Left atrial appendage ligation device

Abstract

The invention relates to the technical field of left atrial appendage ligation machinery, and discloses a left atrial appendage ligation device.The left atrial appendage ligation device comprises a guiding sheathing canal, an adjustable bending conveying sheathing canal, a puncture reversing unit, a lasso unit and a line cutting unit, the puncture reversing unit is used for puncturing a left atrial appendage and driving the left atrial appendage to move, and left atrial appendage reversing is achieved; the lasso unit is provided with a lasso ring which can be shrunk and is used for sleeving and closing a left auricle; and the wire cutting unit is used for cutting and binding redundant parts in the left auricle rear lasso unit. According to the left atrial appendage ligation device, by integrating the puncture reverse unit and the lasso unit, ligation of the left atrial appendage is achieved, and the problems that plugging is poor in the left atrial appendage closing process, and many risks such as instrument residue leakage and related thrombus occurrence rate exist are solved.

Description

Technical Field

[0001] The invention belongs to the technical field of left atrial appendage ligation machinery, and in particular relates to a left atrial appendage ligation device. Background Art

[0002] Left atrial appendage closure is an effective treatment for preventing stroke in patients with non-valvular atrial fibrillation. Atrial fibrillation is a common arrhythmia affecting tens of millions of people worldwide. Thrombosis caused by atrial fibrillation is a major cause of stroke. Studies have shown that over 90% of patients with non-valvular atrial fibrillation experience thrombosis in the left atrial appendage (LAA). Therefore, closure of the LAA can effectively reduce the risk of stroke. In recent years, LAA closure has been widely used clinically, with the number of procedures performed annually increasing worldwide. It has become an important option for preventing stroke in patients with atrial fibrillation.

[0003] At present, the left atrial appendage occluder commonly used in clinical practice is mainly implanted through transcatheter interventional technology. Its core design is to place an occluding disc at the opening of the left atrial appendage to block blood from entering the left atrial appendage, thereby preventing thrombosis. However, the existing occluder design has certain limitations. First, the occluding disc needs to fit tightly to the opening of the left atrial appendage, but due to the complex and diverse anatomical structure of the left atrial appendage, some patients may have problems with incomplete occlusion or device displacement, resulting in unsatisfactory surgical results. Secondly, the long-term exposure of the occluding disc to the blood may cause thrombosis on the surface of the device or incomplete endothelialization, increasing the risk of device-related thrombotic events. In addition, the implantation process of the occluding disc may cause mechanical damage to the surrounding tissues and even lead to complications such as pericardial effusion.

[0004] Therefore, in the face of the problems of poor occlusion, easy thrombosis and damage to surrounding tissues in existing left atrial appendage closure surgery, there is an urgent need for a left atrial appendage closure device that has high surgical safety, reduces postoperative complications and is easy to operate. Summary of the Invention

[0005] In order to address the deficiencies of the prior art, the present invention provides a left atrial appendage ligation device that integrates a puncture reversal unit and a lasso unit to achieve left atrial appendage ligation, thereby solving the problems of poor occlusion during left atrial appendage closure, residual leakage of the device, and related thrombosis incidence.

[0006] The technical effects to be achieved by the present invention are achieved through the following technical aspects: The present invention provides a left atrial appendage ligation device, comprising a guide sheath, the proximal end of which is used to connect to a control unit; An adjustable delivery sheath, wherein the adjustable delivery sheath is movably arranged in the guide sheath, and the distal end of the adjustable guide sheath is used to be close to the left atrial appendage; a puncture reversal unit, movably disposed in the adjustable bend delivery sheath, wherein the proximal end of the puncture reversal unit is connected to the control unit, and the distal end of the puncture reversal unit is used to puncture the left atrial appendage and drive the left atrial appendage to move, thereby achieving the reversal of the left atrial appendage; a lasso unit, movably disposed in the adjustable bend delivery sheath, the proximal end of the lasso unit being connected to the control unit, and the distal end of the lasso unit being formed with a retractable lasso loop, the lasso loop being used to snare and close the left atrial appendage; and The wire cutting unit is movably arranged in the adjustable bend delivery sheath, the proximal end of the wire cutting unit is connected to the control unit, and the distal end of the wire cutting unit is provided with a wire cutter.

[0007] In some embodiments, the puncture reversal unit includes a connecting tube, an anchor, a first control rod, and a hemostatic member; The proximal end of the connecting tube is connected to the control unit, and the distal end of the connecting tube is connected to the proximal end of the anchor; The anchor has a spiral structure and a needle-shaped distal end, and the distal end of the anchor moves through the hemostatic element; The first control rod passes through the connecting tube and the anchor, and the proximal end of the first control rod is connected to the control unit, and the distal end of the first control rod is connected to the hemostatic component, and the hemostatic component is used to abut against the inner wall of the left atrial appendage.

[0008] Preferably, the distal end of the connecting tube is connected to a needle seat, and the connecting tube is connected to the anchor through the needle seat; The needle seat is provided with a first through hole for the first control rod to pass through.

[0009] In some embodiments, the puncture reversal unit includes a puncture guide wire, a puncture needle, a dilator, and an anchoring structure; The puncture needle is a hollow structure, so that the puncture guide wire can be movably passed through the puncture needle, and the distal end of the puncture guide wire reaches the outside of the left atrial appendage under the guidance of the puncture needle; The dilator is a hollow structure, so that the puncture guide wire can be movably passed through the dilator, and the dilator reaches the outer wall of the left atrial appendage under the guidance of the puncture guide wire. The distal end of the dilator is provided with an expansion part, and the outer diameter of the expansion part gradually decreases from the proximal end to the distal end, so as to expand on the basis of puncture by the puncture needle and form an opening on the side wall of the left atrial appendage; The anchoring structure passes through the opening and abuts against the outer side wall of the left atrial appendage to drive the side wall of the left atrial appendage to move inward.

[0010] Preferably, the puncture reversal unit also includes a hemostatic piece fixedly connected to the distal end of the adjustable bend guide sheath, the hemostatic piece includes a hemostatic material whose outer diameter gradually increases toward the distal end, and the hemostatic material is provided with a hollow structure for facilitating the passage of the puncture needle and the expander, and the hemostatic material is used to abut against the inner wall of the left atrial appendage.

[0011] Preferably, the hemostatic member further comprises an adaptive member connected to the interior of the hemostatic material, wherein the adaptive member is provided with a connecting portion and a plurality of adaptive ribs connected to the connecting portion; The connecting portion is located at the proximal end of the hemostatic material and is used for connecting the hemostatic material and the adjustable bend delivery sheath; The adaptive ribs are radially distributed from the connecting portion toward the hemostatic material, and the adaptive ribs are connected to the inner side of the hemostatic material to maintain the structural form of the hemostatic material.

[0012] Preferably, the anchoring structure comprises a control body and an anchoring arm, wherein the control body semi-encloses a control area, and at an open portion of the control area, two ends of the control body are respectively connected to the anchoring arm; The puncture reversal unit further comprises: a second control rod, a proximal end of the second control rod being connected to the control unit and a distal end of the second control rod being connected to the control body to control the movement of the anchoring structure; and A third control rod is movably provided on the second control rod and passes through the control body. The distal end of the third control rod is connected to a control ball, and the control ball is located in the control area. Driven by the third control rod, the control ball approaches the opening of the control area to expand the opening and make the two anchoring arms relatively open and used to abut against the outer wall of the left atrial appendage.

[0013] Preferably, the lasso unit comprises a sheath, a lasso line and a tightening line; The lasso wire is movably inserted into the sheath, and a pre-bent elastic structure is provided at the distal end of the lasso wire to facilitate guiding the sheath and the tightening wire to form a lasso loop at the distal end; the distal end of the lasso wire is a free end to facilitate the withdrawal of the lasso wire after the lasso is completed; The tightening wire is passed through the sheath, and a sliding knot is formed between the portion of the tightening wire located at the distal end of the sheath and the sheath to connect the tightening wire and the sheath and form the noose loop.

[0014] In some embodiments, the lasso wire includes a support segment; The pre-bent elastic structure includes a first bending section and a second bending section connected in sequence to the distal end of the support section, the small angle formed between the support section and the first bending section is an angle a, and the small angle formed between the first bending section and the second bending section is an angle b, wherein 100°≤a≤160°, 25°≤b≤90°.

[0015] Preferably, the lasso unit further comprises a tightening tube, the distal end of the tightening tube is connected to a pushing structure, the sheath is passed through the pushing structure, and the pushing structure is close to the sliding knot to push the sliding knot and adjust the size of the lasso loop.

[0016] In summary, the present invention has at least the following benefits: 1. The left atrial appendage ligation device provided by the present invention integrates a puncture reversal unit and a lasso unit, wherein the puncture reversal unit punctures the left atrial appendage and drives the left atrial appendage, causing the left atrial appendage to retract from a protruding state relative to the heart to the inside of the heart, thereby achieving left atrial appendage reversal, and the lasso unit ligates the root of the reversed left atrial appendage. The left atrial appendage ligation device achieves left atrial appendage closure through a lasso loop, making the lasso loop the only part that is in direct contact with blood, thereby reducing the incidence of device-related thrombosis and avoiding the probability of residual shunt around the device. In addition, compared with the occluder, the combination of the puncture reversal unit and the lasso unit has a smaller size and can be operated through peripheral blood vessels to reduce trauma. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 Schematic diagram of the structure of the wire cutting unit according to embodiment 1 of the present invention.

[0018] Figure 2 This is a schematic structural diagram of the adjustable bend delivery sheath and puncture inversion unit of Example 1 of the present invention.

[0019] Figure 3 This is a schematic structural diagram of the anchor pin and needle seat of Example 1 of the present invention.

[0020] Figure 4 and Figure 5 Schematic diagrams of the structures of the puncture inversion unit and the left atrial appendage in the initial state and the anchoring state respectively according to Example 1 of the present invention.

[0021] Figure 6 Schematic diagram of the structure of the sliding noose of the lasso unit in embodiment 1 of the present invention.

[0022] Figure 7 Schematic diagram of the structure of the lasso unit of embodiment 1 of the present invention.

[0023] Figure 8 for Figure 7 A partial enlarged schematic diagram of part A.

[0024] Figure 9 and Figure 10 Schematic diagram of the structure of the lasso loop of different shapes according to Example 1 of the present invention.

[0025] Figure 11 This is a structural diagram of the secondary shaping of the lasso unit in Example 1 of the present invention.

[0026] Figures 12 to 21 Schematic diagram of the various operating steps of the left atrial appendage ligation device according to Example 1 of the present invention.

[0027] Figure 22 This is a schematic structural diagram of the adjustable bend delivery sheath and hemostatic component of Example 2 of the present invention.

[0028] Figure 23 This is a schematic diagram of the structure of the puncture sheath tube, puncture needle and puncture guide wire of Example 2 of the present invention.

[0029] Figure 24 This is a schematic structural diagram of the adjustable bend delivery sheath, dilator, and puncture guidewire of Example 2 of the present invention.

[0030] Figure 25 This is a schematic structural diagram of the hemostatic device according to embodiment 2 of the present invention.

[0031] Figure 26 Schematic diagram of the explosion of the hemostatic device according to embodiment 2 of the present invention.

[0032] Figure 27 This is a structural diagram of the anchoring structure of Example 2 of the present invention.

[0033] Figure 28 Schematic diagram of the structure of the anchoring structure and the second control rod of Example 2 of the present invention.

[0034] Figure 29 and Figure 30 Schematic diagrams of the structures of the anchoring structure in the initial state and the anchoring state according to Example 2 of the present invention respectively.

[0035] Figure 31 This is a structural schematic diagram of the anchoring structure of Example 2 of the present invention and the left atrial appendage when they are in an anchored state.

[0036] Figure 32 Schematic diagram of the structure of the control ball and the third control rod according to embodiment 2 of the present invention.

[0037] Figures 33 to 38 Schematic diagram of the various operating steps of the left atrial appendage ligation device according to Example 2 of the present invention.

[0038] Markings in the figure: 1. Guide sheath; 2. Adjustable bend delivery sheath; 3. Puncture reversing unit; 31. Connecting tube; 32. Anchor; 321. Needle holder; 322. First through hole; 33. First control rod; 34. Hemostatic member; 341. Hemostatic material; 342. Adaptive member; 3421. Connecting portion; 3422. Adaptive rib; 3423. Connecting hole; 35. Puncture sheath; 36. Puncture guidewire; 37. Puncture needle; 38. Dilator; 381. Dilator; 39. Anchoring structure; 391. Control body; 3911. Control area; 3912. Transition portion; 3913. Second through hole; 392. Anchoring arm; 4. Lasso unit; 41. Sheath; 42. Lasso line; 421. First bending section; 422. Second bending section; 423. Support section; 43. Tightening line; 431. Sliding slipknot; 44. Tightening tube; 45. Pushing structure; 5. Wire cutting unit; 51. Wire cutting guide; 52. Wire cutter; 61. Second control rod; 612. Connecting piece; 62. Third control rod; 63. Control ball. DETAILED DESCRIPTION

[0039] To make the purpose, technical solutions and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. The described embodiments are only part of the embodiments of the present invention, not all of the embodiments.

[0040] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention as claimed, but rather merely represents selected embodiments of the present invention. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without creative effort are also within the scope of protection of the present invention.

[0041] Example 1: Please see the attached Figures 1 to 21 The present embodiment provides a left atrial appendage ligation device, comprising a guide sheath 1, an adjustable delivery sheath 2, a puncture reversal unit 3, a lasso unit 4, and a wire cutting unit 5.

[0042] The guide sheath 1 is a hollow tube that houses other functional units. The proximal end of the guide sheath 1 is connected to a control unit. The control unit is typically a control handle that controls the movement of other functional units or performs functional operations. The guide sheath 1 is primarily used to establish a surgical channel, guide other functional units into their target locations, and support and secure them.

[0043] The adjustable bend delivery sheath 2 is movably arranged in the guide sheath 1. The distal end of the adjustable bend guide sheath 1 is used to approach the left atrial appendage, and the proximal end is used to connect with the control handle. The adjustable bend delivery sheath 2 is a hollow structure, which is used to flexibly adjust the bending angle and to accommodate the puncture reversal unit 3, the lasso unit 4 and the wire cutting unit 5 to guide these units to accurately reach the target position.

[0044] Among them, the puncture reversal unit 3 is movably arranged in the adjustable bend delivery sheath 2, the proximal end of the puncture reversal unit 3 is used to connect with the control unit, and the distal end of the puncture reversal unit 3 is used to puncture the left atrial appendage and drive the left atrial appendage to move, thereby realizing the reversal of the left atrial appendage.

[0045] The lasso unit 4 is movably arranged in the adjustable bend delivery sheath 2. The proximal end of the lasso unit 4 is connected to the control unit. The distal end of the lasso unit 4 is formed with a retractable lasso loop, which is used to snare the root of the left atrial appendage after reversal. The closure of the left atrial appendage is achieved by continuously shrinking the lasso loop.

[0046] The wire cutting unit 5 is movably arranged in the adjustable bend delivery sheath 2, and the proximal end of the wire cutting unit 5 is connected to the control unit. Figure 1 As shown, the wire cutting unit 5 includes a wire cutting catheter 51 and a wire cutter 52 connected to the distal end of the wire cutting catheter 51. After the lasso loop is reduced and the left atrial appendage is closed, the wire cutter 52 cuts the excess part outside the lasso loop, and finally completes the left atrial appendage ligation operation.

[0047] The left atrial appendage ligation device achieves left atrial appendage closure through a lasso, making the lasso the only part in direct contact with blood, thereby reducing the incidence of device-related thrombosis and avoiding the probability of residual shunt around the device.

[0048] The following is an example of a specific structure: like Figure 1 As shown, the puncture reversal unit 3 includes a connecting tube 31, a first control rod 33, an anchor 32 and a hemostatic component 34. Among them, the proximal end of the connecting tube 31 is connected to the control unit, and the distal end of the connecting tube 31 is connected to the proximal end of the anchor 32. The anchor 32 has a spiral structure and a needle-shaped distal end, and the distal end of the anchor 32 can move through the hemostatic component 34. During use, the connecting tube 31 can drive the anchor 32 to move to control the anchor 32 to penetrate or retract into the hemostatic component 34. Preferably, the anchor 32 is made of metal or alloy such as stainless steel, nickel titanium or cobalt chromium alloy to ensure stable puncture of the left atrial appendage. The connecting tube 31 is preferably made of stainless steel, nickel titanium, peek or PI, and the connecting tube 31 is a hollow, tightly wound multi-strand tube with both flexibility and strength.

[0049] A first control rod 33 is provided through the connecting tube 31 and the anchor 32, with the proximal end of the first control rod 33 connected to the control unit, and the distal end of the first control rod 33 connected to the hemostatic member 34. Under the action of the first control rod 33, the hemostatic member 34 moves closer to or further away from the inner wall of the left atrial appendage. When the anchor 32 penetrates the hemostatic member 34 and punctures the left atrial appendage, the hemostatic member 34 abuts against the inner wall of the left atrial appendage to prevent bleeding, particularly blocking blood flow from the left atrial appendage to the pericardium, thereby improving the safety of the left atrial appendage ligation device during use. Preferably, in this embodiment, the hemostatic member 34 is a cylindrical thick pad structure, and the material of the hemostatic member 34 is polycarbonate polyurethane, silicone polyurethane copolymer, or the like.

[0050] Furthermore, to enhance the stability of the connection between the connecting tube 31 and the anchor 32, a needle hub 321 is provided between the connecting tube 31 and the anchor 32. The distal end of the connecting tube 31 is connected to the proximal end of the needle hub 321, and the distal end of the needle hub 321 is connected to the anchor 32. Furthermore, a first through hole 322 is provided in the center of the needle hub 321 to facilitate the passage of the first control rod 33 and its connection with the hemostatic member 34.

[0051] In the initial state of the puncture reversal unit 3, the hemostatic component 34 is relatively located at the distal end of the anchor 32, and the anchor 32 is screwed into the hemostatic component 34, and the needle tip of the anchor 32 is kept flush with the distal end of the hemostatic component 34. During use, the hemostatic component 34 is pressed against the atrial appendage wall, the fixing rod of the hemostatic component 34 is kept stationary, and the connecting tube 31 is driven so that the anchor 32 passes through the hemostatic component 34 and is screwed into the left atrial appendage wall and reaches the outside of the atrial appendage to achieve anchoring. It should be noted that during the puncture process of the anchor 32, the distal end of the hemostatic component 34 must always be kept close to the atrial appendage wall. When the puncture reversal unit 3 is withdrawn, under the anchoring action of the anchor 32, the side wall of the left atrial appendage moves with the movement of the puncture reversal unit 3, and is pulled back from the outside of the left atrium to the inside of the left atrium to achieve left atrial appendage reversal.

[0052] After the left atrial appendage is reversed, the lasso unit 4 needs to be used for contraction and closure. Figures 6 to 8 The lasso unit 4 includes a sheath 41, a lasso wire 42, and a tightening wire 43. The lasso wire 42 is movably threaded within the sheath 41. A pre-bent elastic structure is formed near the distal end of the lasso wire 42 to facilitate guiding the sheath 41 and the tightening wire 43 to form a lasso loop at the distal end of the lasso unit 4. In other words, the lasso wire 42 acts as a shaped lasso loop, facilitating precise entrapment of the left atrial appendage (LAA), even enabling blind manipulation. The distal end of the lasso wire 42 is free, facilitating its retraction after the lasso unit 4 completes closure of the LAA.

[0053] The tightening line 43 is passed through the sheath 41, and the tightening line 43 at the distal end of the sheath 41 forms a sliding knot 431 to connect the tightening line 43 and the sheath 41, and form a noose loop. Figure 9 and Figure 10 The structure of the lasso loop formed under the guidance of the pre-bent elastic structure can be approximately a complete circular structure or a partially arc-shaped structure. It is understandable that the shape of the lasso loop is not specifically limited here.

[0054] Preferably, the lasso wire 42 is made of nickel titanium and is heat-set to obtain a pre-bent elastic structure. In actual use, the lasso wire 42 can also be reshaped. For example, see Figure 11 The lasso wire 42 after secondary shaping is passed through the sheath 41, which guides the sheath 41 to bend in the same direction. Figure 11 The actual lasso unit 4 provided is provided with a lasso wire 42 for secondary shaping, but the structure of the lasso wire 42 is described here based on the direction of the lasso unit 4. The lasso wire 42 includes a support segment 423. The pre-bent elastic structure includes a first bending segment 421 and a second bending segment 422 connected to the distal end of the support segment 423 in sequence. The angle of the small angle formed between the support segment 423 and the first bending segment 421 is a, and the angle of the small angle formed between the first bending segment 421 and the second bending segment 422 is b, wherein 100°≤a≤160°, and 25°≤b≤90°. It should be noted that, under normal conditions, the sheath 41 and the tightening wire 43 and lasso wire 42 passed through the sheath 41 are housed in the adjustable bend delivery sheath 2 in the form of a straight line as a whole. When snaring is required, the sheath 41 and the tightening wire 43 and the lasso wire 42 housed therein extend from the distal end of the adjustable bend delivery sheath 2. At this time, the pre-bent elastic structure recovers, and a lasso loop is formed at the distal end of the lasso unit 4, so as to snare the left atrial appendage.

[0055] In this embodiment, the tightening line 43 is a section of U-shaped wound polymer line, which is used to ligate the reversed left atrial appendage. The sheath 41 is a section of hollow braided polymer tube. Among them, the sliding slipknot 431 is preferably a fisherman's knot. As a one-way knot, the fisherman's knot can prevent the sheath 41 from rebounding in the opposite direction and avoid ligation failure. During the process of ligating the atrial appendage, the tightening line 43 is tightened and the sliding slipknot 431 is pushed, so that the contact area between the sheath 41 and the atrial appendage is gradually reduced until the purpose of ligating the left atrial appendage is achieved. In particular, after the sheath 41 and the left atrial appendage are ligated, the lasso line 42 is withdrawn, and the sliding slipknot 431 is continued to be pushed to further tighten the root of the left atrial appendage to ensure that the ligation is stable. Preferably, the material of the tightening line 43 and the sheath 41 is PET, PE or e-ptfe, etc.

[0056] Furthermore, if Figure 8As shown, to facilitate pushing the sliding slipknot 431, the lasso unit 4 also includes a tightening tube 44. A pushing structure 45 is connected to the distal end of the tightening tube 44. The sheath 41 is inserted through the pushing structure 45, and the distal end of the pushing structure 45 is positioned adjacent to the sliding slipknot 431 to push the sliding slipknot 431 and adjust the size of the lasso loop. The pushing structure 45 can be integrally formed with the tightening tube 44, or it can be a pusher or other structure fixedly connected to the tightening tube 44. In this embodiment, the pushing structure 45 is connected to the interior of the tightening tube 44. A through hole is provided in the middle of the pushing structure 45 to facilitate passage of the sheath 41. The through hole is shaped like a racetrack. The distal end of the pushing structure 45 is positioned adjacent to the sliding slipknot 431. The through hole of the pushing structure 45 should not be too large to prevent the pushing structure 45 from being unable to push the sliding slipknot 431. During use, the tightening tube 44 is controlled to cause the pushing structure 45 to push the sliding slipknot 431 forward, tightening the lasso loop and ligating the atrial appendage. In this embodiment, the tightening tube 44 is a hollow single-layer tube, the distal end of which is fixedly connected to the pusher. The pusher is made of stainless steel, peek or PI.

[0057] like Figure 1 As shown, the wire cutting conduit 51 of the wire cutting unit 5 is a section of internal hollow conduit, and a wire cutter 52 is provided at the distal end of the wire cutting conduit 51. The structure of the wire cutter 52 is a conventional design and can be used to cut the sheath 41 and tighten the wire 43.

[0058] In order to further reduce the damage to the human body during the operation of the left atrial appendage ligation device, the puncture reversal unit 3 also includes a puncture sheath tube 35. Figure 5 As shown, the puncture reversal unit 3 is movably installed in the puncture sheath tube 35 to protect the heart from being damaged by the anchor 32 and to prevent the puncture reversal unit 3 from scratching the heart tissue during the bending process before reaching the target position. The puncture sheath tube 35 is movably installed in the adjustable delivery sheath tube 2.

[0059] The operation process of the left atrial appendage ligation device of this embodiment is described below: The patient undergoes atrial septal puncture through the peripheral blood vessels, and the guide sheath 1 is introduced. The adjustable bend delivery sheath 2 is delivered along the guide sheath 1 to the left atrial appendage, and then the puncture reversal unit 3 is adjusted so that the distal end of the puncture sheath 35 is at the distal end of the left atrial appendage. Figure 12 As shown; The puncture sheath 35 is withdrawn to expose the structure composed of the connecting tube 31, the anchor 32, the first control rod 33 and the hemostatic member 34, and the hemostatic member 34 is controlled and placed close to the inner wall of the left atrial appendage. Figure 13 As shown; By driving the connecting tube 31, the anchor 32 rotates and passes through the hemostatic piece 34 and the side wall of the left atrial appendage in sequence to anchor the left atrial appendage. During this process, the hemostatic piece 34 remains in contact with the inner wall of the left atrial appendage. Figure 14 As shown; The adjustable bend delivery sheath 2 and the puncture reversal unit 3 are withdrawn to drive the left atrial appendage to move toward the inside of the heart, so that the left atrial appendage is reversed. Figure 15 As shown; The lasso unit 4 is delivered from the guide sheath 1 along the adjustable bend delivery sheath 2 until the distal end of the lasso unit 4 reaches the root of the left atrial appendage. The sheath 41 and the tightening wire 43 and lasso wire 42 contained in the sheath 41 extend from the distal end of the guide sheath 1. At this time, a lasso loop is formed at the distal end of the lasso unit 4 to loop around the root of the left atrial appendage after the inversion. Figure 16 and Figure 17 As shown; Along the lasso unit 4, the tightening tube 44 is sent into the guide sheath 1, and the pusher is controlled by the tightening tube 44 to push the sliding knot 431 to reduce the lasso loop so that the root of the left atrial appendage is tightened. Figure 18 As shown; Drive the connecting tube 31 to reversely rotate the anchor 32 from the left atrial appendage wall, while keeping the hemostatic element 34 immobile, withdraw the anchor 32 into the adjustable bend delivery sheath 2, reclaim the lasso line 42 in the lasso unit 4, and continue to push the tightening tube 44, push the sliding knot 431, further tighten the lasso loop, and then tighten the left atrial appendage root, as shown in FIG. Figure 19 As shown; The tightening tube 44 is withdrawn and the self-guiding sheath 1 is fed into the cutting unit 5 to the proximal end of the sliding knot 431 to cut the sheath 41 and the tightening wire 43 in the sheath 41 to complete the closure of the left atrial appendage. Figure 20 As shown; The guiding sheath 1 and other structures in the guiding sheath 1 are withdrawn, and the patient is hemostatically controlled, and the operation is completed. Figure 21 shown.

[0060] The peripheral blood vessel may be the femoral vein or the jugular vein.

[0061] Example 2: The difference between this embodiment and embodiment 1 is that this embodiment provides another structure of the puncture reversal unit 3 .

[0062] Please refer to Figures 22 to 38In this embodiment, the puncture reversal unit 3 includes a puncture guidewire 36, a puncture needle 37, a dilator 38 and an anchoring structure 39. Among them, the puncture needle 37 is a hollow structure, which is conducive to the puncture guidewire 36 being movably inserted into the puncture needle 37, so that the distal end of the puncture guidewire 36 reaches the outside of the left atrial appendage under the guidance of the puncture needle 37. The distal end of the puncture needle 37 is a needle with a bevel, and the proximal end of the puncture needle 37 is connected to the control handle. Preferably, the puncture needle 37 and the control handle are also connected by a flexible spring tube or a snake tube structure to increase flexibility and accuracy. In addition, the distal end of the puncture guidewire 36 is preferably in a "J" shape to prevent the puncture guidewire 36 from easily loosening from the puncture opening and to protect the pericardium, and the specifications of the puncture guidewire 36 can be 0.018''-0.035''.

[0063] The dilator 38 is a hollow structure, and the puncture guidewire 36 is movably provided in the dilator 38. The dilator 38 reaches the outer wall of the left atrial appendage under the guidance of the puncture guidewire 36. During use, the puncture needle 37 punctures the side wall of the left atrial appendage, and then the puncture guidewire 36 reaches the outer side of the side wall of the left atrial appendage under the guidance of the puncture needle 37. The puncture needle 37 is withdrawn, and then the proximal end of the puncture guidewire 36 is passed through the dilator 38, that is, the dilator 38 moves along the puncture guidewire 36 until the distal end of the dilator 38 reaches the side wall of the left atrial appendage. The distal end of the dilator 38 is provided with an expansion part 381, and the outer diameter of the expansion part 381 gradually decreases from the proximal end to the distal end to enlarge the puncture port obtained by the puncture needle 37, and then an opening is formed on the side wall of the left atrial appendage, thereby facilitating the anchoring structure 39 and the puncture sheath tube 35 to pass through the side wall of the left atrial appendage.

[0064] After the opening is formed, the anchoring structure 39 passes through the opening and abuts against the outer wall of the left atrial appendage to achieve anchoring of the left atrial appendage. The side wall of the left atrial appendage moves with the movement of the anchoring structure 39, and the left atrial appendage is pulled back from the outside of the left atrium to the inside of the left atrium to achieve reversal of the left atrial appendage.

[0065] Similar to embodiment 1, the puncture reversal unit 3 further includes a puncture sheath tube 35. Figure 22 and Figure 23 The puncture guide wire 36 , the puncture needle 37 , the dilator 38 and the anchoring structure 39 are movably arranged in the puncture sheath tube 35 , and the puncture sheath tube 35 is movably arranged in the adjustable bend delivery sheath tube 2 .

[0066] In particular, in this embodiment, the distal end of the adjustable delivery sheath 2 is connected to a hemostatic member 34. Figure 25 and Figure 26 As shown, the hemostatic piece 34 includes a hemostatic material 341 whose outer diameter gradually increases toward the distal end, and the hemostatic material 341 is provided with a hollow structure for puncture needle 37 and expander 38 to pass through. The hemostatic piece 34 abuts against the inner wall of the left atrial appendage to prevent blood in the left atrial appendage from overflowing into the pericardium when puncturing the atrial appendage.

[0067] Specifically, the hemostatic member 34 also includes an adaptive member 342 connected to the interior of the hemostatic material 341. The adaptive member 342 has a connecting portion 3421 and a plurality of adaptive ribs 3422 connected to the connecting portion 3421. The connecting portion 3421 protrudes relatively from the proximal end of the hemostatic material 341 and is used to connect the hemostatic material 341 to the adjustable delivery sheath 2. The adaptive ribs 3422 are radially distributed from the connecting portion 3421 toward the hemostatic material 341 and are connected to the inner side of the hemostatic material 341 to maintain the tapered shape of the hemostatic material 341.

[0068] In this embodiment, the connecting portion 3421 is provided with a connecting hole 3423, which is used to connect the connecting portion 3421 to the adjustable delivery sheath 2. It is understood that this is not a limitation on the connection method, and the connection method can also be adhesive bonding or other structures. Preferably, the adaptive member 342 is made of nickel-titanium shape memory metal, and the hemostatic material 341 is made of polycarbonate polyurethane and silicone polyurethane copolymer.

[0069] Furthermore, if Figure 27 As shown, the anchoring structure 39 includes a control body 391 and an anchoring arm 392. The control body 391 as a whole is approximately a circular structure with an open mouth, so the control body 391 semi-encloses a control area 3911. At the open mouth, the two ends of the control body 391 are respectively connected to the anchoring arm 392. In the initial state, the anchoring arm 392 as a whole extends in the direction from the proximal end to the distal end to ensure that the anchoring arm 392 can pass through the opening of the side wall of the left atrial appendage and reach the outside of the left atrial appendage. Preferably, the distal end of the anchoring arm 392 is preferably arc-shaped to prevent the anchoring arm 392 from cutting the left atrial appendage. Furthermore, a polymer braided sheath can be provided on the anchoring arm 392 to protect the atrial appendage wall.

[0070] It should be noted that the puncture reversal unit 3 also includes a second control rod 61. The proximal end of the second control rod 61 is connected to the control unit, and the distal end of the second control rod 61 is connected to the proximal end of the control body 391 to control the movement of the anchoring structure 39. The opening of the control body 391 is located at the distal end of the control body 391 and is aligned with the second control rod 61, so that the second control rod 61 can adjust the position of the anchoring structure 39. Optionally, the second control rod 61 can be a snake tube, a braided tube, or a spring tube, and can be made of stainless steel, PEK, nickel titanium, or PI, etc.

[0071] In addition, the puncture reversal unit 3 also includes a third control rod 62. The second control rod 61 is a hollow structure. The third control rod 62 is disposed through the second control rod 61. The distal end of the third control rod 62 passes through the control body 391 and is connected to a control ball 63. The control ball 63 is located within the control area 3911. Driven by the third control rod 62, the control ball 63 approaches the opening of the control area 3911, thereby expanding the opening and causing the two anchoring arms 392 to open relative to each other, achieving contact between the anchoring arms and the outer wall of the left atrial appendage. Optionally, the third control rod 62 and the control ball 63 are made of stainless steel or nickel titanium.

[0072] Specifically, refer to Figures 29 to 31 Under the action of the third control rod 62, the control ball 63 reaches and expands the opening, causing the control body 391 to deform, driving the anchoring arm 392 to rotate about the end of the opening, causing the anchoring arm 392 to rotate from its initial state of extending in a proximal-to-distal direction to a state of extending tangentially to the opening. At this point, the two anchoring arms 392 are relatively open. The expansion of the anchoring arms 392 helps them abut the outer wall of the left atrial appendage, achieving final anchoring of the left atrial appendage.

[0073] It should be noted that, in the initial state, the control ball 63 is close to the proximal end of the control body 391 to ensure that the anchoring arms 392 are in a relatively retracted state.

[0074] The control body 391 and the anchoring arm 392 can be a symmetrical structure formed in one piece. In particular, the control body 391 is symmetrically provided with a transition portion 3912, which is an arc-shaped structure that further protrudes outward, which helps to ensure that the anchoring arm 392 abuts against the outer wall of the left atrial appendage after it is opened.

[0075] Furthermore, the control body 391 of the anchoring structure 39 has a second through-hole 3913 at its proximal end, which is used to accommodate the second control rod 61. The distal end of the second control rod 61 passes through the control body 391 and is connected to a connector 612. The connector 612 may have through-holes for the second and third control rods 61, 62. In this embodiment, the connector 612 is a circular ring disk and can be made of materials such as stainless steel, Peek, and PI.

[0076] The control ball 63 may be a solid sphere, and a blind hole for connecting with the third control rod 62 is provided at its proximal end.

[0077] Similar to Example 1, the left atrial appendage ligation device also includes a guide sheath 1, an adjustable bend delivery sheath 2, a lasso unit 4, and a thread cutting unit 5. The adjustable bend delivery sheath 2 is movably disposed within the guide sheath 1, and the puncture sheath 35 is movably disposed within the adjustable bend delivery sheath 2. The puncture reversing unit 3 is movably disposed within the puncture sheath 35. The lasso unit 4 and the thread cutting unit 5 are movably disposed within the adjustable bend delivery sheath 2. The structures of the guide sheath 1, adjustable bend delivery sheath 2, lasso unit 4, and thread cutting unit 5 of this embodiment are the same as those of Example 1. Please refer to Example 1 for the similarities.

[0078] The operation process of the left atrial appendage ligation device of this embodiment is described below: The patient undergoes atrial septal puncture through the peripheral blood vessels, and the guide sheath 1 is introduced. The adjustable bend delivery sheath 2 is delivered along the guide sheath 1 to the left atrial appendage, and the hemostatic piece 34 at the distal end is adjusted to fit the left atrial appendage. Then the puncture needle 37 is first punctured to the outside of the atrial appendage, and the puncture guide wire 36 is extended along the puncture needle 37. Then the puncture needle 37 is withdrawn, and the dilator 38 is delivered along the puncture guide wire 36 to the outside of the atrial appendage to expand the puncture opening so that the distal end of the puncture sheath tube 35 can reach the outside of the atrial appendage. Figures 33 to 34 As shown; The anchoring structure 39 is delivered to the left atrial appendage along the puncture sheath tube 35, and the anchoring structure 39 is pushed to reach the distal end of the puncture sheath tube 35. It should be noted that the hemostatic member 34 remains stationary at this time. Figure 35 As shown; By moving the third control rod 62 toward the distal end, the anchoring arm 392 of the anchoring structure 39 is opened and abuts against the outer wall of the left atrial appendage, thereby achieving an anchoring effect, keeping the anchoring structure 39 and the hemostatic member 34 in a fixed position relative to the left atrial appendage, and retracting the adjustable bend delivery sheath 2 to drive the left atrial appendage to move toward the direction of the heart through the anchor, so that the left atrial appendage is reversed, as shown in FIG. Figure 36 As shown; The lasso unit 4 is delivered from the guide sheath 1 along the adjustable delivery sheath 2 until the distal end of the sheath 41 reaches the root of the left atrial appendage. The sheath 41, along with the tightening wire 43 and lasso wire 42 housed therein, extends from the distal end of the guide sheath 1. At this point, a lasso loop is formed at the distal end of the lasso unit 4 to encircle the root of the left atrial appendage. The tightening tube 44 is inserted into the guide sheath 1 along the lasso unit 4, and the tightening tube 44 is controlled to cause the pusher to push the sliding knot 431 to reduce the lasso loop, thereby tightening the root of the left atrial appendage. After the initial tightening of the left atrial appendage root, the anchoring structure 39 can be withdrawn. When the anchoring structure 39 is withdrawn, the puncture sheath tube 35 is first pushed so that the anchoring structure 39 is received in the puncture sheath tube 35. At this time, the sheath 41 should be tightened once. When the puncture sheath tube 35 is withdrawn into the adjustable bend puncture delivery sheath, the sheath 41 should be tightened once more. Figure 37 and Figure 38 As shown; The tightening tube 44 is withdrawn and the thread cutting unit 5 is used to cut the thread. This step is the same as the step of using the thread cutting unit 5 in Example 1. The guide sheath 1 and other structures inside the guide sheath 1 are withdrawn to stop bleeding for the patient. The operation is completed.

[0079] In the present invention, unless otherwise expressly specified or limited, the terms "mounted," "connected," "connect," "fixed," etc. should be understood broadly. For example, they may refer to fixed connection, detachable connection, or integration; mechanical connection or electrical connection; direct connection or indirect connection through an intermediate medium; internal communication between two components or interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0080] In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer" and the like indicate positions or locations based on the positions shown in the accompanying drawings, or the positions or locations in which the inventive product is typically placed when in use. These terms are intended solely to facilitate the description of the present invention and to simplify the description, and are not intended to indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," and "third," etc., are used solely to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0081] Furthermore, terms such as "horizontal," "vertical," and "overhanging" do not necessarily imply that a component must be absolutely horizontal or overhanging, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but rather that it can be slightly tilted.

[0082] In the present invention, unless otherwise expressly specified or limited, a first feature being above or below a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Furthermore, a first feature being above, above, and above the second feature includes the first feature being directly above and obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. A first feature being below, below, and below the second feature includes the first feature being directly below and obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0083] Although the present invention has been described with reference to the above specific embodiments, it will be apparent to those skilled in the art that many substitutions, modifications, and variations can be made based on the above. Therefore, all such substitutions, modifications, and variations are intended to be encompassed within the spirit and scope of the appended claims.

Claims

1. A left atrial appendage ligation device, characterized in that: include a guide sheath, the proximal end of which is used to connect to a control unit; An adjustable delivery sheath, wherein the adjustable delivery sheath is movably arranged in the guide sheath, and the distal end of the adjustable guide sheath is used to be close to the left atrial appendage; a puncture reversal unit, movably disposed in the adjustable bend delivery sheath, wherein the proximal end of the puncture reversal unit is connected to the control unit, and the distal end of the puncture reversal unit is used to puncture the left atrial appendage and drive the left atrial appendage to move, thereby achieving the reversal of the left atrial appendage; A lasso unit is movably arranged in the adjustable bend delivery sheath, the proximal end of the lasso unit is connected to the control unit, and the distal end of the lasso unit is formed with a retractable lasso loop, which is used to snare and close the left atrial appendage; as well as The wire cutting unit is movably arranged in the adjustable bend delivery sheath, the proximal end of the wire cutting unit is connected to the control unit, and the distal end of the wire cutting unit is provided with a wire cutter.

2. The left atrial appendage ligation device according to claim 1, characterized in that: The puncture reversal unit includes a connecting tube, an anchor nail, a first control rod and a hemostatic element; The proximal end of the connecting tube is connected to the control unit, and the distal end of the connecting tube is connected to the proximal end of the anchor; The anchor has a spiral structure and a needle-shaped distal end, and the distal end of the anchor moves through the hemostatic element; The first control rod passes through the connecting tube and the anchor, and the proximal end of the first control rod is connected to the control unit, and the distal end of the first control rod is connected to the hemostatic component, and the hemostatic component is used to abut against the inner wall of the left atrial appendage.

3. The left atrial appendage ligation device according to claim 2, characterized in that: The distal end of the connecting tube is connected to a needle seat, and the connecting tube is connected to the anchor through the needle seat; The needle seat is provided with a first through hole for the first control rod to pass through.

4. The left atrial appendage ligation device according to claim 1, characterized in that: The puncture reversal unit includes a puncture guide wire, a puncture needle, a dilator and an anchoring structure; The puncture needle is a hollow structure, so that the puncture guide wire can be movably passed through the puncture needle, and the distal end of the puncture guide wire reaches the outside of the left atrial appendage under the guidance of the puncture needle; The dilator is a hollow structure, so that the puncture guide wire can be movably passed through the dilator, and the dilator reaches the outer wall of the left atrial appendage under the guidance of the puncture guide wire. The distal end of the dilator is provided with an expansion part, and the outer diameter of the expansion part gradually decreases from the proximal end to the distal end, so as to expand on the basis of puncture by the puncture needle and form an opening on the side wall of the left atrial appendage; The anchoring structure passes through the opening and abuts against the outer side wall of the left atrial appendage to drive the side wall of the left atrial appendage to move inward.

5. The left atrial appendage ligation device according to claim 4, characterized in that: The puncture reversal unit also includes a hemostatic piece fixedly connected to the distal end of the adjustable bend guide sheath, the hemostatic piece includes a hemostatic material whose outer diameter gradually increases toward the distal end, and the hemostatic material is provided with a hollow structure for facilitating the passage of the puncture needle and the expander, and the hemostatic material is used to abut the inner wall of the left atrial appendage.

6. The left atrial appendage ligation device according to claim 5, characterized in that: The hemostatic member further comprises an adaptive member connected to the interior of the hemostatic material, wherein the adaptive member is provided with a connecting portion and a plurality of adaptive ribs; The connecting portion is located at the proximal end of the hemostatic material and is used for connecting the hemostatic material and the adjustable bend delivery sheath; The adaptive ribs are radially distributed from the connecting portion toward the hemostatic material, and the adaptive ribs are connected to the inner side of the hemostatic material to maintain the structural form of the hemostatic material.

7. The left atrial appendage ligation device according to claim 4, characterized in that: The anchoring structure includes a control body and an anchoring arm, wherein the control body semi-encloses a control area, and at an open portion of the control area, two ends of the control body are respectively connected to the anchoring arm; The puncture reversal unit further comprises: a second control rod, wherein a proximal end of the second control rod is connected to the control unit and a distal end of the second control rod is connected to the control body to control the movement of the anchoring structure; and A third control rod is movably provided on the second control rod and passes through the control body. The distal end of the third control rod is connected to a control ball, and the control ball is located in the control area. Driven by the third control rod, the control ball approaches the opening of the control area to expand the opening and make the two anchoring arms relatively open and used to abut against the outer wall of the left atrial appendage.

8. The left atrial appendage ligation device according to any one of claims 1 to 7, characterized in that: The lasso unit includes a sheath, a lasso line and a tightening line; The lasso wire is movably inserted into the sheath, and a pre-bent elastic structure is provided at the distal end of the lasso wire to facilitate guiding the sheath and the tightening wire to form a lasso loop at the distal end; the distal end of the lasso wire is a free end to facilitate the withdrawal of the lasso wire after the lasso is completed; The tightening wire is passed through the sheath, and a sliding knot is formed between the portion of the tightening wire located at the distal end of the sheath and the sheath to connect the tightening wire and the sheath and form the noose loop.

9. The left atrial appendage ligation device according to claim 8, characterized in that: The lasso line includes a support segment; The pre-bent elastic structure includes a first bending section and a second bending section connected in sequence to the distal end of the support section, the small angle formed between the support section and the first bending section is an angle a, and the small angle formed between the first bending section and the second bending section is an angle b, wherein 100°≤a≤160°, 25°≤b≤90°.

10. The left atrial appendage ligation device according to claim 8, characterized in that: The lasso unit further comprises a tightening tube, the distal end of which is connected to a pushing structure, the sheath being passed through the pushing structure, and the pushing structure being close to the sliding knot to push the sliding knot and adjust the size of the lasso loop.

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