Atrial clip assembly and delivery device

Abstract

The atrial clip assembly comprises a first arm assembly. The first arm assembly has a first arm body including a first support and a first spine. A first portion of the first spine extends along and is located within the corresponding first portion of the first support. The first arm assembly further comprises a first suture. A first portion of the first suture is located around the first portion of the first spine, and a second portion of the first suture extends outside the first support. The atrial clip assembly also comprises a second arm assembly. The second arm assembly has a second arm body including a second support. The atrial clip assembly further comprises a hinge connecting a first end of the first arm body to a first end of the second arm body. The hinge is flexible.

Description

Technical Field

[0001] The present invention relates to surgical devices, and more particularly to an atrial clip assembly and a delivery device for an atrial clip assembly.

Background Art

[0002] Atrial fibrillation (AF) is a common arrhythmia that affects millions of people and is associated with ischemic stroke. AF causes insufficient contraction of the left atrium, reduced endurance, and arrhythmia. Without sufficient blood flow in the left atrium, coagulation is enhanced and the risk of thrombosis increases.

[0003] Thrombosis and embolism of the left atrial appendage (LAA) are recognized as the main mechanisms of stroke associated with AF. This stroke mechanism is thought to be correlated with reduced LAA blood flow velocity, thrombosis, hypertension, and atherosclerotic disease of the aorta. The LAA is an auxiliary chamber of the heart and is filled and emptied in response to the movement of the ventricles and atria. The morphological diversity regarding the shape, volume, length, and width of the LAA, particularly the increase in the volume, depth, and number of lobes of the LAA, may be related to thrombosis.

[0004] Currently, pharmacological anticoagulant therapy, particularly warfarin, is recognized as a very effective treatment in the drug treatment of patients with atrial fibrillation (AF). Warfarin is very effective, but its therapeutic range is narrow and it is associated with the risks of serious bleeding and pharmacological contraindications. When these risks and other obstacles to anticoagulant therapy exceed the risk of stroke associated with AF, removing or isolating the LAA becomes an attractive alternative approach for preventing embolism.

[0005] During other cardiac surgeries, blocking the left atrium (LAA) from its communication with the left atrium is a common method of isolating the LAA. Surgical isolation of the LAA by ligation, suturing, or cutting is a procedure that can be routinely performed on patients incidentally during heart valve surgery. Transvenous LAA occlusion is also a known treatment for preventing embolism in patients with atrial fibrillation (AF), involving the placement of an implantable device using a catheter to seal the LAA opening. Percutaneous LAA occlusion is another known treatment that blocks the LAA from blood flow to prevent thrombus formation and subsequent thromboembolic complications. Advantages of percutaneous LAA occlusion include being less invasive than surgical ligation, faster recovery, and a reduced risk of bleeding without the need for anticoagulation therapy. However, LAA occlusion remains challenging. While new approaches to LAA occlusion are being developed, they are more complex and may increase the risk of LAA injury, incomplete occlusion, and device dislodgement. [Brief explanation of the drawing]

[0006] [Figure 1A] This figure shows one embodiment of an atrial clip assembly. [Figure 1B] A different diagram showing a concentric atrial clip assembly. [Figure 1C] A different diagram showing a concentric atrial clip assembly. [Figure 1D] A different diagram showing a concentric atrial clip assembly. [Figure 1E] A different diagram showing a concentric atrial clip assembly. [Figure 1F] A different diagram showing a concentric atrial clip assembly. [Figure 1G] A different diagram showing a concentric atrial clip assembly. [Figure 1H] A different diagram showing a concentric atrial clip assembly.

[0007] [Figure 2A] Figures 1A to 1H are perspective views showing one embodiment of the first spine portion of the atrial clip assembly. [Figure 2B] It is a perspective view of the first spine part.

[0008] [Figure 3A] It is a view showing an embodiment of the second arm body of the atrial clip assembly of FIGS. 1A to 1H. [Figure 3B] It is a different view showing the second arm body. [Figure 3C] It is a different view showing the second arm body. [Figure 3D] It is a different view showing the second arm body. [Figure 3E] It is a different view showing the second arm body. [Figure 3F] It is a different view showing the second arm body.

[0009] [Figure 4A] It is a view showing an embodiment of the first arm body of the atrial clip assembly of FIGS. 1A to 1H. [Figure 4B] It is a different view showing the first arm body. [Figure 4C] It is a different view showing the first arm body. [Figure 4D] It is a different view showing the first arm body. [Figure 4E] It is a different view showing the first arm body.

[0010] [Figure 5] It is a perspective view of an embodiment of an introduction device for engaging the atrial clip assembly of FIGS. 1A to 1H during surgery.

[0011] [Figure 6] It is a side view of the introduction device of FIG. 5 (a part of the housing part is omitted for clarity).

[0012] [Figure 7] It is a detailed side view of FIG. 6.

[0013] [Figure 8A] FIG. 5 is a diagram showing an embodiment of a connection assembly of an introduction device. [Figure 8B] It is a different view of the connection assembly. [Figure 8C] It is a different view of the connection assembly. [Figure 8D] It is a different view of the connection assembly.

[0014] [Figure 9A] FIG. 16 is a diagram showing an embodiment of an atrial assembly. [Figure 9B] It is a different view of the atrial assembly. [Figure 9C] It is a different view of the atrial assembly. [Figure 10] It is a different view of the atrial assembly. [Figure 11] It is a different view of the atrial assembly.

[0015] [Figure 12A] FIG. 34 is a cross-sectional view of an embodiment of an atrial clip assembly in FIGS. 9A - 9C. [Figure 12B] It is a different cross-sectional view of the atrial clip assembly.

[0016] [Figure 13A] FIG. 43 is a partial top view of a hinge portion of an embodiment of an atrial clip assembly in FIGS. 9A - 9C.

[0017] [Figure 13B] FIG. 49 is a cross-sectional view of a hinge portion of an atrial clip assembly in FIG. 13A. [Figure 13C] It is a different cross-sectional view of the hinge portion.

[0018] [Figure 14] FIG. 58 is a diagram showing a further embodiment of an introduction device for an atrial clip assembly. [Figure 15] It is a different view of the introduction device. [Figure 16] It is a different view of the introduction device. [Figure 17] A different diagram of the same installation device. [Figure 18A] A different diagram of the same installation device. [Figure 18B] A different diagram of the same installation device. [Figure 19] A different diagram of the same installation device. [Figure 20A] A different diagram of the same installation device. [Figure 20B] A different diagram of the same installation device. [Figure 21] A different diagram of the same installation device. [Figure 22] A different diagram of the same installation device. [Figure 23] A different diagram of the same installation device. [Figure 24] A different diagram of the same installation device. [Figure 25] A different diagram of the same installation device. [Figure 26] A different diagram of the same installation device. [Figure 27] A different diagram of the same installation device. [Figure 28] A different diagram of the same installation device. [Figure 29] A different diagram of the same installation device.

[0019] [Figure 30A] Figures 14 to 29 show one embodiment of the flexible coupling of the introduction device. [Figure 30B] These are different diagrams of the same flexible coupling. [Figure 30C] These are different diagrams of the same flexible coupling. [Figure 30D] These are different diagrams of the same flexible coupling. [Figure 30E] These are different diagrams of the same flexible coupling. [Figure 30F] These are different diagrams of the same flexible coupling. [Figure 30G] These are different diagrams of the same flexible coupling. [Figure 30H] These are different diagrams of the same flexible coupling. [Figure 30I] These are different diagrams of the same flexible coupling. [Figure 30J] These are different diagrams of the same flexible coupling. [Figure 30K] These are different diagrams of the same flexible coupling. [Figure 30L] These are different diagrams of the same flexible coupling. [Figure 30M] These are different diagrams of the same flexible coupling. [Figure 31A] Figures 14 to 29 show different diagrams illustrating the installation equipment. [Figure 31B] A different diagram of the same installation device. [Figure 32A] A different diagram of the same installation device. [Figure 32B] A different diagram of the same installation device. [Figure 32C] A different diagram of the same installation device. [Figure 32D] A different diagram of the same installation device. [Figure 33A] This figure shows an embodiment of an atrial clip assembly. [Figure 33B] This is a different diagram of a concentric atrial clip assembly. [Figure 33C] This is a different diagram of a concentric atrial clip assembly. [Figure 33D] This is a different diagram of a concentric atrial clip assembly. [Figure 34A] This is a different diagram of a concentric atrial clip assembly. [Figure 34B] This is a different diagram of a concentric atrial clip assembly. [Figure 35A] This is a different diagram of a concentric atrial clip assembly. [Figure 35B] This is a different diagram of a concentric atrial clip assembly. [Figure 35C] This is a different diagram of a concentric atrial clip assembly.

[0020] [Figure 36A] This figure shows one embodiment of an atrial clip assembly. [Figure 36B] This is a different diagram of a concentric atrial clip assembly. [Figure 36C] This is a different diagram of a concentric atrial clip assembly. [Figure 36D] This is a different diagram of a concentric atrial clip assembly.

[0021] [Figure 37A] This figure shows a further embodiment of an introduction device for an atrial clip assembly. [Figure 37B] A different diagram of the same installation device. [Figure 37C] A different diagram of the same installation device. [Figure 37D] A different diagram of the same installation device.

[0022] [Figure 38A] This figure shows one embodiment of the first adjustment assembly and the second adjustment assembly. [Figure 38B] These are different diagrams of the first and second adjustment assemblies. [Figure 39A] These are different diagrams of the first and second adjustment assemblies. [Figure 39B] These are different diagrams of the first and second adjustment assemblies. [Figure 39C] These are different diagrams of the first and second adjustment assemblies. [Figure 39D] These are different diagrams of the first and second adjustment assemblies. [Figure 40A] These are different diagrams of the first and second adjustment assemblies. [Figure 40B] These are different diagrams of the first and second adjustment assemblies. [Figure 41A] These are different diagrams of the first and second adjustment assemblies. [Figure 41B] These are different diagrams of the first and second adjustment assemblies. [Figure 42A] These are different diagrams of the first and second adjustment assemblies. [Figure 42B] These are different diagrams of the first and second adjustment assemblies. [Figure 42C] These are different diagrams of the first and second adjustment assemblies. [Figure 42D] These are different diagrams of the first and second adjustment assemblies. [Figure 43A] These are different diagrams of the first and second adjustment assemblies. [Figure 43B] These are different diagrams of the first and second adjustment assemblies. [Figure 43C] These are different diagrams of the first and second adjustment assemblies.

[0023] [Figure 44A] This figure shows further embodiments of the first and second adjustment assemblies. [Figure 44B] These are different diagrams of the first and second adjustment assemblies. [Figure 44C] These are different diagrams of the first and second adjustment assemblies. [Figure 44D] These are different diagrams of the first and second adjustment assemblies. [Figure 44E] These are different diagrams of the first and second adjustment assemblies. [Figure 44F] These are different diagrams of the first and second adjustment assemblies. [Figure 44G] These are different diagrams of the first and second adjustment assemblies. [Figure 44H] These are different diagrams of the first and second adjustment assemblies.

[0024] [Figure 45A] This figure shows the jaw assembly in the closed position.

[0025] [Figure 45B] This figure shows the jaw assembly in the open position.

[0026] [Figure 45C] This figure shows the jaw assembly located in the intermediate position.

[0027] [Figure 46] This figure shows the jaw assembly shown above.

[0028] [Figure 47A] This diagram shows a jaw assembly with the yoke section omitted for clarity.

[0029] [Figure 47B] This diagram shows a jaw assembly with the yoke and second jaw omitted for clarity.

[0030] [Figure 48A] This figure shows the jaw springs of the jaw assembly shown above. [Figure 48B] This diagram shows the same jaw spring in different positions. [Figure 48C] This diagram shows the same jaw spring in different positions. [Figure 48D] This diagram shows the same jaw spring in different positions. [Figure 48E] This diagram shows the same jaw spring in different positions. [Figure 48F] This diagram shows the same jaw spring in different positions. [Figure 48G] This diagram shows the same jaw spring in different positions.

[0031] [Figure 49A] This figure shows the atrial clip assembly releasably connected to the jaw assembly. [Figure 49B] This is a different diagram of a concentric atrial clip assembly. Detailed description of the invention

[0032] As shown in Figures 1A to 1H, one embodiment of the atrial clip assembly 10 includes a first arm assembly 12 connected to a second arm assembly 14. The first arm assembly 12 can be connected to the second arm assembly 14 in any suitable manner, such as being rotatably connected to the second arm assembly 14, and in one embodiment, it is rotatably and displaceably connected to the second arm assembly 14. The atrial clip assembly 10 is configured to be applied to the left atrial appendage (LAA) of a human heart, with a portion of the LAA positioned between the first arm assembly 12 and the second arm assembly 14, and one or more portions of sutures connected to each of the first arm assembly 12 and the second arm assembly 14, so that the first arm assembly 12 and the second arm assembly 14 can be fixed in a position to clamp the portion of the LAA.

[0033] The first arm assembly 12 includes a first arm body 16 as shown in Figures 1 and 2. As shown in Figures 4A to 4E, the first arm body 16 is elongated and extends along the first arm body axis 22 from a first end 18 to a second end 20. The first arm body 16 includes a first support portion 24 that extends along the first arm body axis 22 from a first end 26 to a second end 28. The first support portion 24 extends from the second end 20 toward the first end 18 of the first arm body 16, with the first end 26 offset from the first end 18 of the first arm body 16. The first support portion 24 may have a rectangular or substantially rectangular shape (cross-sectional shape) along all or part of the first arm body axis 22. A plurality of projections 30 protrude from the engagement surface 32 (e.g., bottom surface) of the first support portion 24.

[0034] The first arm body 16 includes a first connecting portion 34 located at the first end 18 of the first arm body 16. The first connecting portion 34 extends along a first connecting shaft 36. The first connecting shaft 36 is positioned at an angle of 30° to 90° with respect to the axis 22 of the first arm body. The first connecting portion 34 is flat or substantially flat and is defined by a first side surface 42 and a second side surface 44, these sides 42, 44 being parallel to the XZ plane of the reference coordinate system shown in Figure 4A. An elongated slot 40 is formed through the first side surface 42 and the second side surface 44 of the first connecting portion 34 and extends along the first connecting shaft 36. A portion 38 of the first connecting portion 34 is connected to the first end 26 of the first support portion 24. A first notched edge portion 46 extends along a portion of the first support portion 24 from the first end 26 toward the second end 28. When viewed along the Y-axis of the reference coordinate system in Figures 4A and 4B, the second notch edge portion 48 may have a concave curve, an arc shape, or a semicircular shape. The second notch edge portion 48 extends from the second end portion 28 toward the first end portion 26 along a portion of the first support portion 24. When viewed along the Y-axis of the reference coordinate system in Figures 4A and 4B, the second notch edge portion 48 may have a concave curve, a partially concave curve, or a semicircular shape. As shown in Figures 4A and 4B, the support shelf 74 is positioned along all or part of portion 38. The support shelf 74 protrudes from the side edge or side of the first support portion 24. The upper surface of the support shelf 74 includes a channel configured to support part or part of a suture. This suture can be used to fix the atrial clip assembly 10 in a closed position or to fix the atrial clip assembly 10 to the delivery device 200. The portion 38 of the first connecting portion 34 can be connected to the first end 26 of the first support portion 24 in any suitable manner, and the first connecting portion 34 and the first support portion 24 can be integrally formed as a single, one-piece component. The first arm body 16 can be injection molded as a single piece and may be made from or contain a plastic material (e.g., ABS or nylon).

[0035] As shown in the cross-sectional view of Figure 1F, the first arm assembly 12 includes a first spine portion 50 that extends along all or part of the first support portion 24 of the first arm body 16. The first spine portion 50 is elongated and extends from a first end 52 to a second end 54 along a first spine axis 56 that is in line with the axis 22 of the first arm body. The first end 52 is located at or adjacent to (for example, slightly offset from) the first end 26 of the first support portion 24, and the second end 54 is located at or adjacent to (for example, slightly offset from) the second end 28 of the first support portion 24. The first spine portion 50 has any suitable cross-sectional shape or combination of shapes. For example, as shown in Figure 2A, the first spine portion 50 has a cylindrical outer surface 61 that is uniform or substantially uniform from the first end 52 (or a point adjacent to the first end 52) to the second end 54 (or a point adjacent to the second end 54). The first spine portion 50 has a first opening 58 adjacent to the first end 52, which extends along an axis perpendicular to the first spine axis 56. The first spine portion 50 also has a second opening 60 adjacent to the second end 54, which extends along an axis perpendicular to the first spine axis 56.

[0036] The first spine portion 50 can be made of a material harder than the first arm body 16. The first spine portion 50 can be made of a metallic material such as titanium, steel, or aluminum. The first spine portion 50 can be co-molded with the first arm body 16 in any suitable way. For example, the first spine portion 50 can be placed in a mold for molding the first arm body 16 so that a portion of the first arm body 16 surrounds the first spine portion 50. In this way, the first arm opening 62 is formed on a surface that at least partially defines the first notch edge portion 46 of the first support portion 24 (for example, the first end portion 26 or its vicinity in the first support portion 24). The first arm opening 62 is aligned with the first opening 58 of the first spine portion 50. Furthermore, the second arm opening 64 is formed on a surface that at least partially defines the second notch edge portion 48 of the first support portion 24 (for example, the second end portion 28 or its vicinity in the first support portion 24). The second arm opening 64 is aligned with the second opening 60 of the first spine portion 50.

[0037] In one embodiment of the atrial clip assembly 10, the first arm assembly 12 also includes one or more portions of suture 66 that are wrapped around the outer surface 61 of the first spine portion 50 before the first support portion 24 is formed on the first spine portion 50, thereby preventing one or more portions of the suture 66 positioned within the first support portion 24 from displacing relative to the first support portion 24 and fixing them to the first support portion 24. One or more portions of the suture 66 can be wrapped around the outer surface 61 of the first spine portion 50 in any suitable manner. One or more portions of the suture 66 may be wrapped spirally around the outer surface 61 of the first spine portion 50, for example, as shown in Figure 2B. After forming, the first ends 68 of one or more portions of the suture 66 can extend through all or part of the first arm opening 62 of the first support portion 24 and the first opening 58 of the first spine portion 50. Furthermore, after molding, the second ends 70 of one or more portions of the suture 66 can extend through all or part of the second arm opening 64 of the first support portion 24 and the second opening 60 of the first spine portion 50. One or more portions of the suture 66 can be any material or combination of materials that can fix (or cooperate to fix) the first arm assembly 12 to the second arm assembly 14, as will be described in more detail below. Thus, one or more portions of the suture 66 may be, for example, any suture, wire, thread, fabric, or cable.

[0038] As shown in Figure 1F, the atrial clip assembly 10 also includes a second arm assembly 14. The second arm assembly 14 includes a second arm body 116, as shown in Figures 3A to 3F. The second arm body 116 is elongated and extends along the second arm body axis 122 from a first end 118 to a second end 120. The second arm assembly 14 also includes a second support portion 124 that extends along the second arm body axis 122 from a first end 126 to a second end 128. The second support portion 124 extends from the second end 120 toward the first end 118 of the second arm body 116, with the first end 126 being offset from the first end 118 of the second arm body 116. The second support portion 124 has a rectangular or substantially rectangular shape (cross-sectional shape) along all or part of the second arm body axis 122. Multiple projections 130 protrude from the engagement surface 132 (e.g., the upper surface) of the second support portion 124. When the first arm assembly 12 and the second arm assembly 14 are in the engagement position (when the atrial clip assembly 10 is in the engagement position), the engagement surface 132 of the second support portion 124 faces the engagement surface 32 of the first support portion 24. Therefore, one or more of the multiple projections 30 of the first arm assembly 12 and one or more of the multiple projections 130 of the second arm assembly 14 are configured to engage with a portion of the LAA and tightly grip the LAA.

[0039] The second arm body 116 includes a second connecting portion 134 located at the first end 118 of the second arm body 116. The second connecting portion 134 includes a first tab 135 and a second tab 136. The first tab 135 and the second tab 136 are each flat (parallel to the XZ plane of the reference coordinate system in Figure 3D), offset from the second arm body axis 122, and a gap is formed between them. The first tab 135 and the second tab 136 are configured to receive the first side surface 42 and the second side surface 44 of the first connecting portion 34 into the gap formed by the first tab 135 and the second tab 136. The shaft hole 137 is located through a portion of the first tab 135 and the second tab 136. The atrial clip assembly 10 includes a cylindrical shaft member 139 that passes through the shaft hole 137. The cylindrical shaft 139 is housed within a slot 40 of the first arm assembly 12, thereby allowing the first arm assembly 12 to rotate around the cylindrical shaft member 139 relative to the second arm assembly 14 (or vice versa). Furthermore, the cylindrical shaft member 139 has a diameter slightly smaller than the width of the slot 40, thereby allowing the cylindrical shaft member 139 to be displaced linearly within the slot 40 along the first connecting shaft 36, and consequently allowing the first arm assembly 12 to be displaced relative to the second arm assembly 14 (or vice versa) while maintaining its rotational capability. Such displacement allows the first arm assembly 12 to maintain a parallel relationship with the second arm assembly 14 when applied to the LAA, thereby maintaining uniform pressure across the clipped portion of the LAA.

[0040] A portion 138 of the second connecting portion 134 is connected to the first end 126 of the second support portion 124. A first notched edge portion 146 extends along a portion of the second support portion 124 from the first end 126 toward the second end 128. The first notched edge portion 146 may have a concave curve, arc-shaped, or semicircular shape when viewed along the Y-axis of the reference coordinate system in Figures 3D and 3E. A second notched edge portion 148 extends along a portion of the second support portion 124 from the second end 128 toward the first end 126, and the second notched edge portion 148 may have a concave curve, partially concave curve, or semicircular shape when viewed along the Y-axis of the reference coordinate system in Figures 3D and 3E. A support shelf 174 is positioned along all or part of the portion 138. The support shelf 174 protrudes from the side edge or side of the second support portion 124. The lower surface of the support shelf 174 includes channels configured to support one or more portions of a suture. The suture can be used to secure the atrial clip assembly 10 in the closed position or to secure the atrial clip assembly 10 to the delivery device 200. Portion 138 of the second connector 134 can be connected to the first end 126 of the second support 124 in any suitable manner, and the second connector 134 and the second support 124 can be integrally formed as a single, one-piece component. The second arm body 116 can be injection molded as a single piece and may be made from or contain plastic material (e.g., ABS or nylon).

[0041] As shown in the cross-sectional view of Figure 1F, the second arm assembly 14 may include a second spine portion 150 that extends along all or part of the second support portion 124 of the second arm body 116. The second spine portion 150 may be identical to the first spine portion (shown in Figure 2A). The second spine portion 150 is elongated and extends from a first end 152 to a second end 154 along a second spine axis 156 that is in line with the second arm body axis 122. The first end 152 may be at the first end 126 of the second support portion 124, or adjacent to it (for example, slightly offset). The second end 154 may be at the second end 128 of the second support portion 124, or adjacent to it (for example, slightly offset). The second spine portion 150 has a first opening 158 adjacent to the first end 152, and the first opening 518 extends along an axis perpendicular to the second spine axis 156. The second spine portion 150 has a second opening 160 adjacent to the second end 154, and the second opening 160 extends along an axis perpendicular to the second spine axis 156.

[0042] Similar to or in the same manner as the first spine portion 50, the second spine portion 150 can be co-molded with the second arm body 116 in any suitable manner. For example, the second spine portion 150 is placed in a mold for molding the second arm body 116 so that a portion of the second arm body 116 surrounds the second spine portion 150. In this way, the first arm opening 162 is formed on a surface that at least partially defines the first notch edge portion 146 of the second support portion 124 (for example, the first end portion 126 or its vicinity in the second support portion 124). The first arm opening 162 is aligned with the first opening 158 of the second spine portion 150. Furthermore, the second firm opening 164 is formed on a surface that at least partially defines the second notch edge portion 148 of the second support portion 124 (for example, the second end portion 128 or its vicinity in the second support portion 124). The second arm opening 164 is aligned with the second opening 160 of the second spine portion 150.

[0043] In one embodiment of the atrial clip assembly 10, the second arm assembly 14 includes one or more portions of suture 166 that are wrapped around the outer surface 161 of the second spine portion 160 before the second support portion 124 is formed on the second spine portion 150. One or more portions of suture 166 wrapped around the outer surface 161 of the second spine portion 150 may be identical in composition to one or more portions of suture 66 wrapped around the outer surface 61 of the first spine portion 50 as described above. After forming, the first ends 168 of one or more portions of suture 166 may extend through the first arm opening 162 of the second support portion 124 and through all or part of the first opening 158 of the second spine portion 150. Furthermore, after molding, the second ends 170 of one or more portions of the suture thread 166 can extend through all or part of the second arm opening 164 of the second support portion 124 and the second opening 160 of the second spine portion 150.

[0044] When the first arm assembly 12 and the second arm assembly 14 are applied to the LAA using, for example, an introduction device 200 described later, and the first arm assembly 12 and the second arm assembly 14 are in the engagement position (or the atrial clip assembly 10 is in the engagement position) and engage with a portion of the LAA, the first arm assembly 12 and the second arm assembly 14 can be fixed to each other in any suitable way by applying uniform pressure to a portion of the LAA in order to isolate the inside of the LAA. In one embodiment, the first ends 68 of one or more portions of the suture 66 of the first arm assembly 12 can be fixed to the first ends 168 of one or more portions of the suture 166 of the second arm assembly 14. Alternatively or additionally, the second ends 70 of one or more portions of the suture 66 of the first arm assembly 12 may be fixed to the second ends 170 of one or more portions of the suture 166 of the second arm assembly 14. For example, as shown in the embodiments of Figures 1A to 1C, the first crimpable sleeve 80a (shown in an uncrimped configuration for clarity) can be used to secure the first end 68 and the first end 168, and / or the second crimpable sleeve 80b (shown in an uncrimped configuration for clarity) can be used to secure the second end 70 and the second end 170. The crimpable sleeves 80a and 80b can be crimped or secured using a COR-KNOT® device or a COR-KNOT MINI® device manufactured by LSI Solutions, Inc., which can secure the first ends 68 and 168 and the second ends 70 and 170 within a crimp sleeve (not shown).

[0045] The first notched edge portion 46 of the first arm assembly 12 and the first notched edge portion 146 of the second arm assembly 14 work together to provide adequate space or gap to the cylindrical first crimpable sleeve 80a, so that the cylindrical first crimpable sleeve 80a does not contact or interfere with any desired position on the first arm assembly 12 and the second arm assembly 14 when the first arm assembly 12 and the second arm assembly 14 are engaged. Similarly, the second notched edge portion 48 of the first arm assembly 12 and the second notched edge portion 148 of the second arm assembly 14 work together to provide adequate space or gap to the cylindrical second crimpable sleeve 80b, so that the cylindrical second crimpable sleeve 80b does not contact or interfere with any desired position on the first arm assembly 12 and the second arm assembly 14 when the first arm assembly 12 and the second arm assembly 14 are engaged.

[0046] Further embodiments of the atrial clip assembly 300 are provided, as shown in Figures 9A-9C and 36A-36D. This atrial clip assembly 300 is similar to the atrial clip assembly 10, except for the living hinge coupling. In the atrial clip assembly 300, the same reference numerals are used for features that are similar or identical to those of the atrial clip assembly 10. In particular, as shown in Figures 9A and 36A, the first arm assembly 302 of the atrial clip assembly 300 comprises a first arm body 16 extending along the first arm body axis 22 from a first end 18 to a second end 20, and the first arm body 16 comprises a first support portion 24 extending along the first arm body axis 22 from a first end 26 to a second end 28. In this embodiment, the first arm body 16 and the first support portion 24 are identical or have the same length, with the first end 18 of the first arm body 16 corresponding to the first end 26 of the first support portion 24, and the second end 20 of the first arm body 16 corresponding to the second end 28 of the first support portion 24. However, the first end 26 of the first support portion 24 may be offset from the first end 18 of the first arm body 16 along the X-axis of the reference coordinate system in Figure 9A, similar to the atrial clip assembly 300. The first notched edge portion 46 extends along a portion of the first support portion 24 from the first end 26 or its vicinity toward the second end 28, and when viewed along the Y-axis of the reference coordinate system in Figure 9A, the first notched edge portion 46 has a concave, arched, or semicircular shape.

[0047] Furthermore, the second arm assembly 304 of the atrial clip assembly 300 includes a second arm body 116 extending along the second arm body axis 122 from a first end 118 to a second end 120. The second arm assembly 304 includes a second support portion 124 extending along the second arm body axis 122 from a first end 126 to a second end 128. In this embodiment, the second arm body 116 and the second support portion 124 are the same or of the same length, with the first end 118 of the second arm body 116 corresponding to the first end 126 of the second support portion 124, and the second end 120 of the second arm body 116 corresponding to the second end 128 of the second support portion 124. However, the first end 126 of the second support portion 124 may be offset from the first end 118 of the second arm body 116 along the X-axis of the reference coordinate system in Figure 9A, similar to the atrial clip assembly 300. The first notched edge portion 146 extends along a part of the second support portion 124 from the first end portion 126 or its vicinity toward the second end portion 128, and the first notched edge portion 146 has a concave, arched, or semicircular shape when viewed along the Y-axis of the reference coordinate system in Figure 9A.

[0048] Referring to Figures 9A, 10, 11, 36A, and 36C, the atrial clip assembly 300 has a hinge portion 306 that connects the first arm assembly 302 and the second arm assembly 304. The hinge portion 306 extends from the first end 18 of the first arm body 16 of the first arm assembly 302 to the first end 118 of the second arm body 116 of the second arm assembly 304. The hinge portion 306 may be a "living hinge" and is integrally formed with the first end 18 of the first arm body 16 of the first arm assembly 302 and the first end 118 of the second arm body 116 of the second arm assembly 304. As a result, the hinge portion 306, the first arm body 16 of the first arm assembly 302, and the second arm body 116 of the second arm assembly 304 form a single, integrated part, which can be manufactured as an injection-molded plastic part. The hinge portion 306 is flexible and configured to bend and rotate about a pivot axis 309 (see Figure 9C) parallel to the Y-axis of the reference coordinate system in Figure 9A. In one embodiment, the hinge portion 306 has one or more features configured to prevent rotation of the hinge portion 306 about an axis not parallel to the Y-axis.

[0049] Figure 13A is a top view of the linear, "flat" structure of the hinge 306 (the structure as it was when the atrial clip assembly 300 was manufactured). The hinge 306 includes a base member 308 that extends along the base axis 326 from the first end 18 of the first arm body 16 to the first end 118 of the second arm body 116. The base axis 326 is parallel to the X-axis of the reference coordinate system in Figure 13A. The base member 308 is defined at least partially by a top surface 310 and a bottom surface 312 (shown in a cross-sectional view in Figure 13B). The top surface 310 and the bottom surface 312 are planar or substantially planar, and are parallel to the XY plane of the reference coordinate system in Figure 13A.

[0050] The hinge portion 306 is provided with a first support projection 314a and a second support projection 314b projecting upward from the upper surface 310, respectively. The first support projection 314a and the second support projection 314b are aligned along a reference plane 313 parallel to the YZ plane of the reference coordinate system in Figures 13A and 13B, and are arranged symmetrically with respect to the reference plane 313. The inner wall 316a of the first support projection 314a and the inner wall 316b of the second support projection 314b are arranged parallel (or substantially parallel) to the XZ plane of the reference coordinate system in Figures 13A and 13B, respectively, so that the inner side walls 316a and 316b define a central gap 318 arranged along the Y axis of the reference coordinate system in Figure 9A.

[0051] The hinge portion 306 also includes a first engagement projection 320 projecting upward from the upper surface 310 of the base member 308, the first engagement projection 320 extending laterally along an axis perpendicular to (or approximately along) the base axis 326 from the first side edge 322 of the base member 308 to the second side edge 324 of the base member 308. The upper surface 328 (new # needed) of the first engagement projection 320 is parallel to the upper surface 310 of the base member 308, and this upper surface 328 is aligned or approximately aligned with the upper surfaces 330a, 330b of one or both of the first support projections 314a and the second support projections 314b. The first inner tab 332 projects from the first portion of the top of the first engagement projection 320 along the base axis 326 toward the central gap 318. The first inner tab 332 has a width parallel to the Y-axis of the reference coordinate system in Figure 13A. This width is smaller (or slightly smaller) than the distance between the inner side walls 316a and 316b that define the central gap 318. Therefore, when the atrial clip assembly 300 is in the engaged position (closed position) shown in Figure 9A, all or part of the first inner tab 332 is positioned within the first portion of the central gap 318 defined between the inner side walls 316a and 316b. When the atrial clip assembly 300 is in the disengaged position (open position) shown in Figures 33A to 33D, the first inner tab 332 is positioned outside the central gap 318 defined between the inner side walls 316a and 316b. However, in one embodiment, the first inner tab 332 protrudes a sufficient distance toward the central gap 318, so that a portion of the first inner tab 332 may be positioned within the first portion of the central gap 318 defined between the inner side walls 316a, 316b in the disengaged or partially disengaged position.

[0052] Referring again to Figure 13A, the first side wall 336a and the second side wall 336b are formed on the first end projection 340. This first end projection 340 is located on or protrudes from the first end 18 of the first arm body 16. The first side wall 336a and the second side wall 336b define at least partially the first end notch 338 located on the first end projection 340. The first side wall 336a and the second side wall 336b are arranged symmetrically around the base axis 326 and are aligned with the inner side walls 316a and 316b that define the central gap 318. As a result, the first end notch 338 is aligned with the central gap 318.

[0053] The first outer tab 334 protrudes from the second portion of the top of the first engagement projection 320 along the base axis 326 toward the first end notch 338. The first outer tab 334 has a width parallel to the Y-axis of the reference coordinate system in Figure 13A, and this width is smaller (or slightly smaller) than the distance between the first side wall 336a and the second side wall 336b that defines the first end notch 338. Therefore, when the atrial clip assembly 300 is in the engagement position (closed position) shown in Figure 9A, all or part of the first outer tab 334 is positioned within the first end notch 338 defined between the first side wall 336a and the second side wall 336b. When the atrial clip assembly 300 is in the disengaged position (open position) shown in Figures 33A to 33D, the first outer tab 334 is located outside the first end notch 338 defined between the first side wall 336a and the second side wall 336b. However, in some embodiments, the first outer tab 334 protrudes a sufficient distance toward the first end notch 338, thereby allowing the first outer tab 334 to be located within a portion of the first end notch 338 defined between the first side wall 336a and the second side wall 336b in the disengaged or partially disengaged position.

[0054] The hinge portion 306 also includes a second engaging projection 342. This second engaging projection 342 is identical or substantially identical to the first engaging projection 320 and is positioned symmetrically with respect to the first engaging projection 320 with respect to the reference plane 313. The second engaging projection 342 projects upward from the upper surface 310 of the base member 308 and extends laterally along an axis perpendicular to the base axis 326 (or substantially along that axis) from the first side edge 322 of the base member 308 to the second side edge 324 of the base member 308. The top surface 344 of the second engaging projection 342 is parallel to the upper surface 310 of the base member 308. This top surface 344 is aligned or substantially aligned with the top surfaces 330a, 330b of one or both of the first and second support projections 314a, 314b. The second inner tab 346 protrudes from the first portion of the top of the second engagement projection 342 along the base axis 326 toward the central gap 318. The second inner tab 346 has a width parallel to the Y-axis of the reference coordinate system in Figure 13A, and this width is smaller (or slightly smaller) than the distance between the inner side walls 316a and 316b that define the central gap 318. Therefore, when the atrial clip assembly 300 is in the engaged position (closed position) shown in Figure 9A, all or part of the second inner tab 346 is located within the second portion of the central gap 318 defined between the inner side walls 316a and 316b. When the atrial clip assembly 300 is in the disengaged position (open position) shown in Figures 33A to 33D, the second inner tab 346 is located outside the portion of the central gap 318 defined between the inner side walls 316a and 316b. However, in one embodiment, the second inner tab 346 protrudes a sufficient distance toward the central gap 318, so that in the disengaged or partially disengaged position, a portion of the second inner tab 346 may be positioned within the second portion of the central gap 318 defined between the inner side walls 316a and 316b.

[0055] Referring again to Figure 13A, the second end projection 348 is positioned on or protruding from the first end 118 of the second arm body 116, and a first side wall 350a and a second side wall 350b are formed on this second end projection 348. The first side wall 350a and the second side wall 350b define at least partially the second end notch 352 positioned on the second end projection 348. The first side wall 350a and the second side wall 350b are positioned symmetrically around the base axis 326 and are aligned with the inner side walls 316a and 316b that define the central gap 318, respectively, thereby aligning the second end notch 352 with the central gap 318.

[0056] The second outer tab 354 protrudes from the second portion of the top of the second engagement projection 342 along the base axis 326 toward the second end notch 352. The second outer tab 354 has a width parallel to the Y-axis of the reference coordinate system in Figure 13A. This width is smaller (or slightly smaller) than the distance between the first sidewall 350a and the second sidewall 350b that defines the second end notch 352. Therefore, when the atrial clip assembly 300 is in the engagement position (closed position) shown in Figure 9A, all or part of the second outer tab 354 is positioned within all or part of the second end notch 352 defined between the first sidewall 350a and the second sidewall 350b. When the atrial clip assembly 300 is in the disengaged position (open position) shown in Figures 33A to 33D, the second outer tab 354 is positioned outside the second end notch 352 defined between the first side wall 350a and the second side wall 350b. However, in some embodiments, the second outer tab 354 protrudes a sufficient distance toward the second end notch 352, so that a portion of the second outer tab 354 may be positioned within a portion of the second end notch 352 defined between the first side wall 350a and the second side wall 350b in the disengaged or partially disengaged position.

[0057] As described above, the hinge portion 306 is flexible and can be bent or configured to rotate around the pivot axis 309 (see Figure 9C). As the atrial clip assembly 300 moves from the disengaged position shown in Figures 33A to 33D to the engaged position shown in Figure 9A, or as it moves, all or part of the first inner tab 332 of the first engaging projection 320 is positioned within the first portion of the central gap 318, and all or part of the first outer tab 334 of the first engaging projection 320 is positioned within the first end notch 338 of the first end projection 340. Furthermore, all or part of the second inner tab 346 of the second engaging projection 342 is positioned within the second portion of the central gap 318, and all or part of the second outer tab 354 of the second engaging projection 342 is positioned within all or part of the second end notch 352 of the second end projection 348. Therefore, the interaction between the central gap 318, the notches 338 and 352, and the tab maintains the alignment of the first arm assembly 302 and the second arm assembly 304 in the XZ plane of the reference coordinate system shown in Figures 13A and 13B, and the atrial clip assembly 300 can rotate only about the pivot axis 309 parallel to the Y axis of the reference coordinate system in Figure 9A, thereby eliminating torsional forces or other torsional forces about an axis parallel to the X axis of the reference coordinate system in Figure 9A.

[0058] As shown in Figures 35A-35C, the atrial clip assemblies 10, 300 may be covered at least partially by a sheath 444. The sheath 444 can cover all, part, or two or more parts of the atrial clip assemblies 10, 300. For example, the sheath 444 can cover (and / or surround) all or part of the first arm assembly 302, and this sheath 444 (or another sheath 444) can cover (and / or surround) all or part of the second arm assembly 304. In one embodiment, the sheath 444 may be a tube that houses or completely covers the first arm assembly 302, the hinge portion 306, and the second arm assembly 304. The sheath 444 can be made from a material that facilitates connection or attachment to the patient's tissue, such as a fabric material, a synthetic material, a mesh material, or a combination thereof, or other suitable material.

[0059] The first arm assembly 302 and the second arm assembly 304 are supplied to the LAA (for example, by using the introduction device 200 described later), and when the first arm assembly 302 and the second arm assembly 304 are in an engagement position to engage with a portion of the LAA (or when the atrial clip assembly 300 is in an engagement position to engage with a portion of the LAA), the first arm assembly 302 and the second arm assembly 304 are fixed together in any suitable manner to apply uniform pressure to a portion of the LAA and isolate the inside of the LAA. Similar to the atrial clip assembly 10, the atrial clip assembly 300 includes one or more portions of suture 66 that are, for example, spirally wrapped around the outer surface 61 of the first spine portion 50, and one or more portions of suture 166 that are, for example, spirally wrapped around the outer surface 161 of the second spine portion 150. In such embodiments, the first ends 68 of one or more portions of the suture 66 of the first arm assembly 302 are fixed to the first ends 168 of one or more portions of the suture 166 of the second arm assembly 304. Alternatively, or additionally, the second ends 70 of one or more portions of the suture 66 of the first arm assembly 302 are fixed to the second ends 170 of one or more portions of the suture 166 of the second arm assembly 304. For example, as in the embodiments shown in Figures 1A to 1C (and Figures 34A and 35B), a first crimpable sleeve 80a (shown in an uncrimped configuration for clarity) is used to fix the first ends 68 and the first ends 168, and / or a second crimpable sleeve 80b (shown in an uncrimped configuration for clarity) is used to fix the second ends 70 and the second ends 170. In Figures 9A, 12A, 12B, 33D, 34B, 35C, 36A, and 36B, for clarity, one or more portions of the suture 66 of the first spine portion 50 and one or more portions of the suture 166 of the second spine portion 150 have been omitted. Furthermore, in some embodiments of the atrial clip assemblies 10, 300, one or more portions of the suture 66 of the first spine portion 50 and / or one or more portions of the suture 166 of the second spine portion 150 may be omitted, and instead any method for securing the first arm assemblies 12, 302 and the second arm assemblies 14, 304 may be used.

[0060] Referring to Figure 5, the introduction device 200 is used to position the atrial clip assemblies 10, 300 around or adjacent to the LAA and to secure the atrial clip assemblies 10, 300 to a portion of the LAA. The introduction device 200 includes a housing 202 having a grip portion 204. The user grasps the grip portion 204 and engages the actuating lever 206, moving the actuating lever 206 from a first lever position (shown in Figure 5) to a second lever position (not shown, but rotated by the user toward the grip portion 204). The actuating lever 206 is indirectly connected to the atrial clip assemblies 10, 300, and when the actuating lever 206 is in the first lever position, the atrial clip assemblies 10, 300 are in the open position (shown in Figure 8D). When the atrial clip assemblies 10, 300 are positioned in the desired location (such as adjacent to the LAA), the actuating lever 206 is pivoted from the first lever position to the second lever position, displacing the atrial clip assemblies 10, 300 to the engagement position (shown in Figure 5). Referring to Figure 7 (in this figure, a portion of the housing 202 is omitted for clarity), the first portion of the actuating lever 206 is rotatably connected to the housing 202 at the first portion of the housing 202 (i.e., the pivot point). This allows the actuating lever 206 to pivot between the first and second lever positions about the pivot point. The actuating lever 206 can rotate about a pivot axis extending through the pivot point. The pivot axis is perpendicular to a shaft axis 208 extending along a shaft 210 connected to the housing 202. In particular, the first portion of the actuating lever 206 is a pair of aligned bosses. These pair of bosses are received at the pivot point of the housing portion 202, into cylindrical inner walls formed in corresponding internal portions of the housing portion 202. As shown in Figure 7, when the actuating lever 206 is in the first lever position, a portion 212 of the actuating lever 206 contacts a portion 214 of the housing portion 202, thereby preventing the actuating lever 206 from extending beyond the first lever position.The first end of the spring 216 is connected to a part of the operating lever 206, and the second end of the spring 216 is connected to a part inside the housing 202, so that the operating lever 206 is biased to the first lever position by the spring 216.

[0061] Referring to Figure 7, the introduction device 200 includes a selective locking mechanism 226. This selective locking mechanism 226 maintains or locks the position of the atrial clip assembly 10 in a desired position by operating the actuating lever 206. For example, the user engages the selective locking mechanism 226 by rotating the actuating lever 206 toward a specific position toward the housing 202. At this specific position, the selective locking mechanism 226 is engaged in the locked position, in which the first arm assembly 12 and the second arm assembly 14 of the atrial clip assembly 10 are maintained or locked in the closed position. If the actuating lever 206 is rotated further toward the housing 202, the selective locking mechanism 226 is released, and the first arm assembly 12 and the second arm assembly 14 are no longer maintained in the open position. The selective locking mechanism 226 may be identical to the selective locking mechanism described in U.S. Patent Application No. 18 / 107,392, filed on 8 February 2023, and Provisional Patent Application No. 63 / 308,271, filed on 9 February 2022. The contents of each application are incorporated herein by reference in their entirety.

[0062] Referring to Figure 6, the introduction device 200 includes a shaft 210 extending along a shaft axis 208 from a proximal end 218 to a distal end 220, with the shaft axis 208 being linear. One or more portions of the shaft 210 are connected to a second portion of the housing 202, thereby fixing the shaft 210 to the housing 202. However, one or more portions of the shaft 210 may be rotatably connected to the second portion of the housing 202, thereby allowing the shaft 210 to rotate around the shaft axis 208 relative to the housing 202. The shaft 210 is rigid, but in other embodiments, the shaft 210 may be flexible or may have one or more flexible portions.

[0063] The shaft 210, or one or more portions of the shaft 210, has a general shape of an elongated hollow tube. This hollow tube has an inner surface 222 (shown in Figure 7) that defines an interior 224 extending from the proximal end 218 to the distal end 220 of the shaft 210. The shaft 210 and the inner surface 222 have any suitable cross-sectional shape or combination of shapes perpendicular to the shaft axis 208. For example, the shaft 210 has a general shape of an elongated cylindrical shaft 208, and the inner surface 222 has a circular cross-sectional shape perpendicular to the shaft axis 208.

[0064] The introduction device 200 also includes a coupling assembly 228 positioned or coupled to the distal end 220 of the shaft 210. The coupling assembly 228 is configured to be releasably coupled to the atrial clip assemblies 10, 300, allowing the atrial clip assemblies 10 to be properly positioned on the LAA and to be moved from an open position (shown in Figure 8D) to an engaged position (shown in Figure 5). The coupling assembly 228 includes a hub portion 229 fixedly coupled to the distal end 220 of the shaft 210. The hub portion 229 includes a yoke portion 230. As shown in the cross-sectional view in Figure 8C, an opening penetrates the hub portion 229 along the shaft axis 208. The coupling assembly 228 also includes a first rotational assembly 232 rotatably coupled to the hub portion 229. In particular, the first rotational assembly 232 includes a base portion 234 positioned within the yoke portion 230 of the hub portion 229 and rotatably coupled to the yoke portion 230. The base portion 234 (and the entire first rotational assembly 232) rotates around an axis 236. This axis 236 is perpendicular to the shaft axis 208 and parallel to the Z-axis of the reference coordinate system in Figures 8A and 8D. The yoke portion 238 is connected to the base portion 234 distal to the base portion 234. For example, a pin (not shown) is positioned from the first portion of the yoke portion 230 of the hub portion 229 to the second portion of the yoke portion 230 of the hub portion 229, and this pin passes through an opening in the base portion 234 and extends along the axis 236. As shown in the cross-sectional view in Figure 8C, the opening extends through the first rotational assembly 232 along its longitudinal axis.

[0065] The connecting assembly 228 also includes a second rotating assembly 240 rotatably connected to the first rotating assembly 232. In particular, the second rotating assembly 240 includes a base portion 242 located within the yoke portion 238 of the first rotating assembly 232 and rotatably connected to the yoke portion 238. The base portion 242 (and the second rotating assembly 240 as a whole) rotates about an axis 244 perpendicular to the shaft axis 208 and perpendicular to the axis 236 of the first rotating assembly 232, and this axis can be located in the XY plane of the reference coordinate system in Figures 8A and 8D. For example, a pin (not shown) is located from the first portion of the yoke portion 238 of the first rotating assembly 232 to the second portion of the yoke portion 238 of the first rotating assembly 232. This pin extends along the axis 244 through an opening in the base portion 242 of the second rotating assembly 240. As shown in the cross-sectional view of Figure 8C, the opening extends through the second revolving assembly 240 along its longitudinal axis.

[0066] The atrial clip assemblies 10, 300 are removably connected to the second rotational assembly 240 in any suitable manner, so that when the actuation lever 206 is rotated from the first lever position to the second lever position, the atrial clip assembly 10 moves from the open position to the engaged position (closed position). For example, the atrial clip assemblies 10, 300 are removably connected to the yoke portion 246 of the second rotational assembly 240. In particular, one or more portions of the first connecting portion 34 of the first arm assembly 12 and / or one or more portions of the second connecting portion 134 of the second arm assembly 14 are connected to the yoke portion 246 of the second rotational assembly 240, so that the first arm assembly 12 and the second arm assembly 14 are initially in the first open position as shown in Figure 8D. The first arm assembly 12 and / or the second arm assembly 14 are connected to the yoke portion 246 by one or more portions of suture, and one or more portions of suture extend through openings in the hub portion 229, the first rotation assembly 232, the second rotation assembly 240, and the interior 224 of the shaft 210, respectively, and are connected to the actuating lever 206. As a result, when the actuating lever 206 is displaced from the first lever position to the second lever position, the atrial clip assembly 10 is closed or displaced from the open position to the closed position via the tension of one or more portions of suture. As shown in Figure 1C, one or more portions of suture extend through one or more openings formed in the first connecting portion 34 of the first arm assembly 12 and / or the second connecting portion 134 of the second arm assembly 14 (an opening 175 formed in part of the second connecting portion 134 of the second arm assembly 14). When the atrial clip assembly 10 is positioned in the closed position, one or more portions of the suture are cut and removed from the atrial clip assembly 10 through the slots in the shaft 210.

[0067] The position of the atrial clip assembly 10 can be adjusted relative to the shaft 210 using a connecting assembly 228. In particular, the first rotation assembly 232 is connected to a first adjustment section 248, allowing the first rotation assembly 232 to rotate relative to the hub section 229. In one embodiment, the first adjustment section 248 is an adjustment wheel 250 rotatably connected inside the housing section 202, and a spring biases the adjustment wheel 250 to frictionally engage with a portion of the housing section 202, preventing undesirable rotation of the adjustment wheel 250. A portion of the adjustment wheel 250 protrudes from a slot 252 formed in a portion of the housing section 202, thereby allowing the user to rotate the adjustment wheel 250. One or more suture sections (not shown) are connected to the adjustment wheel 250 and, for example, to the base section 234 of the first rotation assembly 232 via an opening 254, so that the rotation of the adjustment wheel 250 allows the first rotation assembly 232 to rotate about an axis 236 relative to the hub section 229.

[0068] Furthermore, the second rotation assembly 240 is connected to a second adjustment section 256 in order to rotate it relative to the first rotation assembly 232. In one embodiment, the second adjustment section 256 is an adjustment wheel 258 rotatably connected inside the housing section 202, and an undesirable rotation of the adjustment wheel 258 can be prevented by biasing the adjustment wheel 258 to frictionally engage with a portion of the housing section 202. A portion of the adjustment wheel 258 protrudes from a slot 260 formed in a portion of the housing section 202, thereby allowing the user to rotate the adjustment wheel 258. One or more suture portions (not shown) are connected to the adjustment wheel 258 and, for example, to the base section 242 of the second rotation assembly 240 via an opening 262, so that the rotation of the adjustment wheel 258 can rotate the second rotation assembly 240 about an axis 244 relative to the first rotation assembly 232.

[0069] Although the introduction device 200 has been described in relation to the atrial clip assembly 10, any clip assembly, such as the atrial clip assembly 300, can also be introduced and applied using the introduction device 200. For example, Figure 14 shows a jaw assembly 403 that fixes the atrial clip assembly 300 in the closed position and the open position (shown by dashed lines). Figure 15 shows the jaw assembly 403 with the atrial clip assembly 300 fixed in the open position.

[0070] As shown in Figures 14 to 29, a further embodiment of the introduction device 400, similar to the introduction device 200, is provided. In the introduction device 400, certain features similar or identical to those in the introduction device 200 are given the same or similar reference numerals. In particular, Figures 16, 17, 18A, 18B, and 29 show an introduction device 400 that includes a flexible coupling 402. As shown in Figures 30A to 30M, the introduction device 400 includes a flexible coupling 402. The flexible coupling 402 extends from a proximal end 432 to a distal end 434 along a coupling axis 436 aligned with the shaft axis 208. The proximal end 432 of the flexible coupling 402 is connected to and / or positioned near the distal end 220 of the shaft 210. For example, as shown in Figure 31A, all or part of the proximal end 432 of the flexible coupling 402 is cylindrical in shape, having a diameter equal to or slightly smaller than the diameter of a portion of the inner surface of the distal end 220 of the shaft 210. All or part of the proximal end 432 of the flexible coupling 402 is received into the opening of the distal end 220 of the shaft 210. The distal end 434 of the flexible coupling 402 is connected to and / or positioned in part of or near the yoke portion 404, as shown in Figures 28, 31A, and 31B. The yoke portion 404 is a jaw assembly It is part of the connecting assembly 228.

[0071] Referring to Figure 30B, the flexible coupling 402 includes an intermediate portion 438 positioned between the proximal end 432 and the distal end 434. The intermediate portion 438 includes a plurality of radial members 410 spaced apart along the coupling axis 436. Each of the plurality of radial members 410 is identical. In one embodiment, each of the plurality of radial members 410 is disc-shaped and has a diameter equal to or approximately equal to the outer diameter of the shaft 210. The intermediate portion 438 also includes a plurality of axial walls 412. The axial walls 412 are positioned between the plurality of radial members 410 and / or project from the plurality of radial members 410. In particular, only one of the plurality of axial walls 412 projects between adjacent radial members 410. Each of the plurality of axial walls 412 is identical except for its orientation with respect to the reference axis 440. The reference axis 440 extends parallel to the Y-axis of the reference coordinate system in Figure 30B through the coupling axis 436, as shown in Figures 30J and 30M. In particular, each of the multiple axial walls 412 is flat and has equal or nearly equal "length" in the dimension extending along the X-axis of the reference coordinate system in Figure 30B. Each of the multiple axial walls 412 has a thickness ranging from approximately 50% to 100% of the thickness of each (or some) of the multiple radial members 410. As shown in the cross-sectional views in Figures 30I, 30J, 30L, and 30M, each of the multiple axial walls 412 intersects the coupling axis 436. Furthermore, each of the multiple axial walls 412 has an orientation relative to the reference axis 440. This orientation regularly alternates between two positions relative to each radial member 410. For example, as shown in Figure 30M, the first axial wall 412a of the multiple axial walls 412 extends proximal from the proximal surface of the first radial member 410a of the multiple radial members, and forms an angle of 135 degrees with the reference axis 440. Furthermore, as shown in Figure 30J, the second axial wall 412b of the multiple axial walls 412 extends distally from the distal surface of the first radial member 410a of the multiple radial members, and forms an angle of 45 degrees with the reference axis 440.The alternating configuration of the axial walls 412 projecting from opposite faces of the multiple radial members 410 is repeated for at least some of the multiple radial members 410 in the intermediate section 438. In some embodiments, this configuration may be repeated for each of the multiple radial members 410 in the intermediate section 438. For example, with respect to a second radial member 410b of the multiple radial members, a second axial wall 412b of the multiple axial walls 412 may project proximally from its proximal face at a 45-degree angle with the reference axis 440, and a third axial wall 412c of the multiple axial walls 412 may project distally from the distal face of the second radial member 410b of the multiple radial members. The third axial wall 412c of the multiple axial walls 412 is aligned with the first axial wall 412a of the multiple axial walls 412 when viewed along the coupling axis 436. Similarly, the fifth axial wall 412e of the plurality of axial walls 412 is aligned with the first axial wall 412a and the third axial wall 412c of the plurality of axial walls 412 when viewed along the coupling axis 436, and the fourth axial wall 412d and the sixth axial wall 412f of the plurality of axial walls 412 are aligned with the second wall 412b of the plurality of axial walls 412 when viewed along the coupling axis 436. As shown in Figures 30A, 30C, and 30D, each of the plurality of radial members 410 includes two or more openings 442, and the corresponding openings of these two or more openings 442 are aligned along an axis extending parallel to the X-axis of the reference coordinate system in Figure 30B.

[0072] The flexible coupling 402 is manufactured, processed, or constructed from a flexible material that allows the distal end 434 of the flexible coupling 402 to bend around the fixed proximal end 432 of the flexible coupling 402. For example, the flexible coupling 402 may be created or manufactured as a single, integral part from a flexible material such as a plastic material (e.g., a silicone material). In other embodiments, the flexible coupling 402 may be created from an assembly of two or more components.

[0073] Referring to Figures 28, 31A, and 31B, the jaw assembly 403 comprises a connecting assembly 228 including a yoke 404. The jaw assembly 403 further includes a first jaw 406 rotatably connected to a first portion of the yoke 404. This first jaw 406 is releasably connected to the first arm assemblies 12, 302 of the atrial clip assemblies 10, 300. The jaw assembly 403 also includes a second jaw 408 rotatably connected to a second portion of the yoke 404. This second jaw 408 is releasably connected to the second arm assemblies 14, 304 of the atrial clip assemblies 10, 300.

[0074] The jaw assembly 403 is displaceable between an open position shown in Figure 45B and a closed position shown in Figure 45A, which will be described in more detail below. In one embodiment, the yoke portion 404 is formed integrally with the second jaw 408, and the first jaw 406 pivots relative to the yoke portion 404 and the second jaw 408. In other embodiments, as shown in the examples in Figures 45A and 45B, the yoke portion 404 consists of a separate component from the first jaw 406 and the second jaw 408.

[0075] As shown in Figures 49A and 49B, the first arm assemblies 12 and 302 of the atrial clip assemblies 10 and 300 can be releasably connected to the first jaw 406 by one or more suture portions. In particular, the first connecting suture 740a is routed along one or more channels 742a formed on the outer surface 744a of the first jaw 406. The distal end of the first connecting suture 740a is connected to a portion of the first arm assemblies 12 and 302 of the atrial clip assemblies 10 and 300, or to a portion (i.e., the distal portion) of the sheath 444 covering the first arm assemblies 12 and 302. The proximal end of the first connecting suture 740a extends through the shaft 210 and is fixed or positioned at any suitable location on the introduction devices 200 and 400. Furthermore, the second arm assemblies 14 and 304 of the atrial clip assemblies 10 and 300 are releasably connected to the second jaw 406 by one or more suture portions. In particular, the second connecting suture 740b is routed along one or more channels 742b formed on the outer surface 744b of the second jaw 406. The distal end of the second connecting suture 740b is connected to a portion of the second arm assemblies 14, 304 of the atrial clip assemblies 10, 300, or to a portion (i.e., the distal portion) of the sheath 444 covering the second arm assemblies 14, 304. The proximal end of the second connecting suture 740b extends through the shaft 210 and is fixed or positioned at any suitable location on the introduction devices 200, 400.

[0076] In this way, when the jaw assembly 403 is displaced from the open position to the closed position, the first arm assemblies 12 and 302 of the atrial clip assemblies 10 and 300 are releasably connected to the first jaw 406, and the second arm assemblies 14 and 304 of the atrial clip assemblies 10 and 300 are releasably connected to the second jaw 406. Furthermore, when the first connecting suture 740a is released from the first jaw 406, the first arm assemblies 12 and 302 are released from the first jaw 406, and when the second connecting suture 740b is released from the second jaw 408, the second arm assemblies 14 and 304 are released from the second jaw 408.

[0077] Referring to Figure 28, two or more control wires 414a, 414b, 414c, and 414d each extend from their proximal to distal ends, with a portion of each extending through the interior 224 of the shaft 210 (see Figure 21). As shown in Figure 31B, two or more control wires 414a, 414b, 414c, and 414d extend through their respective corresponding openings 442 of the multiple radial members 410b. Referring to Figure 20A, the distal ends of each control wire 414a, 414b, 414c, and 414d are connected to corresponding portions of the jaw assembly 403 (i.e., the first jaw 406 and / or the second jaw 408). Furthermore, referring to Figure 26, the proximal ends of each control wire 414a, 414b, 414c, and 414d are connected to corresponding portions of the first control lever assembly 416 and / or the second control lever assembly 418. For example, by rotating the lever 420 of the first control lever assembly 416, the distal ends of one or more corresponding control wires 414a, 414b, 414c, 414d are displaced, and as a result, the jaw assembly 403 is displaced in a first direction relative to the distal end 220 of the shaft 210 by the flexible coupling 402. Furthermore, by rotating the lever 422 of the second control lever assembly 418, the distal ends of one or more corresponding control wires 414a, 414b, 414c, 414d are displaced, and as a result, the jaw assembly 403 is displaced in a second direction relative to the distal end 220 of the shaft 210 by the flexible coupling 402. Thus, by operating the first control lever assembly 416 and / or the second control lever assembly 418, the surgeon can adjust the orientation or position of the jaw assembly 403 relative to the distal end 220 of the shaft 210 during surgery. In one embodiment, the proximal ends of one or more control wires 414a, 414b, 414c, 414d are connected to corresponding portions of the actuating lever 206, and by pivoting the actuating lever 206, the orientation or position of the jaw assembly 403 relative to the distal end 220 of the shaft 210 can be changed. Figures 19, 21-27, 32A-32D show the first control lever assembly 416 and / or the second control lever assembly 418 from various angles.In these diagrams, some parts of the housing 202 and various other components have been omitted for clarity.

[0078] Referring to Figure 20A, the actuating wire 424 extends from its proximal end to its distal end, with a portion of it extending through the interior 224 of the shaft 210 (see Figure 21). The distal end of the actuating wire 424 is connected to the corresponding portion of the jaw assembly 403 (i.e., the first jaw 406). Furthermore, referring to Figures 19, 32C, and 32D, the proximal end of the actuating wire 424 is connected to the corresponding portion of the actuating lever 206. With this configuration, the atrial clip assemblies 10, 300 are connected to the jaw assembly 403 and introduced into the treatment area with the jaw assembly 403 in the open position (shown in Figure 20B). Once the jaw assembly 403 is positioned as desired in the manner described above, the surgeon can close the jaw assembly 403 by moving the actuating lever 206 from the first lever position (shown in Figure 18A) to the second lever position (where the actuating lever rotates toward the grip portion 204). This displacement causes the distal end of the actuarial wire 242, which is connected to a portion of the first jaw 406, to be displaced distally. As a result, the first jaw 406 rotates toward the second jaw 208, closing the jaw assembly 403 and the atrial clip assemblies 10 and 300 connected to the jaw assembly 403.

[0079] As shown in Figures 37A to 37C, further embodiments of the introduction device 500, similar to the introduction devices 200 and 400, are provided. In the introduction device 500, certain features similar to or identical to those in the introduction devices 200 and 400 are given the same reference numerals. The introduction device 500 will be described in more detail. As shown in Figures 45A and 45B, the jaw assembly 403 is shown in the open and closed positions, respectively, and the atrial clip assembly 300 is omitted for clarity. The coupling assembly 228 includes a yoke portion 704. This yoke portion 704 is similar to or identical to the yoke portion 404 shown in Figure 15 and is coupled to the distal end 434 of the flexible coupling 402.

[0080] Referring to Figure 46, the yoke portion 704 includes a drive slot 706 extending in a direction along the shaft axis 210 or substantially along the shaft axis 210. In other embodiments, the drive slot 706 may extend in a direction that forms an acute angle with the shaft axis 208, may be offset from the shaft axis 208, may have one or more portions offset from the shaft axis 208, and / or may be non-linear, or may have one or more non-linear portions. A drive pin 708 is housed in the drive slot 706. The drive pin 708 is configured to be displaceable between a distal position at the distal end of the drive slot 706 and a proximal position at the proximal end of the drive slot 706. The drive pin 708 is connected to a portion of the jaw spring 710 shown in Figures 48A and 48B. For clarity, the jaw assembly 403, atrial clip assembly 300, and flexible coupling 402 are omitted in these figures. Referring to Figure 48A, the drive pin 708 is connected to a first portion of the base portion 721 of the jaw spring 710, which extends along the base axis 723 from the distal end 709a to the proximal end 709b. As shown in Figure 37A, when the jaw assembly 403 is not rotating or pivoting relative to the distal end 220 of the shaft 210, the base axis 723 is aligned with the shaft axis 208. The first portion of the base portion 721 is at or near the distal end 709a of the base portion 721 of the jaw spring 710. The distal end of the actuating wire 424 is connected to a second portion of the jaw spring 710. This second portion is at or near the proximal end 709b of the base portion 721. These first and second portions are aligned along the base axis 723.

[0081] Therefore, when the distal end of the actuation wire 424 is displaced distally by the displacement of the actuation lever 206, the drive pin 708 moves from a proximal position to a distal position within the drive slot 706. When the distal end of the actuation wire 424 moves from a distal position to a proximal position, the drive pin 708 moves from a distal position to a proximal position within the drive slot 706. Figure 45A shows that when the jaw assembly 403 is in the closed position, the drive pin 708 is in the proximal position of the drive slot 706. Figure 45B shows that when the jaw assembly 403 is in the open position, the drive pin 708 is in the distal position of the drive slot 706. Figure 45C shows that when the jaw assembly 403 is in the intermediate position, and the distal end 428b of the first jaw 406 is at or near the distal end 431b of the second jaw 408, the drive pin 708 is in an intermediate position between the distal and proximal positions of the drive slot 706.

[0082] Returning to Figure 45A, the first jaw 406 extends along the first jaw axis 426 from the proximal end 428a to the distal end 428b. In Figure 47A, the atrial clip assembly 300, the flexible coupling 402, and the yoke portion 704 are omitted for clarity. As shown in Figure 47A, the first jaw 406 includes an engagement portion 429 at or near the proximal end 428a. In Figure 47B, the second jaw 408 is further omitted for clarity. As shown in Figure 47B, the first jaw slot 712 extends through a portion of the engagement portion 429 of the first jaw 406. The first jaw slot 712 is configured to receive the drive pin 708. The first jaw slot 712 extends along an axis 711 positioned acutely with respect to the first jaw axis 426. The first jaw slot 712 approaches the first jaw axis 426 as it extends from the distal end 428b to the proximal end 428a. In one embodiment, the angle between the axis 711 and the first jaw axis 426 is between 80° and 10°, for example, between 60° and 25°, or between 60° and 35°.

[0083] Returning to Figure 47A, the second jaw 408 extends along the second jaw axis 427 from the proximal end 431a to the distal end 431b. In Figure 47A, the atrial clip assembly 300, the flexible coupling 402, and the yoke portion 704 are omitted for clarity. As shown in Figure 47A, the second jaw 408 includes an engagement portion 433 at or near the proximal end 431a. The engagement portion 433 is provided with a slot (not shown) extending along the XZ plane of the reference coordinate system in Figure 37A. This slot is configured to receive the engagement portion 429 of the first jaw 204. This allows the engagement portion 429 to rotate in the XZ plane within the slot of the engagement portion 433 of the second jaw 408. The engagement portion 433 of the second jaw 408 includes a second jaw slot 714 configured to receive a drive pin 708. The second jaw slot 714 extends along an axis 715 that forms an acute angle with respect to the second jaw axis 427. As the second jaw slot 714 extends from the distal end 431b to the proximal end 431a, it approaches the second jaw axis 427. In one embodiment, the angle between the axis 715 and the second jaw axis 427 is between 80° and 10°, for example, between 60° and 25°, or between 60° and 35°.

[0084] According to the above configuration, when the distal end of the actuating wire 424 moves from the proximal position to the distal position, the drive pin 708 moves from the proximal position to the distal position within the drive slot 706 of the yoke portion 704. At the proximal position of the drive pin 708, the jaw assembly 403 is in the closed position as shown in Figure 45A. When the distal end of the actuating wire 424 moves distally, the jaw spring 710, and consequently the drive pin 708, also moves distally. Since the drive pin 708 is located within the first jaw slot 712 and the second jaw slot 714, when the drive pin 708 moves distally, the first jaw 406 and the second jaw 408 rotate around the drive pin 708 toward the open position of the jaw assembly 403. When the distal end of the actuating wire 424 has moved to its furthest distal position, the drive pin 708 is in the distal position within the drive slot 706 of the yoke portion 704, and the jaw assembly 403 is in the open position as shown in Figure 45B.

[0085] From this position, for example, the actuation lever 206 can move the distal end of the actuation wire 424 from the distal position toward the proximal position. When the distal end of the actuation wire 424 moves toward the proximal position, the jaw spring 710 and thus the drive pin 708 also move toward the proximal position within the drive slot 706 of the yoke 704. Since the drive pin 708 is located within the first jaw slot 712 and the second jaw slot 714, when the drive pin 708 moves toward the proximal position, the first jaw 406 and the second jaw 408 rotate toward the closed position of the jaw assembly 403 around the drive pin 708. When the distal end of the actuation wire 424 is moved to the intermediate position shown in Figure 45C, the drive pin 708 is in the intermediate position within the drive slot 706 of the yoke 704, and the jaw assembly 403 is in the intermediate position. This will be explained in more detail in the next paragraph. When the distal end of the actuating wire 424 moves to its most proximal position, the drive pin 708 is in the proximal position within the drive slot 706 of the yoke portion 704, and the jaw assembly 403 is in the closed position as shown in Figure 45A.

[0086] Returning to Figure 46, the yoke portion 704 includes a first secondary slot 716a on the first side (e.g., upper side) of the drive slot 706 and a second secondary slot 716b on the second side (e.g., lower side) of the drive slot 706. The first secondary slot 716a extends along the first slot axis 717a, which extends in a direction that forms an acute angle with the shaft axis 210. In one embodiment, this acute angle is in the range of 80° to 10°, for example, 80° to 45°, or 80° to 60°. In other embodiments, the first slot axis 717a, or one or more portions of the first slot axis 717a, extends in any direction relative to the shaft axis 210 and / or is non-linear or has one or more non-linear portions.

[0087] The first secondary slot 716a receives the upper pin 718a. This upper pin 718a is configured to move between a distal position at the distal end of the first secondary slot 716a (corresponding to the open position of the jaw assembly 403 shown in Figure 45B) and a proximal position at the proximal end of the first secondary slot 716a (corresponding to the closed position of the jaw assembly 403 shown in Figure 45A). The upper pin 718a is received in the opening 720 of the first jaw 406, as shown in Figure 47A. In Figure 47A, the jaw assembly 403 is in the open position. In Figure 47A, the upper pin 718a, the atrial clip assembly 300, the flexible coupling 402, and the yoke portion 704 are omitted for clarity. The opening 720 is located in the engagement portion 429 of the first jaw 406 and is configured to prevent the upper pin 718a from being displaced relative to the first jaw 406.

[0088] The upper pin 718 is positioned within the opening 720 and, as shown in Figure 48A, is in contact with a third portion of the jaw spring 710. In particular, the jaw spring 710 has a first spring arm 724a extending from a first end 726a to a second end 728a, with a first cam portion 732a positioned at the second end 728a of the first spring arm 724a. The first end 726a of the first spring arm 724a is connected to a portion of the base portion 721 (such as the proximal end 709b of the base portion 721 or a portion located near it). In one embodiment, the first end 726a of the first spring arm 724a is formed integrally with a portion of the base portion 721. In this configuration, the first spring arm 724a is cantilevered from a portion of the base portion 721, and the second end portion 728a (and / or cam portion 732a) can be displaced relative to the first end portion 726a in a direction substantially perpendicular to the base axis 723 (i.e., along the Z-axis of the reference coordinate system in Figure 48A). Furthermore, all or part of the first spring arm 724a has a shape that provides a restoring force when the second end portion 728a is displaced toward the first end portion 726a in a direction substantially parallel to the base axis 723. For example, the first spring arm 724a has a wave shape between the first end portion 726a and the second end portion 728a. This wave shape is arranged substantially perpendicular to the axis extending from the first end portion 726a to the second end portion 728a and includes two or more segments that are parallel to each other.

[0089] Referring to Figure 48B, the first cam portion 732a includes a first engagement surface portion 734a and a second engagement surface portion 736a. When the upper pin 718a is displaced between a proximal position at the proximal end of the first secondary slot 716a and a distal position at the distal end of the first secondary slot 716a, the upper pin 718a rides or slides along the first engagement surface portion 734a and the second engagement surface portion 736a. In one embodiment, the first engagement surface portion 734a extends in a direction parallel to the base axis 723, and the second engagement surface portion 736a extends in a direction generally perpendicular to the base axis 723. However, the second engagement surface portion 736a may include one or more non-linear portions, may have curves of one or more non-linear portions, and may have a slightly concave shape.

[0090] When the jaw assembly 403 is in the open position as shown in Figure 45B, the upper pin 718a is in the distal position at the distal end of the first secondary slot 716a, the drive pin 708 is at the distal end of the drive slot 706, and the jaw spring 710 is in the distal position. In this position, the upper pin 718a is in contact with a portion of the first spring arm 724a (the first end or a portion near the first engagement surface portion 734a), or, as shown in Figure 48B, with a portion of the first spring arm 724a (the portion located proximal to the first end of the first engagement surface portion 734a).

[0091] As the jaw spring 710 begins to move proximal, and the drive pin 708, which is in the distal position, moves from the distal position to the proximal position within the drive slot 706, the jaw assembly 403 begins to move toward the closed position. Furthermore, the upper pin 718a begins to move proximal from the distal end of the first secondary slot 716a, and the first jaw 406 begins to rotate toward the closed position. During this displacement within the first secondary slot 716a, as the jaw spring 710 begins to move proximal, the upper pin 718a comes into contact with a portion of the first spring arm 724a (the first end of the first engagement surface portion 734a) and slides along that portion, as shown in Figure 48C.

[0092] As the jaw spring 710 continues to move proximal, displacing the drive pin 708 proximal within the drive slot 706, the jaw assembly 403 continues to move toward the closed position. The upper pin 718a is displaced proximal within the first secondary slot 716a and maintains contact with a portion of the first spring arm 724a (the first end of the first engagement surface portion 734a). This contact causes the first cam portion 732a to begin to displace toward the base portion 721. As the contact between the upper pin 718a and the first engagement surface portion 734a continues, a portion of the first cam portion 732a is biased to contact the corresponding portion of the base portion 721, as shown in Figure 48D. Due to the rotation around one or both of the drive pin 708 and the upper pin 718a, and because the drive pin 708 is located within the first jaw slot 712 of the first jaw 406, the distal end 428b of the first jaw 406 begins to move toward the base axis 723, but the proximal end 428a does not.

[0093] As the jaw spring 710 continues to move proximal, a portion of the first cam portion 732a remains in contact with the corresponding portion of the base portion 721 until the upper pin 718a is positioned at the second end of the first engagement surface portion 734a, as shown in Figure 48E. In this position, as shown in Figure 45C, the distal end 428b of the first jaw 406 is positioned adjacent to the base axis 723, and the proximal end 428a is offset from the base axis. In this position, the drive pin 708 is in an intermediate position between the distal and proximal positions of the drive slot 706, and the upper pin 718a is in an intermediate position of the first secondary slot 716a. This position allows the distal end of the atrial clip assembly 10, 300 to engage with the left atrial appendage before the proximal end of the atrial clip assembly 10, 300 during application, resulting in more reliable engagement with the left atrial appendage when the atrial clip assembly 10, 300 is applied to the left atrial appendage.

[0094] As the jaw spring 710 continues to move proximal, the upper pin 718a moves beyond the edge between the second end of the first engagement surface portion 734a and the first end of the second engagement surface portion 736a, as shown in Figure 48F, and moves along the second engagement surface portion 736a from the first end to the second end. As the upper pin 718a moves beyond the edge, the first cam portion 732a is displaced away from the base portion 721. At this position, the distal end 428b of the first jaw 406 is not displaced (or is not displaced significantly) relative to the base axis 723, but the proximal end 428a begins to move closer to the base axis 723.

[0095] As the jaw spring 710 continues to move to its nearest position, the drive pin 708 moves to its nearest position within the drive slot 706. Consequently, as shown in Figure 48G, the upper pin 718a continues to move along the second engagement surface portion 736a to the second end of the second engagement surface portion 736a or to its vicinity. This is the same as in Figure 48A. In one embodiment, the upper pin 718a continues to move along the second engagement surface portion 736a to a point between the first and second ends of the second engagement surface portion 736a. The distal end 428b of the first jaw 406 is not yet displaced (or is not significantly displaced) relative to the base axis 723, but the proximal end 428a continues to move toward the base axis 723 until the first jaw 406 reaches the closed position of the jaw assembly 403 shown in Figure 45A.

[0096] As shown in Figure 46, the yoke portion 704 includes a second secondary slot 716b extending along the second slot axis 717b, the second slot axis 717b extending in a direction that forms an acute angle with the shaft axis 210. In some embodiments, the acute angle formed by the second slot axis 717b and the shaft axis 210 is equal to the acute angle formed by the first slot axis 717a and the shaft axis 210. In some embodiments, this acute angle is 80° to 10°, for example, in the range of 80° to 45° or 80° to 60°. In other embodiments, the second slot axis 717b, or one or more portions of the second slot axis 717b, extends in any or more directions relative to the shaft axis 210 and / or is nonlinear or has one or more nonlinear portions.

[0097] The lower pin 718b is received in the second secondary slot 716b. This lower pin 718b is movable between a distal position at the distal end of the second secondary slot 716b (corresponding to the open position of the jaw assembly 403 shown in Figure 45B) and a proximal position at the proximal end of the second secondary slot 716b (corresponding to the closed position of the jaw assembly 403 shown in Figure 45A). The lower pin 718b is received in the opening 730 of the second jaw 408, as shown in Figure 47A. Figure 47A shows the jaw assembly 403 in the open position, and for clarity, the lower pin 718b, atrial clip assembly 300, flexible coupling 402, and yoke portion 704 are omitted. The opening 730 is located in the engagement portion 433 of the second jaw 408 and prevents the lower pin 718b from being displaced relative to the second jaw 408.

[0098] As shown in Figure 48A, the lower pin 718b is positioned within the opening 730 and contacts the fourth portion of the jaw spring 710. In particular, the jaw spring 710 includes a second spring arm 724b extending from a first end 726b to a second end 728b. A second cam portion 732b is positioned at the second end 728b of the second spring arm 724b. The second spring arm 724b is substantially identical to the first spring arm 724a, or is a mirror image of the first spring arm 724a with respect to the base axis 723. In particular, the first end 726b of the second spring arm 724b is connected to a portion of the base portion 721 (the proximal end 709b or its vicinity). In some embodiments, the first end 726b of the second spring arm 724b may be integrally formed with the portion of the base portion 721. In this configuration, the second spring arm 724b is cantilevered from a portion of the base 721, and the second end 728b can be displaced relative to the first end 726b in a direction substantially perpendicular to the base axis 723 (i.e., along the Z-axis of the reference coordinate system in Figure 48A). Furthermore, the second spring arm 724b has a shape that provides a restoring force when the second end 728b is displaced toward the first end 726b in a direction substantially parallel to the base axis 723. For example, the second spring arm 724b has a wave shape between the first end 726b and the second end 728b. This shape includes two or more parallel segments positioned substantially perpendicular to an axis extending from the first end 726b to the second end 728b.

[0099] Referring to Figure 48B, the second cam portion 732b includes a first engagement surface portion 734b and a second engagement surface portion 736b. The lower pin 718b is configured to ride or slide along the first engagement surface portion 734b and the second engagement surface portion 736b as it moves between a proximal position at the proximal end of the second secondary slot 716b and a distal position at the distal end of the second secondary slot 716b. In one embodiment, the first engagement surface portion 734b extends in a direction parallel to the base axis 723, and the second engagement surface portion 736b extends in a direction generally perpendicular to the base axis 723. However, the second engagement surface portion 736b may include one or more non-linear portions, may have curves of one or more non-linear portions, and may have a slightly concave shape.

[0100] When the jaw assembly 403 is in the open position shown in Figure 45B, the lower pin 718b is in the distal position at the distal end of the second secondary slot 716b, the drive pin 708 is at the distal end of the drive slot 706, and the jaw spring 710 is in the distal position. In this position, the lower pin 718b is in contact with a portion of the second spring arm 724b (the first end or vicinity of the first engagement surface portion 734b) or, as shown in Figure 48B, with a portion of the first spring arm 724b (the portion located proximal to the first end of the first engagement surface portion 734b).

[0101] As the jaw spring 710 begins to move proximal and the drive pin 708 moves from its distal position to the proximal position within the drive slot 706, the jaw assembly 403 begins to move toward the closed position. Furthermore, as the lower pin 718b begins to move proximal from the distal end of the second secondary slot 716b, the second jaw 408 begins to rotate toward the closed position. During this movement within the second secondary slot 716b, as the jaw spring 710 begins to move proximal, the lower pin 718b comes into contact with a portion of the second spring arm 724b (the first end of the first engagement surface portion 734b) and slides along that portion, as shown in Figure 48C.

[0102] As the jaw spring 710 moves proximal, causing the drive pin 708 to move proximal within the drive slot 706, the jaw assembly 403 continues to move toward the closed position. The lower pin 718b maintains contact with a portion of the second spring arm 724b (the first end of the first engagement surface portion 734b) as it moves proximal within the second secondary slot 716b. This contact causes the second cam portion 732b to begin to displace toward the base portion 721. As the contact between the lower pin 718b and the first engagement surface portion 734b continues, a portion of the second cam portion 732b is biased to contact the corresponding portion of the base portion 721, as shown in Figure 48D. Due to the pivoting around one or both of the drive pin 708 and the lower pin 718b, and because the drive pin 708 is located within the second jaw slot 714 of the second jaw 408, the distal end 431b of the second jaw 408 begins to move toward the base axis 723, but the proximal end 431a does not.

[0103] As the jaw spring 710 continues to move proximal, contact between the lower pin 718b, which moves proximal within the second secondary slot 716b, and the first engagement surface portion 734b maintains contact between a portion of the second cam portion 732b and the corresponding portion of the base portion 721 until the lower pin 718b is positioned at the second end of the first engagement surface portion 734b, as shown in Figure 48E. In this position, as shown in Figure 45C, the distal end 431b of the second jaw 408 is positioned adjacent to the base shaft 723, and the proximal end 431a is offset from the base shaft 723. In this position, the drive pin 708 is in an intermediate position between the distal and proximal positions of the drive slot 706, and the lower pin 718b is in an intermediate position within the second secondary slot 716b. This position allows the distal ends of the atrial clip assemblies 10, 300 to engage with the left atrial appendage before the proximal ends of the atrial clip assemblies 10, 300 during application, resulting in a more secure engagement with the left atrial appendage.

[0104] As the jaw spring 710 continues to move proximal, the lower pin 718b moves beyond the edge between the second end of the first engagement surface portion 734b and the first end of the second engagement surface portion 736b, and the lower pin 718b is displaced along the second engagement surface portion 736b from the first end to the second end, as shown in Figure 48F. When the lower pin 718b is displaced beyond the edge, the second cam portion 732b is displaced away from the base portion 721. At this position, the distal end 431b of the second jaw 408 is not displaced (or is not displaced significantly) relative to the base axis 723, but the proximal end 431a begins to move toward the base axis 723.

[0105] As the jaw spring 710 continues to move to its nearest position and the drive pin 708 moves to its nearest position within the drive slot 706, the lower pin 718b continues to displace along the second engagement surface portion 736b toward the second end or its vicinity, as shown in Figure 48G. Note that Figure 48G is identical to Figure 48A. In one embodiment, the lower pin 718b continues to move along the second engagement surface portion 736b until it reaches a point between the first and second ends of the second engagement surface portion 736b. The distal end 431b of the second jaw 408 remains undisplaced (or not significantly displaced) relative to the base axis 723, but the proximal end 431a continues to move toward the base axis 723 until the second jaw 408 reaches the closed position of the jaw assembly 403 shown in Figure 45A.

[0106] Normally, before applying the atrial clip assembly 10,300 to the left atrial appendage, the jaw assembly is displaced from the closed position shown in Figure 45A to the open position shown in Figure 45B. Due to this displacement, the process described above is reversed to move the jaw spring 710 from the nearest position shown in Figure 45A to the most distal position shown in Figure 45B.

[0107] As shown in Figures 37A to 37C, the introduction device 500 can control the orientation of the jaw assembly 403 in a different manner than the introduction devices 200 and 400. In particular, instead of the first control lever assembly 416 and the second control lever assembly 418 shown in the embodiment of introduction device 400, the introduction device 500 includes a first adjustment assembly 502a and a second adjustment assembly 502b. Figures 38A to 39D show various diagrams of the whole or part of the first adjustment assembly 502a and / or the second adjustment assembly 502b, with some parts of the introduction device 500 omitted for clarity. As shown in Figures 38A to 39D, the first adjustment assembly 502a includes a first adjustment wheel 504a (shown in Figures 38A to 38D). The first adjustment wheel 504a is rotatably connected to the first end of the first axle 506. The first axle 506 is aligned with the center point of the first adjustment wheel 504a. The second adjustment assembly 502b includes a second adjustment wheel 504b rotatably connected to the second end of the first axle 506. The first axle 506 is aligned with the center point of the second adjustment wheel 504b. The second adjustment wheel 504b is identical (or substantially identical, or a mirror image) to the first adjustment wheel 504a.

[0108] As shown in Figure 39D, the first spur gear 508a is positioned adjacent to the first end of the first axle 506. The first spur gear 508a rotates with the first adjustment wheel 504a relative to the first axle 506. The second spur gear 508b is positioned adjacent to the second end of the first axle 506. The second spur gear 508b rotates with the first adjustment wheel 504a relative to the first axle 506. The first spur gear 508a meshes with a portion of the first adjustment gear 510a. This first adjustment gear 510a rotates around a first portion of the second axle 512. The second axle 512 has an end fixed to a portion of the housing 202, and rotates relative to the housing 202 but does not displace relative to the housing 202. The second axle 512 is connected to the first axle 506 by a first bar 518a extending from a point adjacent to the first end of the second axle 512 to a point adjacent to the first end of the first axle 512. The second axle 512 is further connected to the first axle 506 by a second bar 518b extending from a point adjacent to the second end of the second axle 512 to a point adjacent to the second end of the first axle 512. The first axle 506 is not connected to the housing 202. However, the second axle 512 and the first axle 506 may be connected to each other and / or to the housing 202 in any suitable manner.

[0109] In this configuration, when the first adjustment wheel 504a rotates around the first axle 506, the first adjustment gear 510a rotates around the second axle 512 accordingly. In particular, when the first adjustment wheel 504a rotates in a first direction, the first adjustment gear 510a rotates in a first direction accordingly, and when the first adjustment wheel 504a rotates in a second direction, the first adjustment gear 510a rotates in a second direction accordingly.

[0110] The proximal ends of the corresponding first control wires 414a, 414b, 414c, and 414d are connected to the corresponding portion of the first regulating gear 510a (or to the drum member 514 fixed to the first regulating gear 510a as shown in Figures 39B and 39C). When the first regulating wheel 504a rotates in a first direction, one or more of the corresponding first control wires 414a, 414b, 414c, and 414d are displaced, thereby displacing the distal ends of one or more of the first control wires 414a, 414b, 414c, and 414d, thereby displacing the jaw assembly 403 in a first direction relative to the distal end 220 of the shaft 210 by the flexible coupling 402, as shown in Figure 37D. For example, the first direction is the first direction along the Z-axis of the reference coordinate system in Figure 37D. Similarly, when the first adjustment wheel 504a rotates in the second direction, one or more of the corresponding first control wires 414a, 414b, 414c, 414d are displaced, thereby displacing the distal ends of the first one or more control wires 414a, 414b, 414c, 414d, and thereby displacing the jaw assembly 403 in the second direction relative to the distal end 220 of the shaft 210 by the flexible coupling. For example, the second direction is the opposite direction to the first direction along the Z-axis of the reference coordinate system in Figure 37D. The first and second directions relative to the distal end 220 of the shaft 210 are separated by any angle, such as 180 degrees. A user holding the introduction device 500 can rotate the first adjustment wheel 504a by using their thumb to contact a portion of the first adjustment wheel 504a that protrudes through a first slot 225a (see Figure 37C) formed in part of the housing 202, thereby swiveling, rotating, or displacing the jaw assembly 403 relative to the distal end 220 of the shaft 210 in a first bending plane, such as the XZ plane of the reference coordinate system shown in Figure 37D. This allows the user to precisely position the jaw assembly 403 during minimally invasive surgery.

[0111] As shown in Figure 39C, the second spur gear 508b meshes with a portion of the second adjustment gear 510b. This second adjustment gear 510b rotates around a second portion of the second axle 512. The second axle 512 is connected to the first axle 506 by a second bar 518b that extends from a point adjacent to the second end of the second axle 512 to a point adjacent to the second end of the first axle 512. In this configuration, the second adjustment gear 510b rotates in accordance with the rotation of the second adjustment wheel 504b. Specifically, when the second adjustment wheel 504b rotates in a first direction, the second adjustment gear 510b rotates in the first direction, and when the second adjustment wheel 504b rotates in a second direction, the second adjustment gear 510b rotates in the second direction.

[0112] The proximal ends of one or more corresponding second control wires 414a, 414b, 414c, and 414d are connected to the corresponding portion of the second regulating gear 510b (or the drum member 514 shown in Figures 39B and 39C). The drum member 514 is fixed to the second regulating gear 510a but not to the first regulating gear 510a. When the second regulating wheel 504b rotates in the first direction, the distal ends of one or more corresponding second control wires 414a, 414b, 414c, and 414d are displaced, thereby causing the jaw assembly 403 to be displaced in a third direction relative to the distal end 220 of the shaft 210 by the flexible coupling 402. For example, the third direction is the first direction along the Y-axis of the reference coordinate system in Figure 37D. Similarly, when the second adjustment wheel 504b rotates in the second direction, the distal ends of one or more of the second control wires 414a, 414b, 414c, and 414d are displaced, thereby causing the jaw assembly 403 to be displaced in a fourth direction relative to the distal end 220 of the shaft 210 by the flexible coupling 402. For example, the fourth direction is the opposite direction of the third direction along the Y-axis of the reference coordinate system in Figure 37D. The first, second, third, and fourth directions relative to the distal end 220 of the shaft 210 are separated by any angular interval, such as 90 degrees. The user holding the introduction device 500 can rotate the second adjustment wheel 504b (see Figure 37C) by using their thumb to contact a portion of the second adjustment wheel 504b (see Figure 37C) that protrudes through a second slot 225b formed in part of the housing 202, thereby rotating the jaw assembly 403 relative to the distal end 220 of the shaft 210 in a second bending plane, such as the XY plane of the reference coordinate system shown in Figure 37D. The second bending plane can be perpendicular to the first bending plane. The ability to rotate in the first and second bending planes allows the jaw assembly 403 to rotate in any direction (along the Y and / or Z axes of the reference coordinate system) around the flexible coupling 402. This allows the user to precisely position the jaw assembly 403 without moving the shaft 210 relative to the patient before fixing the atrial clip assemblies 10, 300 to the LAA during minimally invasive surgery.

[0113] A portion of the second axle 512 extends through an arc-shaped guide path 516a formed on the first adjustment wheel 504a. The first adjustment wheel 504a is prevented from rotating beyond a first point where a first portion of the second axle 512 contacts the first end of the guide path 516a, and is also prevented from rotating beyond a second point where a first portion of the second axle 512 contacts the second end of the guide path 516a. Another portion of the second axle 512 extends through an arc-shaped guide path 516b formed on the second adjustment wheel 504b. The second adjustment wheel 504b is prevented from rotating beyond a first point where a second portion of the second axle 512 contacts the first end of the guide path 516b, and is also prevented from rotating beyond a second point where a second portion of the second axle 512 contacts the second end of the guide path 516b. In this way, by limiting the rotational range of the first adjustment wheel 504a and the second adjustment wheel 504b, the displacement of the jaw assembly 403 relative to the distal end 220 of the shaft 210 is also limited to an acceptable range by the wheel 504b.

[0114] To prevent undesirable rotation of the first adjustment wheel 504a or the second adjustment wheel 504b, and / or to allow the first adjustment wheel 504a and / or the second adjustment wheel 504b to be locked in a desired position, the first adjustment assembly 502a includes a first locking assembly 520a, and the second adjustment assembly 502b includes a second locking assembly 520b. The first locking assembly 520a includes a first locking member 522a that is displaceable relative to the first adjustment wheel 504a. As shown in Figures 39C, 42A to 42D, the first locking member 522a includes a first body portion 523a extending from a first end to a second end. The first body portion 523a is flat and plate-like. A first spring portion 524a is connected to or integrally formed with a portion of the first body portion 523a (e.g., the second end). In the embodiment shown in Figure 42A, the first end of the first spring portion 524a is connected to (or integrally formed with) the second end of the first main body portion 523a, and the second end of the first spring portion 524a is supported by a shelf portion 527a formed in part of the housing portion 202 (see Figures 41A and 41B). When the first main body portion 523a is displaced toward the shelf portion 527a (see Figure 40B), the first spring portion 524a biases the first main body portion 523a away from the shelf portion 527a.

[0115] As shown in Figure 41A, the first main body 523a includes a first hinge portion 542a fixed to or near the first end of the first main body 523a. The first hinge portion 542a is fixed to or within a part of the housing portion 202, such as a recess formed in the housing portion 202. As a result, when the first main body 523a is displaced downward by the user (along the arrow 538 in Figure 40B), the first locking member 522a rotates around the first hinge portion 542a. The first main body 523a includes a first notch 544a formed within the first main body 523a. This first notch 544a is configured to receive all or part of the first bar 518a. The first notch 544a is sized such that the first locking member 522a can be displaced without being obstructed by the first bar 518a. More details will be described below.

[0116] The first locking member 522a includes a first engaging portion 526a that is connected to or integrally formed with a part of the first main body portion 523a (for example, the first end portion). The first engaging portion 526a is configured to engage with a corresponding wheel engaging portion 528a formed on the first adjustment wheel 504a. For example, the wheel engaging portion 528a is a plurality of teeth 530a, which are formed on or along a circumferential ridge 532a offset inward from the periphery 534a of the first adjustment wheel 504a. In this embodiment, the first engaging portion 526a of the first locking member 522a is two or more teeth 536a. These teeth 536a are configured to be positioned between adjacent teeth 530a of the corresponding wheel engaging portion 528a. When the first locking member 522a is in the first position (i.e., the locked position), the first spring portion 524a (acting toward the circumferential ridge 532a) biases the first body portion 523a upward, thereby biasing the first engaging portion 526a to engage with a portion of the wheel engaging portion 528a formed on the first adjustment wheel 504a, as shown in Figure 40A. In other words, in the locked position of the first lock assembly 520a, two or more teeth 536a of the first locking member 522a are biased to be positioned between adjacent teeth 530a of the corresponding wheel engaging portion 528a, thereby preventing the first adjustment wheel 504a from rotating relative to the first locking member 522a (and relative to the housing portion 202 and the first adjustment gear 510a).

[0117] The first locking member 522a also includes a first contact portion 536a. This first contact portion 536a protrudes from a part of the first main body portion 523a (for example, the first end) and is connected to or integrally formed with the first main body portion 523a. In the locked position of the first lock assembly 520a, all or part of the first contact portion 536a protrudes through a first slot 225a formed in a part of the housing portion 202, and all or part of the first contact portion 536a is aligned with the periphery 534a of the first adjustment wheel 504a or protrudes beyond the periphery 534a.

[0118] To rotate the first adjustment wheel 504a and displace the jaw assembly 403, the user pushes downward on the first contact portion 536a using the same thumb that is in contact with the first adjustment wheel 504a. This downward force on the first contact portion 536a displaces the first locking member 522a downward, that is, along or approximately along arrow 538 in Figure 40B (which is parallel or substantially parallel to the Z-axis of the reference coordinate system in Figure 37C). This downward force counteracts an upward biasing force provided by the first spring portion 524a (i.e., along or substantially along arrow 540 in Figure 40A, which is parallel or substantially parallel to the Z-axis of the reference coordinate system in Figure 37C). As a result of this downward displacement, the first locking member 522a rotates around the first hinge portion 542a (see Figure 41A). This is caused by a downward force acting on the first contact portion 536a. This downward displacement of the first locking member 522a causes it to move to a second position, i.e., the unlocked position. In this unlocked position, as shown in Figure 40B, the first engaging portion 526a does not engage with a portion of the wheel engaging portion 528a formed on the first adjustment wheel 504a. In other words, in the unlocked position of the first lock assembly 520a, two or more teeth 536a of the first locking member 522a are offset from the teeth 530a of the corresponding wheel engaging portion 528a, thereby allowing the first adjustment wheel 504a to rotate relative to the first locking member 522a (and relative to the housing portion 202 and the first adjustment gear 510a). When the user displaces the jaw assembly 403 to the desired position, the pressure on the first contact portion 536a is released, thereby biasing the first spring portion 524a to return the first locking member 522a from the unlocked position to the locked position.

[0119] The second lock assembly 520b is identical, substantially identical, or a mirror image of the first lock assembly 520a and can operate in the same manner as the first lock assembly 520a. That is, the second lock assembly 520b includes a second locking member 522b that is displaceable relative to the second adjustment wheel 504b. As shown in Figures 39C and 42A to 42D (these figures show the first locking member 522a), the second locking member 522b includes a second body portion 523b extending from a first end to a second end. The second body portion 523b is flat and has a plate shape. A second spring portion 524b is connected to or integrally formed with a part of the second body portion 523b (e.g., the second end). In the embodiment shown in Figure 42A, the first end of the second spring portion 524b is connected to (or integrally formed with) the second end of the second main body portion 523b, and the second end of the second spring portion 524b is supported by a shelf portion 527b (not shown, identical to the shelf portion 527a in Figure 41A) formed in part of the housing portion 202. Therefore, when the second main body portion 523b is displaced toward the shelf portion 527b (see Figure 40B), the second spring portion 524b biases the second main body portion 523b away from the shelf portion 527b.

[0120] As shown in Figure 38B, the second body portion 523b also includes a second hinge portion 542b fixed to or near the second end of the second body portion 523b. The second hinge portion 542b is attached to the housing portion 202 in the same way as the first hinge portion 542a of the first body portion 523a. The second body portion 523b includes a second notch 544b. The second notch 544b is formed to receive all or part of the second bar 518b and is functionally identical to the first notch 544a.

[0121] The second locking member 522b also includes a second engaging portion 526b which is connected to or integrally formed with a part of the second main body portion 523b (for example, the first end). The second engaging portion 526b is configured to engage with a corresponding wheel engaging portion 528b formed on the second adjustment wheel 504b. For example, the wheel engaging portion 528b is a plurality of teeth 530b. These teeth 530b are formed on or along a circumferential ridge 532b that is offset inward from the periphery 534b of the second adjustment wheel 504b. In this embodiment, the second engaging portion 526b of the second locking member 522b is two or more teeth 536b, each of which is configured to be positioned between adjacent teeth 530b of the corresponding wheel engaging portion 528b. Therefore, when the second locking member 522b is in the first position (i.e., the locked position), the second spring portion 524b (acting toward the circumferential ridge 532b) biases the second body portion 523b upward, thereby engaging the second engaging portion 526b with a portion of the wheel engaging portion 528b formed on the second adjustment wheel 504b, as shown in Figure 40A. In other words, in the locked position of the second lock assembly 520b, two or more teeth 536b of the second locking member 522b are biased to be positioned between adjacent teeth 530b of the corresponding wheel engaging portion 528b, thereby preventing the second adjustment wheel 504b from rotating relative to the second locking member 522b (and the housing portion 202, the second adjustment gear 510b).

[0122] The second locking member 522b also includes a second contact portion 536b. The second contact portion 536b protrudes from a part of the second main body portion 523b (for example, the first end) and is connected to or integrally formed with the second main body portion 523b. In the locked position of the second lock assembly 520b, all or part of the second contact portion 536b protrudes through a second slot 225b formed in a part of the housing portion 202, and all or part of the second contact portion 536b is aligned with the periphery 534b of the second adjustment wheel 504b or protrudes beyond the periphery 534b.

[0123] To rotate the second adjustment wheel 504b and displace the jaw assembly 403, the user pushes the second contact portion 536b downward using the same thumb that is in contact with the second adjustment wheel 504 to rotate the second adjustment wheel 504b. This downward force on the second contact portion 536b displaces the second locking member 522b downward against the upward biasing force provided by the second spring portion 524b. Here, upward is in the direction along or substantially along arrow 540 in Figure 40A, which is parallel or substantially parallel to the Z-axis of the reference coordinate system in Figure 37C. Here, downward is in the direction along or substantially along arrow 538 in Figure 40B, which is parallel or substantially parallel to the Z-axis of the reference coordinate system in Figure 37C. This downward displacement results from the rotation of the second locking member 522b around the second hinge portion 542b (see Figure 38B). This downward displacement of the second locking member 522b causes it to move to a second position, i.e., the unlocked position, as shown in Figure 40B, where the second engaging portion 526b does not engage with a portion of the wheel engaging portion 528b formed on the second adjustment wheel 504b. In other words, in the unlocked position of the second lock assembly 520b, two or more teeth 536b of the second locking member 522b are offset from the teeth 530b of the corresponding wheel engaging portion 528b, thereby allowing the second adjustment wheel 504b to rotate relative to the second locking member 522b (and housing portion 202, second adjustment gear 510b). When the user moves the jaw assembly 403 to the desired position, the pressure on the second contact portion 536b is released, thereby biasing the second spring portion 524b to return the second locking member 522b from the unlocked position to the locked position.

[0124] Figures 44A to 44H show alternative embodiments of the first adjustment assembly 602a and the second adjustment assembly 602b. In this embodiment, the first adjustment wheel 604a and the second adjustment wheel 604b are each selectable to be linearly or rotationally displaced relative to the housing portion 202. The first adjustment wheel 604a of the first adjustment assembly 602a is biased to a first locked position by a first locking member 622a. The first locking member 622a has a first body portion 623a and a first spring portion 624a integrally formed with the first body portion 623a. As shown in Figure 44F, the first spring portion 624a acts on the first shelf portion 627a of the housing portion 202 to bias the first adjustment wheel 604a upward, thereby engaging a plurality of teeth 630a of the first adjustment wheel 604a with a plurality of teeth 631a formed on the lower surface of the first shelf portion 627a.

[0125] To displace the jaw assembly 403 by rotating the first adjustment wheel 604a, the user pushes a portion of the first adjustment wheel 604a, displacing it downward against the biasing force of the first spring portion 624a to the unlocked position (see Figure 44D). In this unlocked position, the teeth 630a of the first adjustment wheel 604a are physically disengaged from the teeth 631a formed on the lower surface of the first shelf portion 627a, thereby allowing the first adjustment wheel 604a to be rotated by the user's thumb. The rotation of the first adjustment wheel 604a rotates the first spur gear 633a, and one or more first control wires 414a, 414b, 414c, 414d, which are directly or indirectly connected to the first spur gear 633a, are displaced in the same manner as described above. To relock the first adjustment assembly 602a, the first adjustment wheel 604a is released from the user's thumb, and the first spring portion 624a displaces the first adjustment wheel 604a upward. This causes the multiple teeth 630a of the first adjustment wheel 604a to re-engage with the multiple teeth 631a formed on the lower surface of the first shelf portion 627a. The second adjustment assembly 602b operates in the same manner as the first adjustment assembly 602a.

[0126] The various advantages of atrial clip assemblies and delivery devices have been described above. The embodiments discussed herein are described as examples. It will be apparent to those skilled in the art that the detailed disclosures described herein are intended to be presented as examples and not limiting. Various changes, improvements and modifications will be made, and are intended to those skilled in the art, although they are not expressly stated herein. These changes, improvements and modifications are intended to be proposed herein and are within the spirit and scope of the claimed invention. The drawings contained herein are not necessarily drawn to exact scale. Furthermore, the order in which processing elements or sequences are described, or the use of numbers, letters, or other designations therefor, is not intended to limit the claims to any order, except as specified in the claims. Accordingly, the present invention is limited only by the following claims and their equivalents.

Claims

1. It comprises a first arm assembly, a second arm assembly, and a hinge portion. The first arm assembly is A first arm body extending along the axis of the first arm body from a first end to a second end, the first arm body having a first support portion extending from the first end to the second end, A first spine portion extending along a first spine axis from a first end to a second end, wherein a first portion of the first spine portion extends along a corresponding first portion of the first support portion, and the first portion of the first spine portion is positioned within the corresponding first portion of the first support portion, A first suture comprising a first portion of the first suture arranged around the first portion of the first spine and a second portion of the first suture extending outside the first support portion, The second arm assembly comprises a second arm body extending along the axis of the second arm body from a first end to a second end, and the second arm body has a second support portion extending from the first end to the second end. An atrial clip assembly in which the hinge portion connects the first end of the first arm body to the first end of the second arm body, and the hinge portion is flexible so that the first arm assembly and the second arm assembly rotate around the hinge portion from a first open position to a second closed position of the atrial clip assembly.

2. The hinge portion comprises a base member extending between the first end of the first arm body and the first end of the second arm body, a first support projection protruding from a first portion of the base member and a second support projection protruding from a second portion, with a central gap formed between the surface of the first support projection and the surface of the second support projection. The hinge portion further includes a first engaging projection that protrudes upward from the third portion of the base member along the axis of the first engaging projection, The first engaging projection includes a first inner tab projecting from a first portion of the first engaging projection in a direction perpendicular to the axis of the first engaging projection, When the atrial clip assembly is in the first open position, the first medial tab is not positioned within the first portion of the central gap. The atrial clip assembly according to claim 1, wherein when the atrial clip assembly is in the second closed position, the first inner tab is positioned within the first portion of the central gap, and the contact between the surface of the first inner tab and the first portion of the surface of the first support projection or the first portion of the surface of the second support projection prevents twisting of the hinge portion.

3. The hinge portion further comprises a second engaging projection that protrudes upward from the fourth portion of the base member along the axis of the second engaging projection, The second engaging projection includes a second inner tab that protrudes from the first portion of the second engaging projection in a direction perpendicular to the axis of the second engaging projection, When the atrial clip assembly is in the first open position, the second medial tab is not positioned within the second portion of the central gap. When the atrial clip assembly is in the second closed position, the second inner tab is positioned within the second portion of the central gap, and the contact between the surface of the second inner tab and the second portion of the surface of the first support projection or the second portion of the surface of the second support projection prevents twisting of the hinge portion. The atrial clip assembly according to claim 2.

4. The atrial clip assembly according to claim 1, wherein all or part of the hinge portion is a living hinge, the first end of the hinge portion is integrally formed with the first end of the first arm body, and the second end of the hinge portion is integrally formed with the first end of the second arm body.

5. The first end of the first support portion of the first arm body is located at or near the first end of the first arm body, and the second end of the first support portion of the first arm body is located at or near the second end of the first arm body, The atrial clip assembly according to claim 1, wherein the first end of the second support portion of the second arm body is located at or near the first end of the second arm body, and the second end of the second support portion of the second arm body is located at or near the second end of the second arm body.

6. The second arm assembly further comprises a second spine portion and a second suture, The second spine portion extends along the second spine axis from the first end to the second end, the first portion of the second spine portion extends along the corresponding first portion of the second support portion, and the first portion of the second spine portion is positioned within the corresponding first portion of the second support portion. The first portion of the second suture is positioned around the first portion of the second spine, and the second portion of the second suture extends outside the second support portion. The atrial clip assembly according to claim 1, wherein the second portion of the first suture is connected to the second portion of the second suture when the first arm assembly and the second arm assembly are in the second closed position.

7. The atrial clip assembly according to claim 6, wherein when the first arm assembly and the second arm assembly are in the second closed position, the second portion of the first suture is connected to the second portion of the second suture.

8. The atrial clip assembly according to claim 1, wherein the rigidity of the first spine portion is higher than the rigidity of the first arm body.

9. The atrial clip assembly according to claim 8, wherein the first spine portion is formed from a metal material and the first support portion of the first arm body is formed from a plastic material.

10. The atrial clip assembly according to claim 1, wherein the first end of the first spine portion is located at or near the first end of the first support portion, and the first portion of the first spine portion is positioned between the first end of the first spine portion and the second end of the first spine portion.

11. The atrial clip assembly according to claim 10, wherein the second end of the first spine portion is positioned at or near the second end of the first support portion.

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