Delivery system installation method, fixation clip, and leaflet fixation method and delivery system

Abstract

The application relates to the field of medical devices, and discloses a delivery system installation method, a fixing clamp, a leaflet fixing method and a delivery system. The delivery system installation method comprises the following steps: the first end of a first control wire is inserted into a first opening and then out of a second opening, the third end of a second control wire is inserted into a second opening of an anchoring tube and then out of the first opening, the third end of the second control wire is pulled to make the fourth end of the second control wire enter a hollow cavity from the second opening, and the fourth end is ensured to abut against the inner wall of the anchoring tube at the first opening; the distal end of a core wire is inserted into the proximal end of the anchoring tube and axially moves along the hollow cavity until the distal end of the core wire is out of the distal end of the anchoring tube and the second end at the second opening is pressed against the inner wall of the anchoring tube, and the fourth end at the first opening is pressed against the inner wall of the anchoring tube; and the distal end of the core wire out of the anchoring tube is connected with the fixing clamp.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a delivery system installation method, a fixing clip and leaflet fixing method, and a delivery system. Background Technology

[0002] The heart has four valves, one of which is the mitral valve. During diastole, it acts like a door, allowing blood to flow from the left atrium to the left ventricle. Located between the left atrium and left ventricle, its main function is to ensure the normal flow of blood from the left atrium to the left ventricle during diastole and to prevent blood from flowing back from the left ventricle to the left atrium during systole. Simply put, the mitral valve opens and closes rhythmically with each heartbeat to facilitate or prevent blood flow, ensuring that blood flows in the correct direction.

[0003] The mitral valve has a complex structure, consisting of multiple parts that work together during heartbeats. The mitral leaflets are one of its important components, comprising the anterior and posterior leaflets. These two leaflets together form the "valve" between the atria and ventricles, and their occlusal surfaces are called junctional leaflets.

[0004] When performing mitral valve surgery, some patients are not suitable for traditional surgery. Therefore, how to provide alternative treatment options for the large number of elderly and high-risk patients who are not suitable for open-heart surgery has become an urgent problem to be solved. Summary of the Invention

[0005] This invention discloses a conveying system installation method, a fixing clamp and a leaf fixing method, and a conveying system, which improves the installation efficiency of the fixing clamp system and the operation efficiency of fixing the fixing clamp and the leaf.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] On one hand, the present invention provides a method for installing a conveying system, comprising:

[0008] An anchoring tube having a hollow cavity, wherein the axis of the hollow cavity is parallel to the length direction of the anchoring tube; the anchoring tube has a first opening and a second opening symmetrically arranged relative to the axis, and both the first opening and the second opening are in communication with the hollow cavity;

[0009] Insert the first end of the first control wire through the first opening and out through the second opening. Pull the first end of the first control wire so that the second end of the first control wire enters the hollow cavity through the first opening, and ensure that the second end abuts against the inner wall of the anchor tube located at the second opening.

[0010] The third end of the second control wire is inserted through the second opening of the anchor tube and exits through the first opening. The third end of the second control wire is pulled so that the fourth end of the second control wire enters the hollow cavity through the second opening, and the fourth end is ensured to abut against the inner wall of the anchor tube located at the first opening.

[0011] The distal end of the core wire is inserted into the proximal end of the anchor tube and moved axially along the hollow cavity until the distal end of the core wire exits from the distal end of the anchor tube, and the second end located at the second opening is pressed against the inner wall of the anchor tube, and the fourth end located at the first opening is pressed against the inner wall of the anchor tube.

[0012] The distal end of the core wire that passes through the anchor tube is connected to the fixing clamp;

[0013] The first end of the first control wire passes through a free end of the fixing clamp and is connected and controlled, and the third end of the second control wire passes through the other free end of the fixing clamp and is connected and controlled, so as to control the relative locking of the fixing clamp and the leaflet position.

[0014] This invention provides a method for fixing a clamp and a leaflet. First, the first end of the first control wire of two control wires is inserted into the first opening of the anchor tube and exits through the second opening. The first end is tightened so that the second end enters the hollow cavity through the first opening and abuts against the inner wall of the anchor tube located at the second opening. The first and second openings are symmetrically arranged with respect to the axis of the anchor tube. Second, the third end of the second control wire is inserted into the second opening of the anchor tube and exits through the first opening. The third end is tightened so that the fourth end enters the hollow cavity through the second opening and abuts against the inner wall of the anchor tube located at the first opening. The first and second openings are symmetrically arranged with respect to the axis of the anchor tube. Third, the core wire is inserted axially along the hollow cavity of the anchor tube and continues to move until the core... The distal end of the core wire passes through the distal end of the anchor tube. After the distal end of the core wire is connected to the fixing clamp, the core wire passes through the first and second openings of the anchor tube and presses the second end at the second opening against the inner wall of the anchor tube. At the same time, it also presses the fourth end at the first opening against the inner wall of the anchor tube. Thus, the fixing of the core wire, control wire, and anchor tube is completed. Only the core wire is needed to fix the two control wires to the anchor tube. This structure is simple and easy to operate. Because the core wire effectively locks the second end of the first control wire and the fourth end of the second control wire, it effectively prevents the second end from passing through the second opening, while the fourth end passes through the first opening. Through the simple pressing method of the core wire and control wire, the relative fixing of the control wire, core wire, and anchor tube is easier and effectively reduces the installation cost. The fourth step involves connecting the free end of the clamp to the first control wire, which means passing the first end of the first control wire through the clamp; connecting the free end of the clamp to the second control wire, which means passing the third end of the second control wire through the clamp. The user can control the first and second control wires independently to lock the clamp relative to the leaflet position, thus fixing some diseased mitral valve leaflets and the contralateral mitral valve leaflets together to form a double-foramen mitral valve, ensuring long-term normal valve function.

[0015] In some embodiments, both the second end and the fourth end form a snap-fit ​​portion, each of the two snap-fit ​​portions includes at least two filaments, the at least two filaments in one snap-fit ​​portion extend from the second end, and the at least two filaments in the other snap-fit ​​portion extend from the fourth end;

[0016] When the core wire is located at the first opening and the second opening, the core wire presses the at least two filaments at the second end against the inner wall of the anchoring tube, and the core wire presses the at least two filaments at the fourth end against the inner wall of the anchoring tube.

[0017] In some embodiments, the first control wire is a hollow tubular structure; the second control wire is a hollow tubular structure.

[0018] In some embodiments, the first end of the first control wire passing through the free end of the fixing clamp is inserted into the control tube assembly, and after passing through the control handle, it is fixed to the control base.

[0019] In some embodiments, the third end of the second control wire, which passes through the free end of the retaining clamp, is inserted into the control tube assembly and then fixed to the control base after passing through the control handle.

[0020] In some embodiments, the control base is provided with a first pull rod and a second pull rod;

[0021] The first end of the first control wire is connected to the first pull rod, and the third end of the second control wire is connected to the second pull rod.

[0022] In some embodiments, the retaining clip includes:

[0023] An anchoring element, wherein the anchoring element is detachably connected to the distal end of the anchoring tube;

[0024] The support frame is installed on the anchor.

[0025] A capture element is disposed on the support frame, the capture element comprising a first capture clamp and a second capture clamp that are controlled separately.

[0026] In some embodiments, the first capture clip has a first opening at its free end away from the anchor member, the first opening being connected to the first control wire, and the second capture clip has a second opening at its free end away from the anchor member, the second opening being connected to the second control wire.

[0027] On the other hand, the present invention provides a method for fixing a clamp and a leaflet, which uses the delivery system installation method described in one aspect to install a delivery system. After operating the delivery system to control the relative locking of the clamp and the leaflet, the clamp is left in the patient's body as an implant, specifically including:

[0028] Release the locking between the distal end of the core wire and the fixing clamp, and pull the core wire out from the distal end to the proximal end of the anchor tube;

[0029] Pulling the first end of the first control wire and the third end of the second control wire causes both control wires to retract, releasing the relative fixation between the two control wires and the fixing clamp.

[0030] A delivery system is installed using one method to deliver the fixation clip to the mitral valve leaflets. During treatment, the user (doctor) holds a control handle outside the patient's body and inserts the clip into the heart valve, such as the mitral valve. As mentioned above, the mitral valve can be accessed surgically or through endovascular techniques, via a retrograde approach through the ventricle or an antegrade approach through the atrium. Once the clip reaches the designated position, the user controls the control handle to capture and fix the leaflets, effectively fixing diseased mitral valve leaflets and contralateral leaflets together to form a two-foramen mitral valve, ensuring long-term normal valve function. After fixing the leaflets with the clip, the distal end of the mandrel is released from the clip, and the mandrel is withdrawn proximally from the anchoring tube. The clip remains as an implant to hold the leaflets together in the engagement position. The fixation clip is then locked to the leaflet. The entire process allows for precise control of the fixation position, improving the success rate and safety of the surgery and reducing damage to other tissues of the patient.

[0031] After removing the core wire, the relative fixation of the core wire, anchor tube, and two control wires is released. Pulling the first and second control wires releases the restriction between the two control wires and the fixation clamp. This operation is relatively simple, easy for doctors to master and implement, and helps to shorten the operation time and reduce the risk to patients during the operation.

[0032] In some embodiments, the diameter of the core wire gradually decreases from the proximal end to the distal end.

[0033] On the other hand, a conveying system includes:

[0034] An anchoring tube having a hollow cavity, the anchoring tube having a first opening and a second opening communicating with the hollow cavity, the first opening and the second opening being arranged opposite to each other;

[0035] A first control wire, the first control wire includes a first end and a second end, the second end having a snap-fit ​​portion;

[0036] The second control wire includes a third end and a fourth end, wherein the fourth end has a snap-fit ​​portion;

[0037] The core wire is movably disposed in the hollow cavity. When the core wire is located in the hollow cavity, the core wire presses the snap-fit ​​portion at the second end and the snap-fit ​​portion at the fourth end against the inner wall surface of the anchor tube. Attached Figure Description

[0038] Figure 1 A schematic flowchart illustrating a method for installing a conveying system according to an embodiment of the present invention;

[0039] Figure 2 A schematic diagram of a conveying system provided in an embodiment of the present invention;

[0040] Figure 3 This is a partial structural schematic diagram of a conveying system provided in an embodiment of the present invention;

[0041] Figure 4 A schematic diagram of the structure of a control wire engagement part in a conveying system in state one, provided by an embodiment of the present invention. Figure 1 ;

[0042] Figure 5 A schematic diagram of the structure of a control wire engagement part in a conveying system in state one, provided by an embodiment of the present invention. Figure 2 ;

[0043] Figure 6 A schematic diagram of the structure of a control wire of a conveying system in state two, provided by an embodiment of the present invention. Figure 1 ;

[0044] Figure 7 A schematic diagram of the structure of a control wire of a conveying system in state two, provided by an embodiment of the present invention. Figure 2 ;

[0045] Figure 8 This is a partial structural diagram of the core wire of a conveying system provided in an embodiment of the present invention;

[0046] Figure 9 This is a schematic diagram of the structure of an anchoring pipe for a conveying system provided in an embodiment of the present invention;

[0047] Figure 10 This is a partial structural diagram of an anchoring pipe for a conveying system provided in an embodiment of the present invention;

[0048] Figure 11 For the corresponding Figure 9 Sectional view at point AA;

[0049] Figure 12 For the corresponding Figure 10 Sectional view at BB in the middle;

[0050] Figures 13a-13d This is a schematic diagram illustrating the installation and release process of the core wire, control wire, and anchor tube in a conveying system according to an embodiment of the present invention.

[0051] In the diagram: 1-Fixing clamp; 11-Anchoring element; 12-Capturing element; 121-First capturing clamp; 122-Second capturing clamp; 13-Support frame; 14-Clamping arm; 2-Anchoring tube; 21-Hollow cavity; 22-First opening; 23-Second opening; 31-First control wire; 311-First end; 312-Second end; 3121-Snap-fit ​​part; 3122-Filament; 32-Second control wire; 4-Core wire; 41-First section; 42-Second section; 43-Third section; 5-Control handle; 6-Control tube assembly; 7-Control base; 81-First pull rod; 82-Second pull rod; Detailed Implementation

[0052] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. In the description of the embodiments of the present invention, "multiple" means two or more.

[0053] Hereinafter, the terms "first" and "second" are used for descriptive purposes only and should not be construed as implying or suggesting relative importance or implicitly indicating the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature, and in the description of the embodiments of the present invention, unless otherwise stated, "a plurality of" means two or more.

[0054] The direction of the rotational axis of an object such as a cylinder or tube is defined as the axial direction; the circumferential direction is the direction around the axis of the object (perpendicular to the axis and also perpendicular to the cross-sectional radius); the radial direction is along the diameter or radius. It is important to note that the term "end" appearing in terms such as "proximal end," "distal end," "one end," "the other end," "first end," "second end," "initial end," "end point," "both ends," "free end," "upper end," and "lower end" is not limited to the end head, endpoint, or end face, but also includes a portion extending axially and / or radially from the end head, endpoint, or end face on the element to which the end head, endpoint, or end face belongs. Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The conventional terminology used in this specification is for the purpose of describing particular embodiments only and should not be construed as limiting the invention.

[0055] In describing the system of the present invention, the proximal end generally refers to the portion close to the operator or body entrance, while the distal end refers to the portion away from the operator and deep inside the body.

[0056] First, let me introduce the application scenarios of this invention: Mitral regurgitation (MR) is the mainstream cause of mitral valve disease and the most common valvular heart disease. The China-DVD study, an epidemiological study of heart valve diseases in China, shows that isolated MR accounts for one-quarter of all cases, far exceeding other valvular diseases. MR patients experience severe clinical symptoms and eventually progress to heart failure; the 5-year hospitalization rate for heart failure and the mortality rate for untreated MR patients are as high as 90% and 50%, respectively. Therefore, intervention for MR is urgent. However, many MR patients cannot tolerate or are unwilling to undergo surgery due to advanced age, multiple comorbidities, etc. This invention is mainly used to treat patients with moderate to severe mitral regurgitation (MR), especially suitable for those at high risk or contraindicated for surgery. Its application scenarios include primary MR (such as leaflet prolapse) and strictly selected secondary MR (such as functional regurgitation caused by heart failure).

[0057] Based on the above application scenarios, such as Figure 1 As shown, the present invention provides a method for installing a conveying system, comprising:

[0058] An anchoring tube with a hollow cavity, the axis of the hollow cavity being parallel to the length direction of the anchoring tube; the anchoring tube having a first opening and a second opening symmetrically arranged relative to the axis, and both the first opening and the second opening communicating with the hollow cavity;

[0059] S1: Insert the first end of the first control wire through the first opening and out through the second opening. Pull the first end of the first control wire so that the second end of the first control wire enters the hollow cavity through the first opening and ensures that the second end abuts against the inner wall of the anchor tube located at the second opening. The first end of the first control wire of the two control wires is inserted through the first opening of the anchor tube and out through the second opening. Tighten the first end so that the second end enters the hollow cavity through the first opening and abuts against the inner wall of the anchor tube located at the second opening. The first opening and the second opening are symmetrically arranged with respect to the axis of the anchor tube.

[0060] S2: Insert the third end of the second control wire through the second opening of the anchor tube and out through the first opening. Pull the third end of the second control wire so that the fourth end of the second control wire enters the hollow cavity through the second opening and ensures that the fourth end abuts against the inner wall of the anchor tube located at the first opening. Insert the third end of the second control wire through the second opening of the anchor tube and out through the first opening. Pull the third end tight so that the fourth end enters the hollow cavity through the second opening and abuts against the inner wall of the anchor tube located at the first opening. The first opening and the second opening are symmetrically arranged with respect to the axis of the anchor tube.

[0061] S3: Insert the distal end of the core wire into the proximal end of the anchor tube and move it axially along the hollow cavity until the distal end of the core wire exits from the distal end of the anchor tube. The second end located at the second opening is pressed against the inner wall of the anchor tube, and the fourth end located at the first opening is pressed against the inner wall of the anchor tube. Continue inserting the core wire axially along the hollow cavity of the anchor tube and move it until the distal end of the core wire exits from the distal end of the anchor tube. The core wire passes through the first and second openings of the anchor tube, pressing the second end at the second opening against the inner wall of the anchor tube, while simultaneously pressing the fourth end located at the first opening against the inner wall of the anchor tube. The fourth end is pressed against the inner wall of the anchor tube; at this point, the fixing of the core wire, control wire, and anchor tube is completed. Only the core wire is needed to fix the two control wires to the anchor tube. This structure is simple and easy to operate. Since the core wire effectively locks the second end of the first control wire and the fourth end of the second control wire, it effectively prevents the second end from passing through the second opening, while the fourth end passes through the first opening. Through the simple pressing method of the core wire and control wire, the relative fixing of the control wire, core wire, and anchor tube is easier, effectively reducing the installation cost.

[0062] S4: The distal end of the core wire that passes through the anchor tube is connected to the fixing clamp;

[0063] S5: The first end of the first control wire passes through one free end of the fixation clamp and is connected and controlled. The third end of the second control wire passes through the other free end of the fixation clamp and is connected and controlled to control the relative locking of the fixation clamp and the leaflet position. The free end of the fixation clamp is connected to the first control wire, that is, the first end of the first control wire passes through the fixation clamp; the free end of the fixation clamp is connected to the second control wire, that is, the third end of the second control wire passes through the fixation clamp. The user can control the first and second control wires independently to lock the relative locking of the fixation clamp and the leaflet position, that is, to fix some diseased mitral valve leaflets and the contralateral mitral valve leaflets together to form a double-foramen mitral valve, ensuring long-term normal valve function.

[0064] For ease of understanding, such as Figure 2As shown, the conveying system is described below. The conveying system includes a control handle 5, a control tube assembly 6, and a fixing clamp 1. The fixing clamp 1 is connected to the control handle 5 through the control tube assembly 6, which in turn connects the control handle 5 to the fixing clamp 1. A control base 7 is provided on the control handle 5. Operating the control base 7 at least enables the action of the fixing clamp 1, that is, the control base 7 is responsible for controlling the opening and closing of the capturing element 12 in the fixing clamp 1. Specifically, it also includes a first control wire 31 and a second control wire 32 located in the control tube assembly 6 and the control handle 5. The first end 311 of the first control wire 31 is connected to a first pull rod 81 provided on the control base 7, and the third end of the second control wire 32 is connected to the fixing clamp 1. By controlling the second control wire 32 through the second pull rod 82 provided on the control base 7, the first pull rod 81 and the second pull rod 82 respectively control the first control wire 31 and the second control wire 32 to control the opening and closing of the capturing element 12 in the fixing clamp 1. For ease of understanding, when the user (doctor) treats a patient, the user holds the control handle 5 and inserts the fixation clip 1 into the body until it reaches the heart valve, such as the mitral valve. As mentioned above, the mitral valve can be accessed surgically or through endovascular techniques, and can be accessed via a retrograde approach through the ventricle or an antegrade approach through the atrium. Once the fixation clip 1 is moved to the designated position, the user controls the control handle 5 to open and close the leaflet fixation clip, capturing and fixing the mitral valve. This means fixing some diseased mitral valve leaflets and the contralateral mitral valve leaflets together to form a double-foramen mitral valve, ensuring long-term normal valve function. After the leaflet fixation clip and leaflet fixation are completed, the leaflet fixation clip 1 separates from the control tube assembly 6, and the leaflet fixation clip remains as an implant to hold the leaflets together in the engagement position.

[0065] like Figure 3 As shown, the delivery system includes a fixation clip 1 and an anchoring tube 2. The anchoring tube 2 has a proximal end and a distal end. The fixation clip 1 is detachably connected to the distal end of the anchoring tube 2. The anchoring tube 2 is separated from the fixation clip 1 and remains in the body as an implant, holding it in the engagement position along with the leaflet. Two control wires are used to individually control the opening and closing of the fixation clip 1. Thus, when it is necessary to fix the fixation clip 1 to the leaflet and leave it in the patient's body, it is only necessary to separate the fixation clip 1 from the anchoring tube 2 and remove the anchoring tube 2 from the patient's body. The anchoring tube 2 has a hollow cavity 21, the axis of which is parallel to the length direction of the anchoring tube 2. The hollow cavity 21 is used to accommodate a core wire 4, and the connection or separation of the anchoring tube 2 and the leaflet fixation clip is achieved by the movement of the core wire 4.

[0066] Continue to refer to Figure 3The fixing clamp 1 includes: an anchor 11, a capturing element 12, a support frame 13, and a clamping arm 14; the anchor 11 is at least partially disposed through the support frame 13, the clamping arm 14 is rotatably disposed on the support frame 13, and the capturing element 12 is disposed on the support frame 13. Specifically, the capturing element 12 includes a first capturing clamp 121 and a second capturing clamp 122. The first capturing clamp 121 is controlled independently by a first control wire 31, and the second capturing clamp 122 is controlled independently by a second control wire 32. The anchoring tube 2 has a first opening 22 and a second opening 23 arranged opposite to each other. Both the first opening 22 and the second opening 23 are connected to the hollow cavity 21. The first end 31 of the first control wire 31 can be inserted through the first opening 22 and exit through the second opening 23. The third end of the second control wire 32 is inserted through the second opening 23 and exits through the first opening 31. When the locking part 3121 of the second end 312 of the first control wire 31 is located in the hollow cavity 21 and the locking part of the fourth end of the second control wire 32 is also located in the hollow cavity 21, the core wire 4 moves along the axis of the hollow cavity 21. The core wire 4 has a proximal end and a distal end. The diameter of the region near the distal end of the core wire 4 is smaller than the diameter of the region near the proximal end of the core wire 4. When the region near the proximal end of the core wire 4 moves to the position near the first opening 22 and the second opening 23 of the anchoring tube 2, the diameter increases, thereby fixing the locking part 3121 and the inner wall of the anchoring tube 2 relative to each other by the compression of the core wire 4.

[0067] For ease of understanding, please refer to Figure 4 The two control wires are a first control wire 31 and a second control wire 32. The first control wire 31 has a first end 311 and a second end 312. The first end 311 forms a snap-fit ​​portion 3121. The snap-fit ​​portion 3121 includes at least two filaments 3122. The at least two filaments 3122 are formed by extending from the first end 31 of the control wire 31. The length of the filaments 3122 is the effective length of the snap-fit ​​portion 3121.

[0068] The conveying system is described in detail below. The device includes an anchoring tube 2, a first control wire 31, a second control wire 32, and a core wire 4. The anchoring tube 2 has a hollow cavity 21 that can accommodate the core wire 4, and has opposing first openings 22 and second openings 23. The first end 311 of the first control wire 31 enters through the first opening 22 and exits through the second opening 23. The locking portion 3121 of its second end 312 also enters through the first opening 22, abuts against the second opening, and remains within the hollow cavity 21. The second control wire 32 follows the opposite direction: its third end enters through the second opening 23 and exits through the first opening 22, while the locking portion of its fourth end enters through the second opening 23, abuts against the first opening, and remains within the hollow cavity 21. The core wire 4 is then inserted into the hollow cavity 21 of the anchor tube 2. Because the diameter of the distal region of the core wire 4 is smaller than that of the proximal region, it is inserted from the proximal end to the distal end of the anchor tube 2. In this way, the locking portions 3121 of the two control wires located in the hollow cavity 21 are squeezed and locked by the core wire 4, thereby achieving relative fixation between the control wires and the anchor tube 2. The two control wires can be fixed to the anchor tube 2 by the core wire 4 alone, which is simple in structure and convenient in operation. The larger diameter part of the core wire 4 can effectively lock the two locking portions 3121 of the first control wire 31 and the second control wire 32, preventing the locking portion 3121 of the second end 312 of the first control wire 31 and the fourth end of the second control wire 32 from passing through the first opening 22 and the second opening 23 respectively. By squeezing the locking portions 3121 of the control wires with the core wire 4, it is easier to fix the control wires, the core wire 4 and the anchor tube 2, thus reducing the installation cost. It should be noted that "proximal" generally refers to the part near the operator or the body entrance, while "distal" refers to the part far from the operator and deep inside the body.

[0069] like Figure 5 As shown, both the first control wire 31 and the second control wire 32 are hollow tubular structures. Figure 5 The provided diagram shows the structure of the first control wire 31 with its second end 312 in a retracted state. The outer diameter d1 of the first control wire 31 ranges from 0.2mm to 0.3mm. For example, the outer diameter d1 of the first control wire 31 can be 0.20mm, 0.21mm, 0.22mm, 0.23mm, 0.24mm, 0.25mm, 0.26mm, 0.27mm, 0.28mm, 0.29mm, or 0.30mm. The wall thickness d2 of the first control wire 31 ranges from 0.05mm to 0.08mm. For example, the wall thickness d2 of the first control wire 31 can be 0.03mm, 0.04mm, 0.05mm, 0.06mm, 0.07mm, or 0.08mm.

[0070] like Figure 6 and Figure 7 Please refer to them together. Figure 5Both the first control wire 31 and the second control wire 32 are slender, highly elastic tubular metals. The specific operation process is illustrated using the first control wire 31 as an example: the second end 32 of the first control wire 31 is cut into 2-6 filaments 3122, for example, 2, 3, 4, 5, or 6 filaments. These are then heat-treated to shape them perpendicular to the axis of the control wire 3 body, resulting in a "petal shape." The outer diameter of the latching portion 3121 of this "petal shape" is 0.6mm-0.8mm. For example, the outer diameter R of the latching portion 3121 can be 0.6mm or 0.62mm. The lengths of the filaments 3122 in the "petal-shaped" snap-fit ​​portion 3121 range from 0.3mm to 0.4mm. For example, the lengths of the filaments 3122 can be 0.31mm, 0.32mm, 0.33mm, 0.34mm, 0.35mm, 0.36mm, 0.37mm, 0.38mm, 0.39mm, or 0.40mm. Figure 6 The illustrated "petal-shaped" snap-fit ​​part 3121 consists of two filaments 3122. Figure 7 The illustrated "petal-shaped" snap-fit ​​part 3121 consists of four filaments 3122.

[0071] like Figure 8 As shown, the outer diameter of the core wire 4 is gradually decreasing, meaning the diameter of the core wire 4 gradually decreases from the proximal end to the distal end. From the proximal end to the distal end, the core wire 4 is sequentially provided with a first segment 41, a second segment 42, and a third segment 43, with the first segment 41 and the third segment 43 connected by the second segment 42. The first segment 41 has the same diameter along its length, and the third segment 43 also has the same diameter along its length. The diameter D2 of the first segment 41 ranges from 0.6mm to 0.8mm; for example, D2 can be 0.6mm, 0.7mm, or 0.8mm. The diameter D1 of the third segment 43 ranges from 0.2mm to 0.4mm; for example, D1 can be 0.2mm, 0.3mm, or 0.4mm. To ensure that the core wire 4 can move within the hollow cavity 21 of the anchor tube 2, the difference between the outer diameter D1 of the core wire 4 and the inner diameter of the anchor tube 2 is set to be greater than twice the wall thickness of the control wire 3. To ensure that the core wire 4 locks the two locking parts 3121 of the first control wire 31 and the second control wire 32 relative to the anchor tube 2, the difference between the outer diameter D2 of the core wire 4 and the inner diameter of the anchor tube 2 is set to be less than twice the wall thickness of the first control wire 31. Similarly, the difference between the outer diameter D2 of the core wire 4 and the inner diameter of the anchor tube 2 is set to be less than twice the wall thickness of the second control wire 32.

[0072] like Figure 9 and Figure 10As shown, the anchoring tube 2 has a hollow cavity 21 and a first opening 22 and a second opening 23 communicating with the hollow cavity 21. To facilitate the processing of the openings, the first opening 22 and the second opening 23 are arranged opposite each other and symmetrical with respect to the axis of the hollow cavity 21, and the diameters of the first opening 22 and the second opening 23 are equal. Of course, the dimensions of the first opening 22 and the second opening 23 can also be different. Figure 11 and Figure 12 As can be seen, a first opening 22 is provided on side I; and a second opening 23 is provided on side II.

[0073] The following is combined with Figures 13a-13d The positions and movement processes of the first control wire 31, the second control wire 32, the core wire 4, and the anchor tube 2 are described in detail below:

[0074] refer to Figures 13a-13cFirst, the first end 31 of the first control wire 31 of the two control wires is inserted into the first opening 22 on the I side of the anchor tube 2 and exits through the second opening 23 on the II side, and is tightened. Second, the third end of the second control wire 32 is inserted into the second opening 23 on the II side of the anchor tube 2 and exits through the first opening 22 on the I side, and is tightened. Third, the core wire 4 is inserted axially along the hollow cavity 21 of the anchor tube 2 and continues to move until the distal end of the core wire 4 exits from the distal end of the anchor tube 2. After the distal end of the core wire 4 is connected to the anchor 11, the second section 42 and the third section 43 of the core wire 4, i.e. the smaller diameter part, pass over the first opening 22 and the second opening 23 of the anchor tube 2. The largest diameter part of the first section 31 of the core wire 4 also passes over the first opening 22 and the second opening 23 at least partially, squeezing the snap-fit ​​part of the first control wire 31 and the second control wire 32 onto the inner wall of the anchor tube 2. At this point, the core wire 4, the two control wires, and the anchor tube 2 are fixed. Fourth step: The free end of the first capture clip 121, away from the anchor 11, is connected to the first control wire 31; that is, the first end 31 of the first control wire 31 is first passed through the first opening at the far end of the first capture clip 121, then inserted into the control tube assembly 6, and finally exits from the control handle 5 and is fixed to the control base 7. Fifth step: The free end of the second capture clip 122, away from the anchor 11, is connected to the second control wire 32; that is, the third end of the second control wire 32 is first passed through the second opening at the far end of the second capture clip 122, then inserted into the control tube assembly 6, and finally exits from the control handle 5 and is fixed to the control base 7. At this point, the two control wires are connected to the fixation clip 1, the control tube assembly 6, and the control handle 5. After the user operates the control handle 5 and moves the fixation clip 1 to the designated position, the user can control the opening and closing of the fixation clip 1 by operating the control handle 5. The user can also control the opening and closing of the first capture clip 121 or the second capture clip 122 by operating the control base 7, thereby capturing and relatively fixing the mitral valve. This means fixing some diseased mitral valve leaflets and the contralateral mitral valve leaflets together to form a double-foramen mitral valve, ensuring long-term normal valve function. Once the fixation clip 1 and the leaflets are fixed, the fixation clip 1 needs to be separated from the control tube assembly 6, leaving the fixation clip 1 as an implant. The separation process of the fixation clip 1 is described in detail below:

[0075] on the other hand, Figure 13d As shown, the present invention provides a method for fixing a clamp and a leaflet, which uses a delivery system installation method to install the delivery system. After the delivery system is operated to control the relative locking of the clamp and the leaflet, the clamp is left in the patient's body as an implant. Specifically, it includes:

[0076] Release the locking between the distal end of the core wire and the fixing clamp, and pull the core wire out from the distal end to the proximal end of the anchor tube;

[0077] Pulling the first end of the first control wire and the third end of the second control wire causes both control wires to retract, releasing the relative fixation between the two control wires and the fixing clamp.

[0078] A delivery system is installed using one method to deliver the fixation clip to the mitral valve leaflets. During treatment, the user (doctor) holds a control handle outside the patient's body and inserts the clip into the heart valve, such as the mitral valve. As mentioned above, the mitral valve can be accessed surgically or through endovascular techniques, via a retrograde approach through the ventricle or an antegrade approach through the atrium. Once the clip reaches the designated position, the user controls the control handle to capture and fix the leaflets, effectively fixing diseased mitral valve leaflets and contralateral leaflets together to form a two-foramen mitral valve, ensuring long-term normal valve function. After fixing the leaflets with the clip, the distal end of the mandrel is released from the clip, and the mandrel is withdrawn proximally from the anchoring tube. The clip remains as an implant to hold the leaflets together in the engagement position. The fixation clip is then locked to the leaflet. The entire process allows for precise control of the fixation position, improving the success rate and safety of the surgery and reducing damage to other tissues of the patient.

[0079] After removing the core wire, the relative fixation of the core wire, anchor tube, and two control wires is released. Pulling the first and second control wires releases the restriction between the two control wires and the fixation clamp. This operation is relatively simple, easy for doctors to master and implement, and helps to shorten the operation time and reduce the risk to patients during the operation.

[0080] like Figure 13d As shown, firstly, the distal end of the core wire 4 is released from the anchor 11. The core wire 4 is then pulled outward from the hollow cavity 21 of the anchor tube 2 along the direction of the arrow, separating the anchor 11 and the anchor tube 2. At this point, the locking parts 3121 of the two control wires are released from the locking parts of the core wire 4 and the anchor tube 2. The two control wires are then pulled out, and the first control wire 31 and the second control wire 32 retract. The relative fixation between the first control wire 31 and the first capture clip 121 is released, and the relative fixation between the second control wire 32 and the second capture clip 122 is released. To facilitate the two control wires, the locking parts 3121 are withdrawn from the first opening of the first capture clip 121 and the second opening of the second capture clip 122. The area of ​​the first opening and the area of ​​the second opening are larger than the outer diameter R of the locking parts 3121. Thus, the fixation clip 1 remains in the patient's body as an implant, and all components of the delivery system except for the fixation clip 1 are removed from the patient's body.

[0081] Obviously, those skilled in the art can make various modifications and variations to the embodiments of the present invention without departing from the spirit and scope of the invention. Therefore, if these modifications and variations fall within the scope of the claims of the present invention and their equivalents, the present invention also intends to include these modifications and variations.

Claims

1. A method for installing a conveying system, characterized in that, include: An anchoring tube having a hollow cavity, wherein the axis of the hollow cavity is parallel to the length direction of the anchoring tube; The anchoring tube has a first opening and a second opening that are symmetrically arranged relative to the axis, and both the first opening and the second opening are in communication with the hollow cavity. The first end of the first control wire is inserted through the first opening and exited through the second opening. The first end of the first control wire is pulled so that the second end of the first control wire enters the hollow cavity through the first opening, and the second end is ensured to abut against the inner wall of the anchor tube located at the second opening; the second end forms a snap-fit ​​part. The third end of the second control wire is inserted through the second opening of the anchor tube and exits through the first opening. The third end of the second control wire is pulled so that the fourth end of the second control wire enters the hollow cavity through the second opening, and the fourth end is ensured to abut against the inner wall of the anchor tube located at the first opening; the fourth end forms a snap-fit ​​part. The distal end of the core wire is inserted into the proximal end of the anchor tube and moved axially along the hollow cavity until the distal end of the core wire exits from the distal end of the anchor tube, and the second end located at the second opening is pressed against the inner wall of the anchor tube, and the fourth end located at the first opening is pressed against the inner wall of the anchor tube. The distal end of the core wire that extends out of the anchor tube is connected to the fixing clip; the core wire has a proximal end and a distal end, and the diameter of the region near the distal end of the core wire is smaller than the diameter of the region near the proximal end of the core wire. The first end of the first control wire passes through one free end of the fixing clamp and is connected and controlled, and the third end of the second control wire passes through the other free end of the fixing clamp and is connected and controlled.

2. The installation method according to claim 1, characterized in that, Each of the two snap-fit ​​portions includes at least two filaments, wherein the at least two filaments in one snap-fit ​​portion extend from the second end, and the at least two filaments in the other snap-fit ​​portion extend from the fourth end; When the core wire is located at the first opening and the second opening, the core wire presses the at least two filaments at the second end against the inner wall of the anchoring tube, and the core wire presses the at least two filaments at the fourth end against the inner wall of the anchoring tube.

3. The installation method according to claim 2, characterized in that, The first control wire is a hollow tubular structure; the second control wire is a hollow tubular structure.

4. The installation method according to claim 1, characterized in that, The first end of the first control wire, which passes through the free end of the fixing clamp, is inserted into the control tube assembly and then fixed to the control base after passing through the control handle.

5. The installation method according to claim 1 or 4, characterized in that, The third end of the second control wire, which passes through the free end of the fixing clamp, is inserted into the control tube assembly and then fixed to the control base after passing through the control handle.

6. The installation method according to claim 5, characterized in that, The control base is provided with a first tie rod and a second tie rod; The first end of the first control wire is connected to the first pull rod, and the third end of the second control wire is connected to the second pull rod.

7. The installation method according to claim 1, characterized in that, The fixing clip includes: An anchoring element, wherein the anchoring element is detachably connected to the distal end of the anchoring tube; The support frame is installed on the anchor. A capture element is disposed on the support frame, the capture element comprising a first capture clamp and a second capture clamp that are controlled separately.

8. The installation method according to claim 7, characterized in that, The first capture clip has a first opening at its free end away from the anchor, and the first opening is connected to the first control wire. The second capture clip has a second opening at its free end away from the anchor, and the second opening is connected to the second control wire.

9. A conveying system, characterized in that, include: An anchoring tube having a hollow cavity, the anchoring tube having a first opening and a second opening communicating with the hollow cavity, the first opening and the second opening being arranged opposite to each other; A first control wire, the first control wire includes a first end and a second end, the second end having a snap-fit ​​portion; The second control wire includes a third end and a fourth end, wherein the fourth end has a snap-fit ​​portion; The core wire is movably disposed in the hollow cavity. When the core wire is located in the hollow cavity, the core wire presses the snap-fit ​​portion at the second end and the snap-fit ​​portion at the fourth end against the inner wall surface of the anchor tube. The core wire has a proximal end and a distal end, and the diameter of the region near the distal end of the core wire is smaller than the diameter of the region near the proximal end of the core wire.

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