Atrial clamping assembly and delivery device

Abstract

An atrial clamping assembly includes a first arm assembly having a first arm body including a first support portion and a first spine portion, where a first portion of the first spine portion extends along and within a corresponding first portion of the first support portion. The first arm assembly further includes a first suture, where a first portion of the first suture is disposed about a first portion of the first spine portion, and where a second portion of the first suture extends outside of the first support portion. The atrial gripping assembly also includes a second arm assembly including a second arm body having a second support portion. The atrial gripping assembly also includes a hinge portion coupling the first end of the first arm body to the first end of the second arm body, the hinge portion being flexible.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of each of U.S. Provisional Patent Application No. 63 / 453,976, filed March 22, 2023; U.S. Provisional Patent Application No. 63 / 467,747, filed May 19, 2023; U.S. Provisional Patent Application No. 63 / 527,438, filed July 18, 2023; and U.S. Provisional Patent Application No. 63 / 624,988, filed January 25, 2024, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] This invention relates to surgical devices, and more particularly, to atrial clamping assemblies and delivery devices for atrial clamping assemblies. Background Technology

[0004] Atrial fibrillation (“AF”) is a common cardiac arrhythmia affecting millions of people and associated with ischemic stroke. AF causes insufficient left atrial contraction, decreased endurance, and irregular heart rhythms. Insufficient blood flow in the left atrium leads to hypercoagulability and thus increases the risk of blood clots.

[0005] Left atrial appendage (“LAA”) thrombosis and embolism are considered major mechanisms of stroke associated with atrial appendage (AF). This stroke mechanism may be associated with decreased LAA blood flow velocity, thrombosis, hypertension, and aortic atherosclerosis. The LAA is an accessory chamber of the heart that fills and empties in response to the dynamics of both the ventricles and atria. Variable morphology of the LAA in terms of shape, volume, length, and width, particularly larger LAA volumes, depths, and number of lobes, may be associated with the likelihood of thrombosis. Currently, pharmacologically based anticoagulation therapy, particularly with warfarin, is considered a highly effective treatment for AF patients. While highly effective, warfarin has a narrow therapeutic range and carries the potential risks of major bleeding and contraindications. When these risks or other anticoagulation limitations outweigh the risk of AF-related stroke, removal or isolation of the LAA may be an attractive alternative for preventing embolic events.

[0006] Closure of the left atrial endocardium (LAA) to the left atrium is a common method for isolating the LAA during other cardiac surgeries. The LAA can be closed through ligation, folding, or amputation procedures routinely performed in patients as an adjunct to heart valve surgery. Transvenous LAA closure is also a known method for preventing embolism in patients with atrial fibrillation (AF) by using catheter deployment with an implantable device to seal the LAA's opening. Percutaneous LAA closure is another known method for blocking the LAA in the bloodstream and thus preventing thrombus formation and subsequent thromboembolic complications. Advantages of percutaneous LAA closure include less surgical trauma, faster recovery compared to surgical ligation, and a reduced risk of potential bleeding in the absence of anticoagulation therapy. However, LAA closure remains challenging. While new LAA closure methods have been developed, they may be more complex and may increase the risk of LAA injury, incomplete closure, and device dislodgement. Attached Figure Description

[0007] Figures 1A to 1H These are various views of embodiments of the atrial clamping assembly;

[0008] Figure 2A and Figure 2B yes Figures 1A to 1H A perspective view of an embodiment of the first ridge portion of the atrial clamping assembly;

[0009] Figure 3A and Figure 3F yes Figures 1A to 1H Various views of an embodiment of the second arm body of the atrial clamping assembly;

[0010] Figure 4A and Figure 4E yes Figures 1A to 1H Various views of an embodiment of the first arm body of the atrial clamping assembly;

[0011] Figure 5 It is used for joining during surgery. Figures 1A to 1H A perspective view of an embodiment of the atrial clamping assembly introducer device;

[0012] Figure 6 yes Figure 5 A side view of an embodiment of the introducer device (a portion of the housing has been removed for clarity);

[0013] Figure 7 yes Figure 6 Detailed side view;

[0014] Figure 8A and Figure 8D yes Figure 5 Various views of embodiments of the connector component of the introducer device;

[0015] Figures 9A to 11 and Figures 33A to 34B These are various views of embodiments of the atrial clamping assembly;

[0016] Figure 12A and Figure 12B yes Figures 9A to 9C A cross-sectional view of an embodiment of the atrial clamping assembly;

[0017] Figure 13A yes Figures 9A to 9C A partial top view of the hinge portion of an embodiment of an atrial clamping assembly;

[0018] Figure 13B and Figure 13C yes Figure 13A A cross-sectional view of the hinge portion of an embodiment of the atrial clamping assembly;

[0019] Figures 14 to 29 , Figure 31A , Figure 31B , Figures 32A to 32D , Figures 33A to 33D , Figures 34A to 34B and Figures 35A to 35C Various views of other embodiments of the introducer device for the atrial clamping assembly are illustrated;

[0020] Figures 30A to 30M The diagram shows Figures 14 to 29 Various views of embodiments of the flexible connector of the inlet device;

[0021] Figures 36A to 36D These are various views of embodiments of the atrial clamping assembly;

[0022] Figures 37A to 37C Various views of other embodiments of the introducer device for the atrial clamping assembly are illustrated;

[0023] Figures 38A to 43C Various views of embodiments of the first adjustment component and the second adjustment component;

[0024] Figures 44A to 44H Various views of yet another embodiment of the first and second adjustment components; and

[0025] Figure 45A The diagram illustrates the jaw assembly in the closed position;

[0026] Figure 45B The diagram shows the jaw assembly in the open position;

[0027] Figure 45B The diagram shows the jaw assembly in the middle position;

[0028] Figure 46 The diagram illustrates the jaw assembly;

[0029] Figure 47A The jaw assembly is illustrated, with the yoke omitted for clarity;

[0030] Figure 47B The jaw assembly is illustrated, with the yoke and second jaw omitted for clarity;

[0031] Figures 48A to 48G The illustration shows the jaw springs of the jaw assembly in various positions;

[0032] Figure 49A and Figure 49B The illustration shows an atrial clamping assembly that can be releasably connected to the jaw assembly. Detailed Implementation

[0033] like Figures 1A to 1H As illustrated in the diagram, an embodiment of the atrial clamping assembly 10 includes a first arm assembly 12 coupled to a second arm assembly 14. The first arm assembly 12 can be coupled to the second arm assembly 14 in any suitable manner, such as pivotally coupled to the second arm assembly 14, and in some embodiments, pivotally and displaceably coupled to the second arm assembly 14. The atrial clamping assembly 10 can be configured for application to the left atrial appendage (“LAA”) of a human heart, and a portion of the LAA can be positioned between the first arm assembly 12 and the second arm assembly 14, and one or more portions of a suture can be coupled to each of the first arm assembly 12 and the second arm assembly 14 to secure the first arm assembly 12 and the second arm assembly 14 in the position of the contracted portion of the LAA.

[0034] The first arm assembly 12 may include... Figures 4A to 4E The first arm body 16 is illustrated in the figure. The first arm body 16 may be elongated and may extend along a first arm body axis 22 from a first end 18 to a second end 20. The first arm body 16 may also include a first support portion 24 extending along the first arm body axis 22 from a first end 26 to a second end 28, and the first support portion 24 may extend from the second end 20 toward the first end 18, such that the first end 26 is positioned 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 (e.g., a cross-sectional shape) in whole or in part along the first arm body axis 22. A plurality of protrusions 30 may extend from the engagement surface 32 (e.g., the bottom surface) of the first support portion 24.

[0035] The first arm body 16 may further include a first connector portion 34 disposed at a first end 18 of the first arm body 16, and the first connector portion 34 may extend along a first connector axis 36 which may be disposed at an angle between 30° and 90° with the axis 22 of the first arm body. The first connector portion 34 may be planar or substantially planar, and may be defined by a first lateral surface 42 and a second lateral surface 44, and each of the surfaces 42, 44 may be parallel to... Figure 4A The XZ plane of the reference coordinate system. An elongated slot 40 can be formed through the first lateral surface 42 and the second lateral surface 44 of the first connector portion 34 and can extend along the first connector axis 36. A portion 38 of the first connector portion 34 can be coupled to the first end 26 of the first support portion 24. A first notch edge portion 46 can extend along a portion of the first support portion 24 from the first end 26 to the second end 28, and when along... Figure 4A and Figure 4B When viewed along the Y-axis of the reference coordinate system, the first notch edge portion 46 can have a concave, arc-shaped, or semi-circular shape. The second notch edge portion 48 can extend along a portion of the first support portion 24 from the second end 28 toward the first end 26, and when along... Figure 4A and Figure 4B When viewed along the Y-axis of a reference coordinate system, the second notch edge portion 48 may have a concave, semi-concave, or semi-circular shape. A support flange 74 may be disposed along all or part of portion 38, and the support flange may extend from a lateral edge or lateral surface of the first support portion 24. The upper surface of the support flange 74 may include a channel configured to support sutures for securing the atrial clamp assembly 10 in a closed position or to one or more portions of the introducer device 200. A portion 38 of the first connector portion 34 may be coupled to the first end 26 of the first support portion 24 in any suitable manner, and the first connector portion 34 and the first support portion 24 may be integrally formed as a single integral part. The first arm body 16 may be injection molded as a single part and may be made of or comprise plastic materials (e.g., ABS or nylon).

[0036] like Figure 1FAs illustrated in the cross-sectional view, the first arm assembly 12 may further include a first ridge 50 extending wholly or partially along a first support portion 24 of the first arm body 16. The first ridge 50 may be elongated and may extend from a first end 52 to a second end 54 along a first ridge axis 56 that may be aligned with the axis 22 of the first arm body. The first end 52 may be located at or adjacent to (e.g., slightly offset from) the first end 26 of the first support portion 24, and the second end 54 may be located at or adjacent to (e.g., slightly offset from) the second end 28 of the first support portion 24. The first ridge 50 may have any suitable cross-sectional shape or combination of shapes. For example, as shown in... Figure 2A As illustrated, the first ridge portion 50 may have an outer cylindrical surface 61 that is uniform or substantially uniform from the first end portion 52 (or from a point adjacent to the first end portion 52) to the second end portion 54 (or to a point adjacent to the second end portion 54). The first ridge portion 50 may have a first hole 58 adjacent to the first end portion 52, and the first hole 58 may extend along an axis perpendicular to the first ridge axis 56. The first ridge portion 50 may also have a second hole 60 adjacent to the second end portion 54, and the second hole 60 may extend along an axis perpendicular to the first ridge axis 56.

[0037] The first ridge portion 50 may be made of or constructed from a material harder than the first arm body 16, and the first ridge portion 50 may be made of or comprise a metallic material, such as titanium, steel, or aluminum. The first ridge portion 50 may be co-molded with the first arm body 16 in any suitable manner. For example, the first ridge portion 50 may be placed in a mold for forming the first arm body 16, and portions of the first arm body 16 may be formed around the first ridge portion 50. Therefore, a first arm hole 62 may be formed on the surface of a first notch edge portion 46 that at least partially defines the first support portion 24 (e.g., at or near the first end 26 in the first support portion 24), and the first arm hole 62 may be aligned with a first hole 58 of the first ridge portion 50. Furthermore, a second arm hole 64 may be formed on the surface of a second notch edge portion 48 that at least partially defines the first support portion 24 (e.g., at or near the second end 28 in the first support portion 24), and the second arm hole 64 may be aligned with a second hole 60 of the first ridge portion 50.

[0038] In some embodiments of the atrial clamping assembly 10, the first arm assembly 12 may further include one or more portions of a suture 66, which may be wrapped around the outer surface 61 of the first ridge portion 50 before the first support portion 24 is molded over the first ridge portion 50, such that the one or more portions of the suture 66 disposed within the first support portion 24 are prevented from shifting relative to the first support portion 24 and are anchored by the first support portion 24. The one or more portions of the suture 66 may be wrapped around the outer surface 61 of the first ridge portion 50 in any suitable manner, and the one or more portions of the suture 66 may be wrapped around the outer surface 61 of the first ridge portion 50 in a helical manner, for example, as... Figure 2B As illustrated in the diagram. After molding, the first end 68 of one or more portions of the suture 66 may extend through all or part of the first arm hole 62 of the first support portion 24 and the first hole 58 of the first ridge portion 50. Furthermore, after molding, the second end 70 of one or more portions of the suture 66 may extend through all or part of the second arm hole 64 of the first support portion 24 and the second hole 60 of the first ridge portion 50. One or more portions of the suture 66 may be any material or combination of materials capable of securing (or engaging to secure) the first arm assembly 12 to the second arm assembly 14, as will be described in more detail below. Therefore, one or more portions of the suture 66 may be, for example, any suture thread, wire, cord, fabric, or cable.

[0039] like Figure 1F As shown in the diagram, the atrial clamping assembly 10 also includes a second arm assembly 14. The second arm assembly 14 may include... Figures 3A to 3FThe second arm body 116 is illustrated in the figure. The second arm body 116 may be elongated and may extend along the second arm body axis 122 from a first end 118 to a second end 120. The second arm assembly 14 may also include a second support portion 124 extending along the second arm body axis 122 from a first end 126 to a second end 128, and the second support portion 124 may extend from the second end 120 toward the first end 118, such that the first end 126 is positioned offset from the first end 118 of the second arm body 116. The second support portion 124 may have a rectangular or substantially rectangular shape (e.g., a cross-sectional shape) wholly or partially along the second arm body axis 122. A plurality of protrusions 130 may extend from the engagement surface 132 (e.g., a top surface) of the second support portion 124. When the first arm assembly 12 and the second arm assembly 14 are in the engaged position (or when the atrial clamping assembly 10 is in the engaged position), the engagement surface 132 of the second support portion 124 may be configured to face (i.e., be opposite to) the engagement surface 32 of the first support portion 24. Therefore, one or more of the plurality of protrusions 30 of the first arm assembly 12 and one or more of the plurality of protrusions 130 of the second arm assembly 14 are configured to engage portions of the LAA to ensure a tight grip on the LAA.

[0040] The second arm body 116 may further include a second connector portion 134 disposed at a first end 118 of the second arm body 116, and the second connector portion 134 may include a first tab 135 and a second tab 136, each of the first tab 135 and the second tab 136 being planar (parallel to) Figure 3D The reference coordinate system (XZ plane) is offset from the second arm body axis 122 to create a gap. The first tab 135 and the second tab 136 are configured to receive the first lateral surface 42 and the second lateral surface 44 of the first connector portion 34 in the gap created by the first tab 135 and the second tab 136. The axis hole 137 can pass through a portion of the first tab 135 and the second tab 136. The atrial clamping assembly 10 may include a cylindrical axle 139 extending through the axis hole 137, and the cylindrical axle 139 can be received within a slot 40 of the first arm assembly 12 such that the first arm assembly 12 can pivot relative to the second arm assembly 14 about the cylindrical axle 139 (and vice versa). Furthermore, the cylindrical axle 139 may have a diameter slightly smaller than the width of the slot 40, allowing the cylindrical axle 139 to linearly displace within the slot 40 along the first connector axis 36 to allow the first arm assembly 12 to displace relative to the second arm assembly 14 (and vice versa), while maintaining pivoting capability. When applied to a LAA, this displacement allows the first arm assembly 12 and the second arm assembly 14 to maintain a parallel relationship in order to maintain uniform pressure on the clamped portion across the LAA.

[0041] A portion 138 of the second connector portion 134 can be connected to the first end 126 of the second support portion 124. A first notch edge portion 146 can extend along a portion of the second support portion 124 from the first end 126 toward the second end 128, and when along... Figure 3D and Figure 3E When viewed along the Y-axis of the reference coordinate system, the first notch edge portion 146 can have a concave, arc-shaped, or semi-circular shape. The second notch edge portion 148 can extend along a portion of the second support portion 124 from the second end 128 toward the first end 126, and when along... Figure 3D and Figure 3E When viewed along the Y-axis of a reference coordinate system, the second notch edge portion 148 may have a concave, semi-concave, or semi-circular shape. A support flange 174 may be disposed along all or part of portion 138, and the support flange 174 may extend from a lateral edge or lateral surface of the second support portion 124. The lower surface of the support flange 174 may include a channel configured to support sutures for securing the atrial clamp assembly 10 in a closed position or to one or more portions of the introducer device 200. A portion 138 of the second connector portion 134 may be coupled to the first end 126 of the second support portion 124 in any suitable manner, and the second connector portion 134 and the second support portion 124 may be integrally formed as a single integral part. The second arm body 116 may be injection molded as a single part and may be made of or comprise plastic materials (e.g., ABS or nylon).

[0042] like Figure 1F As illustrated in the cross-sectional view, the second arm assembly 14 may further include a second ridge portion 150 extending wholly or partially along the second support portion 124 of the second arm body 116. The second ridge portion 150 may be connected to the first ridge portion (…). Figure 2A (As shown in the diagram) It may be elongated and may extend from the first end 152 to the second end 154 along a second ridge axis 156 aligned with the axis 122 of the second arm body. The first end 152 may be located at or adjacent to (e.g., slightly offset from) the first end 126 of the second support portion 124, and the second end 154 may be located at or adjacent to (e.g., slightly offset from) the second end 128 of the second support portion 124. The second ridge portion 150 may have a first hole 158 adjacent to the first end 152, and the first hole 158 may extend along an axis perpendicular to the second ridge axis 156. The second ridge portion 150 may also have a second hole 160 adjacent to the second end 154, and the second hole 160 may extend along an axis perpendicular to the second ridge axis 156.

[0043] Similar to or identical to the first ridge portion 50, the second ridge portion 150 can be co-molded with the second arm body 116 in any suitable manner. For example, the second ridge portion 150 can be placed in a mold for forming the second arm body 116, and a portion of the second arm body 116 can be formed around the second ridge portion 150. Therefore, a first arm hole 162 can be formed on the surface of the first notch edge portion 146 that at least partially defines the second support portion 124 (e.g., at or near the first end 126 in the second support portion 124), and the first arm hole 162 can be aligned with the first hole 158 of the second ridge portion 150. Furthermore, a second arm hole 164 can be formed on the surface of the second notch edge portion 148 that at least partially defines the second support portion 124 (e.g., at or near the second end 128 in the second support portion 124), and the second arm hole 164 can be aligned with the second hole 160 of the second ridge portion 150.

[0044] In some embodiments of the atrial clamping assembly 10, the second arm assembly 14 may further include one or more portions of a suture 166 that may be wrapped around the outer surface 161 of the second ridge portion 150 before the second support portion 124 is molded over the second ridge portion 150, and one or more portions of the suture 166 wrapped around the outer surface 161 of the second ridge portion 150 may be configured in the same manner as one or more portions of the suture 66 previously discussed wrapped around the outer surface 61 of the first ridge portion 50. After molding, a first end 168 of one or more portions of the suture 166 may extend through all or part of the first arm hole 162 of the second support portion 124 and the first hole 158 of the second ridge portion 150. Furthermore, after molding, a second end 170 of one or more portions of the suture 166 may extend through all or part of the second arm hole 164 of the second support portion 124 and the second hole 160 of the second ridge portion 150.

[0045] When the first arm assembly 12 and the second arm assembly 14 are applied to the LAA (e.g., by using the introducer 200, which will be discussed in more detail below), and when the first arm assembly 12 and the second arm assembly 14 are in the engagement position at the portion engaging the LAA (or when the atrial clamping assembly 10 is in the engagement position), the first arm assembly 12 and the second arm assembly 14 can be secured together in any suitable manner to apply uniform pressure across the portion of the LAA to isolate the interior of the LAA. In some embodiments, a first end 68 of one or more portions of the suture 66 of the first arm assembly 12 can be secured to a first end 168 of one or more portions of the suture 166 of the second arm assembly 14. Alternatively or additionally, a second end 70 of one or more portions of the suture 66 of the first arm assembly 12 can be secured to a second end 170 of one or more portions of the suture 166 of the second arm assembly 14. For example, as Figures 1A to 1C As illustrated in the embodiments, a first pressable sleeve 80a (illustrated in an unpressed configuration for clarity) can be used to secure the first end 68 and the first end 168, and / or a second pressable sleeve 80b (illustrated in an unpressed configuration for clarity) can be used to secure the second end 70 and the second end 170. The pressable sleeves 80a and 80b can be COR- manufactured by LSISolutions, Inc. Or COR-KNOT The equipment is crimped or fixed to secure both the first ends 68, 168 and the second ends 70, 170 within the crimping sleeve (not shown).

[0046] The first notch edge portion 46 of the first arm assembly 12 and the first notch edge portion 146 of the second arm assembly 14 can cooperate to provide suitable space or clearance for the cylindrical first pressable sleeve 80a, so that the first pressable sleeve 80a does not contact the first arm assembly 12 and the second arm assembly 14 or interfere with the desired positioning of the first arm assembly 12 and the second arm assembly 14 when in the engaged position. Similarly, the second notch edge portion 48 of the first arm assembly 12 and the second notch edge portion 148 of the second arm assembly 14 can cooperate to provide suitable space or clearance for the cylindrical second pressable sleeve 80b, so that the second pressable sleeve 80b does not contact the first arm assembly 12 and the second arm assembly 14 or interfere with the desired positioning of the first arm assembly 12 and the second arm assembly 14 when in the engaged position.

[0047] like Figures 9A to 9C and Figures 36A to 36D The diagram illustrates another embodiment of the atrial clamping assembly 300 that is similar to the atrial clamping assembly 10, except for the movable hinge connector. Specific features of the atrial clamping assembly 300 that are similar to or identical to those of the atrial clamping assembly 10 will share the same reference numerals. Specifically, as shown... Figure 9Aand Figure 36A As illustrated in the diagram, the first arm assembly 302 of the atrial clamping assembly 300 may include a first arm body 16 extending from a first end 18 to a second end 20 along a first arm body axis 22, and the first arm body 16 may include a first support portion 24 extending from a first end 26 to a second end 28 along the first arm body axis 22. In this embodiment, the first arm body 16 and the first support portion 24 may be identical or extend together, such that the first end 18 of the first arm body 16 corresponds to the first end 26 of the first support portion 24, and the second end 20 of the first arm body 16 corresponds to the second end 28 of the first support portion 24. However, similar to the atrial clamping assembly 300, the first end 26 of the first support portion 24 may extend from the first end 18 of the first arm body 16 (along the first end 18) to the second end 28 of the first support portion 24. Figure 9A The X-axis of the reference coordinate system is offset. The first notch edge portion 46 may extend along a portion of the first support portion 24 from a point at the first end 26 or a point adjacent to the first end 26 toward the second end 28, and when along... Figure 9A When viewed along the Y-axis of the reference coordinate system, the edge portion 46 of the first notch can have a concave, arc, or semi-circular shape.

[0048] Furthermore, the second arm assembly 304 of the atrial clamping assembly 300 may include a second arm body 116 extending from a first end 118 to a second end 120 along the second arm body axis 122, and the second arm assembly 304 may include a second support portion 124 extending from a first end 126 to a second end 128 along the second arm body axis 122. In this embodiment, the second arm body 116 and the second support portion 124 may be identical or extend together, such that the first end 118 of the second arm body 116 corresponds to the first end 126 of the second support portion 124, and the second end 120 of the second arm body 116 corresponds to the second end 128 of the second support portion 124. However, similar to the atrial clamping assembly 300, the second end 126 of the first support portion 124 may extend from the second end 118 of the first arm body 116 (along the second end 128 of the second support portion 124). Figure 9A The X-axis of the reference coordinate system is offset. The first notch edge portion 146 may extend along a portion of the second support portion 124 from a point at or near the first end 126 toward the second end 128, and when along... Figure 9A When viewed along the Y-axis of the reference coordinate system, the edge portion 146 of the first notch can have a concave, arc, or semi-circular shape.

[0049] refer to Figure 9A , Figure 10 , Figure 11 , Figure 36A and Figure 36CThe atrial clamping assembly 300 may also have a hinge portion 306 connecting the first arm assembly 302 and the second arm assembly 304, and the hinge portion 306 extends from a first end 18 of the first arm body 16 of the first arm assembly 302 to a first end 118 of the second arm body 116 of the second arm assembly 304. The hinge portion 306 may be a "movable hinge" and may be 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, such that 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 are a single integral part, and this part may be manufactured or made as an injection-molded plastic assembly. The hinge portion 306 may be flexible and may be configured to bend or surround a space parallel to the... Figure 9A The pivot axis 309 of the Y-axis of the reference coordinate system (see Figure 9C Rotation. In some embodiments, the hinge portion 306 may have one or more features configured to prevent the hinge portion 306 from rotating about any axis not parallel to the Y-axis.

[0050] refer to Figure 13A ,Should Figure 13A This is a top view of a hinge portion 306 in a linear "flat" configuration that may be used to manufacture an atrial clamping assembly 300. The hinge portion 306 may include a hinge portion that can extend from a first end 18 of the first arm body 16 along a path that may be parallel to... Figure 13A The base axis 326 of the reference coordinate system's X-axis extends to the base assembly 308 of the first end 118 of the second arm body 116. The base assembly 308 may be at least partially composed of a top surface 310 and a bottom surface 312 (in... Figure 13B As illustrated in the cross-sectional view, the top surface 310 and the bottom surface 312 can each be planar or substantially planar and can be parallel to... Figure 13A The XY plane of the reference coordinate system.

[0051] The hinge portion 306 may further include a first support protrusion 314a and a second support protrusion 314b, each extending upward from the top surface 310, and the first support protrusion 314a and the second support protrusion 314b may be aligned along a reference plane 313 and are symmetrically arranged about the reference plane 313, which may be parallel to... Figure 13A and Figure 13B The YZ plane of the reference coordinate system. The inner side wall 316a of the first support protrusion 314a and the inner side wall 316b of the second support protrusion 314b can each be parallel to (or substantially parallel to) the reference coordinate system. Figure 13A and Figure 13BThe XZ plane of the reference coordinate system is set so that the inner sidewalls 316a and 316b are defined along... Figure 9A The center gap of the Y-axis of the reference coordinate system is set to 318.

[0052] The hinge portion 306 may further include a first engagement protrusion 320 that extends upward from the top surface 310 of the base member 308 and may extend laterally from a first lateral edge 322 of the base member 308 along (or substantially along) an axis perpendicular to the base axis 326 to a second lateral edge 324 of the base member 308. The top surface 328 of the first engagement protrusion 320 may be parallel to the top surface 310 of the base member 308, and the top surface 328 may be aligned or substantially aligned with the top surfaces 330a, 330b of one or both of the first support protrusion 314a and the second support protrusion 314b. The first inner tab 332 may extend from a first portion of the top of the first engaging protrusion 320 along the base axis 326 toward the central gap 318, and the first inner tab 332 may have a width less than (or slightly less than) the distance between the inner sidewalls 316a, 316b defining the central gap 318 (parallel to) Figure 13A (The Y-axis of the reference coordinate system). Therefore, when the atrial clamping assembly 300 is in Figure 9A In the engaged (closed) position illustrated in the diagram, all or part of the first inner tab 332 is disposed within the first portion of the central gap 318 defined between the inner walls 316a and 316b. When the atrial clamping assembly 300 is in the... Figures 33A to 33D In the disengaged (open) position illustrated in the diagram, the first inner tab 332 may be disposed outside the central gap 318 defined between the inner walls 316a and 316b. However, in some embodiments, the first inner tab 332 may extend toward the central gap 318 a sufficient distance such that, in the disengaged or partially disengaged position, a portion of the first inner tab 332 may be disposed within a first portion of the central gap 318 defined between the inner walls 316a and 316b.

[0053] Refer again Figure 13A The first lateral wall 336a and the second lateral wall 336b may be formed at the first end 18 of the first arm body 16 or in the first end protrusion 340 extending from the first end 18 of the first arm body 16, and the first lateral wall 336a and the second lateral wall 336b may at least partially define the first end recess 338 provided in the first end protrusion 340. The first lateral wall 336a and the second lateral wall 336b may be symmetrically arranged about the base axis 326 and aligned with the corresponding inner lateral walls 316a, 316b defining the center gap 318, such that the first end recess 338 is aligned with the center gap 318.

[0054] The first external protrusion 334 may extend from the second portion of the top of the first engaging protrusion 320 along the base axis 326 toward the first end recess 338, and the first external protrusion 334 may have a width (parallel to) the distance between the first lateral wall 336a and the second lateral wall 336b defining the first end recess 338. Figure 13A (The Y-axis of the reference coordinate system). Therefore, when the atrial clamping assembly 300 is in Figure 9A In the engaged (closed) position illustrated in the diagram, all or part of the first outer protrusion 334 is disposed within the first end recess 338 defined between the first lateral wall 336a and the second lateral wall 336b. When the atrial clamping assembly 300 is in the... Figures 33A to 33D In the disengaged (open) position illustrated in the diagram, the first outer protrusion 334 may be disposed outside the first end recess 338 defined between the first lateral wall 336a and the second lateral wall 336b. However, in some embodiments, the first outer protrusion 334 may extend toward the first end recess 338 a sufficient distance such that, in the disengaged or partially disengaged position, a portion of the first outer protrusion 334 may be disposed within the portion defined between the first lateral wall 336a and the second lateral wall 336b of the first end recess 338.

[0055] The hinge portion 306 may further include a second engagement protrusion 342, which may be identical or substantially identical to the first engagement protrusion 320 and is symmetrically disposed about the reference plane 313 from the first engagement protrusion 320. Specifically, the second engagement protrusion 342 may extend upward from the top surface 310 of the base member 308 and may extend laterally from the first lateral edge 322 of the base member 308 along (or substantially along) an axis perpendicular to the base axis 326 to the second lateral edge 324 of the base member 308. The top surface 344 of the second engagement protrusion 342 may be parallel to the top surface 310 of the base member 308, and the top surface 342 may be aligned or substantially aligned with the top surfaces 330a, 330b of one or both of the first support protrusion 314a and the second support protrusion 314b. The second inner tab 346 may extend from the first portion of the top of the second engaging protrusion 342 along the base axis 326 toward the central gap 318, and the second inner tab 346 may have a width less than (or slightly less than) the distance between the inner sidewalls 316a, 316b defining the central gap 318 (parallel to) Figure 13A (The Y-axis of the reference coordinate system). Therefore, when the atrial clamping assembly 300 is in Figure 9AIn the engaged (closed) position illustrated in the diagram, all or part of the second inner tab 346 is disposed within the second portion of the central gap 318 defined between the inner walls 316a and 316b. When the atrial clamping assembly 300 is in the... Figures 33A to 33D In the disengaged (open) position illustrated in the diagram, the second inner tab 346 may be disposed outside a portion of the central gap 318 defined between the inner walls 316a and 316b. However, in some embodiments, the second inner tab 346 may extend toward the central gap 318 a sufficient distance such that, in the disengaged or partially disengaged position, a portion of the second inner tab 346 may be disposed within a second portion of the central gap 318 defined between the inner walls 316a and 316b.

[0056] Refer again Figure 13A The first lateral wall 350a and the second lateral wall 350b may be formed at the first end 118 of the second arm body 116 or in the second end protrusion 348 extending from the first end 118 of the second arm body 116, and the first lateral wall 350a and the second lateral wall 350b may at least partially define the second end recess 352 provided in the second end protrusion 348. The first lateral wall 350a and the second lateral wall 350b may be symmetrically arranged about the base axis 326 and aligned with the corresponding inner lateral walls 316a, 316b defining the center gap 318, such that the second end recess 352 is aligned with the center gap 318.

[0057] The second outer protrusion 354 can extend from the second portion of the top of the second engaging protrusion 342 along the base axis 326 toward the second end recess 352, and the second outer protrusion 354 can have a width (parallel to) the distance between the first lateral wall 350a and the second lateral wall 350b defining the second end recess 352. Figure 13A (The Y-axis of the reference coordinate system). Therefore, when the atrial clamping assembly 300 is in Figure 9A In the engaged (closed) position illustrated in the diagram, all or part of the second outer protrusion 354 is disposed within all or part of the second end recess 352 defined between the first lateral wall 350a and the second lateral wall 350b. When the atrial clamping assembly 300 is in the... Figures 33A to 33D In the disengaged (open) position illustrated in the diagram, the second outer protrusion 354 may be disposed outside the second end recess 352 defined between the first lateral wall 350a and the second lateral wall 350b. However, in some embodiments, the second outer protrusion 354 may extend toward the second end recess 352 a sufficient distance such that, in the disengaged or partially disengaged position, a portion of the second outer protrusion 354 may be disposed within a portion of the second end recess 352 defined between the first lateral wall 350a and the second lateral wall 350b.

[0058] As previously stated, the hinge portion 306 can be flexible and can be configured to bend or rotate about the pivot axis 309 (see above). Figure 9C When the atrial clamping assembly 300 is from Figures 33A to 33D The detachment position shown in the diagram has been shifted to Figure 9A In the engagement position illustrated in the diagram, all or part of the first inner tab 332 of the first engagement protrusion 320 is disposed within the first portion of the central gap 318, and all or part of the first outer tab 334 of the first engagement protrusion 320 is disposed within the first end recess 338 of the first end protrusion 340. Furthermore, all or part of the second inner tab 346 of the second engagement protrusion 342 is disposed within the second portion of the central gap 318, and all or part of the second outer tab 354 of the second engagement protrusion 342 is disposed within the second end recess 352 of the second end protrusion 348. Therefore, the interaction between the tabs and recesses 338, 352 within the central gap 318 maintains the first arm assembly 302 and the second arm assembly 304 relative to each other. Figure 13A and Figure 13B The alignment of the XZ plane of the reference coordinate system allows the atrial clamping assembly 300 to be positioned only relative to the plane parallel to the reference coordinate system. Figure 9A The pivot axis 309 of the Y-axis of the reference coordinate system pivots, thereby eliminating the parallel to Figure 9A The torsional or twisting force or other torsional or twisting force around the X-axis of the reference coordinate system.

[0059] like Figures 35A to 35C As illustrated in the diagram, the atrial clamping assemblies 10, 300 may at least partially cover the sheath 444. The sheath 444 may cover all, part, or two or more portions of the atrial clamping assemblies 10, 300. For example, the sheath 444 may cover (and / or surround) all or part of the first arm assembly 302, and the sheath 444 (or a separate sheath 444) may cover (and / or surround) all or part of the second arm assembly 304. In one embodiment, the sheath 444 may be a tube that receives or completely covers the first arm assembly 302, the hinge portion 306, and the second arm assembly 304. The sheath 444 may be made of a material that facilitates attachment or connection to patient tissue, such as a cloth material, a synthetic material, a mesh material, or a combination of such materials, or any other suitable material.

[0060] When the first arm assembly 302 and the second arm assembly 304 are applied to the LAA (e.g., by using the introducer 200, which will be discussed in more detail below), and when the first arm assembly 302 and the second arm assembly 304 are in the engaged position (or when the atrial clamping assembly 300 is in the engaged position), engaging portions of the LAA, the first arm assembly 302 and the second arm assembly 304 can be secured together in any suitable manner to apply uniform pressure across portions of the LAA to isolate the interior of the LAA. Like the atrial clamping assembly 10, the atrial clamping assembly 300 may include one or more portions of suture 66 that may be wound, for example, spirally around the outer surface 61 of the first ridge portion 50, and one or more portions of suture 166 that may be wound, for example, spirally around the outer surface 161 of the second ridge portion 150. In such embodiments, a first end 68 of one or more portions of suture 66 of the first arm assembly 302 may be secured to a first end 168 of one or more portions of suture 166 of the second arm assembly 304. Alternatively or additionally, the second end 70 of one or more portions of the suture 66 of the first arm assembly 302 may be secured to the second end 170 of one or more portions of the suture 166 of the second arm assembly 304. For example, as Figures 1A to 1C (as well as Figure 34A and Figure 35B As illustrated in the embodiment, a first pressable sleeve 80a (illustrated in an unpressed configuration for clarity) can be used to secure the first end 68 and the first end 168, and / or a second pressable sleeve 80b (illustrated in an unpressed configuration for clarity) can be used to secure the second end 70 and the second end 170. Figure 9A , Figure 12A , Figure 12B , Figure 33D , Figure 34B , Figure 35C , Figure 36A and Figure 36B For clarity, one or more portions of the suture 66 of the first ridge portion 50 and one or more portions of the suture 166 of the second ridge portion 150 are omitted. Furthermore, in some embodiments of the atrial clamping assemblies 10, 300, one or more portions of the suture 66 of the first ridge portion 50 and / or one or more portions of the suture 166 of the second ridge portion 150 may be omitted, and alternatively, any method of securing the first arm assemblies 12, 302 and the second arm assemblies 14, 304 may be used.

[0061] refer to Figure 5The introducer device 200 can be used to position the atrial clamping assemblies 10, 300 around or adjacent to the LAA, and to secure the atrial clamping assemblies 10, 300 to a portion of the LAA. The introducer device 200 may include a housing portion 202 having a gripping portion 204 adapted for gripping by a user to engage the actuating rod 206 and to move the actuating rod 206 from a first rod position (…). Figure 5 (As shown in the middle diagram) It is moved to the second lever position (not shown, but pivoted by the user toward the gripping part 204). The actuating lever 206 can be indirectly connected to the atrial clamping assemblies 10, 300, such that when the actuating lever 206 is in the first lever position, the atrial clamping assemblies 10, 300 are in the open position. Figure 8D (See diagram). When the atrial clamping assemblies 10, 300 are positioned in the desired location (such as adjacent to the LAA), the actuating rod 206 pivots from the first rod position to the atrial clamping assemblies 10, 300 moving to the engagement position. Figure 5 The position of the second rod (as shown in the diagram). (Reference) Figure 7 (For clarity, portions of housing portion 202 are omitted.) A first portion of the actuating rod 206 can be rotatably coupled to housing portion 202 at a first portion (e.g., a pivot point) such that the actuating rod 206 pivots about the pivot point between a first rod position and a second rod position. The actuating rod 206 can pivot about a pivot axis that extends through the pivot point and is perpendicular to the shaft axis 208 extending along the shaft 210 coupled to housing portion 202. In particular, the first portion of the actuating rod 206 can be a pair of aligned bosses received in corresponding cylindrical inner walls formed on corresponding inner portions of housing portion 202 at the pivot point. Figure 7 As shown, when the actuator 206 is in the first lever position, a portion 212 of the actuator 206 can contact a portion 214 of the housing portion 202 to prevent the actuator 206 from extending excessively beyond the first lever position. A first end of the spring 216 can be connected to a portion of the actuator 206, and a second end of the spring 216 can be connected to a portion of the interior portion of the housing portion 202, such that the actuator 206 is biased to the first lever position by the spring 216.

[0062] refer to Figure 7The introducer device 200 may include a selective locking mechanism 226 to maintain or lock the position of the atrial clamping assembly 10 in a desired position by manipulating an actuating lever 206. For example, a user may engage the selective locking mechanism 226 by pivoting the actuating lever 206 toward the housing portion 202 to a designated position where the selective locking mechanism 226 is engaged in a locked position, in which the first arm assembly 12 and the second arm assembly 14 of the atrial clamping assembly 10 are maintained or locked in a closed position. Further pivoting of the actuating lever 206 toward the housing portion 202 disengages the selective locking mechanism 226, 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 mechanisms described in U.S. Patent Application No. 18 / 107,392, filed February 8, 2023, and U.S. Provisional Patent Application No. 63 / 308,271, filed February 9, 2022, the entire contents of each of which are incorporated herein by reference.

[0063] refer to Figure 6 The introducer device 200 includes a shaft 210 extending from a proximal end 218 along a shaft axis 208 to a distal end 220, and the shaft axis 208 may be linear. One or more portions of the shaft 210 may be coupled to a second portion of the housing portion 202 such that the shaft 210 can be fixed relative to the housing portion 202. However, one or more portions of the shaft 210 may be rotatably coupled to the second portion of the housing portion 202 such that the shaft 210 rotates relative to the housing portion 202 about the shaft axis 208. The shaft 210 may be rigid, but in other embodiments, the shaft 210 may be flexible or may have one or more flexible portions.

[0064] Shaft 210 or one or more portions thereof may have the overall shape of an elongated hollow tube having an internal surface 222 defining an internal portion 224 extending from a proximal end 218 to a distal end 220 of shaft 210. Figure 7 (See diagram). Shaft 210 and inner surface 222 can have any suitable cross-sectional shape or combination of shapes perpendicular to shaft axis 208. For example, when viewed perpendicular to shaft axis 208, shaft 210 can have an overall shape of an elongated cylinder, and inner surface 222 can have a circular cross-sectional shape.

[0065] The introducer device 200 also includes a connector assembly 228 disposed on or coupled to the distal end 220 of the shaft 210. The connector assembly 228 is configured to be releasably coupled to the atrial clamping assembly 10, 300 to allow the atrial clamping assembly 10 to be properly positioned on the LAA and to move the atrial clamping assembly 10 from the open position ( Figure 8D(As shown in the middle diagram) Shift to the joint position ( Figure 5 (See diagram). The connector assembly 228 includes a hub portion 229 fixedly coupled to the distal end 220 of the shaft 210, and the hub portion 229 may include a yoke portion 230, and a bore may extend through the hub portion 229 along the shaft axis 208, as shown. Figure 8C The figure is illustrated in a cross-sectional view. The connector assembly 228 also includes a first rotating assembly 232 rotatably coupled to the hub portion 229. Specifically, the first rotating assembly 232 includes a base portion 234 disposed within and rotatably coupled to the yoke portion 230 of the hub portion 229, such that the base portion 234 (and the entire first rotating assembly 232) about a direction perpendicular to the axis 208 and parallel to... Figure 8A and Figure 8D The reference coordinate system rotates along axis 236 of the Z-axis. The yoke portion 238 is connected to the base portion 234 away from the base portion 234. For example, a pin (not shown) can be disposed from a first portion of the yoke portion 230 of the hub portion 229 to a second portion of the yoke portion 230 of the hub portion 229, and the pin can extend through a hole passing through the base portion 234, and the pin can extend along axis 236. Figure 8C As illustrated in the cross-sectional view, the hole can extend through the first rotating assembly 232 along the longitudinal axis of the first rotating assembly 232.

[0066] The connector assembly 228 further includes a second rotating assembly 240 rotatably coupled to the first rotating assembly 232. Specifically, the second rotating assembly 240 includes a base portion 242 disposed within and rotatably coupled to the yoke portion 238 of the first rotating assembly 232, such that the base portion 242 (and the entire second rotating assembly 240) rotates about an axis 244 perpendicular to the axis 208 and the axis 236 of the first rotating assembly 232, and this axis can be positioned... Figure 8A and Figure 8D In the XY plane of the reference coordinate system. For example, a pin (not shown) can be disposed from a first portion of the yoke portion 238 of the first rotating assembly 232 to a second portion of the yoke portion 238 of the first rotating assembly 232, and the pin can extend through a hole passing through the base portion 242 of the second rotating assembly 240, and the pin can extend along axis 244. Figure 8C As illustrated in the cross-sectional view, the hole can extend through the second rotating assembly 240 along the longitudinal axis of the second rotating assembly 240.

[0067] The atrial clamping assemblies 10, 300 can be removably coupled to the second rotating assembly 240 in any suitable manner to allow the atrial clamping assembly 10 to shift from an open position to an engaged (closed) position when the actuating rod 206 pivots from a first rod position to a second rod position. For example, the atrial clamping assemblies 10, 300 can be removably coupled to the yoke portion 246 of the second rotating assembly 240. In particular, one or more portions of the first connector portion 34 of the first arm assembly 12 and / or one or more portions of the second connector portion 134 of the second arm assembly 14 can be coupled to the yoke portion 246 of the second rotating assembly 240, and the first arm assembly 12 and the second arm assembly 14 can initially be in the position... Figure 8D The first open position. The first arm assembly 12 and / or the second arm assembly 14 can be coupled to the yoke portion 246 using one or more portions of a suture, and one or more portions of the suture can extend through holes in the hub portion 229, the first rotating assembly 232, the second rotating assembly 240, and the inner portion 224 of the shaft 210 to engage with the actuating rod 206, such that tension in one or more portions of the suture displaces the actuating rod 206 from the first rod position to the second rod position, closing the atrial clamping assembly 10 or displacing the atrial clamping assembly 10 from the open position to the closed position. One or more portions of the suture can also extend through one or more holes formed in the first connector portion 34 of the first arm assembly 12 and / or the second connector portion 134 of the second arm assembly 14, such as hole 175 formed in a portion of the second connector portion 134 of the second arm assembly 14, as Figure 1C As shown in the diagram. When the atrial clamping assembly 10 is in the closed position, one or more portions of the suture can be cut to remove it from the atrial clamping assembly 10 via a slot in the shaft 210.

[0068] The position of the atrial clamping assembly 10 relative to the shaft 210 can be adjusted using the connector assembly 228. Specifically, the first rotating assembly 232 can be coupled to the first adjusting portion 248 to rotatably displace the first rotating assembly 232 relative to the hub portion 229. In some embodiments, the first adjusting portion 248 can be an adjusting wheel 250 rotatably coupled to an inner portion of the housing portion 202, and a spring can bias the adjusting wheel 250 into frictional engagement with a portion of the housing portion 202 to prevent undesirable rotation of the adjusting wheel 250. A portion of the adjusting wheel 250 can extend into a slot 252 formed in a portion of the housing portion 202 to allow a user to rotate the adjusting wheel 250. One or more portions of the suture (not shown) can be coupled to the adjusting wheel 250 and the base portion 234 of the first rotating assembly 232 (e.g., through a hole 254) such that rotation of the adjusting wheel 250 causes the first rotating assembly 232 to rotate about an axis 236 relative to the hub portion 229.

[0069] Additionally, the second rotating assembly 240 may be coupled to the second adjusting portion 256 to allow the second rotating assembly 240 to be rotatably displaced relative to the first rotating assembly 232. In some embodiments, the second adjusting portion 256 may be an adjusting wheel 258 rotatably coupled to an inner portion of the housing portion 202, and a spring may bias the adjusting wheel 258 into frictional engagement with a portion of the housing portion 202 to prevent undesirable rotation of the adjusting wheel 258. A portion of the adjusting wheel 258 may extend into a slot 260 formed in a portion of the housing portion 202 to allow a user to rotate the adjusting wheel 258. One or more portions of the suture (not shown) may be coupled to the base portion 242 of the adjusting wheel 258 and the second rotating assembly 240 (e.g., through hole 262) such that rotation of the adjusting wheel 258 causes the second rotating assembly 240 to rotate relative to the first rotating assembly 232 about an axis 244.

[0070] Although the introducer device 200 has been discussed with reference to atrial clamping assembly 10, the introducer device 200 can also be used to introduce and apply any clamping assembly such as atrial clamping assembly 300. For example... Figure 14 The illustration shows a jaw assembly 403 that secures the atrial clamping assembly 300 in the closed position and the open position (shown by the dotted line). Figure 15 The diagram also shows a jaw assembly 403 that secures the atrial clamping assembly 300 in the open position.

[0071] like Figures 14 to 29 The accompanying drawings illustrate yet another embodiment of an introducer device 400 that can be similar to introducer device 200, and specific features of introducer device 400 that are similar to or the same as those of introducer device 200 will share the same reference numerals. In particular, Figure 16 , Figure 17 , Figures 18A to 18B and Figure 29 The illustration shows an inlet device 400 that may include a flexible connector 402, and as shown... Figures 30A to 30M As illustrated, the flexible connector 402 can extend from a proximal end 432 to a distal end 434 along a connector axis 436 that can be aligned with the shaft axis 208. The proximal end 432 of the flexible connector 402 can be coupled to or disposed at or adjacent to the distal end 220 of the shaft 210. For example, as shown... Figure 31A As illustrated, all or part of the proximal end 432 of the flexible connector 402 may have a cylindrical shape, the diameter of which is equal to or slightly smaller than the diameter of the inner surface portion at the distal end 220 of the shaft 210, and all or part of the proximal end 432 of the flexible connector 402 may be received in an opening at the distal end 220 of the shaft 210. Figure 28 , Figure 31A and Figure 31B As shown in the diagram, the distal end 434 of the flexible connector 402 can be connected to and / or disposed at or adjacent to a portion of the yoke portion 404. The yoke portion 404 may be part of the connector assembly 228 of the jaw assembly 403.

[0072] refer to Figure 30B The flexible connector 402 may include an intermediate portion 438 disposed between a proximal end 432 and a distal end 434. The intermediate portion 438 may include a plurality of radial members 410 spaced apart along the connector axis 436, and each of the plurality of radial members 410 may be identical. In some embodiments, each of the plurality of radial members 410 may be disc-shaped and may have a diameter equal to or substantially equal to the outer diameter of the shaft 210. The intermediate portion 438 may also include a plurality of axial walls 412 disposed between and / or extending from the plurality of radial members 410. In particular, a single axial wall of the plurality of axial walls 412 may extend between adjacent radial members 410, and each axial wall of the plurality of axial walls 412, except relative to a reference axis 440 (which extends through the connector axis 436 and is parallel to…), may also extend between adjacent radial members 410. Figure 30B The Y-axis of the reference coordinate system, such as Figure 30J and Figure 30M The orientations of the axial walls (as shown in the diagram) can be the same. In particular, each of the plurality of axial walls 412 can be planar and can have orientations along... Figure 30B The X-axis of the reference coordinate system extends by equal or approximately equal "length" dimensions, and the thickness of each of the plurality of axial walls 412 can be in the range of approximately 50% to 100% of the thickness of each (or some) of the plurality of radial members 410. Figure 30I , Figure 30J , Figure 30L and Figure 30M As illustrated in the cross-sectional view, each of the plurality of axial walls 412 may intersect the connector axis 436. Furthermore, each of the plurality of axial walls 412 may have an orientation relative to the reference axis 440, which alternates regularly between two locations relative to each radial member 410. For example, the first axial wall 412a of the plurality of axial walls 412 extending proximally from the proximal surface of the first radial member 410a may form an angle of 135 degrees with the reference axis 440, such as... Figure 30M The diagram is shown in the middle. Furthermore, a second axial wall 412b of a plurality of axial walls 412 extending distally from the distal surface of the first radial member of the plurality of radial members 410a can form a 45-degree angle with the reference axis 440, as shown in the diagram. Figure 30JThe diagram shows an alternating configuration of axial walls 412 extending from the opposing surfaces of each of the plurality of radial members 410a. This configuration can be repeated for at least a portion of the plurality of radial members 410a in the intermediate portion 438, and in some embodiments, for each of the plurality of radial members 410a in the intermediate portion 438. For example, a second axial wall 412b of the plurality of axial walls 412 can extend proximally from a proximal surface that can form a 45-degree angle with the reference axis 440 relative to a second radial member of the plurality of radial members 410b, and a third axial wall 412c of the plurality of axial walls 412 can extend distally from the distal surface of the second radial member of the plurality of radial members 410b, and when viewed along the connector axis 436, the third axial wall 412c of the plurality of axial walls 412 can be aligned with a first axial wall 412a of the plurality of axial walls 412. Similarly, when viewed along the connector axis 436, the fifth axial wall 412e of the plurality of axial walls 412 can be aligned with the first axial wall 412a and the third axial wall 412c of the plurality of axial walls 412, and when viewed along the connector axis 436, the fourth axial wall 412d and the sixth axial wall 412f of the plurality of axial walls 412 can be aligned with the second axial wall 412b of the plurality of axial walls 412. Figure 30A , Figure 30C and Figure 30D As shown in the diagram, each of the plurality of radial members 410b may include two or more holes 442, and each of the two or more holes 442 may be configured such that a corresponding hole 442 passing through the plurality of radial members 410b can be parallel to... Figure 30B The X-axis of the reference coordinate system is aligned with the extended axis.

[0073] The flexible connector 402 may be made, fabricated, or constructed from a flexible material that allows the distal end 434 of the flexible connector 402 to bend around the fixed proximal end 432 of the flexible connector 402. For example, the flexible connector 402 may be made from a flexible material such as a plastic material (e.g., a silicone material) or manufactured as a single, integral part. In other embodiments, the flexible connector 402 may be made as an assembly of two or more components.

[0074] refer to Figure 28 , Figure 31A and Figure 31BThe jaw assembly 403 may include a connector assembly 228, which may include a yoke portion 404. The jaw assembly 403 may also include a first jaw 406, which may be pivotally coupled to a first portion of the yoke portion 404. The first jaw 406 may be configured to be releasably coupled to a first arm assembly 12, 302 of the atrial clamping assemblies 10, 300. The jaw assembly 403 may also include a second jaw 408, which may be pivotally coupled to a second portion of the yoke portion 404. The second jaw 408 may be configured to be releasably coupled to a second arm assembly 14, 304 of the atrial clamping assemblies 10, 300.

[0075] Jaw assembly 403 can be Figure 45B The opening position shown in the middle diagram and Figure 45A The displacement between the closed positions illustrated in the diagram is as will be described in more detail below. In some embodiments, the yoke portion 404 may be integrally formed with the second jaw 408, such that the first jaw 406 pivots relative to the yoke portion 404 and the first jaw 406. In, for example... Figure 45A and Figure 45B In other embodiments of the embodiments, the yoke portion 404 may be a component separate from the first jaw 406 and the second jaw 408.

[0076] like Figure 49A and Figure 49BAs illustrated in the diagram, the first arm assemblies 12, 302 of the atrial clamping assemblies 10, 300 can be releasably connected to the first jaw 406 using one or more portions of a suture. Specifically, the first connecting suture 740a can be routed along an outer surface 744a formed on or along one or more channels 742a formed on the outer surface 744a of the first jaw 406. The distal end portion of the first connecting suture 740a can be connected to a portion of the first arm assemblies 12, 302 of the atrial clamping assemblies 10, 300 or to a portion of the sheath 444 covering the first arm assemblies 12, 302 (i.e., the distal portion). The proximal end portion of the first connecting suture 740a can extend through the shaft 210 and be secured to or positioned at any suitable location on the introducer device 200, 400. Additionally, the second arm assemblies 14, 304 of the atrial clamping assemblies 10, 300 can be releasably connected to the second jaw 406 using one or more portions of a suture. Specifically, the second connecting suture 740b may be routed along the outer surface 744b formed on or along one or more channels 742b formed on the outer surface 744b of the second clamping jaw 406. The distal end portion of the second connecting suture 740b may be coupled to a portion of the second arm assembly 14, 304 of the atrial clamping assembly 10, 300 or to the portion of the sheath 444 covering the second arm assembly 14, 304 (i.e., the distal portion). The proximal end portion of the second connecting suture 740b may extend through the shaft 210 and be secured or positioned at any suitable location on the introducer device 200, 400.

[0077] In this manner, when the jaw assembly 403 moves from the open position to the closed position, the first arm assemblies 12 and 302 of the atrial clamping assemblies 10 and 300 can be releasably connected to the first jaw 406, and the second arm assemblies 14 and 304 of the atrial clamping assemblies 10 and 300 can be releasably connected to the second jaw 406. Furthermore, releasing the first connecting suture 740a from the first jaw 406 releases the first arm assemblies 12 and 302 from the first jaw 406, and releasing the second connecting suture 740b from the second jaw 408 releases the second arm assemblies 14 and 304 from the second jaw 408.

[0078] See Figure 28 Two or more control lines 414a, 414b, 414c, 414d may each extend from the proximal end to the distal end, and each portion may extend through the inner portion 224 of the shaft 210 (see [link to relevant documentation]). Figure 21 ).like Figure 31B As illustrated in the diagram, two or more control lines 414a, 414b, 414c, 414d may each extend through a corresponding hole 442 in each of the plurality of radial members 410b. (Reference) Figure 20AThe distal end of each control line 414a, 414b, 414c, 414d can be connected to a corresponding portion of the jaw assembly 403 (i.e., the first jaw 406 and / or the second jaw 408). Furthermore, refer to... Figure 26 The proximal end of each control line 414a, 414b, 414c, 414d can be connected to a corresponding portion of the first control lever assembly 416 and / or the second control lever assembly 418. For example, pivoting the lever 420 of the first control lever assembly 416 can displace the distal ends of one or more of the control lines 414a, 414b, 414c, 414d, thereby displacing the distal end 220 of the jaw assembly 403 relative to the shaft 210 in a first direction by means of the flexible connector 402. Furthermore, pivoting the lever 422 of the second control lever assembly 418 can displace the distal ends of one or more of the control lines 414a, 414b, 414c, 414d, thereby displacing the distal end 220 of the jaw assembly 403 relative to the shaft 210 in a second direction by means of the flexible connector 402. Therefore, by manipulating 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 some embodiments, the proximal ends of one or more control lines 414a, 414b, 414c, 414d can be coupled to corresponding portions of the actuating rod 206, and the orientation or position of the jaw assembly 403 relative to the distal end 220 of the shaft 210 can be changed by pivoting the actuating rod 206. Figure 19 , Figures 21 to 27 and Figures 32A to 32D Various views of the first control lever assembly 416 and / or the second control lever assembly 418 are shown, and for clarity, portions of the housing portion 202 and various other components are omitted.

[0079] See Figure 20A The actuation line 424 can extend from the proximal end to the distal end, and a portion of it can extend through the inner portion 224 of the shaft 210 (see...). Figure 21 The distal end of the actuation line 424 can be connected to the corresponding portion of the jaw assembly 403 (i.e., the first jaw 406). Furthermore, refer to... Figure 19 , Figure 32C and Figure 32D The proximal end of the actuation wire 424 can be connected to the corresponding part of the actuation rod 206. With this configuration, the atrial clamping assemblies 10 and 300 can be connected to the jaw assembly 403 and introduced into the treatment area at the open position of the jaw assembly 403. Figure 20B (See diagram). Once the jaw assembly 403 is positioned as desired (in the manner previously described), the surgeon can move the actuating rod 206 from the first rod position (as shown in the diagram). Figure 18A(As shown in the middle diagram) The jaw assembly 403 is closed by shifting to a second lever position in which the actuating lever pivots toward the gripping portion 204. This shift causes the distal end of the actuating line 242, which can be coupled to the portion of the first jaw 406, to shift distally, causing the first jaw 406 to pivot toward the second jaw 208, thereby closing the jaw assembly 403 and the atrial clamping assemblies 10, 300 coupled to the jaw assembly 403.

[0080] like Figures 37A to 37C The illustration shows another embodiment of an introducer device 500 that can be similar to introducer devices 200 and 400, and specific features of introducer device 500 that are similar to or the same as those of introducer devices 200 and 400 will share the same reference numerals. Turning to introducer device 500 in more detail, and as... Figure 45A and Figure 45B In the diagram, the jaw assembly 403 is in the open and closed positions respectively; for clarity, the atrial clamping assembly 300 is omitted. The connector assembly 228 may include a yoke portion 704, which can be coupled with... Figure 15 The yoke portion 404 shown in the figure is similar or identical, and the yoke portion 704 can be connected to the distal end 434 of the flexible connector 402.

[0081] refer to Figure 46 The yoke portion 704 may include a drive slot 706 that may extend along or substantially along the axis 210. In other embodiments, the drive slot 706 may extend in a direction forming an acute angle with the axis 208, may be offset from the axis 208, may have one or more portions that may be offset from the axis 208, and / or may be non-linear or have one or more non-linear portions. The drive slot 706 may receive a drive pin 708 that may be configured to displace between a distal position at a distal end of the drive slot 706 and a proximal position at a proximal end of the drive slot 706. The drive pin 708 may be coupled to... Figure 48A and Figure 48B The diagram shows a portion of the jaw spring 710, where, for clarity, the jaw assembly 403, atrial clamping assembly 300, and flexible connector 402 are omitted. (Reference) Figure 48A The drive pin 708 can be connected to a first portion of the base portion 721 of the jaw spring 710, and the base portion 721 can extend along the base axis 723 from the distal end 709a to the proximal end 709b. For example... Figure 37AAs illustrated, when the jaw assembly 403 is not rotated or pivoted relative to the distal end 220 of the shaft 210, the base axis 723 can be aligned with the shaft axis 208. A first portion of the base portion 721 may be located at or adjacent to the distal end 709a of the base portion 721 of the jaw spring 710. The distal end of the actuation line 424 may be connected to a second portion of the jaw spring 710, such as at or adjacent to the proximal end 709b of the base portion 721. The first and second portions may be aligned along the base axis 723.

[0082] Therefore, when the distal end of the actuation line 424 is displaced distally (by the displacement of the actuation rod 206), the drive pin 708 is displaced between a proximal position and a distal position in the drive slot 706, and when the distal end of the actuation line 424 moves from the distal position toward the proximal position, the drive pin 708 is displaced between a distal position and a proximal position in the drive slot 706. Figure 45A The illustration shows the drive pin 708 located near the drive slot 706, with the jaw assembly 403 in the closed position, and... Figure 45B The illustration shows the drive pin 708 located at the distal end of the drive slot 706, with the jaw assembly 403 in the open position. Figure 45C The illustration shows a drive pin 708 in an intermediate position between a distal position and a proximal position of a drive slot 706, wherein the jaw assembly 403 is in the intermediate position, and in the intermediate position the distal end 428b of the first jaw 406 is located at or near the distal end 431b of the second jaw 408.

[0083] Go to Figure 45A The first jaw 406 can extend along the first jaw axis 426 from the proximal end 428a to the distal end 428b. For example... Figure 47A The diagram shows, for clarity, the atrial clamping assembly 300, flexible connector 402, and yoke portion 704 are omitted. The first clamp 406 may include an engagement portion 429 at or adjacent to the proximal end 428a. Figure 47BThe diagram shows, for clarity, the second jaw 408, which is omitted here. A first jaw slot 712 may extend through a portion of the engagement portion 429 of the first jaw 406, and the first jaw slot 712 may be configured to receive a drive pin 708. The first jaw slot 712 may extend along an axis 711 set at an acute angle to the first jaw axis 426, and the first jaw slot 712 may converge toward the first jaw axis 426 as it extends from the distal end 428b to the proximal end 428a. In some embodiments, the angle between axis 711 and the first jaw axis 426 may be between 80° and 10°, such as in the range between 60° and 25°, or in the range between 60° and 35°.

[0084] Turn to Figure 45A The second jaw 408 can extend along the second jaw axis 427 from the proximal end 431a to the distal end 431b. For example... Figure 47A The diagram shows, for clarity, the atrial clamping assembly 300, flexible connector 402, and yoke portion 704 are omitted. The second clamp 408 may include an engagement portion 433 at or adjacent to the proximal end 431a. The engagement portion 433 may include along... Figure 37A A slot (not shown) extending in the XZ plane of the reference coordinate system may be configured to receive the engagement portion 429 of the first jaw 204, such that the engagement portion 428 is rotatable within the XZ plane of the slot in the engagement portion 433 of the second jaw 408. The engagement portion 433 of the second jaw 408 may include a second jaw slot 714, which may be configured to receive a drive pin 708. The second jaw slot 714 may extend along an axis 715 disposed at an acute angle to the second jaw axis 427, and the second jaw slot 714 may converge toward the second jaw axis 427 as it extends from the distal end 431b to the proximal end 431a. In some embodiments, the angle between the axis 715 and the second jaw axis 427 may be between 80° and 10°, such as in the range between 60° and 25°, or in the range between 60° and 35°.

[0085] With this configuration, when the distal end of the actuation line 424 moves from the proximal position to the distal position, the drive pin 708 shifts between the proximal and distal positions in the drive slot 706 of the yoke portion 704. At this proximal position of the drive pin 708, the jaw assembly 403 is in... Figure 45AThe jaws are in the closed position. When the distal end of the actuation line 424 moves distally, the jaw spring 710 and the drive pin 708 also move distally. Because 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 pivot about the drive pin 708 toward the open position of the jaw assembly 403. When the distal end of the actuation line 424 moves to its farthest 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. Figure 45B The location to open.

[0086] From this position, the distal end of the actuation line 424 can be displaced from the distal position toward the proximal position (e.g., via the actuation rod 206). As the distal end of the actuation line 424 moves proximally, the jaw spring 710 and consequently the drive pin 708 also move proximally in the drive slot 706 of the yoke portion 704. Because the drive pin 708 is disposed within the first jaw slot 712 and the second jaw slot 714, when the drive pin 708 moves proximally, the first jaw 406 and the second jaw 408 pivot about the drive pin 708 toward the closed position of the jaw assembly 403. When the distal end of the actuation line 424 moves to… Figure 45C In the middle position illustrated in the diagram, the drive pin 708 is in the middle position within the drive slot 706 of the yoke portion 704, and the jaw assembly 403 is in the middle position, as will be described in more detail in the following sections. When the distal end of the actuation line 424 moves to its 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 middle position. Figure 45A The closed position.

[0087] Turn to Figure 46 The yoke portion 704 may include a first-stage slot 716a on a first side (e.g., above) of the drive slot 706 and a second-stage slot 716b on a second side (e.g., below) of the drive slot 706. The first-stage slot 716a may extend along a first slot axis 717a, and the first slot axis 717a may extend in a direction forming an acute angle with the axis 210. In some embodiments, the acute angle may be between 80° and 10°, such as in the range between 80° and 45°, or in the range between 80° and 60°. In other embodiments, the first slot axis 717a or one or more portions of the first slot axis 717a may extend relative to the axis 210 in any one or more directions, and / or may be non-linear or have one or more non-linear portions.

[0088] The first-stage slot 716a can receive a top pin 718a, which can be configured to shift between a distal position at the distal end of the first-stage slot 716a and a proximal position at the proximal end of the first-stage slot 716a, the distal position corresponding to Figure 45B The open position of the jaw assembly 403 shown in the middle diagram corresponds to the proximal position. Figure 45A The diagram shows the closed position of the jaw assembly 403. The top pin 718a can be received in... Figure 47A The diagram shows a first jaw 406 with a hole 720, where the jaw assembly 403 is in the open position, and for clarity, the top pin 718a, atrial clamping assembly 300, flexible connector 402, and yoke portion 704 are omitted. The hole 720 may be provided in the engagement portion 429 of the first jaw 406 and may be configured and / or sized to prevent displacement of the top pin 718a relative to the first jaw 406.

[0089] like Figure 48A As illustrated in the diagram, when positioned within the hole 720, the top pin 718a can contact the third portion of the jaw spring 710. Specifically, the jaw spring 710 may include a first spring arm 724a extending from a first end 726a to a second end 728a, and a first cam portion 732a may be disposed at the second end 728a of the first spring arm 724a. The first end 726a of the first spring arm 724a may be coupled to a base portion 721, such as a portion of the base portion 721 at or adjacent to its proximal end 709b. In some embodiments, the first end 726a of the first spring arm 724a may be integrally formed with a portion of the base portion 721. With this configuration, the first spring arm 724a can extend partially cantilevered from the base portion 721, such that the second end 728a (and / or the cam portion 732a) can be positioned relative to the first end 726a in a direction substantially perpendicular to the base axis 723 (i.e., along the...). Figure 48A The first spring arm 724a may be displaced (in the direction of the Z-axis of the reference coordinate system). Additionally, all or part of the first spring arm 724a may have a shape that provides a restoring force when the second end 728a is displaced toward the first end 726a in a direction substantially parallel to the base axis 723. For example, the first spring arm 724a may have an undulating, wavy shape between the first end 726a and the second end 728a. This shape may include two or more parallel segments, and these two or more segments are arranged substantially perpendicular to the axis extending from the first end 726a and the second end 728a.

[0090] refer to Figure 48BThe first cam portion 732a may include a first engagement surface portion 734a and a second engagement surface portion 736a, and the first engagement surface portion 734a and the second engagement surface portion 736a may be configured to allow the top pin 718a to travel or slide along the first engagement surface portion 734a and the second engagement surface portion 736a when the top pin 718a is displaced between a proximal position at the proximal end of the first primary slot 716a and a distal position at the distal end of the first primary slot 716a, and vice versa. In some embodiments, the first engagement surface portion 734a may extend in a direction parallel to the base axis 723, and the second engagement surface portion 736a may extend in a direction substantially perpendicular to the base axis 723. However, the second engagement surface portion 736a may include one or more non-linear portions, and the one or more non-linear portions may be wavy in shape and may be slightly concave in shape.

[0091] When the jaw assembly 403 is in Figure 45B In the open position illustrated in the diagram, the top pin 718a is located at the distal end of the first primary slot 716a, the drive pin 708 is located at the distal end of the drive slot 706, and the jaw spring 710 is in the distal position. In this position, the top pin 718a can contact the portion of the first spring arm 724a at or near the first end portion of the first engagement surface 734a, and the top pin 718a can contact the portion of the first spring arm 724a near the first end portion of the first engagement surface 734a, as shown in the diagram. Figure 48B The diagram is shown in the image.

[0092] When the jaw spring 710 begins to move proximally and the distal position drive pin 708 moves from the distal position toward the proximity in the drive slot 706, the jaw assembly 403 begins to move toward the closed position. Additionally, the top pin 718a begins to move proximally from the distal end of the first-stage slot 716a, and the first arm 406 begins to rotate toward the closed position. During this displacement in the first-stage slot 716a, and when the jaw spring 710 begins to move proximally, the top pin 718a can contact and slide across a portion of the first end portion of the first engagement surface portion 734a, as... Figure 48C The diagram is shown in the image.

[0093] As the jaw spring 710 continues to move proximally and displaces the drive pin 708 proximally in the drive slot 706, the jaw assembly 403 continues to move toward the closed position. The top pin 718a, displaced proximally in the first-stage slot 716a, remains in partial contact with the first end portion of the first spring arm 724a at the first engagement surface portion 734a, and this contact begins to displace the first cam portion 732a toward the base portion 721. Figure 48D As illustrated in the diagram, the continuous contact between the top pin 718a and the first engagement surface portion 734a biases a portion of the first cam portion 732a into contact with the corresponding portion of the base portion 721. Due to pivoting about one or both of the drive pin 708 and the top pin 718a, and because the drive pin 708 is disposed within the first jaw slot 712 of the first jaw 406, the distal end 428b of the first jaw 406 begins to converge toward the base axis 723, while the proximal end 428a does not converge toward the base axis 723.

[0094] As the jaw spring 710 continues to move proximally, the contact between the top pin 718a, which has shifted proximally in the first-stage slot 716a, and the first engagement surface portion 734a continues to maintain contact between the portion of the first cam portion 732a and the corresponding portion of the base portion 721, until the top pin 718a is positioned at the second end portion of the first engagement surface portion 734a, as... Figure 48E As shown in the diagram. At this location, the distal end 428b of the first jaw 406 is adjacent to the base axis 723, while the proximal end 428a is offset from the base axis, as illustrated below. Figure 45C The diagram shows that in this position, the drive pin 708 is located intermediately between the distal and proximal positions of the drive slot 706, and the top pin 718a is located intermediately within the primary slot 716a. This position allows the distal end of the atrial clamping assemblies 10, 300 to engage the left atrial appendage before the proximal end of the atrial clamping assemblies 10, 300 during application, resulting in a more secure engagement with the left atrial appendage when the atrial clamping assemblies 10, 300 are applied.

[0095] As the jaw spring 710 continues to move proximally, the top pin 718a shifts above the edge between the second end portion of the first engagement surface portion 734a and the first end portion of the second engagement surface portion 736a, and the top pin 718a shifts along the second engagement surface portion 736a from the first end portion toward the second end portion, as... Figure 48FAs illustrated in the diagram, when the top pin 718a shifts above the edge, the first cam portion 732a shifts away from the base portion 721. In this position, the distal end 428b of the first jaw 406 does not shift (or shifts insignificantly) relative to the base axis 723, but the proximal end 428a begins to converge toward the base axis 723.

[0096] As the jaw spring 710 continues to move to the nearest side position, wherein the drive pin 708 moves to the nearest side position in the drive slot 706, the top pin 718a continues to move along the second engagement surface portion 736a to a point at or near the second end of the second engagement surface portion 736a, such as... Figure 48G The diagram in the middle shows its relationship with... Figure 48A Similarly. In some embodiments, the top pin 718a continues to shift along the second engagement surface portion 736a to a point between the first end and the second end of the second engagement surface portion 736a. The distal end 428b of the first jaw 406 remains undisplaced (or not significantly displaced) relative to the base axis 723, but the proximal end 428a continues to converge toward the base axis 723 until the first jaw 406 reaches... Figure 45A The closed position of the jaw assembly 403 is shown in the diagram.

[0097] like Figure 46 As illustrated in the figure, the yoke portion 704 may include a second-stage slot 716b, which may extend along a second slot axis 717b, and the second slot axis 717b may extend in a direction forming an acute angle with the axis 210. In some embodiments, the acute angle formed by the second slot axis 717b and the axis 210 may be equal to the acute angle formed by the first slot axis 717a and the axis 210. In some embodiments, the acute angle may be between 80° and 10°, such as in the range between 80° and 45°, or in the range between 80° and 60°. In other embodiments, the second slot axis 717b or one or more portions of the second slot axis 717b may extend relative to the axis 210 in any one or more directions, and / or may be non-linear or have one or more non-linear portions.

[0098] The second-stage slot 716b can receive a bottom pin 718b, which can be configured to shift between a distal position at the distal end of the second-stage slot 716b and a proximal position at the proximal end of the second-stage slot 716b, the distal position corresponding to Figure 45B The open position of the jaw assembly 403 shown in the middle diagram corresponds to the proximal position. Figure 45A The diagram shows the closed position of the jaw assembly 403. The bottom pin 718b can be received in... Figure 47AIn the second jaw 408 shown in the diagram, the jaw assembly 403 is in the open position, and for clarity, the bottom pin 718b, atrial clamping assembly 300, flexible connector 402, and yoke portion 704 are omitted. The hole 730 may be provided in the engagement portion 433 of the second jaw 408 and may be configured and / or sized to prevent displacement of the bottom pin 718b relative to the second jaw 408.

[0099] like Figure 48A As illustrated in the diagram, when positioned within the hole 730, the bottom pin 718b can contact the fourth portion of the jaw spring 710. Specifically, the jaw spring 710 may include a second spring arm 724b extending from a first end 726b to a second end 728b, and a second cam portion 732b may be positioned at the second end 728b of the second spring arm 724b. The second spring arm 724b may be substantially identical to the first spring arm 724a, or may be a mirror image of the first spring arm 724a about the base axis 723. Specifically, the first end 726b of the second spring arm 724b may be coupled to a base portion 721, such as a portion of the base portion 721 at or adjacent to its proximal end 709b. In some embodiments, the first end 726b of the second spring arm 724b may be integrally formed with a portion of the base portion 721. With this configuration, the second spring arm 724b can extend cantileveredly from the base portion 721, such that the second end 728b can extend in a direction substantially perpendicular to the base axis 723 relative to the first end 726b (i.e., along the...). Figure 48A The second spring arm 724b may be displaced in the direction of the Z-axis of the reference coordinate system. Additionally, the second spring arm 724b may have 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 may have an undulating, wavy shape between the first end 726b and the second end 728b. This shape may include two or more parallel segments, and these two or more segments are arranged substantially perpendicular to the axis extending from the first end 726b and the second end 728b.

[0100] refer to Figure 48BThe second cam portion 732b may include a first engagement surface portion 734b and a second engagement surface portion 736b, and the first engagement surface portion 734b and the second engagement surface portion 736b may be configured to allow the bottom pin 718b to travel or slide along the first engagement surface portion 734b and the second engagement surface portion 736a, and vice versa, when the bottom pin 718b is displaced between a proximal position at the proximal end of the second-stage slot 716b and a distal position at the distal end of the second-stage slot 716b. In some embodiments, the second engagement surface portion 734b may extend in a direction parallel to the base axis 723, and the second engagement surface portion 736b may extend in a direction substantially perpendicular to the base axis 723. However, the second engagement surface portion 736b may include one or more non-linear portions, and the one or more non-linear portions may be wavy in shape and may be slightly concave in shape.

[0101] When the jaw assembly 403 is in Figure 45B In the open position illustrated in the diagram, the bottom pin 718b is in the distal position at the distal end of the second-stage 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 bottom pin 718b can contact the portion of the second spring arm 724b at or near the first end portion of the first engagement surface portion 734b, and the bottom pin 718b can contact the portion of the second spring arm 724b near the first end portion of the first engagement surface portion 734b, as shown in the diagram. Figure 48B The diagram is shown in the image.

[0102] When the jaw spring 710 begins to move proximally and the distal position drive pin 708 moves from the distal position to the proximity in the drive slot 706, the jaw assembly 403 begins to move towards the closed position. Additionally, the bottom pin 718b begins to move proximally from the distal end of the secondary slot 716b, and the second arm 408 begins to rotate towards the closed position. Figure 48C As illustrated in the diagram, during this displacement in the second-stage slot 716b, and as the jaw spring 710 begins to move proximally, the bottom pin 718b can contact and partially slide across the first end portion of the first engagement surface portion 734b of the second spring arm 724b.

[0103] As the jaw spring 710 continues to move proximally and displaces the drive pin 708 proximally in the drive slot 706, the jaw assembly 403 continues to move toward the closed position. The bottom pin 718b, displaced proximally in the second-stage slot 716b, remains in partial contact with the first end portion of the first engagement surface portion 734b of the second spring arm 724b, and this contact begins to displace the second cam portion 732b toward the base portion 721. Figure 48D As illustrated in the diagram, the continuous contact between the bottom pin 718b and the first engagement surface portion 734b biases a portion of the second cam portion 732b into contact with the corresponding portion of the base portion 721. Due to pivoting about one or both of the drive pin 708 and the bottom pin 718b, and because the drive pin 708 is disposed within the second jaw slot 714 of the second jaw 408, the distal end 431b of the second jaw 408 begins to converge toward the base axis 723, while the proximal end 431a does not converge toward the base axis 723.

[0104] As the jaw spring 710 continues to move proximally, the contact between the bottom pin 718b, which has shifted proximally in the second-stage slot 716b, and the first engagement surface portion 734b continues to maintain contact between the portion of the second cam portion 732b and the corresponding portion of the base portion 721, until the bottom pin 718b is positioned at the second end portion of the first engagement surface portion 734b, as shown. Figure 48E As shown in the diagram. At this location, the distal end 431b of the second jaw 408 is positioned adjacent to the base axis 723, while the proximal end 431a is offset from the base axis 723, as illustrated below. Figure 45C The diagram shows that in this position, the drive pin 708 is positioned between the distal and proximal positions of the drive slot 706, and the bottom pin 718b is positioned in the middle of the secondary slot 716b. This position allows the distal end of the atrial clamping assemblies 10, 300 to engage the left atrial appendage before the proximal end of the atrial clamping assemblies 10, 300 during application, resulting in a more secure engagement with the left atrial appendage.

[0105] As the jaw spring 710 continues to move proximally, the bottom pin 718b shifts above the edge between the second end portion of the first engagement surface portion 734b and the first end portion of the second engagement surface portion 736b, and the bottom pin 718b shifts along the second engagement surface portion 736b from the first end portion toward the second end portion, as... Figure 48F As illustrated in the diagram, when the bottom pin 718b shifts above the edge, the second cam portion 732b shifts away from the base portion 721. In this position, the distal end 431b of the second jaw 408 does not shift (or shifts insignificantly) relative to the base axis 723, but the proximal end 431a begins to converge toward the base axis 723.

[0106] As the jaw spring 710 continues to move into the nearest-side position, wherein the drive pin 708 moves into the nearest-side position in the drive slot 706, the bottom pin 718b continues to move along the second engagement surface portion 736b to a point at or near the second end of the second engagement surface portion 736a, as with Figure 48A The same Figure 48G As illustrated in the diagram. In some embodiments, the bottom pin 718b continues to shift along the second engagement surface portion 736b to a point between the first end and the second end 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 converge toward the base axis 723 until the second jaw 408 reaches... Figure 45A The closed position of the jaw assembly 403 is shown in the diagram.

[0107] In order to remove the jaw assembly from Figure 45A The closed position is shifted to Figure 45B The opening position is typically achieved before applying the atrial clamping assembly 10, 300 to the left atrial appendage, when the jaw spring 710 is released from... Figure 45A The nearest side position is moved to Figure 45B At the farthest position, the previously described process is reversed.

[0108] like Figures 37A to 37C As illustrated in the diagram, the introducer device 500 can control the orientation of the jaw assembly 403 in a manner different from that of introducer devices 200 and 400. Specifically, instead of the first control lever assembly 416 and the second control lever assembly 418 illustrated in the embodiment of introducer device 400, introducer device 500 may include a first adjustment assembly 502a and a second adjustment assembly 502b. Figures 38A to 39D The diagram in the middle shows, Figures 38A to 39D Various views of all or part of the first adjustment component 502a and / or the second adjustment component 502b are provided (where portions of the introducer device 500 are removed for clarity), the first adjustment component 502a may include a first adjustment wheel 504a ( Figures 43A to 43C (As shown in the diagram), the first adjusting wheel 504a is rotatably connected to a first end portion of the first wheel axle 506, and the first wheel axle 506 can be aligned with the center point of the first adjusting wheel 504a. The second adjusting assembly 502b may include a second adjusting wheel 504b, which is rotatably connected to a second end portion of the first wheel axle 506, and the center point of the first wheel axle 506 can be aligned with the center point of the second adjusting wheel 504b. The second adjusting wheel 504b may be identical to (or substantially identical to), or a mirror image of, the first adjusting wheel 504a.

[0109] like Figure 39D As shown in the diagram, a first spur gear 508a may be disposed adjacent to a first end portion of a first axle 506, and the first spur gear 508a may rotate relative to the first axle 506 together with a first adjusting wheel 504a. A second spur gear 508b may be disposed adjacent to a second end portion of the first axle 506, and the second spur gear 508b may rotate relative to the first axle 506 together with the first adjusting wheel 504a. The first spur gear 508a may mesh with a portion of the first adjusting gear 510a that may rotate about a first portion of a second axle 512. The second axle 512 may have an end portion fixed to a housing portion 202, such that the second axle 512 rotates relative to the housing portion 202 but does not shift relative to the housing portion 202. The second axle 512 may be connected to the first axle 506 via a first rod 518a extending from a point adjacent to a first end portion of the second axle 512 to a point adjacent to a first end portion of the first axle 512. The second axle 512 can be further connected to the first axle 506 via a second rod 518b, which 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 way, the first axle 506 is not connected to the housing portion 202. However, the second axle 512 and the first axle 506 can be connected to each other and / or connected to the housing portion 202 in any suitable manner.

[0110] In this configuration, rotation of the first adjusting wheel 504a around the first wheel shaft 506 causes a corresponding rotation of the first adjusting gear 510a around the second wheel shaft 512. Specifically, rotation of the first adjusting wheel 504a in a first direction causes a corresponding rotation of the first adjusting gear 510a in the first direction, and rotation of the first adjusting wheel 504a in a second direction causes a corresponding rotation of the first adjusting gear 510a in the second direction.

[0111] The proximal ends of one or more of the first control lines 414a, 414b, 414c, and 414d can be connected to the corresponding portion of the first adjusting gear 510a (or connected to...). Figure 39B and Figure 39C The roller member 514 shown in the diagram can be fixed to the first adjusting gear 510a, such that when the first adjusting wheel 504a rotates in the first direction, one or more corresponding control lines 414a, 414b, 414c, 414d shift, thereby shifting the distal ends of the first or more control lines 414a, 414b, 414c, 414d, and thus, by means of the flexible connector 402, shifting the distal end 220 of the jaw assembly 403 relative to the shaft 210 in the first direction, as shown in the diagram. Figure 37D The diagram shows an example. For instance, the first direction could be along... Figure 37DThe first direction of the Z-axis of the reference coordinate system. Correspondingly, when the first adjusting wheel 504a rotates in the second direction, one or more corresponding control lines 414a, 414b, 414c, 414d shift, thereby shifting the distal ends of the first or more control lines 414a, 414b, 414c, 414d, thereby shifting the distal end 220 of the jaw assembly 403 relative to the shaft 210 in the second direction by means of the flexible connector 402. For example, the second direction may be along the Z-axis of the reference coordinate system. Figure 37D The Z-axis of the reference coordinate system is in the opposite direction to the first direction. The first and second directions relative to the distal end 220 of the shaft 210 can be separated by any angular distance, such as 180 degrees. Therefore, by touching the extension of the first adjusting wheel 504a with the thumb through the portion of the first slot 225a formed in the portion of the housing portion 202 (see... Figure 37C The user of the gripper device 500 can rotate the first adjusting wheel 504a to position the jaw assembly 403 in a manner such as... Figure 37D The distal end 220 of the reference coordinate system illustrated in the figure can be pivoted, rotated, or displaced relative to the axis 210 in the first curved plane of the XZ plane, thereby allowing the user to precisely position the jaw assembly 403 during minimally invasive surgery.

[0112] like Figure 39C As illustrated in the diagram, the second spur gear 508b can mesh with a portion of the second adjusting gear 510b that can pivot about a second portion of the second axle 512. The second axle 512 is further connected to the first axle 506 via a second rod 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. In this configuration, rotation of the second adjusting wheel 504b causes a corresponding rotation of the second adjusting gear 510b. Specifically, rotation of the second adjusting wheel 504b in a first direction causes a corresponding rotation of the second adjusting gear 510b in the first direction, and rotation of the second adjusting wheel 504b in a second direction causes a corresponding rotation of the second adjusting gear 510b in the second direction.

[0113] The proximal ends of one or more of the corresponding second control lines among control lines 414a, 414b, 414c, and 414d can be connected to the corresponding portion of the second adjusting gear 510b (or connected to...). Figure 39B and Figure 39CThe roller member 514 shown in the diagram can be fixed to the second adjusting gear 510a if it is not fixed to the first adjusting gear 510a. This allows the corresponding second or more control lines among the control lines 414a, 414b, 414c, and 414d to shift when the second adjusting wheel 504b rotates in the first direction. This shifts the distal ends of the second or more control lines 414a, 414b, 414c, and 414d, thereby displacing the distal end 220 of the jaw assembly 403 relative to the shaft 210 in a third direction by means of the flexible connector 402. For example, the third direction could be along... Figure 37D The first direction of the Y-axis of the reference coordinate system. Correspondingly, when the second adjusting wheel 504b rotates in the second direction, one or more corresponding second control lines among the control lines 414a, 414b, 414c, 414d are displaced, thereby displacing the distal ends of the second or more control lines 414a, 414b, 414c, 414d, thereby displacing the distal end 220 of the jaw assembly 403 relative to the shaft 210 in the fourth direction by means of the flexible connector 402. For example, the fourth direction may be along the... Figure 37D The Z-axis of the reference coordinate system is in the opposite direction to the third direction. The first, second, third, and fourth directions relative to the distal end 220 of axis 210 can be separated by any angular distance, such as 90 degrees. Therefore, by contacting the extension of the second adjusting wheel 504b with the thumb through the portion of the second slot 225b formed in the portion of the housing portion 202 (see...) Figure 37C The user gripping the introducer device 500 can rotate the second adjustment wheel 504b to cause the jaw assembly 403 to pivot, rotate, or shift relative to the distal end 220 of the shaft 210 in a second curved plane that can be perpendicular to the first curved plane, for example... Figure 37D The XY plane of the reference coordinate system is illustrated in the diagram. The ability to rotate in the first and second bending positions will allow the jaw assembly 403 to pivot about the flexible connector 402 in any direction aligned with or aligning with the Y-axis and / or Z-axis of the reference coordinate system, thereby allowing the user to precisely position the jaw assembly 403 during minimally invasive surgery, to precisely position the jaw assembly 403 before securing the atrial clamping assemblies 10, 300 to the LAA, without moving relative to the patient axis 210.

[0114] A portion of the second wheel axle 512 may extend through a partially circular guide path 516a formed in the first adjusting wheel 504a, preventing the first adjusting wheel 504a from rotating beyond a first point where the first portion of the second wheel axle 512 contacts a first end portion of the guide path 516a, and beyond a second point where the first portion of the second wheel axle 512 contacts a second end portion of the guide path 516a. Another portion of the second wheel axle 512 may extend through a partially circular guide path 516b formed in the second adjusting wheel 504b, preventing the second adjusting wheel 504b from rotating beyond a first point where the second portion of the second wheel axle 512 contacts a first end portion of the guide path 516b, and beyond a second point where the second portion of the second wheel axle 512 contacts a second end portion of the guide path 516b. Therefore, by limiting the range of rotational movement of each of the first adjusting wheel 504a and the second adjusting 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.

[0115] To prevent undesirable rotation of the first adjusting wheel 504a or the second adjusting wheel 504b, and / or to allow the first adjusting wheel 504a and / or the second adjusting wheel 504b to lock in a desired position, the first adjusting assembly 502a may include a first locking assembly 520a and the second adjusting assembly 502b may include a second locking assembly 520b. The first locking assembly 520a may include a first locking member 522a, which may be displaceable relative to the first adjusting wheel 504a. Figure 39C and Figures 42A to 42D As illustrated in the diagram, the first locking member 522a may include a first body portion 523a extending from a first end to a second end, and the first body portion 523a may be planar and may have a plate shape. A first spring portion 524a may be coupled to a portion of the first body portion 523a (e.g., the second end) or integrally formed with a portion of the first body portion 523a. Figure 42A In one embodiment, the first end of the first spring portion 524a may be coupled to (or integrally formed therewith) the second end of the first body portion 523a, and the second end of the first spring portion 524a may be formed by a flange portion 527a formed on a portion of the housing portion 202 (see [link to relevant documentation]). Figure 41A and Figure 41B ) support. Therefore, when the first main body portion 523a shifts toward the flange portion 527a (see Figure 40B The first spring portion 524a biases the first main body portion 523a away from the flange portion 527a.

[0116] like Figure 41AAs shown in the diagram, the first main body portion 523a may further include a first hinge portion 542a, which may be fixed to a first end of the first main body portion 523a or a portion adjacent to the first end of the first main body portion 523a, and may be fixed within or to a portion of the housing portion 202, such as a recess formed in the housing portion 202, such that when the first main body portion 523a is moved downward by the user (along...) Figure 40B When arrow 538 is drawn, the first locking member 522a can pivot about the first hinge portion 542a. The first body portion 523a may also include a first cutout 544a formed within the first body portion 523a and configured to receive all or part of the first rod 518a. The size and dimensions of the first cutout 544a may be designed to allow the first locking member 522a to move as described in more detail below without being obstructed by the first rod 518a.

[0117] The first locking member 522a further includes a first engaging portion 526a, which may be coupled to a portion of the first body portion 523a (e.g., its first end) or integrally formed with a portion of the first body portion 523a. The first engaging portion 526a may be configured to engage a corresponding wheel engaging portion 528a formed on the first adjusting wheel 504a. For example, the wheel engaging portion 528a may be a plurality of teeth 530a formed on or along a circumferential ridge 532a offset inward from the circumferential edge 534a of the first adjusting wheel 504a. In this embodiment, the first engaging portion 526a of the first locking member 522a may be two or more pointed teeth 536a, each pointed tooth 536a being configured to be disposed between adjacent teeth 530a of the corresponding wheel engaging portion 528a. Therefore, when the first locking member 522a is in the first position (i.e., the locked position), the first spring portion 524a (acting against the circumferential protrusion 532a) biases the first main body portion 523a upward, and in doing so, biases the first engaging portion 526a into engagement with the portion of the wheel engaging portion 528a formed on the first adjusting wheel 504a, as... Figure 40A As shown in the diagram. That is, in the locked position of the first locking 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 engagement portion 528a, thereby preventing the first adjusting wheel 504a from rotating relative to the first locking member 522a (and relative to the housing portion 202 and the first adjusting gear 510a).

[0118] The first locking member 522a also includes a first contact portion 536a that extends from a portion (e.g., a first end) of the first body portion 523a and is coupled to or integrally formed with the first body portion 523a. In the locked position of the first locking assembly 520a, all or part of the first contact portion 536a may extend through a first slot 225a formed in a portion of the housing portion 202, and all or part of the first contact portion 536a may be aligned with or extend beyond the circumferential edge 534a of the first adjusting wheel 504a.

[0119] When the user wishes to rotate the first adjusting wheel 504a to displace the jaw assembly 403, the user presses the first contact portion 536a with the same thumb that contacts the first adjusting wheel 504a, and presses downward to rotate the first adjusting wheel 504a. The downward force on the first contact portion 536a causes the first locking member 522a to shift downward (i.e., along or substantially along, which may be parallel or substantially parallel to). Figure 37C The Z-axis of the reference coordinate system in Figure 40B Arrow 538 in the middle), to resist the upward bias provided by the first spring portion 524a (i.e., along or substantially along which may be parallel or substantially parallel to). Figure 37C The Z-axis of the reference coordinate system in Figure 40A (Arrow 540 in the middle). This downward displacement may be caused by a downward force on the first contact portion 536a, with the first locking member 522a surrounding the first hinge portion 542a (see arrow 540 in the middle). Figure 41A The result of the pivoting is that this downward displacement of the first locking member 522a moves the first locking member 522a to the second or unlocked position, wherein the first engaging portion 526a does not engage with the portion of the wheel engaging portion 528a formed on the first adjusting wheel 504a, as... Figure 40B The diagram shows that, in the unlocked position of the first locking assembly 520a, two or more teeth 536a of the first locking member 522a are offset from the teeth 530a of the corresponding wheel engagement portion 528a, thereby allowing the first adjusting wheel 504a to rotate relative to the first locking member 522a (and relative to the housing portion 202 and the first adjusting gear 510a). When the user moves the jaw assembly 403 to the desired position, the pressure on the first contact portion 536a is released, and the first spring portion 524a biases the first locking member 522a back from the unlocked position to the locked position.

[0120] The second locking component 520b may be the same as, substantially the same as, or a mirror image of the first locking component 520a, and the second locking component 520b may operate in the same manner as the first locking component 520a. That is, the second locking component 520b may include a second locking member 522b that is displaceable relative to the second adjusting wheel 504b. Figure 39C and Figures 42A to 42D As illustrated in the diagram (showing the first locking member 522a), the second locking member 522b may include a second body portion 523b extending from the first end to the second end, and the second body portion 523b may be planar and may have a plate shape. A second spring portion 524b may be coupled to a portion of the second body portion 523b (e.g., the second end) or integrally formed with a portion of the second body portion 523b. Figure 42A In one embodiment, the first end of the second spring portion 524b may be coupled to (or integrally formed therewith) the second end of the second body portion 523b, and the second end of the second spring portion 524b may be formed by a flange portion 527b (not shown, but similar to) formed on a portion of the housing portion 202. Figure 41A The flange portion 527a is the same as that in the middle. Therefore, when the second body portion 523b is displaced toward the flange portion 527b (see...), Figure 40B The second spring portion 524b biases the second body portion 523b away from the flange portion 527b.

[0121] like Figure 38B As illustrated in the diagram, the second body portion 523b may further include a second hinge portion 542b, which may be fixed to or adjacent to a second end of the second body portion 523b. The second hinge portion 542b may be fixed within or to a portion of the housing portion 202 in the same manner as the first hinge portion 542a of the first body portion 523b. The second body portion 523b may also include a second cutout 544b formed within the second body portion 523b and configured to receive all or part of the second rod 518b. The second cutout 544b may be functionally identical to the first cutout 544a.

[0122] The second locking member 522b also includes a second engaging portion 526b, which may be coupled to a portion of the second body portion 523b (e.g., its first end) or integrally formed with a portion of the second body portion 523b. The second engaging portion 526b may be configured to engage a corresponding wheel engaging portion 528b formed on the second adjusting wheel 504b. For example, the wheel engaging portion 528b may be a plurality of teeth 530b formed on or along a circumferential ridge 532b offset inward from the circumferential edge 534b of the second adjusting wheel 504b. In this embodiment, the second engaging portion 526b of the second locking member 522b may be two or more pointed teeth 536b, each pointed tooth 536b being configured to be disposed 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 against the circumferential protrusion 532b) biases the second main body portion 523b upward, and in doing so, biases the second engaging portion 526b into engagement with the portion of the wheel engaging portion 528b formed on the second adjusting wheel 504b, as shown. Figure 40A As shown in the diagram. That is, in the locked position of the second locking 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 engagement portion 528b, thereby preventing the second adjusting wheel 504b from rotating relative to the second locking member 522b (and relative to the housing portion 202 and the second adjusting gear 510b).

[0123] The second locking member 522b also includes a second contact portion 536b, which extends from a portion (e.g., a first end) of the second body portion 523b and is coupled to or integrally formed with the second body portion 523b. In the locked position of the second locking assembly 520b, all or part of the second contact portion 536b may extend through the second slot 225b formed in the housing portion 202, and all or part of the second contact portion 536b may be aligned with or extend beyond the circumferential edge 534b of the second adjusting wheel 504b.

[0124] When the user wishes to rotate the second adjusting wheel 504b to displace the jaw assembly 403, the user presses the second contact portion 536b with the same thumb that contacts the second adjusting wheel 504b, and presses downward to rotate the second adjusting wheel 504b. The downward force on the second contact portion 536b causes the second locking member 522b to shift downward (i.e., along or substantially along, which may be parallel or substantially parallel to). Figure 37CThe Z-axis of the reference coordinate system in Figure 40B Arrow 538 in the middle), to resist the upward bias provided by the second spring portion 524b (i.e., along or substantially along which may be parallel or substantially parallel to). Figure 37C The Z-axis of the reference coordinate system in Figure 40A (Arrow 540 in the middle). This downward displacement may be caused by a downward force on the second contact portion 536b, with the second locking member 522b surrounding the second hinge portion 542b (see arrow 540 in the middle). Figure 38B The result of the pivoting is that this downward displacement of the second locking member 522b moves the second locking member 522b to a second position or unlocked position, wherein the second engaging portion 526b does not engage with a portion of the wheel engaging portion 528b formed on the second adjusting wheel 504b, as... Figure 40B The diagram shows that, in the unlocked position of the second locking assembly 520b, two or more teeth 536b of the second locking member 522b are offset from the teeth 530b of the corresponding wheel engagement portion 528b, thereby allowing the second adjusting wheel 504b to rotate relative to the second locking member 522b (and relative to the housing portion 202 and the second adjusting gear 510b). When the user moves the jaw assembly 403 to the desired position, the pressure on the second contact portion 536b is released, and the second spring portion 524b biases the second locking member 522b from the unlocked position back to the locked position.

[0125] Figures 44A to 44H An alternative embodiment of the first adjustment assembly 602a and the second adjustment assembly 602b is illustrated. In this embodiment, the first adjustment wheel 604a and the second adjustment wheel 604b are each selectively displaced linearly and rotatably 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 having a first body portion 623a and a first spring portion 624a integrally formed on the first body portion 623a. Figure 44F As shown in the figure, the first spring portion 624a acts on the first flange portion 627a of the housing portion 202 to bias the first adjusting wheel 604a upward, such that a plurality of teeth 630a of the first adjusting wheel 604a are biased to engage with a plurality of teeth 631a formed on the lower surface of the first flange portion 627a.

[0126] When the user wishes to rotate the first adjusting wheel 604a to shift the jaw assembly 403, the user presses a portion of the first adjusting wheel 604a against the bias of the first spring portion 624a, moving the first adjusting wheel 604a downward to the unlocked position (see [link]). Figure 44DIn this unlocked position, the teeth 630a of the first adjusting wheel 604a are physically displaced and do not engage with the teeth 631a formed on the lower surface of the first flange portion 627a, allowing the first adjusting wheel 604a to be rotated by the user's thumb. Rotation of the first adjusting wheel 604a also rotates the first spur gear 633a, and the corresponding first or more control lines 414a, 414b, 414c, 414d, which are directly or indirectly connected to the first spur gear 633a, are displaced in a manner similar to or the same as previously described. To relock the first adjusting assembly 602a, the first adjusting wheel 604a is released by the user's thumb, and the first spring portion 624a causes the first adjusting wheel 604a to move upward, causing the teeth 630a of the first adjusting wheel 604a to engage again with the teeth 631a formed on the lower surface of the first flange portion 627a. The second adjusting assembly 602b operates in the same manner as the first adjusting assembly 602a.

[0127] The various advantages of the atrial clamping assembly and the introducer device have been discussed above. In this specification, embodiments discussed herein have been described by way of example. It will be apparent to those skilled in the art that the foregoing detailed disclosure is intended only by way of example and not by way of limitation. Although not explicitly stated herein, various changes, improvements, and modifications will be conceived and intended to be made by those skilled in the art. These changes, improvements, and modifications are intended to be made thereby and are within the spirit and scope of the claimed invention. The drawings included herein are not necessarily drawn to scale. Furthermore, the order of description of elements or sequences, or the use of numbers, letters, or other names, is therefore not intended to limit the claims to any order unless otherwise specified in the claims. Thus, the invention is limited only to the appended claims and their equivalents.

Claims

1. An atrial clamping assembly, comprising: First arm assembly, the first arm assembly comprising: A first arm body extends from a first end to a second end along a first arm body axis. The first arm body includes a first support portion extending from the first end to the second end. A first ridge portion extends along a first ridge axis from a first end to a second end, and wherein a first portion of the first ridge portion extends along a corresponding first portion of the first support portion, wherein the first portion of the first ridge portion is disposed within the corresponding first portion of the first support portion; and A first suture, wherein a first portion of the first suture is disposed around a first portion of the first ridge portion, and wherein a second portion of the first suture extends outside the first support portion; and The second arm assembly includes: A second arm body extending from a first end to a second end along a second arm body axis; the second arm body includes a second support portion extending from the first end to the second end; and The hinge portion connects a first end of the first arm body to a first end of the second arm body, wherein the hinge portion is flexible, such that the first arm assembly and the second arm assembly are configured to pivot about the hinge portion from a first open position of the atrial clamping assembly to a second closed position of the atrial clamping assembly.

2. The atrial clamping assembly according to claim 1, wherein the hinge further comprises: A base member extending between a first end of the first arm body and a first end of the second arm body; A first support protrusion extending from a first portion of the base member and a second support protrusion extending from a second portion, wherein a central gap is formed between the surfaces of the first support protrusion and the second support protrusion; A first engagement protrusion, extending upward from a third portion of the base member along the axis of the first engagement protrusion, includes: A first inner protrusion extends from a first portion of the first engaging protrusion in a direction perpendicular to the axis of the first engaging protrusion. Specifically, when the atrial clamping assembly is in the first open position, the first inner protrusion is not disposed within the first portion of the central gap, and when the atrial clamping assembly is in the second closed position, the first inner protrusion is disposed within the first portion of the central gap, such that the contact between the surface of the first inner protrusion and the first portion of the surface of the first support protrusion or the first portion of the surface of the second support protrusion prevents the hinge portion from twisting or warping.

3. The atrial clamping assembly according to claim 2, wherein the hinge further comprises: A second engagement protrusion, extending upward from the fourth portion of the base member along the axis of the second engagement protrusion, includes: The second inner protrusion extends from the first portion of the second engaging protrusion in a direction perpendicular to the axis of the second engaging protrusion. Specifically, when the atrial clamping assembly is in the first open position, the second inner protrusion is not disposed within the second portion of the central gap, and when the atrial clamping assembly is in the second closed position, the second inner protrusion is disposed within the second portion of the central gap, such that the contact between the surface of the second inner protrusion and the second portion of the surface of the first support protrusion or the second portion of the surface of the second support protrusion prevents the hinge portion from twisting or warping.

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

5. The atrial clamping assembly according to claim 1, wherein: 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 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 atrial clamping assembly according to claim 1, wherein the second arm assembly further comprises: A second ridge portion extends from a first end to a second end along a second ridge axis, and wherein a first portion of the second ridge portion extends along a corresponding first portion of the second support portion, wherein the first portion of the second ridge portion is disposed within the corresponding first portion of the first support portion; and The second suture, wherein a first portion of the second suture is disposed around the first portion of the second ridge portion, and wherein a second portion of the second suture extends outside the second support portion, wherein the second portion of the first suture is configured to connect 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 clamping 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 configured to be connected to the second portion of the second suture.

8. The atrial clamping assembly according to claim 1, wherein, The hardness of the first ridge portion is greater than the hardness of the first arm body.

9. The atrial clamping assembly according to claim 8, wherein, The first ridge portion is made of metal, and the first support portion of the first arm body is made of plastic.

10. The atrial clamping assembly according to claim 1, wherein, The first end of the first ridge portion is disposed at or near the first end of the first support portion, and the first part of the first ridge portion is disposed between the first end of the first ridge portion and the second end of the first ridge portion.

11. The atrial clamping assembly according to claim 10, wherein, The second end of the first ridge portion is disposed at or near the second end of the first support portion.

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