Delivery system for medical devices

Abstract

The invention provides a delivery system of a medical device. The delivery system comprises a first delivery device and a second delivery device. The first delivery device includes a first handle and a first catheter including a bendable distal section. The second delivery device includes a second handle and a second conduit extending coaxially through the first delivery device. The second catheter has a first section along an axial length thereof and a second section having a reduced outer diameter, the second section being located at a distal end of the first section. The first handle is operated to force the distal section of the first catheter to bend, and the second section of the second catheter can be shaped into a bent form by the bent distal section and can at least partially restore to the initial form from the bent form after extending out of the bent distal section. The delivery system can reasonably and effectively deliver the medical device to a target area in the body of a patient, and the success rate of an operation is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and in particular to a delivery system of a medical device. BACKGROUND

[0002] Heart disease is one of the major health threats worldwide, among which heart valve disease is the most common. For heart valve disease caused by various pathologies, compared with open-heart surgery, interventional surgery has the characteristics of smaller invasiveness, minimally invasive and safety. Therefore, in recent years, the technology for treating pathological sites through interventional surgery has developed rapidly. The current mainstream interventional surgery schemes include artificial chordae tendineae implantation, edge-to-edge repair and annuloplasty, etc. Generally, such surgeries are minimally invasive through catheter technology to implement treatment in the patient's body, which needs to be completed under the guidance of medical imaging and remote control outside the patient's body. Since the interventional surgery is performed under non-direct vision, how to use the delivery system to deliver the interventional device to the target treatment site in the patient's body to correctly position the interventional device to successfully perform the surgery still brings various challenges, such as low success rate of surgery, and even seriously endangering the life safety of the patient. SUMMARY

[0003] The purpose of the present application is to provide a delivery system of a medical device, which can reasonably and effectively deliver the medical device to the target region in the patient's body and improve the success rate of surgery.

[0004] To achieve the above-mentioned purpose, in a first aspect, the present application provides a delivery system of a medical device, comprising:

[0005] a first delivery device comprising a first handle and a first catheter extending distally from the first handle, the first catheter comprising a bendable distal section; and

[0006] a second delivery device comprising a second handle and a second catheter extending distally from the second handle, the second catheter extending coaxially through the first delivery device, the second catheter having a first section and a second section with a reduced outer diameter along an axial length thereof, the second section being located distally of the first section;

[0007] manipulating the first handle to force the distal section of the first catheter to bend, the second section of the second catheter being shaped into a curved configuration by the bendable distal section and being capable of at least partially recovering from the curved configuration to an initial configuration after being extended out of the bendable distal section.

[0008] In a second aspect, the present application further provides a transcatheter delivery system of a medical device, comprising:

[0009] a first delivery device comprising a first handle and a first catheter extending distally from the first handle, the first catheter comprising a distal section that is bendable and / or pre-shaped; and

[0010] a second delivery device comprising a second handle and a second catheter extending distally from the second handle, the second catheter extending coaxially through the first delivery device; and

[0011] a third delivery device comprising a third handle and a third catheter extending distally from the third handle, the third catheter comprising a bendable section at a distal end, the first catheter extending coaxially through the third delivery device;

[0012] wherein the second catheter comprises a proximal section extending along an axial length thereof, the proximal section comprising a laser-cut tube; the second delivery device is capable of delivering the medical device through a blood vessel to a target region of a heart in a body under a bending cooperation of the distal section and the bendable section, the proximal section being positioned outside the body at all times.

[0013] In one embodiment thereof, the laser-cut tube has a rigidity that is constant along an axial length thereof, and the axial length thereof ranges from 400 mm to 600 mm.

[0014] In one embodiment thereof, the laser-cut tube has a plurality of cutting patterns that are uniformly spaced around a circumference of the laser-cut tube; wherein a plurality of groups of the cutting patterns are uniformly arranged axially on the laser-cut tube, and the cutting patterns of each two adjacent groups are radially / circumferentially offset.

[0015] In one embodiment thereof, the cutting patterns are one of a rugby-shaped pattern, a waist-shaped pattern, an elliptical pattern, and a square-shaped pattern.

[0016] In one embodiment thereof, a tube wall of the second catheter comprises, radially from inside to outside, a first polymeric layer, a first reinforcing layer, and a second polymeric layer, the first polymeric layer and the second polymeric layer being capable of combining with each other to enclose the first reinforcing layer between the first polymeric layer and the second polymeric layer; wherein the first reinforcing layer comprises the laser-cut tube and a braided mesh connected to a distal end of the laser-cut tube.

[0017] In one embodiment thereof, the second catheter further comprises a middle section and a distal section extending along an axial length thereof, the middle section connecting the proximal section and the distal section, the braided mesh being located in the middle section and the distal section, and a material hardness of the second polymeric layer in the middle section and the proximal section being higher than a material hardness of the second polymeric layer in the distal section.

[0018] In one embodiment, the second polymeric layer has a material hardness gradually decreasing from proximal to distal in the distal section.

[0019] In one embodiment, the first catheter further comprises a proximal section connected to a proximal end of the distal section, the proximal section comprising a material harder than the distal section, the harder material not comprising a laser cut tube; after the transvascular delivery of the medical device to a target region of a heart in a body by the catheter delivery system, a portion of the proximal section is positioned outside the body and another portion is positioned inside the body.

[0020] In one embodiment, the first catheter further comprises a pull tube lumen extending at least partially through the proximal section and the distal section; a distal end of at least one pull member is attached to the distal section, a proximal end of the pull member extends through the pull tube lumen and is attached to the first handle; the distal section is pre-shaped with a curved curve, the distal section is movable within a range of bending angles from 20 degrees to 120 degrees under the joint action of the curved curve and the pull member.

[0021] In one embodiment, the wall of the first catheter radially comprises, from inside to outside, a third polymeric layer, a second reinforcing layer, and a fourth polymeric layer, the third polymeric layer and the fourth polymeric layer are capable of combining with each other to encapsulate the second reinforcing layer between the third polymeric layer and the fourth polymeric layer; wherein the second reinforcing layer is a woven mesh, the pull tube lumen is located between the third polymeric layer and the woven mesh.

[0022] In one embodiment, a distal end of the distal section is fixedly provided with a distal coupler, a distal end of the distal section is fixedly provided with a protective coupler; the distal coupler has an axial through engagement cavity, an outer surface of the protective coupler is formed with a circumferential engagement surface, the circumferential engagement surface is capable of being circumferentially engaged in the engagement cavity.

[0023] In a third aspect, the present application further provides a delivery system of a medical device, comprising:

[0024] a first delivery device comprising a first handle and a first catheter extending distally from the first handle, a distal end of the first catheter is fixedly provided with a distal coupler; and

[0025] a second delivery device comprising a second handle and a second catheter extending distally from the second handle, the second catheter coaxially extends through the first delivery device; a distal end of the second catheter is fixedly provided with a protective coupler, the medical device is removably engaged to the protective coupler;

[0026] The distal coupler has an axial through engagement cavity, and the protective coupler has a circumferential engagement surface formed on the outer surface thereof, which is capable of being circumferentially engaged in the engagement cavity to shorten the axial distance between the medical device and the distal coupler.

[0027] In one of the embodiments, the cross-sectional dimension of the engagement cavity is greater than the cross-sectional dimension of the circumferential engagement surface, and the cross-sectional dimension of the circumferential engagement surface is greater than the inner diameter of the first catheter.

[0028] In one of the embodiments, the cross-section of the engagement cavity and the cross-section of the circumferential engagement surface are both circular, the diameter of the engagement cavity is greater than the cross-sectional diameter of the circumferential engagement surface, and the cross-sectional diameter of the circumferential engagement surface is greater than the inner diameter of the first catheter.

[0029] In one of the embodiments, a limiting portion is arranged in the engagement cavity, which is capable of limiting the circumferential engagement surface from entering the first catheter.

[0030] In one of the embodiments, the limiting portion forms a limiting cavity therearound, and the cross-sectional dimension of the limiting cavity is smaller than the cross-sectional dimension of the circumferential engagement surface, so that the circumferential engagement surface is limited by the limiting cavity from entering the first catheter.

[0031] In one of the embodiments, the axial distance between the limiting portion and the distal opening of the engagement cavity ranges from 0.15mm to 2.4mm.

[0032] In one of the embodiments, the distal coupler further has a connecting portion fixedly connected with the first catheter, and the protective coupler further has a connecting end fixedly connected with the second catheter, both the connecting portion and the connecting end are tubular, and both the tubular side walls have a plurality of openings.

[0033] In one of the embodiments, the first catheter includes a bendable distal section, a proximal section, and a pull tube lumen extending at least partially through the proximal section and the distal section; a distal pull ring is fixedly arranged in the distal section, a distal end of a pull wire is attached to the distal pull ring, and a proximal end of the pull wire extends through the pull tube lumen and is attached to the first handle; the first handle is operated to actuate the pull wire to bend the distal section; the distal coupler is fixedly arranged at the distal end of the distal section, and the distal pull ring is arranged within a preset range from the proximal end of the distal coupler.

[0034] In one embodiment, the second delivery device further includes an axially incompressible coil extending coaxially through the second catheter; the medical device includes a valve clip, and the protective coupler further includes a protruding tubular joint, the distal end of which is removably engaged with the valve clip, and the proximal end of which abuts with the distal end of the coil.

[0035] In one embodiment, the coil forms an axially extending through cavity, and a release rod extends coaxially through the cavity of the coil and the tubular joint, and can switch between extending out of the distal end of the tubular joint and retracting into the distal end of the tubular joint, thereby forcing the valve to switch between engaging with the protective coupler and disengaging from the engagement.

[0036] In one embodiment, the delivery system may further include a third delivery device, the third delivery device including a third handle and a third conduit extending distally from the third handle, the first conduit extending coaxially through the third delivery device;

[0037] Under the operation of the first handle, the first catheter is advanced distally and extends distally from the third catheter, and the circumferential engagement surface can circumferentially engage within the engagement cavity to shorten the axial distance of the medical device extending from the third catheter.

[0038] The delivery system provided by the present invention improves the success rate of surgery by rationally and effectively designing the first delivery device and the second delivery device to successfully deliver the medical device to the target area inside the patient's body. Attached Figure Description

[0039] 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.

[0040] Figure 1 A schematic diagram of the delivery system of the medical device in the first embodiment is shown, with the second section of the second catheter shaped into a curved form.

[0041] Figure 2 It shows Figure 1 A schematic diagram showing the state of the second section restored to its initial form.

[0042] Figure 3 A cross-sectional view of a coil extending axially through a second conduit is shown.

[0043] Figure 4A state diagram showing the second catheter extending distally from the first catheter and moving a distance of a stroke.

[0044] Figure 5 A structural diagram showing the second catheter extending coaxially through the first catheter.

[0045] Figure 6 A structural diagram showing a lubricious coating on the second catheter.

[0046] Figure 7 A structural diagram showing Figure 1 a delivery system in the first embodiment.

[0047] Figure 8 Another structural diagram showing a lubricious coating on the second catheter.

[0048] Figure 9 A scenario diagram showing a range of bending angles for a distal section of the first catheter.

[0049] Figure 10 A structural diagram showing a puller of the first catheter.

[0050] Figure 11 A scenario diagram showing the first catheter extending distally from the third catheter.

[0051] Figure 12 A scenario diagram showing a range of bending angles for the first catheter under the influence of the puller and the bending curve.

[0052] Figure 13 A structural diagram showing the first catheter being bendable in two directions.

[0053] Figure 14 A structural diagram showing a catheter-based delivery system for a medical device in a second embodiment.

[0054] Figure 15 A structural diagram showing the second catheter in the second embodiment. Figure 14

[0055] A structural diagram showing a laser-cut tube in the second embodiment. Figure 16 Figure 15 A layered structure of the second catheter in a proximal section.

[0056] Figure 17 A layered structure of the second catheter in an intermediate section.

[0057] Figure 18 A layered structure of the second catheter in a distal section.

[0058] Figure 19 ​​

[0059] Figure 20 A side cross-sectional view showing the second catheter inside the first catheter.

[0060] Figure 21 A schematic view showing the first catheter as a segmented structure.

[0061] Figure 22 A cross-sectional view showing the first catheter as a layered structure.

[0062] Figure 23 A schematic view showing a scenario of the delivery system of the medical device in the third embodiment.

[0063] Figure 24 A schematic view showing Figure 23 A schematic view showing the structure of the distal end coupler and the guard coupler.

[0064] Figure 25 A schematic view showing Figure 24 A side cross-sectional view showing the first delivery device.

[0065] Figure 26 A side cross-sectional view showing the second delivery device. Figure 24

[0066] A schematic view showing the state of the delivery system delivering the valve clip to the target area of the mitral valve of the heart. Figure 27

[0067] A schematic view showing the state of the delivery system of the second embodiment, in which the distal end of the second catheter is bent to a direction substantially perpendicular to the plane of the annulus of the mitral valve. Figure 28 Figure 27 A schematic view showing the state of the delivery system of the third embodiment, in which the distal end of the second catheter is bent to a direction substantially perpendicular to the plane of the annulus of the mitral valve.

[0068] Figures 29a-29f A schematic view showing the state of the delivery system of the third embodiment, in which the distal end of the second catheter is bent to a direction substantially perpendicular to the plane of the annulus of the mitral valve. Figure 27

[0069] The following detailed description will further describe the present application in conjunction with the above-mentioned drawings. DETAILED DESCRIPTION

[0070] The technical solutions in the embodiments of the present application will be described clearly and completely below in conjunction with the drawings of the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative effort belong to the scope of protection of the present application.

[0071] ​​In addition, the description of the following embodiments is made with reference to the accompanying drawings, which illustrate specific embodiments to which the present application can be put into practice. The directional terms mentioned in the present application, such as "upper", "lower", "front", "back", "left", "right", "inner", "outer", "lateral" and the like, are only the directions of the accompanying drawings, thus the directional terms used are for better, clearer illustration and understanding of the present application, and are not intended to indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus cannot be understood as a limitation of the present application.

[0072] It should be noted that, in order to more clearly describe the delivery system of the medical device provided by the present application, the terms "proximal end" and "distal end" defined in the specification are conventional terms in the field of interventional medicine. Specifically, "distal end" refers to the end far from the operator during the operation, and "proximal end" refers to the end close to the operator during the operation; the direction of the central axis of a rotating object such as a column or a tube is defined as the axial direction or the longitudinal axis; the circumferential direction is the direction around the axis of the object such as a column or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius); the radial direction is the direction along the diameter or radius. It should be noted that, regardless of the "end" appearing in the words "proximal end", "distal end", "one end", "the other end", "first end", "second end", "initial end", "terminal end", "two ends", "free end", "upper end" and "lower end", it is not limited to the end, end point or end face, but also includes a part extending an axial distance and / or a radial distance from the end, end point or end face on the element to which the end, end point or end face belongs. Unless otherwise defined, all technical and scientific terms used in the present application have the same meaning as understood by those skilled in the art to which the present application belongs. The conventional terms used in the specification of the present application are only for the purpose of describing specific embodiments and cannot be understood as a limitation of the present application.

[0073] The present application provides a delivery system 100a of a medical device for delivering a medical device 300 into a patient's body to treat a heart disease, for example, the delivery system 100a can enter the patient's body through a transapical path, or can enter the patient's body through a trans-catheter path. Specifically, referring to FIGS. 1 and 2, the delivery system 100a includes a first delivery device 20 and a second delivery device 30. Figure 1 and Figure 2 The first delivery device 20 includes a first handle 21 and a first catheter 22 extending distally from the first handle 21, the first catheter 22 including a bendable distal section 221. The second delivery device 30 includes a second handle 31 and a second catheter 32 extending distally from the second handle 31, the second catheter 32 extending coaxially through the first delivery device 20.

[0074] The second conduit 32 has a first segment 321 and a second segment 322 with a reduced outer diameter along its axial length, the second segment 322 being located distal to the first segment 321. Figure 1 As shown, manipulating the first handle 21 forces the distal segment 221 of the first catheter 22 to bend, allowing the second segment 322 of the second catheter 32 to be shaped into a curved form by the bent distal segment 221, and enabling it to extend from the bent distal segment 221. Figure 1 The bending shape shown is at least partially restored to the state shown. Figure 2 The initial shape shown. In some embodiments, the initial shape is an unbent shape.

[0075] For some applications, the second segment 322 of the second catheter 32 is shaped into a curved shape, including: firstly, manipulating the first handle 21 to force the distal segment 221 of the first catheter 22 to bend, and then driving the second catheter 32 to translate axially to control its second segment 322 to pass through the bent distal segment 221 and be shaped into a curved shape; and secondly, the second segment 322 of the second catheter 32 is pre-received within the distal segment 221 of the first catheter 22, and when the first handle 21 is manipulated to force the distal segment 221 to bend, the second segment 322 is shaped into a curved shape by the bent distal segment 221.

[0076] Given that the outer diameter of the second segment 322 of the second catheter 32 is smaller than that of the first segment 321, the recovery performance of the second segment 322 is necessarily stronger than that of the first segment 321. Therefore, after extending from the curved distal segment 221, the second segment 322 can quickly return to its initial shape from its curved form. This ensures that during cardiac surgery, after extending from the first catheter 22, the second catheter 32 can maintain a near-constant coaxiality with the first catheter 22, especially at its distal ends, such as maintaining X-axis coaxiality. Ultimately, this ensures the precision of subsequent manipulation of the second catheter 32 relative to the first catheter 22, greatly improving the accuracy of the surgery.

[0077] The delivery system 100a of the present invention ensures the recovery performance of the second catheter 32, avoiding the defect in the prior art where the second catheter 32 is prone to unexpected movement or bending deformation after extending from the first catheter 22, ultimately causing the second catheter 32 and the first catheter 22 to lose their coaxiality. For example, this can cause the X' axis of the distal second catheter 32 to deviate from the X-axis of the distal first catheter 22 (see...). Figure 2). Meanwhile, the delivery system 100a of the present application further ensures the accuracy of the operation during the surgery, greatly shortens the operation time, and avoids the unexpected deformation of the second catheter 32 extending out of the first catheter 22 in the prior art, which further leads to the excessive operation of the first catheter 22 and thus easily causes various other unexpected accidents and prolongs the operation time.

[0078] In addition, under the operation of the second handle 31, the second catheter 32 can move, such as twist and / or axially translate, in the first catheter 22. During the twist and / or axial translation, especially when the second catheter 32 moves in the already curved distal section 221, the second catheter 32 and the distal section 221 are more likely to generate excessive friction force, which further leads to the twist and / or axial translation not being smooth. The delivery system 100a of the present application reduces the outer diameter of the second section 322 of the second catheter 32 relative to the first section 321, which greatly reduces the friction force between the second section 322 of the second catheter 32 and the curved distal section 221, so as to ensure that the second section 322 of the second catheter 32 can smoothly extend out of the distal section 221 of the second catheter 32, and further improves the delivery effect of the delivery system 100a.

[0079] Of course, in order to enhance the recovery performance of the second catheter 32 in the delivery system 100a, in further embodiments, as shown in Figure 3 , the second delivery device 30 further comprises an axially incompressible coil 33, which coaxially extends through the second catheter 32. The coil 33 can enhance the recovery performance of the second catheter 32, i.e., the coil 33 enhances the recovery performance of the second section 322 from the curved shape to the initial shape. Preferably, the coil 33 is a flat wire spring tube.

[0080] For some applications, the coil 33 coaxially extends through the entire lumen of the second catheter 32; that is, the axial length of the coil 33 is equal to the axial length of the second catheter 32. For other applications, in order to ensure that the release rod 34 in Figure 5 can smoothly pass through and move in the second catheter 32, the coil 33 is formed with an axially extending through cavity 330 for the release rod 34 to pass through.

[0081] In some embodiments, as shown in Figure 4 , the second catheter 32 can extend out of the distal end of the distal section 221 of the first catheter 22 and be movable by a stroke distance S. Wherein, the axial length L2 (see Figure 5) is equal to the stroke distance S. After the stroke distance S is moved, the second section 322 of the second catheter 32 will be fully extended from the self-bent distal section 221, and the distal end of the first section 321 will be positioned at the distal end of the distal section 221. Since the gap between the first section 321 and the first catheter 22 is smaller than the gap between the second section 322 and the first catheter 22, positioning the distal end of the first section 321 at the distal end of the distal section 221 is more conducive to the coaxial positioning between the first catheter 22 and the second catheter 32, such as maintaining the X-axis coaxial positioning. Therefore, the above design enhances the coaxial positioning of the first catheter 22 and the second catheter 32 without the need to re-orient the first catheter 22, thereby providing accurate positioning for subsequent twisting and other operations of the second catheter 32. Preferably, the stroke distance S ranges between 40mm and 80mm.

[0082] For some applications, the distal end of the distal section 221 of the first catheter 22 is fixed with a distal coupler 23. The second catheter 32 can move a stroke distance S after sequentially passing through the first catheter 22 and the distal coupler 23. After the stroke distance S is moved, the distal end of the first section 321 will be positioned at the distal coupler 23. The distal coupler 23 is made of metal, such as stainless steel. Due to the smoothness and low friction of the metal material, the distal coupler 23 made of metal material is more conducive to guiding the smooth advancement of the first catheter 22 in the blood vessel or other instruments.

[0083] For other applications, the distal end of the second section 322 of the second catheter 32 is fixed with a protective coupler 35. Specifically, the distal coupler 23 has an axially through engagement cavity 230, and the outer surface of the protective coupler 35 is formed with a circumferential engagement surface 350, which can be circumferentially engaged in the engagement cavity 230. For specific structures, cooperation relationships and corresponding technical effects of the distal coupler 23 and the protective coupler 35, please refer to the subsequent discussion of the drawings, which will not be described in detail here. Figures 23-26

[0084] In some embodiments, as shown in FIG. 6, the distal end of the second section 322 of the second catheter 32 is fixed with a distal coupler 23. The distal coupler 23 is made of metal, such as stainless steel. The distal coupler 23 is axially through, and the outer surface of the distal coupler 23 is formed with a circumferential engagement surface 230, which can be circumferentially engaged in the engagement cavity 230 of the first catheter 22. For specific structures, cooperation relationships and corresponding technical effects of the distal coupler 23 and the protective coupler 35, please refer to the subsequent discussion of the drawings, which will not be described in detail here. Figure 5 ​As shown, the outer diameter difference between the first section 321 and the second section 322 of the second catheter 32 ranges from 0.3mm to 1.05mm. Specifically, assuming the axial length of the first section 321 is L1, the outer diameter of the first section 321 is D1, the axial length of the second section 322 is L2, the outer diameter of the second section 322 is D2, the inner diameter of the first catheter 22 is D3, and the axial length of the distal section 221 of the first catheter 22 is L3. To ensure that the second catheter 32 can extend through the first catheter 22 and move smoothly within the first catheter 22, thereby reducing the mutual interference between the two during delivery, it is necessary that D3>D1>D2. Meanwhile, to ensure that the axial length L2 of the second section 322 with reduced outer diameter can be completely covered within the bendable distal section 221, thereby reducing the friction generated by the movement of the second catheter 32 within the curved distal section 221, it is preferable that L1>L2>L3. For some applications, the outer diameter D1 of the first section 321 ranges from 3.65mm to 3.95mm, the outer diameter D2 of the second section 322 ranges from 2.9mm to 3.65mm, and the inner diameter D3 of the first catheter 22 ranges from 4.1mm to 4.8mm.

[0085] Further, to avoid the risk of fracture at the junction between the first section 321 and the second section 322 of the second catheter 32 due to the sharp change in outer diameter, a smooth taper with a taper distance ranging from 10mm to 25mm is provided between the first section 321 and the second section 322 to achieve a smooth transition between the two.

[0086] It should be particularly noted that in some embodiments, please refer to Figure 5 , the medical device 300 includes valve clips, and the second delivery device 30 utilizes a release rod 34 movable within the second catheter 32 to removably engage the valve clips to the distal end of the second catheter 32 or a guard coupler 35 through the release rod 34. To ensure that the release rod 34 can move smoothly within the second catheter 32, the inner diameter of the first section 321 is equal to the inner diameter of the second section 322.

[0087] Of course, to further reduce the friction between the first catheter 22 and the second catheter 32, as Figures 6-8 shown, the second catheter 32 further includes a lubricating coating 320. The lubricating coating 320 can be a biocompatible polyvinylpyrrolidone (PVP) material attached to the outer surface of the second catheter 32 through a light curing process, or a PTFE inner etched tube with a low friction coefficient attached to the outer surface of the second catheter 32 through a hot melt welding process.

[0088] For some applications, as Figure 6As shown, the lubricating coating 320 is provided on the outer surface of the second section 322 of the second catheter 32, and the length L of the lubricating coating 320 is equal to the axial length L2 of the second section 322.

[0089] For other applications, such as Figures 7-8 As shown, the delivery system 100a further comprises a third delivery device 40, which comprises a third handle 41 and a third catheter 42 extending distally from the third handle 41. The first catheter 22 coaxially extends through the third delivery device 40 and is movable, such as twisted and / or axially translated, within the third delivery device 40. In particular, the third catheter 42 comprises a bendable section 421 at the distal end, which preferably can be bent within an angle range of 0 degree to 120 degree. Further, the outer surface of the second section 322 and at least part of the first section 321 of the second catheter 32 is provided with a continuous lubricating coating 320, which has a length L greater than or equal to the sum of the axial length L2 of the second section 322, the axial length L3 of the distal section 221 of the first catheter 22, and the axial length L4 of the bendable section 421 of the third catheter 42. That is, the length L of the lubricating coating 320 is L≥L2+L3+L4, and preferably the length L is within a range of 120 mm to 180 mm. Preferably, the length L of the lubricating coating 320 is equal to the axial length of the second catheter 32, i.e. L=L1+L2, and the entire outer surface of the second catheter 32 is coated with the lubricating coating 320.

[0090] Further, in order to ensure that the distal section 221 of the first catheter 22 can be moved within a predetermined range of bending angles, so that the first catheter 22 can be positioned at a target region within the heart according to a predetermined route, such as at a substantially central position above the annulus, in some embodiments, as shown in Figure 9 As shown, the first catheter 22 further comprises a proximal section 222 and a pull tube lumen 220 extending at least partially through the proximal section 222 and the distal section 221. A distal end of at least one pull member 223 is attached to the distal section 221, and a proximal end of the pull member 223 extends through the pull tube lumen 220 and is attached to the first handle 21. The first handle 21 is manipulated to actuate the pull member 223 to pull the distal section 221, so that the distal section 221 is moved within a range of bending angles of 0 degree to 90 degree, thereby shaping the second section 322 of the second catheter 32 into a curved configuration having substantially the same curvature as the distal section 221.

[0091] In particular, please further refer to Figure 10As shown, the traction member 223 comprises a traction wire 223a and a distal pull ring 223b. The distal pull ring 223b is fixedly arranged at the distal section 221, such as being heat-fused to the distal end of the distal section 221, and the distal end of the traction wire 223a is connected to the distal pull ring 223b, and the proximal end extends through the traction lumen 220 and is attached to the first handle 21. Under the manipulation of the first handle 21, the traction wire 223a can be pulled and tensioned to force the distal section 221 of the first catheter 22 to bend or deform. The bent distal section 221 shapes the second section 322 in a curved configuration, and under the restoring performance of the second section 322, the second section 322 can quickly at least partially restore from the curved configuration to the initial configuration.

[0092] In view of the application scenario as shown in Figure 11 , the third catheter 42 is positioned in the atrium after passing through the atrial septum 51 of the heart. Then, the first catheter 22 is manipulated to extend from the distal end of the third catheter 42, and then the first catheter 22 is bent. However, in the process of manipulating the first catheter 22 to extend from the distal end of the third catheter 42, the first catheter 22 or the medical device 300 extending from the distal end of the first catheter 22 is extremely easy to accidentally touch the inner side of the atrial wall 52 opposite to the atrial septum 51, thereby causing the defect of atrial tissue damage.

[0093] In order to ensure that the delivery system 100a can completely avoid the first catheter 22 from touching the heart tissue when extending from the distal end of the third catheter 42, such as avoiding the inner side of the atrial wall 52, in the application scenario as shown in Figure 11 , further, please refer to Figure 11 and 12 As shown, the distal section 221 of the first catheter 22 is pre-shaped with a bending curve. Preferably, the angle range of the bending curve is between 20 degrees and 30 degrees, and the axial length L5 is in the range of 20mm-25mm. That is, when the first catheter 22 is in a natural state without external force, the distal section 221 thereof is bent outward at an angle range of 20 degrees to 30 degrees away from the X axis.

[0094] In view of the fact that the distal section 221 of the first catheter 22 can move within a bending angle range of 0 degrees to 90 degrees under the traction of the traction member 223, under the joint action of the bending curve and the traction member 223, the bending angle range of the distal section 221 of the first catheter 22 is superimposed, that is, it can move within a bending angle range of 20 degrees to 120 degrees, thereby shaping the second section 322 of the second catheter 32 into a curved configuration having substantially the same curvature as the distal section 221 of the first catheter 22.

[0095] Of course, in other embodiments, as shown in Figure 13As shown, to enable the delivery system 100a to adapt to different application scenarios, the distal section 221 of the first catheter 22 is capable of bidirectional bending to thereby ensure bidirectional control of the second catheter 32. Specifically, the puller 223 includes two pull wires 223a, which are arranged at 180 degrees relative to the X axis of the first catheter 22, and both of which have a distal end attached to the same distal pull ring 223b and a proximal end attached to the first handle 21. In use, the first handle 21 is manipulated to pull the two pull wires 223a respectively to control the distal section 221 to bend in opposite directions respectively, thereby achieving bidirectional bending control of the second catheter 32.

[0096] Generally, when a delivery system enters the interior of a heart via a trans-catheter path, in order to guide the distal end of a catheter, such as the distal end of the first catheter 22, the distal end of the second catheter 32, and / or the distal end of the third catheter 42, to a target region in the interior of the heart, a physician must apply an axial driving force and / or a torsional force from the proximal end of the catheter. The catheter must be sufficiently rigid to be pushed through a blood vessel for transmitting these forces from the proximal end to the distal end, but must also be sufficiently flexible to pass through a tortuous and winding blood vessel, and must also have sufficient torsional stiffness to transmit the applied torque. Thus, the designer needs to strike a balance between axial stiffness, torsional stiffness, and flexibility.

[0097] In some embodiments, as shown in FIG. 1, the trans-catheter delivery system 100b of the medical device 300 enters the interior of the human body via a trans-catheter path, such as via a femoral vein, to deliver the medical device 300 into the heart in the body for treating a heart disease. Figure 14

[0098] Specifically, the trans-catheter delivery system 100b includes a first delivery device 20, a second delivery device 30, and a third delivery device 40. The first delivery device 20 includes a first handle 21 and a first catheter 22 extending distally from the first handle 21, the first catheter 22 including a bendable and / or pre-shaped distal section 221. The second delivery device 30 includes a second handle 31 and a second catheter 32 extending distally from the second handle 31, the second catheter 32 coaxially extending through the first delivery device 20. The third delivery device 40 includes a third handle 41 and a third catheter 42 extending distally from the third handle 41, the third catheter 42 including a bendable section 421 at the distal end (see FIG. 2), the first catheter 22 coaxially extending through the third delivery device 40. Figure 8

[0099] Further, the second catheter 32 is provided with different sections in axial length to balance the requirements for axial stiffness, torsional stiffness, and flexibility. Specifically, as shown in FIG. 3, the second catheter 32 includes a proximal section 322, a middle section 323, and a distal section 324. The proximal section 322 is made of a material having a high axial stiffness and a high torsional stiffness, such as a metal material. The middle section 323 is made of a material having a low axial stiffness and a low torsional stiffness, such as a polymer material. The distal section 324 is made of a material having a high axial stiffness and a low torsional stiffness, such as a metal material. Figure 15 ​​As shown, the second catheter 32 comprises a proximal section 323 extending along the axial length thereof, in order to ensure that the proximal section 323 can meet the requirements of twistability and support stability at the same time, the proximal section 323 comprises a laser-cut tube 36. Wherein, the second delivery device 30 can deliver the medical device 300 to the target area of the heart in the body through the blood vessels under the bending cooperation of the distal section 221 and the bendable section 421, while the proximal section 323 will always be positioned outside the body. That is, the laser-cut tube 36 of the proximal section 323 will not enter the blood vessels, neither affecting the compliance requirements of the blood vessels nor posing the risk of puncturing the blood vessels, ensuring the safety of the operation.

[0100] It should be particularly pointed out that the specific structure of the bendable or pre-shaped distal section 221 can refer to the drawings and the corresponding descriptions thereof, which will not be repeated here. Figures 9-13 As shown and the corresponding description thereof, which will not be repeated here. The second catheter 32 can be a non-variable diameter catheter with a constant outer diameter as shown in Figure 15 , or a variable diameter catheter with a variable outer diameter as shown in Figures 1-2 .

[0101] It can be understood that, in order to balance the requirements of axial stiffness, torsional stiffness and flexibility of the catheter delivery system 100b, the second catheter 32 is designed as a segmented structure. Specifically, please continue to refer to Figure 15 , the second catheter 32 further comprises a middle section 324 and a distal section 325 extending along the axial length thereof, and the middle section 324 connects the distal section 325 and the proximal section 323. Wherein, the distal section 325 can be a distal section with a constant outer diameter as shown in Figure 15 , or a distal section with a variable outer diameter as shown in Figure 2 . In Figure 2 , the axial length of the distal section 325 is greater than the axial length of the second section 322, that is, the distal section 325 comprises the second section 322 and part of the first section 321. Preferably, the length of the proximal section 323 ranges from 400mm to 600mm, the length of the middle section 324 ranges from 640mm to 790mm, and the length of the distal section 325 ranges from 110mm to 160mm.

[0102] Please refer to Figure 15 and Figure 16 , in order to ensure the uniformity of the support of the proximal section 323 in the axial length, so as to avoid the risk of fracture, in some embodiments, the laser-cut tube 36 has a constant stiffness along the axial length of the laser-cut tube 36, and the axial length thereof ranges from 400mm to 600mm (see Figure 14), and the thickness thereof ranges from 0.1 mm to 0.3 mm. Specifically, the laser-cut tube 36 has a plurality of cutting lines 360, which are uniformly spaced around the circumference of the laser-cut tube 36. In this regard, the laser-cut tube 36 has a plurality of groups of cutting lines 360 uniformly arranged in the axial direction, and each adjacent two groups of cutting lines 360 are radially / circumferentially offset.

[0103] In some embodiments, in order to ensure that the laser-cut tube 36 is uniformly symmetrical in the axial and radial directions, the cutting lines 360 are one of a symmetrical waist-shaped line 360a, an olive-shaped line 360b, an elliptical line (not shown), and a square line (not shown). Specifically, as shown in FIG. 4, the aspect ratio of each cutting line 360 (including the waist-shaped line 360a and the olive-shaped line 360b) is 20, and the axial spacing Z1 between adjacent two cutting lines 360 is greater than the radial / circumferential spacing Z2. For example, Z1 can be 3.5 mm, and Z2 can range from 0.9 mm to 1.0 mm. Figure 16

[0104] In addition, the distal end of the laser-cut tube 36 is formed with a fusion end 361 (including fusion ends 361a and 361b) having an opening for connecting with the components in the middle section 324, such as being fused with the woven mesh in the middle section 324. In this regard, the axial length Z3 of the fusion end 361 is 13 mm, and the axial spacing Z4 of the fusion end 361 from the cutting line 360 at the distal end is 6 mm.

[0105] It can be understood that, in order to further balance the requirements of the catheter delivery system 100b for axial stiffness, torsional stiffness, and flexibility, in some embodiments, the second catheter 32 is designed as a layered structure. Specifically, referring to FIGS. 3 and 4, the second catheter 32 has a tube wall that radially includes, from the inside out, a first polymeric layer 32a, a first reinforcing layer 32c, and a second polymeric layer 32b. The first polymeric layer 32a and the second polymeric layer 32b can be combined with each other to encapsulate the first reinforcing layer 32c between the first polymeric layer 32a and the second polymeric layer 32b. In this regard, the first reinforcing layer 32c includes the laser-cut tube 36 and the woven mesh 37 connected to the distal end of the laser-cut tube 36. Preferably, the laser-cut tube 36 is located in the proximal section 323, and the woven mesh 37 is located in the middle section 324 and the distal section 325. Figure 15 Figures 17-19

[0106] ​​​In some embodiments, the second catheter 32 is provided with different stiffness in the proximal section 323, the intermediate section 324, and the distal section 325, respectively. In particular, the proximal section 323 has a higher stiffness than the intermediate section 324, and the intermediate section 324 has a higher stiffness than the distal section 325. Of course, in other embodiments, the second catheter 32 can also be provided with a layered structure with two or more sections having different stiffness.

[0107] It can be appreciated that the intermediate section 324 with the medium stiffness can reduce the loss in the transmission of the torque from the proximal section 323 to the distal section 325. At the same time, the intermediate section 324 can smoothly pass through the femoral vein due to the lower stiffness than the proximal section 323, satisfying the blood vessel compliance requirement. The distal section 325 has the lowest stiffness among the three sections, aiming to reduce the deformation of the distal end of the second catheter 32 extending out of the first catheter 22.

[0108] In order to ensure that the second catheter 32 has different stiffness in the three sections, specifically the proximal section 323, the intermediate section 324, and the distal section 325, in some embodiments, the first polymeric layer 32a comprises PTFE, nylon, or a combination thereof, and preferably the three sections are made of the same low-friction high-molecular material with the same stiffness, such as a PTFE lining with a thickness ranging from 0.05 mm to 0.10 mm. Meanwhile, the laser-cut tube 36 of the first reinforcing layer 32c is located in the proximal section 323, and the woven mesh 37 of the first reinforcing layer 32c is a double-layer woven mesh in the intermediate section 324, such as a woven mesh tube woven by stainless steel wires. The first layer of the woven mesh tube uses stainless steel wires with a circular cross-section, a diameter ranging from 0.05 mm to 0.10 mm, a number of 16 strands, and a PPI of 15 to 21. The second layer of the woven mesh tube uses stainless steel wires with a rectangular cross-section, a thickness ranging from 0.05 mm to 0.08 mm, a width of 0.14 mm to 0.24 mm, a number of 16 strands or 32 strands, and a PPI of 35 to 62. In other embodiments, the woven mesh 37 is made of a material with higher stiffness, such as tungsten wires. The woven mesh 37 of the first reinforcing layer 32c is a single-layer woven mesh in the distal section 325, which is formed by extending the first layer of the woven mesh tube in the intermediate section 324 along the axial direction. In addition, the second polymeric layer 32b comprises Pebax, nylon, or a combination thereof, but the stiffness of the three sections is different. Preferably, the material of the second polymeric layer 32b in the intermediate section 324 and the proximal section 323 has a higher stiffness than the material in the distal section 325. For example, the second polymeric layer 32b in the intermediate section 324 and the proximal section 323 is preferably made of nylon 12 with a higher stiffness, with a stiffness of 72D to 85D. The second polymeric layer 32b in the distal section 325 is made of Pebax with a lower stiffness, and the stiffness gradually decreases from the proximal end of the distal section 325 to the distal end of the distal section 325. Preferably, the proximal end of the distal section 325 has a stiffness ranging from 40D to 55D, and a proximal end length ranging from 20 mm to 40 mm; the distal end of the distal section 325 has a stiffness ranging from 25D to 35D, and a distal end length ranging from 90 mm to 120 mm.

[0109] Finally, after the materials of the proximal section 323, the intermediate section 324, and the distal section 325 of the second catheter 32 are butted against each other, the second polymeric layer 32b is heat-fused. The fluid of the second polymeric layer 32b can flow into the first reinforcing layer 32c and the first polymeric layer 32a, thereby encapsulating the first reinforcing layer 32c between the first polymeric layer 32a and the second polymeric layer 32b.

[0110] Further, as shown in FIG. 3, the second catheter 32 comprises a first reinforcing layer 32c and a second polymeric layer 32b. The first reinforcing layer 32c is located in the center of the second catheter 32, and the second polymeric layer 32b is located on the outer side of the first reinforcing layer 32c. The first reinforcing layer 32c is made of a material with a higher stiffness than the second polymeric layer 32b, and the second polymeric layer 32b is made of a material with a lower stiffness than the first reinforcing layer 32c. In some embodiments, the first reinforcing layer 32c is a laser-cut tube 36 or a woven mesh 37, and the second polymeric layer 32b is a Pebax tube or a nylon tube. In other embodiments, the first reinforcing layer 32c is a woven mesh 37, and the second polymeric layer 32b is a Pebax tube or a nylon tube. Figure 20As shown, the second delivery device 30 also includes an axially incompressible coil 33, which extends coaxially through the second conduit 32. Preferably, the coil 33 is a flat wire spring tube. In this embodiment, the second conduit 32 has a central cavity and a plurality of circumferential cavities evenly arranged around the central cavity. The coil 33 extends coaxially through the central cavity of the second conduit 32, and other components of the conduit delivery system 100b extend axially through the plurality of circumferential cavities. For some applications, in order to ensure... Figure 5 The release rod 34 can pass smoothly through and move within the second conduit 32, and the coil 33 forms an axially extending through cavity 330 for the release rod 34 to pass through.

[0111] Of course, in order to ensure the support of the proximal end of the first catheter 22, such as Figure 21 As shown, the first catheter 22 also includes a proximal segment 222 connected to the proximal end of the distal segment 221, the proximal segment 222 comprising a material more rigid than the distal segment 221. After the medical device 300 is delivered transvascularly to the target region of the heart via the catheter delivery system 100b, a portion of the proximal segment 222 is positioned outside the body, and another portion is positioned inside the body (see...). Figure 14 The harder material does not include the laser cutting tube to avoid the proximal segment 222 located in the body puncturing blood vessels or other contact tissues.

[0112] Similarly, to ensure that the distal segment 221 of the first catheter 22 can be positioned within the target area of ​​the heart according to the preset route, and to avoid damage to the heart tissue caused by the first catheter 22 touching the heart tissue when it extends from the third catheter 42, please refer again to... Figures 9-13 The first catheter 22 also includes a traction lumen 220 that extends at least partially through the proximal section 222 and the distal section 221. The distal end of at least one traction element 223 is attached to the distal section 221, and the proximal end of the traction element 223 extends through the traction lumen 220 and is attached to the first handle 21. Simultaneously, the distal section 221 of the first catheter 22 is pre-shaped with a curved curve, allowing it to move within a bending angle range of 20 to 120 degrees under the combined action of the curved curve and the traction element 223. The traction element 223 includes a traction wire 223a and a distal loop 223b; the specific structure and corresponding connection relationships can be found in the appendix. Figures 9-13 The relevant discussion will not be elaborated upon here.

[0113] In some embodiments, the first conduit 22 is designed as a multi-layered structure. The wall of the first conduit 22, radially from the inside out, includes a third polymer layer 22a, a second reinforcing layer 22c, and a fourth polymer layer 22b. The third polymer layer 22a and the fourth polymer layer 22b can be bonded together to encapsulate the second reinforcing layer 22c between the third polymer layer 22a and the fourth polymer layer 22c, and the traction lumen 220 is located between the third polymer layer 22a and the second reinforcing layer 22c.

[0114] Specifically, the third polymer layer 22a comprises PTFE, nylon, or a combination thereof, preferably PTFE. The second reinforcing layer 22c is a braided mesh of a non-laser-cut tube, such as a single-layer braided mesh, a double-layer braided mesh, or a combination of both. The fourth polymer layer 22b comprises Pebax, nylon, or a combination thereof, preferably Pebax.

[0115] In some embodiments, a distal coupler 23 is fixedly provided at the distal end of the distal segment 221 of the first conduit 22, and a protective coupler 35 is fixedly provided at the distal end of the distal segment 325 of the second conduit 32. Specifically, the distal coupler 23 has an axially penetrating engagement cavity 230, and the outer surface of the protective coupler 35 has a circumferential engagement surface 350, which can circumferentially engage with the engagement cavity 230. For the specific structure, mating relationship, and corresponding technical effects of the distal coupler 23 and the protective coupler 35, please refer to the following appendix. Figures 23-26 The discussion on this topic will not be elaborated upon here.

[0116] Of course, in other embodiments, the third catheter 42 can also be designed as a multi-segment layered structure. For details, please refer to the detailed discussion of the first catheter 22 or the second catheter 32, which will not be repeated here.

[0117] In some embodiments, to avoid such Figure 23 In the application scenario shown, the axial distance between the medical device 300 and the distal end of the first catheter 22 is too large, which makes it very easy for the distal end of the medical device 300 to accidentally touch the inner side of the atrial wall 52 opposite to the interatrial septum 51, thereby causing damage to the atrial tissue. The present invention also provides a delivery system 100c for the medical device 300.

[0118] Specifically, please refer to Figures 23-24The delivery system 100c includes a first delivery device 20 and a second delivery device 30. The first delivery device 20 includes a first handle 21 and a first conduit 22 extending distally from the first handle 21. A distal coupler 23 is fixedly provided at the distal end of the first conduit 22. The second delivery device 30 includes a second handle 31 and a second conduit 32 extending distally from the second handle 31. The second conduit 32 extends coaxially through the first delivery device 20. A protective coupler 35 is fixedly provided at the distal end of the second conduit 32. The medical device 300 is removably coupled to the protective coupler 35. The distal coupler 23 has an axially penetrating engagement cavity 230. The outer surface of the protective coupler 35 forms a circumferential engagement surface 350, which can circumferentially engage within the engagement cavity 230 to shorten the axial distance between the medical device 300 and the distal coupler 23.

[0119] Of course, the delivery system 100c may also include a third delivery device 40. The third delivery device 40 includes a third handle 41 and a third catheter 42 extending distally from the third handle 41, with the first catheter 22 extending coaxially through the third delivery device 40. Under the operation of the third handle 41, the distal end of the third catheter 42 can pass through the interatrial septum 51 inside the heart and be positioned in the atrium inside the heart. Under the operation of the first handle 21, guided by the third catheter 42, the first catheter 22 is advanced distally and extends beyond the distal end of the third catheter 42 for subsequent operations, such as the first catheter 22 having a flexible distal section 221 for bending operations. At this time, the second catheter 32 is accommodated within the first catheter 22, the protective coupler 35 is accommodated within the distal coupler 23, and the medical device 300 engaged with the protective coupler 35 is always positioned outside the distal coupler 23.

[0120] Given that the circumferential engagement surface 350 can circumferentially engage with the engagement cavity 230 during the process of the first catheter 22 extending out of the third catheter 42, the axial distance of the medical device 300 extending out of the third catheter 42 is shortened, thereby effectively avoiding the defect that the medical device 300 accidentally touches the inner side of the atrial wall 52 and causes damage to the atrial tissue.

[0121] To prevent the protective coupler 35 from entering the cavity of the first conduit 22 through the engagement cavity 230 of the distal coupler 23, such as Figure 24 As shown, the cross-sectional dimension of the mating cavity 230 is larger than the cross-sectional dimension of the circumferential mating surface 350, and the cross-sectional dimension of the circumferential mating surface 350 is larger than the inner diameter of the first conduit 22. In some embodiments, the cross-sections of both the mating cavity 230 and the circumferential mating surface 350 are circular; wherein the diameter of the mating cavity 230 is larger than the cross-sectional diameter of the circumferential mating surface 350, and the cross-sectional diameter of the circumferential mating surface 350 is larger than the inner diameter of the first conduit 22.

[0122] Of course, in order to better prevent the protective coupler 35 from entering the lumen of the first conduit 22 through the engagement cavity 230 of the distal coupler 23, a limiting portion 231 is arranged in the engagement cavity 230, which is capable of limiting the circumferential engagement surface 350 from entering the first conduit 22. Specifically, as shown in Figure 25 the limiting portion 231 is arranged to form a limiting cavity 232. The cross-sectional dimension of the limiting cavity 232 is smaller than that of the circumferential engagement surface 350, so that the circumferential engagement surface 350 is limited by the limiting cavity 232 from entering the first conduit 22. Naturally, the cross-sectional dimension of the limiting cavity 232 is larger than the outer diameter of the second conduit 32, so that the second conduit 32 can freely pass through the limiting cavity 232 to control the protective coupler 35 to disengage from the circumferential engagement of the distal coupler 23 and extend out of the distal coupler 23. In some embodiments, the axial distance S1 between the limiting portion 231 and the distal opening of the engagement cavity 230 is in the range of 0.15mm-2.4mm, and the protective coupler 35 can enter or disengage from the distal coupler 23 through the distal opening of the engagement cavity 230, so as to shorten the axial distance S1. Preferably, S1 is 1.5mm.

[0123] In addition, in order to ensure the stable fixation of the distal coupler 23 and the protective coupler 35, the distal coupler 23 is further provided with a connecting portion 233 fixedly connected with the first conduit 22, and the protective coupler 35 is further provided with a connecting end 351 fixedly connected with the second conduit 32 (see Figure 26 ). The connecting portion 233 and the connecting end 351 are both tubular, and the sidewall of the tubular has a plurality of openings 200 (see Figure 23 ). When the distal coupler 23 is connected in the first conduit 22 by heat melting, and the protective coupler 35 is connected in the second conduit 32 by heat melting, the fluid of heat melting can flow into the plurality of openings 200, thereby enhancing the fixed connection between the two.

[0124] In the application scenario as shown in Figure 23 , after the first conduit 22 is pushed to the distal end and extends out of the distal end of the third conduit 42, the first conduit 22 will be further subjected to a bending operation. Specifically, please continue to refer to Figure 25, the first catheter 22 comprises a bendable distal section 221, a proximal section 222, and a pull lumen 220 extending at least partially through the proximal section 222 and the distal section 221. A distal end pull ring 223b is fixedly arranged at the distal section 221, such as being heat fused to the distal end of the distal section 221. A distal end of a pull wire 223a is attached to the distal end pull ring 223b, and a proximal end of the pull wire 223a extends through the pull lumen 220 and is attached to the first handle 21. Upon manipulation of the first handle 21, the pull wire 223a can be tensioned, and in turn, the distal section 221 is bent or deformed by actuating the pull wire 223a to shape the second catheter 32 into a curved configuration having substantially the same curvature as the distal section 221 of the first catheter 22, and finally to move the medical device 300 away from the inner side of the atrial wall 52 to completely avoid the inner side of the atrial wall 52.

[0125] In some embodiments, the distal end coupler 23 is fixedly arranged at the distal end of the distal section 221, and the distal end pull ring 223b is arranged at a preset range S2 from the proximal end of the distal end coupler 23. Preferably, S2 is 0-2 mm.

[0126] It can be understood that, please refer to Figure 24 and Figure 26 , the second delivery device 30 further comprises an axially incompressible coil 33 coaxially extending through the second catheter 32. Preferably, the coil 33 is a flat wire spring tube. In some embodiments, the medical device 300 comprises a valve clip 300a, and the guard coupler 35 further comprises a protruding tubular joint 352. Wherein, the distal end of the tubular joint 352 is removably engaged with the valve clip 300a, and the proximal end of the tubular joint 352 is in abutment with the distal end of the coil 33.

[0127] Further, the coil 33 is formed with an axially extending through cavity 330, and a release lever 34 coaxially extends through the coil 33 and the lumen of the tubular joint 352, and can be switched between extending out of the distal end of the tubular joint 352 and retracting into the distal end of the tubular joint 352, thereby forcing the valve clip 300a to switch between being engaged with the guard coupler 35 and being disengaged from the guard coupler 35. In some embodiments, the cross section of the through cavity 330 and the cross section of the lumen of the tubular joint 352 are both circular; the inner diameter of the through cavity 330 is equal to the inner diameter of the lumen of the tubular joint 352, so that the release lever 34 can move smoothly within the second catheter 32.

[0128] For some applications, the distal end coupler 23 and the guard coupler 35 are both made of metal material, such as stainless steel.

[0129] It can be understood that the delivery system 100a, 100b, 100c can be applied to mitral valve repair to clamp the anterior leaflet and the posterior leaflet of the mitral valve by using the medical device 300 to avoid mitral regurgitation, and can also be applied to tricuspid valve repair, aortic repair and other heart intervention medical devices. Therefore, in order to adapt to different application scenarios, all the technical features discussed in the delivery system 100a, 100b and 100c can be used in combination, and will not be repeated here.

[0130] The following will take the delivery of the valve clip 300a to the target area of the heart mitral valve and the clamping of the anterior leaflet and the posterior leaflet of the mitral valve as an example to illustrate the multiple application scenarios of the delivery system 100a, 100b, 100c.

[0131] Specifically, as shown in Figure 27 , the third catheter 42 is used to establish a path from outside the patient's body to the left atrium 53 of the heart, and the first catheter 22 extends through the third catheter 42 and extends from the distal end of the third catheter 42.

[0132] Then, the first catheter 22 and the third catheter 42 are bent to achieve the direction of the distal end of the second catheter 32 substantially perpendicular to the mitral valve annulus plane C as shown in Figure 28 .

[0133] Then, by further bending the first catheter 22 and the third catheter 42, the distal end of the second catheter 32 connected with the valve clip 300a is bent, and the following six-dimensional motion adjustments of the second catheter 32 are realized to adapt the position and direction of the valve clip 300a to the target area, and finally to ensure the best treatment effect. The six-dimensional motion adjustments include:

[0134] First dimension: please refer to Figure 29a , keep the third catheter 42 and the second catheter 32 still, and adjust the bending angle of the first catheter 22 to realize the swing of the valve clip 300a between the 1 area and the 3 area of the annulus plane C.

[0135] Second dimension: please refer to Figure 29b , by pushing or retracting the entire delivery system, the translational motion of the valve clip 300a between the 1 area and the 3 area of the annulus plane C is realized.

[0136] Third dimension: please refer to Figure 29c , keep the third catheter 42 and the second catheter 32 still, and rotate the first catheter 22 to realize the swing of the valve clip 300a between the A area and the P area of the annulus plane C.

[0137] Fourth dimension: please refer to Figure 29d, keeping the second catheter 32 stationary, the third catheter 42 is rotated while the first catheter 22 is counter-rotated to achieve a translational movement of the valve clip 300a between the A and P regions of the annulus plane C.

[0138] Fifth dimension: see Figure 29e , keeping the third catheter 42 and the first catheter 22 stationary, the second catheter 32 is rotated to achieve a rotation of the valve clip 300a above the annulus plane C such that the two clip arms of the valve clip 300a are perpendicular to the valve opening line Y.

[0139] Sixth dimension: see Figure 29f , keeping the third catheter 42 and the first catheter 22 stationary, the second catheter 32 is pushed forward or withdrawn to achieve the valve clip 300a to enter the left ventricle 54 or to retreat back to the left atrium 53 of the heart (see Figure 27 ).

[0140] The above is the embodiment of the present application, it should be pointed out that, for those skilled in the art, without departing from the principles of the present application, can also make a number of improvements and refinements, these improvements and refinements also regarded as the protection scope of the present application. The above is the embodiment of the present application, it should be pointed out that, for those skilled in the art, without departing from the principles of the present application, can also make a number of improvements and refinements, these improvements and refinements also regarded as the protection scope of the present application.

Claims

1. A delivery system for a medical device, the delivery system comprising: The delivery system comprises: a first delivery device comprising a first handle and a first catheter extending distally from the first handle, the first catheter comprising a bendable distal section; and a second delivery device comprising a second handle and a second catheter extending distally from the second handle, the second catheter extending coaxially through the first delivery device, the second catheter having a first section and a second section with a reduced outer diameter along an axial length thereof, the second section being distal to the first section; manipulating the first handle to force the distal section of the first catheter to bend, the second section of the second catheter being capable of being molded into a bent configuration by the bendable distal section and capable of recovering at least partially from the bent configuration to an initial configuration after being extended from the bendable distal section.

2. The delivery system of claim 1, wherein, The second delivery device further comprises an axially incompressible coil extending coaxially through the second catheter, the coil being capable of enhancing recovery performance of the second section from the bent configuration to the initial configuration.

3. The delivery system of claim 1, wherein, The second catheter is capable of being extended from a distal end of the distal section and movable by a stroke distance, the axial length of the second section being equal to the stroke distance.

4. The delivery system of claim 3, wherein, A distal coupler is fixed to the distal end of the distal section, the second catheter being capable of being moved by the stroke distance after sequentially passing through the first catheter and the distal coupler.

5. The delivery system of claim 1, wherein, A distal coupler is fixed to the distal end of the distal section, the second section being fixed with a guard coupler at a distal end thereof; the distal coupler has an engagement cavity axially extending therethrough, the outer surface of the guard coupler is formed with a circumferential engagement surface capable of being circumferentially engaged in the engagement cavity.

6. The delivery system of any of claims 1-5, wherein, The axial length of the second section is greater than the axial length of the distal section.

7. The delivery system of any of claims 1-5, wherein, The outer diameter difference between the first section and the second section ranges from 0.3mm to 1.05mm.

8. The delivery system of any of claims 1-5, wherein, The first section and the second section have a smooth taper with a taper distance ranging from 10mm to 25mm.

9. The delivery system of any of claims 1-5, wherein, The second catheter comprises a lubricating coating, the lubricating coating being provided on the outer surface of the second section, and the length of the lubricating coating being equal to the axial length of the second section.

10. The delivery system of any of claims 1-5, wherein, The delivery system further comprises a third delivery device, the third delivery device comprising a third handle and a third catheter extending distally from the third handle, the third catheter comprising a bendable section at a distal end thereof, the first catheter extending coaxially through the third delivery device; wherein the second section of the second catheter and at least part of the outer surface of the first section have a continuous lubricating coating, the length of the lubricating coating being greater than or equal to the sum of the axial length of the second section, the axial length of the distal section and the axial length of the bendable section.

11. The delivery system of any of claims 1-5, wherein, The first catheter further comprises a proximal section and a pull tube lumen extending at least partially through the proximal section and the distal section; a distal end of at least one pull member is attached to the distal section, a proximal end of the pull member extends through the pull tube lumen and is attached to the first handle; manipulating the first handle to actuate the pull member to pull the distal section to enable the distal section to articulate within a range of bending angles from 0 degree to 90 degree, in turn to shape the second section of the second catheter into a curved configuration having substantially the same curvature as the distal section.

12. The delivery system of claim 11, wherein, The distal section is pre-shaped with a curved curve, the distal section is capable of articulating within a range of bending angles from 20 degree to 120 degree under the combined action of the curved curve and the pull member, in turn to shape the second section of the second catheter into a curved configuration having substantially the same curvature as the distal section.

13. The delivery system of any of claims 1-5, wherein, The medical device comprises a valve clip removably coupled to the second catheter via a release lever; an inner diameter of the first section of the second catheter is equal to an inner diameter of the second section to allow the release lever to pass through the first section and the second section.

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