Left auricle closing device and using method thereof

Abstract

The invention relates to the technical field of medical instruments, in particular to a left atrial appendage closing device and a using method thereof.The left atrial appendage closing device comprises a balloon guiding sheath, a puncture assembly and a lasso assembly, the balloon guiding sheath is used for reaching a left atrial appendage through a blood vessel and blocking an opening of the left atrial appendage, and the puncture assembly is used for penetrating into the balloon guiding sheath and used for guiding the left atrial appendage to close the opening of the left atrial appendage; and the lasso assembly is used for penetrating into the puncture assembly, extending out of the left auricle wall ferrule and locking the root of the left auricle. The lasso assembly extends out of the left auricle wall ferrule along the interior of the puncture assembly and locks the root of the left auricle, the left auricle is tightened from the root to the opening, the opening of the left auricle is completely closed, thrombus can be prevented from entering blood circulation, meanwhile, direct contact with blood can be avoided to the maximum extent, and the thrombus puncture effect is improved. Therefore, the left atrial appendage closing device solves the problem that the occurrence rate of the instrument-related thrombus in the existing left atrial appendage closing operation is high.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a left atrial appendage closure device and a medical device containing the same. Background Art

[0002] Left atrial appendage closure is a surgical procedure used to prevent thromboembolic complications associated with atrial fibrillation. When atrial fibrillation occurs, blood flow in the left atrial appendage of the heart is prone to stasis, and thus it is easy to form thrombi. Once a thrombus detaches, it can flow to blood vessels throughout the body along with the blood circulation, leading to serious consequences such as cerebral embolism (causing stroke). Left atrial appendage closure is to close or isolate the left atrial appendage in various ways, reduce the risk of thrombus formation, and thus reduce the possibility of embolism events in patients with atrial fibrillation.

[0003] Currently, the most common method is to use a occluder to block. A special left atrial appendage occluder is sent to the left atrial appendage along the vascular access, and then the occluder is released. The occluder will unfold like an "umbrella" in the left atrial appendage, blocking the opening of the left atrial appendage, preventing blood from flowing in and out, and achieving the closing effect.

[0004] The above method may not only have occluder-related complications, such as occluder displacement and detachment. If the occluder detaches and moves to other vascular sites with the blood flow, it may cause serious vascular blockage. It may also cause heart-related injuries such as cardiac perforation and pericardial effusion. In addition, during the implementation process, the instrument needs to be in direct contact with the blood, and after the occluder is placed in the left atrial appendage, it is in contact with the blood for a long time, which will activate the coagulation mechanism, change the local blood flow state, and thus easily cause instrument-related thrombus formation.

[0005] Therefore, there is an urgent need to design a left atrial appendage closure device that can prevent thrombi from entering the blood circulation while avoiding direct contact with the blood to the greatest extent, so as to reduce the incidence of instrument-related thrombi and improve the effectiveness and safety of preventing thromboembolic complications in patients with atrial fibrillation. Summary of the Invention

[0006] In view of this, the present invention provides a left atrial appendage closure device to solve the problem of high incidence of instrument-related thrombi in the existing left atrial appendage closure.

[0007] To solve the above technical problems, a technical solution adopted by the present invention is to provide a left atrial appendage closure device, which includes a balloon guiding sheath, a puncture assembly, and a lasso assembly. The balloon guiding sheath is used to reach the left atrial appendage through the blood vessel and block the opening of the left atrial appendage. The puncture assembly is used to penetrate into the interior of the balloon guiding sheath and puncture the left atrial appendage wall when extending out of the balloon guiding sheath. The lasso assembly is used to penetrate into the interior of the puncture assembly and extend out of the left atrial appendage wall to loop and lock the root of the left atrial appendage.

[0008] As an embodiment of the present invention, the puncture assembly includes a puncture needle and an adjustable bending sheath tube. The adjustable bending sheath tube penetrates into the inside of the balloon guiding sheath tube. The puncture needle penetrates into the inside of the adjustable bending sheath tube and extends out for puncturing the left atrial appendage wall.

[0009] As an embodiment of the present invention, the puncture assembly further includes a puncture guide wire and a dilator. The puncture guide wire penetrates into the inside of the puncture needle and extends out for reserving an opening in the left atrial appendage wall to be punctured. The dilator penetrates into the adjustable bending sheath tube and is sleeved outside the puncture guide wire, and expands the opening in the left atrial appendage wall to be punctured along the puncture guide wire, and enables one end of the adjustable bending sheath tube to pass through the opening in the left atrial appendage wall to be punctured and be placed outside the left atrial appendage wall.

[0010] As an embodiment of the present invention, the left atrial appendage closing device further includes a shaping and bending adjustment sheath tube. The shaping and bending adjustment sheath tube penetrates into the adjustable bending sheath tube and is sleeved outside the lasso assembly, and extends out of the left atrial appendage wall along the lasso assembly. Then, one end of the shaping and bending adjustment sheath tube forms a bending part for controlling the lasso assembly to reach and lasso the root of the left atrial appendage.

[0011] As an embodiment of the present invention, the lasso assembly includes a wire locking device and a lasso wire. The wire locking device has a through hole and a one-way hole. The fixed end of the lasso wire is fixedly connected to the through hole and is placed outside the left atrial appendage wall through the adjustable bending sheath tube. The tightening end of the lasso wire is placed inside the adjustable bending sheath tube. The lasso wire passes through the one-way hole, and the lasso wire between the through hole and the one-way hole forms a loop-shaped lasso wire for lassoing the root of the left atrial appendage. The one-way through hole is used to limit the one-way movement of the lasso assembly in the tightening direction towards the puncture assembly.

[0012] As an embodiment of the present invention, the lasso assembly includes a lasso loop and a lasso ring. The loop-shaped lasso wire is placed in the lasso loop, and the lasso ring is sleeved on the lasso loop.

[0013] As an embodiment of the present invention, the lasso assembly further includes a lasso sheath. The lasso sheath is sleeved on the lasso loop. The lasso sheath is provided with a plurality of lead holes, and the lasso wire sequentially passes through the plurality of lead holes.

[0014] As an embodiment of the present invention, the left atrial appendage closing device further includes a suction assembly. The suction assembly is used to penetrate into the inside of the adjustable bending sheath tube and extend out of the left atrial appendage wall to suck out the blood outside the pericardium.

[0015] As an embodiment of the present invention, the left atrial appendage closure device further includes a wire cutting assembly, which is used to penetrate into the adjustable bending sheath tube and extend to the opening of the left atrial appendage, and cut the lasso wire located outside the one-way hole after the lasso wire tightens the root of the left atrial appendage.

[0016] To solve the above technical problems, the present invention also provides a method for using the above left atrial appendage closure device, and the method includes the following steps: controlling the balloon guiding sheath tube to reach the left atrial appendage along the blood vessel inlet and block the opening of the left atrial appendage;

[0017] Controlling the puncture assembly to penetrate into the interior of the balloon guiding sheath tube and extend to the wall of the left atrial appendage to puncture the wall of the left atrial appendage;

[0018] Controlling the lasso assembly to penetrate into the interior of the puncture assembly and extend out of the wall of the left atrial appendage, controlling the lasso assembly to reach the root of the left atrial appendage, and forming a loop and locking the root of the left atrial appendage.

[0019] Compared with the prior art, the left atrial appendage closure device and its using method provided by the embodiment of the present invention have the following advantages:

[0020] 1. In the left atrial appendage closure device provided by the present invention, the balloon guiding sheath tube reaches the left atrial appendage through the blood vessel and blocks the opening of the left atrial appendage, which can play a physical barrier role in the operation to reduce the blood flow into the left atrial appendage from the source and create a relatively stable environment for subsequent puncture, lasso and other operations; by using the puncture assembly to penetrate along the interior of the balloon guiding sheath tube and puncture the wall of the left atrial appendage when extending out of the balloon guiding sheath tube, the accurate positioning and fixation of the left atrial appendage are realized, providing an accurate position for the subsequent operation of the lasso assembly; by the lasso assembly penetrating along the interior of the puncture assembly and extending out of the wall of the left atrial appendage to form a loop and lock the root of the left atrial appendage, a tightening from the root to the opening of the left atrial appendage is formed, and the complete closure of the opening of the left atrial appendage is realized. It can not only prevent thrombus from entering the blood circulation, but also avoid direct contact with blood to the greatest extent, so as to reduce the incidence of device-related thrombus. Therefore, the present invention solves the problem of high incidence of device-related thrombus in the existing left atrial appendage closure surgery.

[0021] 2. In the left atrial appendage closure device provided by the present invention, by setting the puncture guide wire to remain in the puncture opening to help the puncture needle to retract, it facilitates the retraction of the puncture needle and avoids unnecessary damage to the punctured part. The dilator is sent into the adjustable bending sheath tube along the puncture guide wire, which can enable the adjustable bending sheath to reach the outside of the wall of the left atrial appendage along the dilator.

[0022] 3. In the left atrial appendage closure device provided by the present invention, by arranging a shaping and bending sheath tube to penetrate into the adjustable bending sheath tube, sleeving it outside the lasso assembly, and extending it outside the left atrial appendage wall along the lasso assembly, then one end of the shaping and bending sheath tube forms a bending part, which is used to control the lasso assembly to reach and sleevethe root of the left atrial appendage, providing the functions of guiding and precise positioning for the lasso assembly to accurately reach and sleevethe root of the left atrial appendage. By using its bending part to better fit the human physiological structure and the position characteristics of the left atrial appendage, the accuracy of the lasso assembly sleeving the root of the left atrial appendage is improved, which helps to enhance the lasso efficiency of sleeving the root of the left atrial appendage.

[0023] 4. In the left atrial appendage closure device provided by the present invention, through the through hole and the one-way hole of the wire locking device, the fixed end of the lasso wire is fixedly connected to the through hole, and is placed outside the left atrial appendage wall through the adjustable bending sheath tube. The tightening end of the lasso wire is placed inside the adjustable bending sheath tube, so that the lasso wire passes through the one-way hole, and the lasso wire between the through hole and the one-way hole forms a loop-shaped lasso wire for sleeving the root of the left atrial appendage. And the one-way hole restricts the one-way movement of the lasso assembly in the tightening direction, thereby realizing the effective control of the tightening action of the lasso wire, ensuring that the lasso wire can tighten the root of the left atrial appendage and maintain the tightened state, making the tightening operation of the lasso wire more stable and reliable, and can also control the degree of tightening and avoid accidental loosening of the lasso wire, ensuring that the root of the left atrial appendage is reliably closed.

[0024] 5. In the left atrial appendage closure device provided by the present invention, by placing the loop-shaped lasso wire in the lasso loop and sleeving the lasso ring on the lasso loop, the lasso wire can follow the lasso loop to maintain the same shaped form, which helps to stably perform operations such as snaring on the left atrial appendage, improving the success rate of the operation and the standardization of the atrial appendage closure treatment.

[0025] 6. In the left atrial appendage closure device provided by the present invention, by arranging a lasso sheath, the lasso sheath is provided with a plurality of lead holes, and the lasso wire passes through the plurality of lead holes in sequence, which can unify and maintain the shape of the lasso wire and the lasso loop, ensuring the consistency of the overall structure of the lasso wire and the lasso loop, facilitating the exertion of its snaring function, thereby enhancing the stability and reliability of the lasso assembly during use, avoiding poor snaring effects caused by factors such as shape changes, and further optimizing the snaring quality in the left atrial appendage closure operation.

[0026] 7. In the left atrial appendage closure device provided by the present invention, by penetrating the suction assembly into the adjustable bending sheath tube and extending it outside the left atrial appendage wall to suck out the blood outside the pericardium, it can timely handle the possible blood outside the pericardium, maintain a relatively clear and clean environment in the operation area of the left atrial appendage closure operation, avoid interference with the operation caused by blood accumulation, etc., and reduce the risk of operation errors caused by blood influence.

[0027] 8. In the left atrial appendage closure device provided by the present invention, after threading the wire cutting assembly into the adjustable bending sheath tube and extending it to reach the opening of the left atrial appendage, and tightening the root of the left atrial appendage with the lasso assembly, the lasso wire located outside the one-way hole is cut, so that after the lasso operation is completed, the redundant lasso wire can be cleaned up, avoiding potential risks caused by the remaining redundant wire bodies, optimizing the local condition after the operation, reducing problems such as infection and interference that may be caused by the redundant wire bodies, and improving the standardization and safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0029] Among them:

[0030] Figure 1 shows a schematic structural diagram of the balloon guiding sheath tube of the left atrial appendage closure device provided in Embodiment 1 of the present invention;

[0031] Figure 2 shows a schematic structural diagram of the puncture assembly of the left atrial appendage closure device provided in Embodiment 1 of the present invention;

[0032] Figure 3 shows a schematic structural diagram of the lasso assembly of the left atrial appendage closure device provided in Embodiment 1 of the present invention;

[0033] Figure 4 shows Figure 3 a partial enlarged view of A in;

[0034] Figure 5 shows a schematic structural diagram of the wire locking device of the left atrial appendage closure device provided in Embodiment 1 of the present invention;

[0035] Figure 6 shows a schematic structural diagram of the combination of the balloon guiding sheath tube and the balloon of the left atrial appendage closure device provided in Embodiment 1 of the present invention;

[0036] Figure 7 shows a schematic structural diagram of the suction assembly of the left atrial appendage closure device provided in Embodiment 1 of the present invention;

[0037] Figure 8 shows a schematic structural diagram of the shaping and bending sheath tube of the left atrial appendage closure device provided in Embodiment 1 of the present invention;

[0038] Figure 9Shows a schematic structural diagram of the lasso wire of the left atrial appendage closure device provided in the first embodiment of the present invention;

[0039] Figure 10 Shows a schematic cross-sectional structural diagram of the connection between the lasso wire and the wire locking device of the left atrial appendage closure device provided in the first embodiment of the present invention;

[0040] Figure 11 Shows a schematic diagram of a partial structure of the left atrial appendage closure device provided in the first embodiment of the present invention;

[0041] Figure 12 Shows Figure 11 A partial enlarged view of C in;

[0042] Figure 13 Shows Figure 11 A side view of the partial structure shown in;

[0043] Figure 14 Shows a schematic structural diagram of the lasso loop of the left atrial appendage closure device provided in the first embodiment of the present invention Figure One ;

[0044] Figure 15 Shows a schematic structural diagram of the lasso loop of the left atrial appendage closure device provided in the first embodiment of the present invention Figure Two ;

[0045] Figure 16 Shows Figure 15 A partial enlarged view of B in;

[0046] Figure 17 Shows a schematic structural diagram of the wire cutting assembly of the left atrial appendage closure device provided in the first embodiment of the present invention;

[0047] Figures 18 - 30 Shows a schematic diagram of the application process of the left atrial appendage closure device provided in the first embodiment of the present invention.

[0048] Explanation of reference numerals:

[0049] 1. Left atrial appendage closure device; 2. Left atrial appendage;

[0050] 11. Balloon guiding sheath tube; 12. Puncture assembly; 13. Lasso assembly; 14. Wire locking device; 15. Suction assembly; 16. Shaping and bending sheath tube; 17. Wire cutting assembly; 18. Balloon; 21. Left atrial appendage opening; 22. Left atrial appendage wall; 23. Left atrial appendage root;

[0051] 121. Puncture needle; 122. Adjustable bending sheath tube; 123. Puncture guide wire; 124. Dilator; 131. Lasso wire; 132. Lasso loop; 133. Lasso ring; 134. Lasso sheath; 141. Through hole; 142. One-way hole; 143. Elastic damping; 151. Suction catheter; 161. Bending part; 171. Wire cutting catheter; 172. Wire cutter

[0052] 1311. Fixed end; 1312. Tightening end; 1313. Connection end; 1321. Shaping end; 1322. Support end; 1323. Telescopic end Detailed implementation manners

[0053] To facilitate the understanding of this application, the following will describe this application more comprehensively with reference to the relevant drawings. Embodiments of this application are shown in the drawings. However, this application can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, these embodiments are provided to make the disclosure of this application more thorough and comprehensive.

[0054] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which this application belongs. The terms used in the description of this application herein are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0055] It can be understood that the singular forms of "a", "an" and "the" may also include the plural forms unless the context clearly indicates otherwise. It should also be understood that the terms "include" or "have", etc. specify the existence of the stated features, wholes, steps, operations, components, parts or combinations thereof, but do not exclude the possibility of the existence or addition of one or more other features, wholes, steps, operations, components, parts or combinations thereof.

[0056] It should be noted that when an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be intermediate elements present simultaneously. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only. In the present invention, the terms "upper", "lower", "left", "right", "front", "rear", "top", "bottom", "inner", "outer", "middle", "vertical", "horizontal", "lateral", "longitudinal", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings. These terms are mainly used to better describe the present invention and its embodiments, and are not used to limit that the indicated device, element or component must have a specific orientation, or be constructed and operated in a specific orientation. Moreover, in addition to being able to represent the orientation or positional relationship, some of the above terms may also be used to represent other meanings. For example, the term "upper" may also be used to represent a certain attachment relationship or connection relationship in some cases. For those of ordinary skill in the art, the specific meanings of these terms in the present invention can be understood according to the specific circumstances.

[0057] In addition, the terms "arranged", "provided with", "connected", "coupled" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral structure; it can be a mechanical connection or an electrical connection; it can be directly connected, or indirectly connected through an intermediate medium, or there is internal communication between two devices, elements or components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0058] Embodiment 1

[0059] The first embodiment of the present invention discloses a left atrial appendage occlusion device 1, which can be used, but is not limited to, in left atrial appendage occlusion surgery to ligate the left atrial appendage 2 and solve the problem that the devices used in current left atrial appendage occlusion surgery based on the prior art cannot completely occlude the left atrial appendage.

[0060] Please refer to Figures 1 to 3 and Figure 18 As shown, the left atrial appendage occlusion device 1 includes a balloon guiding sheath 11, a puncture assembly 12, and a lasso assembly 13. The balloon guiding sheath 11 is used to reach the left atrial appendage 2 through blood vessels and occlude the left atrial appendage opening 21. The puncture assembly 12 is used to penetrate into the interior of the balloon guiding sheath 11 and puncture the left atrial appendage wall 22 when extending out of the balloon guiding sheath 11. The lasso assembly 13 is used to penetrate into the interior of the puncture assembly 12 and extend out of the left atrial appendage wall 22 to loop and lock the root of the left atrial appendage 23.

[0061] Further, please refer to Figure 6 and Figure 18As shown, the left atrial appendage closure device 1 further includes a balloon 18 and a control handle (not shown in the figure). The balloon 18 is disposed at the distal end of the balloon guiding sheath 11, and the control handle is disposed at the proximal end of the balloon guiding sheath 11 and is connected to the balloon 18. The control handle controls the filling medium inside the balloon 18, and the medium can be and is not limited to air and physiological saline. After the inside of the balloon 18 is filled with the medium, the opening of the left atrial appendage 2 is blocked, and the blocking of the opening 21 of the left atrial appendage can block the blood flow between the left atrium and the left atrial appendage 2.

[0062] It can be understood that by reaching the left atrial appendage 2 through the blood vessel via the balloon guiding sheath 11 and blocking the opening 21 of the left atrial appendage, a physical barrier can be formed for the opening 21 of the left atrial appendage during the operation, reducing the blood flowing into the left atrial appendage 2 from the source and creating a relatively stable environment for subsequent operations such as puncture and lasso; by using the puncture assembly 12 to penetrate into the inside of the balloon guiding sheath 11 and puncture the wall 22 of the left atrial appendage when extending out of the balloon guiding sheath 11, the accurate positioning and fixation of the left atrial appendage 2 can be achieved, providing an accurate position for the subsequent operation of the lasso assembly 13; by the lasso assembly 13 penetrating into the inside of the puncture assembly 12 and extending out of the wall 22 of the left atrial appendage to form a loop and lock the root 23 of the left atrial appendage, a tightening from the root to the opening of the left atrial appendage 2 is formed, and the complete closure of the opening 21 of the left atrial appendage is achieved. This can not only prevent thrombus from entering the blood circulation, but also avoid direct contact with blood to the greatest extent, thereby reducing the incidence of device-related thrombus. Therefore, the embodiments of the present invention effectively solve the problem of high incidence of device-related thrombus in the existing left atrial appendage closure procedures.

[0063] Further, please refer to Figure 2 and Figure 18 As shown, the puncture assembly 12 includes a puncture needle 121 and an adjustable bending sheath 122. The adjustable bending sheath 122 penetrates into the inside of the balloon guiding sheath 11, and the puncture needle 121 penetrates into the inside of the adjustable bending sheath 122 and extends out for puncturing the wall 22 of the left atrial appendage.

[0064] It can be understood that by setting the adjustable bending sheath tube 122 to penetrate into the balloon guiding sheath tube 11, the inside of the adjustable bending sheath tube 122 can accommodate the puncture needle 121 and the dilator 124 to pass through, facilitating the withdrawal of the puncture needle 121 and the dilator 124. Moreover, the adjustable bending sheath tube 122 can also accommodate the snare assembly 13, the aspiration catheter 151, and the wire cutting assembly 17 to pass through and reach the outside of the left atrial appendage wall 22, making it a passage for accommodating and protecting the instruments to pass through the left atrial appendage wall 22, which can avoid unnecessary scratches, frictions and other damages to the tissues along the way during the entry of the instruments. Additionally, the function of the adjustable bending sheath tube 122 facilitating the withdrawal of the instruments also reduces the risks of complications such as the instruments being left in the body or bleeding and perforation caused by improper operation, improving the safety of the operation from multiple aspects. Furthermore, it is convenient for the withdrawal and replacement of the instruments, enabling the connection between each operation step to be more compact and smooth, and helping to shorten the operation time.

[0065] Further, the puncture assembly 12 further includes a puncture guide wire 123 and a dilator 124. The puncture guide wire 123 penetrates into the puncture needle 121 and extends out, for being reserved at the punctured opening of the left atrial appendage wall 22. The dilator 124 penetrates into the adjustable bending sheath tube 122 and is sleeved outside the puncture guide wire 123, and expands the punctured opening of the left atrial appendage wall 22 along the puncture guide wire 123, and makes one end of the adjustable bending sheath tube 122 pass through the punctured opening of the left atrial appendage wall 22 and be placed outside the left atrial appendage wall 22.

[0066] It can be understood that by setting the puncture guide wire 123 to be reserved at the puncture opening to assist the withdrawal of the puncture needle 121, it facilitates the withdrawal of the puncture needle 121 and avoids unnecessary damage to the punctured part. The dilator 124 penetrates into the adjustable bending sheath tube 122 and is sleeved outside the puncture guide wire 123, and expands the punctured opening of the left atrial appendage wall 22 along the puncture guide wire 123. By sending the dilator 124 along the puncture guide wire 123 into the adjustable bending sheath tube 122, the adjustable bending sheath 122 can reach the outside of the left atrial appendage wall 22 along the dilator 124.

[0067] Specifically, the adjustable bending sheath tube 122 is a composite catheter with a hollow interior, which can accommodate the puncture needle 121 and the dilator 124 to pass through, enabling the withdrawal of the puncture needle 121 and the dilator 124, and can also accommodate the snare assembly 13, the aspiration catheter 151, and the wire cutting assembly 17 to pass through and reach the outside of the left atrial appendage wall 22.

[0068] Specifically, the distal end of the puncture needle 121 that extends out is a beveled and hollow metal needle tip, which is used for puncturing the left atrial appendage wall 22. The proximal end is fixedly connected to a flexible spring tube or a snake bone tube, etc. The inside of the puncture needle 121 can accommodate the puncture guide wire 123 to pass through.

[0069] Specifically, the specification of the puncture guide wire 123 can be 0.018 mm to 0.035 mm. The distal end of the puncture guide wire 123 is bent and has soft elasticity, being a "J"-type guide wire, passing through the inside of the puncture needle 121 in a straight state, and after passing through the puncture needle 121 and protruding, its distal end rebounds to be bent.

[0070] More specifically, after the puncture needle 121 completes the puncture of the left atrial appendage wall 22, the puncture guide wire 123 passes through the inside of the puncture needle 121 in a straight state and protrudes. After protruding, the distal end of the puncture guide wire 123 is in a bent state, facilitating the puncture guide wire 123 to be reserved at the opening of the left atrial appendage wall 22. After the puncture needle 121 is retracted, the dilator 124 reaches the opening along the guidance of the puncture guide wire 123 and expands the opening. It can be understood that the structure of the puncture needle 121 is sharp and hard. By reserving the position of the puncture guide wire 123 and guiding and transporting other instruments, it can prevent the puncture needle 121 from damaging and injuring other instruments and the left atrial appendage 2 tissue.

[0071] Specifically, the distal end of the dilator 124 is a conical surface for dilating the puncture opening of the left atrial appendage 2. The dilator 124 is a hollow polymer catheter for accommodating the puncture guide wire 123 to pass through, reaching the left atrial appendage wall 22 along the puncture guide wire 123 to dilate the punctured opening, and for guiding the steerable sheath 122 to pass through the left atrial appendage wall 22.

[0072] Further, please refer to Figure 7 and Figure 20 As shown, the left atrial appendage closure device 1 further includes a suction assembly 15. The suction assembly 15 is used to penetrate into the inside of the steerable sheath 122 and protrude outside the left atrial appendage wall 22 to suck out the blood outside the pericardium.

[0073] It can be understood that by penetrating the suction assembly 15 into the inside of the steerable sheath 122 and protruding outside the left atrial appendage wall 22 to suck out the blood outside the pericardium, it can timely handle the possible blood outside the pericardium, maintain a relatively clear and clean environment in the operation area of the left atrial appendage 2 closure operation, avoid interference with the operation caused by blood accumulation, etc., and reduce the risk of operation errors caused by the influence of blood.

[0074] Specifically, the suction assembly 15 includes a suction catheter 151 and a suction pump (not shown in the figure). The suction catheter 151 is a hollow polymer single-layer catheter. The suction catheter 151 penetrates through the inside of the steerable sheath 122 and protrudes to the outside of the left atrial appendage wall 22, inside the pericardium. The suction pump is used to provide suction force. The suction pump is connected to the proximal end of the suction catheter 151 to control the suction catheter 151 to suck away the excess blood flowing into the pericardium during puncture.

[0075] Further, please refer to Figure 8 and Figure 23As shown, the left atrial appendage closure device 1 further includes a shaping and deflecting sheath 16. The shaping and deflecting sheath 16 is inserted into the deflectable sheath 122, sleeved outside the lasso assembly 13, and extends outside the left atrial appendage wall 22 along the lasso assembly 13. Then, one end of the shaping and deflecting sheath 16 forms a bending portion 161 for controlling the lasso assembly 13 to reach and enclose the root of the left atrial appendage 2.

[0076] It can be understood that by arranging the shaping and deflecting sheath 16 to be inserted into the deflectable sheath 122, sleeved outside the lasso assembly 13, and extending outside the left atrial appendage wall 22 along the lasso assembly 13, and then making one end of the shaping and deflecting sheath 16 form a bending portion 161 for controlling the lasso assembly 13 to reach and enclose the root of the left atrial appendage 2, it provides a guiding and precise positioning function for the lasso assembly 13 to accurately reach and enclose the root of the left atrial appendage 23. By using its bending portion 161 to better fit the human physiological structure and the position characteristics of the left atrial appendage 2, the accuracy of the lasso assembly 13 in enclosing the root of the left atrial appendage 23 is improved, which helps to enhance the lasso efficiency of enclosing the root of the left atrial appendage 23.

[0077] Specifically, the shaping and deflecting sheath 16 is an internally hollow deflectable composite tube. The distal end of the shaping and deflecting sheath 16 undergoes shaping changes and is shaped and bent by 180° to 270° for adjusting the position of the lasso assembly 13 outside the atrial appendage wall to control the lasso assembly 13 to reach and enclose the root of the left atrial appendage 2.

[0078] Further, please refer to Figures 3 to 5 , and Figures 10 to 12 As shown, the lasso assembly 13 includes a wire locking device 14 and a lasso wire 131. The wire locking device 14 has a through hole 141 and a one-way hole 142. The fixed end 1311 of the lasso wire 131 is fixedly connected to the through hole 141, and is placed outside the left atrial appendage wall 22 through the deflectable sheath 122. The tightening end 1312 of the lasso wire 131 is placed inside the deflectable sheath 122. The lasso wire 131 passes through the one-way hole 142, and the lasso wire 131 between the through hole 141 and the one-way hole 142 forms a loop-shaped lasso wire 131 for enclosing the root of the left atrial appendage 2. The one-way through hole 141 is used to restrict the lasso assembly 13 from moving unidirectionally in the tightening direction towards the puncture assembly 12.

[0079] It can be understood that through the through hole 141 and the one-way hole 142 of the wire locking device 14, the fixed end 1311 of the lasso wire 131 is fixedly connected to the through hole 141, and is placed outside the left atrial appendage wall 22 through the adjustable deflectable sheath 122. The tightening end 1312 of the lasso wire 131 is placed inside the adjustable deflectable sheath 122, so that the lasso wire 131 passes through the one-way hole 142, and the lasso wire 131 between the through hole 141 and the one-way hole 142 forms a loop-shaped lasso wire 131 for lassoing the root of the left atrial appendage 2. The one-way hole 142 restricts the one-way movement of the lasso assembly 13 in the tightening direction, thereby effectively controlling the tightening action of the lasso wire 131, ensuring that the lasso wire 131 can tightly tie the root 23 of the left atrial appendage and maintain the tightened state, making the tightening operation of the lasso wire 131 more stable and reliable. It can also control the degree of tightening and prevent the lasso wire 131 from accidentally loosening, ensuring that the root 23 of the left atrial appendage is reliably closed.

[0080] Specifically, an elastic damper 143 is arranged inside the one-way hole 142 of the wire locking device 14. The elastic damper 143 is in interference fit with the lasso assembly 13, squeezing the lasso assembly 13, so that the lasso assembly 13 cannot freely pass through the single wire hole and only allows one-way movement, thereby restricting the one-way movement of the lasso assembly 13 in the tightening direction of the puncture assembly 12 and achieving the purpose of ligating and tightening the left atrial appendage 2 by the lasso assembly 13.

[0081] Furthermore, the lasso assembly 13 includes a lasso loop 132 and a lasso ring 133. The loop-shaped lasso wire 131 is placed in the lasso loop 132, and the lasso ring 133 is sleeved on the lasso loop 132.

[0082] It can be understood that by placing the loop-shaped lasso wire 131 in the lasso loop 132 and sleeving the lasso ring 133 on the lasso loop 132, the lasso wire 131 can maintain the same shaped setting as the lasso loop 132, which helps to stably perform operations such as lassoing on the left atrial appendage 2, improving the success rate of the operation and the standardization of the atrial appendage closing treatment.

[0083] Specifically, the lasso wire 131 is a polymer wire, and the material can be and is not limited to any one of materials such as e-PTFE, PE, PET, etc. The lasso wire 131 is in a "U" - shaped bent state. The "U" - shaped part is the tightening end 1312, and the proximal end is the connection end 1313 and the fixed end 1311. The fixed end 1311 passes through the through hole 141 and is fixedly connected to the through hole 141. The tightening end 1312 and the connection end 1313 pass through the one-way hole 142 of the wire locking device 14 and are threaded inside the puncture assembly 12 to be connected to the control handle. The control handle controls the tightening end 1312 to retract towards the connection end 1313.

[0084] Specifically, the through hole 141 of the wire locking device 14 and the fixed end 1311 of the lasso wire 131 are fixedly connected by means such as bonding and crimping. An elastic damper 143 is provided on the inner wall of the one-way hole 142 of the wire locking device 14. The connecting end 1313 of the lasso wire 131 is accommodated, and the elastic damper 143 and the connecting end 1313 of the lasso wire 131 are in interference fit, squeezing the connecting end 1313 of the lasso wire 131 so that the lasso wire 131 cannot freely pass through the one-way hole 142.

[0085] It can be understood that during the operation, by pulling the connecting end 1313 of the lasso wire 131, the tightening end 1312 of the lasso wire 131 becomes shorter and shorter. The setting of the one-way hole 142 enables the wire locking device 14 to perform infinite self-locking on the connecting end 1313 of the lasso wire 131, so as to achieve the purpose of ligating and tightening the left atrial appendage root 23 by the lasso wire 131.

[0086] Specifically, please refer to Figures 11 to 16 As shown, the lasso loop 132 is composed of round wire and can be made of nitinol material and processed by heat setting, but it should not be a limitation of the lasso loop 132. The sizing end 1321 of the lasso loop 132 is sized to be circular or oval at the distal end through sizing. The proximal end of the lasso loop 132 is divided into a support end 1322 and a telescopic end 1323. The support end 1322 passes through the shaping and bending sheath 16 and is connected to the control handle. The proximal end of the telescopic end 1323 is a blunt head, and the distal end of the telescopic end 1323 extends to the sizing end 1321. In the initial state, the sizing end 1321 of the lasso loop 132 is at the distal end, and the support end 1322 and the telescopic end 1323 are accommodated in the shaping and bending sheath 16 in a straight state at the proximal end.

[0087] More specifically, the sizing end 1321 of the lasso loop 132 is used to loop around the root of the left atrial appendage 2. Among them, the sizing dimension of the sizing end 1321 can accommodate left atrial appendages 2 of all sizes to pass through; the support end 1322 is used to connect the sizing end 1321 and the control handle, and the control handle controls the support end 1322 to be pushed and retracted in the shaping and bending sheath 16; the telescopic end 1323 is used to adjust and adapt to reduce the pulling force of the sizing end 1321 on the left atrial appendage 2 during the looping process of the left atrial appendage 2.

[0088] Optionally, there are two ways for the sizing end 1321. The first way is to directly extend from the tangential direction of the sizing end 1321 through the telescopic end 1323, and the support end 1322 is close to the telescopic end 1323 for sizing, so as to achieve the looping function; the second way is to perform secondary shaping during actual use, so that the sizing end 1321 presents a preset angle with the support end 1322 and the telescopic end 1323, so as to achieve the function of looping around the left atrial appendage 2.

[0089] Exemplarily, please refer to Figure 13As shown, the preset angle is a. In the embodiment of the present invention, the angle of a is 25° to 65°.

[0090] Specifically, the lasso loop 133 is a polymer wire-wound ring structure. The number of lasso loops 133 is two. The two lasso loops 133 are arranged at the distal end of the lasso line 131 close to the "U" shape. The inner edge of the lasso loop 133 is fixedly connected to the lasso line 131. The middle ring hole in the lasso loop 133 sleeves the lasso ring 132, so that the lasso line 131 can maintain the same shaped state as the lasso ring 132 in the working state.

[0091] Further, please refer to Figure 3 and Figure 11 As shown, the lasso assembly 13 further includes a lasso sheath 134. The lasso sheath 134 sleeves the lasso ring 132. The lasso sheath 134 is provided with a plurality of lead holes. The lasso line 131 sequentially passes through the plurality of lead holes.

[0092] It can be understood that by setting the lasso sheath 134, the lasso sheath 134 is provided with a plurality of lead holes, and the lasso line 131 sequentially passes through the plurality of lead holes, which can unify and maintain the shapes of the lasso line 131 and the lasso ring 132, ensure the consistency of the overall structure of the lasso line 131 and the lasso ring 132, facilitate the lasso function, thereby improving the stability and reliability of the lasso assembly 13 during use, avoiding poor lasso effect caused by factors such as shape change, and further optimizing the lasso quality in the closing operation of the left atrial appendage 2.

[0093] Specifically, the lasso sheath 134 is fixedly connected to the distal end of the tightening end 1312 of the lasso line 131, specifically by a unilateral cross-connection method. The inside of the lasso sheath 134 can accommodate the extension end of the lasso ring 132 passing through the lasso loop 133 and the shaping end 1321, so that the lasso line 131 has the same outer shape as the lasso ring 132.

[0094] More specifically, the proximal end of the lasso ring 132, the proximal end of the lasso line 131, and the wire locking device 14 are accommodated in the shaping and bending sheath 16. After the action of looping the left atrial appendage 2 is completed, the extension end of the lasso ring 132 can leave the lasso line 131, the lasso loop 133, and the lasso sheath 134 under the traction of the supporting end 1322 of the lasso ring 132. By pulling the connecting end 1313 of the lasso line 131, a tightening action can be performed, continuously reducing the tightening end 1312 of the lasso line 131, thereby completing the tightening of the left atrial appendage 2.

[0095] Further, please refer to Figure 17 and Figure 29As shown, the left atrial appendage occlusion device 1 further includes a wire cutting assembly 17. The wire cutting assembly 17 is configured to penetrate into the inner part of the steerable sheath 122 and extend to the left atrial appendage opening 21, and cut the lasso wire 131 located outside the one-way hole 142 after the lasso wire 131 tightens the root of the left atrial appendage 23.

[0096] It can be understood that by penetrating the wire cutting assembly 17 into the inner part of the steerable sheath 122 and extending it to reach the left atrial appendage opening 21, and cutting the lasso wire 131 located outside the one-way hole 142 after the lasso assembly 13 tightens the root of the left atrial appendage 23, it is possible to clean the redundant lasso wire 131 after the ligation operation, avoid potential risks caused by the remaining redundant wire bodies, optimize the local condition after the operation, reduce problems such as infection and interference that may be caused by the contact between the redundant wire bodies and blood, and improve the standardization and safety.

[0097] Specifically, the wire cutting assembly 17 includes a wire cutting catheter 171 and a wire cutter 172. The wire cutting catheter 171 is disposed inside the steerable sheath 122 and extends to reach the left atrial appendage opening 21. The inside of the wire cutting catheter 171 is hollow. The wire cutter 172 is disposed inside the wire cutting catheter 171 and is connected to the distal end of the wire cutting catheter 171, and is used to cut the lasso wire 131, recover the redundant lasso wire 131, and withdraw it from the distal end and introduce the lasso wire 131 to the proximal end.

[0098] For ease of understanding, the operation steps of using the left atrial appendage occlusion device 1 are specifically described herein. Please refer in sequence to Figures 18 to 30As shown, in the first step, the patient is first given local anesthesia, and the atrial septum is punctured through the peripheral blood vessels, which can be the femoral vein or the jugular vein. Then, the puncture component 12 is placed in the balloon guide sheath 11, and enters the vicinity of the left atrial appendage 2 through the atrial septum passage. Then, the balloon 18 of the balloon guide sheath 11 is filled with normal saline to expand the balloon 18 in the left atrial appendage 2, blocking the left atrial appendage opening 21 and blocking the blood flow into the left atrium; in the second step, the puncture component 12 is controlled to extend from the balloon 18 guide sheath to puncture the left atrial appendage wall 22, and then the puncture needle 121 is removed from the balloon 18. The guide sheath is withdrawn, and the puncture guide wire 123 is reserved, and then the dilator 124 is sent in, so that the adjustable curved sheath 122 reaches the outside of the left atrial appendage 2 along the dilator 124, and the puncture guide wire 123 and the dilator 124 are withdrawn; the third step is to extend the control suction component 15 from the adjustable curved sheath 122 to the outside of the left atrial appendage 2, and suck the blood outside the pericardium out of the body to avoid possible complications of pericardial tamponade, and then withdraw the suction component 15; the fourth step is to extend the lasso component 13 from the adjustable curved sheath 122 to the outside of the left atrial appendage 2, and then pull back the adjustable curved sheath 122 to assist The first step is to assist in controlling the lasso assembly 13 so that the distal end of the lasso assembly 13 enters the gap between the left atrial appendage 2 and the atrial wall; the fifth step is to deliver the shaping and bending adjustment sheath 16 to control the proximal end of the lasso assembly 13 to move toward the root on the other side of the left atrial appendage 2, and make the distal end of the lasso assembly 13 reach the root 23 of the left atrial appendage; the sixth step is to deliver the lasso assembly 13, and cooperate with the shaping and bending adjustment sheath 16 to perform auxiliary control on the lasso assembly 13 so that the proximal end of the lasso reaches the root 23 of the left atrial appendage; the seventh step is to recycle the lasso loop 132 in the lasso assembly 13 and tighten the lasso line 131 through the wire locker 14 to make the lasso The wire 131 ties the root of the left atrial appendage 23 and will not rebound under the movement of the atrial appendage under the action of the wire locker 14; in the eighth step, the balloon 18 is recovered, and the balloon guide sheath 11 is pulled back into the left atrium, and the lasso wire 131 is further tightened; in the ninth step, the shaping and bending sheath 16 is completely withdrawn, and the lasso wire 131 is continued to be tightened; in the tenth step, the wire cutting assembly 17 is transported along the adjustable bending sheath 122 to the left atrial appendage opening 21, and the distal end of the wire cutting assembly 17 reaches the atrial appendage ligation site to cut the lasso wire 131, and finally all catheters are withdrawn and the patient is hemostatic, and the operation is completed.

[0099] Example 2

[0100] A second embodiment of the present invention discloses a method for using a left atrial appendage closure device 1, the method comprising the following steps:

[0101] Controlling the balloon guide sheath 11 to reach the left atrial appendage 2 and block the left atrial appendage opening 21;

[0102] Controlling the puncture assembly 12 to penetrate into the interior of the balloon guide sheath 11 and extend to reach the left atrial appendage wall 22 to puncture the left atrial appendage wall 22;

[0103] Control the lasso assembly 13 to penetrate into the interior of the puncture assembly 12 and extend out of the left atrial appendage wall 22, control the lasso assembly 13 to reach the root 23 of the left atrial appendage, and loop and lock the root of the left atrial appendage 2.

[0104] The function of the usage method provided in the second embodiment of the present invention is the same as that of the left atrial appendage closing device 1 provided in the first embodiment, and will not be described in detail herein.

[0105] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification.

[0106] The above embodiments only represent several implementation manners of the present application. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several deformations and improvements can still be made, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

Claims

1. A left atrial appendage occlusion device, characterized in that: The left atrial appendage closure device includes a balloon guiding sheath, a puncture assembly, and a lasso assembly. The balloon guiding sheath is used to reach the left atrial appendage through a blood vessel and block the opening of the left atrial appendage. The puncture assembly is used to penetrate into the interior of the balloon guiding sheath and puncture the wall of the left atrial appendage when extending out of the balloon guiding sheath. The lasso assembly is used to penetrate into the interior of the puncture assembly and extend out of the wall of the left atrial appendage to form a loop and lock the root of the left atrial appendage.

2. The left atrial appendage closure device according to claim 1, wherein: The puncture assembly includes a puncture needle and an adjustable bending sheath. The adjustable bending sheath penetrates into the interior of the balloon guiding sheath. The puncture needle penetrates into the interior of the adjustable bending sheath and extends out for puncturing the wall of the left atrial appendage.

3. The left atrial appendage occlusion device according to claim 2, characterized in that: The puncture assembly further includes a puncture guide wire and a dilator. The puncture guide wire penetrates into the interior of the puncture needle and extends out for being reserved at the opening of the wall of the left atrial appendage to be punctured. The dilator penetrates into the adjustable bending sheath and is sleeved outside the puncture guide wire, and expands the opening of the wall of the left atrial appendage to be punctured along the puncture guide wire, and enables one end of the adjustable bending sheath to pass through the opening of the wall of the left atrial appendage to be punctured and be placed outside the wall of the left atrial appendage.

4. The left atrial appendage occlusion device according to claim 3, wherein: The left atrial appendage closure device further includes a shaping and bending sheath. The shaping and bending sheath penetrates into the adjustable bending sheath and is sleeved outside the lasso assembly, and extends out of the wall of the left atrial appendage along the lasso assembly. Then, one end of the shaping and bending sheath forms a bending part for controlling the lasso assembly to reach and sleeve the root of the left atrial appendage.

5. The left atrial appendage closure device according to claim 3, characterized in that: The lasso assembly includes a wire locking device and a lasso wire. The wire locking device has a through hole and a one-way hole. The fixed end of the lasso wire is fixedly connected to the through hole and is placed outside the wall of the left atrial appendage through the adjustable bending sheath. The tightening end of the lasso wire is placed inside the adjustable bending sheath. The lasso wire passes through the one-way hole, and the lasso wire between the through hole and the one-way hole forms a loop-shaped lasso wire for sleeving the root of the left atrial appendage. The one-way hole is used to limit the one-way movement of the lasso assembly in the tightening direction towards the puncture assembly.

6. The left atrial appendage occlusion device according to claim 5, characterized in that: The lasso assembly includes a lasso loop and a lasso ring. The loop-shaped lasso wire is placed in the lasso loop, and the lasso ring is sleeved on the lasso loop.

7. The left atrial appendage occlusion device according to claim 6, characterized in that: The lasso assembly further includes a lasso sheath. The lasso sheath is sleeved on the lasso loop. The lasso sheath is provided with a plurality of lead holes, and the lasso wire sequentially passes through the plurality of lead holes.

8. The left atrial appendage closure device according to claim 3, characterized in that: The left atrial appendage closure device further includes a suction assembly. The suction assembly is used to penetrate into the interior of the adjustable bending sheath and extend out of the wall of the left atrial appendage to suck out the blood outside the pericardium.

9. The left atrial appendage occlusion device according to claim 5, wherein: The left atrial appendage closure device further includes a wire cutting assembly. The wire cutting assembly is used to penetrate into the interior of the adjustable bending sheath and extend to the opening of the left atrial appendage, and cut the lasso wire located outside the one-way hole after the lasso wire tightens the root of the left atrial appendage.

10. A method for using a left atrial appendage occlusion device as described in claim 1, characterized in that: The usage method includes the following steps: Control the balloon guiding sheath to reach the left atrial appendage and block the opening of the left atrial appendage; Control the puncture assembly to penetrate into the interior of the balloon guiding sheath and extend to the wall of the left atrial appendage to puncture the wall of the left atrial appendage; Control the lasso assembly to penetrate into the interior of the puncture assembly and extend out of the left atrial appendage wall, control the lasso assembly to reach the root of the left atrial appendage, and loop and lock the root of the left atrial appendage.

Images