Systems and methods for heart valve repair

Through the transcatheter heart valve repair system, the combination of clamps and locking mechanisms is used to solve the minimally invasive surgical problem of heart valve reflux in elderly patients, achieving efficient and low-risk valve repair results.

CN114173680BActive Publication Date: 2025-05-06THE TRUSTEES OF COLUMBIA UNIV IN THE CITY OF NEW YORK
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Patent Information

Application Number
CN202080019668.4
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2019-11-13
Filing Date
2020-01-08
Publication Date
2025-05-06
Estimated Expiration
2040-01-08

AI Technical Summary

Technical Problem

The prior art is difficult to effectively repair the heart valve reflux problem in elderly patients through minimally invasive surgery, especially for patients who are not suitable for happy surgery, the surgery has high risk and limited effect.

Method used

A transcatheter heart valve repair system is provided, including a sheath, at least two clamps and a locking mechanism, inserting the clamp into the heart chamber through a dedicated delivery system, clamping the leaflets of the valve, and fixing the clamp through a locking mechanism.

Benefits of technology

The system can effectively repair the heart valve through minimally invasive surgery, reduce surgical risks, improve the treatment success rate of elderly patients, and reduce in-hospital mortality after surgery.

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Abstract

The disclosed subject matter relates to a transcatheter heart valve repair system comprising: a sheath; at least two clamps, each clamp comprising: a ventricular jaw, an atrial jaw and a cable; and a locking mechanism.
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Description

[0001] Citation of Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 789,612, filed on January 8, 2019, entitled “SYSTEMS AND METHODS FOR CARDIAC VALVE REPAIR,” and U.S. Provisional Application No. 62 / 934,606, filed on November 13, 2019, entitled “SYSTEMS AND METHODS FOR CARDIAC VALVE REPAIR,” both of which are incorporated herein by reference in their entirety. Technical Field

[0003] The disclosed subject matter relates to devices and systems for heart valve repair. Background Art

[0004] The mitral and tricuspid heart valves allow unidirectional flow of blood from the atria to the ventricles and prevent backflow back into the atria during ventricular contraction. Regurgitation results when the valve leaflets fail to coapt. Coaptation failure may occur simply because of ventricular dilation resulting in stretching of the annulus and / or tethering of the valve leaflets, known as secondary regurgitation. Regurgitation can also be caused by abnormal valve leaflets, abnormal papillary muscles / tendons and is known as primary regurgitation.

[0005] Mitral valve anatomy: The mitral valve controls blood flow between the left atrium and left ventricle. Figure 1 As shown, the mitral valve has two leaflets, the anterior leaflet AL and the posterior leaflet PL. The anterior leaflet AL is larger in area, while the posterior leaflet PL is crescent-shaped. The line of coaptation (LOC) is semilunar in shape. Both leaflets are supported by fan-shaped chordae tendineae that attach the leaflets to the papillary muscles ( Figure 2 ).

[0006] As the name implies, the tricuspid valve consists of three leaflets (anterior leaflet AL, posterior leaflet PL, and septal leaflet SL) and controls blood flow between the right atrium and right ventricle ( Figure 4 ). Like the mitral valve, the tricuspid valve is connected to the papillary muscles and the ventricle by chordae tendineae.

[0007] Mitral regurgitation affects more than 10% of the general population aged 75 years and older. Previously, treatment for severe mitral regurgitation consisted solely of surgical mitral valve repair or replacement. In some conditions where both treatments are difficult or require a long time, the Alfieri stitch has been used, particularly in the treatment of mitral valve failure ( Figure 3 ). This sutures the two leaflets of the mitral valve roughly in the middle, thus converting the mitral orifice into a double orifice. A similar concept has been applied to tricuspid valve repair with some success ( Figure 5). Approximately 50% of patients with severe symptomatic mitral and tricuspid regurgitation are not suitable for open-heart surgery due to increased surgical risks (primarily related to aging and impaired left ventricular function). In addition, in-hospital mortality after mitral valve surgery in octogenarians has been reported to be as high as 6% after mitral valve repair and 13% after mitral valve replacement. Mortality after tricuspid valve surgery is also high.

[0008] There are other methods on the market. However, said methods do not allow the possibility to attach a chord structure between the clamp and the ventricle if necessary, independently of or in addition to the clamp mechanism.

[0009] Therefore, minimally invasive surgery that is more suitable for older patients with relevant comorbidities addresses an unmet clinical need. Summary of the invention

[0010] A transcatheter heart valve repair system is provided, comprising: a sheath; at least two clamps, each clamp comprising: a ventricular clamp, an atrial clamp and a cable; and a locking mechanism.

[0011] In some embodiments, the locking mechanism is configured to lock at least two clamps together or to lock cables of the clamps together.

[0012] In some embodiments, the system includes three clamps.

[0013] In some embodiments, the system includes four clamps.

[0014] On the other hand, a method for repairing a heart valve is provided, the method comprising: inserting a sheath into a chamber of a patient's heart; inserting at least two clamps into the sheath using a dedicated delivery system, wherein each of the clamps comprises a ventricular clamp, an atrial clamp and a cable; clamping a first leaflet of a valve in the patient's heart using a first clamp of the at least two clamps; and clamping a second leaflet of a valve in the patient's heart using a second clamp of the at least two clamps.

[0015] In some embodiments, the method further comprises clamping one of the first leaflet, the second leaflet, and the third leaflet of the valve in the patient's heart with a third clamp.

[0016] In some embodiments, the method further includes clamping one of the first leaflet, the second leaflet, and the third leaflet of the valve in the patient's heart with a fourth clamp; and securing the at least two clamps together by a locking mechanism.

[0017] In some embodiments, the locking mechanism is configured to lock the cables holding the clamps together.

[0018] In some embodiments, the method further comprises severing a cable of each of the at least two clamps and removing the cable from the sheath.

[0019] In some embodiments, a sheath is inserted into the left atrium of the heart of the patient.

[0020] In some embodiments, the valve is a mitral valve.

[0021] In some embodiments, the valve is a tricuspid valve.

[0022] In another aspect, a transcatheter heart valve repair system is provided, comprising: a sheath; at least two clamps, each clamp comprising a ventricular jaw having a first width and a first length, an atrial jaw having a second width and a second length, and a cable; and a locking mechanism.

[0023] In some embodiments, the first width and the second width are different.

[0024] In some embodiments, the first length and the second length are different.

[0025] In some embodiments, the system includes three or more clamps.

[0026] In some embodiments, the locking mechanism is configured to lock at least two clamps together or to lock cables of the clamps together.

[0027] On the other hand, a transcatheter heart valve repair system is provided, comprising: a sheath; at least two clamps, each clamp comprising a ventricular jaw internally defining a plurality of first teeth for engaging the leaflets of a heart valve, an atrial jaw internally defining a plurality of second teeth for engaging the leaflets of a heart valve, and a cable; and a locking mechanism.

[0028] In some embodiments, the first plurality of teeth is different from the second plurality of teeth.

[0029] In another aspect, a transcatheter heart valve repair system is provided, the system comprising: a sheath; at least two clamps, each clamp comprising: a ventricular jaw, an atrial jaw, a cable; and a locking mechanism adapted to engage the clamps in a plurality of configurations

[0030] In some embodiments, the locking mechanism is configured to lock at least two clamps together or to lock cables of the clamps together.

[0031] In some embodiments, the locking mechanism includes a coupling to lock at least two clamps together.

[0032] In some embodiments, the coupler allows the clamp to be attached such that full eversion of the leaflet is achieved.

[0033] In some embodiments, the coupler allows the clamp to be attached such that 50% eversion of the leaflets is achieved.

[0034] In some embodiments, the coupler allows the clamp to be attached such that 0-10% eversion of the leaflets is achieved.

[0035] In some embodiments, the coupler comprises a hinge mechanism.

[0036] In some embodiments, the coupler defines a plurality of slots to capture the clamp in a plurality of positions.

[0037] In some embodiments, the coupling is flexible to grasp the clamp in multiple positions

[0038] In another aspect, a transcatheter heart valve repair system is provided, comprising: a sheath; an anchor and an artificial chord connected to the anchor, the anchor being constructed to secure at least one clamp slidable on the chord to a ventricle, the clamp comprising a ventricular jaw, an atrial jaw and a locking mechanism constructed to secure the clamp to the chord.

[0039] In another aspect, a method for repairing a heart valve is provided, the method comprising: providing an anchor and an artificial chord connected to the anchor; providing a clamp that can slide on the chord, the clamp comprising a ventricular jaw and a ventricular jaw; inserting a sheath into a chamber of the patient's heart; inserting the anchor and the artificial chord into the chamber of the heart; fixing the anchor in the ventricle of the heart; sliding the clamp on the artificial chord; clamping a first leaflet of a valve in the patient's heart with the clamp; and fixing the position of the clamp on the artificial chord with a locking mechanism.

[0040] In some embodiments, the method further comprises severing the artificial chord outside of the chamber of the heart.

[0041] In some embodiments, the method further comprises withdrawing the artificial chord. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] The disclosed aspects will hereinafter be described in conjunction with the accompanying drawings, which are provided to illustrate rather than limit the disclosed aspects, wherein like reference numerals denote like elements.

[0043] Figure 1 and Figure 2 Illustration of the structure of the mitral valve of the human heart.

[0044] Figure 3 A technique for repairing the mitral valve is illustrated.

[0045] Figure 4 Diagram showing the structure of the tricuspid valve of the human heart.

[0046] Figure 5 A technique for repairing the tricuspid valve is illustrated.

[0047] Figure 6 A schematic cross-sectional view of a human heart is illustrated.

[0048] Figure 7 An early stage of clamp installation according to an exemplary embodiment of the disclosed subject matter is illustrated.

[0049] Figure 8 A subsequent stage of clamp installation according to an exemplary embodiment of the disclosed subject matter is illustrated.

[0050] Fig. 9 A further stage of clamp installation according to an exemplary embodiment of the disclosed subject matter is illustrated.

[0051] Fig.10 An early stage of clamp installation according to an exemplary embodiment of the disclosed subject matter is illustrated.

[0052] Fig.11 Pictured Fig.10 A close-up view of the clamp shown in FIG.

[0053] Fig.12 FIG. 1 illustrates a clamp-mounted Fig.10 After this stage there is another further stage.

[0054] Fig.13 Insertion of a second clamp is illustrated according to an exemplary embodiment of the disclosed subject matter.

[0055] Fig.14 Securing of a clip to a leaflet is illustrated according to an exemplary embodiment of the disclosed subject matter.

[0056] Figure 15-17 Various techniques for clamping and coupling clamps are illustrated in accordance with exemplary embodiments of the disclosed subject matter.

[0057] Figure 18-Figure 21 Various configurations of clamps on the mitral valve are illustrated in accordance with exemplary embodiments of the disclosed subject matter.

[0058] Fig. 22 The configuration of a clamp on a tricuspid valve according to an exemplary embodiment of the disclosed subject matter is illustrated.

[0059] Figure 23-Figure 25 Various configurations of clamps according to exemplary embodiments of the disclosed subject matter are illustrated.

[0060] Figure 26-Figure 31 The figure shows the morphology of the valve structure of the human subject.

[0061] Figure 32-Figure 35 Various configurations of clamps according to exemplary embodiments of the disclosed subject matter are illustrated.

[0062] 36(A) illustrates a side view of a clamp according to an exemplary embodiment of the disclosed subject matter.

[0063] 36(B) illustrates a front view of a clamp according to an exemplary embodiment of the disclosed subject matter.

[0064] 37(A) illustrates a side view of a clamp according to an exemplary embodiment of the disclosed subject matter.

[0065] 37(B) illustrates a front view of a clamp according to an exemplary embodiment of the disclosed subject matter.

[0066] 38(A) illustrates a side view of a clamp according to an exemplary embodiment of the disclosed subject matter.

[0067] 38(B) illustrates a front view of a clamp according to an exemplary embodiment of the disclosed subject matter.

[0068] 39(A) illustrates a side view of a clamp according to an exemplary embodiment of the disclosed subject matter.

[0069] 39(B) illustrates a front view of a clamp according to an exemplary embodiment of the disclosed subject matter.

[0070] Fig.40 A front view of a clamp according to an exemplary embodiment of the disclosed subject matter is illustrated.

[0071] Figure 41-43 Various positions of a coupling mechanism according to exemplary embodiments of the disclosed subject matter are illustrated.

[0072] Figure 44-Figure 47 The diagram illustrates the stages of installation of a chord and clamp in a human heart according to an exemplary embodiment of the disclosed subject matter. DETAILED DESCRIPTION

[0073] Various aspects of the apparatus and method disclosed herein are described more fully below with reference to the accompanying drawings. However, the present disclosure may be implemented in many different forms and should not be construed as limited to any specific structure or function presented throughout the disclosure.

[0074] One of the characteristics of the mitral and tricuspid valves is the variability of the leaflets in length, width, tissue quality, number and arrangement of chords, presence of clefts, and variable subvalvular anatomy morphology.

[0075] The present disclosure provides devices, systems and methods that use a clamp design to facilitate capture of a single leaflet or similar structure and, if desired, provide a mechanism to couple with another clamp of similar design.

[0076] The devices, systems and methods disclosed herein can increase surgical flexibility and enable the use of multiple clamps in a custom configuration for valve repair. The devices, systems and methods can mitigate the risk of stenosis and avoid the need to clamp the valve leaflets simultaneously or the difficulty in clamping the valve leaflets due to anatomical abnormalities and varying heart geometry. The devices, systems and methods disclosed herein can also repair the tricuspid valve and avoid surgical imaging issues and improve maneuverability during surgery.

[0077] It should be understood that both the foregoing general description and the following detailed description are exemplary and illustrative only and are not limiting of the invention as claimed. In this application, the use of the singular includes the plural, the word "a" means "at least one", and unless otherwise specifically stated, the use of "or" means "and / or". In addition, the use of the term "includes" and other forms such as "included" are not limiting. Moreover, unless otherwise specifically stated, terms such as "element" or "component" cover both elements or components including one unit and elements or components including multiple units.

[0078] The device may include a clamp, a delivery system, and a mechanism to ensure that the clamps are locked together. The clamp 21, also referred to herein as a "V-clamp," includes three elements: a ventricular jaw 16, an atrial jaw 18, and a cable 20 ( Fig.11 ). As will be described in more detail herein, the design of the various parts can be varied as desired.

[0079] Figure 6 , which includes the right atrium RA, the left atrium LA, the right ventricle RV, the left ventricle LV, the mitral valve MV and the tricuspid valve TV. Figure 7 As shown, a sheath 12 (proprietary or commercially available) is inserted through the femoral vein, through a septal puncture, and then into the left atrium, as currently performed for various procedures. In some embodiments, the sheath 12 is a steerable sheath.

[0080] like Figure 8 As shown, a first V-shaped clamp is then inserted into the left atrium through the sheath 12 using a dedicated delivery system 14. The delivery system 14 can include a variety of configurations. For example, the clamp can be elastic or a shape memory alloy. When the clamp is retained in the delivery system 14 (e.g., a sleeve configuration), the clamp is in a compressed or folded configuration through a manipulable sheath or an additional inner sheath.

[0081] exist Fig. 9, ventricular jaw 16 is deployed from delivery system 14 and sheath 12 and allowed to assume the expanded configuration as shown and positioned beneath one leaflet (eg, anterior leaflet AL).

[0082] like Figure 10-11 As shown, the atrial jaw 18 is deployed from the delivery system 14 and the sheath 12 and allowed to assume the expanded configuration as shown. In some embodiments, both jaws 16 and 18 are exposed together, and then the ventricular jaw 16 is placed under the posterior leaflet PL. The leaflet is captured or "clipped" by the ventricular jaw 16 and the atrial jaw 18, for example, by closing the clamp by bringing the ventricular jaw 16 and the atrial jaw 18 together, and confirming the leaflet capture. In some embodiments, the ventricular jaw 16 and the atrial jaw 18 are approximated by using a wire, cable, etc.

[0083] like Fig.12 As shown, the delivery system 14 is removed through the sheath 12 and the cable 20 attached to the first V-clamp is secured outside the sheath.

[0084] like Fig.13 As shown, the second V-shaped clamp is introduced by the second delivery system 14'. In a similar manner as described above with respect to the first clamp, the ventricular jaw portion 16' can be introduced first, followed by the atrial jaw portion 18', and then the ventricular jaw 16 and the atrial jaw 18 are brought into proximity. In some embodiments, the order of the jaw portions 16 / 18 can be changed, or both jaw portions 16 / 18 can be introduced together.

[0085] The second V-shaped clamp is placed on the other leaflet in the area determined to achieve the greatest reduction in regurgitation ( Fig.14 ). For example, it may be possible to best reduce regurgitation by applying one clamp on one leaflet and two clamps on the other leaflet. In this case, each clamp is placed in the desired location. Since each individual leaflet is captured individually, the procedure can accommodate different valve physiologies and has a higher success rate. For example, two, three, or four clamps may be placed in this manner with the cables holding each clamp secured outside the body.

[0086] Once the jaw portions of the clamp are positioned in their desired positions, the jaw portions 16 / 18 or 16' / 18' are then coupled together, for example, to be secured around the leaflet for long-term installation. For example, a locking mechanism 24 within the structure of the clamp can be used to couple the jaws. In some embodiments, the jaws are coupled by locking the cable 20 / 20' that holds the clamp (see FIG. 1 ). Figure 15-17 ). Fig.15 The clamp and cable are shown coupled together and the cable has been severed. Fig.16 It is shown that the coupling is carried out at the level of the cable 20 / 20'. Fig.17The connection is shown to be achieved at the level of the clamps 21 / 21'. In some embodiments, the locking mechanism 24 is reversible to ensure satisfactory results. This configuration will allow the position or number of clamps to be changed as required, and one or more clamps can be moved or removed if desired. Once the clamps are locked together using either mechanism, the cable 20 / 20' is released or cut and withdrawn from the sheath.

[0087] Various clamp placement configurations Figure 18-Figure 22 For example, Figure 18-Figure 21 The placement of the V-clip on the mitral valve relative to the anterior leaflet AL and the posterior leaflet PL is illustrated. Fig.18 Shown are two V-clamps coupled together. Figure 19-20 An alternative placement of three V-shaped clamps joined together on the mitral valve, such as two clamps on the ventricular leaflets ( Fig.19 ) or two clamps on the anterior leaflet ( Fig. 20 ). Fig.21 Four V-shaped clamps coupled together are shown, such as two clamps on the ventricular valve leaflets and two clamps on the anterior valve leaflet. Fig. 22 Three V-shaped clips are shown deployed on the tricuspid valve. This configuration is important to facilitate installation in the tricuspid valve, which has three fragile leaflets that are typically widely spaced. Each clip is placed on the anterior leaflet AL, the posterior leaflet PL, and the septal leaflet SL.

[0088] Various embodiments of V-clamps are Figure 23-Figure 25 . In some embodiments, the atrial jaws and the ventricular jaws have interlocking hollow jaws. In some embodiments, the atrial jaws are buckles and the ventricular jaws are hollow jaws. In some embodiments, the structure of the jaws is such that the jaws are compressed into a linear shape when sheathed and expand into a wider paddle shape when not sheathed. In some embodiments, either jaw is covered with cloth or pericardial material. In some embodiments, either jaw varies in the number of clamps / teeth to ensure leaflet capture and promote tissue growth. The opening and closing of each jaw can be independently controlled, thereby allowing for safe placement of the clamp.

[0089] exist Fig.23 In the embodiment, the V-shaped clamp 321 includes a ventricular jaw 316 and a front jaw 318, wherein the ventricular jaw 316 has a hollow space for accommodating the valve leaflets and the front jaw 318 has a clamp. Fig.23 In the embodiment, the V-shaped clamp 421 includes a front jaw 418 and a ventricular jaw 416, wherein the front jaw 418 has a hollow space for accommodating the valve leaflets, and the ventricular jaw 416 has serrations for holding the valve leaflets. Fig.24, V-shaped clamp 521 includes a front jaw 518 having a clamp and a ventricular jaw 516 having serrations or, alternatively, no serrations.

[0090] The various embodiments of the V-clip design described herein account for variations in patient morphology. For example, the posterior mitral valve leaflet may have multiple slits that result in regurgitation ( Figure 26-Figure 27 In some patients, the anterior mitral leaflet, AML, is longer than the posterior mitral leaflet, PML, and in many cases is tethered ( Fig.28 The septal leaflet SL of the tricuspid valve is more fragile and is also attached directly to the right ventricle by a chord. Leaflet length and quality vary between leaflets, so the anterior leaflet AL of the mitral and tricuspid valves is longer and has better tissue quality than the other leaflets, e.g., the septal leaflet SL and the posterior leaflet PL ( Fig.29 ). In different patients, the subvalvular configuration varies; the number of papillary muscles varies; and the number and distribution of chords varies ( Figure 30-Figure 31 ). Therefore, similar clamp designs used to capture / fix all leaflet variations may be the cause of failure and low efficiency

[0091] The implementation of the V-shaped clamp allows for individual leaflet capture and also allows for removal. Final attachment of the individual clamps is achieved and the type of clamp used to effectively and reliably capture each leaflet can be varied.

[0092] like Fig.32 As shown, the clamp 640 for capturing the posterior mitral valve leaflet can be wider and shorter in a given situation, coupled to a longer and thinner anterior clamp 642. Fig.33 As shown, two thinner and longer clamps 742, 744 used on either side of the split across the chord can be coupled to a single clamp 740 at the front. Fig.34 As shown, two clamps 840, 842 can be used horizontally to close the rupture. Fig.35 As shown, three clamps 940, 942, 944 of different lengths and widths can be used to couple the tricuspid valve leaflets together.

[0093] like Figure 36(A)-Figure 40As shown, a grasping mechanism is provided to match the type of leaflet used in each surgical condition. For example, when the anterior leaflet is thicker and larger in volume, a clamp with more rows of teeth can be used, while a clamp with fewer teeth can be used to grasp the posterior leaflet to avoid damaging the leaflet. FIG36(A) is a side view of a clamp with 5 teeth on the anterior jaw, and FIG36(B) is a front view of a clamp with 5 teeth on the anterior jaw. FIG37(A) is a side view of a clamp with three teeth on the distal end of the anterior jaw, and FIG37(B) is a front view of a clamp with three teeth on the distal end of the anterior jaw. FIG38(A) is a side view of a clamp with three teeth equally spaced along the length of the anterior jaw, and FIG38(B) is a front view of a clamp with three teeth equally spaced along the length of the anterior jaw. 39(A) is a side view of a clamp having three teeth equally spaced laterally on the front jaw, and FIG. 39(B) is a front view of a clamp having three teeth equally spaced laterally on the front jaw. Fig.40 is a front view of a clamp having five teeth distributed on the distal end of the front jaw.

[0094] In some embodiments, the coupling mechanism 1024 is used to gather the leaflets to different degrees of compactness and eversion / inversion ( Figure 41-43 )

[0095] When fully coupled, the leaflet edges are inverted and opposite, but when partially coupled, the leaflets may still be close together to bridge the clamp but are only partially inverted.

[0096] In the event that the leaflets are too far apart, the "coupler 1024" can be designed in a manner to fill the gap. This versatility will increase the ability to bridge different degrees of leaflet gaps without lengthening the length of the clamp, and will reduce the excessive tensioning of the leaflets that occurs with existing devices when the gap is too wide, leading to leaflet tearing, clamp disengagement, and / or residual MR. For example, the coupler can include hinges, elongated slots, or can be flexible to accommodate different positions of the leaflets.

[0097] In some embodiments, a V-shaped clamp is used to implant an artificial chord into a prolapsed leaflet PML. Fig.44 As shown, one or more artificial strings of pre-measured or adjustable lengths may be implanted on the papillary muscles or ventricles. Fig.45 As shown, the V-shaped clamp can "track" or slide over the chord mechanism, thereby grasping the prolapsed valve leaflet. Release the clamp.

[0098] like Fig.46 As shown, the string length is adjusted by using a coupling made of metal / fabric / string material. The length achieved eliminates backflow or achieves the desired effect. Fig.47 As shown, the string is then secured with a coupler and cut. The V-clamp mechanism allows this process to be performed with a single catheter.

[0099] Although the present disclosure has been illustrated and described in detail in the drawings and the foregoing description, such illustration and description are to be considered illustrative or exemplary rather than restrictive. The present disclosure is not limited to the disclosed embodiments. By studying the drawings, the disclosure, and the appended claims, those skilled in the art can understand and implement changes to the disclosed embodiments and / or implementations when practicing the claimed disclosure.

Claims

1. A transcatheter heart valve repair system, comprising: jacket; at least two clamps deployable from the sheath, each of the clamps comprising: a ventricular jaw and an atrial jaw for approximating around leaflets of the valve, and a cable; as well as Locking mechanism, The at least two clamps include a first clamp applied to a first leaflet of the valve and a second clamp applied to a second leaflet of the valve, The width of the first clamp is different from the width of the second clamp and / or the length of the first clamp is different from the length of the second clamp, The system comprises three clamps, one of the three clamps being applied to one leaflet of the valve and two of the three clamps being applied to the other leaflet of the valve, The locking mechanism includes a single coupler that locks the three clamps together or that locks the cables of the three clamps together.

2. The system according to claim 1, characterized in that Each clamp includes a ventricular jaw having a first width and a first length and an atrial jaw having a second width and a second length, the first width and the second width being different.

3. The system according to claim 1, characterized in that Each clamp includes a ventricular jaw having a first width and a first length and an atrial jaw having a second width and a second length, the first length and the second length being different.

4. The system according to claim 1, characterized in that Each clamp includes a ventricular jaw defining a plurality of first teeth therein for engaging the leaflets of the heart valve, and an atrial jaw defining a plurality of second teeth therein for engaging the leaflets of the heart valve.

5. The system according to claim 4, characterized in that The plurality of first teeth are different from the plurality of second teeth.

6. The system according to claim 1, characterized in that The coupling allows the clamp to be attached so that complete eversion of the leaflet is achieved.

7. The system according to claim 1, characterized in that The coupler allows the clamp to be attached so that 50% inversion of the leaflet is achieved.

8. The system according to claim 1, characterized in that The coupler allows the clamp to be attached such that 0-10% inversion of the leaflet is achieved.

9. The system according to claim 1, characterized in that The coupler includes a hinge mechanism.

10. The system according to claim 1, characterized in that The coupler defines a plurality of slots for capturing the clamp in a plurality of positions.

11. The system according to claim 1, characterized in that The coupler is flexible to grasp the clamp in multiple positions.

12. A transcatheter heart valve repair system, comprising: jacket; an anchor and an artificial chord connected to the anchor, the anchor being configured for fixation to a ventricle; at least two clamps slidable on the string, each of the clamps comprising: Ventricular clamp, Atrial clamp, and a locking mechanism configured to secure the clamp to the string, The at least two clamps include a first clamp applied to a first leaflet of the valve and a second clamp applied to a second leaflet of the valve, The width of the first clamp is different from the width of the second clamp and / or the length of the first clamp is different from the length of the second clamp, The system comprises three clamps, one of the three clamps being applied to one leaflet of the valve and two of the three clamps being applied to the other leaflet of the valve, The locking mechanism includes a single coupler that locks the three clamps together or that locks the cables of the three clamps together.

Citation Information

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