Transcatheter heart valve repair system

Abstract

This invention provides a transcatheter heart valve repair system, comprising a first slender catheter and a second slender catheter, the second slender catheter extending coaxially through the first slender catheter. The second slender catheter includes a proximal end, a distal end, and a main body segment and a flexible segment extending axially from the proximal end to the distal end. The length of the main body segment ranges from 700mm to 1500mm, and the stiffness ratio of the flexible segment to the main body segment ranges from 0.05 to 0.2. Torque is applied to the proximal end of the second slender catheter to drive it to rotate circumferentially relative to the first slender catheter. The torque generated at the proximal end of the second slender catheter is transmitted to the distal end of the second slender catheter via the main body segment and the flexible segment with a torque transmission efficiency of not less than 35%. The transcatheter heart valve repair system provided by this invention can effectively improve the torque control performance of the second slender catheter, not only significantly shortening the operation time but also further reducing the risk of accidental catheter contact with human tissue.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a transcatheter heart valve repair system. Background Technology

[0002] Transcatheter interventional therapy (TCA) involves delivering a medical device to the patient's heart via a catheter and then remotely manipulating it from outside the patient's body to repair or replace diseased tissue, thereby treating heart disease. Because this technique requires only a relatively small incision and access to the desired location within the heart via a blood vessel, it reduces surgical risks and time compared to traditional surgical methods. It also ensures a smaller incision for the patient, thus accelerating recovery and reducing the risk of complications. Generally, to meet the physician's need for catheter torsion, the physician must apply torsional force from the proximal end of the catheter to the distal end. However, in TCA, existing delivery devices have low torsion transmission efficiency and poor torsion control performance, requiring physicians to repeatedly attempt adjustments to the distal end of the catheter to achieve the ideal angle. Therefore, improving the torsion control performance of catheters is a key technical challenge and an urgent problem to be solved in the field of TCA. Summary of the Invention

[0003] The purpose of this invention is to provide a transcatheter heart valve repair system that can effectively improve the torsion control performance of the catheter, thereby shortening the operation time and reducing the defect of accidental catheter contact with human tissue.

[0004] To achieve the above objectives, the present invention provides a transcatheter heart valve repair system, comprising:

[0005] First slender duct; and

[0006] A second slender conduit extends coaxially through the first slender conduit; the second slender conduit includes a proximal end, a distal end, and a main body section and a flexible section extending axially from the proximal end to the distal end, the length of the main body section ranging from 700mm to 1500mm, and the hardness ratio of the flexible section to the main body section ranging from 0.05 to 0.2.

[0007] Specifically, a torque is applied to the proximal end to drive the second elongated catheter to rotate circumferentially relative to the first elongated catheter, and the torque generated at the proximal end is transmitted to the distal end via the main body section and the flexible section with a torque transmission efficiency of not less than 35%.

[0008] The transcatheter heart valve repair system provided by this invention features a specially designed length for the main body segment of the second slender catheter and variations in the stiffness between the flexible and main body segments. This design ensures that the main body segment can adapt to complex vascular structures while maximizing its torsional stiffness, thereby significantly enhancing its torsional performance and overcoming the technical problem of low torque transmission efficiency. Therefore, compared to existing technologies, the transcatheter heart valve repair system provided by this invention significantly reduces the time required to adjust the distal end of the second slender catheter to the ideal angle, ultimately shortening the surgical time and further reducing the risk of accidental contact between the second slender catheter and human tissue. Attached Figure Description

[0009] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0010] Figure 1 Schematic diagrams of transcatheter heart valve repair systems in some embodiments are shown.

[0011] Figure 2 It shows Figure 1 A schematic diagram of the structure of the second slender conduit in the image.

[0012] Figure 3-4 A cross-sectional view of an elastic coil extending axially through a second slender conduit is shown.

[0013] Figure 5-6 Another structural schematic diagram of the second slender conduit is shown.

[0014] Figure 7 A schematic diagram of the layered structure of the second slender catheter in the flexible section is shown.

[0015] Figure 8 A schematic diagram of the layered structure of the second slender conduit in the main body section is shown.

[0016] Figure 9 A schematic diagram of a single-strand woven mesh is shown.

[0017] Figure 10 A schematic diagram of the structure of a double-strand woven mesh is shown.

[0018] Figure 11 A schematic diagram of the structure of a laser-cut tube is shown.

[0019] Figure 12The diagram shows a structure that includes a first handpiece and a second handpiece in the transcatheter heart valve repair system.

[0020] Figure 13 A schematic diagram showing the second slender catheter moving within the first slender catheter is shown.

[0021] Figure 14 A schematic diagram of the structural improvement of the first protector located at the distal end of the first slender conduit is shown.

[0022] Figure 15 It shows Figure 14 A magnified view of the middle V section.

[0023] Figure 16 The diagram illustrates a scenario where a transcatheter heart valve repair system, including a third slender catheter and a third handle, is used to deliver a valve clip to the target region of the mitral valve via a femoral vein approach.

[0024] Figure 17 A schematic diagram of a transcatheter heart valve repair system within the mitral valve is shown.

[0025] Figure 18 A schematic diagram of the structure of the second protector located at the distal end of the second slender conduit is shown.

[0026] Figure 19 It shows the use of Figure 16 A schematic diagram of a transcatheter heart valve repair system, showing how the distal end of a second slender catheter is adjusted to be substantially perpendicular to the plane of the mitral valve annulus.

[0027] Figure 20 It shows Figure 19 A schematic diagram of a scene in which the distal end of the second slender duct rotates circumferentially along a direction parallel to the plane of the mitral valve annulus.

[0028] The following detailed description, in conjunction with the accompanying drawings, will further illustrate the present invention. Detailed Implementation

[0029] 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 a part of the embodiments of the present invention, and not all of the 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.

[0030] Furthermore, the following descriptions of the embodiments are made with reference to the accompanying illustrations, which illustrate specific embodiments in which the invention can be implemented. Directional terms used in this invention, such as "up," "down," "front," "rear," "left," "right," "inner," "outer," and "side," are merely directional references to the accompanying illustrations. Therefore, the directional terms used are for better and clearer explanation and understanding of the invention, and are not intended to indicate or imply that the referred device or element must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as limiting the invention.

[0031] It should be noted that, for the purpose of more clearly describing the transcatheter heart valve repair system provided by this invention, the limiting terms "proximal" and "distal" used in this specification are conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end away from the operator during the surgical procedure, and "proximal" refers to the end closer to the operator during the surgical procedure; the direction of the rotational axis of an object such as a cylinder or tube is defined as the axial or longitudinal axis; circumferential is the direction around the axis of the object such as a cylinder or tube (perpendicular to the axis and also perpendicular to the cross-sectional radius); radial is the direction along the diameter or radius. It is worth noting that the term "end" appearing in terms such as "proximal," "distal," "one end," "the other end," "first end," "second end," "initial end," "terminal," "both ends," "free end," "upper end," and "lower end" is not limited to the tip, endpoint, or end face, but also includes a portion extending axially and / or radially from the tip, endpoint, or end face on the element to which the tip, 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 specific embodiments only and should not be construed as limiting the invention.

[0032] The present invention provides a transcatheter heart valve repair system 100 that enters the human heart via a catheter route, such as through the femoral vein, femoral artery, subclavian vein or carotid artery, and enters the human heart via blood vessels, for the purpose of delivering a medical device 200 to the human heart to treat heart disease.

[0033] In some embodiments, please also refer to Figure 1-2As shown, the transcatheter heart valve repair system 100 includes a first elongated catheter 21 and a second elongated catheter 31, the second elongated catheter 31 extending coaxially through the first elongated catheter 21. The second elongated catheter 31 includes a proximal end 31a, a distal end 31b, and a main body segment 311 and a flexible segment 312 extending axially from the proximal end 31a to the distal end 31b. It is understood that the flexible segment 312 is located at the distal end of the main body segment 311. The main body segment 311 is designed primarily for support, while the flexible segment 312 is designed to be able to bend at different angles to accommodate different expected angles under different access routes.

[0034] Given the considerable length of the second slender catheter 31, it inevitably generates significant friction with the first slender catheter 21 during torsion, resulting in substantial loss of torque applied to the proximal end of the second slender catheter 31. This ultimately leads to extremely low torque transmission efficiency and a very slow torsion response speed for the second slender catheter 31. For example, existing catheter products that enter the heart via a catheter pathway only achieve torque transmission efficiencies ranging from 0% to 33%, with an average torque transmission efficiency of only 13.89%, which cannot be improved. Therefore, existing catheter products require repeated attempts by physicians to adjust the distal end of the catheter to the ideal angle, significantly increasing surgical time. Furthermore, the repeated adjustments greatly increase the risk of accidental catheter contact with human tissue, causing damage.

[0035] Furthermore, given that the first slender catheter 21 enters the human heart via a catheter pathway, and generally, the length of both the main body segment of the first slender catheter 21 and the main body segment 311 of the second slender catheter 31 are relatively large, the length L1 and stiffness of the main body segment 311 of the second slender catheter 31 have a crucial impact on its torsional transmission efficiency.

[0036] Therefore, the present invention makes special designs on the length L1 of the main body section 311 of the second slender catheter 31 and the hardness variation of the flexible section 312 and the main body section 311, so as to ensure that the main body section 311 can not only adapt to complex vascular structures, but also maximize the torsional stiffness of the main body section 311 to greatly enhance its torsional stiffness, thereby ensuring the torsional performance of the second slender catheter 31 and overcoming the technical problem of low torque transmission efficiency.

[0037] Specifically, in some embodiments of the present invention, the length L1 of the main body segment 311 ranges from 700mm to 1500mm, and the stiffness ratio of the flexible segment 312 to the main body segment 311 ranges from 0.05 to 0.2. Given that the second elongated catheter 31 is used to enter the heart via blood vessels to repair heart valves, the following data are based on experiments conducted on multiple sample sizes with the length L of the second elongated catheter 31 ranging from 900mm to 1600mm. The experimental data in Table 1 below show that when a torque F is applied to the proximal end 31a of the second elongated catheter 31 to drive the second elongated catheter 31 to rotate circumferentially relative to the first elongated catheter 21, the torque generated at the proximal end 31a is transmitted to the distal end 31b via the main body segment 311 and the flexible segment 312 with a torque transmission efficiency of not less than 35%. In other words, the special design of the second elongated catheter 31 in this invention completely overcomes the technical problem in the prior art where the torque transmission efficiency can only hover between 0-33%. Therefore, compared with the prior art, the time for doctors to adjust the distal end 31b of the second slender catheter 31 of the present invention to the ideal angle will be greatly reduced, which will ultimately greatly shorten the operation time and also greatly reduce the risk of the second slender catheter 31 accidentally touching human tissue.

[0038] Table 1

[0039]

[0040] A reasonable analysis of the above experimental data revealed that the greater the difference in hardness between the flexible section 312 and the main section 311, i.e., the harder the main section 311, the better the torque transmission efficiency of the second slender conduit 31. Conversely, the smaller the difference in length between the length L1 of the main section 311 and the total length L of the second slender conduit 31, i.e., the shorter the length of the flexible section 312, the better the torque transmission efficiency of the second slender conduit 31.

[0041] Therefore, based on the above data, preferably, the applicant designs the length L1 of the main body section 311 of the second slender catheter 31 to be in the range of 1100mm-1500mm, and the length L2 of the flexible section 312 to be in the range of 100mm-200mm. In this case, the second slender catheter 31 is suitable for transvascular localization to the four atria, four ventricles, or aortic arch of the heart. Given that the main body section 311 is relatively rigid, the torque transmission efficiency of the second slender catheter 31 is better; and the length L2 of the flexible section 312 is also relatively short, thus further reducing the impact on the torsional transmission efficiency of the second slender catheter 31. According to the experimental data in Table 1 above, when a torque F is applied to the proximal end 31a of the second slender conduit 31 within the data range to drive the second slender conduit 31 to rotate circumferentially relative to the first slender conduit 21, the torque generated at the proximal end 31a can be transmitted to the distal end 31b via the main body section 311 and the flexible section 312 with a torque transmission efficiency that can be maintained between 38% and 85%, that is, its average torque transmission efficiency can reach 52.96%, which is 39.07% higher than the prior art. Therefore, the torque control performance of the second slender conduit 31 is greatly optimized.

[0042] It is understandable that the lengths L, L1, and L2 are not limited to integers, and the hardness ratio is not limited to the number of decimal places.

[0043] To further enhance the torque transmission efficiency of the second elongated conduit 31, in some embodiments, such as Figure 3-4 As shown, an axially incompressible elastic coil 32 is also coaxially mounted inside the second elongated conduit 31. Preferably, the elastic coil 32 is a flat wire spring tube. Given that the elastic coil 32 is elastic, it can assist in the torsion of the main body section 311 and the flexible section 312 to a certain extent, thereby enhancing the overall torque transmission efficiency of the second elongated conduit 31.

[0044] In some applications, the flexible coil 32 extends coaxially through and is fitted into the entire lumen of the second elongated catheter 31; that is, the axial length of the flexible coil 32 is equal to the axial length of the second elongated catheter 31. In other applications, the flexible coil 32 forms an axially extending through-cavity 320 to allow one or more other components of the transcatheter heart valve repair system 100 to pass smoothly through and move within the second elongated catheter 31.

[0045] Understandably, the second slender catheter 31 can be as follows: Figure 3 The single-lumen tube shown has an elastic coil 32 coaxially mounted in the central single-lumen channel 310a of the second slender conduit 31. Of course, the second slender conduit 31 can also be as follows: Figure 4The multi-lumen tube shown specifically comprises a central cavity 310b and multiple circumferential lumens 310c uniformly arranged around the central cavity 310b. The elastic coil 32 is coaxially mounted in the central cavity 310b of the second elongated catheter 31, and multiple other components of the catheter-based heart valve repair system 100 extend axially through their respective circumferential lumens 310c.

[0046] To further reduce the frictional force between the first elongated catheter 21 and the second elongated catheter 31, and to further improve the torsional performance of the second elongated catheter 31, in some embodiments, such as Figure 5-6 As shown, the second elongated catheter 31 is designed with a variable diameter. Specifically, the outer diameter D1 of the flexible section 312 of the second elongated catheter 31 is set to be smaller than the outer diameter D2 of the main section 311, thereby reducing the friction between the flexible section 312 and the first elongated catheter 21. Simultaneously, to avoid the risk of breakage at the junction of the flexible section 312 and the main section 311 due to the abrupt change in outer diameter, a smooth taper is formed between the flexible section 312 and the main section 311 to constitute the transition section 313 of the second elongated catheter 31, thus creating a smooth transition between the flexible section 312 and the main section 311. Furthermore, the inner diameter D3 of the flexible section 312 is set to be equal to the inner diameter D4 of the main section 311, allowing other components of the transcatheter heart valve repair system 100, such as the release lever 33, to pass through smoothly.

[0047] Therefore, with the outer diameter of the flexible section 312 of the second slender conduit 31 reduced relative to the outer diameter of the main section 311, the probability of contact between the flexible section 312 and the inner wall of the first slender conduit 21 is greatly reduced, thereby significantly reducing the probability of friction between them. When a torque F is applied to the proximal end 31a of the second slender conduit 31 to drive it to rotate circumferentially relative to the first slender conduit 21, the torque generated at the proximal end 31a will experience reduced or even effectively prevent losses due to friction in the flexible section 312, further enhancing the torsional transmission efficiency of the second slender conduit 31 and improving its torsional performance.

[0048] Therefore, based on the above discussion, in a further embodiment of the present invention, when dealing with such... Figure 1-2The second slender conduit 31 in this embodiment is improved by adding an elastic coil 32 inside the second slender conduit 31 and reducing the outer diameter of the flexible section 312. Furthermore, considering manufacturing costs and process difficulty, the hardness ratio between the flexible section 312 and the main body section 311 is set within the range of 0.1-0.15 to maintain torque transmission efficiency similar to or better than that shown in Table 1. Experimental data in Table 2 below show that when a torque F is applied to the proximal end 31a of the second slender conduit 31 in this embodiment to drive the second slender conduit 31 to rotate circumferentially relative to the first slender conduit 21, the torque generated at the proximal end 31a is transmitted to the distal end 31b via the main body section 311 and the flexible section 312 with a torque transmission efficiency maintained between 50% and 85%. This achieves both good torque control performance of the second slender conduit 31 and consideration of manufacturing costs and process difficulty, thereby greatly improving the effective promotion and application of the second slender conduit 31.

[0049] Table 2

[0050]

[0051] Specifically, for example, when a torque F is applied, causing the proximal end 31a of the second elongated conduit 31 to generate torque to drive the proximal end 31a to rotate 90 degrees circumferentially, under the transmission of the main body section 311 and the flexible section 312 with reduced outer diameter of the second elongated conduit 31, and simultaneously under the combined action of the elastic coil 32, the distal end 31b of the second elongated conduit 31 can follow the proximal end 31a to rotate circumferentially relative to the first elongated conduit 21. At this time, the circumferential rotation angle of the distal end 31b is in the range of 45 degrees to 72 degrees. For example, under the same test conditions, when a torque F is applied, causing the proximal end 31a of the second slender catheter 31 to generate torque and drive the proximal end 31a to rotate circumferentially by 135 degrees, the circumferential rotation angle range of the distal end 31b of the second slender catheter 31 can reach 68 degrees to 112 degrees under the transmission of torque from the main body section 311 and the flexible section 312 with a reduced outer diameter, and simultaneously under the combined action of the elastic coil 32. At this time, the time required for the physician to adjust the distal end 31b of the second slender catheter 31 of the present invention to the ideal angle will be further effectively reduced.

[0052] Of course, in order to effectively ensure that the main body section 311 and the flexible section 312 of the second slender catheter 31 can form an effective hardness ratio, in some embodiments, such as Figure 7-8As shown, the wall of the second elongated conduit 31, radially from the inside out, includes a first polymer layer 315a, a reinforcing layer 315b, and a second polymer layer 315c. The first polymer layer 315a and the second polymer layer 315c can be bonded together to encapsulate the reinforcing layer 315b between the first polymer layer 315a and the second polymer layer 315c. Specifically, after the materials of each layer of the main body section 311, the transition section 313, and the flexible section 312 of the second elongated conduit 31 are joined together, the second polymer layer 315c is thermally fused. Fluid in the second polymer layer 315c can flow into the gap between the reinforcing layer 315b and the first polymer layer 315a, thereby encapsulating the reinforcing layer 315b between the first polymer layer 315a and the second polymer layer 315c.

[0053] The hardness of the flexible section 312 and the main section 311 is formed by the differentiated structure of the reinforcing layer 315b and the second polymeric layer 315c. The first polymeric layer 315a has the same hardness in all three sections: the main section 311, the flexible section 312, and the transition section 313. In some embodiments, the first polymeric layer 315a comprises PTFE, nylon, or a combination thereof, preferably all three sections are made of a low-friction polymer material with the same hardness, such as a PTFE liner.

[0054] To ensure that the hardness ratio between the main body section 311 and the flexible section 312 of the second slender conduit 31 reaches 0.1-0.15, in the first embodiment of the present invention, the reinforcing layer 315b is composed of a combination of single-strand braided mesh and double-strand braided mesh, and the second polymer layer 315c is made of Pebax tubing (nylon elastomer) with different hardness. Specifically, please also refer to... Figure 7-10As shown, the reinforcing layer 315b includes a single-strand woven mesh 3151b with a weaving density ranging from 35 PPI to 50 PPI and a double-strand woven mesh 3152b with a weaving density ranging from 25 PPI to 35 PPI. The proximal portion of one of the single-strand woven mesh 3151b and the double-strand woven mesh 3152b is stacked with the other of the single-strand woven mesh 3151b and the double-strand woven mesh 3152b to form a double-layer woven mesh of the main body section 311, i.e., the reinforcing layer 315b forming the main body section 311; while the distal portion of one of the aforementioned single-strand woven mesh 3151b and the double-strand woven mesh 3152b forms a single-layer woven mesh of the flexible section 312, i.e., the reinforcing layer 315b forming the flexible section 312. Meanwhile, the second polymer layer 315c is a Pebax tube with a hardness range of 65D-80D in the main body section 311, and a Pebax tube with a hardness range of 20D-40D in the flexible section 312. The reinforcing layer 315b extends further from the single-layer braided mesh in the flexible section 311 to the transition section 313, forming the reinforcing layer 315b in the transition section 313; the second polymer layer 315c in the transition section 313 is a Pebax tube with a hardness range of 45D-60D.

[0055] In some preferred embodiments, the distal portion of the single-strand woven mesh 3151b forms a single-layer woven mesh of the flexible section 312. In addition, a double-strand woven mesh 3152b is stacked on top of the proximal portion of the single-strand woven mesh 3151b to form a double-layer woven mesh of the main section 311.

[0056] Furthermore, in this embodiment, both the single-strand woven mesh 3151b and the double-strand woven mesh 3152b are woven from stainless steel wire 3153b, specifically from one of the following: round stainless steel wires with a diameter between 0.03mm and 0.30mm or flat stainless steel wires with length and width dimensions between 0.03mm and 0.30mm respectively. In other embodiments, the single-strand woven mesh 3151b and the double-strand woven mesh 3152b can also be formed from tungsten wire of other weaving densities through weaving, winding, or other methods to create the woven mesh.

[0057] Of course, in other embodiments, the reinforcing layer 315b may also be composed of at least two single-layer woven meshes, and each woven mesh may be woven from single-strand or double-strand filaments. The second polymeric layer 315c may also be made of other thermoplastic materials with different hardness. In some embodiments, the reinforcing layer 315b may be made of PA (nylon), PC (polycarbonate), TPU (thermoplastic polyurethane elastomer), PE (polyethylene), PTFE (polytetrafluoroethylene), Pebax (nylon elastomer), or a combination thereof.

[0058] It is understood that in this first embodiment of the present invention, the reinforcing layer 315b of the main body section 311 of the second slender catheter 31 is a double-layer structure formed by stacking single-strand braided mesh 3151b and double-strand braided mesh 3152b, while the second polymer layer 315c is made of Pebax tubing with higher rigidity. This not only ensures the rigidity of the main body section 311 of the second slender catheter 31, but also further reduces the torque loss of the second slender catheter 31 during torsion, thus significantly improving its torque transmission efficiency. At the same time, the reinforcing layer 315b of the flexible section 312 of the second slender catheter 31 is made of single-strand braided mesh 3151b, while the Pebax tubing of the second polymer layer 315c has lower rigidity than the main body section 311. This not only ensures the flexibility of the flexible section 312 of the second slender catheter 31, but also further ensures that the second slender catheter 31 can adapt to complex vascular pathways.

[0059] Furthermore, to ensure that the hardness ratio between the main body section 311 and the flexible section 312 of the second slender conduit 31 reaches 0.1-0.15, in some embodiments of the present invention, the reinforcing layer 315b is composed of a combination of a single-strand braided mesh and a laser-cut tube, and the second polymer layer 315c is made of Pebax tubes with different hardness. For details, please also refer to... Figure 9 and Figure 11 The reinforcing layer 315b in the flexible section 312 includes a single-strand braided mesh 3151b with a braiding density ranging from 35 PPI to 50 PPI, and the reinforcing layer 315b in the main body section 311 includes a laser-cut tube 3154b. The laser-cut tube 3154b is a stainless steel tube with a thickness t ranging from 0.10 mm to 0.30 mm; and the laser-cut tube 3154b has multiple cutting lines 3155b, each cutting line 3155b having a width w ranging from 0.10 mm to 0.60 mm. Meanwhile, the second polymer layer 315c in the main body section 311 is a Pebax tube with a hardness ranging from 65D to 80D, and the second polymer layer 315c in the flexible section 312 is a Pebax tube with a hardness ranging from 20D to 40D. Furthermore, the reinforcing layer 315b extends from the single-layer braided mesh of the flexible section 311 to the transition section 313, forming the reinforcing layer 315b of the transition section 313; the second polymer layer 315c in the transition section 313 is a Pebax tube with a hardness range of 45D-60D. Of course, in other embodiments, the laser-cut tube 3154b can also be laser-cut from tungsten material with other parameters.

[0060] Preferably, the thickness t of the laser-cut tube 3154b is 0.15 mm. Simultaneously, the laser-cut tube 3154b forms multiple cutting lines 3155b through laser cutting. These multiple cutting lines 3155b are evenly arranged along the axial direction of the laser-cut tube 3154b, and each pair of adjacent cutting lines 3155b forms a radial / circumferential misalignment. Furthermore, the angle α formed by each pair of cutting lines 3155b spaced circumferentially along the laser-cut tube 3154b ranges from 60 degrees to 150 degrees; in this embodiment, 120 degrees is preferred.

[0061] Of course, to ensure that the laser-cut tube 3154b is uniformly symmetrical in both the axial and radial directions, the cutting pattern 3155b is one of the following: a symmetrical waist-shaped pattern, an oval pattern, an elliptical pattern, or a square pattern. In addition, the farthest end of the laser-cut tube 3154b is formed with a welding end 3156b having a far-end opening for welding with the single-strand braided mesh 3151b.

[0062] It is understood that in this second embodiment of the present invention, the reinforcing layer 315b of the main body section 311 of the second slender conduit 31 is a thallium tube structure. The thallium tube structure improves the rigidity and torsional control performance of the main body section 311 of the second slender conduit 31. Therefore, compared to the double-layer braided mesh design, the torsional control force of the thallium tube structure is reduced less, thus ensuring that the torque transmission efficiency of the second slender conduit 31 is not too low.

[0063] Further, please refer to Figure 12 As shown, the transcatheter heart valve repair system 100 also includes a first handle 22 and a second handle 34. The first handle 22 is coupled to a first elongated catheter 21, and the second handle 34 is coupled to a second elongated catheter 31. The second elongated catheter 31 extends coaxially through the first handle 22 and the first elongated catheter 21. The first handle 22 is used to control the movement of the first elongated catheter 21, and the second handle 34 is used to control the movement of the second elongated catheter 31. Specifically, the second handle 34 is configured to respond to an external force to generate a torque applied to the proximal end 31a of the second elongated catheter 31.

[0064] In some embodiments, such as Figure 13 As shown, the first elongated conduit 21 includes a flexible and / or pre-bent distal section 211. A first guard 23 is fixedly provided at the distal end of the distal section 211, and the first guard 23 forms an axial passage cavity 230 for the second elongated conduit 31 to pass through. The flexible section 312 of the second elongated conduit 31 can be forcibly bent by the bent distal section 211 of the first elongated conduit 21. At this time, the second elongated conduit 31 generates multiple restoring forces f, wherein the direction of the restoring forces f is opposite to the direction of bending.

[0065] Under the action of the reverse force f, the flexible section 312 of the second slender conduit 31, on the side opposite to the bending direction, will adhere tightly to the inner wall of the first slender conduit 21, resulting in a large frictional force due to the excessively large contact area. Under the constraint of this frictional force, the torsion of the second slender conduit 31 within the first slender conduit 21 will inevitably be affected. This not only delays the torsion of the second slender conduit 31, affecting its torsion control performance, but also causes the second slender conduit 31 to cause the first slender conduit 21 to swing.

[0066] To resolve the above issues, please also refer to Figure 14-15 As shown, in this invention, the inner diameter d1 of the axial passage cavity 230 of the first protector 23 is set to be smaller than the inner diameter d2 of the first slender conduit 21, and the axial center line X1 of the axial passage cavity 230 is set to overlap with the axial center line X2 of the first slender conduit 21. At this time, the axial passage cavity 230 of the first protector 23 is coaxial with the inner cavity of the first slender conduit 21, and the inner diameter d1 of the axial passage cavity 230 is smaller than the inner diameter d2 of the first slender conduit 21. This ensures that the flexible section 312 of the second slender conduit 31 can always remain at the center position of the first slender conduit 21. Even if it is forcibly bent by the curved distal section 211 of the first slender conduit 21, it will not cause a defect where one side of the flexible section 312 is tightly attached to the inner wall of the first slender conduit 21, thereby further improving the torsion control performance of the second slender conduit 31.

[0067] Specifically, the first elongated conduit 21 forms a curved distal section 211, which may include a pre-bent shape, a bent shape, or a combination of both. Specifically, the pre-bent shape of the distal section 211 involves the first elongated conduit 21 detaching from other components, such as detaching from... Figure 14 The third slender conduit 41 is controlled to restore the pre-bent shape. The bending shape of the distal section 211 is specifically as follows: under the control of the bending function of the first handle 22, the distal section 211 of the first slender conduit 21 can be bent and eventually form the bending shape of the distal section 211.

[0068] In some embodiments, the first guard 23 is made of metal, such as stainless steel. Due to the smoothness and low friction of metal, the metal first guard 23 is more conducive to guiding the first slender catheter 21 smoothly into blood vessels or other instruments.

[0069] The following describes the transcatheter heart valve repair system 100 in detail, using the medical device 200 as a valve clip and the transcatheter heart valve repair system 100 as an example, which is used to enter the blood vessel via the femoral vein and deliver the valve clip 200 to the target area of ​​the mitral valve and clamp the anterior and posterior leaflets of the mitral valve.

[0070] Specifically, such as Figure 16-17 As shown, in some embodiments, the transcatheter heart valve repair system 100 further includes a third elongated catheter 41 and a third handle 42 coupled to the third elongated catheter 41. The third elongated catheter 41 includes a distally flexible section 411, and a first elongated catheter 21 extends coaxially through the third handle 42 and the third elongated catheter 41. The first elongated catheter 21 and the third elongated catheter 41 are single-lumen tubes with a single central lumen, and the second elongated catheter 31 is... Figure 4 The diagram shows a multi-lumen tube with multiple cavities.

[0071] Please also refer to Figure 14 and Figure 17-18 The second slender catheter 31 has a second guard 35 fixedly attached to the distal end of its flexible section 312. The second guard 35 also includes a protruding tubular connecting end 351. The distal end of the tubular connecting end 351 is removably engaged with the valve clip 200, and the proximal end of the tubular connecting end 351 is abutted with the distal end of the elastic coil 32. Furthermore, a release lever 33 extends coaxially through the cavity 320 of the elastic coil 32 and the cavity of the tubular connecting end 351, and can switch between extending the distal end of the tubular connecting end 351 and retracting the distal end of the tubular connecting end 351, thereby forcing the valve clip 200 to switch between engaging with the second guard 35 and disengaging from the engagement. In some embodiments, the cross-section of the through cavity 320 and the cross-section of the tubular joint end 351 are both circular; the inner diameter of the through cavity 320 is equal to the inner diameter of the tubular joint end 351, so that the release rod 33 can move smoothly within the second elongated conduit 31.

[0072] In some embodiments, the second guard 35 is made of metal, such as stainless steel. Due to the smoothness and low friction of metal, the metal second guard 35 is more conducive to guiding the smooth advancement of the second slender catheter 31 within a blood vessel or other device.

[0073] The third slender catheter 41 is introduced via the femoral vein and, with the help of the flexible section 411, establishes a path from outside the body to the left atrium 51 of the heart. Specifically, after entering via the femoral vein, the third slender catheter 41 further passes through the inferior vena cava 52 and through the interatrial septum 53 until it enters the left atrium 51 of the heart. At this time, the first slender catheter 21 and the second slender catheter 31 can extend through the third handle 42 and the third slender catheter 41 and can protrude from the distal opening of the third slender catheter 41.

[0074] Next, please continue reading. Figures 19-20As shown, manipulating the first handle 22 bends the distal segment 211 of the first elongated catheter 21, and / or, the distal segment 211 of the first elongated catheter 21 is freed from the constraint of the third elongated catheter 41 and bends itself. Thus, the first elongated catheter 21, under the bending of this distal segment 211, points towards the mitral valve, specifically, the distal opening of the distal segment 211 points towards the mitral valve, to achieve... Figure 19 The distal end of the second elongated catheter 31 shown is substantially perpendicular to the plane C of the mitral valve annulus. Finally, by manipulating the second handle 34, the second elongated catheter 31 can be pushed and retracted along the axial direction of the first elongated catheter 21 to position the valve clamp 200 at the desired location near the mitral valve. At this time, as... Figure 20 As shown, the second handle 34 can be twisted to generate a torque applied to the proximal end 31a of the second slender catheter 31. The distal end 31b of the second slender catheter 31 can rotate circumferentially in a direction parallel to the mitral valve annulus plane C under the action of this torque, thereby adjusting the angle of the valve clip 200 relative to the mitral valve, so that the position and orientation of the valve clip 200 are adapted to the target area, ultimately ensuring the best treatment effect.

[0075] Understandably, the transcatheter heart valve repair system 100 can be used for mitral valve repair, using valve clips 200 to clamp the anterior and posterior leaflets of the mitral valve to prevent mitral regurgitation. Of course, it can also be used in other cardiac interventional medical devices such as mitral valve replacement, tricuspid valve repair and / or replacement, and aortic repair and / or replacement.

[0076] The above describes the embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of the embodiments of the present invention, and these improvements and modifications are also considered within the scope of protection of the present invention.

Claims

1. A transcatheter heart valve repair system, characterized in that, include: First slender duct; as well as A second slender conduit extends coaxially through the first slender conduit; The second slender catheter includes a proximal end, a distal end, and a main body section and a flexible section extending axially from the proximal end to the distal end. The length of the main body section ranges from 700 mm to 1500 mm, and the hardness ratio of the flexible section to the main body section ranges from 0.05 to 0.

2. Specifically, a torque is applied to the proximal end to drive the second elongated catheter to rotate circumferentially relative to the first elongated catheter, and the torque generated at the proximal end is transmitted to the distal end via the main body section and the flexible section with a torque transmission efficiency of not less than 35%.

2. The transcatheter heart valve repair system as described in claim 1, characterized in that, The length of the second slender conduit ranges from 900mm to 1600mm.

3. The transcatheter heart valve repair system as described in claim 1, characterized in that, The length of the main body section ranges from 1100mm to 1500mm, the length of the flexible section ranges from 100mm to 200mm, and the torque transmission efficiency of the torque generated at the proximal end to the distal end via the main body section and the flexible section is between 38% and 85%.

4. The transcatheter heart valve repair system as described in claim 3, characterized in that, An axially incompressible elastic coil is coaxially installed inside the second slender conduit to enhance the torque transmission efficiency of the second slender conduit.

5. The transcatheter heart valve repair system as described in claim 4, characterized in that, The outer diameter of the flexible section is smaller than the outer diameter of the main section, the inner diameter of the flexible section is equal to the inner diameter of the main section, and a smooth taper is formed between the flexible section and the main section.

6. The transcatheter heart valve repair system as described in claim 5, characterized in that, The hardness ratio between the flexible section and the main section is in the range of 0.1-0.15, and the torque transmission efficiency of the torque generated at the proximal end to the distal end via the main section and the flexible section is between 50% and 85%.

7. The transcatheter heart valve repair system as described in claim 6, characterized in that, The torque generated at the proximal end drives the proximal end to rotate 90 degrees circumferentially. Under the transmission of the main body section and the flexible section, the circumferential rotation angle of the distal end of the second slender catheter ranges from 45 degrees to 72 degrees.

8. The transcatheter heart valve repair system as described in claim 6, characterized in that, The torque generated at the proximal end drives the proximal end to rotate circumferentially by 135 degrees. Under the transmission of the main body section and the flexible section, the circumferential rotation angle of the distal end of the second elongated catheter ranges from 68 degrees to 112 degrees.

9. The transcatheter heart valve repair system as described in claim 6, characterized in that, The second slender conduit has a wall that includes a first polymer layer, a reinforcing layer, and a second polymer layer from the inside out. The first polymer layer and the second polymer layer can be bonded to each other to encapsulate the reinforcing layer between the first polymer layer and the second polymer layer. The rigidity of the flexible section and the main body section is formed by the different structures of the reinforcing layer and the second polymer layer.

10. The transcatheter heart valve repair system as described in claim 9, characterized in that, The reinforcing layer includes a single-strand woven mesh with a weaving density ranging from 35 PPI to 50 PPI and a double-strand woven mesh with a weaving density ranging from 25 PPI to 35 PPI. The proximal portion of one of the single-strand woven mesh and the double-strand woven mesh is stacked with the other of the single-strand woven mesh and the double-strand woven mesh to form a double-layer woven mesh of the main body section. The distal portion of one of the single-strand woven mesh and the double-strand woven mesh forms a single-layer woven mesh of the flexible section. as well as The second polymer layer in the main body section is a Pebax tube with a hardness range of 65D-80D, and the second polymer layer in the flexible section is a Pebax tube with a hardness range of 20D-40D.

11. The transcatheter heart valve repair system as described in claim 10, characterized in that, Both the single-strand woven mesh and the double-strand woven mesh are woven from one of the following: round stainless steel wires with a diameter between 0.03mm and 0.30mm, or flat stainless steel wires with length and width dimensions between 0.03mm and 0.30mm respectively.

12. The transcatheter heart valve repair system as described in claim 6, characterized in that, The reinforcing layer in the flexible section comprises a single-strand woven mesh with a weaving density ranging from 35 PPI to 50 PPI. The reinforcing layer in the main body section comprises a laser-cut tube, which is a stainless steel tube with a thickness ranging from 0.10 mm to 0.30 mm. The laser-cut tube has multiple cutting lines, each with a width ranging from 0.10 mm to 0.60 mm. The second polymer layer in the main body section is a Pebax tube with a hardness range of 65D-80D, and the second polymer layer in the flexible section is a Pebax tube with a hardness range of 20D-40D.

13. The transcatheter heart valve repair system as described in any one of claims 1-12, characterized in that, The transcatheter heart valve repair system further includes a first handle and a second handle, the first handle being coupled to the first elongated catheter and the second handle being coupled to the second elongated catheter; The second elongated conduit extends coaxially through the first handle and the first elongated conduit, the second handle being configured to respond to an external force to generate the torque.

14. The transcatheter heart valve repair system as described in any one of claims 1-12, characterized in that, The first elongated conduit includes a flexible and / or pre-bent distal section, the distal end of which is fixedly provided with a first guard, the first guard forming an axial passage cavity for the second elongated conduit to pass through; the axial centerline of the axial passage cavity overlaps with the axial centerline of the first elongated conduit, but the inner diameter of the axial passage cavity is smaller than the inner diameter of the first elongated conduit.

15. The transcatheter heart valve repair system as described in any one of claims 1-12, characterized in that, The transcatheter heart valve repair system further includes a third slender catheter and a third handle coupled to the third slender catheter. The first slender catheter extends coaxially through the third handle and the third slender catheter. The first slender catheter includes a flexible and / or pre-bent distal segment, and the third slender catheter includes a distal flexible segment. The first and third slender catheters are single-lumen tubes, and the second slender catheter is a multi-lumen tube. The third slender catheter is accessed via the femoral vein and can establish an external pathway to the left atrium of the heart under the action of the flexible segment. The first slender catheter is oriented towards the mitral valve under the bending of the distal segment, and the distal end of the second slender catheter is circumferentially rotated in a direction parallel to the plane of the mitral valve annulus under the action of torque.

16. The transcatheter heart valve repair system as described in claim 4, characterized in that, A second protector is fixedly provided at the distal end of the flexible segment. The second protector includes a protruding tubular engagement end. The distal end of the tubular engagement end is removably engaged with a valve clip. The proximal end of the tubular engagement end is abutted against the distal end of the elastic coil. A release lever extends coaxially through the cavity of the elastic coil and the cavity of the tubular engagement end, and can switch between extending from the distal end of the tubular engagement end and retracting from the distal end of the tubular engagement end, thereby forcing the valve clip to switch between engaging with the second protector and disengaging from the engagement.

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