An interventional left atrial appendage ligation device and ligation system having the same

Abstract

The present application relates to the technical field of medical devices, in particular to an interventional left atrial appendage ligation device and a ligation system with the same. The interventional left atrial appendage ligation device comprises a connecting tube, a snare and a suture. The snare is a flexible ring with two built-in channels, and is connected to one end of the connecting tube. A slit is formed on the inner side of the snare corresponding to the position of one of the channels. A deformable skeleton ring is embedded in the other channel of the snare. The suture passes through both ends of the connecting tube, and a one-way knot is tied between the end of the suture and the body of the suture, forming a contractile ligation loop. The ligation loop is embedded in the corresponding channel from the slit. The other end of the suture can be pulled outward relative to the other end of the connecting tube under the action of external force, so that the ligation loop is pulled out and contracted from the slit. Advantage: The structure is reasonable, and the left atrial appendage can be effectively ligated in the heart cavity through percutaneous intervention.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an interventional left atrial appendage ligator and a ligation system having the same. Background Technology

[0002] The left atrial appendage is a long, narrow, tubular blind cavity with an irregular shape and multiple bends. It is about the size of a thumb, with an opening ranging from 10mm to 40mm. The left atrial appendage contains abundant pectinate muscles and trabeculae, making it prone to eddies and slowed blood flow, thus making it a common site for thrombosis.

[0003] Patients with atrial fibrillation (AF) have a significantly increased risk of stroke. Studies suggest that 60% of cardiogenic thrombi in patients with rheumatic heart disease and atrial fibrillation originate from the left atrial appendage (LAA), and 91% of strokes caused by non-valvular atrial fibrillation (AF) are due to thrombi within the LAA. Therefore, removing the LAA will help reduce left atrial thrombosis and stroke events.

[0004] Current clinical treatment methods include oral anticoagulants, radiofrequency ablation, percutaneous left atrial appendage occlusion, and surgical left atrial appendage resection. However, the clinical results of any of these methods are not entirely satisfactory.

[0005] Therefore, left atrial appendage ligation was developed, and corresponding matching instruments were also created. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide an interventional left atrial appendage ligator and a ligation system having the same, which effectively overcomes the defects of the prior art.

[0007] The technical solution of the present invention to solve the above-mentioned technical problems is as follows:

[0008] An interventional left atrial appendage ligation device includes a connecting tube, a snare, and a suture. The snare is a flexible ring with built-in dual channels and is connected to one end of the connecting tube. The inner side of the snare has a slit corresponding to one of the channels, connecting to that channel. A deformable skeleton ring is embedded in the other channel of the snare. The suture passes through both ends of the connecting tube, and one end of the suture is tied with its body in a one-way knot to form a retractable ligation coil. The ligation coil is embedded in the corresponding channel through the slit. The other end of the suture can be pulled outward relative to the other end of the connecting tube under external force, thereby causing the ligation coil to be pulled out from the slit and retract.

[0009] Based on the above technical solution, the present invention can be further improved as follows.

[0010] Furthermore, the aforementioned snare is a polytetrafluoroethylene (PTFE) loop or a TPU tube.

[0011] Furthermore, the aforementioned connecting pipe is a polytetrafluoroethylene (PTFE) pipe or a TPU pipe.

[0012] Furthermore, the aforementioned skeleton ring is a nickel-titanium wire ring.

[0013] Furthermore, it also includes a handle pull cable assembly, which includes a handle sleeve and a pulling part. One end of the handle sleeve is fitted and fixed to the outside of the other end of the connecting tube, and the pulling part is installed at the other end of the handle sleeve and connected and fixed to the other end of the sewing thread.

[0014] Furthermore, the outer surface of the side wall of the aforementioned handle sleeve is provided with a groove between its two ends, and an indicator is slidably installed in the groove. A through-hole is provided on the groove along the extension direction of its two ends. A positioning member is provided inside the handle sleeve. An elastic member is connected between the positioning member and the interior of one end of the handle sleeve. The tension member extends into the interior of the other end of the handle sleeve and is connected to the positioning member. The other end of the stitch passes through a matching thread hole on the positioning member and is connected and fixed to the tension member. The tension member can be pulled outward relative to the other end of the connecting tube under the action of external force, stretching the elastic member and driving the stitch and positioning member to move, thereby driving the indicator to move along the groove to abut against the corresponding end of the groove. Alternatively, after the external force is removed, the elastic member returns to its initial state and drives the positioning member, tension member and indicator to move back to their original positions.

[0015] The beneficial effects of this invention are: the structure is reasonably designed and can effectively perform ligation of the left atrial appendage through the cardiac chamber.

[0016] An interventional left atrial appendage ligation system is also provided, including a delivery sheath, a suture cutter, a grasping forceps, and an interventional left atrial appendage ligator.

[0017] The beneficial effects are:

[0018] 1) This makes the left atrial appendage ligation procedure simple and convenient, eliminating the need to measure the compatibility between the left atrial appendage opening size and the left atrial appendage occluder size during interventional occlusion. It also avoids the need for repositioning and adjustment due to mismatch or incomplete release.

[0019] 2) The entire surgical procedure is performed inside the body with almost "zero" implantation. Postoperative anticoagulation is generally not required, making the surgery safer. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the interventional left atrial appendage ligator of the present invention;

[0021] Figure 2This is a partially enlarged view of the snare, suture, and connecting tube in the interventional left atrial appendage ligator of the present invention.

[0022] Figure 3 This is a cross-sectional view of the snare in the interventional left atrial appendage ligator of the present invention;

[0023] Figure 4 This is a schematic diagram of the handle pull wire assembly in the interventional left atrial appendage ligator of the present invention;

[0024] Figure 5 This is a schematic diagram of the interventional left atrial appendage ligation system of the present invention.

[0025] The attached diagram lists the components represented by each number as follows:

[0026] 1. Connecting tube; 2. Snatch; 3. Thread; 4. Handle pull-thread assembly; 5. Delivery sheath; 6. Thread cutter; 7. Gripping pliers; 21. Skeleton ring; 31. One-way knot; 32. Ligating coil; 41. Handle sleeve; 42. Pulling part; 411. Slide; 412. Indicator; 413. Gap; 414. Positioning element; 415. Elastic element; 421. Connecting rod. Detailed Implementation

[0027] The principles and features of the present invention are described below with reference to the accompanying drawings. The examples given are only for explaining the present invention and are not intended to limit the scope of the present invention.

[0028] Example 1

[0029] like Figure 1 , 2 As shown in Figure 3, the interventional left atrial appendage ligator of this embodiment includes a connecting tube 1, a snare 2, and a suture 3. The snare 2 is a flexible ring with built-in dual channels and is connected to one end of the connecting tube 1. The inner side of the snare 2 has an opening corresponding to one of the channels, connecting to that channel. A deformable skeleton ring 21 is embedded in the other channel of the snare 2. The suture 3 passes through both ends of the connecting tube 1, and a one-way knot 31 is tied between one end of the suture 3 and its body to form a retractable ligation coil 32. The ligation coil 32 is embedded in the corresponding channel through the opening. The other end of the suture 3 can be pulled outward relative to the other end of the connecting tube 1 under the action of external force, thereby causing the ligation coil 32 to be pulled out from the opening and retracted.

[0030] In this embodiment, during operation, one end of the connecting tube 1 equipped with the snare 2 is delivered into the heart chamber through the sheath. The snare 2 is placed around the outside of the inverted left atrial appendage tissue inside the heart chamber. Next, the suture 3 at the other end of the connecting tube 1 is pulled outward from outside the body, thereby pulling the ligation coil 32 out from the suture opening and contracting it outside the inverted tissue of the left atrial appendage. As the tension changes, it is gradually tightened and ligated outside the left atrial appendage. After ligation, the suture is cut outside the one-way knot 31. The whole process is simple and quick. This device can effectively perform ligation operations on the left atrial appendage through the heart chamber.

[0031] The aforementioned one-way knot 31 is a knot of the prior art. For details, you can refer to the tying method of the Melzer knot. Of course, the tying method is not limited to this one, as long as it can satisfy the requirement of unidirectional contraction of the ligature coil 32.

[0032] Preferably, the snare 2 is a polytetrafluoroethylene (PTFE) loop or a TPU tube, specifically a medical-grade PTFE loop or TPU tube.

[0033] Preferably, the connecting tube 1 is a polytetrafluoroethylene (PTFE) tube or a TPU tube, specifically a medical-grade PTFE loop tube or a TPU tube.

[0034] In this embodiment, the skeleton ring 21 is a non-closed ring structure made of nickel-titanium wire with a diameter of 25-40mm.

[0035] The two channels inside the snare 2 can be arranged vertically or horizontally (in this arrangement, the inner channel is the channel for embedding the ligation coil).

[0036] In a preferred embodiment, the assembly also includes a handle pull cord assembly 4, which includes a handle sleeve 41 and a tension part 42. One end of the handle sleeve 41 is detachably fitted onto the outside of the other end of the connecting tube 1, and the tension part 42 is mounted on the other end of the handle sleeve 41 and is connected and fixed to the other end of the sewing thread 3.

[0037] In this embodiment, by applying external force through the tension part 42, the tension part 42 can be pulled away from the handle sleeve 41, thereby pulling the other end of the suture 3 outward, so that the ligation coil 32 can be effectively contracted outside the left atrial appendage tissue, making it convenient for medical staff to operate.

[0038] Specifically, such as Figure 4As shown, the outer surface of the side wall of the aforementioned handle sleeve 41 has a groove 411 between its two ends. An indicator 412 is slidably installed in the groove 411. A through-hole 413 is provided on the groove 411 along its two-end extension direction. A positioning member 414 is provided inside the handle sleeve 41. An elastic member 415 is connected between the positioning member 414 and the interior of one end of the handle sleeve 41. One end of the tension part 42 is provided with a connecting rod 421 that extends into the interior of the other end of the handle sleeve 41. A notch is provided in the middle of the connecting rod 421 and along its length on the side wall. The end of the connecting rod 421 that extends into the handle sleeve 41 is connected to the positioning member. 414 connection, the other end of the above-mentioned sewing thread 3 passes through the matching thread hole on the above-mentioned positioning member 414, and extends through the inside of the above-mentioned connecting rod 421 and the notch to be connected and fixed to the above-mentioned tension part 42. The above-mentioned tension part 42 can be pulled outward relative to the other end of the above-mentioned connecting tube 1 under the action of external force, and stretch the above-mentioned elastic member 415, and drive the above-mentioned sewing thread 3 and positioning member 414 to move, thereby driving the above-mentioned indicator 412 to move along the above-mentioned slide groove 411 to abut against the corresponding end of the slide groove 411, or after the external force is removed, the above-mentioned elastic member 415 returns to the initial state, and drives the above-mentioned positioning member 414, tension part 42 and indicator 412 to move back to their positions.

[0039] In this embodiment, during the outward pulling process, the tensioning part 42 drives the positioning part 414 to move "outward" and stretches the elastic part 415. During this process, the suture 3 moves together with the tensioning part 42, achieving good contraction and ligation of the ligation coil 32 outside the left atrial appendage tissue. When the indicator 412 touches the other end of the slide groove 411 (in this state, the tensioning part 42 moves to the limit position, and the connecting rod 421 and its notch are exposed, facilitating subsequent suture cutting), the ligation coil 32 is just completed, without excessive ligation that could damage the inner wall of the left atrial appendage. The overall design is relatively reasonable, with a limit on the contraction and ligation of the ligation coil 32, avoiding over-ligation.

[0040] The aforementioned elastic element 415 is a spring.

[0041] The aforementioned positioning member 414 can be a columnar component that matches the inner cavity of the handle sleeve 41, and can slide along the inner wall of the handle sleeve 41 during movement.

[0042] Example 2

[0043] like Figure 5 As shown, the interventional left atrial appendage ligation system of this embodiment includes a delivery sheath 5, a suture cutter 6, a grasping forceps 7, and the interventional left atrial appendage ligator from Embodiment 1.

[0044] In this embodiment, the suture cutter 6 is a prior art technology and a 6F intracardiac suture cutter can be used.

[0045] The aforementioned grasping forceps 7 are also existing technology and can be medical forceps of the type of live sampling forceps.

[0046] The aforementioned delivery sheath 5 is a 14F delivery sheath.

[0047] The implementation process is as follows:

[0048] Step 1: Guide the 14F delivery sheath into the femoral vein, puncture through the interatrial septum into the left atrium, and point towards the left atrial appendage;

[0049] Step 2: The interventional left atrial appendage ligator is delivered to the opening of the left atrial appendage through the delivery sheath. The loop at the front end automatically opens when it protrudes outside the delivery sheath opening.

[0050] Step 3: The grasping forceps 7 are delivered through the delivery sheath to the opening of the left atrial appendage, pass through the hollow ring of the looper, and extend into the bottom of the blind cavity of the left atrial appendage to grasp the inner wall of the left atrial appendage and flip it outward. (Keep the grasping forceps still and do not release them.)

[0051] Step 4: With the assistance of the angiography machine, push the snare 2 of the ligation device to the root of the left atrial appendage, pull the suture 3 outward at another point, and the ligation coil 32 pre-embedded in the channel inside the snare 2 will begin to contract and pass out from the opening until the root of the left atrial appendage is firmly ligated.

[0052] Step 5: Release the grasping forceps 7 and then withdraw the grasping forceps 7 and the interventional left atrial appendage ligator.

[0053] Step 6: Pass the loose end of the knot through the thread cutter 6, cut off the excess thread, and remove the thread cutter 6.

[0054] The surgery is now complete. The entire procedure is simple and convenient, eliminating concerns about the need to measure the compatibility between the left atrial appendage opening size and the left atrial appendage occluder size during interventional occlusion. There are also no issues with repositioning or adjustment due to mismatch or incomplete deployment. The procedure remains entirely within the body, with virtually no implantation, and postoperative anticoagulation is generally unnecessary, making it safer.

[0055] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An interventional left atrial appendage ligation device, characterized in that: The device includes a connecting tube (1), a snare (2), and a suture (3). The snare (2) is a flexible ring with a built-in double channel and is connected to one end of the connecting tube (1). The inner side of the snare (2) has an opening corresponding to one of the channels, and a deformable skeleton ring (21) is embedded in the other channel of the snare (2). The suture (3) passes through both ends of the connecting tube (1), and one end of the suture is tied with a one-way knot (31) between itself and the body, forming a retractable ligation coil (32). The ligation coil (32) is embedded in the corresponding channel from the opening. The other end of the suture (3) can be pulled outward relative to the other end of the connecting tube (1) under the action of external force, so that the ligation coil (32) is pulled out from the opening and retracted. It also includes a handle pull cable assembly (4), which includes a handle sleeve (41) and a tension part (42). One end of the handle sleeve (41) is detachably fitted onto the outside of the other end of the connecting tube (1), and the tension part (42) is loaded onto the other end of the handle sleeve (41) and connected and fixed to the other end of the sewing thread (3). The tension part (42) can move relative to the handle sleeve (41) under the action of external force, so as to drive the suture (3) and shrink the ligation coil (32). The snare (2) is used to be placed on the outside of the inverted left atrial appendage tissue inside the heart chamber. The tension part (42) is used to pull the suture (3) after the snare (2) is placed on the outside of the left atrial appendage tissue, so that the ligation coil (32) is pulled out from the suture opening and contracted to ligate the left atrial appendage tissue. The outer surface of the side wall of the handle sleeve (41) is provided with a groove (411) between its two ends. An indicator (412) is slidably installed in the groove (411). When the pulling part (42) is pulled outward, the ligation coil (32) is just ligated when the indicator (412) touches the other end of the groove (411).

2. The interventional left atrial appendage ligation device according to claim 1, characterized in that: The snare (2) is a polytetrafluoroethylene loop or a TPU tube.

3. The interventional left atrial appendage ligation device according to claim 1, characterized in that: The connecting pipe (1) is a polytetrafluoroethylene pipe or a TPU pipe.

4. The interventional left atrial appendage ligation device according to claim 1, characterized in that: The skeleton ring (21) is a nickel-titanium wire ring.

5. The interventional left atrial appendage ligation device according to claim 1, characterized in that: The groove (411) has a through-hole (413) extending along both ends. The handle sleeve (41) has a positioning member (414) inside. An elastic member (415) is connected between the positioning member (414) and one end of the handle sleeve (41). One end of the tension part (42) has a connecting rod (421) extending into the other end of the handle sleeve (41). The connecting rod (421) has a notch in the middle and on the side wall along the length direction. One end of the connecting rod (421) extending into the handle sleeve (41) is connected to the positioning member (414). The other end of the stitch (3) passes through the positioning member (414). 4) The upper fitting thread hole extends through the inside of the connecting rod (421) and the notch to be connected and fixed to the tension part (42). The tension part (42) can be pulled outward relative to the other end of the connecting tube (1) under the action of external force, and stretch the elastic member (415), and drive the sewing thread (3) and the positioning member (414) to move, thereby driving the indicator (412) to move along the slide (411) to abut against the corresponding end of the slide (411), or after the external force is removed, the elastic member (415) returns to the initial state, and drives the positioning member (414), the tension part (42) and the indicator (412) to move back to their original positions.

6. An interventional left atrial appendage ligation system, characterized in that: It includes a delivery sheath (5), a suture cutter (6), a grasping forceps (7), and an interventional left atrial appendage ligator as described in any one of claims 1 to 5; the grasping forceps (7) is used to grasp the inner wall of the left atrial appendage and turn it outward.

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