Left atrial appendage ablation device and control method

Abstract

The application discloses a left atrial appendage ablation device and a control method, and relates to the field of medical instruments.The device comprises a closure device for being placed at a left atrial appendage opening, a first conductive part is arranged on the closure device, and the first conductive part is used for transmitting first ablation energy to tissue; a conveyor is used for conveying the closure device, the conveyor comprises a support capable of relatively moving relative to the closure device, a second conductive part is arranged on the support, and the second conductive part is used for transmitting second ablation energy to tissue; and the first ablation energy and the second ablation energy are opposite in polarity. By using the application, one-stop treatment of ablation function and closure function can be realized.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a left atrial appendage ablation device and a control method. BACKGROUND

[0002] Atrial fibrillation is the most common persistent arrhythmia, and the incidence of atrial fibrillation will continue to increase with age. Data shows that the incidence of atrial fibrillation in people over 75 years old can reach 10%. In addition, the prevalence of atrial fibrillation is also closely related to diseases such as coronary heart disease, hypertension, and heart failure.

[0003] In the heart tissue, the left atrial appendage is not only the main site of atrial fibrillation thrombosis due to its special morphology and structure, but also one of the key areas of its occurrence and maintenance. Some atrial fibrillation patients can benefit from active left atrial appendage electrical isolation surgery.

[0004] The "radiofrequency ablation + left atrial appendage occlusion" one-stop treatment is one of the hot spots of atrial fibrillation treatment today. At present, the one-stop treatment method combining catheter radiofrequency ablation and left atrial appendage occlusion has achieved many successful cases of treating atrial fibrillation. In the one-stop treatment method, through left atrial appendage occlusion, patients can still obtain good stroke prevention effect without the need for lifelong anticoagulant drugs; combined with catheter radiofrequency ablation to restore and maintain sinus rhythm and improve the symptoms of atrial fibrillation patients, patients can obtain stable long-term treatment effect.

[0005] However, the current ablation method mainly includes: through pulmonary vein electrical isolation (PVI) plus ablation of "atrial fibrillation foci" other than the pulmonary vein, without increasing left atrial appendage electrical isolation (unless the trigger focus from the left atrial appendage can cause persistent atrial fibrillation, atrial flutter or atrial tachycardia). With this ablation method, the one-year atrial fibrillation recurrence rate of patients is high. Studies have shown that for long-term persistent atrial fibrillation patients, left atrial appendage electrical isolation can reduce postoperative atrial fibrillation recurrence without increasing surgical complications. At the same time, the ablation catheter currently used for treating atrial fibrillation is designed for pulmonary vein ablation. Due to the great difference in the size, depth and position of the left atrial appendage opening of different patients, the existing pulmonary vein ablation catheter is obviously not suitable for left atrial appendage ablation.

[0006] If left atrial ablation and occlusion are performed during the above one-stop treatment, the ablation catheter and the left atrial ablation device need to be introduced in an interventional manner, and the key is to position the two devices at the left atrial appendage opening position in turn, and then perform ablation and occlusion, respectively, which is not conducive to the one-stop treatment of ablation and occlusion functions. SUMMARY

[0007] The present application aims at the problem that the existing medical devices related to surgical treatment of the left atrial appendage are not conducive to one-stop treatment of ablation and occlusion functions, and provides a left atrial appendage ablation device and a control method.

[0008] The technical solution of the present application for the above technical problems is as follows:

[0009] In one aspect, the present application provides a left atrial appendage ablation device, comprising:

[0010] An occlusion device for being placed at the opening of the left atrial appendage, the occlusion device being provided with a first conductive part for transmitting first ablation energy to the tissue;

[0011] A delivery device for delivering the occlusion device, the delivery device comprising a support capable of moving relative to the occlusion device, the support being provided with a second conductive part for transmitting second ablation energy to the tissue, the first ablation energy and the second ablation energy being opposite in polarity.

[0012] According to the above left atrial appendage ablation device, the support is used to move along the axial direction of the occlusion device to the distal end, and is positioned inside or at the distal end of the occlusion device, and transmits ablation energy to the tissue together with the occlusion device;

[0013] The support is also used to move along the axial direction of the occlusion device to the proximal end to separate from the occlusion device.

[0014] According to the above left atrial appendage ablation device, the support comprises an umbrella-shaped frame body arranged radially, and the second conductive part is arranged on the umbrella-shaped frame body.

[0015] According to the above left atrial appendage ablation device, the umbrella-shaped frame body comprises a plurality of umbrella ribs arranged radially around the axis, and a support connecting rod is arranged between two adjacent umbrella ribs, and the second conductive part is arranged on the support connecting rod.

[0016] According to the above left atrial appendage ablation device, the circumferential end of at least one umbrella rib is provided with a hook portion bent towards the axis direction of the umbrella-shaped frame body.

[0017] According to the above left atrial appendage ablation device, the support comprises:

[0018] A straight rod body, and the second conductive part is arranged on the straight rod body; or,

[0019] A spiral-shaped frame body, and the second conductive part is arranged on the spiral-shaped frame body; or,

[0020] A ring body, and the second conductive part is arranged on the ring body; or,

[0021] The second conductive part is arranged on a basket body of the basket;

[0022] The second conductive part is arranged on a woven mesh disc.

[0023] According to the left atrial appendage ablation device, the stent is a conductor, and the second conductive part is located in a preset conductive area of the stent; or,

[0024] The stent comprises an electrode member for connecting with an external power source, and the second conductive part is located on the electrode member.

[0025] According to the left atrial appendage ablation device, the stent is a conductor, and the second conductive part is located in a preset conductive area of the stent; or,

[0026] The stent comprises an electrode member for connecting with an external power source, and the second conductive part is located on the electrode member.

[0027] According to the left atrial appendage ablation device, the second conductive part is also used for collecting an electrophysiological signal in a target tissue area.

[0028] According to the left atrial appendage ablation device, the delivery device comprises an outer sheath, an inner sheath arranged in the outer sheath, and a pulling member arranged in the inner sheath, a distal end of the outer sheath is connected with a proximal end of the occlusion device, and a distal end of the pulling member is connected with a proximal end of the stent.

[0029] The occlusion device comprises a hollow channel, an inner cavity of the outer sheath is in communication with the hollow channel, the inner sheath and the stent accommodated in the inner sheath are used for penetrating through the outer sheath and the hollow channel and entering the inside of the occlusion device, and the stent is used for being released from the inner sheath inside or at a distal end of the occlusion device.

[0030] The first conductive part is arranged adjacent to a distal end of the occlusion device.

[0031] According to the left atrial appendage ablation device, the occlusion device is a closed mesh cage body, and the stent is used for being released from the inner sheath inside the occlusion device.

[0032] According to the left atrial appendage ablation device, the occlusion device is a semi-closed mesh cage body,

[0033] A through hole, through which the stent in a contracted state extends out of the semi-closed mesh cage body, is arranged at a distal end of the semi-closed mesh cage body; or,

[0034] An opening, through which the stent in a contracted state or an expanded state extends out of the semi-closed mesh cage body, is arranged at a distal end of the semi-closed mesh cage body.

[0035] According to the left atrial appendage ablation device, the first ablation energy and the second ablation energy are any one of the following ablation energies:

[0036] Pulse ablation energy, radio frequency ablation energy.

[0037] In another aspect, the application also provides a control method applied to the left atrial appendage ablation device, the method comprising:

[0038] The delivery device is used to deliver the occluder to the left atrial appendage opening for release to occlude the left atrial appendage opening, and the first conductive part is located at the first preset position;

[0039] The bracket is controlled to move so that the second conductive part moves to the second preset position;

[0040] The first conductive part and the second conductive part are used to transmit energy to the tissue area for ablation;

[0041] If the ablation is completed, the bracket is controlled to move proximally relative to the occluder until it is separated from the occluder.

[0042] The technical scheme provided by the embodiment of the application has the following beneficial effects:

[0043] In the application, after the left atrial appendage ablation device is implanted into the left atrial appendage in the heart, the proximal end of the occluder covers the left atrial appendage opening, and the distal end of the occluder is fixed in the inner cavity of the left atrial appendage, and the circumferential surfaces of the two are used to abut against the left atrial appendage tissue, thereby stably occluding the left atrial appendage opening. At the same time, the first conductive part on the occluder and the second conductive part on the bracket are used to realize pulse ablation or radio frequency ablation on the left atrial appendage tissue, so that one-stop treatment of ablation and occlusion functions can be realized.

[0044] The left atrial appendage ablation device of the application integrates the functions of occlusion and ablation, so that when it is applied to left atrial appendage ablation and occlusion, the positioning difficulty at the left atrial appendage opening can be reduced, the surgical procedure can be simplified, the operation time can be shortened, and the convenience of one-stop treatment of ablation and left atrial appendage occlusion can be improved. BRIEF DESCRIPTION OF DRAWINGS

[0045] In order to more clearly illustrate the technical scheme in the embodiments of the application, the following will briefly introduce the drawings needed to be used in the embodiment description. Obviously, the drawings in the following description are only some embodiments of the application, and other drawings can be obtained by those skilled in the art without any creative effort on the basis of these drawings.

[0046] Figure 1 The schematic diagram of the principle structure of the left atrial appendage ablation device provided by the application is shown.

[0047] Figure 2 Structure schematic diagram of the left atrial appendage ablation device provided by the present application in the first embodiment;

[0048] Figure 3 Perspective structure schematic diagram of the stent provided by the present application in the first embodiment;

[0049] Figure 4 Top view structure schematic diagram of the stent provided by the present application in the first embodiment;

[0050] Figure 5 Perspective structure schematic diagram of the stent provided by the present application in the first embodiment;

[0051] Figure 6 Perspective structure schematic diagram of the stent provided by the present application in the second embodiment;

[0052] Figure 7 Perspective structure schematic diagram of the stent provided by the present application in the third embodiment;

[0053] Figure 8 Perspective structure schematic diagram of the stent provided by the present application in the fourth embodiment;

[0054] Figure 9 Front view structure schematic diagram of the stent provided by the present application in the fifth embodiment;

[0055] Figure 10 Top view structure schematic diagram of the stent in the Figure 9

[0056] Structure schematic diagram of the left atrial appendage ablation device provided by the present application in the second embodiment; Figure 11

[0057] Structure schematic diagram of the left atrial appendage ablation device provided by the present application in the third embodiment; Figure 12

[0058] Structure schematic diagram of the left atrial appendage ablation device provided by the present application in the fourth embodiment; Figure 13

[0059] Flow chart of the control method of the left atrial appendage ablation device provided by the present application. Figure 14 DETAILED DESCRIPTION

[0060] ​In order to make the objects, technical solutions and advantages of the present application clearer, the embodiments of the present application will be further described in detail below with reference to the drawings. It should be noted that in the field of interventional medical devices, the end of a medical device implanted in a human or animal body closer to an operator is generally referred to as a proximal end, and the end farther from the operator is generally referred to as a distal end, and the proximal end and the distal end of any component of the medical device are defined according to this principle. Without deviating from the technical principles of the present application, the specific technical solutions in the following embodiments can be mutually applicable.

[0061] Reference is made to Figure 1 The schematic diagram of the principle structure of the left atrial appendage ablation device provided by the present application is shown. In order to facilitate observation and determination of the expression of the corresponding parts, the back structure part of the left atrial appendage ablation device 1 is processed for elimination, but it does not limit the overall structure of the left atrial appendage ablation device 1. It can be understood that the left atrial appendage ablation device in each of the following embodiments is processed by referring to this processing method.

[0062] As Figure 1 shown, the left atrial appendage ablation device 1 includes an occluder 11 and a delivery device 12 for delivering the occluder 11, wherein the occluder 11 is used to be placed at the opening of the left atrial appendage to form occlusion to the left atrial appendage. The delivery device 12 includes a support 121 capable of moving relative to the occluder 11. Here, the support 121 is positioned and released outside the occluder 11, and can move inside the occluder 11 at least in the delivery state, and in some embodiments, the support 121 can also be positioned and released inside the occluder 11.

[0063] The occluder 11 is provided with a first conductive part 111 for transmitting first ablation energy to the tissue. Correspondingly, the support 121 is provided with a second conductive part 1211 for transmitting second ablation energy to the tissue. The first ablation energy and the second ablation energy are opposite in polarity. In the application scenario of ablation treatment, the first conductive part 111 and the second conductive part 1211 are electrically connected with an external corresponding ablation signal source to transmit energy for ablation of the corresponding tissue of the left atrial appendage, thereby achieving ablation of the tissue. The ablation signal source is used to provide ablation energy for the first conductive part 111 and the second conductive part 1211. Specifically, the first ablation energy and the second ablation energy can be high-voltage pulse ablation energy with opposite polarities, or radio frequency ablation energy with opposite polarities.

[0064] The left atrial appendage ablation device 1 has a whole rotary body structure, and the occluder 11 includes a sealing part or sealing disc at the proximal end (i.e. the lower end in the figure) and an anchoring part or anchoring disc at the distal end (i.e. the upper end in the figure). The sealing part or sealing disc is used to cover the opening of the left atrial appendage, and the anchoring part or anchoring disc is used to be fixed in the inner cavity of the left atrial appendage, and the circumferential surfaces of the two are used to abut against the left atrial appendage tissue, thereby being stably occluded at the opening of the left atrial appendage.

[0065] After the left atrial appendage ablation device 1 is implanted into the left atrial appendage in the heart, the sealing part or sealing disc of the occluder 11 forms a cover for the left atrial appendage opening, and the anchoring part or anchoring disc is fixed in the inner cavity of the left atrial appendage, and the circumferential surfaces of both are used to abut against the left atrial appendage tissue, so as to firmly occlude the left atrial appendage opening. At the same time, the first conductive part 111 on the occluder 11 and the second conductive part 1211 on the stent 121 are used to realize pulse ablation or radiofrequency ablation on the left atrial appendage tissue, so that one-stop treatment of ablation and occlusion functions can be realized.

[0066] The left atrial appendage ablation device of the present application integrates the functions of occlusion and ablation, so that when it is applied to left atrial appendage ablation and occlusion, the positioning difficulty at the left atrial appendage opening can be reduced, the surgical procedure can be simplified, the operation time can be shortened, and the convenience of one-stop treatment of "ablation + left atrial appendage occlusion" can be improved.

[0067] Here, when the ablation energy is high-voltage pulse ablation energy, the pulse ablation uses high-intensity pulse electric field to cause irreversible electric perforation of cell membrane (also known as Irreversible electroporation, IRE), so as to cause cell apoptosis, and then realize non-thermal effect ablation of cells, so it is not affected by the heat sink effect. The high-voltage pulse sequence produces little heat, and does not need to be flushed with physiological saline to cool, which can effectively reduce the occurrence of air explosion, eschar and thrombus. The pulse ablation treatment time is short, and the treatment time of a group of pulse sequences is less than one minute, and the whole ablation time is generally not more than five minutes. And because there are differences in the response threshold of different tissues to pulse electric field, it provides the possibility of ablation of myocardium without interfering with other adjacent tissues, so that the adjacent tissues of the left atrial appendage can be avoided to be injured.

[0068] Compared with other ablation energies, pulse ablation does not need heat conduction to ablate deep tissues, and all myocardial cells distributed above a certain electric field intensity will be electrically perforated, reducing the requirement for ablation on the pressure of the catheter. Therefore, even if the ablation instrument does not completely adhere to the inner wall of the left atrial appendage after entering the left atrial appendage, it does not affect the irreversible electric perforation ablation effect. The electrode that applies pulse energy can also collect intracardiac electrical signals. Before ablation, the intracardiac electrocardiogram signal is transmitted to an electrocardiogram synchronizer to synchronize the pulse output in the absolute refractory period of myocardial contraction, so as to not interfere with the heart rate and reduce sudden arrhythmia; after ablation is completed, it can also be determined whether the tissue is completely electrically isolated through the intracardiac signal.

[0069] In some embodiments of the present application, the stent 121 is capable of moving axially relative to the occluder 21 towards the proximal end and the distal end, facilitating flexible adjustment of the relative position between the first conductive part 111 and the second conductive part 1211, and the ablation electric field region formed between the first conductive part 111 and the second conductive part 1211. Therefore, the position of the stent 21 can be adjusted according to the anatomical structure of the left atrial appendage, so as to set a better ablation region, so that a closed annular electric isolation zone is formed in the left atrial appendage lumen, improving the efficiency and success rate of ablation.

[0070] It can be understood that the stent 121 can also be used to move axially relative to the occluder 11 towards the proximal end along the axis of the occluder 11 to separate from the occluder 11. That is, after the ablation is completed, the occluder 21 is left in the left atrial appendage, and the handle in the delivery device controls the stent 121 and the second conductive part 1211 to move towards the proximal end and withdraw from the body. The stent 121 in the left atrial appendage ablation device 1 which is not used to occlude the left atrial appendage is withdrawn from the body, so that the structure of the medical device left in the body is relatively simple, and the safety for the patient is higher.

[0071] Of course, in other embodiments, the stent 121 is capable of moving along a path inclined to the axis of the occluder 11 body, so as to adjust the position of the stent 21 according to the anatomical structure of the left atrial appendage, so as to set a better ablation region, so that a closed annular electric isolation zone is formed in the left atrial appendage lumen, improving the efficiency and success rate of ablation.

[0072] Referring to Figure 2 The structure schematic diagram of the left atrial appendage ablation device provided by the present application in the first embodiment is shown. The left atrial appendage ablation device 2 comprises an occluder 21 and a delivery device 22, the delivery device 22 comprises a handle 223 and an outer sheath 222 connected with the handle 223, the distal end of the outer sheath 222 is detachably connected with the proximal end of the occluder 21, and the operator controls the position of the occluder 21 through the outer sheath 222. The outer sheath 22 is in the form of a hollow tube, and is also used to provide a channel for the stent 221 and other catheters, guide wires and the like to move axially relative to the occluder 21.

[0073] The occluder 21 comprises an anchoring disc 211 and a sealing disc 212, wherein the sealing disc 212 is used to cover the opening of the left atrial appendage to form an occlusion of the opening of the left atrial appendage, and the anchoring disc 211 is used to be fixed in the lumen of the left atrial appendage to form the fixation of the whole occluder 21 and the lumen of the left atrial appendage. In the present embodiment, the first conductive part 2111 is arranged on the anchoring disc 211. Here, the first conductive part 2111 is arranged circumferentially on the anchoring disc 211, and the annular ablation structure formed thereby can be one turn or multiple turns. It can be understood that in other variant structures of the present embodiment, the first conductive part 2111 can also be arranged on the sealing disc 212.

[0074] In the embodiment, the anchoring disc 211 and the sealing disc 212 are in a split structure, that is, a connecting member is arranged between the sealing disc 212 and the anchoring disc 211 for connection. In the embodiment, the sealing disc 212 and the anchoring disc 211 are respectively formed by laser cutting of a metal pipe material, and are integrated by the connecting member or welding and bonding. It can be understood that in the alternative embodiment, at least one of the sealing disc 212 and the anchoring disc 211 is formed by weaving of a wire material. In one embodiment, the sealing disc 212 and the anchoring disc 211 are integrally cut or integrally woven.

[0075] In the embodiment, the sealing disc 212 and the anchoring disc 211 are both provided with a multi-mesh frame body, and the multi-mesh frame body is relatively Figure 1 The occluder structure shown has more support bodies, enhances the overall structural strength, and also increases the contact area with the inner wall of the left atrial appendage, which helps to improve the uniformity of the stress of the occluder 21 on the tissue of the inner wall of the left atrial appendage, so as to form a better occlusion effect.

[0076] In the embodiment, the first conductive part 2111 is arranged adjacent to the distal end of the occluder 21. Specifically, the frame body of the anchoring disc 211 includes a main stem 2112 radially extending from the center of the disc body and a first conductive part 2111 for connecting adjacent main stems 2112. Here, the first conductive part 2111 includes a plurality of inter-rod connecting rods 2113 connected with the main stem 2112 and connected with each other, and the inter-rod connecting rods 2113 are conductors. More specifically, the inter-rod connecting rods 2113 are straight rod bodies, and the inter-rod connecting rods 2113 connected with each other form a first broken line type wave, the peaks of the first broken line type wave are connected with the end portions of the main stem 2112, and a connecting member is further arranged at the trough position of the first broken line type wave, and the connecting member is an inter-frame connecting rod 2114.

[0077] The anchoring disc 211 further includes a second broken line type wave which is mirror-symmetrical to the first broken line type wave, and the second broken line type wave is arranged at the other end of the inter-frame connecting rod 2114, and the peaks of the second broken line type wave are connected with the inter-frame connecting rod 2114. A backfolding type skeleton 2115 backfolding to the axis direction of the disc body is further connected at the trough of the second broken line type wave. The backfolding type skeleton 2115 arranged can reduce the possibility of tissue damage caused by the anchoring disc 211.

[0078] In the embodiment, the inter-frame connecting rod 2114 can also be a straight rod body, and barbs and slots formed by cutting the barbs are arranged thereon.

[0079] In some embodiments, the frame of the anchor disc 211 is a conductive metal frame, and in this case, the first conductive part 2111 can be distinguished from the rest of the frame by insulating the corresponding part of the first skeleton or the second skeleton, for example, by applying an insulating coating or adhering an insulating film to the frame outside the area of the first conductive part 2111. In this case, the first conductive part 2111 is an integral structure with the anchor disc 211.

[0080] In the case where the frame of the anchor disc 211 is a conductive metal frame, the first conductive part 2111 can also be an electrode piece arranged on the anchor disc 211. The electrode piece can be a ring-shaped electrode, a rod-shaped electrode, a sheet-shaped electrode, a wire-shaped electrode, or the like. The material of the electrode piece is a conductive metal, and the material of the electrode piece is different from that of the anchor disc 211. For example, the material of the electrode piece can provide better conductive parameters to improve the ablation performance.

[0081] In another embodiment, the frame of the anchor disc 211 can also be an insulating frame, and in this case, the first conductive part 2111 can be obtained by arranging a metal piece as an electrode piece at the corresponding position on the first skeleton or the second skeleton.

[0082] In some embodiments, a flow-blocking film can be arranged on the anchor disc 211 and / or the sealing disc 212 to prevent thrombus in the deep part of the left atrial appendage from entering the left atrium. In other embodiments, the flow-blocking film can further be used to prevent blood flow from forming at the opening of the left atrial appendage.

[0083] In the present embodiment, the delivery device 22 includes a stent 221, an outer sheath 222, a handle 223, and an inner sheath (not shown) arranged in the outer sheath 222. The distal end of the outer sheath 222 is detachably connected to the proximal end of the occlusion device 21, such as by screwing. The outer sheath 222 is tubular and has a channel for the stent 221 and the inner sheath to be arranged therein and movable relative to the occlusion device 21. The proximal end of the sealing disc 212 is electrically connected to an external ablation signal source through a conductive member (not shown), which can be a conductive wire or a conductive tube. The conductive member passes through the outer sheath 222 and the handle 223 to connect the external ablation signal source, thereby providing the first ablation energy to the first conductive part 2111 on the anchor disc 211. Here, the stent 221 is a radial expansion umbrella-shaped frame, and the second conductive part 2211 is arranged on the umbrella-shaped frame.

[0084] In the embodiment, the occluder 21 comprises a hollow channel 213 which penetrates the sealing disc 212 and the anchoring disc 211. In the embodiment, the sealing disc 212 and the anchoring disc 211 are both hollow net-shaped, and the hollow channel 213 can be a combination of a space surrounded by the sealing disc 212 and the anchoring disc 211 and a space communicated between the sealing disc 212 and the anchoring disc 211. The inner cavity of the outer sheath 222 is communicated with the hollow channel 213, and the inner sheath 224 and the stent 221 accommodated in the inner sheath 224 are used to pass through the outer sheath 222 and the hollow channel 213 and enter the inside of the occluder 21, and the stent 221 is used to be released from the inner sheath at the inside or the distal end of the occluder 21, and the first conductive part 2111 is arranged adjacent to the distal end of the occluder 21.

[0085] In some specific application examples of the embodiment, the stent 221 is made of metal material, and the corresponding position of the stent 221 is insulated to obtain the insulating part which is different from the second conductive part 2211, for example, the insulating treatment is performed on the stent body outside the second conductive part 2211 by using the method of coating insulating coating or adhering insulating film, and in this case, the second conductive part 2211 and the stent 221 are integrated. In the alternative embodiment, the second conductive part 211 and the stent 211 made of conductive material are separate structures, that is, the second conductive part 211 is an additional electrode part arranged on the stent 211.

[0086] In another specific application example of the embodiment, the stent 221 is an insulating stent body, and in this case, the metal part is arranged as the electrode part at the corresponding position of the stent 221 to obtain the second conductive part 2211.

[0087] Referring to Figures 3 to 5 , wherein, Figure 3 a perspective structural schematic view of the stent provided by the application in the first embodiment; Figure 4 a top view structural schematic view of the stent provided by the application in the first embodiment; Figure 5This is a perspective structural diagram of the stent provided by the present invention in a first embodiment. The umbrella-shaped frame of the stent 221 includes multiple umbrella ribs 2212 arranged radially around its axis. The second conductive part includes interconnected stent connecting rods 2213, and each stent connecting rod 2213 is also used to connect two adjacent umbrella ribs 2212. Here, the structure formed by the interconnected stent connecting rods 2213 can also form a zigzag wave, and the crest of the zigzag wave is connected to the end of the umbrella rib 2212, while the trough is connected to a hook portion 2214 bent towards the axis of the umbrella-shaped frame. The hook portion 2214 can be used to prevent the end of the stent 221 from damaging the left atrial appendage wall tissue. Of course, in some variant structures of this embodiment, the structure of the hook portion 2214 may be omitted from the stent 221.

[0088] Figure 3 and Figure 4 The structure shown corresponds Figure 2 The stent structure includes a hollow inner sheath 224. During delivery, the stent 211 is completely housed within the inner sheath. After the distal end of the inner sheath 224 reaches the predetermined position, the stent 221 extends from the distal end of the inner sheath 224. The inner sheath 224 is used to deliver the stent within the hollow channel 213 of the outer sheath 222 and the occluder 21. Here, the distal end of the inner sheath 224 is used to position the stent at the distal end of the channel of the occluder 21, while the stent 221 is used for release at the distal end of the occluder fixed to the left atrial appendage orifice.

[0089] In this embodiment, the conveyor 22 may further include a pulling member 225, which is housed within the hollow pipe 213. Here, the pulling member 225 may also be a tubular structure or a solid rod, such as a steel cable, which is used to control the movement of the support 221 and also to connect to the ablation signal source to provide second ablation energy to the second conductive part 2211 on the support 221.

[0090] In this embodiment, the distal end of the traction member 225 is connected to the proximal end of the support 221, and can move together with the support 221 within the inner sheath 224 along the hollow channel 213, thereby achieving the traction effect on the support.

[0091] See Figures 6 to 10 ,in, Figure 6 A three-dimensional structural diagram of the bracket provided by the present invention in a second embodiment; Figure 7 A three-dimensional structural diagram of the bracket provided by the present invention in a third embodiment; Figure 8 A three-dimensional structural diagram of the bracket provided by the present invention in the fourth embodiment; Figure 9 This is a front view schematic diagram of the bracket provided by the present invention in the fifth embodiment; Figure 10 for Figure 9 A top view of the support structure. (See diagram below.)Figure 6 As shown, the bracket 221' includes a straight rod body, and its second conductive part 2211' is provided at the end position of the far end of the bracket 221', and is also a straight rod body.

[0092] like Figure 7 As shown, the proximal end of the support 221'' is housed within an inner sheath and has an exposed portion extending out of the inner sheath, on which the second conductive part 2211'' is disposed. Here, the exposed portion of the support 221'' includes multiple helical rods, each helical rod coiled circumferentially from its proximal end to its distal end, making the support 221'' a helical frame. In the structure of the support 221'' in this embodiment, a second conductive part 2211'' is provided at the middle of each helical rod. The proximal ends of each helical rod are joined together, and the distal ends of each helical rod are joined together. The support 221'' also includes two interlocking tension members; the distal end of one tension member is connected to the distal end of the multiple helical rods, and the distal end of the other tension member is connected to the proximal end of the multiple helical rods. The relative axial movement of the two tension members enables changes in the radial dimension of the support 221''.

[0093] like Figure 8 As shown, the support 221``` includes a ring body at the distal end and a straight rod body at the proximal end. The straight rod body is used to be installed in the inner sheath tube, and a second conductive part 2211``` is disposed on the ring body. The second conductive part 2211``` includes a plurality of portions arranged at intervals along the extension direction of the ring body. It can be understood that the axis of the ring body can be coaxial with the axis of the straight rod body.

[0094] In addition, the stent may be in the form of a basket, with the second conductive part disposed on the basket to transmit the second ablation energy to the tissue.

[0095] like Figure 9 and Figure 10 As shown, the support 221```` includes a woven mesh disc at the distal end and a straight rod at the proximal end. After the support 221```` is released, the straight rod is used to house the inner sheath tube, and the second conductive part 2211```` is disposed on the woven mesh disc. Compared to Figures 3 to 7 In this embodiment, the stent 221 is a conductor, so the entire stent can be used as an electrode to transmit ablation energy to the tissue.

[0096] Combination Figures 3 to 10The bracket 221 can be a conductor, and the second conductive part 2211 is located in a preset conductive area of the bracket 221 (which is set according to different requirements), wherein the surface of the preset conductive area is conductive and does not need to be insulated, and the area outside the preset conductive area is an insulating area, and the surface of the insulating area needs to be insulated. The insulating area can be obtained by insulating the bracket 221, for example, by coating an insulating material on the non-pre-set conductive area of the bracket, or by adhering an insulating film to the non-pre-set conductive area of the bracket. Of course, as a variant structure, the second conductive part 2211 can also include an electrode member such as a metal member for connecting with an external power source. In addition to transmitting the second ablation energy to the tissue, the second conductive part 2211 can also collect the electrophysiological signals in the target tissue area, so as to monitor whether the inner wall of the left atrial appendage is ablated completely in real time.

[0097] In combination Figures 2 to 10 The occluder 21 can include a hollow channel, and the inner cavity of the outer sheath tube 222 can be in communication with the hollow channel, and the inner sheath tube 224 and the bracket 221 accommodated in the inner sheath tube 224 are used to pass through the outer sheath tube 222 and the hollow channel and enter the inside of the occluder 21, and the bracket 221 is used to be released from the inner sheath tube 224 inside or at the distal end of the occluder 21.

[0098] Referring to Figure 11 The structure schematic diagram of the left atrial appendage ablation device provided by the application in the second embodiment is shown. The left atrial appendage ablation device 3 also includes an occluder 31 and a delivery device 32, and the delivery device 32 includes a handle 323 and an outer sheath tube 322 connected with the handle 323, and the outer sheath tube 322 is used to provide a channel for the bracket 321 to move relative to the occluder 31.

[0099] The difference between the left atrial appendage ablation device of the first embodiment and the left atrial appendage ablation device of the second embodiment is that:

[0100] The occluder 31 is a one-piece woven structure, including a semi-closed mesh cage body. It can be understood that the semi-closed type has a cavity for accommodating the bracket 321 in the expanded state or the contracted state, and the cavity is further provided with a through hole or an open structure such as an opening for the inner sheath tube and the bracket 321 to extend out. The structure without the corresponding opening or through hole is a closed type.

[0101] In the embodiment, the semi-closed mesh stent body is a columnar body with a hollow surface, and a woven mesh formed by woven wires is arranged on the side surface, the proximal end and the distal end. The semi-closed mesh stent body has a cavity, and a through hole is arranged at the distal end of the semi-closed mesh stent body for the inner sheath to extend out. It can be understood that the stent 321 is in a contracted state in the inner sheath. In the embodiment, the through hole is a channel in the distal end steel sleeve of the occluder 31, and the steel sleeve is in a tubular shape and used for accommodating and fixing the end portions of the plurality of woven wires. In an embodiment, the through hole is a mesh hole formed between the woven wires. The semi-closed mesh stent body includes an anchoring portion 311 and a sealing portion 312, wherein the sealing portion 312 is used for covering the opening of the left atrial appendage to form occlusion of the opening of the left atrial appendage, and the anchoring portion 311 is used for being fixed in the inner cavity of the left atrial appendage to form fixation of the whole occluder 31 and the inner cavity of the left atrial appendage. In the embodiment, the first conductive portion 3111 is arranged on the anchoring portion 311. It can be understood that in other variant structures of the embodiment, the first conductive portion 3111 can also be arranged on the sealing portion 312.

[0102] In the anchoring portion 311, the first conductive portion 3111 includes an electrode member 313 used for connecting with an external power source, and the electrode member 313 is annularly wrapped around the circumferential surface of the anchoring portion 311, as shown in FIG. 6. The electrode member 313 is arranged at the position close to the axial middle segment of the anchoring portion 311, and the surface of the electrode member 313 is used for transmitting ablation energy to the tissue. Figure 11 In a variant embodiment, the electrode member 313 includes a carrier in an annular shape and a plurality of annular electrodes arranged on the carrier in a spaced manner, wherein the carrier is not used for transmitting ablation energy to the tissue, and the annular electrodes are used for transmitting ablation energy to the tissue.

[0103] It can be understood that when the semi-closed mesh stent body of the occluder 31 is a metal stent body, since the electrode member 313 is additionally arranged and not integrated with the occluder 31, the whole occluder 31 is preferably insulated, and the ablation is performed by the electrode member 313 to avoid mutual short circuit between the electrode member 313 and the stent body of the occluder 31. Of course, the first conductive portion 3111 can also be other forms of electrode members arranged on the anchoring portion 311, and the electrode member can be an annular electrode, a rod-shaped electrode, a sheet-shaped electrode, a wire-shaped electrode, etc. The material of the electrode member and the anchoring portion 311 of the occluder 31 is a conductive metal, and the material of the electrode member is different from that of the anchoring portion 311, for example, the material of the electrode member can provide better conductive parameters to improve the ablation performance. Further, as a variant structure, an electrode member 313 described above can be further arranged on the basis of the annular conductive portion, at this time, the electrode member 313 can be arranged on the annular conductive portion, or can be arranged at other positions of the anchoring portion 311, or can be arranged on the sealing portion 312 to perform ablation on the left atrial appendage.

[0104] In the embodiment, the hollow pipe is arranged at the middle axis position of the semi-closed net cage body of the occluder 31, and the support 321 and the inner sheath can extend out of the semi-closed net cage body through the hollow pipe.

[0105] In the embodiment, the left atrial appendage ablation device 3 forms a cover for the left atrial appendage opening by using the sealing part 312 of the occluder 31, and the anchoring part 311 is fixed in the inner cavity of the left atrial appendage. The circumferential surfaces of the two are used to abut against the left atrial appendage tissue, so as to be firmly occluded at the left atrial appendage opening. At the same time, the first conductive part 3111 on the occluder 31 and the second conductive part 3211 on the support 321 are used to realize pulse ablation or radio frequency ablation on the left atrial appendage tissue, so that one-stop treatment of ablation and occlusion functions can be realized. In the case that the first conductive part 3111 and the occluder 31 are integrated, and the second conductive part 3211 and the support 321 are integrated, the risk of thrombosis of the conductive area on the left atrial appendage ablation device can be reduced, the phenomenon of electrode separation from the skeleton can be avoided, and the reliability of application can be improved.

[0106] Referring to Figure 12 The structure schematic diagram of the left atrial appendage ablation device provided by the application in the third embodiment is shown. The left atrial appendage ablation device 4 also comprises an occluder 41 and a delivery device 42, and the delivery device 42 comprises a handle 423 and an outer sheath 422 connected with the handle 423. The outer sheath 422 is used to provide a channel for the support 421 to move relative to the occluder 41.

[0107] The difference between the left atrial appendage ablation device of the second embodiment and the left atrial appendage ablation device of the third embodiment is that:

[0108] The occluder 41 is a whole structure, comprising a closed net cage body with a cavity structure, and the support 421 is arranged in the cavity structure, that is, the inside of the occluder. The occluder 41 also comprises an anchoring part 411 and a sealing part 412. The first conductive part 4111 is located at the distal end of the closed net cage body, and is specifically arranged on the anchoring part 411. The first conductive part 4111 can comprise an electrode 413 used to be connected with an external power source.

[0109] In the embodiment, the support 421 is used to be positioned in the inside of the closed net cage body, and thus the second conductive part 4211 is used to release ablation energy in the closed net cage body and transmit the ablation energy to the tissue together with the first conductive part 4111 located outside the closed net cage body, so as to realize ablation on the tissue.

[0110] Referring to Figure 13This is a schematic diagram of the left atrial appendage ablation device provided by the present invention in a fourth embodiment. The left atrial appendage ablation device 5 also includes an occluder 51 and a delivery device 52. The delivery device 52 includes a handle 523 and an outer sheath 522 connected to the handle 523. The outer sheath 522 is used to provide a channel for the stent 521 to move relative to the occluder 51.

[0111] The difference between this device and the left atrial appendage ablation device in the third embodiment is that the occluder 51 is an integral woven structure, including a semi-enclosed mesh cage frame, with an opening 514 at its distal end for the support 521 to extend from the distal end of the semi-enclosed mesh cage frame in either the contracted or expanded state. It is understood that an integral structure obtained by cutting tubing or an integral structure obtained by weaving wire can achieve the same mesh cage frame effect.

[0112] like Figure 13 As shown, the plug 51 includes an anchoring part 511 and a sealing part 512, while the bracket 52 is in an extended state and is disposed inside the semi-enclosed wire mesh frame. The second conductive part 5211 is located at the far end of the semi-enclosed wire mesh frame, and the first conductive part 5111 of the plug 51 includes an electrode 513 for connecting to an external power source.

[0113] In conjunction with the left atrial appendage ablation devices of the first to fourth embodiments, the occluders are all frame structures:

[0114] The first conductive part is used to transmit the first ablation energy to the tissue to achieve the ablation function of the tissue. It can be made by insulating the corresponding part of the metal frame of the occluder to obtain a pre-set non-insulated conductive area, or by setting the corresponding part of the frame structure of the occluder with ring electrode, rod electrode, sheet electrode, or wire electrode. The form of setting can be to be bonded to the frame structure of the occluder, or to be connected to the frame structure of the occluder through a connector, or to be intertwined and fixed with the frame structure.

[0115] It is understood that the conductive parts of the first conductive part can be arranged continuously or at preset intervals.

[0116] The second conductive part is used to transmit the second ablation energy to the tissue to achieve the ablation function of the tissue. Similar to the first conductive part, the second conductive part can also be made by insulating the corresponding part of the specific metal structure to obtain the uninsulated preset conductive area, or by setting electrode wires, electrode sheets, electrode rings and electrode rods on the corresponding part of the support. The form of setting can be to be bonded to the support structure, or to be connected to the frame structure of the occluder through a connector, or to be intertwined and fixed with the frame structure.

[0117] It can be understood that the second conductive part can be arranged continuously or at a preset interval.

[0118] It can be understood that when the first conductive part and the second conductive part are made of a preset conductive area obtained by insulating a metal main body (the whole occluder is made of metal material, and the whole stent is made of metal material), the first conductive part and the occluder are in an integrated structure, and the second conductive part and the stent are in an integrated structure, so that the risk of thrombosis of the conductive area on the left atrial appendage ablation device can be further reduced, and the phenomenon of electrode separation from the skeleton can be avoided, thereby improving the reliability of application.

[0119] In the present application, the projections of the first conductive part and the second conductive part on the occluder axis do not completely coincide, preferably, the projections of the first conductive part and the second conductive part on the occluder axis do not coincide with each other, that is, they are arranged staggered, thereby facilitating reducing the probability of short circuit caused by contact between the first conductive part and the second conductive part.

[0120] The left atrial appendage ablation device provided by the present application can further include a delivery sheath (not shown in the figure), in the delivery state: the occluder is in a compressed state in the radial direction and is accommodated in the delivery sheath, and after reaching the first preset position, the occluder is released from the delivery sheath. The occluder expands and is fixed to the left atrial appendage opening, and the circumferential direction of the anchoring part / anchoring disc abuts against the left atrial appendage inner cavity tissue, so that the first conductive part can directly contact the left atrial appendage tissue. The stent is accommodated in the inner sheath in the delivery state, enters the inside of the occluder or extends out from the distal end of the occluder along with the inner sheath, until the distal end of the inner sheath reaches the corresponding position. Thereafter, the inner sheath and the pulling member are controlled to guide the stent to be released from the distal end of the inner sheath at the second preset position, that is, to be released at the distal end or inside of the occluder. In the case that the ablation source is a pulse ablation signal, the second conductive part does not require high adhesion to the left atrial appendage tissue, and does not affect the irreversible electroporation ablation effect, so that the setting position after release can be relatively arbitrary, but preferably the stent is staggered with the first conductive part, so as to avoid short circuit. Thereafter, the handle controls the first conductive part and the second conductive part to transmit ablation energy with opposite polarities to the tissue, thereby realizing ablation of the left atrial appendage inner cavity tissue. After ablation is completed, the handle controls the pulling member to drive the stent to be retrieved into the inner sheath, and the inner sheath and the stent are withdrawn from the hollow channel and the outer sheath to the outside of the body, and then the distal end of the outer sheath is separated from the proximal end of the occluder, and the handle drives the outer sheath and the stent to be withdrawn from the body.

[0121] Referring to Figure 14 The flow chart of the control method of the left atrial appendage ablation device provided by the present application is applied to the above-mentioned left atrial appendage ablation device, and the control method can include the following flow:

[0122] S101: delivering the occluder to the left atrial appendage opening by the delivery device to release the occluder to occlude the left atrial appendage opening, and the first conductive part is located at the first preset position.

[0123] In this step, the delivery device can specifically include the handle, the outer sheath, the inner sheath and the stent, the occluder is arranged in the outer sheath when in the contracted state, and the first conductive part is released after being delivered to the first preset position to expand to the size matched with the left atrial appendage opening and to occlude the left atrial appendage opening.

[0124] S102: controlling the stent to move to make the second conductive part move to the second preset position.

[0125] In this step, the inner sheath inside the outer sheath and the stent in the inner sheath move relative to the occluder and are released by the distal end of the inner sheath at the corresponding position to make the stent be at the second preset position. Here, the first preset position can be the same as or different from the second preset position, and when the same, the projections of the two on the axis of the occluder at least partially overlap.

[0126] It can be understood that the stent is arranged in the inner sheath when in the contracted state and is released after being delivered to the second preset position.

[0127] S103: transmitting energy to the tissue area by the first conductive part and the second conductive part to perform ablation.

[0128] In this step, the ablation signal source provides ablation energy with opposite polarities to the first conductive part and the second conductive part respectively, and transmits the ablation energy to the tissue through the two to perform ablation.

[0129] S104: if the ablation is completed, controlling the stent to move to the proximal end relative to the occluder until the stent is separated from the occluder.

[0130] In this step, the ablation condition can be monitored in real time, and when the monitoring shows that the ablation is completed, the stent is controlled to contract and retract into the inner sheath. Then, the inner sheath and the stent in the inner sheath move to the proximal end relative to the occluder to be separated from the occluder, so as to realize relatively complete ablation treatment control of the left atrial appendage.

[0131] It can be understood that the left atrial appendage ablation device in each of the above embodiments can be controlled by the above control method to perform left atrial appendage ablation treatment control, so that the left atrial appendage ablation device can be stably occluded in the left atrial appendage opening. At the same time, the first conductive part on the occluder and the second conductive part of the stent are used to realize pulse ablation or radiofrequency ablation on the left atrial appendage tissue, so as to realize one-stop treatment of ablation function and occlusion function.

[0132] It can be understood that the control method of the left atrial appendage ablation device can be mainly executed in a computer, which can include a processor, a memory, and a computer program stored in the memory and executable on the processor, such as a control program of the left atrial appendage ablation device. When the processor executes the computer program, each step in the control method is implemented, for example Figure 14 the steps S101 to S104 shown. Alternatively, when the processor executes the computer program, the functions of each module in the device embodiment are implemented.

[0133] The above merely describes the preferred embodiments of the present application and is not intended to limit the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A left atrial appendage ablation device, characterized in that, include: An occluder for insertion into the opening of the left atrial appendage, the occluder having a first conductive part for transmitting first ablation energy to the tissue, the first conductive part being disposed near the distal end of the occluder; A delivery device for delivering the occluder includes a support movable relative to the occluder, the support having a second conductive portion for transmitting a second ablation energy to the tissue, the first ablation energy being opposite in polarity to the second ablation energy; the delivery device includes an outer sheath, an inner sheath disposed within the outer sheath, and a traction member disposed within the inner sheath, the distal end of the outer sheath being connected to the proximal end of the occluder, and the distal end of the traction member being connected to the proximal end of the support; the occluder includes a hollow channel, the inner cavity of the outer sheath communicating with the hollow channel, the inner sheath and the support housed within the inner sheath being used to pass through the outer sheath and the hollow channel to enter the interior of the occluder; The occluder is a closed mesh cage frame, and the support is used to release the occluder from the inner sheath at its distal end.

2. The left atrial appendage ablation device according to claim 1, characterized in that, The stent is used to move distally relative to the occluder along the axial direction of the occluder, and together with the occluder, deliver ablation energy to the tissue; The support is also used to move proximally relative to the occluder along the axial direction of the occluder to separate from the occluder.

3. The left atrial appendage ablation device according to claim 2, characterized in that, The support includes a radially unfolded umbrella-shaped frame, and the second conductive part is disposed on the umbrella-shaped frame.

4. The left atrial appendage ablation device according to claim 3, characterized in that, The umbrella-shaped frame includes multiple umbrella ribs arranged radially around its axis, and a support connecting rod is provided between two adjacent umbrella ribs. The second conductive part is located on the support connecting rod.

5. The left atrial appendage ablation device according to claim 4, characterized in that, The circumferential end of at least one umbrella rib is provided with a hook portion that bends toward the axis of the umbrella frame.

6. The left atrial appendage ablation device according to claim 1, characterized in that, The support includes: A straight rod body, with the second conductive part disposed on the straight rod body; or... A spiral frame, with the second conductive part located on the spiral frame; or... A ring body, wherein the second conductive portion is disposed on the ring body; or... The basket body has the second conductive part disposed on the basket body of the basket body; A woven mesh tray, wherein the second conductive part is disposed on the woven mesh tray.

7. The left atrial appendage ablation device according to claim 1, characterized in that, The support is a conductor, and the second conductive part is located in a predetermined conductive area of ​​the support; or, The bracket includes electrode components for connection to an external power source, and the second conductive portion is located on the electrode components.

8. The left atrial appendage ablation device according to claim 1, characterized in that, The occluder is a conductor, and the first conductive part is located in a predetermined conductive area of ​​the support; or, The plug includes an electrode for connection to an external power source, with the first conductive portion located on the electrode.

9. The left atrial appendage ablation device according to claim 1, characterized in that, The second conductive part is also used to collect electrophysiological signals in the target tissue region.

10. The left atrial appendage ablation device according to any one of claims 1 to 9, characterized in that, Both the first ablation energy and the second ablation energy are any one of the following ablation energies: Pulse ablation energy, radiofrequency ablation energy.

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