A leaflet cutting device and application thereof

Abstract

The present invention provides a leaflet cutting device and application, the leaflet cutting device comprises a leaflet clamping catheter, the leaflet clamping catheter is connected to a cutting catheter, the leaflet clamping catheter and the cutting catheter both pass through a delivery sheath, the leaflet clamping catheter comprises a leaflet clamping member, the leaflet clamping member comprises two clamping plates, any one of the clamping plates is provided with a guide groove arranged at intervals on the end surface away from the other clamping plate, the cutting catheter comprises a push cutting portion, the push cutting portion cooperates with the guide groove, the push cutting portion comprises a traction rod arranged at intervals, any one of the traction rods is provided with a cutting knife that can be accommodated in the cutting portion, and the blades of the two cutting knives are arranged in an alternating manner. The present invention adopts a cutting knife to be accommodated in the cutting portion, and after reaching the target position, the cutting knife is extended by pulling the internal traction rod, and the bilateral cutting knives are extended at the same time to complete the puncture of the target leaflet; the target leaflet is cut by pulling or pushing the cutting catheter.

Description

[0001] The present invention relates to the technical field of medical devices, and in particular to a valve leaflet cutting device and application thereof. Background Art

[0002] Transcatheter aortic valve replacement (TAVR) is a minimally invasive valve replacement procedure that uses interventional catheter technology to deliver an artificial aortic valve to the original aortic valve, thereby replacing the diseased valve and achieving the purpose of treatment. Coronary artery obstruction, a complication that threatens the patient's condition, may occur during TAVR surgery. Current prevention strategies include the use of preventive coronary stent protection or leaflet cutting technology. Preventive coronary stent protection carries the risk of coronary stent deformation, stent thrombosis, and greatly increases the difficulty of coronary intervention for patients in the future. Leaflet cutting technology (such as BASILICA, CATHEDRAL technology, etc.) is achieved through guiding catheters, guidewires, snares, and electrosurgical cutting devices. This type of technology has the following technical defects: There is currently no equipment specifically used for this technology, so the technology is difficult and requires skilled and experienced interventional doctors to complete; during the operation, the guidewire punctures the leaflet and may damage the aortic root, causing serious surgical complications.

[0003] Invention patent CN114081674A provides a leaflet segmentation device, which cuts the leaflets by pushing a cutting catheter. This method may have the following technical defects: difficult positioning, large resistance to the cutting catheter, and thus reliance on an electrosurgical cutting system.

[0004] Invention patent CN113924052A provides a leaflet tearing device that uses a blade to puncture and cut the leaflets, but the device only provides a mechanical cutting method and has the following technical defects: there is a possibility of cutting failure for severe calcified valve lesions.

[0005] Therefore, how to design a leaflet cutting device that improves the existing leaflet cutting device so as to facilitate doctors to locate and cut the diseased leaflets and its application has become an urgent problem to be solved. Summary of the invention

[0006] In view of the problems existing in the prior art, the present invention provides a leaflet cutting device and application to solve at least one of the above-mentioned technical problems.

[0007] The technical solution of the present invention is: a leaflet cutting device, including a leaflet clamping catheter, which is connected to a cutting catheter, both of which pass through a delivery sheath, the leaflet clamping catheter including a leaflet clamping member, the leaflet clamping member including two clamping plates, any one of the clamping plates being provided with guide grooves arranged at intervals on the end surface away from the other clamping plate, the cutting catheter including a pushing cutting portion, the pushing cutting portion cooperating with the guide groove, the pushing cutting portion including traction rods arranged at intervals, any one of the traction rods being provided with a cutting knife that can be received in the cutting portion, and the blades of the two cutting knives being arranged alternately.

[0008] The present invention adopts a cutting knife that is stored in the cutting part. After reaching the target position, the cutting knife is extended by pulling the internal traction rod. The cutting knives on both sides are extended at the same time to complete the puncture of the target valve leaflet; the target valve leaflet is cut by pulling or pushing the cutting catheter, which is convenient for the doctor to locate and cut the diseased valve leaflet.

[0009] The technical solution of the present invention is: an application of a valve leaflet cutting device that first punctures the valve leaflet and then cuts it, comprising the following steps:

[0010] R1. Deliver the leaflet-holding catheter to the aortic root through the third catheter lumen;

[0011] R2. Deliver a snare or angiography catheter through the first catheter lumen to locate the target sinus;

[0012] R3. Push the handle of the leaflet clamp to make the leaflet clamp reach the target position. The leaflet clamp does not exceed the snare used for positioning to avoid damaging the aortic root structure.

[0013] R4. Push the cutting catheter to the target position, pull the traction rod to complete the puncture of the valve leaflet, and lock the traction rod handle;

[0014] R5. Pull the cutting catheter to complete leaflet cutting.

[0015] During use, the present invention adopts a valve leaflet clamping member that does not exceed the snare used for positioning, thereby avoiding damage to the aortic root structure, solving the technical defect that the aortic root may be damaged when the guide wire punctures the valve leaflet during operation, causing serious surgical complications; by using the method of puncturing the valve leaflet first and then cutting, the technical defects of difficult positioning and large resistance to the cutting catheter lifting, thus relying on the electric cutting system, are solved.

[0016] The technical solution of the present invention is: an application of a leaflet cutting device to directly complete leaflet cutting, comprising the following steps:

[0017] S1. Deliver the leaflet-holding catheter to the aortic root through the third catheter lumen;

[0018] S2. Delivering a snare or an angiography catheter through the first catheter lumen to complete the positioning of the target valve sinus;

[0019] S3. Push the push handle of the leaflet clamp to make the leaflet clamp reach the target position. The leaflet clamp does not exceed the snare used for positioning to avoid damaging the aortic root structure.

[0020] S4. Pull the traction rod directly and lock the traction rod handle;

[0021] S5. Pull the cutting catheter to complete leaflet cutting.

[0022] The present invention adopts a valve leaflet clamping member that does not exceed the snare used for positioning during use, thereby avoiding damage to the aortic root structure and solving the technical defect that the aortic root may be damaged when the guide wire punctures the valve leaflet during operation, causing serious surgical complications.

[0023] The technical solution of the present invention is: an application of a valve leaflet cutting device that first punctures the valve leaflet and then performs electro-cutting to assist cutting, comprising the following steps:

[0024] T1. Deliver the leaflet-holding catheter to the aortic root through the third catheter lumen;

[0025] T2. Deliver a snare or angiography catheter through the first catheter lumen to locate the target sinus;

[0026] T3. Push the handle of the leaflet clamp to make the leaflet clamp reach the target position. The leaflet clamp does not exceed the snare used for positioning to avoid damaging the aortic root structure.

[0027] T4. Push the cutting catheter to the target position, pull the traction rod to complete the puncture of the valve leaflet, and lock the traction rod handle;

[0028] T5. The pulling resistance of the cutting knife rod is large, and it is difficult to cut the valve leaflet. At this time, the cutting knife is connected to the electric cutting system, and the cutting catheter is pulled with the assistance of electric cutting to complete the valve leaflet cutting.

[0029] During use, the present invention adopts a valve leaflet clamping member that does not exceed the snare used for positioning, thereby avoiding damage to the aortic root structure, solving the technical defect that the aortic root may be damaged when the guide wire punctures the valve leaflet during the operation, causing serious surgical complications; by using the method of first puncturing the valve leaflet and then electro-cutting to assist in cutting, the technical defect that there may be cutting failure for severe calcified valve lesions is solved. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 It is a schematic diagram of the installation structure of the present invention.

[0031] Figure 2 This is a usage state diagram of the present invention.

[0032] Figure 3 It is a schematic diagram of the structure of the cutting part of the present invention.

[0033] Figure 4 for Figure 3 Left view of .

[0034] Figure 5 It is a top view of the leaflet clamp of the present invention.

[0035] Figure 6 for Figure 5 AA cross-section diagram.

[0036] Figure 7 It is a schematic diagram of the structure of the delivery sheath tube of the present invention.

[0037] In the figure: 1. leaflet clamp; 2. push cutting part; 3. raised part; 4. delivery sheath; 5. snare; 6. guide wire; 101. guide groove; 102. hollow groove; 201. first connecting part; 202. cutting knife; 203. second connecting part; 204. traction rod; 205. cutting part; 401. first catheter cavity; 402. second catheter cavity; 403. third catheter cavity. DETAILED DESCRIPTION

[0038] The present invention will be further described below in conjunction with the accompanying drawings.

[0039] See also Figure 1-7 The structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention, so they have no substantial technical significance. Any modification of the structure, change of the proportional relationship or adjustment of the size should still fall within the scope of the technical content disclosed by the present invention without affecting the effects and purposes that can be achieved by the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description, and are not used to limit the scope of the implementation of the present invention. The change or adjustment of their relative relationship should also be regarded as the scope of the implementation of the present invention without substantially changing the technical content.

[0040] Embodiment 1: A leaflet cutting device and application, referring to Figure 1 , Figure 3 , Figure 4 , Figure 6, including a leaflet clamping catheter, which is connected to a cutting catheter, and both the leaflet clamping catheter and the cutting catheter pass through a delivery sheath 4, the leaflet clamping catheter including a leaflet clamping member 1, the leaflet clamping member 1 including two clamping plates, any one of the clamping plates away from the other clamping plate end surface is provided with a guide groove 101 arranged at intervals, the guide groove 101 is a guide rail of the clamping plate, the cutting catheter includes a head end cutting portion and a catheter body for pushing, the head end cutting portion includes a pushing cutting portion 2, the pushing cutting portion 2 cooperates with the guide groove 101, the pushing cutting portion 2 includes a traction rod 204 arranged at intervals, any one of the traction rods 204 is provided with a cutting knife 202 that can be received in the cutting portion 205, and the blades of the two cutting knives 202 are arranged alternately. The present invention adopts a cutting knife that is stored in the cutting part. After reaching the target position, the cutting knife is extended by pulling the internal traction rod. The cutting knives on both sides are extended at the same time to complete the puncture of the target valve leaflet; the target valve leaflet is cut by pulling or pushing the cutting catheter, which is convenient for the doctor to locate and cut the diseased valve leaflet.

[0041] Embodiment 2: Based on Embodiment 1, two groups of cutting parts 205 are provided on any of the traction rods 204, and any group of cutting parts 205 are symmetrically arranged and distributed on the two traction rods 204; guide blocks arranged at intervals are provided on the end faces of any group of cutting parts 205 that are close to each other, and the guide blocks are arranged one-to-one with the guide grooves 101, and a sink groove is provided in the middle of any cutting part 205; the cutting part 205 can be externally connected to an electric cutting system, and all parts except the cutting part 205 are made of surface insulating materials. The present invention adopts a one-to-one arrangement of the guide blocks of the cutting part and the guide grooves, and the cutting catheter is pushed forward along the guide rail of the clamping plate to achieve the clamping of the two clamping plates.

[0042] Embodiment 3: Based on Embodiment 2, a cutting knife 202 is provided between the two cutting portion 205 recesses on any one of the traction rods 204, one end of the handle of the cutting knife 202 is connected to the cutting portion 205 away from one side thereof through a first connecting member 201, and the other end of the handle of the cutting knife 202 is connected to the cutting portion 205 away from one side thereof through a second connecting member 203, and the first connecting member 201 and the second connecting member 203 are cross-arranged on the same traction rod 204. The present invention adopts the cross-arrangement of the handle of the cutting knife on the same traction rod through the first connecting member and the second connecting member to realize the extension or return of the cutting knife and complete the puncture of the target leaflet.

[0043] Embodiment 4: Based on Embodiment 2, refer to Figure 5 A hollow groove 102 is provided between the two guide grooves 101, and the hollow groove 102 is used to pass the cutting knife 202. The present invention adopts a hollow groove provided between the two guide grooves, and the middle hollow groove is used to pass the cutting knife.

[0044] Embodiment 5: Based on embodiment 2, dozens of protrusions 3 arranged at intervals are provided on the end surface of any clamping plate close to another clamping plate, and the protrusions 3 are either barbs or serrated protrusions. The present invention adopts the method of providing either barbs or serrated protrusions on the surface of the clamping plate in contact with the leaflet, thereby increasing the friction force of clamping, improving the stability of clamping, and facilitating leaflet cutting.

[0045] Example 6: Based on Example 2, refer to Figure 7 The delivery sheath 4 includes a third catheter cavity 403, which is located at the central hole, and the leaflet clamping catheter passes through the third catheter cavity 403. The present invention uses the third catheter cavity for passing the leaflet cutting device.

[0046] Embodiment 7: Based on Embodiment 6, Figure 2 The outer ring of the central hole is provided with two separately arranged first catheter cavities 401 and second catheter cavities 402. The first catheter cavity 401 is used to pass the positioning catheter and snare 5, and the second catheter cavity 402 is used to pass the guide wire 6; the inner diameter of the third catheter cavity 403 is larger than the inner diameter of the first catheter cavity 401, and the inner diameters of the first catheter cavity 401 and the second catheter cavity 402 are the same or similar. The present invention adopts the first catheter cavity for passing the positioning catheter and snare, etc., and supports the injection of contrast agent to clearly locate; the second catheter cavity is used to pass the guide wire.

[0047] Embodiment 8: An application of a leaflet cutting device for puncturing the leaflet first and then cutting, characterized in that it comprises the following steps:

[0048] R1. Delivering the leaflet clamping catheter to the aortic root through the third catheter lumen 403;

[0049] R2. The snare 5 or the angiography catheter is delivered through the first catheter lumen 401 to complete the positioning of the target sinus;

[0050] R3. Push the handle of the leaflet holder 1 to make the leaflet holder 1 reach the target position. The leaflet holder 1 does not exceed the snare 5 for positioning to avoid damaging the aortic root structure.

[0051] R4. Push the cutting catheter to the target position, pull the traction rod 204 to complete the puncture of the valve leaflet, and lock the handle of the traction rod 204;

[0052] R5. Pull the cutting catheter to complete the leaflet cutting. In the present invention, the leaflet clamp does not exceed the snare used for positioning during use, so as to avoid damaging the aortic root structure, and solve the technical defect that the aortic root may be damaged when the guide wire punctures the leaflet during the operation, causing serious surgical complications; by puncturing the leaflet first and then cutting, the technical defects of difficult positioning and large resistance to the cutting catheter, which leads to reliance on the electric cutting system, are solved.

[0053] Embodiment 9: An application of a leaflet cutting device to directly perform leaflet cutting, characterized in that it comprises the following steps:

[0054] S1. Delivering the leaflet clamping catheter to the aortic root through the third catheter lumen 403;

[0055] S2. The snare 5 or the angiography catheter is delivered through the first catheter lumen 401 to complete the positioning of the target valve sinus;

[0056] S3. Push the push handle of the leaflet clamp 1 to make the leaflet clamp 1 reach the target position, and the leaflet clamp 1 does not exceed the snare 5 used for positioning to avoid damaging the aortic root structure;

[0057] S4. Pull the traction rod 204 directly to lock the traction rod handle 204;

[0058] S5. Pull the cutting catheter to complete the leaflet cutting. In the present invention, the leaflet clamp does not exceed the snare used for positioning during use, avoiding damage to the aortic root structure, and solving the technical defect that the aortic root may be damaged when the guide wire punctures the leaflet during the operation, causing serious surgical complications.

[0059] Embodiment 10: An application of a valve leaflet cutting device to first puncture the valve leaflet and then perform electro-cutting to assist in cutting, characterized in that it comprises the following steps:

[0060] T1. Delivering the leaflet clamping catheter to the aortic root through the third catheter lumen 403;

[0061] T2. The snare 5 or the angiography catheter is delivered through the first catheter lumen 401 to complete the positioning of the target valve sinus;

[0062] T3. Push the push handle of the leaflet clamp 1 to make the leaflet clamp 1 reach the target position. The leaflet clamp 1 does not exceed the snare 5 used for positioning to avoid damaging the aortic root structure.

[0063] T4. Push the cutting catheter to the target position, pull the traction rod 204 to complete the puncture of the valve leaflet, and lock the handle of the traction rod 204;

[0064] T5. The pulling resistance of the cutting knife rod is large, and it is difficult to cut the valve leaflet. At this time, the cutting knife 202 is connected to the electrocuting system, and the cutting catheter is pulled with the assistance of electrocuting to complete the valve leaflet cutting. In use, the present invention adopts a valve leaflet clamp that does not exceed the snare used for positioning to avoid damaging the aortic root structure, and solves the technical defect that the aortic root may be damaged when the guide wire punctures the valve leaflet during the operation, causing serious surgical complications; by puncturing the valve leaflet first and then electrocuting to assist cutting, the technical defect that there may be a possibility of cutting failure for severe calcified valve lesions is solved.

[0065] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the protection scope of the present invention.

Claims

1. A leaflet cutting device, comprising a leaflet clamping catheter, characterized in that: The leaflet clamping catheter is connected to the cutting catheter, and both the leaflet clamping catheter and the cutting catheter pass through the delivery sheath. The leaflet clamping catheter includes a leaflet clamping member, and the leaflet clamping member includes two clamping plates. The end surface of any clamping plate away from the other clamping plate is provided with guide grooves arranged at intervals. The cutting catheter includes a pushing and cutting part, which cooperates with the guide groove. The pushing and cutting part includes traction rods arranged at intervals. Any traction rod is provided with a cutting knife that can be accommodated in the cutting part, and the blades of the two cutting knives are arranged in an alternating manner. The leaflet clamping member does not exceed the snare used for positioning. After the cutting catheter is pushed, it moves forward along the guide rail of the clamping plate to achieve the clamping of the two clamping plates, and the internal traction rod is pulled to achieve the extension of the cutting knife. The cutting knives on both sides are extended at the same time to complete the puncture. Cutting is performed by pulling or pushing the cutting catheter. Two groups of cutting parts are arranged on any of the traction rods, and any group of cutting parts are symmetrically arranged on the two traction rods; guide blocks arranged at intervals are arranged on the end faces of any group of cutting parts that are close to each other, and the guide blocks and guide grooves are arranged one by one; a sink groove is arranged in the middle of any cutting part; the cutting part can be externally connected to an electric cutting system, and all parts except the cutting part are surface insulating materials; Dozens of protrusions arranged at intervals are arranged on the end surface of any one of the clamping plates close to the other clamping plate, and the protrusions are either barbs or serrated protrusions.

2. A leaflet cutting device according to claim 1, characterized in that: A cutting knife is arranged between the two cutting part grooves on any one of the traction rods, one end of the handle of the cutting knife is connected to the cutting part away from the side thereof through a first connecting piece, and the other end of the handle of the cutting knife is connected to the cutting part away from the side thereof through a second connecting piece, and the first connecting piece and the second connecting piece are cross-arranged on the same traction rod.

3. A leaflet cutting device according to claim 1, characterized in that: A hollow groove is arranged between the two guide grooves, and the hollow groove is used for passing a cutting knife.

4. A leaflet cutting device according to claim 1, characterized in that: The delivery sheath comprises a third catheter cavity, the third catheter cavity is located at the central hole, and the leaflet clamping catheter passes through the third catheter cavity.

5. A leaflet cutting device according to claim 4, characterized in that: The outer circle of the central hole is provided with two separately arranged first catheter cavities and second catheter cavities, the first catheter cavity is used for passing the positioning catheter and the snare, and the second catheter cavity is used for passing the guide wire; the inner diameter of the third catheter cavity is larger than the inner diameter of the first catheter cavity, and the inner diameters of the first catheter cavity and the second catheter cavity are the same or similar.

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