An adjustable bend interventional instrument delivery system

Abstract

The application discloses a bending-adjustable interventional instrument delivery system, which has opposite distal and proximal ends, and comprises an operation handle at the proximal end, a sheath tube assembly connected with the operation handle and extending towards the distal end, and a sheath core assembly. The sheath core assembly comprises a core tube, a locking piece fixed at the distal end of the core tube for connecting the interventional instrument, and a bending-adjustable tube sleeved on the outer periphery of the core tube. The distal ends of the bending-adjustable tube and the core tube are fixedly connected with each other, the proximal ends of the two are relatively slidable and are both extended and connected to the operation handle. The sheath tube is slidably matched with the outer periphery of the sheath core assembly. The distal end of the sheath tube is a diameter-expanded loading section for accommodating the interventional instrument. The loading section adopts a multi-layer structure, and comprises, from inside to outside, an inner liner tube, a metal tube and an outer wrapping film. The proximal end of the sheath tube is extended and connected to the operation handle.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to a delivery system of an interventional device. BACKGROUND

[0002] The delivery system of the interventional device generally comprises a sheath core assembly and a sheath tube slidingly sleeved outside the sheath core assembly, both of which constitute a sheath tube assembly and have a distal end capable of entering the vasculature of a human body and a proximal end connected to an operating handle. Considering the tortuous characteristics of the vasculature of the human body and long-distance operation, the direction of the distal end needs to be adjusted and controlled so as to be moved to a target position. Thus, the sheath core assembly and the sheath tube are required to have axial support and bendable compliance, and the force application position and the force application mode during bending also affect the safety and the difficulty of operation control to some extent. SUMMARY

[0003] The present application provides a bendable delivery system of an interventional device, which is improved for the sheath tube and other related components, and is more conducive to bending and operation.

[0004] The bendable delivery system of the interventional device has opposite distal and proximal ends, and comprises an operating handle at the proximal end and a sheath tube assembly connected to the operating handle and extending toward the distal end. The sheath tube assembly comprises a sheath tube and a sheath core assembly.

[0005] The sheath core assembly comprises a core tube, a locking piece fixed to the distal end of the core tube for connecting the interventional device, and a bending tube sleeved outside the core tube. The distal ends of the bending tube and the core tube are fixedly connected to each other, and the proximal ends of the two are relatively slidable and both extend to the operating handle.

[0006] The sheath tube is slidingly fitted outside the sheath core assembly. The distal end of the sheath tube is a loading section with an expanded diameter for accommodating the interventional device. The loading section has a multi-layer structure, and comprises, from inside to outside, an inner liner tube, a metal tube and an outer wrapping film. The proximal end of the sheath tube extends to the operating handle.

[0007] The following also provides several optional modes, but not as an additional limitation to the above general scheme, but only as a further supplement or preference. Without technical or logical contradiction, each optional mode can be combined with the above general scheme alone, and can also be combined between multiple optional modes.

[0008] The present application also provides a sheath tube assembly, which comprises a sheath tube and a sheath core assembly. The sheath core assembly comprises a core tube, a locking piece fixed to the distal end of the core tube for connecting the interventional device, and a bending tube nested with the core tube. The distal ends of the bending tube and the core tube are fixedly connected to each other, and the proximal ends of the two are relatively slidable and both extend to the operating handle.

[0009] The sheath tube is slidably fitted on the outer periphery of the sheath core assembly, the distal end of the sheath tube is a loading section with an enlarged diameter for receiving the interventional instrument, the loading section has a multi-layer structure, and the loading section comprises, from inside to outside, an inner liner tube, a metal tube and an outer covering film, and the proximal end of the sheath tube is extended and connected to the operation handle.

[0010] Optionally, the core tube extends the lock piece to the distal end and is fixed with a guide head at the most distal end of the extension position, and the loading position of the interventional instrument is between the guide head and the lock piece, and the interventional instrument in the compressed state is connected to the lock piece in the loading position.

[0011] Optionally, the core tube comprises a compliant section adjacent to the lock piece and a third extension section opposite to the compliant section and extending to the proximal end, wherein the compliant section adopts a hypotube, and the length of the compliant section ranges from 120mm to 18mm, and the third extension section adopts a steel cable tube or a hypotube.

[0012] Optionally, the bending tube comprises, from the distal end to the proximal end, a pulling section and a second extension section, wherein the pulling section is an integral structure and adopts a hypotube.

[0013] Optionally, the pulling section comprises, from the distal end to the proximal end, a first pulling section, a transition section and a second pulling section, the first pulling section has higher flexibility than the second pulling section, and the length ratio of the first pulling section to the compliant section is 1:0.7-1.5.

[0014] Optionally, the compliant section is formed with an axially extending first reinforcing rib in a cutting manner.

[0015] Optionally, the cutting seam of the compliant section has a width of 0.1-1mm, and the seam spacing is 0.1-1mm.

[0016] Optionally, in the compliant section, the closer to the distal end, the smaller the limit curvature radius after bending.

[0017] Optionally, in the compliant section, the cutting seam width gradually changes, and the closer to the distal end, the larger the cutting seam width.

[0018] Optionally, in the compliant section, the seam spacing gradually changes, and the closer to the distal end, the smaller the seam spacing.

[0019] Optionally, in the compliant section, the rigidity gradually changes, and the closer to the distal end, the lower the rigidity.

[0020] Optionally, the first pulling section is formed with an axially extending second reinforcing rib in a cutting manner, and the circumferential position of the second reinforcing rib is different from that of the first reinforcing rib by 180 degrees.

[0021] Optionally, the cutting slot of the first pulling section has a width of 0.03-0.5 mm and a slot interval of 0.2-0.85 mm.

[0022] Optionally, the second pulling section is formed by cutting to have two third reinforcing ribs extending in the axial direction, the two third reinforcing ribs being diametrically opposite and each being 90 degrees apart from the circumferential position of the first reinforcing rib.

[0023] Optionally, the cutting slot of the second pulling section has a width of 0.03-0.5 mm and a slot interval of 0.2-0.85 mm.

[0024] Optionally, the transition section is an uncut structure in the whole circumferential direction.

[0025] Optionally, the bending tube is sleeved on the outer periphery of the core tube or is inside the core tube.

[0026] Optionally, the sheath tube is sequentially divided into a loading section, a bending adapting section and a first extending section in the axial direction from the distal end to the proximal end, and the sheath tube has a multi-layer structure, comprising:

[0027] an inner sheath tube, which is distributed in the bending adapting section and the first extending section in the axial direction;

[0028] an inner liner tube, which is connected to the distal end of the inner sheath tube and is distributed in the loading section in the axial direction;

[0029] a metal tube, which is wrapped around the outer periphery of the distal end portion of the inner sheath tube and the inner liner tube and is distributed in the bending adapting section and the loading section in the axial direction;

[0030] an outer wrapping film, which is wrapped around the outer periphery of the metal tube and is distributed in the bending adapting section and the loading section in the axial direction.

[0031] Optionally, the metal tube comprises a head tube, a main tube and an extension tube connected in sequence from the distal end to the proximal end, wherein the head tube and the main tube are both distributed in the loading section in the axial direction, and the extension tube is distributed in the bending adapting section.

[0032] Optionally, the head tube comprises a body section, a plurality of elastic expansion pieces arranged on the distal end side of the body section and spaced apart in the circumferential direction, and a first connector on the proximal end side of the body section, the distal end side of the main tube is provided with a second connector, and the first connector and the second connector are mutually embedded and complementary in shape.

[0033] Optionally, each expansion piece has a hollow area.

[0034] Optionally, each expansion piece is uniformly arranged in the circumferential direction, and the number is 3-6.

[0035] Optionally, the first connector is T-shaped.

[0036] Optionally, the body section forms a developing area in a hollowed-out manner for installing a developing point.

[0037] Optionally, the body section and the first connecting head are both provided with through holes, and the inner liner and the outer envelope are heat-fused with each other at the through hole positions.

[0038] Optionally, the hollowed-out area is a plurality of through holes arranged at intervals along the sheath tube axis, and the total area of the through holes on each expansion piece is less than 50% of the area of the expansion piece.

[0039] Optionally, the closer the through hole is to the distal end, the larger the area of the through hole on the same expansion piece.

[0040] Optionally, the through holes are circular or elliptical, and the number of through holes on the same expansion piece is 2-5.

[0041] Optionally, the hollowed-out area is a strip-shaped hole, and the strip-shaped hole extends axially along the head-end tube.

[0042] Optionally, the strip-shaped hole is two on the same expansion piece.

[0043] Optionally, the strip-shaped hole extends with equal width.

[0044] Optionally, the two ends of the strip-shaped hole in the length direction are arc-shaped inner edges.

[0045] Optionally, the space between the two adjacent expansion pieces is an interval opening, each expansion piece has a narrowed part at the proximal end, and the interval opening has a widened part at the proximal end corresponding to the narrowed part.

[0046] Optionally, the inner edge of the widened part is a smooth curve.

[0047] Optionally, the middle region of the interval opening in the length direction extends with equal width.

[0048] Optionally, the width of the equal-width extension of the interval opening is substantially the same as the width of the strip-shaped hole.

[0049] Optionally, the proximal end side of the strip-shaped hole crosses the narrowed part of the expansion piece.

[0050] Optionally, the proximal end side of the strip-shaped hole crosses the narrowed part of the expansion piece by 1-5 mm.

[0051] Optionally, the distal end of the expansion piece has a smooth outer edge.

[0052] Optionally, the head-end tube is cut from a nickel-titanium alloy tube, and the main tube and the extension tube are cut from a stainless steel tube.

[0053] Optionally, the head-end tube is made of nickel-titanium alloy material, and each expansion piece has a sheathing state of extending along the sheath tube in the axial direction and an eversion state of moving away from each other.

[0054] Optionally, the extension tube is made of hypotube.

[0055] Optionally, the inner sheath tube has a multi-layer structure, and a fourth reinforcing rib extending in the axial direction is arranged in the interlayer. The fourth reinforcing rib is two, one of which is at the same circumferential position as the first reinforcing rib, and the other is 180 degrees away from the circumferential position of the first reinforcing rib.

[0056] Optionally, the distal end of the fourth reinforcing rib extends to the proximal end of the extension tube or the distal end of the extension tube.

[0057] Optionally, a fifth reinforcing rib extending in the axial direction is arranged in the extension tube. The fifth reinforcing rib is one, and is at the same circumferential position as the first reinforcing rib; or the fifth reinforcing rib is two, one of which is at the same circumferential position as the first reinforcing rib, and the other is 180 degrees away from the circumferential position of the first reinforcing rib.

[0058] Optionally, the head-end tube and the main tube are connected to each other by a shape-complementary connector, and the main tube and the extension tube are connected to each other by a hook.

[0059] Optionally, the wall of the main tube is distributed with two hollowed-out areas, and between the two hollowed-out areas, two guide ribs extending in the axial direction and arranged in opposite directions in the radial direction are arranged.

[0060] Optionally, along the axial direction of the sheath tube, the outer covering includes multiple segments, each segment is made of different material, or at least two segments are made of the same material.

[0061] Optionally, the strength of the outer covering corresponding to the main tube is greater than the strength of the outer covering corresponding to the distal end of the head-end tube.

[0062] Optionally, the main tube and the head-end tube are cut from metal tubes made of different materials.

[0063] Optionally, the operating handle includes a control assembly, a bending assembly, and a front-end handle; the control assembly includes:

[0064] a first support body fixed relative to the front-end handle;

[0065] a first connecting piece slidingly installed on the first support body, and the proximal end of the sheath tube is fixed to the first connecting piece;

[0066] a first driving piece movably installed on the first support body and driving the first connecting piece to slide;

[0067] The bending assembly comprises:

[0068] a second support body fixed opposite to the first support body;

[0069] a second connecting member slidingly mounted on the second support body, and the proximal end of the bending tube is fixed on the second connecting member after passing through the sheath tube;

[0070] a second driving member movably mounted on the second support body and driving the second connecting member to slide;

[0071] a tube joint fixedly mounted on the proximal end of the second support body, and the proximal end of the core tube is fixed on the tube joint after passing through the bending tube.

[0072] Optionally, the front end handle is connected with a catheter sleeved outside the sheath tube.

[0073] Optionally, the first driving member is rotatably sleeved on the outer periphery of the first support body, and a limiting mechanism limiting the rotation angle of the first driving member is arranged between the front end handle and the first driving member.

[0074] Optionally, the limiting mechanism comprises:

[0075] a sliding key mounted on one of the front end handle and the first driving member;

[0076] a locking hole arranged on the other one of the front end handle and the first driving member.

[0077] Optionally, a sliding groove is arranged on the outer wall of the front end handle, the sliding key is mounted in the sliding groove, and the locking hole is arranged on the end face of the first driving member in the axial direction.

[0078] Optionally, the limiting mechanism comprises a locking pin threadedly mounted on the first driving member and abutting against the first support body.

[0079] Optionally, the first support body is in a cylindrical shape, a guide slot hole extending in the axial direction is arranged on the side wall of the first support body, the first connecting member is slidingly mounted in the interior of the first support body, the first connecting member is provided with a guide key extending in the radial direction and out of the guide slot hole, and the inner wall of the first driving member is provided with a threaded structure matched with the guide key.

[0080] Optionally, the second support body is in a cylindrical shape and arranged coaxially with the first support body, and the second support body and the first support body are fixed in an integral structure or in a separate structure.

[0081] Optionally, the second driving member is rotatably mounted relative to the second support body, the second support body is provided with an operation opening, a portion of the second driving member is arranged inside the second support body, and at least a part of the second driving member is exposed to the operation opening as a force applying part, and the second connecting member is arranged inside the second support body and is linked with the second driving member.

[0082] Optionally, the second driving member is provided with an internal thread, at least a part of the second connecting member is provided with an external thread and extends into the second driving member, and the second driving member drives the second connecting member to slide in a threaded manner.

[0083] Optionally, an inner wall of the second support body is provided with an axially extending guide strip, and at least a part of the second connecting member is arranged inside the second support body, and an outer wall of the part is provided with a guide groove matched with the guide strip.

[0084] The application further provides a processing method of the sheath, comprising:

[0085] S100, providing an inner sheath and processing a flared portion at a distal end of the inner sheath;

[0086] S200, sleeving and fixing an inner liner tube at an outer periphery of the flared portion;

[0087] S300, sleeving a metal tube at an outer periphery of the distal end of the inner sheath and an outer periphery of the inner liner tube;

[0088] S400, segmentally coating the metal tube with an outer coating material, and integrally forming an outer coating film after heat melting of each segment of the outer coating material.

[0089] The sheath can be the sheath of the application, i.e., the application further provides a processing method of the sheath, comprising:

[0090] S100, processing a flared portion at a distal end of the inner sheath;

[0091] S200, sleeving and fixing the inner liner tube at an outer periphery of the flared portion;

[0092] S300, sleeving the metal tube at an outer periphery of the inner sheath and the inner liner tube;

[0093] S400, segmentally coating the metal tube with an outer coating material, and integrally forming the outer coating film after heat melting of each segment of the outer coating material.

[0094] Optionally, in S200, a plurality of ear pieces are arranged at the proximal end of the inner liner tube in a circumferential direction, the plurality of ear pieces are wrapped at the outer periphery of the flared portion, and the plurality of ear pieces are heat fused and fixed after being wrapped with a fixing sleeve.

[0095] Optionally, the ear pieces are arranged circumferentially uniformly in 3-6.

[0096] Optionally, the inner liner tube is made of PTFE.

[0097] Optionally, the fixing sleeve is made of Pebax.

[0098] Optionally, the step S400 specifically comprises:

[0099] Step S410, wrapping a first connecting sleeve at the abutting part of the main tube and the head-end tube, wrapping a head-end outer sleeve at the head-end tube, and hot-melting fixing the first connecting sleeve and the head-end outer sleeve;

[0100] Step S420, wrapping a main tube outer sleeve at the outer periphery of the main tube and hot-melting fixing;

[0101] Step S430, wrapping a second connecting sleeve at the inner sheath tube of the extension tube proximal end and the adjacent part, and hot-melting fixing the second connecting sleeve;

[0102] Step S440, wrapping a connecting sleeve tube at the outer periphery of the extension tube and hot-melting fixing.

[0103] Optionally, the main tube has hollowed-out areas with interval parts, and guide ribs are formed between adjacent hollowed-out areas, and before wrapping the main tube outer sleeve at the outer periphery of the main tube in step S420, the method further comprises placing a gasket in each hollowed-out area and hot-melting fixing.

[0104] Optionally, the gasket is made of Pebax.

[0105] Optionally, the head-end outer sleeve and the connecting sleeve tube are made of TPU.

[0106] Optionally, the first connecting sleeve, the second connecting sleeve, and the main tube outer sleeve are all made of Pebax.

[0107] The application also provides a delivery method of an interventional instrument, comprising: after loading the interventional instrument into a delivery system, delivering to the distal end;

[0108] The delivery system comprises an operation handle at the proximal end and a sheath tube assembly connected with the operation handle and extending to the distal end, the sheath tube assembly comprises a sheath tube and a sheath core assembly, the interventional instrument is connected with the sheath core assembly and wrapped by the sheath tube, the sheath core assembly comprises a core tube, a locking piece fixed at the distal end of the core tube for connecting the interventional instrument, and a bending adjusting tube, the distal ends of the bending adjusting tube and the core tube are fixedly connected with each other, the proximal ends of the two are relatively slidable and both extend to the operation handle;

[0109] During the delivery process, the proximal end of the bending adjusting tube is pulled to make the proximal ends of the bending adjusting tube and the core tube relatively slide, and the distal end of the core tube is driven to change the pointing direction to adapt to the interventional path.

[0110] The conveying system of the present application is more convenient for bending operations and meets the performance requirements of various components. BRIEF DESCRIPTION OF THE DRAWINGS

[0111] Figure 1 This is a schematic diagram of the structure of the conveying system of this application;

[0112] Figure 2 for Figure 1 Exploded view of the conveying system;

[0113] Figure 3a for Figure 1 Schematic diagram of the internal structure of the middle operating handle;

[0114] Figure 3b for Figure 1 Another perspective of the internal structure of the middle operating handle;

[0115] Figure 3c for Figure 3b A local enlarged schematic diagram in FIG.

[0116] Figure 4 for Figure 1 Exploded view of the operating handle;

[0117] Figure 5a This is a schematic structural diagram of a core tube assembly in an embodiment of the present application in which the locking element adopts a wire control method;

[0118] Figure 5b for Figure 5a Schematic diagram of the cooperation between the central locking piece and the access device;

[0119] Figure 5c This is a structural diagram of a core tube assembly in one embodiment of the present application;

[0120] Figure 6 This is a schematic structural diagram of an adjustable elbow in one embodiment of the present application;

[0121] Figure 7 This is a structural diagram of a core tube (compliant section) in one embodiment of the present application;

[0122] Figure 8 for Figure 7 Schematic diagram of the structure of the core tube (compliant section) from another angle;

[0123] Figure 9 This is a schematic structural diagram of an adjustable elbow in one embodiment of the present application;

[0124] Figure 10 for Figure 9 Schematic diagram of the structure of the center adjustment elbow at another angle;

[0125] Figure 11 forFigure 9 Expanded view of the center adjustment elbow;

[0126] Figure 12 This is a schematic structural diagram of a sheath tube in one embodiment of the present application;

[0127] Figure 13 for Figure 5c 、 Figure 6 、 Figure 12 Schematic diagram of the structure after the components are assembled;

[0128] Figure 14 This is a cross-sectional view of a sheath assembly in one embodiment of the present application;

[0129] Figure 15a for Figure 14 Schematic diagram of the structure after the interventional device is loaded;

[0130] Figure 15b for Figure 15a Schematic diagram of the structure of the interventional device when it is half released;

[0131] Figure 15c for Figure 15a Schematic diagram of the structure of the interventional device after it is fully released;

[0132] Figure 15d This is a schematic diagram of the relative relationship between the axial sections of each pipe fitting in one embodiment of the present application;

[0133] Figure 16 This is a cross-sectional view of a sheath tube and an inner core assembly in one embodiment of the present application;

[0134] Figure 17a for Figure 16 Schematic diagram of the structure after the interventional device is loaded;

[0135] Figure 17b for Figure 17a Schematic diagram of the structure of the interventional device when it is half released;

[0136] Figure 17c for Figure 17a Schematic diagram of the structure of the interventional device after it is fully released;

[0137] Figure 17d This is a schematic diagram of the relative relationship between the axial sections of each pipe fitting in one embodiment of the present application;

[0138] Figure 18 It is an indicator diagram of each component in the sheath;

[0139] Figure 19a Schematic diagram of the structure of the head end tube;

[0140] Figure 19b Schematic diagram of the expanded structure of the head end tube in another embodiment;

[0141] Figure 20 Schematic view of the distal part of the delivery system of the present application;

[0142] Figure 21 Schematic view of the distal part of the delivery system of the present application; Figure 20

[0143] Schematic view of the distal part of the delivery system of the present application; Figure 22 Figure 21 Schematic view of the distal part of the delivery system of the present application;

[0144] Figure 23 Figure 20 Schematic view of the distal part of the delivery system of the present application;

[0145] Figure 24 Schematic view of the distal part of the delivery system of the present application; Figure 20

[0146] Schematic view of the distal part of the delivery system of the present application; Figures 25 to 34

[0147] Schematic view of the distal part of the delivery system of the present application; Figure 35

[0148] Schematic view of the distal part of the delivery system of the present application; Figures 36 to 40 Schematic view of the distal part of the delivery system of the present application.

[0149]

[0150] 100, operating handle;

[0151] 110, bending assembly; 111, second support body; 112, second driving member; 113, second connecting member; 114, guide bar; 115, guide slot; 116, operating port; 117, force applying part; 118, luer joint;

[0152] 120, control assembly; 121, first support body; 122, first driving member; 123, first connecting member; 124, guide key; 125, guide bar hole; 126, lock hole;

[0153] 130, front end handle; 131, sliding key; 132, sliding slot;

[0154] 200, catheter;

[0155] 300, sheath; 310, loading section; 320, bending adapting section; 330, first extending section;

[0156] ​​​340, head end tube; 341, spacer opening; 342, developing area; 343, first connector; 344, expansion piece; 345, hollow area; 346, main body section; 347, through hole; 348, narrowing portion; 349, proximal side of the strip hole;

[0157] 350, main tube; 351, second connector; 352, closing portion; 353, hollow area; 354, hollow area; 355, guide rib;

[0158] 360, extension tube; 3601, reinforcement rib (fifth reinforcement rib); 3602, reinforcement rib (fifth reinforcement rib);

[0159] 370, inner sheath; 370A, distal portion; 370B, proximal portion; 3701, PTFE inner layer; 3702, braided layer; 3703, reinforcing rib (fourth reinforcing rib); 3704, braided layer; 3705, outer layer; 371, distal end; 372, mandrel; 373, truncated cone section; 374, flared portion; 375, inner liner; 376, cutting area; 377, fixing sleeve;

[0160] 380, outer membrane; 381, first connecting sleeve; 382, ​​head end jacket; 383, first lining; 384, second lining; 385, main body jacket; 386, second connecting sleeve; 387, connecting sleeve;

[0161] 400, sheath core assembly;

[0162] 410, bending adjustment tube; 411, first pulling section; 4111, reinforcing rib (second reinforcing rib); 412, second pulling section; 4121, reinforcing rib (third reinforcing rib); 4122, reinforcing rib (third reinforcing rib); 413, second extension section; 414, transition section;

[0163] 420, core tube assembly; 421, guide head; 422, lock piece; 4221, lock hole; 4222, distribution plate; 4223, pull wire; 4224, lock rod; 4225, threading sleeve; 423, pressure strip; 424, inner core; 425, core tube; 4251, compliance section; 4252, third extension section; 4253, reinforcement rib (first reinforcement rib);

[0164] 500. Interventional device; 501. Connecting ear;

[0165] 600. Aortic valve. DETAILED DESCRIPTION

[0166] With reference to the drawings, the technical solutions in the embodiments of the present application will be clearly and completely described, obviously, the described embodiments are only some 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 work are within the scope of protection of the present application.

[0167] It should be noted that when a component is referred to as being "connected with" another component, it can be directly connected with the other component or there can be a middle component. When a component is referred to as "arranged on" another component, it can be directly arranged on the other component or there can be a middle component.

[0168] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0169] Referring to Figures 1 to 4 In an embodiment of the present application, a delivery system is provided, having opposite distal and proximal ends, the delivery system comprising a handle 100 at the proximal end and a sheath tube 300 and a sheath core assembly 400 connected with the handle 100 and extending distally, the sheath tube 300 being slidably fitted on the outer periphery of the sheath core assembly 400.

[0170] The sheath core assembly comprises a core tube, a locking piece fixed at the distal end of the core tube for connecting with the interventional instrument, the locking piece can have various forms of structures, for example, a groove form for connecting with a connecting lug on the stent, or a protruding lug form protruding radially outward, or a wire control form for connecting with the stent by a long wire or a wire ring, no matter which form is used, the purpose is to realize the connection with the connecting lug of the stent.

[0171] In some embodiments, the sheath core assembly further comprises a bending tube sleeved on the outer periphery of the core tube, the distal ends of the bending tube and the core tube are fixedly connected with each other, and the proximal ends of the two are both connected to the handle and can slide relative to each other.

[0172] In some embodiments, the sheath core assembly further comprises a bending tube inside the core tube, the distal ends of the bending tube and the core tube are fixedly connected with each other, and the proximal ends of the two can slide relative to each other.

[0173] Regardless of the inner-outer relationship between the core tube and the bending tube, relative movement is needed at the proximal end. Generally, when bending, the proximal end of the core tube is kept unchanged, or is taken as a reference, and the proximal end of the bending tube is pulled. Different inner-outer relationships between the core tube and the bending tube can result in different abutting positions at the turning part. The following embodiments and drawings mainly take the bending tube as an example. Regarding the structure of the operating handle, the proximal ends of the core tube and the bending tube can be adjusted to enable relative movement.

[0174] In other embodiments, the delivery system can further include a catheter 200 fixed relative to the operating handle 100, which is used to establish a channel to prevent the sheath tube 300 from injuring the body tissue during reciprocating movement. The interventional instrument is loaded on the sheath core assembly 400 and enters the body together with the catheter 200 under the wrapping of the sheath tube 300, and then the sheath tube 300 can move axially relative to the other two to release the interventional instrument and, if necessary, to perform a recovery operation.

[0175] The bending is mainly achieved by the operating handle 100. Referring to an embodiment shown in Figure 3a and Figure 4 The operating handle 100 is used to connect the proximal ends of three tubes nested in sequence from inside to outside, and drive the proximal ends of the three tubes to move relative to each other. The three tubes are the core tube, the bending tube, and the sheath tube from inside to outside. The operating handle 100 includes a control assembly 120, a bending assembly 110, and a front handle 130.

[0176] The control assembly 120 includes:

[0177] a first support body 121 fixed relative to the front handle 130;

[0178] a first connecting piece 123 slidingly installed on the first support body 121, and the proximal end of the sheath tube is fixed to the first connecting piece 123;

[0179] a first driving piece 122 movably installed on the first support body 121 and driving the first connecting piece 123 to slide;

[0180] The bending assembly 110 includes:

[0181] a second support body 111 fixed relative to the first support body 121;

[0182] a second connecting piece 113 slidingly installed on the second support body 111, and the proximal end of the bending tube is fixed to the second connecting piece 113 after passing through the sheath tube;

[0183] a second driving piece 112 movably installed on the second support body 111 and driving the second connecting piece 113 to slide;

[0184] A pipe joint is fixedly installed at the proximal end of the second support body 111, and the proximal end of the core pipe is fixedly installed at the pipe joint after passing through the bending pipe.

[0185] Specifically, the control assembly 120 includes a first support body 121, a first driving member 122 is rotatably sleeved on the outer periphery of the first support body 121, a guide slot 125 extending in the axial direction is formed in the side wall of the first support body 121, a first connecting member 123 is slidingly installed in the interior of the first support body 121, the first connecting member 123 is provided with a guide key 124 extending out of the guide slot 125, and the inner wall of the first driving member 122 is provided with a threaded structure matched with the guide key 124.

[0186] In the first support body 121, in an embodiment, the first support body 121 is cylindrical, the guide slot 125 extending in the axial direction is formed in the side wall of the first support body 121, the first connecting member 123 is slidingly installed in the interior of the first support body 121, the first connecting member 123 is provided with the guide key 124 extending out of the guide slot 125 in the radial direction, and the inner wall of the first driving member 122 is provided with the threaded structure matched with the guide key 124.

[0187] Specifically, the first support body 121 is substantially cylindrical, and can adopt an integrated structure or a split structure (such as Figure 4 When the first driving member 122 rotates, the first connecting member 123 is driven to slide in the interior of the first support body 121 through the guide key 124, and the first connecting member 123 does not rotate, i.e., only moves in the axial direction, due to the limitation of the guide slot 125.

[0188] The front end handle 130 is fixedly connected relative to the first support body 121, the proximal end of the catheter 200 is fixedly inserted on the front end handle 130, and the proximal end of the sheath tube 300 is fixedly installed on the first connecting member 123, and the sheath tube 300 extends to the distal end through the catheter 200.

[0189] In the cooperation relationship between the first support body 121 and the second support body 111, in an embodiment, the second support body 111 is cylindrical and is coaxially arranged with the first support body 121, and the second support body 111 and the first support body 121 adopt an integrated structure or a split structure.

[0190] In the cooperation relationship between the second driving member 112 and the second support body 111, in an embodiment, the second driving member 112 is rotatably installed relative to the second support body 111, the second support body 111 is provided with an operation port 116, a part of the second driving member 112 is located in the interior of the second support body 111, at least a part thereof is exposed to the operation port 116 as a force applying portion 117, and the second connecting member 113 is located in the interior of the second support body 111 and is linked with the second driving member 112.

[0191] Specifically, the bending adjusting assembly 110 comprises a second support body 111 which is also substantially cylindrical and fixedly connected to the first support body 121. The second support body 111 can be a single body or a split body fixedly connected in a radial direction. Figure 4 The second support body 111 is coaxially arranged with the first support body 121 and fixedly connected to the first support body 121 in a split body connection manner.

[0192] Correspondingly, the bending adjusting assembly 110 further comprises a second driving member 112. In an embodiment, the second driving member 112 is internally threaded, and at least a portion of the second connecting member 113 is externally threaded and extends into the second driving member 112. The second driving member 112 drives the second connecting member 113 to slide in a threaded manner.

[0193] Specifically, the second driving member 112 is rotatably connected to the second support body 111. The second support body 111 is partially provided with an operation opening 116. A portion of the second driving member 112 is arranged inside the second support body 111, and at least a portion of the second driving member 112 is exposed to the operation opening 116 as a force applying portion 117. The second driving member 112 is a cylindrical structure and internally threaded. The second connecting member 113 is slidably arranged inside the second driving member 112.

[0194] In order to limit the movement of the second connecting member 113, in an embodiment, the inner wall of the second support body 111 is provided with an axially extending guide strip 114. At least a portion of the second connecting member 113 is arranged inside the second support body 111, and the outer wall of the portion is provided with a guide groove 115 matched with the guide strip 114. In this embodiment, the matched guide groove 115 and guide strip 114 allow the second connecting member 113 to slide axially relative to the second support body 111.

[0195] As can be understood from the foregoing, the bending function of the operation handle 100 is mainly realized by the rotation of the components. In order to prevent the instability of the bending state caused by the movement of the components relative to each other during the operation, a limiting mechanism can be provided. In an embodiment, the first driving member 122 is rotatably arranged on the outer periphery of the first support body 121. A limiting mechanism limiting the rotation angle of the first driving member 122 is arranged between the front end handle 130 and the first driving member 122.

[0196] Correspondingly, the embodiment exemplarily provides a setting manner of the limiting mechanism. In an embodiment, the limiting mechanism comprises:

[0197] a sliding key 131 arranged on one of the front end handle 130 and the first driving member 122;

[0198] Lock hole 126 is arranged on the other one of front handle 130 and first driving member 122.

[0199] When sliding key 131 engages with lock hole 126, the circumferential position of front handle 130 and first driving member 122 is determined, thus the axial position of first connecting member 123 relative to front handle 130 is determined, the function of operating handle 100 to adjust the bending is limited, and the stability during use is ensured. In the actual product, the specific setting can refer to an embodiment, the outer wall of front handle 130 is provided with sliding groove 132, and sliding key 131 is installed in sliding groove 132, and lock hole 126 is arranged on the axial end face of first driving member 122.

[0200] Lock hole 126 can realize the locking of first driving member 122 in multiple positions through the increase of its number. Referring to Figure 3c , multiple lock holes are arranged on the axial end face of first driving member 122, and are arranged in sequence along the peripheral surface of first driving member 122. The increase of the number of lock holes 126 can increase the locking positions of first driving member 122, but correspondingly, the increase of the number of lock holes 126 will increase the manufacturing difficulty of first driving member 122 and reduce the gap between adjacent lock holes 126, thereby reducing the strength of single lock hole 126, so the specific number can be adjusted according to the design needs, actual working conditions and actual product size.

[0201] In Figure 3b and Figure 3c embodiments, because first driving member 122 is a split structure that is buckled up and down, the lock holes 126 close to the separation place have two kinds of settings, one of which is open towards the separation place, and the other is to avoid the separation place to realize the closed setting. In the specific product, only one of the two setting modes may appear.

[0202] Correspondingly, the limiting mechanism can also be arranged between first driving member 122 and first support body 121 to realize the above-mentioned function. Referring to an embodiment, the limiting mechanism includes a locking pin (not shown in the figure) which is screwed on first driving member 122 and abuts against first support body 121. The screwing of locking pin and first driving member 122 can realize the relative position of itself and first driving member 122, thereby realizing the positioning of first support body 121. When the relative position of first driving member 122 and first support body 121 is determined, the function of the above-mentioned limiting mechanism is also realized, so the principle of locking is not repeated.

[0203] An embodiment of the present application provides a sheath core assembly for conveying an interventional instrument, which comprises a core tube, a locking piece fixed to the distal end of the core tube for connecting the interventional instrument, and a bending tube sleeved on the outer periphery of the core tube, the distal ends of the bending tube and the core tube are fixedly connected to each other, and the proximal ends of the two are relatively slidable. The sheath core assembly 400 comprises an inner and outer nested bending tube 410 and a core tube 425, the bending tube 410 is wrapped outside the core tube 425, the distal ends of the two are fixedly connected to each other, and the proximal ends of the two are relatively slidable, wherein the proximal end of the bending tube 410 is fixed to the second connecting piece 113, the proximal end of the core tube 425 extends out of the second connecting piece 113 and is fixed to the tail end of the second support body 111, i.e., the proximal end side, in order to facilitate the butt joint with the external pipe, the proximal end of the core tube 425 is provided with a pipe joint, for example, a luer joint 118 or the like.

[0204] When the interventional instrument needs to be released or recovered, the first driving piece 122 is rotated to axially move the first connecting piece 123, i.e., to drive the sheath tube 300 to move relative to the sheath core assembly 400. When bending is needed, the second driving piece 112 is rotated to axially move the second connecting piece 113, i.e., to drive the proximal end of the bending tube 410 to move relative to the proximal end of the core tube 425, since the distal ends of the two are fixedly connected to each other, the relative movement of the proximal ends will cause the distal ends of the two to be deflected and bent together in the radial direction.

[0205] Referring to Figures 5a to 11 The sheath core assembly 400 comprises a bending tube 410 and a core tube assembly 420, wherein the core tube assembly 420 comprises a core tube 425, the distal end of the core tube 425 is provided with a locking piece 422 for connecting the interventional instrument, the bending tube 410 is sleeved on the outer periphery of the core tube 425, and the distal ends of the bending tube 410 and the core tube 425 are fixedly connected to each other, and the proximal ends of the two are relatively slidable.

[0206] The distal end side of the bending tube 410 extends adjacent to the proximal end side of the locking piece 422, the bending tube 410 can be directly fixed with the core tube 425, or directly fixed with the proximal locking piece 422, or both, the bending tube 410 and the core tube 425 can both adopt a metal material such as a hypotube, and are fixed by welding, bonding or fasteners.

[0207] The distal end of the core tube 425 further extends out of the locking piece 422 and is fixed with a guide head 421. The distal end of the guide head 421 has a round head structure with converging shape to facilitate the in-vivo guiding and advancing, and the position between the guide head 421 and the locking piece 422 serves as a loading position of the interventional instrument, and the interventional instrument in a compressed state is located in this position and is limitedly matched with the locking piece 422.

[0208] In one embodiment, the inner core 424 is inserted into the core tube 425, the distal end of the inner core 424 extends out of the locking member 422 and is fixed with the guide head 421, the proximal end of the inner core 424 extends to a certain length, which is not strictly limited, and the position on the outer periphery of the inner core between the guide head and the locking member is the loading position of the interventional instrument, the interventional instrument in the compressed state is located in this position and is limited by the locking member 422. Since the core tube 425 does not extend to the loading position, the inner core 424 has a smaller outer diameter relative to the core tube 425, and thus the radial space of the loading position is expanded.

[0209] Referring to Figure 5a and Figure 5b In some embodiments, the locking member adopts a wire control mode, the proximal end of the interventional instrument 500 is provided with a connecting ear 501, the connecting ear 501 is generally provided with a hanging hole or a hook for inserting the pull wire 4223, the locking member 422 is provided with a locking hole 4221, the distal end of the locking rod 4224 is matched with the locking hole 4221, and the proximal end can extend to the operation handle.

[0210] In the loading state, the pull wire 4223 is sleeved on the locking rod 4224 after passing through the connecting ear 501, and since the distal end of the locking rod 4224 is inserted into the locking hole 4221, the connecting ear 501 can be limited from being pulled out of the locking member 422 by the pull wire 4223. When it is needed to be released, the locking rod 4224 is pulled towards the proximal end and is pulled out of the locking hole 4221, and the pull wire 4223 is also released, so that the connecting ear 501 is allowed to be pulled out of the locking member 422.

[0211] When there are multiple connecting ears 501, multiple pull wires 4223 can be arranged, each pull wire 4223 extends towards the distal end through a wire distribution disc 4222, and in order to regularize the wire harness, a wire sleeve 4225 can be sleeved on the outer periphery of the core tube 425 to form an extension channel of the pull wire 4223.

[0212] The matching locking rod 4224 and the locking hole 4221 form a set of locking mechanisms, and multiple sets of locking mechanisms can be arranged according to needs and are arranged in sequence along the circumference of the locking member 422.

[0213] Referring to Figure 5c In some embodiments, one or more limiting grooves are arranged on the outer periphery of the locking member 422, the interventional instrument is provided with a connecting ear which is arranged in the limiting groove, the limiting groove is used for axial limiting of the interventional instrument and only allows the interventional instrument to be released after radial expansion. In order to prevent the connecting ear from being accidentally pulled out or suddenly outwardly poked to hurt the tissue when being released, a pressing strip 423 matched with each limiting groove is further fixed on the locking member 422, the pressing strip 423 restricts the connecting ear in the limiting groove after loading and is limited by the sheath, which further improves the safety, and the flexible pressing strip 423 is outwardly poked to allow the connecting ear to be pulled out of the locking member 422 when being released.

[0214] The inner core 424 and the core tube 425 are both tubular structures. The core tube 425 and the inner core 424 do not require axial relative movement, so they are nested and welded together, with one or more weld fixation points being provided. If necessary, bushings can be added to the welded areas to fill radial gaps between the inner core 424 and the core tube 425, respectively, and the bushings can be welded to the inner core 424 and the core tube 425, respectively. The bushings can be made of the same material as the core tube 425.

[0215] One end of the core tube 425 is directly or indirectly fixed to the proximal side of the locking member 422, and the other end extends toward the operating handle.

[0216] In one embodiment, to facilitate bending, the core tube 425 includes a compliant segment 4251 adjacent to the locking element 422, and a third extension segment 4252 extending proximally from the compliant segment 4251. The compliant segment has a lower stiffness than the third extension segment, i.e., it has better flexibility and is easier to bend.

[0217] In one embodiment, the compliant section 4251 is made of a hypotube or a spring tube (ie, a tube wall interlayer with spirally extending reinforcing ribs), and has a length ranging from 120 mm to 180 mm, for example, 150 mm.

[0218] The third extension section 4252 is made of a hypotube or a steel cable tube (made of braided or twisted metal wires); the steel cable tube can be wrapped with a PTFE film to play a lubricating role.

[0219] In other embodiments, the core tube 425 is a whole hypotube. The hypotube can ensure axial support and bend radially. To control the bending direction of the compliant section 4251, the compliant section 4251 can have an axially extending reinforcing rib, which is obtained by cutting the corresponding part of the hypotube (the uncut area or the area with relatively sparse cuts becomes the reinforcing rib). The reinforcing rib can extend to the nearest end of the core tube 425. However, since there is no obvious bending adjustment requirement when the core tube 425 is near the proximal end, the reinforcing rib can also extend to the middle of the core tube 425 or slightly closer to the proximal end.

[0220] See also Figure 7 , Figure 8 When the conforming section 4251 is cut, the cutting slit width (i.e., the laser spot diameter) is 0.1 to 1 mm, and the slit spacing (i.e., the uncut portion between adjacent cutting slits) is 0.1 to 1 mm; an uncut portion extends axially to form a reinforcing rib 4253.

[0221] In some embodiments, the core tube is the object to be bent, and the compliant segment is configured so that the closer it is to the distal end, the smaller the ultimate curvature radius after the bending. This allows the distal end of the core tube to better adapt to complex paths. Specifically, with respect to the compliant segment, at least one of the following methods may be employed, for example:

[0222] The slit width gradually changes in the compliant section, and the slit width is larger as it is closer to the distal end.

[0223] The slit distance gradually changes in the compliant section, and the slit distance is smaller as it is closer to the distal end.

[0224] The rigidity (flexibility) gradually changes in the compliant section, and the rigidity is lower as it is closer to the distal end.

[0225] Referring to Figures 9 to 11 The bending tube 410 is sleeved outside the core tube 425, and the bending tube 410 sequentially comprises a pulling section and a second extension section 413 from the distal end to the proximal end, wherein the pulling section is an integral structure and adopts a hypotube.

[0226] The distal end side of the pulling section extends close to the proximal end side of the lock piece 422, and is fixed with the core tube 425. In order to prevent the pulling section from being reversed during processing, different marks such as punching can be made at both ends of the pulling section to identify the assembly direction of the distal end and the proximal end.

[0227] The pulling section sequentially comprises a first pulling section 411, a transition section 414 and a second pulling section 412 from the distal end to the proximal end.

[0228] In the present application, the bending tube 410 is outside the core tube 425, that is, the main part of the force is outside, and the passive part is inside, so that a larger bending angle can be allowed compared with the case where the main part is inside and the passive part is outside.

[0229] The first pulling section 411 is formed with a reinforcing rib 4111 in a cutting manner, and the reinforcing rib 4111 is 180 degrees away from the circumferential position of the reinforcing rib 4253 of the compliant section 4251.

[0230] The second pulling section 412 is also cut, and the cutting slit width of the first pulling section 411 and the second pulling section 412 is respectively 0.03-0.5mm, and the slit distance is 0.2mm-0.85mm; wherein the first pulling section 411 is at the expected bending position, and should be relatively soft and more flexible, and the second pulling section 412 is relatively hard, but in order to ensure a certain softness, it can be bent during transportation and packaging, and after entering the human body during surgery, it can be bent according to the blood vessels, so the cutting method is adopted, and the slit width and the slit distance can be adjusted according to the softness requirements of different sections during actual operation.

[0231] The second pulling section 412 is provided with a reinforcing rib 4121 and a reinforcing rib 4122 formed by cutting, the two reinforcing ribs are diametrically opposite, that is, 180 degrees away from the circumferential position, and both are 90 degrees away from the circumferential position of the reinforcing rib 4111 of the first pulling section 411.

[0232] The transition section 414 is not cut, and the transition section 414 connects the first pulling section 411 and the second pulling section 412, and also shares the pulling stress at different circumferential positions.

[0233] The second extension section 413 does not have special bending requirements, and mainly bears the transmission of the pulling force, for example, a hypotube is not additionally cut, and the like, extends to the proximal end and is connected to the operating handle.

[0234] During the bending process, the first pulling section 411 and the compliant section 4251 are mainly bent to a large extent, and therefore the bending angle is generally required to be > 270° when the hypotube is cut, and the single reinforcing structure arranged in the first pulling section 411 and the compliant section 4251 respectively ensures that the bending stress is not stretched, and the softness of the first pulling section 411 and the compliant section 4251 is moderate after being overlapped inside and outside, which is easy to bend and ensures the transmission of force. Overall, the bending tube 410 is 5 mm to 10 mm longer than the core tube 425 to match the axial offset after bending, and the core tube 425 and the sheath tube 300 are passive during bending, and the bending tube 410 is active.

[0235] Referring to Figures 12 to 13 , in order to adapt to the change of the distal direction during bending or in-vivo passing, the outermost sheath tube 300 also has different softness distribution at different axial positions, and the sheath tube 300 includes, from the distal end to the proximal end, a loading section 310, a bending-adaptive section 320, and a first extension section 330. During use, the bending mainly occurs on the proximal side of the loading area adjacent to the interventional instrument 500, that is, the bending-adaptive section 320.

[0236] Referring to Figures 14 to 15d , the nesting relationship of the sheath tube 300, the core tube assembly 420, and the bending tube 410, and the release process of the interventional instrument are illustrated in an embodiment, and the approximate axial position relationship of each section in the sheath tube 300, the core tube assembly 420, and the bending tube 410 is also illustrated in Figure 15d , for each section, the sheath tube 300 adopts a multi-layer composite structure, that is, for a certain section, a multi-layer structure is adopted and different components are included during processing, and the structure and process of the sheath tube 300 are also improved in the present application.

[0237] Referring to Figures 16 to 17d , the nesting relationship of the sheath tube 300, the core tube assembly 420, and the release process of the interventional instrument are illustrated in an embodiment, and the approximate axial position relationship of each section in the sheath tube 300, the core tube assembly 420, and the bending tube 410 is also illustrated in Figure 15dThe sheath tube 300 is also shown in the approximate axial position of each section of the core tube assembly 420. For each section, the sheath tube 300 adopts a multi-layer composite structure, i.e. for a section, the multi-layer structure is adopted and different components are included in the processing. The structure and process of the sheath tube 300 are also one of the improvements of the present application. In the embodiment, the core tube assembly 420 includes a core tube 425, the core tube 425 is fixed with a locking piece 422, the core tube 425 further extends the locking piece 422 at the distal end and is fixed with a guide head 421 at the most distal end. The distal end of the guide head 421 has a converging round head structure to facilitate the in-vivo threading and advancing, and the position between the guide head 421 and the locking piece 422 serves as a loading position of the interventional instrument. The compressed interventional instrument is located in the position and is limited by the locking piece 422.

[0238] In an embodiment, the core tube 425 is provided with an inner core 424, the distal end of the inner core 424 extends out of the locking piece 422 and is fixed with the guide head 421, the distal end of the core tube 425 only extends to the locking piece 422, and the extension length of the proximal end of the inner core 424 is not strictly limited. Since the core tube 425 does not extend to the loading position, the inner core 424 has a smaller outer diameter relative to the core tube 425, so that the radial space of the loading position is expanded.

[0239] In an embodiment of the present application, a sheath tube for conveying an interventional instrument is provided, the distal end of the sheath tube is a loading section 310 for receiving the interventional instrument, the loading section 310 adopts a multi-layer structure, and sequentially includes an inner liner tube 375, a metal tube and an outer wrapping film 380 from inside to outside, wherein the metal tube includes a main tube 350 and a head tube 340 which are mutually butted from the proximal end to the distal end;

[0240] The head tube 340 includes a body section 346, a plurality of expansion pieces 344 which are arranged at the distal end side of the body section and are spaced apart in the circumferential direction, and a first connecting head 343 which is at the proximal end side of the body section, and the distal end side of the main tube 350 is provided with a second connecting head 351, the first connecting head 343 and the second connecting head 351 are mutually embedded and complementary in shape.

[0241] In an embodiment of the present application, a sheath tube for conveying an interventional instrument is provided, the sheath tube is sequentially divided into a loading section 310, a bending section 320 and a first extension section 330 from the distal end to the proximal end in the axial direction, wherein the loading section 310 is used for receiving the interventional instrument 500, and the sheath tube adopts a multi-layer structure, which includes: an inner sheath tube 370 which is distributed in the bending section and the first extension section in the axial direction;

[0242] An inner liner tube 375 which is butted to the distal end of the inner sheath tube 370 and is distributed in the loading section in the axial direction;

[0243] A metal tube which is wrapped around the outer periphery of the distal end portion of the inner sheath tube and the inner liner tube, and is distributed in the bending section and the loading section in the axial direction;

[0244] The outer envelope 380 is wrapped around the outer periphery of the metal tube and is distributed in the axial direction on the bending section and the loading section.

[0245] The loading section 310 has a larger diameter relative to the sheath tube at the proximal end of the loading section 310 (i.e. the bending section 320 and the first extension section 330) because it needs to wrap the interventional instrument.

[0246] Figure 18 The partial visible components of the sheath tube 300 are shown. The distal end of the sheath tube 300 has a three-layer structure in general, the inner and outer layers are both high molecular materials, and the middle layer is a metal tube. The middle layer adopts a three-section butt joint structure, including a head tube 340, a main tube 350 and an extension tube 360 in sequence from the distal end to the proximal end. In the axial direction, the head tube and the main tube are distributed on the loading section, and the extension tube is distributed on the bending section.

[0247] The bending section can be bent to change the direction of the distal end of the sheath tube during delivery, and the first extension section mainly provides sufficient axial pushing and pulling force and has sufficient length to connect the operation handle.

[0248] The head tube 340 is cut from a nickel-titanium alloy tube, and the main tube 350 and the extension tube 360 are cut from stainless steel tubes respectively. The head tube 340 and the main tube 350 have a larger tube diameter relative to the extension tube 360 because they need to wrap the interventional instrument, and in combination with the axial position relationship, the joint part of the main tube 350 and the extension tube 360 is also flared and changed in diameter. Figure 18

[0249] Referring to Figure 19a In an embodiment, a plurality of spaced openings 341 are formed on the distal side of the head tube 340 in the circumferential direction, and an expansion piece 344 is arranged between adjacent two spaced openings 341, and each expansion piece 344 has a hollow area 345. In a preferred embodiment, the expansion pieces 344 are uniformly arranged in the circumferential direction, and the number is 3-6, for example, 5.

[0250] In general, the head tube 340 preferably adopts an integral structure, the body section 346 forms the developing area 342 in a hollow manner for installing the developing point, and the first connecting head 343 is T-shaped for butt joint and axial positioning with the main tube 350. The body section 346 and the first connecting head 343 are both distributed with through holes 347, which can better fuse the high molecular materials as the inner and outer layers of the sheath tube.

[0251] ​The spacing opening 341 is a strip-shaped gap, open at the distal end and closed at the proximal end. Since the head-end tube 340 is made of a resilient metal material such as nickel-titanium alloy, the expansion pieces 344 can be radially everted, can adapt to the gradual deformation of the interventional instrument when the interventional instrument is released, can prevent the interventional instrument from suddenly collapsing at the end of the release, and when the recovery is needed, the expansion pieces 344 are radially everted to form a trumpet mouth, which facilitates the gradual radial compression of the interventional instrument and the storage of the interventional instrument in the sheath tube 300. In order to obtain better resilience, the head-end tube 340 can be made of nickel-titanium alloy material, and each expansion piece has a surrounding state extending along the axial direction of the sheath tube and an everted state away from each other.

[0252] The hollowed-out area 345 of the expansion piece 344 facilitates the deformation of the expansion piece and reduces the everted resistance. In an embodiment, the hollowed-out area 345 is a strip-shaped hole, and the strip-shaped hole extends along the axial direction of the head-end tube 340. On the same expansion piece, there is one, two or more strip-shaped holes.

[0253] In a preferred embodiment, the strip-shaped hole extends with the same width. The two ends of the strip-shaped hole in the length direction are arc-shaped inner edges. This can avoid cracking caused by excessive stress concentration during deformation.

[0254] In an embodiment, each expansion piece 344 has a narrowed portion 348 at the proximal end, and the spacing opening has a corresponding widened portion at the proximal end, i.e., corresponding to the narrowed portion 348.

[0255] In order to disperse stress, the inner edge of the widened portion adopts a smooth curve, such as a large head part of a water drop shape.

[0256] In an embodiment, the spacing opening itself extends with the same width except for the distal end side to adapt to the chamfer of the expansion piece and the widened portion at the proximal end side.

[0257] The width of the part where the spacing opening extends with the same width is substantially the same as the width of the strip-shaped hole, for example, the width of the part where the spacing opening extends with the same width is the reference width ±20% of the width of the strip-shaped hole.

[0258] In order to facilitate the everted of each expansion piece 344 at the narrowed portion 348 and reduce the deformation resistance of the proximal side of the narrowed portion, in an embodiment, the proximal side 349 of the strip-shaped hole exceeds the narrowed portion of the expansion piece where the strip-shaped hole is located. In a preferred embodiment, the proximal side 349 of the strip-shaped hole exceeds the narrowed portion of the expansion piece where the strip-shaped hole is located by 1-5 mm, for example, 1.5-3 mm.

[0259] In order to avoid safety hazards, in an embodiment, the distal end of the expansion piece has a smooth outer edge, for example, adopts a rounded corner, or is a whole arc shape protruding to the distal end.

[0260] Referring to Figure 19bIn an embodiment, each of the expansion pieces 344 has a hollowed area 345, which is a plurality of through holes arranged in an axial direction of the sheath tube, and the total area of the through holes on each expansion piece is less than 50% of the area of the expansion piece. As can be seen in the figure, the closer the through hole is to the distal end, the larger the area of the through hole. The through holes are circular or elliptical, and the number of through holes on the same expansion piece is 2-5.

[0261] With Figure 19a In a corresponding embodiment, the body section 346 of the head tube is formed in a hollowed manner to form the developing area 342 for mounting the developing point, and the first connector 343 is T-shaped for connecting with the main tube and axially limiting. The body section 346 and the first connector 343 are both provided with through holes 347, which can make the high molecular materials of the inner and outer layers of the sheath tube better fused. The space openings 341 between adjacent expansion pieces 344 are strip-shaped openings, which are open at the distal end and closed at the proximal end. The expansion pieces 344 are narrower and narrower towards the distal end, and the most distal part adopts an arc-shaped edge to improve safety.

[0262] To prevent the metal material of the intermediate layer from scratching the blood vessel wall, the outermost layer at least wraps the head tube 340, the main tube 350 and the extension tube 360. The outer wrapping film 380 can be made of high molecular material. Since the metal material part is a multi-section structure, the outer wrapping film 380 is also a multi-section spliced structure during processing and then fused into one.

[0263] For example, along the axial direction of the sheath tube, the outer wrapping film 380 includes multiple sections, each of which is made of different materials, or at least two of which are made of the same material.

[0264] In one of the embodiments, the strength of the corresponding outer wrapping film of the main tube 350 is greater than that of the corresponding outer wrapping film of the distal end of the head tube 340.

[0265] The inner layer includes the inner sheath tube 370 and the inner liner tube 375. One side of the inner sheath tube 370 extends towards the proximal end, and the other side extends to the joint of the main tube 350 and the extension tube 360. The inner sheath tube 370 further extends to the distal end side of the head tube 340 through the inner liner tube 375 from the joint of the main tube 350 and the extension tube 360. The inner liner tube 375 can be made of PTFE material.

[0266] The axial position of the distal end part of the extension tube 360 corresponds to the compliant section 4251 and the first pulling section 411. The extension tube 360 can also be formed with a reinforcing rib by cutting.

[0267] Referring to Figures 20 to 24 , the inner sheath tube 370 itself adopts a multi-layer structure, which includes a PTFE inner layer 3701, a woven layer 3702, a woven layer 3704 and an outer layer 3705 from inside to outside. Two reinforcing ribs 3703 extending in the axial direction are fixedly wrapped between the woven layer 3702 and the woven layer 3704.

[0268] One of the two reinforcing ribs 3703 is at the same circumferential position as the reinforcing rib 4253, and the other is 180 degrees away from the circumferential position of the reinforcing rib 4253.

[0269] The woven layer 3702 and the woven layer 3704 do not require a clear layered structure, and can be woven into one body and clamped with the reinforcing rib. The outer layer 3705 can be made of Pebax material.

[0270] The reinforcing rib 4253 is arranged in the compliant section 4251, and the reinforcing rib 4111 is arranged in the first pulling section 411. The reinforcing rib 4253 and the reinforcing rib 4111 are circumferentially staggered by 180 degrees.

[0271] The sheath in the cross-sectional view only shows part of the extension tube 360. The extension tube 360 can be provided with a reinforcing rib 3601. The reinforcing rib 3601 is on the same side in the radial direction as the reinforcing rib 4253, that is, at the same circumferential position.

[0272] Or in other embodiments, the extension tube 360 is provided with two reinforcing ribs, namely the reinforcing rib 3601 and the reinforcing rib 3602. The reinforcing rib 3601 is on the same side in the radial direction as the reinforcing rib 4253, that is, at the same circumferential position. The reinforcing rib 3602 is on the same side in the radial direction as the reinforcing rib 4111, that is, 180 degrees away from the circumferential position of the reinforcing rib 4253.

[0273] The inner sheath 370 exists in the bending section 320 and the first extension section 330. Since the bending section 320 has a larger bending angle during bending, the inner sheath 370 has different strengths in the bending section 320 and the first extension section 330. The inner sheath 370 is softer in the bending section 320. For example, the outer layer 3705 of the inner sheath 370 in the bending section 320 is made of 30-59D Pebax, and the outer layer 3705 of the inner sheath 370 in the first extension section 330 is made of 60-90D Pebax. The woven layer and the PTFE inner layer 3701 at different positions of the inner sheath 370 can be arranged in the same way. See Figures 25 to 34 An embodiment of the present application provides a processing method of the sheath 300, comprising:

[0274] Step S100, a flared portion is formed at the distal end of the inner sheath.

[0275] The end of the inner sheath, that is, the distal end 371, can be heated and softened and combined with the inserted mandrel 372 to perform diameter expansion treatment on the distal end 371 to form a flared portion 374. Part of the outer circumference of the mandrel 372 can be processed into a circular truncated cone section 373 according to the expected shape of the flared portion 374.

[0276] Step S200, an inner liner tube is sleeved and fixed on the outer circumference of the flared portion.

[0277] Take the inner liner tube 375 of PTFE material, the end of the inner liner tube 375 is circumferentially provided with spaced-apart tabs, and the cutting area 376 is between the tabs. The end is wrapped around the flared portion 374, and then wrapped with the fixing sleeve 377. After heat melting, the inner liner tube 375 is connected to the distal end 371 of the inner sheath tube.

[0278] The fixing sleeve 377 and the flared portion 374 are made of the same material, such as Pebax, etc., and the cutting area 376 facilitates the fusion of the fixing sleeve 377 and the flared portion 374, ensuring the connection strength of the inner liner tube 375.

[0279] Step S300, the metal tube is sleeved on the outer periphery of the inner sheath tube and the inner liner tube;

[0280] The extension tube 360, the main tube 350, and the head-end tube 340 are sequentially butted, and the adjacent two are axially limited by hooks, buckles, etc. The head-end tube 340 is made of a nickel-titanium alloy tube, and the extension tube 360 and the main tube 350 can be made of stainless steel tube material.

[0281] The proximal end side of the head-end tube 340 is provided with a T-shaped first connecting head 343, and the distal end side of the main tube 350 is provided with a T-shaped second connecting head 351. The first connecting head 343 and the second connecting head 351 are axially limited by the shape complementary to each other.

[0282] The proximal end side of the main tube 350 is provided with a necking portion 352, and the main tube 350 is butted with the extension tube 360 through the necking portion 352. The butting can be achieved by using conventional hooks or buckles, etc. The tube wall of the main tube 350 is distributed with a hollow area 353 and a hollow area 354, and an axially extending guide rib 355 is distributed between the two. The guide rib 355 can limit the bending direction of the sheath tube 300, and the guide rib 355 is radially arranged in two parts.

[0283] After the extension tube 360, the main tube 350, and the head-end tube 340 are sequentially butted, they are sleeved outside the inner sheath tube 370 and the inner liner tube 375. The position of the flared portion 374 corresponds to the axial position of the necking portion 352, and the inner liner tube 375 is slightly longer than the head-end tube 340. The inner liner tube 375 is also cut open at a position corresponding to the spaced-apart opening 341 to adapt to the deformation of the expansion piece.

[0284] Step S400, the outer packaging material is segmentedly coated on the outer surface of the metal tube, and the outer packaging material is heat-fused to form an outer packaging film. Specifically, it includes:

[0285] Step S410, wrapping a first connecting sleeve 381 at the butting position of the main tube 350 and the head-end tube 340, and wrapping a head-end outer sleeve 382 on the outer periphery of the head-end tube 340. The first connecting sleeve 381 and the head-end outer sleeve 382 are heat-fused and fixed.

[0286] The head end sleeve 382 is also slightly longer than the head end tube 340 and is aligned with the inner liner tube 375, and then the first connecting sleeve 381 and the head end sleeve 382 are heat-welded together with the corresponding positions of the inner liner tube 375, so as to fix the abutting part of the main body tube 350 and the head end tube 340 and the inner and outer wrapping of the head end tube 340.

[0287] The first gasket 383 and the second gasket 384 are placed in the hollowed-out areas 353 and 354, and then heat-welded with the corresponding positions of the inner liner tube 375, so that the first gasket 383 and the second gasket 384 penetrate into the corresponding hollowed-out areas and are filled.

[0288] In step S420, the main body sleeve 385 is wrapped around the outer periphery of the main body tube 350 and is heat-welded and fixed.

[0289] The distal end side of the main body sleeve 385 is approximately aligned with the proximal end side of the first connecting sleeve 381, and the proximal end side of the main body sleeve 385 wraps around the abutting part of the extension tube 360 and the main body tube 350.

[0290] The head end sleeve 382 requires better flexibility, and the material can be TPU or the like, while the first connecting sleeve 381, the first gasket 383, the second gasket 384, and the main body sleeve 385 can use Pebax or the like with better strength, wherein the first gasket 383 and the second gasket 384 can have a relatively thin thickness relative to the main body sleeve 385, for example, the thickness of the first gasket 383 and the second gasket 384 is about 0.15mm, while the thickness of the main body sleeve 385 can be increased to 0.35mm.

[0291] In addition, the first connecting sleeve 381 requires greater strength, so it can be made of relatively hard material, for example, hardness 60-72D, while the main body sleeve 385 mainly plays a protective role, and the hardness can be appropriately reduced, for example, 40-55D.

[0292] In step S440, the connecting sleeve tube 387 is wrapped around the outer periphery of the extension tube 360 and is heat-welded and fixed.

[0293] The axial position of the connecting sleeve tube 387 is proximal to the second connecting sleeve 386 and distal to the main body sleeve 385.

[0294] The second connecting sleeve 386 uses Pebax or the like with better strength, and the connecting sleeve tube 387 requires better flexibility due to being at the bending adjustment position, and the material can be TPU or the like, in addition, the connecting sleeve tube 387 can also prevent the internal metal tube from directly contacting and scratching the blood vessel, and also plays a sealing role.

[0295] The segments of material wrapped around the outer periphery of the extension tube 360, the main tube 350, and the head tube 340 are finally fused together to form the outer wrapping film 380, and the portion of the head tube 340 that extends beyond the distal end is finally heat-fused and closed. The portion corresponding to the spacing opening 341 can also be cut open to adapt to possible deformation of the spacing opening 341, or to adapt to the elasticity of the material of the head sleeve 382.

[0296] Referring to Figures 35 to 40 The bending system of the present application can actively change the orientation of the distal end by pulling the bending tube at the operating handle, and can better adapt to the delivery of complex paths. For example, when the interventional instrument 500 is disposed in the aortic valve 600, the distal end of the sheath tube assembly is directed to and located at the aortic valve 600 by bending when passing through the aortic arch. Since the bending tube pulls the core tube assembly, the interventional instrument loaded in the core tube assembly does not change the orientation when the sheath tube is withdrawn to release the interventional instrument, and the misalignment risk during release can be avoided.

[0297] The technical features of the above-described embodiments can be combined in any manner. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described, but as long as the combinations of the technical features do not contradict, they should be considered within the scope of the present disclosure. When the technical features in different embodiments are embodied in the same figure, it can be considered that the figure also discloses the combination of the embodiments involved.

[0298] The above-described embodiments only express several implementation manners of the present application, and the description is relatively specific and detailed, but it should not be understood as a limitation on the patentable scope of the application. It should be noted that for those skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are within the scope of the present application.

Claims

1. A delivery system for an adjustable-bend interventional instrument, having opposite distal and proximal ends, the delivery system comprising an operating handle at the proximal end and a sheath assembly connected to the operating handle and extending toward the distal end, the sheath assembly comprising a sheath and a sheath core assembly, characterized in that: The sheath-core assembly includes a core tube, a locking piece fixed to the distal end of the core tube for connecting to an interventional instrument, and a bend adjustment tube nested with the core tube, the bend adjustment tube being sleeved on the outer circumference of the core tube, the distal end of the bend adjustment tube extending adjacent to the proximal end of the locking piece, the distal ends of the bend adjustment tube and the core tube being fixedly connected to each other, and the proximal ends of the two being relatively slidable and both extending and connected to the operating handle; The core tube includes a compliant section adjacent to the locking element. In the compliant section, the closer to the distal end, the smaller the limit curvature radius after being bent. The core tube extends distally beyond the locking element, and a guide head is fixed to the distal end of the extended section. A loading position for the interventional instrument is located between the guide head and the locking element. The interventional instrument in a compressed state is located in the loading position and connected to the locking element. The sheath tube is slidably fitted on the outer periphery of the sheath core assembly. The distal end of the sheath tube is an enlarged loading section for accommodating interventional instruments. The loading section adopts a multi-layer structure, which includes an inner lining tube, a metal tube and an outer membrane from the inside to the outside. The proximal end of the sheath tube extends and is connected to the operating handle.

2. The adjustable bend interventional device delivery system according to claim 1, wherein: The core tube further includes a third extension segment connected to the compliant segment and extending toward the proximal end, wherein the compliant segment has a lower rigidity than the third extension segment.

3. The adjustable bend interventional device delivery system according to claim 2, wherein: The length of the compliant section ranges from 120 to 18 mm, and the third extension section adopts a steel cable tube or a hypotube.

4. The adjustable bend interventional device delivery system according to claim 2, wherein: The compliant section adopts a hypo tube or a spring tube.

5. The adjustable bend interventional device delivery system according to claim 4, characterized in that: The compliant section is formed with an axially extending first reinforcing rib by cutting.

6. The adjustable bend interventional device delivery system according to claim 5, characterized in that: The cutting slit width of the compliant section is 0.1-1 mm, and the slit spacing is 0.1-1 mm.

7. The adjustable bend interventional device delivery system according to claim 5, characterized in that: The bending adjustment tube includes a pulling section and a second extension section from the distal end to the proximal end, wherein the pulling section is an integrated structure and adopts a sea wave tube; the pulling section includes a first pulling section, a transition section and a second pulling section from the distal end to the proximal end, wherein the first pulling section has higher flexibility than the second pulling section, and the ratio of the length of the first pulling section to the length of the compliant section is 1:0.7~1.

5.

8. The adjustable bend interventional device delivery system according to claim 7, wherein: The first pulling section is formed with an axially extending second reinforcing rib by cutting, and the circumferential position of the second reinforcing rib is 180 degrees different from that of the first reinforcing rib.

9. The adjustable bend interventional device delivery system according to claim 8, wherein: The cutting slit width of the first pulling section is 0.03-0.5 mm, and the slit spacing is 0.2 mm-0.85 mm.

10. The adjustable bend interventional device delivery system according to claim 7, wherein: The second pulling section is formed with two axially extending third reinforcing ribs by cutting, and the two third reinforcing ribs are radially opposite to each other and are 90 degrees different from the circumferential position of the first reinforcing rib.

11. The adjustable bend interventional device delivery system according to claim 10, wherein: The cutting slit width of the second pulling section is 0.03-0.5 mm, and the slit spacing is 0.2 mm-0.85 mm.

12. The adjustable bend interventional device delivery system according to claim 7, wherein: The transition section is a complete uncut structure in the circumferential direction.

13. The adjustable bend interventional device delivery system according to claim 1, wherein: The sheath is divided into a loading section, a bending section, and a first extension section in sequence from the distal end to the proximal end in the axial direction. The sheath adopts a multi-layer structure, including: An inner sheath tube, which is distributed in the bending section and the first extension section in the axial direction; An inner liner tube, the inner liner tube being connected to the distal end of the inner sheath tube and being distributed in the loading section in the axial direction; A metal tube, the metal tube being wrapped around the distal end of the inner sheath tube and the outer periphery of the inner liner tube, and the metal tube being distributed in the bending section and the loading section in the axial direction; The outer membrane is wrapped around the outer periphery of the metal tube and is distributed in the bending section and the loading section in the axial direction.

14. The adjustable bend interventional device delivery system according to claim 13, wherein: The metal tube includes a head end tube, a main body tube and an extension tube which are connected in sequence from the distal end to the proximal end, wherein in the axial direction, the head end tube and the main body tube are both distributed in the loading section, and the extension tube is distributed in the bending section.

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