Devices and methods for treating vascular insufficiency

Abstract

To improve devices and methods for treating heart valve insufficiency.SOLUTION: Embodiments of a leaflet clip device and a method for reducing regurgitation through a native heart valve are disclosed. The leaflet clip device can include an elongated clipping member having a first end portion and a second end portion, and a tensioning mechanism coupled to the clipping member. The leaflet clip device can further include one or more tensioning members disposed within a lumen of the clipping member, where the one or more tensioning members are operatively connected to the tensioning mechanism to transform the clipping member from a delivery configuration to an implantation configuration.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure relates to devices and methods for treating heart failure.

Background Art

[0002] Heart failure generally involves the backflow of blood through a heart valve that cannot close completely or properly, impairing cardiovascular function. Valvular insufficiency can affect, for example, the mitral valve, aortic valve, or tricuspid valve, and may be associated with calcification or deviated valve leaflets, and / or dilation or deformation of the valve annulus. One way to treat heart failure is to use one or more valve leaflet clips to improve the apposition of the native valve leaflets. However, conventional valve leaflet clips can be difficult to implant, may interfere with or damage the function of associated valve structures such as chordae tendineae, and are often limited in use to a single type of heart valve. Therefore, improvements in devices and methods for treating heart failure are desirable.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Summary of the Invention

Means for Solving the Problems

[0004] An exemplary embodiment of a valve leaflet clipping device may comprise an elongated clipping member having a first and a second terminal portion, and a tensioning mechanism coupled to the clipping member. The valve leaflet clipping device may further comprise one or more tensioning members disposed within the lumen of the clipping member, the one or more tensioning members being operably connected to the tensioning mechanism to convert the clipping member from a delivery configuration to an implantation configuration. Some embodiments of the clipping device may further comprise a retaining mechanism disposed within the lumen of the clipping member, the retaining mechanism holding the shape of the clipping member in an implantation configuration.

[0005] In some embodiments of the clipping device, the clipping member may comprise a shape memory material. Additionally and / or alternatively, a tensioning mechanism may be coupled to the clipping member centrally with respect to a first end and a second end. In some embodiments, one or more tensioning members may comprise a first tensioning member, the distal end of which is fixed to the first end portion of the clipping member, and the proximal end portion of the first tensioning member operably connected to a tensioning mechanism; and a second tensioning member, the distal end of which is fixed to the second end portion of the clipping member, and the proximal end portion of the second tensioning member operably connected to a tensioning mechanism. In some embodiments of the clipping device, rotation of at least a portion of the tensioning mechanism may cause tension to be applied to one or more tensioning members.

[0006] In some embodiments of the clipping device, the retaining configuration may include a primary clipping region defined between the two leg portions of the clipping member. Additionally and / or alternatively, the tensioning mechanism may include a retaining mechanism configured to hold the clipping member in the retaining configuration. Additionally and / or alternatively, one or more tensioning members may extend through a portion of the tensioning mechanism. Additionally and / or alternatively, one or more tensioning members may have one end fixed to a portion of the tensioning mechanism.

[0007] Additionally and / or alternatively, an exemplary leaflet clipping device may comprise a clipping member comprising a tubular body having a lumen and two leg portions, which is convertible between a substantially linear delivery configuration and a retention configuration in which the leg portions are drawn together to capture a pair of leaflets between them; and a tensioning mechanism configured to convert the clipping member from the delivery configuration to the retention configuration. Additionally and / or alternatively, the clipping device may further comprise one or more cords disposed within the lumen of the clipping member, which are operably connected to the tensioning mechanism to convert the clipping member from the delivery configuration to the retention configuration. Additionally and / or alternatively, rotation of at least a portion of the tensioning mechanism may cause tensioning of one or more cords, which causes the clipping member to convert from the delivery configuration to the retention configuration.

[0008] In some embodiments of the clipping device, the tensioning mechanism may comprise a screw and a nut, to which one or more cords are connected such that rotation of the screw causes the nut to move axially along the screw, applying tension to one or more cords. In some embodiments, the leaflet clipping device may further comprise a retaining mechanism disposed within the lumen of the clipping member, which holds the clipping member in a fixed configuration.

[0009] Additionally and / or alternatively, the tubular body may comprise a metal tube having circumferential grooves spaced axially along the length of the tubular body. Additionally and / or alternatively, the retaining clipping member may have the shape of the Greek letter omega. Additionally and / or alternatively, when the clipping member is a retaining configuration, the leg portions may extend toward each other from each end of the middle portion of the tubular body to define a clipping region for capturing a pair of valve leaflets, and the leg portions extend toward each other while moving toward the clipping region.

[0010] An exemplary method for reducing regurgitation through a spontaneous heart valve may include the steps of positioning a leaflet clip device adjacent to the junctional edges of two adjacent leaflets of a heart valve, wherein the leaflet clip device comprises a clipping member and first and second tensioning members disposed within the lumen of the clipping member, the first tensioning member being fixed to a first end portion of the clipping member and the second tensioning member being fixed to a second end portion of the clipping member; and applying tension to the tensioning members to convert the clipping member from a delivery configuration to an implantation configuration in which the junctional edges of the leaflets are captured between the two leg portions of the clipping member.

[0011] Additionally and / or alternatively, the step of applying tension may include rotating a tension-applying mechanism operably coupled to the first and second tension-applying members. In some embodiments, the method may include engaging a retaining mechanism to hold the clipping member in a retaining configuration. Additionally and / or alternatively, the clipping member may have a substantially linear shape in the delivery configuration.

[0012] The above and other objects, features, and advantages of the present invention will become more apparent from the following detailed description with reference to the accompanying drawings. [Brief explanation of the drawing]

[0013] [Figure 1] This is a perspective view of a typical embodiment of a valve leaflet clip device with a portion of the tension-applying mechanism removed for illustrative purposes. [Figure 2] This figure shows a magnified view of the clipping member of the clipping device in Figure 1, partially peeled off for illustrative purposes. [Figure 3] This figure shows a magnified view of the valve leaflet clip device in Figure 1, partially peeled back for illustrative purposes. [Figure 4] This is a perspective view of another typical embodiment of a valve leaflet clip device having multiple integrated clipping members for engaging multiple pairs of valve leaflets. [Figure 5] Front view of another exemplary embodiment of the leaflet clip device. [Figure 6] Perspective view of an exemplary embodiment of the leaflet clip device implanted in a native aortic valve. [Figure 7] Side view of the delivery device and the leaflet clip device loaded into the delivery device for delivery to a patient's body. [Figure 8] Front view of another exemplary embodiment of the leaflet clip device. [Figure 9] Front view of another exemplary embodiment of the leaflet clip device. [Figure 10] Front view of the screw of the leaflet clip device shown in FIG. 9. [Figure 11] Front view of another exemplary embodiment of the leaflet clip device. [Figure 12] Front view of another exemplary embodiment of the leaflet clip device. [Figure 13] Front view of a clipping member formed from a laser-cut metal tube according to one embodiment. [Figure 14] Diagram showing a cut pattern for laser-cutting a metal tube to form a clipping member as shown in FIG. 13. [Figure 15] Enlarged view of a portion of the cut pattern shown in FIG. 14. [Figure 16] Front view of a clipping member formed from a laser-cut metal tube according to another embodiment. [Figure 17] Enlarged view of a portion of a cut pattern for laser-cutting a metal tube to form a clipping member as shown in FIG. 16.

Mode for Carrying Out the Invention

[0014] For the purposes of this description, several aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The methods, apparatus, and systems disclosed are not to be construed as limiting in any way. Rather, the present disclosure covers all novel and non-obvious features and aspects of various embodiments disclosed, individually and in various combinations and partial combinations with each other. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, and the embodiments disclosed do not require that any particular advantage or problem be solved.

[0015] Features, integers, properties, compounds, chemical parts, or groups described in connection with a particular aspect, embodiment, or example should be understood to be applicable to any other aspect, embodiment, or example described herein, insofar as they do not conflict with it. All features disclosed herein (including any appended claims, abstract, and drawings) and / or all steps of any method or process disclosed herein may be combined in any combination, except for combinations in which at least some of such features and / or steps are mutually exclusive. The present invention is not limited to the details of any disclosed embodiment. The present invention extends to any novel one or any novel combination of features disclosed herein (including any appended claims, abstract, and drawings) and / or any novel one or any novel combination of any step of any method or process disclosed herein.

[0016] Some operations of the disclosed method are described in a specific sequential order for the sake of presentation; however, please understand that this manner of description may involve rearrangement unless a specific order is required by the special wording described below. For example, operations described sequentially may, in some cases, be rearranged or performed simultaneously. Furthermore, for simplicity, the accompanying diagrams cannot illustrate the various ways in which the disclosed method may be used in relation to other methods. In addition, the description may use terms such as “provide” or “implement” to describe the disclosed method. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and will be readily identifiable to those skilled in the art.

[0017] In this application and as used in the claims, the numerals “a,” “an,” and “the” include the plural unless the context explicitly states otherwise. In addition, the term “includes” means “to comprise.” Furthermore, the terms “combined” and “related” generally mean to be combined or linked electrically, electromagnetically, and / or physically (e.g., mechanically or chemically), and do not exclude the presence of intermediate elements between combined or related items unless a specific opposite wording is used.

[0018] As used herein, the term “proximal” refers to a location, orientation, or part of the device that is closer to the user and further from the implantation site. As used herein, the term “distal” refers to a location, orientation, or part of the device that is further from the user and closer to the implantation site. For example, the proximal movement of the device is the movement of the device toward the user, and the distal movement of the device is the movement of the device away from the user. The terms “longitudinal” and “axial” refer to axes extending in the proximal and distal directions, respectively, unless explicitly specified otherwise.

[0019] As used herein, the terms “integrally formed” and “single-piece structure” refer to a structure which does not involve welding, fasteners, or other means for fastening several separately formed materials together.

[0020] Figure 1 shows a typical embodiment of a valve leaflet clipping device 10. The clipping device 10 of the illustrated embodiment comprises an elongated clipping member 12 and a tension-applying mechanism 14. The clipping member 12 may comprise an elongated, generally tubular or cylindrical body having a first end portion 16, a second end portion 18, and a lumen 20 extending from the first end portion 16 to the second end portion 18. The tension-applying mechanism 14 may comprise one or more cords or tension-applying members 22 disposed within the lumen 20 of the clipping member 12. As used herein, the terms “tension-applying member” or “cord” refer to an elongated material that may be formed from a single wire, strand, fiber, or filament, or may include multiple wires, strands, fibers, or filaments.

[0021] The clipping member 12 can be converted from a delivery configuration to a retention configuration, and vice versa. In the delivery configuration, the clipping member 12 can be substantially extended longitudinally or straightened (see Figure 7). In the retention configuration (see Figure 1), the two portions of the clipping member 12 are attracted to each other to form a primary clipping region 24, which allows for the capture or clamping of one or more portions of a natural valve leaflet between the two portions of the clipping member within the primary clipping region (see Figure 6).

[0022] The clipping member 12 in the illustrated embodiment has a shape similar to the Greek letter "omega" in its retained configuration. In particular, the clipping member 12 may have an intermediate portion 26 (which may extend linearly as shown, or may be curved) and first and second leg portions 28, 30, respectively, the leg portions 28, 30 extending toward each other while moving toward each other in a direction away from the respective ends of the intermediate portion 26 to form a clipping region 24. The leg portions 28, 30 then extend toward each other while moving toward the direction away from the clipping region 24. Other delivery configurations of the clipping member 12 are also possible. For example, the clipping member 12 may be folded in half such that the first and second leg portions 28, 30 are straightened and extend side-to-side parallel to each other in the delivery configuration.

[0023] The leaflet clip device 10, and any other leaflet clip embodiments described herein, can be used to treat valvular insufficiency or regurgitation by remodeling the cardiac annulus and / or cardiac leaflets. For example, Figure 6 shows the leaflet clip device 10 located on a natural aortic valve 200. The natural aortic valve 200 may include three leaflets 210, 212, and 214 attached to the annulus 216. Leaflets 210 and 212 may form a first commissure 218, leaflets 212 and 214 may form a second commissure 220, and leaflets 210 and 214 may form a third commissure 222.

[0024] The leaflet clip device 10 is shown positioned adjacent to the first commissure 218 so that the leaflet clip device 10 engages with the leaflets 210 and 212. The leaflet clip device 10 is also shown positioned near the wall of the valve ring 216. In this way, the leaflet clip 10 can improve the joining of the leaflets 210, 212 at the commissure 218, thereby reducing backflow through the valve 200 due to valve closure failure. In addition, although the leaflet clip 10 is shown clipped to each leaflet adjacent to the valve ring 216, the leaflet clip 10 can be clipped to the leaflets at any preferred position along the leaflets, including the center of the natural valve, if necessary.

[0025] Although one clip device 10 is shown implanted in a natural aortic valve, multiple leaflet clips 10 can be implanted to reduce the dilation of the annulus 216 and / or to address malformations of the annulus 216. For example, a leaflet clip 10 may be implanted in each pair of leaflets, for example, at each commissure 218, 220, 222. Alternatively or additionally, multiple clip devices 10 may be implanted along the junctional edges of adjacent leaflet pairs. For example, multiple clip devices 10 may be implanted along the junctional edges of the leaflet pair 210, 212.

[0026] Referring again to Figure 1, the tensioning mechanism 14 can be operably coupled to the clipping member 12 by the tensioning member 22, which applies tension to the clipping member 12 in order to convert the clipping member 12 from a delivery configuration to a retaining configuration and / or to bring the leg portions 28, 30 closer together to form the final retaining configuration after partial deployment from the delivery configuration, as will be further described below.

[0027] In certain embodiments of the valve leaflet clipping device 10, the clipping member 12 may be formed from a metal tube (for example, by laser cutting) as shown in Figures 13 and 16. The tube may be formed with multiple grooves or cuts along its length to facilitate bending of the tube from the delivery configuration to the retention configuration.

[0028] In some embodiments, the clipping member 12 can be formed from a nonlinear elastic material, a superelastic material, and / or a shape memory material such as Nitinol, and is shaped in the implantation configuration. The clipping member 12 can be held in the delivery configuration while the device is delivered inside the patient's body, for example, by using the delivery device sheath, and when released from the delivery configuration, the clipping member 12 automatically returns to the implantation configuration. In some embodiments, the clipping member 12 can self-deploy from the delivery configuration to a partially deployed configuration under its own elasticity such that the leg portions 28, 30 are spaced apart from each other in the clipping region 24. A tension-applying mechanism 14 may then be used to pull the leg portions 28, 30 together closer to the implantation configuration shown in Figure 1 with enough force to engage and secure itself with the pair of natural valve leaflets. In other embodiments, the clipping member can be shaped in a substantially straight or linear delivery configuration, and the tension-applying mechanism 14 is used to deform or bend the clipping member from the delivery configuration to the implantation configuration.

[0029] In an alternative embodiment, the clipping device 10 lacks a tensioning mechanism 14, and the shape memory material of the clipping member 12 allows the clipping member 12 to transform from a delivery configuration to a retention configuration under its own elasticity, thereby providing sufficient force to the natural valve leaflets to secure the clipping member 12 to the pair of natural valve leaflets without a separate tensioning mechanism.

[0030] In other embodiments, the clipping member 12 may be formed from a linear elastic material such as stainless steel or a cobalt-chromium alloy. In such embodiments, a tension-applying mechanism 14 can be used to convert or deform the clipping member 12 from a delivery configuration to a retention configuration. Linear elastic metals such as stainless steel or a cobalt-chromium alloy also undergo plastic deformation after the applied force exceeds a predetermined threshold. In some embodiments, a tension-applying mechanism 14 can be used to plastically deform the clipping member 12 when it is deformed from a delivery configuration to a retention configuration.

[0031] Figure 13 shows an example of a clipping member 12 formed from a laser-cut metal tube. Figure 14 shows an exemplary cut pattern for the metal tube used to form the clipping member 12 shown in Figure 13. Figure 15 is a magnified view of a portion of the cut pattern shown in Figure 14. Although not shown, the clipping member may include a covering that extends over and covers the outer surface of the metal tube. The covering may include a suitable woven fabric (e.g., polyethylene terephthalate (PET) woven fabric), a non-woven polymer material (e.g., polyethylene or silicone), or a natural tissue (e.g., pericardial tissue).

[0032] As shown in Figures 14 and 15, a series of axially spaced circumferential cuts may be formed at selected locations on the clipping member 12. Along the leg portions 28, 30, the cuts form a series of circumferential gaps 80 having tabs 82 and notches 84 on either side of the central portion of the gap 80. In the illustrated embodiment, the clipping member 12 has little to no shape memory to the retaining configuration, and is shown in Figure 13 in its natural, stationary state before being converted to the retaining configuration. The clipping member in this example may include, for example, a metal tube made of stainless steel or a cobalt-chromium alloy. By applying force to the clipping member 12, as will be further described below, the clipping member 12 may be converted from a substantially straight or linear configuration to the retaining configuration shown in Figure 1. The gaps 80 facilitate the bending of the clipping member when it bends to become the retaining configuration. The tabs 82 may be present in the corresponding notches 84 so as not to impart undesirable torque to the clipping member when it is converted to the retaining configuration.

[0033] Figure 16 shows another example of a clipping member 12 formed from a laser-cut metal tube. The clipping member 12 in Figure 16 can be substantially the same as the clipping member in Figure 13, except that the circumferential cuts form a mating feature that helps maintain the shape of the clipping member when converted to a retaining configuration. In particular, as shown in Figure 17, the cuts form a series of circumferential gaps 86 having tabs 88 and notches 90 on both sides of the central portion of the gap 86. The tabs 88 have nonlinear opposing edges 92 that can engage with similarly shaped nonlinear edges 94 of the notches 90 when the clipping member is bent toward the retaining configuration. The edges 92 of the tabs 88 can engage with the edges 94 of the notches 90 by friction to prevent the clipping member from straightening out toward the retaining configuration. Figure 16 shows the clipping member held in a partially unfolded state by the retaining feature of the cuts without any other force being applied to the clipping member. In some embodiments, the cut retention function can be configured to hold the shape of the clipping member in the retaining configuration shown in Figure 1.

[0034] When the clipping member 12 is in an implantable configuration, the clipping strength of the leaflet clip device can be determined. As used herein, the terms “clip retention force” and “clipping strength” refer to the proximal force that the leaflet clip device can withstand without dislodging from the leaflet of the heart valve when the clipping member is in an implantable configuration. In some embodiments, the clip device and / or delivery equipment for the clip device may include strain gauges or equivalent devices that are operable to measure the retention force of the leaflet clip device 10.

[0035] The tension-applying mechanism 14 may be configured to allow a fine closing action to the retaining configuration of the valve leaflet clip device. In certain embodiments, the clip retention force can be fully controlled by the tension-applying mechanism 14. For example, in the embodiments shown in Figures 1 and 3, the tension-applying mechanism 14 may comprise a screw 32 and a movable element such as a nut 34 that screws onto the screw 32 and is movable along the length of the screw 32. The tension-applying mechanism 14 may further comprise a housing 54 including the screw 32 and nut 34, as well as two plates or rods 56 on both sides of the nut 34. The plates 56 contact adjacent surfaces of the nut 34 and prevent the nut 34 from rotating when the screw 32 rotates. Thus, the rotation of the screw 32 causes the axial movement of the nut 34 along the length of the screw within the housing 54.

[0036] The screw 32 may have a proximal end portion 58 that can be detachably connected to a delivery device or another tool that can be operated to rotate the screw 32. For example, the rotatable shaft of the delivery device or another tool may have a distal end portion that can be detachably connected to the proximal end portion 58 of the screw 32. The proximal end portion of the shaft can be rotated by the user (either manually or by operating a motor that rotates the shaft), which in turn rotates the screw 32.

[0037] The first cord 22a may have a distal end portion 36 attached to the first end portion 16 of the clipping member 12, and the second cord 22b may have a distal end portion 38 attached to the second end portion 18 of the clipping member 12. The distal end portions 36 and 38 of the cords 22a and 22b can be fixed to the clipping member 12 by welding the distal end portions 36 and 38 to the lumen surface of the clipping member 12, for example. The proximal end portions 40 and 42 of the first and second cords 22a and 22b can be fixed to the clipping member 12 by, for example, inserting the proximal end portions 40 and 42 into the respective holes 60 in the nut 34 and welding them to the predetermined position. As indicated by arrow 62, tension can be applied to the first and second cords 22a and 22b by moving the nut 34 away from the clipping member 12 along the length of the screw 32 in the proximal direction. The tension on the first and second cords 22a and 22b can be released or relieved by moving the nut 34 distally toward the clipping member 12, as indicated by the arrow 64.

[0038] Applying tension to the cords 22a and 22b has the effect of applying compressive or buckling forces to the legs 28 and 30, thereby tightening the legs in the clipping region 24 and / or drawing the legs closer together in the clipping region, applying sufficient retaining force to the natural valve leaflets along the joint edges of the valve leaflets. Furthermore, applying tension to the cords 22a and 22b can enable the manipulation of the intermediate portion 26 of the clipping member to reshape the leaflet region of the natural valve. As described above, the clipping member 12 may consist of, for example, thinning and / or flex cutting of the pipe material at a predetermined position along the clipping member 12 where bending of the clipping member 12 is desired. The length, positioning, frequency, and amount of material removal for the flex cutting can enable a number of options for creating a curve in a particular area with a defined curvature, in a defined order, position, and resolution.

[0039] The fine closing action of the valve leaflet clipping device 10 can be determined by the thread pitch of the screw 32. For example, a relatively small pitch will increase the amount of control over the spacing between the leg portions 28 and 30 in the clipping region 24, and the retaining force applied to the pair of natural valve leaflets.

[0040] In addition to or instead of the locking flex cut (as shown in Figure 17), some embodiments of the leaflet clip device 10 may include one or more retaining functions that help hold the clipping member 12 in its implantation configuration. For example, the clipping member 12 may have a retaining mechanism 46 at each bend 44, the retaining mechanism 46 holding that portion of the clipping member in its deformed state when it reaches a predetermined bending angle. As shown in Figure 2, each locking mechanism 46 may be disposed within the lumen of the clipping member 12 at the bend 44. Each locking mechanism 46 may include at least a first locking member 48 and a second locking member 50 configured to move relative to each other when the clipping member is converted from a delivery configuration to an implantation configuration. The locking members 48, 50 may have opposing edges having complementary shapes that fit together in the implantation configuration. For example, the first locking member 48 may have a notch 68 that receives the protrusion 70 of the second locking member 50.

[0041] When the clipping member 12 is substantially straightened in the delivery configuration, the locking members 48 and 50 are positioned to overlap each other and can slide relative to each other as the clipping member 12 moves toward the retention configuration. When the bend 44 reaches a predetermined curve, for example, when it reaches the retention configuration, the projection 70 moves and engages in the notch 68, as shown in Figure 2. The locking members 48 and 50 can be biased laterally relative to each other to engage the projection 70 in the notch 68. The engagement of the locking members 48 and 50 resists further bending of the clipping member in the bend 44 beyond the retention configuration and bending of the clipping member toward the delivery configuration in the bend 44. The retaining member 46 can reduce the load on the cords 22a and 22b and can increase the ability of the clipping device to maintain a constant retaining force on the valve leaflets for longer periods of time.

[0042] As an addition and / or alternative, the tension-applying mechanism 14 may also include a retaining or locking mechanism for holding the clipping member 12 in a retained configuration. For example, the tension-applying mechanism 14 may hold the clipping member in a retained configuration for balancing the tension in one or more cords 22 by frictional force between the screw 32 and the nut 34. In this way, the screw 32 and the nut 34 act as a retaining mechanism. As an addition and / or alternative, a variable-pitch screw may provide a retaining mechanism, thereby allowing the nut 34 to move along a first portion of the screw having a first pitch, and then lock onto or create mechanical interference with a second portion of the screw having a second pitch different from the first pitch, as will be further described below in relation to Figures 9-10.

[0043] Figure 7 shows the distal end portion of a delivery device 400 for percutaneously delivering and implanting a clip device 10 into a patient's body according to one embodiment. The delivery device may comprise an outer sheath 402, a first shaft 404 extending through the sheath 402, and a second shaft 406 extending through the first shaft 404. The sheath 402 has a lumen sized to receive and hold the clip device 10 of the delivery configuration for delivery through the patient's body. The inner shaft 404 may be detachably connected to a convenient position on the clip device as a tensioning mechanism 14, as shown in the figure. The shaft 404 can be used to manipulate or adjust the position of the clip device 10 relative to the sheath 402 and the implantation position. For example, the shaft 404 can be used to unfold the clip device 10 from the sheath 402, move the clip device distally and proximal to the implantation position, and / or rotate the clip device relative to the implantation position. The second shaft 406 can be detachably coupled to the proximal end portion 58 of the screw 32 of the tensioning mechanism 14. The second shaft 406 can be rotated by the user relative to the first shaft 404 to rotate the screw 32 and adjust the tension on the cords 22a, 22b. The proximal end portions of the sheath 402, the first shaft 404, and the second shaft 406 can be coupled to a handle of a delivery device, the handle may include a suitable control device (e.g., a knob) that allows the user to control the movement of the sheath 402, the first shaft 404, and the second shaft 406.

[0044] The delivery device 400 and the clip device 10 contained within the sheath 402 may be introduced into the patient's vascular structure (e.g., from the femoral artery or other preferred access point) and advanced percutaneously into the patient's heart together with the valve leaflet clip device 402 using any of a variety of delivery techniques. In a transfemoral procedure, the delivery device 400 may be inserted retrogradely through the femoral artery and aorta to the heart (used, but not limited to, to deploy clips to the leaflets of the aortic or mitral valve). Similarly, the delivery device 400 may be inserted antegradely through the femoral vein and vena cava to the right side of the heart (used, but not limited to, to deploy clips to the leaflets of the pulmonary or tricuspid valve). In a transventricular procedure, the delivery device 400 may be inserted by a surgical incision made in the chest and at a bare spot on the inferior anterior ventricular wall (used, but not limited to, to deploy clips to the leaflets of the aortic or mitral valve). Similarly, the delivery device 400 may be inserted by a surgical incision in the wall of the right ventricle to access the pulmonary valve or tricuspid valve. In transatrial procedures, the delivery device 400 may be inserted by a surgical incision made in the wall of the left or right atrium to access the natural valves of the left or right side of the heart, respectively. In transaortic procedures, the delivery device 400 may be inserted by a surgical incision made in the ascending aorta and advanced toward the heart (used, but not limited to, to deploy clips to the leaflets of the aortic or mitral valve). In transseptal procedures, the delivery device 400 may be advanced from the femoral vein, for example, through the septum separating the right and left ventricles to the right atrium (used, but not limited to, to deploy clips to the leaflets of the aortic or mitral valve). Further details of delivery techniques for accessing the natural valves of the heart are disclosed in U.S. Patent Publication 2014 / 0067052.

[0045] When positioned in close proximity to the desired heart valve, the leaflet clip device 10 can then be deployed from the sheath 402 by pushing the clip device 10 distally from the sheath 402 using the shaft 404, and / or retracting the sheath 402 relative to the clip device. Once the clip device is deployed from the sheath, it may be advanced distally, retracted proximally, and / or rotated as necessary to position the leaflet clip device 10 so that the first and second leaflet pairs are positioned as a whole within the primary clipping area 24, with the first leg portion 28 adjacent to one leaflet and the second leg portion 30 adjacent to the other leaflet.

[0046] The delivery device can be used to adjust the tensioning mechanism 14 until a desired predetermined retention configuration is achieved, in which the valve leaflets are engaged and pinched between the leg portions 28 and 30. For example, the user can rotate the shaft 406, which rotates the screw 32, thereby increasing the tension on the cords 22a and 22b until the retention configuration is achieved.

[0047] In alternative embodiments, the clipping device may comprise multiple clipping members configured to engage with multiple pairs of natural valve leaflets. As shown in Figure 4, for example, the leaflet clipping device 300 comprises an annular ring having three clipping members 302, 304, and 306, spaced about 120 degrees apart from each other, each configured to be retained on a pair of natural valve leaflets, such as at the commissus of a natural valve. The clipping device 300 comprises a tubular structure and may be formed from, for example, a shape memory material (e.g., nitinol) or a plastically deformable material (e.g., stainless steel or cobalt-chromium alloy). In other embodiments, the clipping device may comprise an annular ring having two clipping members spaced about 180 degrees apart from each other for retaining on the leaflets of a natural mitral valve, for example.

[0048] In an alternative embodiment, the clipping device may comprise an open ring (i.e., a ring less than 360 degrees) having several clipping members, fewer than the number of natural valve leaflets of the valve in which the device will be implanted. For example, the clipping device may comprise an open ring having two clipping members spaced about 120 degrees apart from each other, which engage with two pairs of natural valve leaflets but not with a third pair of natural valve leaflets.

[0049] The valve leaflet clipping device may include one of several different tensioning mechanisms configured to apply tension to one or more cords disposed within the clipping member and / or to convert the clipping member from a delivery configuration to a retention configuration. For example, Figures 5 and 8-12 show various embodiments of valve leaflet clipping devices having different tensioning mechanisms.

[0050] Figure 5 shows a valve leaflet clip device 500 according to another embodiment. The valve leaflet clip 500 comprises a tensioning mechanism 502 and a clipping member 504 defining the lumen 506. The tensioning mechanism 502 may comprise one or more fasteners 508. One or more cords 510 can be disposed within the lumen 506 and can be attached at their respective positions on the clipping member 504 at their distal end portions 512, as described above in relation to the embodiment of Figure 1. One or more cords 510 may pass through the fasteners 508 and have a proximal end portion that connects to a delivery device and / or extends outside the patient's body. The fasteners 508 (such as suture clips) are advanced along the cords 510 in the direction indicated by arrow 516 and can be pressed against the middle portion 514 of the clipping member 504 to maintain tension on the cords. The proximal portion of the cords on the clipping member 504 may be cut by a delivery device or another tool.

[0051] The fastener 508 may be a suture clip or another type of fastener that can be deployed from a catheter and secured to a suture in the patient's body. Various suture clips and suture clip deployment techniques that can be used in the method disclosed in this application are disclosed in U.S. Patent Publications 2014 / 0031864 and 2008 / 0281356, and U.S. Patent No. 7,628,797. In the case of a sliding fastener, the fastener 508 may be configured to move distally toward the clipping member along the cord 510 and to resist proximal movement along the cord in the opposite direction. Thus, when placed in contact with the clipping member, the fastener 508 can prevent the cord 510 from being pulled through the fastener under the tension of the cord. In this way, the fastener 508 acts as a retaining member that helps maintain the shape of the clipping member in the implantation configuration.

[0052] The delivery device may include a mechanism configured to adjust the tension applied to the cord 510 until a desired predetermined retention configuration is achieved. For example, the cord 510 may be coupled detachably to a shaft or other component that can be controlled by the user. The delivery device may also include a mechanism for deploying a fastener 508 on the cord and / or advancing the fastener 508 on the cord until it contacts a clipping member.

[0053] Figure 8 shows a valve leaflet clipping device 600 according to another embodiment. The clipping device 600 comprises a tensioning mechanism 602 and a clipping member 604 defining a lumen 606. The tensioning mechanism 602 may comprise a pulley system 610 comprising one or more fasteners 608 (e.g., suture clips) and one or more pulleys or sheaves 612 disposed within the lumen 606. One or more cords 614 may be disposed within the lumen 606 as described above in relation to the embodiment of Figure 1, and their distal end portions 616 may be attached to the respective positions on the clipping member 604. One or more cords 614 may pass through fasteners 608 that allow the cords 614 to move in one direction through the fasteners. As shown, the cords 614 may be advanced in a way that sews around the sheaves 612 as they extend through the lumen.

[0054] The delivery device may include a mechanism that allows tension to be applied to the cord 614 within the clipping member 604 until a desired predetermined implantation configuration is achieved, as described above in relation to the embodiment of Figure 5, and a mechanism for deploying and advancing the fastener 608 on the cord 614. The use of a pulley 612 to support the cord 614 is advantageous because it significantly reduces the force required to deform the clipping member into the implantation configuration by applying tension to the cord. The pulley 612 is also positioned strategically within the lumen to facilitate the bending of the clipping member at the desired position when tension is applied to the cord. Other uses of the pulley system may further distribute the tension / load on the cord as needed for the procedure.

[0055] Figure 9 shows a valve leaflet clipping device 700 according to another embodiment. The clipping device 700 comprises a tensioning mechanism 702 and a clipping member 704 defining a lumen 706. The tensioning mechanism 702 may comprise a screw 708 and a nut 710 disposed on the screw, similar to the tensioning mechanism 14 in Figure 1. Instead of a separate housing for the tensioning mechanism, the screw 708 may be disposed, at least partially, within the lumen 706 of the clipping member. Two walls or protrusions 718 may be placed on either side of the nut 710 within the lumen 706 to contact when the screw 708 rotates and prevent the nut 710 from rotating.

[0056] One or more cords 712 can be arranged within the lumen 706 and, as described above, their distal end portions 714 can be attached to their respective positions on the clipping member 704. The cords 712 can be attached to the nut 710 at their proximal end portions. Thus, rotation of the screw 708 has the effect of moving the nut 710 axially along the screw to adjust the tension on the cord, as described in detail above in relation to the embodiment of Figure 1.

[0057] The tension-applying mechanism 702 may include a mechanism for holding or locking the variable-pitch screw configuration. For example, as best shown in Figure 10, a screw 708 may include a first threaded portion 720 having threads that define a first pitch, and a second threaded portion 722 having threads that define a second pitch smaller than the first pitch. A nut 710 has a female thread corresponding to the threads of the first threaded portion 720 and can move axially along the screw as the screw rotates. When the nut 710 reaches the second threaded portion 722, the female thread of the nut 710 is substantially different from the threads of the second threaded portion 722 (for example, the threads have a larger and / or smaller pitch than the threads of the second threaded portion) so that mechanical interference occurs that resists further movement of the nut, helping to hold the clipping member in its deformed state.

[0058] Figure 11 shows a valve leaflet clipping device 800 according to another embodiment. The clipping device 800 comprises a tensioning mechanism 802 and a clipping member 804 defining a lumen 806. The tensioning mechanism 802 may comprise a worm screw 808 and a worm wheel or gear 810 engaging with the screw 808. The screw 808 and wheel 810 can be mounted in the lumen 806 with the proximal end of the screw 808 exposed outside the clipping member for connection to a delivery device or a tool used to rotate the screw. Rotation or torque on the worm screw 808 is converted into rotation and torque on the worm wheel 810.

[0059] One or more cords 812 can be disposed within the lumen 806 and, as previously described, can be attached at their distal ends 814 to their respective positions on the clipping member 804. One or more cords 812 can be attached at their proximal ends to the central axis 816 of the worm wheel 810. A mechanism in the delivery system (e.g., a torque shaft) can rotate the screw 808, causing the worm wheel 810 and the axis 816 to rotate. As the worm wheel 810 rotates, tension is applied to one or more cords 812 as the slack in the cords wraps around the axis 816. As shown, a single worm wheel 810 can be used to apply tension to multiple cords 812. In alternative embodiments, first and second worm wheels 810 may be mounted on their respective axes on either side of the screw 808, with each wheel 810 connected to its respective cord 812 extending through that side of the clipping member. Tension can be applied to one or more cords 812 within the clipping member 804 until a desired predetermined retention configuration is achieved.

[0060] Figure 12 shows a valve leaflet clipping device 900 according to another embodiment. The clipping device 900 may comprise a tensioning mechanism 902 and a clipping member 904 defining a lumen 906. The tensioning mechanism 902 may comprise a central bevel gear 908 and one or more side bevel gears 910 disposed on either side of the central bevel gear 908. Each side gear 910 may be mounted on its own shaft 916 or on a common shaft extending through both side gears 910. The gears 908, 910 may be mounted in the lumen 906, except that the shaft portion 909 of the central gear 908 may be exposed outside the clipping member for connection to a delivery device or a tool used to rotate a screw. The rotation or torque of the central gear 908 (by rotating the shaft portion 909) is converted into rotation or torque in the two side gears 910.

[0061] One or more cords 912 can be disposed within the lumen 906 and, as previously described, can be attached at their distal end portions 914 to their respective positions on the clipping member 904. Each of the one or more cords 912 can be attached at its proximal end portion to the shaft 916 of each side gear 910. A mechanism within the delivery system (e.g., a torque shaft) can rotate the central gear 908, causing the side gears 910 to rotate. As the side gears 910 rotate, tension is applied to one or more cords 912 as the slack in each cord wraps around its respective shaft 916. Tension can be applied to one or more cords 912 within the clipping member 904 until a desired predetermined retention configuration is achieved.

[0062] In light of the many possible embodiments to which the principles of the disclosed technology can be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be taken as limiting the scope of this disclosure. Rather, the scope of this disclosure is defined by the following claims. [Additional note 1] A valve leaflet clipping device, An elongated clipping member having a first end portion and a second end portion, comprising a shape memory material and shaped by a retaining configuration. Equipped with, A valve leaflet clipping device wherein the shape memory material of the clipping member is configured to bias the clipping member to the retention configuration, and the retention configuration includes a clipping region defined between the two leg portions of the clipping member. [Additional note 2] The valve leaflet clip device according to Appendix 1, further comprising a retaining mechanism disposed within the clipping member, wherein the retaining mechanism maintains the shape of the clipping member in the retaining configuration. [Additional note 3] The valve leaflet clip device according to Appendix 2, wherein the retaining mechanism includes a first locking member and a second locking member having opposing edges having complementary shapes that fit together in the retention configuration. [Additional note 4] The valve leaflet clipping device according to any one of the appendices 1 to 3, wherein the clipping member is shaped to be substantially straight or linear in the delivery configuration. [Additional note 5] A valve leaflet clipping device according to any one of the appendices 1 to 4, wherein, when the clipping member is in the retaining configuration, the first section of each of the two leg portions extends toward each other from the respective ends of the intermediate portion of the clipping member, and the second section of each of the two leg portions extends toward each other while moving toward the clipping region. [Additional note 6] The valve leaflet clip device according to Appendix 5, wherein the clipping member of the retaining configuration has the shape of the Greek letter omega. [Additional note 7] The valve leaflet clipping device according to any one of the appendices 1 to 6, wherein the clipping member comprises a tubular body having a lumen. [Additional note 8] A valve leaflet clipping device according to any one of the appendices 1 to 7, further comprising a plurality of clipping members. [Additional note 9] The valve leaflet clipping device according to appendix 8, further comprising an annular ring having the plurality of clipping members. [Additional Note 10] The valve leaflet clipping device according to Appendix 9, wherein the annular ring has two clipping members spaced approximately 180 degrees apart from each other, or three clipping members spaced approximately 120 degrees apart from each other. [Additional Note 11] The valve leaflet clipping device according to appendix 8, further comprising an opening ring having the plurality of clipping members. [Additional Note 12] The valve leaflet clipping device according to Appendix 11, wherein the opening ring has two clipping members spaced approximately 120 degrees apart from each other. [Additional Note 13] A valve repair system for repairing a patient's natural valve, A delivery device having at least one lumen, A valve leaflet clip device coupled to the delivery device, wherein the valve leaflet clip device is An elongated clipping member having a first end portion and a second end portion, A tension-applying mechanism coupled to the clipping member, One or more tension-applying members disposed within the lumen of the clipping member, and operably connected to the tension-applying mechanism for converting the clipping member from a delivery configuration to a retention configuration, The system includes, and the one or more tension-applying members, A first tension-applying member having a proximal end portion operably connected to the tension-applying mechanism and a distal end portion connected to the first terminal portion of the clipping member, A second tension-applying member having a proximal end portion operably connected to the tension-applying mechanism and a distal end portion connected to the second terminal portion of the clipping member, Equipped with, A valve leaflet clip device, A valve repair system equipped with the following features. [Additional Note 14] The valve repair system according to Appendix 13, wherein the lumen of the delivery device is sized to receive the valve leaflet clip device and to hold the elongated clipping member of the valve leaflet clip device in the delivery configuration for delivery through the patient's body. [Additional Note 15] The valve repair system according to Appendix 14, wherein the delivery device comprises a first shaft and a second shaft extending through the lumen. [Additional Note 16] The valve repair system according to appendix 15, wherein the first shaft is coupled to the leaflet clipping device so that a user can move the first shaft to move the leaflet clipping device within the lumen of the delivery device, and the second shaft is coupled to the tensioning mechanism of the leaflet clipping device so that a user can rotate the second shaft to move the elongated clipping member between the delivery configuration and the retention configuration. [Additional Note 17] The valve repair system according to Appendix 16, wherein the proximal ends of the first shaft and the second shaft are coupled to the handle of the delivery device. [Additional Note 18] The valve repair system according to any one of appendices 13 to 17, wherein the valve leaflet clip device further comprises a retaining mechanism disposed within the lumen of the clipping member, the retaining mechanism maintaining the shape of the clipping member in the retention configuration. [Additional Note 19] The valve repair system according to Appendix 18, wherein the retaining mechanism comprises a first locking member and a second locking member for retaining the shape of the elongated clipping member in the retaining configuration, and the conversion of the elongated clipping member to the retaining configuration results in movement of the first locking member and the second locking member relative to each other. [Additional Note 20] The valve repair system according to any one of appendices 13 to 19, wherein the retention configuration of the elongated clipping member includes a primary clipping region defined between two leg portions of the elongated clipping member, the primary clipping region being configured to capture a pair of valve leaflets, and the adjacent surfaces of the valve leaflets being in contact with each other. [Additional Note 21] The valve repair system according to any one of appendices 13 to 20, wherein the tension-applying mechanism is coupled to the elongated clipping member at its center with respect to the first and second end portions of the elongated clipping member. [Additional Note 22] The valve repair system according to any one of appendices 13 to 21, wherein the rotation of at least a portion of the tension-applying mechanism causes tension to be applied to one or more tension-applying members. [Additional Note 23] The valve repair system according to any one of the appendices 13 to 22, wherein the one or more tension-applying members comprises at least one of a wire, stranded wire, fiber, or filament. [Explanation of Symbols]

[0063] 10. Leaflet clip device 12 Clipping members 14. Tension-applying mechanism 16 First End Section 18 Second End Section 20 lumen 22 Tension-applying member 24 Clipping area 26 Middle part 28 Leg section 30 leg part 32 screws 34 nuts 36 Distal end section 38 Distal end section 40 Proximal end portion 42 Proximal end portion 44. Bending section 46. ​​Holding mechanism, locking mechanism 48 Locking Members 50 Locking Members 54 Housing 56 plates, rods 58 Proximal end portion 60 holes 68 Notches 70 Protrusion 80 Gap 82 tabs 84 Notches 86 Gap 88 tabs 90 notches 92 Edge 94 Edge 200 Natural Aortic Valve 210 Valve Leaflet 212 Valve Leaflet 214 Valve Leaflet 216 valve rings 218 commissure 220 commissure 222 Commissure 300 valve leaflet clip device 302 Clipping member 304 Clipping member 306 Clipping Member 400 Delivery equipment 402 Sheath 404 First shaft 406 Second shaft 500 valve leaflet clip device 502 Tension-applying mechanism 504 Clipping member 506 Lumen 508 Fasteners 510 Code 600 valve leaflet clip device 602 Tension-applying mechanism 604 Clipping member 606 Lumen 608 Fasteners 610 Pulley System 612 Sieve 614 Code 616 Distal end section 700 valve leaflet clip device 702 Tension-applying mechanism 704 Clipping member 706 Lumen 708 screw 710 Nut 712 Code 800 valve leaflet clip device 802 Tension-applying mechanism 804 Clipping member 806 Lumen 808 Worm screw 810 Worm wheel, gear 812 Code 900 valve leaflet clip device 902 Tension-applying mechanism 904 Clipping member 906 Lumen 908 Center bevel gear 909 Shaft part 910 Side gear 912 Code 914 Distal end section 916 axis

Claims

1. A valve leaflet clipping device, A clipping member comprising a first portion and a second portion, The clipping member can be converted from a delivery configuration to a retention configuration. The first and second portions of the clipping member are configured to capture one or more natural valve leaflets in the implantation configuration. The first and second portions are attracted to each other when the clipping member is converted from the delivery configuration to the retention configuration, A strain gauge that is operable to measure the holding force of the clipping member, A valve leaflet clip device equipped with the following features.

2. The valve leaflet clipping device according to claim 1, wherein the clipping member is configured to be substantially extended in the longitudinal direction in the delivery configuration.

3. The valve leaflet clipping device according to claim 1, wherein the clipping member further comprises an intermediate portion between the first portion and the second portion.

4. The valve leaflet clipping device according to claim 1, wherein the clipping member is a tubular or cylindrical member.

5. The valve leaflet clip device according to claim 1, wherein the first portion and the second portion are configured to engage with the one or more pairs of natural valve leaflets of the natural valve at the center of the natural valve.

6. The valve leaflet clip device according to claim 1, wherein the first portion and the second portion are configured to be fixed along the joint edge of one or more pairs of natural valve leaflets.

7. The valve leaflet clip device according to claim 1, wherein the clipping member is shaped in the retention configuration.

8. The valve leaflet clipping device according to claim 7, wherein the elasticity of the shape memory material of the clipping member provides sufficient force for the one or more natural valve leaflets to the pair to fix the clipping member to the pair of natural valve leaflets.

9. The valve leaf clip device according to claim 1, wherein the valve leaf clip device further comprises a cover, the cover being positioned to cover the clipping member.

10. The valve leaflet clip device according to claim 9, wherein the cover comprises one or more of the following: textile, PET, polymer material, polyurethane, silicone, natural tissue, and pericardial tissue.

11. The valve leaflet clipping device according to claim 1, wherein the strain gauge is configured to determine the clipping strength of the clipping member.

12. Delivery equipment and A valve leaflet clipping device coupled to the aforementioned delivery device, wherein the valve leaflet clipping device is A clipping member comprising a first portion and a second portion, The clipping member can be converted from a delivery configuration to a retention configuration. The first and second portions of the clipping member are configured to capture one or more natural valve leaflets in the implantation configuration. The clipping member is configured to be substantially extended in the longitudinal direction in the delivery configuration, and the first portion and the second portion are attracted to each other when the clipping member is converted from the delivery configuration to the retention configuration. A strain gauge that is operable to measure the holding force of the clipping member, A valve leaflet clip device comprising, A system that includes these features.

13. The system according to claim 12, wherein the first portion and the second portion are configured to engage with the pair of one or more natural valve leaflets at the center of the natural valve along the joint edge of the pair of natural valve leaflets.

14. The system according to claim 12, wherein the clipping member is shaped in the implantation configuration, and the elasticity of the shape memory material of the clipping member provides sufficient force on the pair of one or more natural valve leaflets to fix the clipping member to the pair of natural valve leaflets.

15. The system according to claim 12, wherein the strain gauge is configured to determine the clipping strength of the clipping member.

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