A left atrial appendage suture device

Abstract

This disclosure provides a left atrial appendage suturing device, applied in the field of medical device technology, comprising: a delivery device, an anchoring device, and a suture device. The delivery device includes a first handle and a sheath mounted on the first handle. The first handle controls the bending of the sheath in different directions and includes a hollow inner cavity. The anchoring device includes a second handle and an anchoring catheter and a push rod connected to the second handle. The anchoring catheter contains a foldable implant and a suture, which allows the foldable implant to be folded. The push rod is located inside the anchoring catheter, which is placed inside the sheath through the hollow inner cavity. The suture device includes a third handle, a suturing catheter, a suturing assembly, and a cutting element. The left atrial appendage suturing device can occlude the left atrial appendage, reducing the occurrence of thrombosis and thus reducing the occurrence of other complications.

Description

Technical Field

[0001] This disclosure relates to the field of medical device technology, and in particular to a left atrial appendage suturing device. Background Technology

[0002] Atrial fibrillation (AF) is one of the most common arrhythmias. During AF, the heart rate is often rapid and irregular, and the atria lose their effective contractile function. Currently, the complication of AF causing cerebral infarction has received widespread attention from clinicians. The cause of this complication is left atrial appendage thrombosis. The left atrial appendage is a long, narrow, and curved blind-ended structure extending anteroinferiorly along the anterior wall of the left atrium. Due to its blind-ended structure, when AF occurs, the atria lose function and beat irregularly. Blood within the atria easily forms eddies at the opening of the left atrial appendage, causing slow blood flow and increasing the risk of thrombus formation. Thrombus detachment can lead to complications such as cerebral infarction, acute occlusion of lower extremity arteries, and mesenteric embolism. Therefore, to prevent complications caused by AF, it is necessary to occlude the left atrial appendage to reduce the risk of thrombus formation. Summary of the Invention

[0003] The purpose of this disclosure is to provide a left atrial appendage suturing device to achieve suturing of the left atrial appendage orifice and thereby reduce the risk of thrombosis. The specific technical solution is as follows:

[0004] This disclosure provides a left atrial appendage suturing device, comprising:

[0005] A conveying device, the conveying device including a first handle and a sheath installed on the first handle, the first handle being used to control the sheath to bend in different directions, the first handle including a hollow inner cavity;

[0006] An anchoring device, the anchoring device including a second handle and an anchoring conduit and a push rod connected to the second handle, the push rod being located inside the anchoring conduit, the anchoring conduit being placed inside the sheath through the hollow inner cavity, the second handle being used to control the movement of the anchoring conduit within the sheath to pierce the myocardial walls on both sides of the left atrial appendage;

[0007] A first folded implant located within the anchoring catheter and a first suture wrapped around the first folded implant, the first folded implant abutting against the second end of the push rod, the first end of the first suture extending out of the anchoring catheter and the first handle, the second end of the first suture having a first knot wrapped around it, the first suture being used to form a folded structure on the inner and outer sides of the myocardial wall on the first side of the left atrial appendage through the first knot;

[0008] The second folded implant is located within the anchoring catheter, and a second suture is wrapped around the second folded implant. The second folded implant abuts against the second end of the push rod. The first end of the second suture extends out of the anchoring catheter and the first handle. The second end of the second suture is wrapped with a second knot. The second suture is used to make the second folded implant form a folded structure on the inner and outer sides of the myocardial wall on the second side of the left atrial appendage through the second knot.

[0009] A suture device, comprising a third handle, a suture conduit, a suture assembly, and a cutting element, wherein after the anchoring device is withdrawn, the suture device is placed within the sheath through the hollow inner cavity, the first suture and the second suture are located within the suture conduit and fixed to the third handle, the suture assembly releases a latch along the first suture and the second suture for locking the first suture and the second suture, the third handle is provided with a pusher for pushing the latch toward a position closer to the left atrial appendage to bring the first suture and the second suture together, thereby suturing the left atrial appendage, and the cutting element is used to cut the first suture and the second suture at the end of the latch near the third handle.

[0010] The left atrial appendage suturing device provided in this embodiment includes a delivery device, an anchoring device, and a suturer. The delivery device includes a first handle and a sheath for delivering surgical instruments used in left atrial appendage suturing. The first handle can control the sheath to bend in different directions during the procedure, allowing the sheath to be aligned with different target positions in the left atrial appendage as needed. The first handle has a hollow inner cavity through which other surgical instruments can pass. The anchoring device includes a second handle, an anchoring conduit, and a push rod. The second handle is connected to the anchoring conduit and the push rod. The push rod is located inside the anchoring conduit, which is placed inside the sheath through the hollow inner cavity. The length of the anchoring conduit is greater than the length of the delivery device, allowing a portion of the anchoring conduit to extend outside the sheath. The second handle controls the movement of the anchoring conduit within the sheath, enabling puncture of the myocardial walls on both sides of the left atrial appendage within the sheath.

[0011] The left atrial appendage suturing device also includes a first folded implant and a first suture. The first suture is wrapped around the first folded implant. The first folded implant and the first suture are located inside an anchoring catheter. The first folded implant abuts against the second end of a push rod, which can push the first folded implant. The first end of the first suture is the end closer to the surgical operating end, extending out of the anchoring catheter and the first handle. The second end of the first suture is the end away from the surgical operating end, and a first knot is wrapped around the second end of the first suture. During the operation, pulling the first suture, through the interaction between the myocardial wall on the first side of the left atrial appendage and the first suture, allows the first folded implant to form a folded structure on the inner and outer sides of the myocardial wall on the first side of the left atrial appendage. This folded structure then comes into close contact with the myocardial wall on the first side of the left atrial appendage. The first suture can move the myocardial wall on the first side of the left atrial appendage through the folded structure.

[0012] The left atrial appendage suturing device also includes a second folded implant and a second suture located within an anchoring catheter. The second suture is wrapped around the second folded implant, which is located within the anchoring catheter. The second end of the push rod abuts against one end of the second folded implant. The first end of the second suture can extend out of the anchoring catheter and the first handle. The second end of the second suture is wrapped with a second knot. The second folded implant and the second suture correspond to the second target position during the left atrial appendage suturing procedure. Similarly to the first folded implant, during the procedure, pulling the second suture allows the second folded implant to form a folded structure on the inner and outer sides of the myocardial wall on the second side of the left atrial appendage through the interaction between the myocardial wall on the second side of the left atrial appendage and the second suture. This folded structure then adheres closely to the myocardial wall on the second side of the left atrial appendage, and the second suture can move the myocardial wall on the second side of the left atrial appendage through the folded structure.

[0013] The suture device includes a third handle, a suture catheter, a suture assembly, and a cutting element. An anchoring device withdraws from the sheath after folding the first and second foldable implants. The suture device can be placed inside the sheath through the hollow cavity along the first and second sutures. The first and second sutures are located inside the suture catheter and fixed to the third handle. The suture assembly releases a locking mechanism along the first and second sutures, which locks the first and second sutures. The third handle has a pusher that moves the locking mechanism closer to the left atrial appendage, causing the first and second sutures to come together. During this process, the aforementioned folding structure brings the myocardial walls on the first and second sides together, thus suturing the left atrial appendage. After the locking mechanism secures the sutures, the cutting element in the suture device cuts the first and second sutures near the third handle, allowing the suture device to be withdrawn from the sheath, completing the left atrial appendage suturing procedure. The left atrial appendage suturing device provided in this embodiment can deliver the folded implant and sutures to the left atrial appendage opening via a delivery device and suture the opening, thereby closing the left atrial appendage opening and greatly reducing the risk of thrombosis.

[0014] In addition, the left atrial appendage suturing device according to the embodiments of this disclosure may also have the following technical features:

[0015] In some embodiments, when the first handle controls the sheath to bend in a first direction, the anchoring catheter moves along the sheath and pierces the myocardial wall on the first side of the left atrial appendage. After piercing the myocardial wall on the first side of the left atrial appendage, the push rod is pushed to allow the foldable implant and the suture to pass through the myocardial wall on the first side of the left atrial appendage. By pulling the first suture, the first foldable implant forms a first overlapping structure on the outer side of the myocardial wall on the first side of the left atrial appendage. Under the action of the first knot, a second overlapping structure is formed on the inner side of the myocardial wall on the first side of the left atrial appendage. The first foldable implant completes the folding.

[0016] When the first handle controls the sheath to bend in the second direction, the anchoring catheter moves along the sheath and pierces the myocardial wall on the second side of the left atrial appendage. After piercing the myocardial wall on the second side of the left atrial appendage, the push rod is pushed to make the foldable implant and the suture extend out of the anchoring catheter and pass through the myocardial wall on the second side of the left atrial appendage. By pulling the second suture, the second foldable implant forms a third overlapping structure on the outer side of the myocardial wall on the second side of the left atrial appendage. Under the action of the second knot, a fourth overlapping structure is formed on the inner side of the myocardial wall on the second side of the left atrial appendage. The second foldable implant completes the folding.

[0017] In some embodiments, the end of the anchoring conduit furthest from the second handle is a beveled cut.

[0018] In some embodiments, the anchoring catheter is provided with a septum that divides the inner lumen of the anchoring catheter into a first cavity and a second cavity. The first cavity is parallel to the length direction of the anchoring catheter, and the guidewire located in the first cavity coincides with the tip of the oblique incision. The first end of the guidewire extends beyond the second handle. The guidewire is used to pierce the myocardial walls on both sides of the left atrial appendage before the anchoring catheter pierces them.

[0019] In some embodiments, the first knot is located where the first foldable implant abuts against the push rod, and the second knot is located where the second foldable implant abuts against the push rod.

[0020] In some embodiments, the second ends of both the first foldable implant and the second foldable implant are provided with a first imaging ring, and the positions of the first knot and the second knot are provided with a second imaging ring. When the distance between the first imaging ring and the second imaging ring is less than 1 mm, it is used to indicate that the first foldable implant and the second foldable implant have completed folding.

[0021] In some embodiments, the third handle is provided with a suture button, which is used to release the latch, which is used to lock the first suture and the second suture, and under the action of the pusher, suture the myocardial walls on both sides of the left atrial appendage.

[0022] In some embodiments, the latch includes a through hole, a sliding groove communicating with the through hole, and a locking member located in the sliding groove, wherein the opening size of the sliding groove at the end near the left atrial appendage myocardial wall is larger than the opening size of the sliding groove at the end away from the left atrial appendage myocardial wall.

[0023] In some embodiments, the second handle is further provided with a fastening button, a loosening button, and a winding device. The winding device includes a drive member and a thread wheel. The fastening button is used to limit the rotation of the thread wheel. The loosening button is used to drive the thread wheel to rotate in a first direction or in a direction opposite to the first direction through the drive member, so that the thread wheel tightens or loosens the thread.

[0024] In some embodiments, the second handle is further provided with a sliding button, which is used to push the push rod to move towards or away from the myocardial wall of the left atrial appendage.

[0025] In some embodiments, the first handle is provided with an actuator for controlling the bending of the sheath in the first direction or the second direction. Attached Figure Description

[0026] To more clearly illustrate the technical solutions in the embodiments of this disclosure or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this disclosure. For those skilled in the art, other drawings can be obtained based on these drawings.

[0027] Figure 1 A schematic diagram illustrating the cooperation between the anchoring device and the conveying device, and the cooperation between the sewing device and the conveying device, provided in the embodiments of this disclosure.

[0028] Figure 2 A schematic diagram of a conveying device provided in an embodiment of this disclosure;

[0029] Figure 3 A schematic diagram of the anchoring device provided in the embodiments of this disclosure;

[0030] Figure 4(a) is a schematic diagram of the suture provided in an embodiment of this disclosure;

[0031] Figure 4(b) is a structural diagram of the latch provided in an embodiment of this disclosure;

[0032] Figure 5 This is a schematic diagram of the internal structure of the anchoring conduit provided in an embodiment of the present disclosure;

[0033] Figure 6 This is a schematic diagram illustrating the interaction between a foldable implant and a suture provided in an embodiment of this disclosure.

[0034] Figures 7(a) and 7(b) are schematic diagrams of the delivery device provided in the embodiments of this disclosure inside the heart;

[0035] Figures 8-12 A schematic diagram of the suturing device provided in this embodiment of the present disclosure fixing the implant at a first target position in the left atrial appendage;

[0036] Figure 13 A schematic diagram of the suturing device provided in this embodiment of the present disclosure fixing the implant at a second target position in the left atrial appendage;

[0037] Figure 14 A schematic diagram of the suture extending from the sheath provided in an embodiment of this disclosure;

[0038] Figure 15 , Figure 16 This is a schematic diagram of the release latch of the suture device provided in an embodiment of this disclosure.

[0039] The attached figures are labeled as follows:

[0040] 10-Delivery device; 11-First handle; 12-Sheath; 110-Actuator; 120-Main tube lumen; 140-Manipulation lumen; 121-Manipulation wire; 20-Anchoring device; 21-Second handle; 22-Anchoring catheter; 223-Baffle; 210-Sliding button; 211-Tightening button; 212-Loosening button; 221-Push rod; 222-Beveled incision; 224-First cavity; 225-Second cavity; 226-Guide wire; 230-Suture wheel; 30-Suturing device; 31-Third handle; 32-Suturing catheter; 311-Suture button; 312-Cut button; 320-Cut element; 321-Cut blade; 322-Cut blade; 40-First folded implant; 50-Second folded implant; 41-First suture; 42-First overlapping structure; 43-Second overlapping structure; 51-Second suture; 52-Third overlapping structure; 53-Fourth overlapping structure; 25-Knot; 23-First imaging ring; 24-Second imaging ring; 33-Lock; 330-Through hole; 331-Locking element; 13-Left atrial appendage; 130-Myocardial wall. Detailed Implementation

[0041] The technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this disclosure, and not all embodiments. Based on the embodiments of this disclosure, all other embodiments obtained by those skilled in the art based on this disclosure are within the scope of protection of this disclosure.

[0042] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0043] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0044] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented, such as rotated 90 degrees or in other directions, and the spatial relative descriptors used in the text will be interpreted accordingly.

[0045] To reduce the risk of blood clot formation in the heart, embodiments of this disclosure provide a left atrial appendage suturing device, such as... Figures 1 to 4(b) As shown, the left atrial appendage suturing device includes a delivery device 10, an anchoring device 20, and a suturer 30. The delivery device 10 includes a first handle 11 and a sheath 12 mounted on the first handle 11. The first handle 11 is used to control the bending of the sheath 12 in different directions, and the first handle 11 includes a hollow inner cavity. The anchoring device 20 includes a second handle 21 and an anchoring conduit 22 and a push rod 221 connected to the second handle 21. The push rod 221 is located inside the anchoring conduit 22. The anchoring conduit 22 is placed inside the sheath 12 through the hollow inner cavity. The length of the anchoring conduit 22 is greater than the length of the delivery device 10. The second handle 21 is used to control the movement of the anchoring conduit 22 within the sheath 12 to puncture the myocardial walls 130 on both sides of the left atrial appendage 13.

[0046] like Figure 5 , Figure 6As shown, the left atrial appendage suturing device also includes a first folded implant 40 located within the anchoring catheter 22 and a first suture 41 wrapped around the first folded implant 40. The first folded implant 40 abuts against the second end of the push rod 221. The first end of the first suture 41 extends out of the anchoring catheter 22 and the first handle 11. The second end of the first suture 41 is wrapped with a first knot 25. The first suture 41 is used to form a folded structure on the inner and outer sides of the myocardial wall on the first side of the left atrial appendage through the first knot 25.

[0047] The left atrial appendage suturing device also includes a second folded implant 50 located within the anchoring catheter 22 and a second suture 51 wrapped around the second folded implant 50. The second folded implant 50 abuts against the second end of the push rod 221. The first end of the second suture 51 extends out of the anchoring catheter 22 and the first handle 11. The second end of the second suture 51 is wrapped with a second knot 25. The second suture 51 is used to form a folded structure on the inner and outer sides of the myocardial wall on the second side of the left atrial appendage through the second knot 25.

[0048] The suture device 30 includes a third handle 31, a suture conduit 32, a suture assembly, and a cutting element 320. After the anchoring device 20 is withdrawn, the suture device 30 is placed inside the sheath 12 through the hollow inner cavity. The first suture 41 and the second suture 51 are located inside the suture conduit 32 and fixed to the third handle 31. The suture assembly releases a latch 33 along the first suture 41 and the second suture 51 to lock the first suture 41 and the second suture 51. The third handle 31 is provided with a pusher for pushing the latch 33 to move closer to the left atrial appendage to bring the first suture 41 and the second suture 51 together, thereby suturing the left atrial appendage. The cutting element 320 is used to cut the first suture 41 and the second suture 51 at the end of the latch 33 near the third handle 31.

[0049] In this embodiment, the left atrial appendage suturing device includes a delivery device 10, an anchoring device 20, and a suture device 30. The delivery device 10 includes a first handle 11 and a sheath 12 for delivering surgical instruments used in left atrial appendage suturing. The first handle 11 can control the sheath 12 to bend in different directions during the operation, so the sheath 12 can be aligned with different target positions in the left atrial appendage, i.e., the positions on both sides of the left atrial appendage, as needed. The first handle 11 has a hollow inner cavity, through which other surgical instruments can pass. The anchoring device 20 includes a second handle 21, an anchoring conduit 22, and a push rod 221. The second handle 21 is connected to the anchoring conduit 22 and the push rod 221. The push rod 221 is located inside the anchoring conduit 22. The anchoring conduit 22 is placed inside the sheath 12 through a hollow inner cavity. The length of the anchoring conduit 22 is greater than the length of the delivery device 10, so a part of the anchoring conduit 22 can extend out of the sheath 12. The second handle 21 can control the movement of the anchoring conduit 22 inside the sheath 12. The anchoring conduit 22 can complete the puncture of the myocardial walls on both sides of the left atrial appendage inside the sheath 12.

[0050] The left atrial appendage suturing device also includes a first folded implant 40 and a first suture 41. The first suture 41 is wrapped around the first folded implant 40. The first folded implant 40 and the first suture 41 are located inside the anchoring catheter 22. The first folded implant 40 abuts against the second end of a push rod 221, which can push the first folded implant 40. The first end of the first suture 41 is closer to the surgical operating end and extends out of the anchoring catheter 22 and the first handle 11. The second end of the first suture 41 is farther away from the surgical operating end. The second end of the first suture 41 is wrapped with a first knot 25. During the operation, pulling the first suture 41 causes the first folded implant 40 to form a folded structure on the inner and outer sides of the myocardial wall on the first side of the left atrial appendage through the interaction force between the myocardial wall on the first side of the left atrial appendage and the first suture 41. This folded structure then comes into close contact with the myocardial wall on the first side of the left atrial appendage. The folded structure, which is in contact with the myocardial wall on the first side of the left atrial appendage, can move the myocardial wall on the first side of the left atrial appendage.

[0051] like Figure 13As shown, the left atrial appendage suturing device also includes a second folded implant 50 and a second suture 51 located within the anchoring catheter 22. The second suture 51 is wrapped around the second folded implant. The second folded implant 50 and the second suture 51 are located within the anchoring catheter 22. The second end of the push rod 221 abuts against one end of the second folded implant 50. The first end of the second suture 51 can extend out of the anchoring catheter 22 and the first handle 11. The second end of the second suture 51 is wrapped with a second knot 25. The second folded implant... The second suture 50 and the second suture 51 correspond to the second target position during the left atrial appendage suturing procedure. Similarly, with the first folded implant, when the second suture 51 is pulled during the procedure, the interaction force between the myocardial wall on the second side of the left atrial appendage and the second suture 51 can cause the second folded implant 50 to form a folded structure on the inner and outer sides of the myocardial wall on the second side of the left atrial appendage. This folded structure then adheres closely to the myocardial wall on the second side of the left atrial appendage, and the folded structure that adheres to the myocardial wall on the second side of the left atrial appendage can drive the movement of the myocardial wall on the second side.

[0052] As shown in Figure 4(a) and Figure 4(b) Figures 14 to 16 As shown, the suture device 30 includes a third handle 31, a suture catheter 32, a suture assembly, and a cutting element 320. After the anchoring device 20 completes the folding of the first foldable implant 40 and the second foldable implant 50, it is withdrawn from the sheath 12. The suture device 30 can be placed in the sheath 12 through the hollow inner cavity along the first suture 41 and the second suture 51. The first suture 41 and the second suture 51 are located in the suture catheter 32 and fixed to the third handle 31. The suture assembly releases the latch 33 along the first suture 41 and the second suture 51. The latch 33 can lock the first suture 41 and the second suture 51. The third handle 31 is provided with a pusher. The pusher pushes the latch 33 to move closer to the left atrial appendage, so that the first suture 41 and the second suture 51 come closer to each other. During the process of the first suture 41 and the second suture 51 coming closer to each other, the aforementioned overlapping structure drives the myocardial wall on the first side and the myocardial wall on the second side to come closer to each other, thereby suturing the left atrial appendage. The cutting element 320 includes a connector and a cutting blade 321. The cutting blade 321 is connected to the cutting button 312 via the connector. The cutting blade 321 also includes a cutting edge 322. The cutting blade 321 has a hole for the first suture 41 to pass through. By pulling the cutting button 312, the cutting blade 321 can be pulled towards the third handle 31. The cutting edge 322 is used to cut the first suture 41 and the second suture 51 at the end of the lock 33 near the third handle 31, and the suture device 30 is withdrawn from the sheath 12, completing the left atrial appendage suturing surgery. The left atrial appendage suturing device provided in this embodiment can deliver the folded implant and sutures to the left atrial appendage opening via the delivery device 10 and suture the left atrial appendage opening, which can close the left atrial appendage opening and greatly reduce the risk of thrombosis.

[0053] Specifically, in related techniques, an occluder umbrella is implanted at the left atrial appendage opening via interventional methods. The occluder umbrella itself is relatively large and heavy, and its connection to human tissue via barbed structures poses a risk of detachment. Furthermore, it is difficult to achieve endothelialization within the body, increasing the risk of thrombosis. Occluder umbrellas often employ a structure of a metal stent and an occlusive membrane. To ensure the self-expansion performance of the occluder umbrella, the metal stent is often made of nickel-titanium alloy; however, excessive release of nickel ions can be harmful to the body. Completely sealing the left atrial appendage structure with the occluder umbrella can cause atrophy of the left atrial appendage due to ischemia. Because the atrial appendage wall is thin, it is difficult to securely hold the occluder umbrella after atrophy, posing a risk of displacement. Intraoperative risks also include occluder embolism. The foldable implant disclosed herein is made of polyester or other common surgical suture materials. It is small in size and weight, and can be firmly connected to the left atrial appendage, effectively reducing the risk of implant dislodgement. This material has good biocompatibility, reduces thrombus formation, and makes the foldable implant safer in the human body. The foldable implant also has good tensile strength, making it less likely to break when the suture pulls on it, thus making the surgical procedure smoother and safer.

[0054] Specifically, the sheath 12 is provided with a main tube cavity 120, an operating cavity 140, and an operating wire 121. A perforation exists between the main tube cavity 120 and the operating cavity 140. The operating wire 121 passes through the operating cavity 140 and enters the main tube cavity 120 via the perforation. The proximal end of the operating wire 121 is fixedly connected to the actuator 110, and the distal end of the operating wire 121 is fixedly connected to the distal end of the sheath 12. The connection method can be welding or bonding. In an exemplary embodiment, the distal end of the operating wire 121 is fixedly connected to the sheath 12 via a pull ring. The operating wire 121 and the pull ring are welded together. The pull ring and the sheath 12 can be connected by thermal bonding. Specifically, the pull ring is sleeved inside the wall of the distal end of the sheath 12, and the pull ring is thermally bonded to the outer elastomer layer of the inner wall of the sheath 12. The connection between the pull ring and the wall of the sheath 12 increases the connection area, thereby improving connection stability. Furthermore, when the control wire 121 is pulled, the sheath 12 is subjected to uniform circumferential force, facilitating bending and deformation of the sheath 12 by the control wire 121. Therefore, by manipulating the actuator 110 to pull the control wire 121, and consequently the distal end of the sheath 12, the bending shape of the distal end of the sheath 12 can be adjusted.

[0055] The distal end mentioned above refers to the end closer to the left atrial appendage, while the proximal end refers to the end farther from the left atrial appendage.

[0056] Specifically, the first foldable implant 40 includes at least three folding forms, such that at least one first folding form is located on the outer side of the myocardial wall to form a first overlapping structure 42, at least one second folding form penetrates the myocardial wall, and the third folding form is located inside the left atrial appendage.

[0057] Furthermore, as shown in Figures 7(a) and 7(b), the sheath 12 is percutaneously inserted to the left atrial appendage opening under the control of the first handle 11, including but not limited to the approach via the jugular vein through the superior vena cava through the interatrial septum to the left atrial appendage opening and the approach via the femoral vein through the inferior vena cava through the interatrial septum to the left atrial appendage opening.

[0058] Furthermore, a cutting button 312 is provided on the third handle 31 to control the cutting element 320 to cut the thread.

[0059] In some embodiments of this disclosure, when the first handle 11 controls the sheath 12 to bend in a first direction, the anchoring catheter 22 moves along the sheath 12 and pierces the myocardial wall on the first side of the left atrial appendage. After piercing the myocardial wall 130 on the first side of the left atrial appendage, the push rod 221 is pushed to allow the folded implant and suture to pass through the myocardial wall on the first side of the left atrial appendage. By pulling the first suture 41, the first folded implant 40 forms a first overlapping structure 42 on the outer side of the myocardial wall on the first side of the left atrial appendage. Under the action of the first knot 25, a second overlapping structure 43 is formed on the inner side of the myocardial wall 130 on the first side of the left atrial appendage. The first folded implant 40 is then folded. When the first handle 11 controls the sheath 12 to bend in the second direction, the anchoring catheter 22 moves along the sheath 12 and pierces the myocardial wall 130 on the second side of the left atrial appendage. After piercing the myocardial wall 130 on the second side of the left atrial appendage, the push rod 221 is pushed to make the folded implant and suture extend out of the anchoring catheter 22 and pass through the myocardial wall 130 on the second side of the left atrial appendage. By pulling the second suture 51, the second folded implant 50 forms a third overlapping structure 52 on the outer side of the myocardial wall 130 on the second side of the left atrial appendage. Under the action of the second knot 25, a fourth overlapping structure 53 is formed on the inner side of the myocardial wall on the second side of the left atrial appendage. The second folded implant 50 is then folded.

[0060] In this embodiment, the first handle 11 can control the sheath 12 to bend along a first direction, so that the anchoring catheter 22 inside the sheath 12 can be aligned with the first target position, namely the position on the first side of the left atrial appendage. Under the drive of external energy, the anchoring catheter 22 can pierce the myocardial wall located on the first side of the left atrial appendage. After piercing the myocardial wall on the first side of the left atrial appendage, as... Figure 9 As shown, by pushing the push rod 221, the foldable implant and suture pass through the myocardial wall on the first side of the left atrial appendage, so that a portion of the foldable implant and suture is located on the outer side of the myocardial wall, pulling the first suture 41, as... Figure 10 and Figure 11 As shown, the force acting on the first suture 41 can cause the first folded implant 40 to change from an extended shape to a folded shape on the outer side of the myocardial wall of the first side of the left atrial appendage, so that the first folded implant forms a first folded structure 42 on the outer side of the myocardial wall at the first target position, and the first suture 41 is further tightened, as... Figure 12 As shown, the first foldable implant can form a second overlapping structure 43 on the inner side of the myocardial wall of the first side of the left atrial appendage under the action of the first knot 25. The first foldable implant 40 forms a first overlapping structure 42 and a second overlapping structure 43 on the outer and inner sides of the myocardial wall, respectively, and the first foldable implant 40 completes the folding.

[0061] The first handle 11 can control the sheath 12 to bend in the second direction, so that the anchoring catheter 22 inside the sheath 12 can be aligned with the second target position, namely the position on the second side of the left atrial appendage. Under the drive of external energy, the anchoring catheter 22 can pierce the myocardial wall located on the second side of the left atrial appendage. After piercing the myocardial wall on the second side of the left atrial appendage, the push rod 221 is pushed to make the folded implant and suture extend out of the anchoring catheter 22 and pass through the myocardial wall on the second side of the left atrial appendage, so that part of the folded implant and suture is located on the outside of the myocardial wall, pulling the second suture 51. The force acting on the second suture 51 can... The second folded implant 50 is changed from an extended shape to a folded shape on the outer side of the second myocardial wall of the left atrial appendage. The second folded implant 50 forms a third overlapping structure 52 on the outer side of the second myocardial wall of the left atrial appendage. By continuing to tighten the second suture 51, the second folded implant can form a fourth overlapping structure 53 on the inner side of the second myocardial wall of the left atrial appendage under the action of the second knot 25. The second folded implant 50 forms the third overlapping structure 52 and the fourth overlapping structure 53 on the outer and inner sides of the second target position of the myocardial wall, respectively. The second folded implant 50 is now folded.

[0062] The first foldable implant 40 and the second foldable implant 50 are respectively implanted on both sides of the left atrial appendage opening, namely the first side and the second side. During the implantation process, the overlapping structure formed drives the myocardial walls on both sides to move, and moves towards the left atrial appendage through the locking buckle 33 released by the suture assembly, so that the first suture 41 and the second suture 51 come closer to each other. The first suture 41 drives the myocardial wall on the first side to move through the first overlapping structure 42 and the second overlapping structure 43, and the second suture 51 drives the myocardial wall on the second side to move through the third overlapping structure 52 and the fourth overlapping structure 53, so that the myocardial walls on both sides of the left atrial appendage come closer to each other and complete the suturing, so as to carry out subsequent surgical procedures.

[0063] like Figure 3 and Figure 5 As shown, in some embodiments of this disclosure, the end of the anchoring catheter 22 away from the second handle 21 is a bevel 222. In embodiments of this disclosure, the bevel 222 at one end of the anchoring catheter 22 makes it easier for the anchoring catheter 22 to penetrate the myocardial wall.

[0064] like Figure 5As shown, in some embodiments of this disclosure, the anchoring catheter 22 is provided with a partition 223, which divides the inner lumen of the anchoring catheter 22 into a first cavity 224 and a second cavity 225. The first cavity 224 is parallel to the length direction of the anchoring catheter 22, and the guide wire 226 located in the first cavity 224 coincides with the tip of the oblique incision 222. The first end of the guide wire 226 extends beyond the second handle 21. Before the anchoring catheter 22 pierces the myocardial walls on both sides of the left atrial appendage, the guide wire 226 is used to pierce the myocardial walls on both sides of the left atrial appendage.

[0065] like Figure 5 and Figure 8 As shown in this embodiment, the anchoring catheter 22 has a first cavity 224 and a second cavity 225 inside, separated by a partition 223. The partition 223 has an exchange hole (not shown). A guidewire 226 is disposed within the first cavity 224. The first end of the guidewire 226 can extend out of the second handle 21. During the pre-installation stage of the anchoring catheter 22, the second end of the guidewire 226 can enter the first cavity 224 through the exchange hole. The second end of the guidewire 226 coincides with the tip of the oblique incision 222, allowing the anchoring catheter 22 to penetrate the myocardial wall 130 along the guidewire 226, thus providing good guidance. During the procedure, the surgeon manipulates the guidewire 226 to penetrate the first target position of the myocardial wall, allowing the anchoring catheter 22 to then pass through the myocardial wall along the guidewire 226. The second cavity 225 can be used to accommodate a foldable implant and sutures. A guidewire 226 is placed inside the anchoring catheter 22 to puncture the myocardial wall. Because the guidewire 226 is thinner, it makes the anchoring catheter 22 easier and smoother during the puncture process. Dividing the inside of the anchoring catheter 22 into a first cavity 224 and a second cavity 225 can separate the guidewire 226 from the folded implant and sutures, avoiding interference between the guidewire 226 and sutures during the operation.

[0066] Furthermore, the guidewire 226 can move within the first cavity 224. An energy source is connected to the first end of the guidewire 226, which can transmit power to the guidewire 226, enabling it to penetrate the myocardial wall. The guidewire 226 can move within the first cavity 224.

[0067] Furthermore, the second cavity 225 is parallel to the first cavity 224.

[0068] In some embodiments of this disclosure, the first knot 25 is located at the position where the first foldable implant 40 abuts against the push rod 221, and the second knot 25 is located at the position where the second foldable implant 50 abuts against the push rod 221.

[0069] In this embodiment, the first knot 25 is located at the position where the first foldable implant 40 abuts against the push rod 221. After the first overlapping structure 42 is formed, when the first suture 41 is pulled further, the first knot 25 can push the first foldable implant 40 to fold outwards towards the myocardial wall, thereby forming the second overlapping structure 43. Similarly, the second knot 25 is located at the position where the second foldable implant 50 abuts against the push rod 221. After the third overlapping structure 52 is formed, when the second suture 51 is pulled further, the second knot can push the second foldable implant 50 to fold outwards towards the myocardial wall 130, thereby forming the fourth overlapping structure 53.

[0070] In some embodiments of this disclosure, the second ends of the first foldable implant 40 and the second foldable implant 50 are provided with a first imaging ring 23, and the positions of the first knot 25 and the second knot 25 are provided with a second imaging ring 24. When the distance between the first imaging ring 23 and the second imaging ring 24 is less than 1 mm, it is used to indicate that the first foldable implant 40 and the second foldable implant 50 have completed folding.

[0071] In this embodiment, during the folding process of the foldable implant, the second imaging ring 24 and the first imaging ring 23 can approach each other. When the distance between the first imaging ring 23 and the second imaging ring 24 is less than 1 mm, the first foldable implant 40 and the second foldable implant 50 are folded. The imaging rings can convert the folding state information of the foldable implant into the distance information between the first imaging ring 23 and the second imaging ring 24, thereby determining whether the foldable implant is fully folded.

[0072] Specifically, the positions of the first contrast ring 23 and the second contrast ring 24 can be monitored by intracardiac ultrasound or digital angiography.

[0073] In some embodiments of this disclosure, the third handle 31 is provided with a suture button 311, which is used to release the latch 33. The latch 33 is used to lock the first suture 41 and the second suture 51, and under the action of the pusher, suture the myocardial walls 130 on both sides of the left atrial appendage.

[0074] In this embodiment, the third handle 31 of the suture device 30 is provided with a suture button 311. The suture button 311 can release the latch 33, which can bring the first suture 41 and the second suture 51 together and fix them relatively. The suture device 30 is provided with a pusher, which can act on the latch 33. After the first foldable implant 40 and the second foldable implant 50 are fully folded, the first suture 41 and the second suture 51 are brought out of the body. At the same time, the first suture 41 and the second suture 51 are pulled to bring the first target position of the myocardial wall 130 closer to the second target position. The suture button 311 can also push the pusher, which pushes the latch 33 to move towards the left atrial appendage. Under cardiac ultrasound monitoring or DSA, the suture is pulled until the left atrial appendage is well closed, then the pusher is stopped. The latch 33 fixes the first suture 41 and the second suture 51 at the position of the closed left atrial appendage.

[0075] As shown in Figure 4(b), in some embodiments of this disclosure, the latch 33 includes a through hole 330, a sliding groove communicating with the through hole 330, and a locking member 331 located in the sliding groove. The opening size of the sliding groove at the end near the left atrial appendage myocardial wall is larger than the opening size of the sliding groove at the end away from the left atrial appendage myocardial wall.

[0076] In this embodiment, the latch 33 includes a through hole 330, a sliding groove, and a locking member 331. The opening size of the sliding groove at the end near the left atrial appendage myocardial wall 130 is larger than the opening size at the end away from the left atrial appendage myocardial wall 130, which allows the latch 33 to tighten the first suture 41 and the second suture 51. When the latch 33 moves away from the left atrial appendage, the latch 33 will be tightened even more to prevent the latch 33 from slipping off.

[0077] In some embodiments of this disclosure, the second handle 21 is further provided with a fastening button 211, a loosening button 212 and a winding device. The winding device includes a drive member and a sewing wheel 230. The fastening button 211 is used to limit the rotation of the sewing wheel 230. The loosening button 212 is used to drive the sewing wheel 230 to rotate in a first direction or in a direction opposite to the first direction through the drive member, so that the sewing wheel 230 tightens or loosens the sewing thread.

[0078] In this embodiment, the winding device is mounted on the second handle 21. The winding device includes a drive member and a suture wheel 230. The first segment of the suture is wound around the suture wheel 230, which controls the tension of the suture. The drive member drives the suture wheel 230 to rotate. When the fastening button 211 on the second handle 21 is pressed, the suture wheel 230 is fixed and cannot rotate. At this time, the first suture 41, the first folded implant 40, and the anchoring catheter 22 remain relatively stationary. When the release button 212 is pressed, the suture wheel 230 can rotate, and the first folded implant 40 can move relative to the anchoring catheter 22.

[0079] In some embodiments of this disclosure, the second handle 21 is also provided with a sliding button 210, which is used to push the push rod 221 to move toward or away from the myocardial wall of the left atrial appendage.

[0080] In this embodiment of the present disclosure, the second handle 21 is also provided with a sliding button 210. The sliding button 210 can control the push rod 221 to move along the anchoring catheter 22 in the second cavity 225 toward the left atrial appendage myocardial wall or away from it, thereby pushing the foldable implant closer to the left atrial appendage myocardial wall, so as to realize the control of the foldable implant at the operating end.

[0081] In some embodiments of this disclosure, the first handle 11 is provided with a driver 110 and an adjustment button 110 for controlling the adjustment sheath 12 to bend in a first direction or a second direction.

[0082] In this embodiment of the present disclosure, the first handle 11 is provided with a driver 110, which can control the bending angle of the sheath 12, thereby adjusting the bending of the sheath 12 in the first direction or the second direction, so that the sheath 12 is aligned with the first target position or the second target position. By directly controlling the bending shape of the sheath 12 through the driver 110, the sheath 12 can be aligned with different target positions in the body, which can make the suturing procedure more convenient and faster, and reduce damage to the human body.

[0083] The above description is merely a preferred embodiment of this disclosure and is not intended to limit the scope of protection of this disclosure. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this disclosure are included within the scope of protection of this disclosure.

Claims

1. A left atrial appendage suturing device, characterized in that, include: A conveying device, comprising a first handle and a sheath mounted on the first handle, the first handle being used to control the sheath to bend in different directions, the first handle comprising a hollow inner cavity; An anchoring device, comprising a second handle and an anchoring conduit and a push rod connected to the second handle, the push rod being located inside the anchoring conduit, the anchoring conduit being placed inside the sheath through a hollow inner cavity, the second handle being used to control the movement of the anchoring conduit within the sheath to pierce the myocardial walls on both sides of the left atrial appendage; The first folded implant is located inside the anchoring catheter and the first suture is wrapped around the first folded implant. The first folded implant abuts against the second end of the push rod. The first end of the first suture extends out of the anchoring catheter and the first handle. The second end of the first suture is wrapped with a first knot. The first suture is used to make the first folded implant form a folded structure on the inner and outer sides of the myocardial wall on the first side of the left atrial appendage through the first knot. The second folded implant is located inside the anchoring catheter and the second suture is wrapped around the second folded implant. The second folded implant abuts against the second end of the push rod. The first end of the second suture extends out of the anchoring catheter and the first handle. The second end of the second suture is wrapped with a second knot. The second suture is used to make the second folded implant form a folded structure on the inner and outer sides of the myocardial wall on the second side of the left atrial appendage through the second knot. The suture device includes a third handle, a suture conduit, a suture assembly, and a cutting element. After the anchoring device is withdrawn, the suture device is placed inside the sheath through a hollow inner cavity. The first and second sutures are located inside the suture conduit and fixed to the third handle. The suture assembly releases a latch along the first and second sutures to lock them in place. The third handle is equipped with a pusher to move the latch closer to the left atrial appendage to bring the first and second sutures together, thereby suturing the left atrial appendage. The cutting element is used to cut the first and second sutures at the end of the latch near the third handle.

2. The left atrial appendage suturing device according to claim 1, characterized in that, When the first handle controls the sheath to bend in the first direction, the anchoring catheter moves along the sheath and pierces the myocardial wall on the first side of the left atrial appendage. After piercing the myocardial wall on the first side of the left atrial appendage, the first foldable implant and the first suture pass through the myocardial wall on the first side of the left atrial appendage by pushing the push rod. By pulling the first suture, the first foldable implant forms a first overlapping structure on the outside of the myocardial wall on the first side of the left atrial appendage. Under the action of the first knot, a second overlapping structure is formed on the inside of the myocardial wall on the first side of the left atrial appendage. The first foldable implant completes the folding. When the first handle controls the sheath to bend in the second direction, the anchoring catheter moves along the sheath and pierces the myocardial wall on the second side of the left atrial appendage. After piercing the myocardial wall on the second side of the left atrial appendage, the second folded implant and the second suture extend out of the anchoring catheter and pass through the myocardial wall on the second side of the left atrial appendage by pushing the push rod. By pulling the second suture, the second folded implant forms a third overlapping structure on the outer side of the myocardial wall on the second side of the left atrial appendage. Under the action of the second knot, a fourth overlapping structure is formed on the inner side of the myocardial wall on the second side of the left atrial appendage. The second folded implant completes its folding.

3. The left atrial appendage suturing device according to claim 1, characterized in that, The end of the anchoring conduit furthest from the second handle has an oblique cut.

4. The left atrial appendage suturing device according to claim 3, characterized in that, The anchoring catheter has a septum that divides the inner lumen of the anchoring catheter into a first cavity and a second cavity. The first cavity is parallel to the length direction of the anchoring catheter, and the guidewire located in the first cavity coincides with the tip of the oblique incision. The first end of the guidewire extends beyond the second handle. Before the anchoring catheter pierces the myocardial walls on both sides of the left atrial appendage, the guidewire is used to pierce the myocardial walls on both sides of the left atrial appendage.

5. The left atrial appendage suturing device according to claim 1, characterized in that, The first knot is located at the position where the first folded implant abuts against the push rod, and the second knot is located at the position where the second folded implant abuts against the push rod.

6. The left atrial appendage suturing device according to claim 5, characterized in that, The first foldable implant and the second foldable implant are both provided with a first imaging ring at their second ends, and a second imaging ring is provided at both the first knot and the second knot positions. When the distance between the first imaging ring and the second imaging ring is less than 1 mm, it is used to indicate that the first foldable implant and the second foldable implant have completed folding.

7. The left atrial appendage suturing device according to claim 1, characterized in that, The third handle is equipped with a suture button, which is used to release the latch. The latch is used to lock the first and second sutures, and under the action of the pusher, sutures the myocardial walls on both sides of the left atrial appendage.

8. The left atrial appendage suturing device according to claim 7, characterized in that, The latch includes a through hole, a sliding groove communicating with the through hole, and a locking element located in the sliding groove. The opening size of the sliding groove at the end near the myocardial wall of the left atrial appendage is larger than the opening size of the sliding groove at the end away from the myocardial wall of the left atrial appendage.

9. The left atrial appendage suturing device according to any one of claims 1-8, characterized in that, The second handle is also equipped with a fastening button, a loosening button, and a winding device. The winding device includes a drive and a thread wheel. The fastening button is used to limit the rotation of the thread wheel, and the loosening button is used to drive the thread wheel to rotate in a first direction or the opposite direction through the drive, so that the thread wheel tightens or loosens the thread.

10. The left atrial appendage suturing device according to any one of claims 1-8, characterized in that, The second handle is also equipped with a sliding button, which is used to push the push rod to move towards or away from the myocardial wall of the left atrial appendage.

11. The left atrial appendage suturing device according to any one of claims 1-8, characterized in that, The first handle is equipped with a driver, which is used to control the bending of the adjustment sheath in a first direction or a second direction.

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