured to reduce the likelihood of the device or implant being temporarily caught or blocked by CTs. For example, implantable devices or implants can take on a wide variety of configurations, such as being configured to actively or passively narrow, thereby reducing the width of the paddle frame at the anchor portion of the device, and consequently reducing the surface area of ​​the device, thereby facilitating the device / implant to move beyond and / or through CTs.

[0141] Referring to Figures 57–68, various configurations relating to an example of an implantable device or implant 400 are shown. The device / implant 400 is configured to be more easily maneuvered to a position for implantation within the heart by reducing contact and / or friction between the device / implant 400 and the natural structures of the heart, such as cords. The device / implant 400 may include any other features relating to an implantable device or implant, such as those described in this application or in applications or patent documents incorporated herein by reference, and the device 400 may be positioned to engage with valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein). In addition, any device or implant described herein may have features relating to the device / implant 400.

[0142] The device / implant 400 may include a joint or connecting portion 404 and an anchor portion 406. The anchor portion may include two or more anchors 408. In some implementations, the joint portion 404 optionally includes one or more connecting members 410 (e.g., spacers, connecting members, gap fillers, etc.). The spacers, connecting members, connecting members, etc. 410 may take any suitable form, such as any form described in this application.

[0143] Each anchor 408 includes a plurality of paddles 420 (for example, three in each illustrated example) and one or more clasps 430 (for example, three in the illustrated examples shown in Figures 57 to 59). The clasps 430 can take any suitable form, such as any form described herein.

[0144] Although the illustrated examples show anchors 408 containing three paddles 420, it should be understood that anchors 408 may contain any appropriate number of paddles 420, such as two or more paddles, three or more paddles, four or more paddles, five or more paddles, and so on.

[0145] In some implementations, each of the anchors 408 may contain a clasp 430 corresponding to each of the paddles 420 (as shown in Figures 57-59), or each anchor 408 may contain only a single clasp 430 corresponding to a single paddle of multiple paddles 420 (for example, as shown in Figures 60-68). However, it will be understood that each anchor 408 may contain any number of paddles 420 with corresponding clasps 430, and any number of paddles 420 without corresponding clasps 430.

[0146] The joining member 410 and the anchor 408 can be joined in various ways. For example, as shown in the illustrated example, the joining member 410 and the anchor 408 can be joined to each other by optionally forming the joining member 410 and the anchor 408 as a single integrated component. This can be achieved, for example, by forming the joining member 410 and the anchor 408 from a continuous strip of braided or woven material, such as braided or woven Nitinol wire. In some implementations, multiple components are formed individually and attached to each other.

[0147] The device or implant 400 may also include a mounting portion 405 for attaching the device 400 to a delivery system 402 (Figures 69 to 73). The delivery system 402 may be identical or similar to other delivery systems described herein, such as 102, 202, and may include one or more of the following: catheters, sheaths, guide catheters / sheaths, delivery catheters / sheaths, maneuverable catheters, implant catheters, tubes, channels, pathways, combinations thereof, etc. The mounting portion 405 may include a proximal collar 411 for engaging with the delivery system 402 (for example, with the implant catheter of the delivery system). For example, the proximal collar 411 may be configured to engage with the capture mechanism of the delivery system 402 (for example, the capture mechanism 213 shown in Figures 43 to 49) (for example, the capture mechanism of the implant catheter).

[0148] The anchor 408 is configured to allow the device or implant 400 to be more easily maneuvered to a position for implantation within the heart by reducing contact and / or friction between the anchor 408 and the natural structure of the heart, such as a cord-like structure. The anchor 408 includes a plurality of paddles 420 such that one or more gaps G are formed between the paddles 420. Contact between the natural structure of the heart and the anchor 408 is reduced so that the natural structure of the heart can extend into the gaps G as the device 400 is driven through the heart. This allows the device or implant 400 to be more easily maneuvered within the heart. In addition, the gaps G allow the paddles to flex toward each other when in contact with the anchor 408 and the natural structure of the heart, such as a cord-like structure. This flexing also allows the device / implant 400 to be more easily maneuvered through the heart. The device / implant can also be configured to drive the paddles toward each other by opening and closing the paddles 420. This drive mechanism, which directs the paddles toward each other, also allows the device / implant 400 to be more easily steered through the heart.

[0149] Anchor 408 can have a total width TW of 4mm to 20mm, such as 6mm to 15mm, such as 8mm to 12mm, such as approximately 10mm. Each paddle 420 can have a width W of 0.2mm to 2mm, such as 0.3mm to 1.5mm, such as 0.5mm to 1mm. Although each paddle 420 is shown as having the same width W, it will be understood that the width W of any two paddles 420 may not be equal to the width W of the other paddles 420. The ratio of the total width TW to the width W can be, for example, 7 / 1 to 15 / 1, such as approximately 10 / 1, such as 5 / 1 to 20 / 1. The ratio of the total width to the sum of the widths W of the paddles 420 can be, for example, 3 / 1 to 10 / 1, such as approximately 4 / 1, such as approximately 2 / 1 to 15 / 1.

[0150] In the illustrated example, the inner paddle axis IPA of the inner paddles 420 of the multiple paddles 420 is substantially aligned with respect to the central axis CA of the device 400, and the outer paddle axis OPA of one or more outer paddles 420 extends at an angle α away from the inner paddle axis IPA of the inner paddles 420. The angle α can be 5 to 60 degrees, such as 15 to 45 degrees, or 20 to 35 degrees.

[0151] Referring to Figures 57 to 62, each of the paddles 420 has a length L of 6 mm to 18 mm, such as 8 mm to 16 mm, 10 mm to 14 mm, or approximately 12 mm. Although each of the paddles 420 is shown as having the same length L, it will be understood that the length L of any one paddle 420 may not be equal to the length L of the other paddles (see, for example, Figures 63 to 68).

[0152] Figures 60–62 illustrate an exemplary implementation of the portable device or implant 400 shown in Figures 57–59. In this example, the device or implant 400 is identical to the example shown in Figures 57–59, except that each anchor 408 includes only a single clasp 430 connected to one of a plurality of paddles 420. In the illustrated example, the clasp 430 is connected to the inner paddle 420 of each anchor 408, and the outer paddle of each anchor 408 does not include a corresponding clasp. In some implementations, each of the outer paddles 420 may include a corresponding clasp 430, and the inner paddles 420 may not include a corresponding clasp. It will be understood that any number of paddles 420 may include a corresponding clasp 430, and any number of paddles 420 may not include a corresponding clasp 430.

[0153] Figures 63 to 65 illustrate an exemplary implementation of the implantable device or implant 400 shown in Figures 60 to 62. In this example, the device 400 is identical to the example shown in Figures 60 to 62, except that the inner paddle 420 of each anchor 408 has a length IL that is longer than the length OL of the outer paddle 420. The length IL can be 6 mm to 18 mm, such as 8 mm to 16 mm, such as 10 mm to 14 mm, such as approximately 12 mm, etc. The length OL can be 4 mm to 16 mm, such as 6 mm to 14 mm, such as 8 mm to 12 mm, such as approximately 10 mm, etc. The ratio of length IL to length OL can be 10 / 9 to 2 / 1, such as 8 / 7 to 3 / 2, such as approximately 6 / 5, etc.

[0154] Figures 66 to 68 illustrate an exemplary implementation of the implantable device or implant 400 shown in Figures 60 to 62. In this example, the device 400 is identical to the example shown in Figures 60 to 62, except that the inner paddle 420 of each anchor 408 has a length IL that is shorter than the length OL of the outer paddle 420. The length OL can be 6 mm to 18 mm, such as 8 mm to 16 mm, such as 10 mm to 14 mm, such as approximately 12 mm, etc. The length IL can be 4 mm to 16 mm, such as 6 mm to 14 mm, such as 8 mm to 12 mm, such as approximately 10 mm, etc. The ratio of length OL to length IL can be 10 / 9 to 2 / 1, such as 8 / 7 to 3 / 2, such as approximately 6 / 5, etc.

[0155] In the examples shown in Figures 63 to 68, each anchor 408 is illustrated having a single clasp 430 corresponding to an inner paddle 420. However, it should be understood that each paddle 420 of an anchor 408 may include a corresponding clasp 430 (for example, as shown in Figures 57 to 59), or any number of paddles 420 may include a corresponding clasp 430, and any number of paddles 420 may not include a corresponding clasp 430.

[0156] Referring to Figures 69 to 73, the device 400 is shown at various stages of deployment from the delivery system 402. The delivery system 402 can take any suitable form, such as any form described herein. Although examples of the device / implant 400 illustrated in Figures 57 to 59 are shown with reference to Figures 69 to 73, it will be understood that the deployment of the device / implant 400 from the delivery system 402 also applies to the examples of the device / implant 400 shown in Figures 60 to 68.

[0157] Referring to Figure 69, the device / implant 400 is shown in a compressed position within the delivery system 402. The connecting member 410 and paddle 420 are formed from a compressible material that allows the device 400 to be in a compressed position when the device 400 is driven to a desired position within the patient's heart. While the device / implant 400 is located within the delivery system 402, and until the device / implant 400 is deployed from the delivery system 402 and implanted onto a natural heart valve (e.g., a natural mitral valve, a natural tricuspid valve, etc.), the capture mechanism 413 is connected to the collar 411 of the device / implant 400.

[0158] Figure 70 shows the device or implant 400 in its deployed and closed position. When the device / implant 400 is deployed from the delivery system 402, the joint member 410 expands outward M, and the outer paddles 420 of each anchor 408 rotate or articulate outward in direction N to their normal positions, thereby creating a gap G (Figures 57 and 59) between the inner paddle 420 and each outer paddle 420.

[0159] The drive shaft 412 extends from the delivery system 402 and engages with the paddle 420, driving the paddle 420 from the closed position to the open position. Referring to Figure 71, driving the drive shaft 412 in direction Y engages with the paddle 420 and applies force to the paddle 420, driving the paddle 420 outward in direction X to the open position. That is, the paddle 420 can be rotatably or flexibly connected to the joining member 410 at the connection point 470 so that when force is applied to the paddle 420, the paddle 420 can rotate, bend and / or articulate with respect to the joining member 410. Referring again to Figure 71, the clasp 430 is maintained in the open position relative to the paddle 420 by the corresponding drive line 416 applying tension F on the clasp 430 so that a tissue trapping area exists between the paddle 420 and the clasp 430.

[0160] Referring to Figure 72, after the leaflet tissue is positioned within the tissue capture region between the clasp 430 and the paddle 420, the clasp 430 is driven in direction Z to capture the tissue and fix the device 400 to the tissue. The clasp 430 can be biased toward the closed position so as to be driven toward the closed position by releasing the tension F (Figure 71) from the drive line 416, or the clasp 430 can be driven toward the closed position by making the drive line 416 actively controllable by the user.

[0161] Referring to Figure 73, after the device 400 is secured to the leaflet tissue by the paddles 420 and clasps 430, the drive shaft 412 is disengaged from the paddles 420 and driven backward into the delivery system 402, thereby driving the paddles 420 back to their normal occluded position. After the device 400 is secured to the tissue and the anchor 408 is in the occluded position, the capture mechanism 413 is detached from the collar 411, and the delivery system 402 can be removed from the patient, so that the device 400 is no longer attached to the delivery system 402.

[0162] Referring to Figures 74 to 85, various configurations relating to an example of an implantable device or implant 500 are shown. The device or implant 500 is configured to be more easily maneuvered to a position for implantation within the heart by reducing contact and / or friction between the device or implant 500 and the natural structures of the heart, such as cords. The device or implant 500 may include any other features relating to an implantable device or implant, such as those described in this application or in applications or patent documents incorporated herein by reference, and the device 500 may be positioned to engage with valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein). In addition, any device or implant described herein may have features relating to the device / implant 500.

[0163] The implantable device or implant 500 includes a joint or connecting portion 504, a proximal or attachment portion 505, an anchor portion 506, and a distal portion 507. In some implementations, the joint portion 504 includes a connecting member 510 (e.g., a spacer, connecting member, gap filler, etc.) which can be used to implant between the lobes 20, 22 in, for example, a natural mitral valve MV. The connecting member 510 can take any suitable form, such as any form described herein. The attachment portion 205 includes a first collar or proximal collar 511 for engaging with a capture mechanism 513 of a delivery sheath or delivery system 202 (see Figures 86A, 86B, 87A, 87B, 88, and 89). The proximal collar 511 can take any suitable form, such as any form described herein.

[0164] The anchor portion 506 may include two or more anchors 508, each anchor 508 including a plurality of paddle members 519 (for example, three in each illustrated example) and one or more clasps 530 (for example, three in the illustrated examples shown in Figures 74 to 76). The clasps 530 can take any suitable form, such as any form described herein. The distal portion 507 includes a cap 514 attached to the paddle portion 519 so that the cap 514 can be driven to move the paddle portion 519 between an open position and a closed position. The cap 514 can take any suitable form, such as any form described herein.

[0165] The paddle members 519 may each include an outer paddle 520 and an inner paddle 522. The paddle members 519 may be formed from, for example, a metal cloth such as mesh, a woven cloth, a braid, or any other suitable form, or from a flexible material that is laser-cut or otherwise cut. The material may be cloth, a shape memory alloy wire such as Nitinol to provide shape-setting ability, or any other flexible material suitable for implantation in the human body. In some implementations, the paddle members 519 further include a paddle frame (not shown) that supports the inner paddle 522 and the outer paddle 520. The paddle frame may take any suitable form, such as any form relating to the paddle frame described herein.

[0166] The joining member 510 is optional. In the illustrated example, the joining member 510 and the paddle member 519 are formed from a continuous strip of material. The material can be any material described in this application with respect to the paddle member 519, for example. In some implementations, multiple components are formed individually and mounted together. The joining member 510 extends from the proximal collar 511 to the inner paddle 522.

[0167] The joint member 510 has an overall elongated and rounded shape. In particular, the joint member 510 has an elliptical shape or cross-section when viewed from above (for example, as shown in Figure 74), a tapered shape or cross-section when viewed from the front (for example, as shown in Figure 75), and a rounded shape or cross-section when viewed from the side (for example, as shown in Figure 76). A combination of these three geometric shapes can result in a three-dimensional shape relating to the illustrated joint member 510 that achieves the advantages described herein.

[0168] Although the illustrated examples show anchors 508 each containing three paddle members 519, it will be understood that an anchor 508 may contain any appropriate number of paddle members 519, such as two or more paddle members, three or more paddle members, four or more paddle members, five or more paddle members, etc. In addition, each anchor 508 may include a clasp 530 corresponding to each of the paddle members 519 (as shown in Figures 74 to 76), or each anchor 508 may include only a single clasp 530 corresponding to a single paddle member of multiple paddle members 519 (as shown in Figures 77 to 79, for example). However, it will be understood that each anchor 508 may contain any number of paddle members 519 with corresponding clasps 530, and any number of paddle members 519 without corresponding clasps 530.

[0169] The anchor 508 is configured to allow the device 500 to be more easily maneuvered to a position for implantation within the heart by reducing contact and / or friction between the anchor 508 and the natural structure of the heart, such as a cord-like structure. The anchor 508 includes a plurality of paddles 520 such that one or more gaps G are formed between the paddles 520. Contact between the natural structure of the heart and the anchor 508 is reduced so that the natural structure of the heart can extend into the gaps G as the device 500 is driven through the heart. This allows the device 500 to be more easily maneuvered within the heart. In addition, the gaps G allow the paddles to flex toward each other when in contact with the anchor 508 and the natural structure of the heart, such as a cord-like structure. This flexing also allows the device 500 to be more easily maneuvered through the heart. The device can also be configured to drive the paddles 520, 522 toward each other by opening and closing the paddles 520, 522. This drive, directed toward each other by the paddles, also allows the device 500 to be more easily controlled through the heart.

[0170] Anchor 508 can have a total width TW of 4mm to 20mm, such as 6mm to 15mm, such as 8mm to 12mm, such as approximately 10mm. Each paddle 519 can have a width W of 0.2mm to 2mm, such as 0.3mm to 1.5mm, such as 0.5mm to 1mm. Although each paddle 519 is shown as having the same width W, it will be understood that the width W of any two paddles 519 may not be equal to the width W of the other paddles 519. The ratio of the total width TW to the width W can be, for example, 7 / 1 to 15 / 1, such as approximately 10 / 1, such as 5 / 1 to 20 / 1. The ratio of the total width to the sum of the widths W of the paddles 519 can be, for example, 3 / 1 to 10 / 1, such as approximately 4 / 1, such as approximately 2 / 1 to 15 / 1.

[0171] Referring to Figures 74 to 79, each of the inner paddles 522 has a length L of 6 mm to 18 mm, such as 8 mm to 16 mm, 10 mm to 14 mm, or approximately 12 mm. Although each of the inner paddles 522 is shown as having the same length L, it will be understood that the length L of any one inner paddle 522 may not be equal to the length L of another inner paddle (see, for example, Figures 63 to 68).

[0172] Figures 77–79 illustrate an example of the implantable device or implant 500 shown in Figures 74–76. In this example, the device 500 is identical to the example shown in Figures 74–76, except that each anchor 508 includes only a single clasp 530 attached to one of the paddle members 519. In the illustrated example, the clasp 530 is aligned to the center of one of the inner paddles 522 of each anchor 508, while the outer ones on the inner paddle members 522 do not include a corresponding clasp. In some implementations, the outer ones on the paddle members 519 may include a corresponding clasp 530, while the inner ones on the paddle members 519 may not include a corresponding clasp. It will be understood that any number of paddle members 519 may include a corresponding clasp 530, and any number of paddle members 519 may not include a corresponding clasp 530.

[0173] Figures 80 to 82 illustrate an exemplary implementation of the implantable device or implant 500 shown in Figures 77 to 79. In this example, the device / implant 500 is identical to the example shown in Figures 77 to 79, except that the inner part of the anchor 508 in the paddle 519 has a length IL that is longer than the length OL of the outer part of the paddle 519. The length IL can be 6 mm to 18 mm, such as 8 mm to 16 mm, such as 10 mm to 14 mm, such as approximately 12 mm, etc. The length OL can be 4 mm to 16 mm, such as 6 mm to 14 mm, such as 8 mm to 12 mm, such as approximately 10 mm, etc. The ratio of length IL to length OL can be 10 / 9 to 2 / 1, such as 8 / 7 to 3 / 2, such as approximately 6 / 5, etc.

[0174] Figures 83 to 85 illustrate an exemplary implementation of the implantable device or implant 500 shown in Figures 77 to 79. In this example, the device 500 is identical to the example shown in Figures 77 to 79, except that the inner paddle member 519 of each anchor 508 has a length IL that is shorter than the length OL of the outer paddle member 519. The length OL can be 6 mm to 18 mm, such as 8 mm to 16 mm, such as 10 mm to 14 mm, such as approximately 12 mm, etc. The length IL can be 4 mm to 16 mm, such as 6 mm to 14 mm, such as 8 mm to 12 mm, such as approximately 10 mm, etc. The ratio of length OL to length IL can be 10 / 9 to 2 / 1, such as 8 / 7 to 3 / 2, such as approximately 6 / 5, etc.

[0175] In the examples shown in Figures 80 to 85, each anchor 508 is illustrated having a single clasp 530 corresponding to an inner paddle member 519. However, it should be understood that each paddle member 519 of the anchor 508 may include a corresponding clasp 530 (for example, as shown in Figures 74 to 76), or any number of paddle members 519 may include a corresponding clasp 530, and any number of paddle members 519 may not include a corresponding clasp 530.

[0176] Referring to Figures 86A, 87A, and 88-90, the device or implant 500 is shown at various stages of deployment from the delivery system 502. The delivery system 502 can take any suitable form and may be identical or similar to other delivery systems herein, such as 102, 202, 402, etc., and may further include one or more of the following: catheters, sheaths, guide catheters / sheaths, delivery catheters / sheaths, maneuverable catheters, implant catheters, tubes, channels, pathways, combinations thereof, etc. Although examples of the device or implant 500 illustrated in Figures 74-76 are shown with reference to Figures 86A, 87A, and 88-90, it will be understood that the deployment of the device / implant 500 from the delivery system 502 also applies to the examples of the device / implant 500 shown in Figures 77-85.

[0177] Referring to Figure 86A, the device or implant 500 is shown in a compressed position within the delivery system 502. The connecting member 510 and the paddle member 519 are formed from a compressible material that can compress the device 500 as it is driven to a desired position within the patient's heart. While the device 500 is located within the delivery system 502, and until the device 500 is deployed from the delivery system 502 and implanted onto a natural mitral valve MV (or other natural heart valve), the capture mechanism 513 is connected to the collar 511 of the device 500.

[0178] Figure 87A shows the device 500 in its deployed closed position. When the device 500 is deployed from the delivery system 502, the connecting member 510 expands outward M, and the outer members 519 of each anchor 508 rotate outward in direction N to their normal position, thereby creating a gap G (Figures 74 and 76) between the inner paddle member 519 and each outer paddle member 519.

[0179] Figure 86B shows an example similar to the one in Figure 86A, where the paddle member 519 is in an extended position inside the delivery system 502. Because the paddle is not positioned around the outside of the bonding member 510, the device / implant 500 can be compressed to a smaller size compared to the example in Figure 86A. As a result, in the example shown in Figure 86B, a smaller delivery system 502 (compared to the delivery system used in the example shown in Figure 86A) can be used to deliver a device of the same size.

[0180] Figure 87B shows the device or implant 500 configured as shown in Figure 86B being led out of the delivery system 502. When the device / implant 500 is deployed from the delivery system 502, the connecting member 510 expands outward M, and the paddle member 519 remains extended. After being led out of the delivery system, the paddle member 519 can be closed (i.e., moved to the position shown in Figure 87A).

[0181] A drive member 512 (e.g., a drive wire, drive shaft, etc.) extends from the delivery system 502 and engages with the cap 514, driving the paddle member 519 from the closed position to the open position. Referring to Figure 88, driving the drive member 512 engages with the cap 514 and drives the cap 514 in direction Y, thereby driving the paddle member 519 outward in the open position X (for example, similar to the engagement between the drive member 212 and the cap 214 for driving the anchor 208 shown in Figures 22 to 37). The clasp 530 is maintained in the open position relative to the paddle member 519 by the corresponding drive line 516 applying tension F on the clasp 530 so that a tissue trapping area exists between the paddle member 519 and the clasp 530.

[0182] Referring to Figure 89, after the leaflet tissue is positioned within the tissue capture region between the clasp 530 and the paddle member 519, the clasp 530 is driven in direction Z to capture the tissue and fix the device / implant 500 to the tissue. The clasp 530 can be biased toward the occluded position so as to be driven toward the occluded position by releasing the tension F (Figure 88) from the drive line 516, or the clasp 530 can be driven toward the occluded position by making the drive line 516 actively controllable by the user.

[0183] Referring to Figure 90, after the device or implant 500 is secured to the leaflet tissue by the paddle member 519 and clasp 530, the drive member 512 drives the paddle member 519 to the closed position by driving the cap 514 back to its normal position D, and then the drive member 512 is detached from the cap 514 and driven backward into the delivery system 502. After the device 500 is secured to the tissue and the anchor 508 is in the closed position, the capture mechanism 513 is detached from the collar 511 and the delivery system 502 can be removed from the patient so that the device 500 is no longer attached to the delivery system 502.

[0184] Referring to Figures 91 to 95, an exemplary implementation of the implantable device or implant 600 (Figure 94) includes an anchor portion 606 having one or more paddle frames 624. The paddle frames 624 are configured to make it easier to maneuver the device or implant 600 to a position for implantation in the heart by reducing contact and / or friction between the device 600 and the natural structures of the heart, such as cords. Specifically, the paddle frames 624 are configured to move between an expanded position (when the device 600 is in an closed position) and a constricted position (when the device 600 is in an open position), and when the paddle frames 624 are in a constricted position, contact between the natural structures of the heart and the device 600 is reduced. The device or implant 600 may include any other features relating to an implantable device or implant, such as those described in this application or in applications or patent documents incorporated herein by reference, and the device 600 may be positioned to engage with valve tissue 20, 22 as part of any suitable valve restoration system (e.g., any valve restoration system disclosed herein). In addition, any device or implant described herein may have features relating to the device or implant 600.

[0185] Referring to Figure 94, the implantable device or implant 600 includes a joint or connecting portion 604, a proximal or attachment portion 605, an anchor portion 606, and a distal portion 607. The joint 604, attachment portion 605, and distal portion can take any suitable form, such as the forms relating to these portions in the device 200 shown in Figures 22 to 37, or any other form described herein. In some implementations, the joint 604 optionally includes a connecting member 610 (e.g., a spacer, connecting member, gap filler, etc.) which can be used, for example, to implant between the lobes 20, 22 in a natural mitral valve MV. The spacer, connecting member, connecting member, etc. 610 can take any suitable form, such as any form described herein.

[0186] The mounting portion 605 includes a first collar or proximal collar 611 for engaging with a capture mechanism (e.g., a capture mechanism 213 shown in Figures 44 to 49) of a delivery sheath or delivery system (e.g., a delivery system 202 shown in Figures 38 to 49). The proximal collar 611 can take any suitable form, such as any form described herein.

[0187] The distal portion 607 includes a cap 614 attached to the anchor 608 of the anchor portion 606, such that the anchor 608 can be driven between an open position and a closed position by driving the cap 614. The cap 614 can take any suitable form, such as any form described herein. The cap 614 can be driven by a drive member 612, such as a drive wire or drive shaft, by extending or retracting it (for example, as described herein with respect to the device 200 and drive member 212 shown in Figures 22 to 37).

[0188] The anchor portion 606 of device 600 can take any suitable form, such as the form of the anchor portion 206 in device 200 shown in Figures 22 to 37 (except that the paddle frame 224 is replaced by a paddle frame 624, as shown in Figures 91 to 95 and described in more detail below), or any other form described in this application that may include a paddle frame 624. The anchor portion 606 may include a plurality of anchors 608, each anchor 608 including an outer paddle 620, an inner paddle 622, a paddle extension member or paddle frame 624, and a clasp (e.g., a clasp 230 shown in Figures 22 to 37).

[0189] The outer paddle 620 is articulately attached to the inner paddle 622 and to the cap 614 of the distal portion 607 by a connecting portion 623, and the inner paddle 622 is articulately attached to the joining member 610. In this way, the anchor 608 is configured similarly to a leg, in that the inner paddle 622 resembles the upper part of a leg, the outer paddle 620 resembles the lower part of a leg, and the connecting portion 623 resembles the knee portion of a leg.

[0190] The paddle frame 624 has a first connecting member 601 (Figures 91 and 95) at its distal portion 607 for attaching the paddle frame 624 to the cap 614, so that the paddle frame 624 is fixedly connected to the cap 614. The connecting member 601 can be, for example, a notch that engages with a corresponding notch in the cap. The paddle frame 624 has one or more second connecting members 603 (Figures 91 and 95) that connect to the connecting portion 623 between the inner paddle 622 and the outer paddle 620, so that the paddle frame 624 is fixedly connected to the anchor 608. The connecting members 603 can be, for example, eyelets that allow the paddle frame 624 to be sewn to the cover, and also allow for sewing to the inner paddle 622 and the outer paddles 622 and 620. In some implementations, the paddle frame 624 is formed from a more rigid and harder material compared to the material forming the paddles 622, 620, so that the paddle frame 624 provides support for the paddles 622, 620.

[0191] The paddle frame 624 provides additional clamping force between the inner paddle 622 and the joint member 610. The paddle frame assists in wrapping the valve leaf around the sides of the joint member 610 for better sealing between the joint member 610 and the valve leaf. That is, the paddle frame 624 can be configured to have a rounded three-dimensional shape extending from the cap 614 to the connecting portion 623 of the anchor 608. The connections between the paddle frame 624, the outer paddle 620 and the inner paddle 622, the cap 614, and the joint member 610 can restrict the movement of each of these members (for example, to the movement and position described with reference to Figures 22 to 37). In particular, the connecting portion 623 is restricted by its connection between the outer paddle 620 and the inner paddle 622, and by its connection to the paddle frame 624. Similarly, the paddle frame 624 is constrained by its attachment to the connecting portion 623 (and thus to the inner paddle 622 and the outer paddle 620) and by its attachment to the cap 614.

[0192] By configuring the paddle frame 624 in this way, the surface area is increased compared to the inner paddle 622 alone. This makes it easier, for example, to grasp and fix the natural valve leaf. The increased surface area also allows the clamping force of the paddle 620 and paddle frame 624 on the natural valve leaf to be distributed over a relatively large surface area of ​​the natural valve leaf, further protecting the natural valve leaf tissue. In some implementations, the increased surface area of ​​the paddle frame 624 can also allow the natural valve leaf to be clamped against the implantable device or implant 200 so that the natural valve leaf is fully bonded to the periphery of the bonding member 610. This can improve the sealing of the natural valve leaf, for example, and thus prevent or further reduce mitral valve regurgitation.

[0193] The paddle frame 624 is configured to be driven between an expanded position (e.g., as shown in Figure 91) and a constricted position (e.g., as shown in Figures 92 and 95). When in the expanded position, the paddle frame 624 has an increased surface area, which provides the aforementioned advantages for securing the device 600 to the natural valve of the heart. When in the constricted position, the paddle frame 624 has a reduced width compared to the paddle frame in the expanded position, which makes it easier to maneuver the device 600 to a position for implantation in the heart by reducing contact and / or friction between the device 600 and the natural structures of the heart, such as cords. The paddle frame 624 is driven between the expanded and constricted positions by driving the anchor 608 between an open position and an closed position.

[0194] In the illustrated example, the drive member 612 (e.g., a drive wire, a drive shaft, etc.) extends from the delivery system (e.g., any delivery system described herein) and engages with the cap 614, thereby enabling the device 600 to be driven by driving the cap 614 toward direction Y relative to the joining member or spacer 610. The drive member 612 can engage with the cap and drive the cap by any suitable means, such as any means provided herein. By driving the cap 614 away from the joining member 610, the anchor 608 is driven to the open position (as shown in Figure 94), and by driving the joining member 610 toward the joining member 610, the anchor is driven to the closed position.

[0195] Based on the configuration of the paddle frame 624, and based on its connection to the cap 614 and the connection portion 623 of the anchor 608, the paddle frame 624 is in an expanded position when the anchor 608 is in a closed position, and in a constricted position when the anchor 608 is in an open position. That is, referring to Figure 91, when the anchor 608 is driven to the open position, the cap 614 is driven to move away from the joining member 610 in direction Y (Figure 94), and because the paddle frame 624 is fixedly connected to the cap 614 and the connection portion 623 of the anchor 608, a tension F is applied to the paddle frame 624.

[0196] Referring to Figures 91 and 92, the paddle frame 624 has a width W and a thickness T that is greater than the width W. Because the thickness T is greater than the width W, when tension F is applied to the paddle frame 624, the degree to which the paddle frame 624 is compressed in direction X increases. This is because the stiffness of the paddle frame in the direction of width W is less than the stiffness in the direction of thickness T. In some implementations, the ratio of thickness T to width W is, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2, or 10 / 9 to 3 / 1.

[0197] Referring to Figure 95, the paddle frame 624 has a length L2 and a total width W2 when in the constricted position. The length L2 can be 9mm to 21mm, for example, 12mm to 18mm, for example, approximately 15mm. The width W2 can be 3mm to 12mm, for example, 5mm to 10mm, for example, 7mm to 9mm, for example, approximately 8mm. The ratio of the total width (not shown) of the paddle frame 624 in the extended position to the total width W2 can be 10 / 9 to 3 / 1, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2. The ratio of the length (not shown) of the paddle frame 624 in the extended position to the length L2 can be 10 / 9 to 3 / 1, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2.

[0198] Referring to Figure 93, the paddle frame 624 is shown in a compressed position inside the delivery system 602. The delivery system 602 can take any suitable form, for example, the delivery system 602 can be identical or similar to other delivery systems herein, such as 102, 202, 402, 502, etc., and may further include one or more of the following: catheters, sheaths, guide catheters / sheaths, delivery catheters / sheaths, maneuverable catheters, implant catheters, tubes, channels, pathways, combinations thereof, etc. The configuration of the paddle frame 624 allows the paddle frame to more easily maintain a compressed position inside the delivery system 602. That is, because the paddle frame 624 has a thickness T (Figure 91) that is greater than its width W (Figure 91), the paddle frame 624 can be more easily compressed because the stiffness of the paddle frame in the direction of width W is less than the stiffness in the direction of thickness T.

[0199] Referring to Figures 96-98, 101, and 104, an example of a paddle frame 724 for an implantable device or implant (e.g., device 200 shown in Figures 22-37, device 600 shown in Figure 94, or any other suitable device) includes a main support section 785, a first connecting member 701 for attachment to the cap of the implantable device or implant, a second connecting member 703 for attachment to the anchor of the device, and a transition portion 771 located between the first connecting member 701 and the main support section 785. The paddle frame 724 can be attached to the anchor connecting portion and to the cap by any suitable means, such as any means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness may be substantially the same as the width, the thickness may be greater than the width (as shown in Figures 91-95), or the width may be greater than the thickness.

[0200] The connecting member 701 of the paddle frame 724 includes an extension portion 773 configured to connect the paddle frame 724 to the cap by extending into the cap of the implantable device or implant. In this example, the outer surface 775 of the main support section 785, the outer surface 777 of the transition portion 771, and the outer surface 779 of the connecting member 701 are substantially aligned such that each of these outer surfaces faces the same orientation Z (Figure 104).

[0201] Referring to Figure 98, the paddle frame 724 is shown in an closed position relative to the connecting member or spacer 710 of the implantable device or implant. Referring to Figures 101 and 104, the paddle frame is shown in an open position relative to the connecting member 710. The connecting member 710 can take any suitable form, such as any form described in this application.

[0202] Referring to Figures 99, 102, and 105, an example of a paddle frame 824 for an implantable device or implant (e.g., device 200 shown in Figures 22-37, device 600 shown in Figure 94, or any other suitable device) includes a main support section 885, a first connecting member 801 for attachment to a cap of the implantable device or implant, a second connecting member (e.g., connecting member 603 shown in Figure 91) for attachment to an anchor of the device, and a transition section 871 located between the first connecting member 801 and the main support section 885. The paddle frame 824 can be attached to the anchor connecting section and to the cap by any suitable means, such as any means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness may be substantially the same as the width, the thickness may be greater than the width (as shown in Figures 91-95), or the width may be greater than the thickness.

[0203] The connecting member 801 of the paddle frame 824 includes an extension portion 873 configured to connect the paddle frame 824 to the cap by extending into the cap of the implantable device or implant. In this example, the outer surface 879 of the connecting member 801 is positioned at an angle of approximately 45 degrees from the outer surface 875 of the main support section 885, such that the transition portion 871 is twisted around its axis.

[0204] The paddle frame can be shaped with the twists shown in Figures 99 and 102. In some implementations, the paddle frame can be shaped in the form shown in Figures 96, 98, and 101, and the connecting member 801 can be twisted to the position shown in Figures 99 and 102 and can be held in the twisted orientation by attachment to the cap. In some implementations, the paddle frame 824 can be shaped with the connecting member 801 set to the position shown in Figures 99 and 102, but can be shaped in a twisted state so that it returns to the position shown in Figures 96, 98, and 101 by connection to the cap.

[0205] Referring to Figure 99, the paddle frame 724 is shown in an closed position relative to the connecting member or spacer 810 of the implantable device or implant. Referring to Figures 102 and 105, the paddle frame is shown in an open position relative to the connecting member 810. The connecting member 810 can take any suitable form, such as any form described herein.

[0206] The angle between the outer surface 879 of the connecting member 801 and the outer surface 875 of the main support section 885 (and the corresponding twisted transition portion 871) increases torque and generates stress within the material of the paddle frame 824 when the paddle frame is driven from the closed position to the open position. This increase in torque and stress within the material of the paddle frame is due to the fact that the paddle frame is fixedly connected to both the inner and outer paddles (at the transition portion between them) and to the cap of the implantable device or implant. When the cap pulls the outer paddle, the twist of the transition portion 871 expands along the length of the paddle frame. As a result, the paddle frame 824 becomes narrower when the cap pulls the paddle to the open position compared to a paddle frame that does not include the twisted translation portion 871. This additional reduction in the width of the paddle frame makes it easier to maneuver the implantable device or implant into position for implantation within the heart by reducing contact and / or friction between the device and the heart's natural structures, such as cord-like structures.

[0207] Although the illustrated example shows that the outer surface 879 is positioned at an angle of approximately 45 degrees from the outer surface 875, it will be understood that the outer surface 879 may be positioned at any other suitable angle relative to the outer surface 875 to torque and drive the paddle frame to a narrower position (compared to a paddle frame without a torsional translational portion) when the paddle frame is driven from a closed position to an open position.

[0208] Generally, the greater the amount of torsion, the greater the torque and stress generated, resulting in greater paddle constriction. For example, in Figures 100, 103, and 106, an example of a paddle frame 924 has a 90-degree torsion. In the example illustrated in Figures 100, 103, and 106, the implantable device or implant (e.g., device 200 shown in Figures 22-37, device 600 shown in Figure 94, or any other suitable device) includes a main support section 985, a first connecting member 901 for attachment to the cap of the implantable device or implant, a second connecting member (e.g., connecting member 603 shown in Figure 91) for attachment to the anchor of the device, and a transition portion 971 located between the first connecting member 901 and the main support section 985. The paddle frame 924 can be attached to the anchor connecting portion and to the cap by any suitable means, such as any means described herein. The thickness and width of the paddle frame can take any suitable form; for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in Figures 91 to 95), or the width can be greater than the thickness.

[0209] The connecting member 901 of the paddle frame 924 includes an extension portion 973 configured to connect the paddle frame 924 to the cap by extending into the cap of the implantable device or implant. In this example, the outer surface 979 of the connecting member 901 is positioned at an angle of approximately 90 degrees from the outer surface 975 of the main support section 985, such that the transition portion 971 is twisted around its axis.

[0210] The paddle frame can be shaped with the twists shown in Figures 100 and 103. In some implementations, the paddle frame can be shaped in the form shown in Figures 96, 98, and 101, and the connecting member 901 can be twisted to the position shown in Figures 100 and 103 and can be held in the twisted orientation by attachment to the cap. In some implementations, the paddle frame 924 can be shaped with the connecting member 901 set to the position shown in Figures 100 and 103, but can be shaped in a twisted state so that it returns to the position shown in Figures 96, 98, and 101 by connection to the cap.

[0211] Referring to Figure 100, the paddle frame 924 is shown in an closed position relative to the connecting member or spacer 910 of the implantable device or implant. Referring to Figures 103 and 106, the paddle frame is shown in an open position relative to the connecting member 910. The connecting member 910 can take any suitable form, such as any form described in this application.

[0212] The angle between the outer surface 979 of the connecting member 901 and the outer surface 975 of the main support section 985 (and the corresponding twisted transition portion 971) increases torque and generates stress within the material of the paddle frame 924 when the paddle frame is driven from the closed position to the open position. This increase in torque and stress within the material of the paddle frame is due to the fact that the paddle frame is fixedly connected to both the inner and outer paddles (at the transition portion between them) and to the cap of the implantable device or implant. When the cap pulls the outer paddle, the twist of the transition portion 971 expands along the length of the paddle frame. As a result, the paddle frame 924 becomes narrower when the cap pulls the paddle to the open position compared to a paddle frame that does not include the twisted translation portion 971. This additional reduction in the width of the paddle frame makes it easier to maneuver the implantable device or implant into position for implantation within the heart by reducing contact and / or friction between the device and the heart's natural structures, such as cord-like structures.

[0213] Referring to Figures 107 and 108, an example of a paddle frame 1024 for an implantable device or implant (e.g., device 200 shown in Figures 22-37, device 600 shown in Figure 94, or any other suitable device) includes a main support section 1085, a first connecting member 1001 for attachment to the cap of the implantable device or implant, and a second connecting member 1003 for attachment to the anchor of the device. The paddle frame 1024 can be attached to the anchor connection and to the cap by any suitable means, such as any means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness may be substantially the same as the width, the thickness may be greater than the width (as shown in Figures 91-95), or the width may be greater than the thickness.

[0214] The main support section 1085 includes an inner portion 1072 and an outer portion 1074. The inner portion 1072 is connected to a connecting member 1001 at connection point 1076 and to a connecting member 1003 at connection point 1078. The inner portion 1072 is configured to drive the paddle frame 1024 from a normal expanded position (Figure 107) when the anchor of the implantable device or implant is in an closed position, to a constricted position (Figure 108) when the anchor of the device is driven to an open position. The outer portion 1074 is connected to the inner portion at connection point 1080, and the outer portion 104 defines the overall width of the paddle frame 1024 (e.g., the expanded width EW shown in Figure 107 and the constricted width NW shown in Figure 108).

[0215] In the illustrated example, the inner portion 1072 of the main support section 1085 is diamond-shaped. Referring to Figure 108, when the anchor of the implantable device or implant is driven to the open position, the paddle frame 1024 is subjected to tension F because the paddle frame 1024 is fixedly connected to the cap and to the transition portion between the inner and outer paddles of the device. This tension F applied to the paddle frame 1024 drives connection points 1076 and 1078 outward OD, thereby driving connection point 1080 inward ID. By driving connection point 1080 inward ID, the outer portion 1074 is driven inward ID, thereby driving the overall width of the paddle frame 1024 from the expanded width EW (Figure 107) to the narrowed width NW (Figure 108). By driving the paddle frame 1024 to a constricted position, the implantable device or implant can be more easily maneuvered to a position for implantation within the heart by reducing contact and / or friction between the device and the natural structures of the heart, such as cord-like structures.

[0216] The expanded width EW of the paddle frame 1024 can be, for example, 7mm to 12mm, for example, 9mm to 11mm, for example, approximately 10mm, or 5mm to 15mm. The narrowed width NW of the paddle frame 1024 can be, for example, 5mm to 10mm, for example, 7mm to 9mm, for example, approximately 8mm, or 3mm to 12mm. The ratio of the expanded width EW to the narrowed width NW can be, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2, or 10 / 9 to 3 / 1.

[0217] Although the illustrated example shows the inner portion 1072 of the main support section 1085 to be diamond-shaped, it will be understood that the inner portion 1072 can take any form that allows the paddle frame to be driven to a stenotic position when tension F is applied to the paddle frame 1024, thereby enabling the paddle frame to more easily maneuver the implantable device or implant to a position for implantation in the heart.

[0218] Referring to Figures 109 and 110, an example of a paddle frame 1124 for an implantable device or implant (e.g., device 200 shown in Figures 22–37, device 600 shown in Figure 94, or any other suitable device) includes a main support section 1185, a first connecting member 1101 for attachment to the cap of the implantable device or implant, and a second connecting member 1103 for attachment to the anchor of the device. The paddle frame 1124 can be attached to the anchor connection and to the cap by any suitable means, such as any means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness may be substantially the same as the width, the thickness may be greater than the width (as shown in Figures 91–95), or the width may be greater than the thickness.

[0219] The main support section 1185 includes an inner portion 1172 and an outer portion 1174. The inner portion 1172 is connected to the connecting member 1103 at connection point 1178. The outer portion 1174 is connected to the inner portion 1172 at connection point 1180, and the outer portion 1174 extends to the connecting member 1101. The outer portion 1174 defines the overall width of the paddle frame 1124 (e.g., the expanded width EW shown in Figure 109 and the constricted width NW shown in Figure 110). The inner portion 1172 is configured to drive the paddle frame 1124 from a normal expanded position (Figure 109) when the anchor of the implantable device or implant is in the closed position, to a constricted position (Figure 110) when the anchor of the device is driven to the open position.

[0220] In the illustrated example, the inner portion 1172 of the main support section 1185 includes an arm 1182 that extends inward from connection point 1180 and converges with it at connection point 1178, such that the inner portion 1172 has a triangular shape. Referring to Figure 110, when the anchor of the implantable device or implant is driven to the open position, the paddle frame 1124 is subjected to tension F because the paddle frame 1124 is fixedly connected to the cap and to the transition portion between the inner and outer paddles of the device. This tension F applied to the paddle frame 1124 drives connection point 1178 and connecting member 1101 outward OD, thereby driving connection point 1080 inward ID. By driving the connection point 1080 inward (ID), the outer portion 1174 is driven inward (ID), thereby driving the entire width of the paddle frame 1124 from the expanded width EW (Figure 109) to the narrowed width NW (Figure 110). By driving the paddle frame 1124 to the narrowed position, the implantable device or implant can be more easily maneuvered to a position for implantation in the heart by reducing contact and / or friction between the device and the natural structures of the heart, such as cords.

[0221] The expanded width EW of paddle frame 1124 can be, for example, 7mm to 12mm, for example, 9mm to 11mm, for example, approximately 10mm, or 5mm to 15mm. The narrowed width NW of paddle frame 1124 can be, for example, 5mm to 10mm, for example, 7mm to 9mm, for example, approximately 8mm, or 3mm to 12mm. The ratio of expanded width EW to narrowed width NW can be, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2, or 10 / 9 to 3 / 1.

[0222] In the illustrated example, the inner portion 1172 of the main support section 1185 is shown having an arm 1182 that extends inward from connection point 1180 and merges with it at connection point 1178, so that the inner portion 1172 has a triangular shape. However, it will be understood that the inner portion 1072 can take any form that allows the paddle frame to be driven to a stenotic position when tension F is applied to the paddle frame 1124, so that the paddle frame can be more easily manipulated to a position for implantation into the heart.

[0223] In the illustrated example, the inner portion 1172 of the main support section 1185 includes an arm 1182 that extends inward from connection point 1180 and merges with it at connection point 1178, such that the inner portion 1172 has a triangular shape. Referring to Figure 110, when the anchor of the implantable device or implant is driven to the open position, the paddle frame 1124 is subjected to tension F because the paddle frame 1124 is fixedly connected to the cap and to the anchor of the device. This tension F applied to the paddle frame 1124 drives connection point 1178 and connecting member 1101 outward OD, thereby driving connection point 1180 inward ID. By driving connection point 1180 inward ID, the outer portion 1174 is driven inward ID, thereby driving the overall width of the paddle frame 1124 from the expanded width EW (Figure 109) to the narrowed width NW (Figure 110). By driving the paddle frame 1124 to a constricted position, the implantable device or implant can be more easily maneuvered to a position for implantation within the heart by reducing contact and / or friction between the device and the natural structures of the heart, such as cord-like structures.

[0224] In the illustrated example, the inner portion 1172 of the main support section 1185 is shown having an arm 1182 that extends inward from connection point 1180 and merges with it at connection point 1178, so that the inner portion 1172 has a triangular shape. However, it will be understood that the inner portion 1172 can take any form that allows the paddle frame to be driven to a stenotic position when tension F is applied to the paddle frame 1124, so that the paddle frame can be more easily manipulated to a position for implantation into the heart.

[0225] Referring to Figure 111, an example of a paddle frame 1224 for an implantable device or implant (e.g., device 200 shown in Figures 22-37, device 600 shown in Figure 94, or any other suitable device) includes a main support section 1285, a first connecting member 1201 for attachment to the cap of the implantable device or implant, and a second connecting member 1203 for attachment to the anchor of the device. The paddle frame 1224 can be attached to the anchor connection and to the cap by any suitable means, such as any means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness may be substantially the same as the width, the thickness may be greater than the width (as shown in Figures 91-95), or the width may be greater than the thickness.

[0226] The main support section 1285 includes an inner portion 1272 and an outer portion 1274. The inner portion 1272 is connected to the connecting member 1203 at connection point 1278. The outer portion 1274 is connected to the inner portion 1272 at connection point 1280 and extends to the connecting member 1201. The outer portion 1274 defines the overall width TW of the paddle frame 1224. The inner portion 1272 is configured to drive the paddle frame 1224 from a normal expanded position (Figure 111) when the anchor of the implantable device or implant is in an closed position, to a constricted position when the anchor of the device is driven to an open position.

[0227] In the illustrated example, the inner portion 1272 of the main support section 1185 includes an arm 1282 and a round member 1284. The arm 1282 extends inward from connection point 1280, and the round member 1284 is connected to each of the arms 1282 and to connection point 1278. When the anchor of the implantable device or implant is driven to the open position, the paddle frame 1224 is subjected to tension (e.g., tension F shown in Figures 108 and 110) because the paddle frame 1224 is fixedly connected to the cap and to the anchor of the device. This tension F applied to the paddle frame 1224 drives connection point 1278 and connecting member 1201 outward, thereby driving connection point 1280 inward. By driving the connection point 1280 inward, the outer portion 1274 is driven inward, thereby driving the entire width TW of the paddle frame 1224 to a constricted position, which makes it easier to maneuver the implantable device or implant to a position for implantation in the heart by reducing contact and / or friction between the device and the natural structures of the heart, such as cords.

[0228] When in the normal extended position, the total width TW of the paddle frame 1224 can be, for example, 7mm to 12mm, for example, 9mm to 11mm, for example, approximately 10mm, or 5mm to 15mm. The narrowed width of the paddle frame 1124 can be, for example, 5mm to 10mm, for example, 7mm to 9mm, for example, approximately 8mm, or 3mm to 12mm. The ratio of the total width TW to the narrowed width can be, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2, or 10 / 9 to 3 / 1.

[0229] In the illustrated example, the inner portion 1272 of the main support section 1285 is shown having an arm 1282 that extends inward from connection point 1280 and is connected to a round member 1284 connected to connection point 1278. However, it will be understood that the inner portion 1272 can take any form that allows the paddle frame to be driven to a stenotic position when tension F is applied to the paddle frame 1224, so as to allow the paddle frame to be more easily manipulated to a position for implantation into the heart.

[0230] Referring to Figures 112 to 114, an example of a paddle frame 1324 for an implantable device or implant (e.g., device 200 shown in Figures 22 to 37, device 600 shown in Figure 94, or any other suitable device) includes a main support section 1385, a first connecting member 1301 for attachment to the cap of the implantable device or implant, and a second connecting member 1303 for attachment to the anchor of the device. The paddle frame 1324 can be attached to the anchor connection and to the cap by any suitable means, such as any means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness may be substantially the same as the width, the thickness may be greater than the width (as shown in Figures 91 to 95), or the width may be greater than the thickness.

[0231] The main support section 1385 includes an inner portion 1372 and an outer portion 1374. The inner portion 1372 is connected to the connecting member 1303 at connection point 1378. The outer portion 1374 is connected to the inner portion 1372 at connection point 1380 and extends to the connecting member 1301. The outer portion 1374 defines the overall width TW of the paddle frame 1324. The inner portion 1372 is configured to drive the paddle frame 1324 from its normal expanded position (Figures 112-114), when the anchor of the implantable device or implant is in the closed position, to its constricted position, when the anchor of the device is driven to the open position.

[0232] In the illustrated example, the inner portion 1372 of the main support section 1385 includes an arm 1382 and a round member 1384. The arm 1382 extends inward from a connection point 1380, and the round member 1384 is connected to each of the arms 1382 and to a connection point 1378. The configurations of the paddle frame 1324 shown in Figures 112 to 114 are similar to each other, except that the connection point 1380 between the inner portion 1372 and the outer portion 1374 of the paddle frame 1324 is located at a different position from the connecting member 1301 with respect to each of these configurations. For example, the connection point 1380 in the configuration of the paddle frame 1324 shown in Figure 112 is located further from the connecting member 1301 compared to the configuration of the paddle frame shown in Figure 113, and the connection point 1380 in the configuration of the paddle frame 1324 shown in Figure 113 is located further from the connecting member 1301 compared to the configuration of the paddle frame shown in Figure 114. Due to these different configurations, the width Z between the connection points 1380 is different for each configuration. For example, the width Z in the configuration of the paddle 1324 shown in Figure 112 is larger than the width Z in the configuration of the paddle 1324 shown in Figure 113, and the width Z in the configuration of the paddle 1324 shown in Figure 113 is larger than the width Z in the configuration of the paddle 1324 shown in Figure 114.

[0233] When the anchor of the implantable device or implant is driven to the open position, the paddle frame 1324 is subjected to tension (e.g., tension F shown in Figures 108 and 110) because the paddle frame 1324 is fixedly connected to the cap and to the transition portion between the inner and outer paddles of the device. This tension F applied to the paddle frame 1324 drives the connection point 1378 and connecting member 1301 outward, thereby driving the connection point 1380 inward. By driving the connection point 1380 inward, the outer portion 1374 is driven inward, thereby driving the overall width TW of the paddle frame 1324 to a constricted position, which makes it easier to maneuver the implantable device or implant to a position for implantation in the heart by reducing contact and / or friction between the device and the natural structures of the heart, such as cords.

[0234] When in the normal extended position, the total width TW of the paddle frame 1324 can be, for example, 7mm to 12mm, for example, 9mm to 11mm, for example, approximately 10mm, or 5mm to 15mm. The narrowed width of the paddle frame 1124 can be, for example, 5mm to 10mm, for example, 7mm to 9mm, for example, approximately 8mm, or 3mm to 12mm. The ratio of the total width TW to the narrowed width can be, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2, or 10 / 9 to 3 / 1.

[0235] In the illustrated example, the inner portion 1372 of the main support section 1385 is shown having an arm 1382 that extends inward from connection point 1380 and is connected to a round member 1384 connected to connection point 1378. However, it will be understood that the inner portion 1372 may take any form that allows the paddle frame to be driven to a stenotic position when tension F is applied to the paddle frame 1324, so as to allow the paddle frame to be more easily maneuvered to a position for implantation in the heart.

[0236] Referring to Figures 115-116, an example of a paddle frame 1424 for an implantable device or implant (e.g., device 200 shown in Figures 22-37, device 600 shown in Figure 94, or any other suitable device) includes a main support section 1485, a first connecting member 1401 for attachment to the cap of the implantable device or implant, and a second connecting member 1403 for attachment to the anchor of the device. The paddle frame 1424 can be attached to the anchor connection and to the cap by any suitable means, such as any means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness may be substantially the same as the width, the thickness may be greater than the width (as shown in Figures 91-95), or the width may be greater than the thickness.

[0237] The main support section 1485 includes an inner portion 1472 and an outer portion 1474. The inner portion 1472 of the main support section 1485 includes an arm 1482 that extends inward from connection point 1480 and is connected to connection point 1478. The outer portion 1474 is connected to the inner portion 1472 at connection point 1480 and is connected to connection point 1478 via a biasing member 1484, and the outer portion 1474 extends to the connecting member 1401. The biasing member 1484 curves at least a portion of the outer portion 1474 such that the paddle has a curved lateral edge 1486 (Figure 16). The curved lateral edge 1486 may be configured to be formed in contact with the outer shape of a spacer or connecting member (e.g., any connecting member described herein) in an implantable device or implant. The biasing member 1484 can be, for example, a spring member, or the paddle frame 1474 can be any other member having a curved lateral edge 1486.

[0238] The outer portion 1474 defines the overall width TW of the paddle frame 1424. The inner portion 1472 and the biasing member 1484 are configured to drive the paddle frame 1424 from the normal expanded position (Figures 115-116), when the anchor of the implantable device or implant is in the closed position, to the constricted position, when the anchor of the device is driven to the open position.

[0239] When the anchor of the implantable device or implant is driven to the open position, the paddle frame 1424 is subjected to tension (e.g., tension F shown in Figures 108 and 110) because the paddle frame 1424 is fixedly connected to the cap and to the transition portion between the inner and outer paddles of the device. This tension F applied to the paddle frame 1424 drives the connection point 1478 and the connecting member 1401 outward, thereby driving the connection point 1480 inward. By driving the connection point 1380 inward, the outer portion 1474 is driven inward, thereby driving the overall width TW of the paddle frame 1424 to the constricted position. In addition, by driving the connection point 1478 outward, the biasing member 1484 curves the curved lateral edge 1486 in direction B (Figure 116), thereby driving the overall width TW of the paddle frame 1424 to the constricted position. By driving the paddle frame 1424 to a constricted position, the implantable device or implant can be more easily maneuvered to a position for implantation within the heart by reducing contact and / or friction between the device and the natural structures of the heart, such as cords.

[0240] When in the normal extended position, the total width TW of the paddle frame 1424 can be, for example, 7mm to 12mm, for example, 9mm to 11mm, for example, approximately 10mm, or 5mm to 15mm. The narrowed width of the paddle frame 1124 can be, for example, 5mm to 10mm, for example, 7mm to 9mm, for example, approximately 8mm, or 3mm to 12mm. The ratio of the total width TW to the narrowed width can be, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2, or 10 / 9 to 3 / 1.

[0241] In some implementations, the biasing member 1484 can passively allow the anchor of the implantable device or implant to be more open when needed, and can assist in joining in conjunction with the movement of the valve leaf when the implantable device or implant is attached to a natural valve leaf of the heart.

[0242] In the illustrated example, the inner portion 1472 of the main support section 1485 is shown having an arm 1482 extending inward from connection point 1480 and connected to connection point 1478. However, it will be understood that the inner portion 1472 may take any form that allows the paddle frame to be driven to a stenotic position when tension F is applied to the paddle frame 1424, thereby enabling the paddle frame to more easily maneuver the implantable device or implant to a position for implantation in the heart.

[0243] Referring to Figures 117 to 121, an example of an implantable device or implant 1500 includes an anchor portion 1506 having one or more paddle frames 1524. The paddle frames 1524 are configured to allow the device 1500 to be more easily maneuvered to a position for implantation in the heart by reducing contact and / or friction between the device 1500 and the natural structures of the heart, such as cords. That is, the paddle frames 1524 are configured to be driven between an expanded position (when the device 1500 is in an closed position) and a constricted position (when the device 1500 is in an open position), and / or the paddle frame may include a flexible outer portion that reduces the width of the paddle by bending inward when the flexible outer portion comes into contact with the natural structures of the heart, such as cords.

[0244] When the paddle frame 1524 is in a stenotic position, friction between the natural structure of the heart and the device 1500 is reduced. The device 1500 may include any other features relating to an implantable device or implant, as described in this application or in applications or patent documents incorporated herein by reference, and the device 1500 may be positioned to engage with valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein). In addition, any device described herein may have features relating to the device 1500.

[0245] The implantable device or implant 1500 includes a joint or connecting portion 1504, a proximal or attachment portion 1505, an anchor portion 1506, and a distal portion 1507. The joint 1504, attachment portion 1505, and distal portion 1507 can take any suitable form, such as the forms relating to these portions in the device 200 shown in Figures 22 to 37, or any other form described herein. In some implementations, the joint 1504 optionally includes a connecting member 1510 (e.g., a spacer, connecting member, gap filler, etc.) which can be used to implant, for example, between the lobes 20, 22 in a natural mitral valve MV. The spacer, connecting member, connecting member, etc. 1510 can take any suitable form, such as any form described herein. In the illustrated example, the connecting member is formed from a woven wire.

[0246] The mounting portion 1505 includes a first collar or proximal collar 1511 for engaging with a capture mechanism 1513 (Figure 119) of a delivery system (e.g., a delivery system 502 shown in Figures 86A, 87A, 88, and 89). The proximal collar 1511 can take any suitable form, such as any form described herein. The capture mechanism 1513 can take any suitable form, such as any form described herein.

[0247] The distal portion 1507 includes a cap 1514 attached to the anchor 1508 of the anchor portion 1506, such that the cap 1514 can be driven to drive the anchor 1508 between an open position and a closed position. The cap 1514 can take any suitable form, such as any form described herein. In the illustrated example, a drive member 1512 (e.g., a drive wire, a drive shaft, etc.) extends from a delivery system (e.g., any delivery system described herein) and engages with the cap 1514 to enable the device 1500 to be driven by driving the cap 1514 relative to the connecting member or spacer 1510. The drive member 1512 can engage with the cap and drive the cap by any suitable means, such as any means provided herein.

[0248] The anchor portion 1506 of device 1500 can take any suitable form, such as the form of the anchor portion 206 in device 200 shown in Figures 22 to 37 (except that the paddle frame 224 is replaced by a paddle frame 1524, as shown in Figures 91 to 95 and described in more detail below), or any other form described in this application that may include a paddle frame 1524. The anchor portion 1506 may include a plurality of anchors 1508, each anchor 1508 including an outer paddle 1520, an inner paddle 1522, a paddle extension member or paddle frame 1524, and a clasp 1530.

[0249] The paddle frame 1524 includes a main support section 1585, a first connecting member for attachment to the cap of an implantable device or implant (e.g., connecting member 601 shown in Figures 91-95, or any other connecting member described herein), and a second connecting member for attachment to the anchor of the device (connecting member 603 shown in Figures 91-95, or any other connecting member described herein). The paddle frame 1524 can be attached to the anchor connection and to the cap by any suitable means, such as any means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness may be substantially the same as the width, the thickness may be greater than the width (as shown in Figures 91-95), or the width may be greater than the thickness.

[0250] The main support section 1585 includes a rigid inner portion 1572 and a flexible outer portion 1574. The rigid inner portion 1572 has a first end 1581 connected to the cap 1514 and a second end 1583 connected to the anchor 1508. Referring to Figures 120 and 121, the rigid inner portion is configured to support the anchor paddles 1520 and 1522 and to provide sufficient force to facilitate the joining of the natural valve leaves 20 and 22 to the joint member 1510 when the anchor 1508 is in the closed position. The rigid inner portion 1572 can be formed from, for example, metal, plastic, etc.

[0251] Referring again to Figures 117-121, the flexible outer portion 1574 is connected to the rigid inner portion and defines the overall width of the paddle frame 1524. That is, the flexible outer portion 1574 has a larger overall width than the rigid inner portion 1572. The flexible outer portion 1574 is configured to bend due to force (e.g., force from the flexible outer portion 1574 in contact with the cord-like structure during implantation of the device 1500), and further to allow for easier maneuvering of the device 1500 to a position for implantation in the heart. Referring to Figures 120 and 121, when the anchor 1508 is in the closed position and the valve leaf is joined to the joining member 1510, the flexible outer portion 1574 maintains its normal overall width and provides a larger surface area in contact with the valve leaf (compared to the rigid inner portion 1572) to hold the valve leaf against the joining member 1510. The flexible outer portion 1574 can be formed from, for example, metal and plastic.

[0252] The total width of the flexible outer portion 1574 can be, for example, 7mm to 12mm, for example, 9mm to 11mm, for example, approximately 10mm, or 5mm to 15mm. The width of the inner portion 1572 can be, for example, 4mm to 6mm, for example, approximately 5mm, or 2mm to 8mm.

[0253] In some implementations, the flexible outer portion 1574 is shaped to face inward so that its overall width is reduced when the anchor 1508 is in the open position, and so that it returns to its normal full width when the anchor 1508 is driven to the closed position.

[0254] Although the illustrated example shows a rigid inner portion 1572 with a rounded shape and a flexible inner portion 1574 with a rounded shape, it will be understood that the inner portion 1572 and the outer portion 1574 can take any configuration that allows for easier maneuvering of the device 1500 to a position for implantation in the heart, while providing sufficient support to facilitate joining the leaflets of a natural heart valve to the connecting member 1510.

[0255] Referring to Figures 122 to 124, an exemplary implementation of the implantable device or implant 1600 includes a junction portion 1604, a proximal or attachment portion 1605, an anchor portion 1606, and a distal portion 1607. The implantable device or implant 1600 is configured to allow for easier maneuvering of the device 1600 to a position for implantation in the heart by driving the paddle frame 1624 of the anchor portion 1606 to a stenotic position (Figure 124), thereby reducing contact and / or friction between the device 1600 and the natural structure of the heart, such as a cord-like structure. Specifically, the paddle frame 1624 is configured to be driven between an expanded position (Figure 122) when the device 1600 is in an occluded position and a stenotic position (Figure 123) when the device 1600 is in an open position, and when the paddle frame 1624 is in the stenotic position, contact between the natural structure of the heart and the device 1600 is reduced. Device 1600 may include any other features relating to an implantable device or implant, as described in this application or in applications or patent documents incorporated herein by reference, and Device 1600 may be positioned to engage with valve tissue 20, 22 as part of any suitable valve restoration system (e.g., any valve restoration system disclosed herein). In addition, any device described herein may have features relating to Device 1600.

[0256] The mounting portion 1605 includes a first collar or proximal collar 1611 for engaging with a capture mechanism (e.g., a capture mechanism 213 shown in Figures 44 to 49) of a delivery system (e.g., a delivery system 202 shown in Figures 38 to 49). The proximal collar 1611 can take any suitable form, such as any form described herein. The distal portion 1607 includes a cap 1614 mounted on the outer paddle 1620 of the anchor 1608 so that the anchor 1608 can be driven between an open position and a closed position by driving the cap 1614. The cap 1614 can take any suitable form, such as any form described herein.

[0257] The anchor portion 1606 can take any suitable form, such as the form of the anchor portion 206 in the device 200 shown in Figures 22 to 37, or any other form described in this application that may include a paddle frame 1524. The anchor portion 1606 may include a plurality of anchors 1608, each anchor 1608 including an outer paddle 1620, an inner paddle 1622, a paddle extension member or paddle frame 1624, and a clasp 1630. In the illustrated example, the inner paddle 1622 is formed from a material having greater hardness compared to the material of the outer paddle 1620.

[0258] Referring to Figure 124, the paddle frame 1624 includes a main support section 1685, a first connecting member 1601 for attachment to the cap 1614 of the device 1600, and a second connecting member 1603 for attachment to the connecting portion 1623 between the inner paddle 1622 and the outer paddle 1620 of the anchor 1608. The paddle frame 1624 can be attached to the connecting portion and the cap of the anchor by any suitable means, such as any means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in Figures 91 to 95), or the width can be greater than the thickness. However, the paddle frame 1624 can take any suitable form, such as any form described herein.

[0259] In some implementations, the joint or connecting portion 1604 includes a connecting member 1610 (for example, a connecting member 1610 that may be used to implant between the lobes 20, 22 in a natural mitral valve MV). The spacer, connecting member, connecting member, etc. 1610 can take any suitable form, such as any form described herein. The connecting member 1610 is connected to the connecting portion 1623 of the inner paddle 1622 in the anchor 1608. In the illustrated example, the connecting member 1610 includes one or more flexible portions 1687 connected to the inner paddle 1622. The flexible portion 1687 may be formed from a woven material having a looser weave compared to the inner paddle portion and / or the rest of the joining member 1610, or from an elastic material that is more elastic compared to the inner paddle portion and / or the rest of the joining member 1610, or in any other manner that makes the flexible portion 1687 more flexible and / or more stretchable compared to the inner paddle portion and / or the rest of the joining member 1610.

[0260] During transplantation, the paddles 1620 and 1622 of the anchor 1608 are opened and closed, allowing the valve leaves of the natural valve to be gripped between the paddles 1620 and 1622 and the connecting member 1610. The anchor 1608 is driven between a closed position (Figure 122) and various open positions (for example, the positions shown in Figure 123) by extending and retracting the drive member 1612 (e.g., a drive wire, drive shaft, etc.). Extending and retracting the drive member 1612 increases and decreases the distance between the connecting member 1610 and the cap 1614, respectively. The proximal collar 1611 and the connecting member 1610 slide along the drive wire 1612 when driven, which changes the distance between the connecting member 1610 and the cap 1614, driving the paddles 1620 and 1622 between different positions, thereby gripping the valve leaves of the natural valve during transplantation.

[0261] In the illustrated example, the drive wire 1612 includes a wide portion 1689 for easily driving the paddle frame 1624 to a constricted position. Referring to Figure 123, when the anchor 1608 is driven from a closed position to an open position by driving the drive wire 612 downward through the connecting member 610 in direction Y, the wide portion 1689 of the drive wire 1612 engages with the flexible portion 1687 of the connecting member 1610, driving the flexible portion 1687 outward Z. This drive of the flexible portion 1687 outward Z drives the connection portion 1625 of the inner paddle 1622 outward D relative to the cap 1614, which in turn drives the connection portion 1623 of the anchor 1608 (to which the paddle frame 1624 is connected) in direction D as well. The rigid stiffness of the inner paddle 1622 helps to facilitate the driving of the connecting portion 1623. Because the paddle frame 1624 is connected to the cap 1614 and to the connecting portion 1623 of the anchor 1608, this driving with respect to the connecting portion 1623 in orientation D applies tension F (Figure 124) to the paddle frame 1624, thereby driving the paddle frame 1624 to a constricted position (Figure 124). In the illustrated example, the wide portion 1689 of the drive wire 1612 has a tapered shape to facilitate driving the paddle frame 1624 to the constricted position by engaging with the flexible portion 1687 of the joining member 1610. In some implementations, the wide portion 1689 can have a spherical shape or any other suitable shape.

[0262] In some implementations, the wide portion 1689 is configured to widen the transition portion 1625 only for a small portion of the drive wire's movement. For example, the drive wire's movement path may include a path having a starting portion corresponding to the complete closure of the device and an ending portion corresponding to the complete closure of the device. The wide portion 1689 can be configured to keep the transition portion 1625 at its original width along the starting portion of the movement path, to drive the transition portion 1625 to a wider width during the middle portion of the movement path, and to return the transition portion 1625 to its original width along the ending portion of the movement path.

[0263] Referring to Figure 124, when the paddle frame 1624 is in the constricted position, it has a length L2 and a total width W2. When the paddle frame 1424 is in the normal extended position, the width can be 5mm to 15mm, for example, 7mm to 12mm, for example, 9mm to 11mm, for example, approximately 10mm. The constricted width W2 of the paddle frame 1124 can be 3mm to 12mm, for example, 5mm to 10mm, for example, 7mm to 9mm, for example, approximately 8mm. The ratio of the normal width to the constricted width W2 can be 10 / 9 to 3 / 1, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2, for example.

[0264] Referring to Figures 125 and 126, an example of a paddle frame 1724 for an implantable device or implant (e.g., device 200 shown in Figures 22–37, device 600 shown in Figure 94, or any other suitable device) includes a main support section 1785, a first connecting member 1701 for attachment to the cap of the implantable device or implant, and a second connecting member for attachment to the anchor of the device (e.g., connecting member 603 shown in Figures 91–95, or any other connecting member described herein). The paddle frame 1724 can be attached to the anchor connection and to the cap by any suitable means, such as any means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness may be substantially the same as the width, the thickness may be greater than the width (as shown in Figures 91–95), or the width may be greater than the thickness.

[0265] The main support section 1785 includes an inner portion 1772 and an outer portion 1774. The inner portion 1772 is connected to the outer portion 1774 at connection point 1780, and the outer portion 1774 extends to the connecting member 1701. In the illustrated example, the inner portion 1772 includes arms 1782 that extend inward from each connection point 1780 and converge at connection portion 1778, such that the arms 1782 have a V-shape when the paddle frame 1724 is in the extended position (Figure 126). The connection portion 1780 between the inner portion 1772 and the outer portion 1774 may include an opening 1773 for receiving a retaining device (e.g., sutures, pins, or other suitable device) for connecting the openings 1773 to each other in order to maintain the paddle frame 1724 in the constricted position (Figure 125). When the retaining device is removed from the openings 1773 so that the openings 1773 are no longer connected, the paddle frame 1724 is configured to be driven outward in direction Z toward its normal extended position. That is, the paddle frame 1724 can be formed from a pre-formed material toward the extended position (as shown in Figure 126). By using the retaining device, the openings 1773 can be connected at the connection point 1780, thereby maintaining the paddle frame 1724 in the folded, constricted position (as shown in Figure 125). Subsequently, by removing the retaining device, the paddle frame 1724 returns to its normal extended position by spring force.

[0266] When driving the implantable device or implant to a position for implantation onto the lobes of the patient's natural valve (e.g., mitral valve lobes 20, 22, tricuspid valve lobes 30, 32, 34, or other valve lobes), the paddle frame 1724 is maintained in a stenotic position, thereby making it easier to maneuver the implantable device or implant to a position for implantation in the heart by reducing contact and / or friction between the device and the natural structures of the heart, such as cords. After the device is positioned for implantation, the retaining device is removed from the opening 1773, thereby driving the paddle frame 1724 to an expanded position so that the device's anchors have a larger surface area for capturing the lobes of the natural valve.

[0267] The outer portion 1774 defines the overall width of the paddle frame 1724 (for example, the expanded width EW shown in Figure 126 and the narrowed width NW shown in Figure 125). When in the normal expanded position, the expanded width EW of the paddle frame 1424 can be 5mm to 15mm, for example, 7mm to 12mm, for example, 9mm to 11mm, for example, approximately 10mm. The narrowed width NW of the paddle frame 1124 can be 3mm to 12mm, for example, 5mm to 10mm, for example, 7mm to 9mm, for example, approximately 8mm. The ratio of the normal width to the narrowed width W2 can be 10 / 9 to 3 / 1, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2, for example.

[0268] In the illustrated example, the inner portion 1772 of the main support section 1785 is shown having an arm 1782 that forms a V shape, but it will be understood that the inner portion 1772 can take any form that allows the paddle frame 1724 to be folded into a constricted position and maintained in that constricted position when engaged with the retaining device, and that allows the paddle frame 1724 to be driven into an extended position when the retaining device is released from the paddle frame 1724.

[0269] Referring to Figures 127-130, an exemplary implementation of an implantable device or implant 1800 includes an anchor portion 1806 having one or more paddle frames 1824 that can be driven to a constricted position, thereby making it easier to maneuver the device 1800 to a position for implantation in the heart by reducing contact and / or friction between the device 1800 and the natural structure of the heart, such as a cord. That is, when the device 1800 is positioned for implantation on a natural valve lobe, a drive line 1890 drives the paddle frame 1824 to a constricted position by generating a compressive force C (Figure 128) on the paddle frame 1824, which is controlled by the user, thereby reducing contact and / or friction between the device 1800 and the natural structure of the heart. Device 1800 may include any other features relating to an implantable device or implant, as described in this application or in applications or patent documents incorporated herein by reference, and Device 1800 may be positioned to engage with valve tissue 20, 22 as part of any suitable valve restoration system (e.g., any valve restoration system disclosed herein). In addition, any device described herein may have features relating to Device 1800.

[0270] The implantable device or implant 1800 includes a joint or connecting portion 1804, a proximal or attachment portion 1805, an anchor portion 1806, and a distal portion 1807. The joint portion 1804, the attachment portion 1805, and the distal portion 1807 can take any suitable form, such as the forms relating to these portions in the device 200 shown in Figures 22 to 37, or any other form described herein. In some implementations, the joint portion 1804 includes a connecting member 1810 (e.g., a spacer, connecting member, gap filler, etc.) which can be used to implant between the lobes 20, 22 in a natural mitral valve MV, for example. The connecting member 1810 can take any suitable form, such as any form described herein.

[0271] The mounting portion 1805 includes a first collar or proximal collar 1811 for engaging with a capture mechanism (e.g., a capture mechanism 213 shown in Figures 44 to 49) of a delivery system (e.g., a delivery system 202 shown in Figures 38 to 49). The proximal collar 1811 can take any suitable form, such as any form described herein.

[0272] The distal portion 1807 includes a cap 1814 attached to the anchor 1808 of the anchor portion 1806, such that the cap 1814 can be driven to drive the anchor 1508 between an open position and a closed position. The cap 1814 can take any suitable form, such as any form described herein. In the illustrated example, a drive member 1812 (e.g., a drive wire, a drive shaft, etc.) extends from a delivery system (e.g., any delivery system described herein) and engages with the cap 1814 to enable the device 1800 to be driven by driving the cap 1814 relative to the connecting member or spacer 1810. The drive member 1812 can engage with the cap and drive the cap by any suitable means, such as any means provided herein.

[0273] The anchor portion 1806 can take any suitable form, such as the form of the anchor portion 206 in the device 200 shown in Figures 22 to 37, or any other form described herein. The anchor portion 1806 may include a plurality of anchors 1808, each anchor 1808 including an outer paddle 1820, an inner paddle 1822, a paddle extension member or paddle frame 1824, and a clasp 1830. The paddle frame 1824 may include a main support section 1885, a first connecting member for attachment to a cap 1814, and a second connecting member for attachment to a connecting portion 1823 of an anchor 1808. The paddle frame 1824 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any means described herein. The thickness and width of the paddle frame 1824 can take any suitable form; for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in Figures 91 to 95), or the width can be greater than the thickness.

[0274] The paddle frame 1824 includes an end 1801 configured to be attached to a cap 1814 and a free end 1803. The paddle frame 1824 includes a first opening 1891 and a second opening 1892 for receiving one or more drive lines 1890 of the delivery system. Referring to Figures 127–129, in some examples a single drive line 1890 extends into the delivery system through the first opening 1891 and the second opening 1892 of each paddle frame 1824, so that a user can drive the paddle frame 1824 to a constricted position by pulling the drive line 1890. Referring to Figure 129, the drive line 1890 may also extend through an opening 1893 of a clasp 1830 in each paddle 1808 before extending into the delivery system. Referring to Figure 128, when the user pulls the drive line 1890, a force is generated in direction Y at each end of the drive line 1890, based on the drive line extending through openings 1891 and 1892, and a compressive force C is applied to the paddle frame 1824. The compressive force C drives the paddle frame 1824 to a constricted position.

[0275] Referring to Figure 129, the drive line 1890 can also extend through the opening 1893 of the clasp 1830 in each paddle 1808 before extending into the delivery system. When the user pulls the drive line 1890, the clasp 1830 is released and the paddle frame 1824 is driven to the constricted position.

[0276] Referring to Figure 130, in some examples, a connecting drive line 1889 extends in a closed loop between the first opening 1891 and the second opening 1892 of each paddle frame 1824, and a single drive line 1890 extends through the closed loop formed by each connecting line 1889, so that the user can drive both paddle frames 1824 to the constricted position by simply pulling the single drive line 1890. That is, pulling the single drive line 1890 generates a compressive force (for example, a compressive force similar to compressive force C shown in Figure 128) on each paddle frame 1824, and at the same time the paddle frame 1824 is driven to the constricted position. In the illustrated example, the single drive line 1890 extends through the joining member 1810 before extending into the delivery system. Referring to Figures 127 to 130, the drive lines 1889 and 1890 can be, for example, sutures.

[0277] Referring to Figure 128, when the paddle frame 1824 is in the constricted position, it has a length L2 and a total width W2. When the paddle frame 1424 is in the normal extended position, its width can be 5mm to 15mm, for example, 7mm to 12mm, for example, 9mm to 11mm, for example, approximately 10mm. The constricted width W2 of the paddle frame 1124 can be 3mm to 12mm, for example, 5mm to 10mm, for example, 7mm to 9mm, for example, approximately 8mm. The ratio of the normal width to the constricted width W2 can be 10 / 9 to 3 / 1, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2, for example. The dimensions described above for the paddle frame 1824 in the constricted and extended positions are based on the examples shown in Figures 127 to 129, but it should be understood that the same dimensions can be applied to the example shown in Figure 130.

[0278] Referring to Figures 131 to 136, an exemplary implementation of an implantable device or implant 1900 includes an anchor portion 1906 having one or more paddle frames 1924 that can be driven to a constricted position, thereby making it easier to maneuver the device 1900 to a position for implantation in the heart by reducing contact and / or friction between the device 1900 and the natural structure of the heart, such as a cord. That is, when the device 1900 is positioned for implantation on a valve leaf of a natural valve, a drive line 1990 drives the paddle frame 1924 to a constricted position by generating a compressive force on the paddle frame 1924 (e.g., a compressive force similar to compressive force C in Figure 128), thereby reducing contact and / or friction between the device 1900 and the natural structure of the heart. Device 1900 may include any other features relating to an implantable device or implant, as described in this application or in applications or patent documents incorporated herein by reference, and Device 1900 may be positioned to engage with valve tissue (e.g., valve lobes 20, 22, etc.) as part of any suitable valve restoration system (e.g., any valve restoration system disclosed herein). In addition, any device described herein may have features relating to Device 1900.

[0279] The implantable device or implant 1900 includes a joint or connecting portion 1904, a proximal or attachment portion 1905, an anchor portion 1906, and a distal portion 1907. The joint 1904, attachment portion 1905, and distal portion 1907 can take any suitable form, such as the forms relating to these portions in the device 200 shown in Figures 22 to 37, or any other form described herein. In some implementations, the joint 1904 includes a connecting member 1910 (e.g., a spacer, connecting member, gap filler, etc.) which can be used to implant between the lobes 20, 22 in a natural mitral valve MV, for example. The spacer, connecting member, connecting member, etc. 1910 can take any suitable form, such as any form described herein.

[0280] The mounting portion 1905 includes a first collar or proximal collar 1911 for engaging with a capture mechanism (e.g., a capture mechanism 213 shown in Figures 44 to 49) of a delivery system (e.g., a delivery system 202 shown in Figures 38 to 49). The proximal collar 1911 can take any suitable form, such as any form described herein.

[0281] The distal portion 1907 includes a cap 1914 attached to the anchor 1908 of the anchor portion 1906, such that the cap 1914 can be driven to drive the anchor 1908 between an open position and a closed position. The cap 1914 can take any suitable form, such as any form described herein. In the illustrated example, a drive member 1912 (e.g., a drive wire, a drive shaft, etc.) extends from a delivery system (e.g., any delivery system described herein) and engages with the cap 1914 to enable the device 1900 to be driven by driving the cap 1914 relative to the connecting member or spacer 1910. The drive member 1912 can engage with the cap and drive the cap by any suitable means, such as any means provided herein.

[0282] The anchor portion 1906 can take any suitable form, such as the form of the anchor portion 206 in the device 200 shown in Figures 22 to 37, or any other form described herein. The anchor portion 1906 may include a plurality of anchors 1908, each anchor 1908 including an outer paddle 1920, an inner paddle 1922, a paddle extension member or paddle frame 1924, and a clasp 1930. The paddle frame 1924 may include a main support section 1985, a first connecting member 1901 for attachment to a cap 1914, and a second connecting member 1903 for attachment to a connecting portion 1923 of an anchor 1908. The paddle frame 1924 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any means described herein. The thickness and width of the paddle frame 1924 can take any suitable form; for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in Figures 91 to 95), or the width can be greater than the thickness.

[0283] The main support section 1985 includes an inner portion 1972 and an outer portion 1974 connected to the connecting member 1901. In the illustrated example, the inner portion 1972 has a pair of arms 1982 extending from the connecting member 1901 to the connecting member 1903, the arms 1982 providing support for the anchor 1908. The outer portion 1974 has a pair of arms 1980 extending outward from the connecting member 1901 than the arms 1982 of the inner portion 1972, so that the arms 1980 define the overall width of the paddle frame 1924 (e.g., the overall width W2 shown in Figure 128). Referring to Figure 131, each of the arms 1983 includes an opening 1992 for receiving one or more drive lines 1990 of the delivery system (Figures 132 to 136). The arms 1982 may also include an opening 1991 for receiving one or more drive lines 1990. The opening 1991 can be an opening in the connecting member 1903 for connecting to the connecting portion 1923 of the anchor 1908 (as shown in the illustrated example), or the opening 1991 can be a separate opening from the connecting member 1903.

[0284] Referring to Figures 132 and 133, in some examples, a single drive line 1990 drives each paddle frame 1924 to a constricted position. In the illustrated example, the drive line 1990 extends through openings 1991 and 1992 of the paddle frame 1924, so that a user can apply a tensile force to the drive line 1990 to drive the paddle frame 1924 to a constricted position. Each drive line 1990 has a first end 1993 and a second end 1994. The first end 1993 extends from the delivery system through the opening 1991 of one arm 1982 in the inner portion 1972, through the opening 1992 of one arm 1980 in the outer portion 1974, through the opening 1992 of the other arm 1980 in the outer portion 1974, and through the opening 1991 of the other arm 1982 in the inner portion 1972, while the second end 1994 of the drive line 1990 extends into the delivery system. In the example shown in Figure 132, applying tensile forces to both ends 1993 and 1994 of the drive line 1990 generates a compressive force on the arm 1980 of the outer portion 1974 (Figure 131), driving the arm 1980 toward the inner portion 1972 of the paddle frame 1924, thereby driving the paddle frame to a constricted position.

[0285] Referring to Figure 133, the drive line 1990 can also extend through the opening 1931 of the clasp 1930 of each paddle 1908 before extending into the delivery system. In the example shown in Figure 132, applying tensile force to both ends 1993, 1994 of the drive line 1990 drives the paddle frame to a constricted position and releases the clasp.

[0286] Referring to Figure 134, a single drive line 1990 drives each paddle frame 1924 to a constricted position, corresponding to each paddle frame 1924. Each drive line 1990 has a first end (not shown) extending from the delivery system through the connecting member 1910, through the opening 1992 of one arm 1980 in the outer portion 1974, through the opening 1991 of one arm 1982 in the inner portion 1972, through the opening 1991 of the other arm 1982 in the inner portion 1972, and through the opening 1992 of the other arm 1980 in the outer portion 1974, and a second end (not shown) of the drive line 1990 extending into the delivery system through the connecting member 1910. By applying tensile force to both ends of the drive line 1990, a compressive force is generated on the arm 1980 (Figure 131) of the outer portion 1974, driving the arm 1980 toward the inner portion 1972 of the paddle frame 1924, thereby driving the paddle frame 1924 to a constricted position.

[0287] Referring to Figures 135 and 136, in some implementations, the connection drive line 1989 is connected to each paddle frame 1924, and the drive line 1990 is connected to the connection drive line 1989, so that the user can drive the paddle frame 1924 to a constricted position by pulling the drive line 1990. Referring to Figure 135, in some implementations, the connection drive line 1989 extends in a closed loop between the opening 1991 of the inner portion 1972 of the paddle frame 1924 and the opening 1992 of the outer portion 1974. Referring to Figure 136, in some implementations, the connection drive line 1989 extends in a closed loop between the openings 1992 of the outer portion 1974 of the paddle frame 1924, but the connection drive line 1989 does not extend through the opening 1991 of the inner portion 1972.

[0288] In both examples shown in Figures 135 and 136, applying a tensile force to the drive line 1990 generates a compressive force on the arm 1980 (Figure 131) of the outer portion 1974, driving the arm 1980 toward the inner portion 1972 of the paddle frame 1924, thereby driving the paddle frame to a constricted position. Although the examples shown in Figures 135 and 136 show separate drive lines 1990 attached to the drive connection line 1989 of each paddle frame 1924, in some implementations a single drive line (e.g., a drive line similar to line 1890 shown in Figure 130) can be attached to the connecting drive line 1989 of each paddle frame 1924 so as to drive both paddle frames 1924 to a constricted position by pulling the end of the single drive line. Referring to Figures 131 to 136, the drive lines 1989, 1990 can be, for example, sutures.

[0289] Referring further to Figures 131 to 136, the total width of the paddle frame 1924 (defined by the outer portion 1974 of the paddle frame 1924) when in the normal extended position can be, for example, 7mm to 12mm, for example, 9mm to 11mm, for example, approximately 10mm, or 5mm to 15mm. The narrowed width of the paddle frame 1124 can be, for example, 5mm to 10mm, for example, 7mm to 9mm, for example, approximately 8mm, or 3mm to 12mm. The ratio of the normal width to the narrowed width can be, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2, or 10 / 9 to 3 / 1.

[0290] Referring to Figures 137–148, an exemplary implementation of an implantable device or implant 2000 (Figures 139–144) includes an anchor portion 2006 having one or more paddle frames 2024. The paddle frames 2024 are configured to allow for easier maneuvering of the device 2000 to a position for implantation in the heart by reducing contact and / or friction between the device 2000 and the natural structures of the heart, such as cords. For example, a drive line is controlled by the user to generate a compressive force (e.g., compressive force C shown in Figure 128) on the paddle frame 2024 to move it from a normal expanded position (Figures 140 and 142) to a constricted position (Figures 139 and 141) when the device 2000 is positioned for implantation on the leaflets of a natural valve, thereby reducing friction between the natural structures of the heart and the device 2000. Device 2000 may include any other features relating to an implantable device or implant, as described in this application or in applications or patent documents incorporated herein by reference, and Device 2000 may be positioned to engage with valve tissue 20, 22 as part of any suitable valve restoration system (e.g., any valve restoration system disclosed herein). In addition, any device described herein may have features relating to Device 2000.

[0291] Referring to Figures 143 to 144, the implantable device or implant 2000 includes a joint or connecting portion 2004, a proximal or attachment portion 2005, an anchor portion 2006, and a distal portion 2007. The joint 2004, attachment portion 2005, and distal portion 2007 can take any suitable form, such as the forms relating to these portions in the device 200 shown in Figures 22 to 37, or any other form described herein. In some implementations, the joint 2004 optionally includes a connecting member 2010 (e.g., a spacer, connecting member, gap filler, etc.) which can be used to implant between the lobes 20, 22 in, for example, a natural mitral valve MV. The spacer, connecting member, connecting member, etc. 2010 can take any suitable form, such as any form described herein.

[0292] The mounting portion 2005 includes a first collar or proximal collar 2011 for engaging with a capture mechanism (e.g., a capture mechanism 213 shown in Figures 44 to 49) of a delivery system (e.g., a delivery system 202 shown in Figures 38 to 49). The proximal collar 2011 can take any suitable form, such as any form described herein.

[0293] The distal portion 2007 includes a cap 2014 attached to the anchor 2008 of the anchor portion 2006, such that the cap 2014 can be driven to drive the anchor 2008 between an open position and a closed position. The cap 2014 can take any suitable form, such as any form described herein. A drive member (for example, the same or similar drive member to the drive member 212 shown in Figures 22 to 37) extends from a delivery system (for example, any delivery system described herein) through an opening 2009 (Figure 143) and through the connecting member 2010, and engages with the cap 2014, thereby enabling the device 2000 to be driven by driving the cap 2014 relative to the connecting member 2010. The drive member can engage with the cap and drive the cap by any suitable means, such as any means provided herein.

[0294] The anchor portion 2006 can take any suitable form, such as the form of the anchor portion 206 in the device 200 shown in Figures 22 to 37, or any other form described herein. The anchor portion 2006 may include a plurality of anchors 2008, each anchor 2008 including an outer paddle 2020, an inner paddle 2022, a paddle extension member or paddle frame 2024, and a clasp (e.g., clasp 230 shown in Figures 22 to 37). Referring to Figures 137 and 138, the paddle frame 2024 may include a main support section portion 2085 and a connecting member 2003 for attachment to the cap 2014. The paddle frame 2024 can be attached to the cap 2014 by any suitable means, such as any means described herein. Referring to Figures 145 to 148, in the illustrated example, both anchors 2008 are defined by a paddle ribbon 2001, which includes an inner paddle 2022 and an outer paddle 2020 for each anchor 2008. The inner paddle 2022 of each anchor 2008 is attached by a connecting portion 2025 configured to connect the inner paddle 2022 to the joint member 2010 (as shown in Figure 148). In the illustrated example, the connecting portion 2025 includes an opening 2094 for receiving the distal portion of the joint member 2010. The outer paddle 2020 of each anchor 2008 is attached by a connecting portion 2021 configured to connect the outer paddle 2020 to the cap 214 (as shown in Figure 148). In the illustrated example, the connecting portion 2021 includes an opening 2096 for receiving a portion of the cap 2014. Each inner paddle 2022 is attached to its corresponding outer paddle 2020 by a connecting portion 2023.

[0295] Referring to Figures 137 and 138, the paddle frame 2024 includes two or more arms 2080 that define the overall width TW of the anchor 2008, where at least some of the arms 2080 are connected at the distal portion of the paddle frame 2024 (e.g., the portion of the paddle frame 2024 adjacent to the connecting member 2003). Each of the arms 2080 includes one or more openings 2091, 2092 for receiving one or more drive lines (e.g., drive lines 1890 shown in Figures 127-130), thereby allowing the paddle frame 2024 to be driven to a constricted position by a user pulling on the drive lines. The illustrated example includes two arms 2080, each with a proximal opening 2091 and a distal opening 2092. In some implementations, a single drive line can extend through each opening 2091, 2092 so that the paddle frame 2024 can be driven to a constricted position by a single drive line. However, it will be understood that, in driving the paddle frame 2024 to the constricted position, any appropriate number of drive lines may extend through the openings 2091 and 2092.

[0296] Referring to Figure 137, the arms 2080 are connected to each other at the distal portion of the paddle frame 2024 via a connecting link 2083. This connection between the two arms 2080 causes the arms 2080 to rotate, flex, and / or articulate inward Z around the connecting link 2083 when the user applies tension F to the paddle frame 2024 by pulling one or more drive lines extending through openings 2091, 2092. This rotation, flexion, and / or articulation of the arms 2080 drives the main support section portion 2085 of the arms 2080 inward X, thereby constricting the paddle frame 2024. In the illustrated example, the connecting link 2083 has a first member 2087 attached to one arm 2080, a second member 2089 attached to the other arm 2080, and a thin arch-shaped member 2086 connecting the first member 2087 to the second member 2089. However, the connecting link 2083 can take any suitable form that allows the arm to rotate, bend, and / or articulate inward Z when tension F is applied to the paddle frame 2024. In some embodiments, the connecting link 2083 is integral with the arm 2080 of the paddle frame 2024.

[0297] Referring further to Figure 137, the total width TW of the paddle frame 1924 when in the normal extended position can be 5mm to 15mm, for example, 7mm to 12mm, for example, 9mm to 11mm, for example, approximately 10mm. The narrowed width of the paddle frame 1124 can be 3mm to 12mm, for example, 5mm to 10mm, for example, 7mm to 9mm, for example, approximately 8mm. The ratio of the normal width to the narrowed width W2 can be 10 / 9 to 3 / 1, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2.

[0298] Figures 149–156 show various exemplary implementations of a paddle frame 2024 that may be used with the implantable device or implant 2000 shown in Figures 139–144. Referring to Figure 149, the device 2000 may include a paddle frame 2124 having an inner portion 2172 and an outer portion 2174. The outer portion 2174 has two arms 2180, each containing an opening 2192 for receiving one or more drive lines (e.g., drive lines 1890 shown in Figures 27–30), so that the paddle frame can be driven to a constricted position by a user pulling on the drive lines. The arms 2180 define the total width TW of the anchor in the device 2000.

[0299] The arms 2180 are connected to each other at the distal portion of the paddle frame 2124 via a connecting link 2183. This connection between the two arms 2180 causes the arms 2180 to rotate, flex, and / or articulate inward Z around the connecting link 2183 when the user applies tension F to the paddle frame 2024 by pulling one or more drive lines extending through the opening 2192. This rotation, flexion, and / or articulation of the arms 2180 drives the main support section portion 2185 of the arms 2180 inward X, thereby constricting the paddle frame 2124. In the illustrated example, the connecting link 2183 includes a first member 2187 attached to one arm 2180, a second member 2189 attached to the other arm 2180, and a thin arch-shaped member 2186 connecting the first member 2187 to the second member 2189. The connecting link 2183 can take any suitable form, such as any form described with respect to the connecting link 2083 shown in Figure 137.

[0300] The inner portion 2172 of the paddle frame 2124 has two arms 2182 that extend inward and downward from the proximal portion of arm 2180 and assist in easily driving the paddle frame 2124 to a constricted position. The arms 2182 are connected to arm 2180 at connection point 2197. In some implementations, connection point 2197 includes a thin, arched portion that assists in easily driving arms 2180 and 2182 inward X. The arms 2182 are connected to each other at connection point 2198. Connection point 2198 may include a thin, rounded portion that further assists in easily driving arms 2180 and 2182 inward X.

[0301] Referring to Figure 150, in some implementations, the device 2000 may include a paddle frame 2224 having an inner portion 2272 and an outer portion 2274. The outer portion 2274 has two arms 2280, each containing an opening 2292 for receiving one or more drive lines (e.g., drive lines 1890 shown in Figures 27 to 30), so that a user can drive the paddle frame to a constricted position by pulling the drive lines. The arms 2280 define the total width TW of the anchor in the device 2000.

[0302] The arms 2280 are connected to each other at the distal portion of the paddle frame 2224 via a connecting link 2283. This connection between the two arms 2280 causes the arms 2280 to rotate, flex, and / or articulate inward Z around the connecting link 2283 when the user applies tension F to the paddle frame 2224 by pulling one or more drive lines extending through the opening 2292. This rotation, flexion, and / or articulation of the arms 2280 drives the main support section portion 2285 of the arms 2280 inward X, thereby constricting the paddle frame 2224. In the illustrated example, the connecting link 2283 has a first member 2287 attached to one arm 2280, a second member 2289 attached to the other arm 2280, and a thin arch-shaped member 2286 connecting the first member 2287 to the second member 2289. The connecting link 2283 can take any suitable form, such as any form described with respect to the connecting link 2083 shown in Figure 137.

[0303] The inner portion 2272 of the paddle frame 224 has two arms 2282 that extend inward and downward from the proximal portion of arm 2280 and assist in easily driving the paddle frame 2224 to a constricted position. The arms 2282 are connected to arm 2280 at connection point 2297. In some implementations, connection point 2297 includes a thin arched portion that assists in easily driving arms 2280 and 2282 inward X. The arms 2282 are connected to each other at connection point 2298. Connection point 2298 may include a thin arched portion that further assists in easily driving arms 2280 and 2282 inward X. In the illustrated example, each of the arms 2282 has a recess that is attached to each other at the thin arched portion of connection point 2298, which assists in facilitating bending of the arms 2282 inward X.

[0304] Referring to Figure 151, in some implementations, the device 2000 may include a paddle frame 2324 having an inner portion 2372 and an outer portion 2374. The outer portion 2374 has two arms 2380, each containing an opening 2392 for receiving one or more drive lines (e.g., drive lines 1890 shown in Figures 27 to 30), so that a user can drive the paddle frame to a constricted position by pulling the drive lines. The arms 2380 define the total width TW of the anchor in the device 2000.

[0305] The arms 2380 are connected to each other at the distal portion of the paddle frame 2324 via a connecting link 2383. This connection between the two arms 2380 causes the arms 2380 to rotate, flex, and / or articulate inward Z around the connecting link 2383 when the user applies tension F to the paddle frame 2324 by pulling one or more drive lines extending through the opening 2392. This rotation, flexion, and / or articulation of the arms 2380 drives the main support section 2385 of the arm 2280 inward X, thereby constricting the paddle frame 2324. In the illustrated example, the connecting link 2283 has a first member 2387 attached to one arm 2380, a second member 2389 attached to the other arm 2380, and a thin arch-shaped member 2386 connecting the first member 2387 to the second member 2389. The connecting link 2383 can take any suitable form, such as any form described with respect to t...

Claims

[Claim 1] A portable device substantially described in relation to the specification and accompanying drawings.

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