A bending sheath tube and a delivery system using the same

Abstract

The present invention discloses a bending adjustment sheath and a delivery system using the bending adjustment sheath, wherein the bending adjustment sheath includes a tube body, the tube body has a distal end and a proximal end, the tube wall of the tube body is further connected to a traction wire, one end of the traction wire extends toward the proximal end of the tube body, the other end of the traction wire is connected to the tube body at a location adjacent to the distal end of the tube body, and at least one section of the traction wire is free outside the tube body at the distal end adjacent to the tube body. The traction wire in the bending adjustment sheath of the present invention has a section free outside the sheath body, and has a posture that facilitates force application when pulled. It can also adaptively change the point of force through relative movement with the tube body, thereby improving the safety and flexibility of operation in cases where the turning radius is large or the interventional instrument is long, hard and difficult to bend.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a bending sheath tube and a delivery system using the bending sheath tube. Background Art

[0002] Interventional surgery causes little trauma to the human body and is less invasive. It is a medical technology that has rapidly emerged and been promoted in recent years. It usually requires the use of interventional diagnostic sheaths (such as delivery sheaths, guide sheaths, etc.) to establish a channel between the lesion site in the patient's body and the external operating end to introduce diagnostic and therapeutic instruments, drugs, interventional instruments, etc. to the lesion site. The interventional diagnostic sheath has a distal end and a proximal end. The distal end can enter the human vascular system, and the proximal end is connected to the operating handle. When in use, a guidewire track is usually established in advance, and the distal end of the sheath or other auxiliary instruments are connected to puncture into the blood vessel. The physician controls the distal end of the sheath through the operating handle to move along the pre-established guidewire track to the lesion site to release drugs, instruments, etc.

[0003] Due to the tortuous nature of the human vascular system and the consideration of long-distance operation, the sheath should usually have sufficient axial and radial support force and good compliance. Before reaching the lesion site, the sheath's own compliance can enable the distal end of the sheath to adaptively adjust its bending direction to conform to the body's veins while moving along the guidewire track through the push of the physician. Due to the influence of blood flow in the blood vessels, the sheath usually advances along the blood vessel wall. In the early stage, this does not have much impact on the sheath's route. However, when releasing drugs and devices, the distal end of the sheath needs to be aligned with the lesion site. Obviously, the direction of the distal end of the sheath must be adjusted and controlled at this time to move it to the target position.

[0004] Taking heart valve replacement as an example, the human heart valve is located in the center of the blood vessel. When the heart valve needs to be replaced, the distal end of the sheath needs to reach the center of the valve, and then the carried heart valve replacement device is released, so that the heart valve replacement device can replace its own valve to perform its function. Since the sheath moves along the blood vessel wall, when it approaches the lesion site, it is necessary to adjust the direction of the distal end of the sheath to move toward the center of the valve. For example, the diameter of the aortic valve is about 26 mm, and the diameter of the blood vessel at this location is obviously larger than the diameter of the aortic valve. The diameter of the distal end of the sheath is usually about 7 mm, so the distal end of the sheath should be moved at least about 9 mm in the diameter direction of the blood vessel.

[0005] One solution is to shape the distal end of the catheter according to the distribution of blood vessels or the anatomy of the human body. Customized catheters with different shapes and structures can be created to meet the needs of reaching the lesion site within the tortuous blood vessels. For example, U.S. Patent No. 2003144657 discloses a catheter assembly that uses an outer catheter with a pre-shaped distal end and an inner catheter with a pre-shaped end. The relative rotation and extension of the inner and outer catheters provide an adjustable shape of the distal end of the catheter assembly to improve positioning through the right atrium and insertion into the coronary sinus. However, this method cannot adapt to individual physiological and anatomical structures, which can easily affect surgical outcomes.

[0006] At present, the commonly adopted solution is to use a sheath with adjustable distal bend, which usually has one or more traction wires (also called pull wires), the distal end of which is fixed to the distal end of the sheath and extends along the side wall of the tube to the proximal end of the sheath, and is connected to the adjustment mechanism on the proximal handle of the sheath. The traction wire can slide in the catheter to allow the doctor to actively change the curvature of the catheter, bend the distal end of the sheath, and guide it to turn and move to the target site.

[0007] For example, the Chinese patent document with publication number CN102921089A discloses a catheter with controllable bending head for interventional treatment. The head of the multi-lumen catheter is connected to a main catheter soft head. The tail of the multi-lumen catheter is connected to an extension tube through a connector. A handle is provided on the outside of the extension tube. A handle sliding device is movably connected to the inside of the handle. The sliding device is squeezed and matched with the extension tube. The upper and lower ends of the sliding device extend to the outside of the housing of the handle. The upper and lower sides of the sliding device are respectively connected to a traction wire. The other end of the traction wire passes through the auxiliary cavity on the same side of the multi-lumen catheter and the main catheter soft head and is fixedly connected to the head of the main catheter soft head. The other end of the extension tube extends to the outside of the handle and is connected to a joint. After the catheter enters the body, the traction wire is controlled by the handle according to the structure of the blood vessel or related parts. The traction wire is pulled by the traction force of the handle sliding device to pull the main catheter soft head at the distal end of the catheter. The main catheter soft head is bent back by the pulling force of the traction wire, thereby achieving direction adjustment.

[0008] Even if traction wires are used in the prior art, the traction wires are generally threaded and bound in the pipe or channel in which they are located. Therefore, when large bending adjustments are required or the interventional device with a long or hard distal end of the sheath is wrapped, it is difficult to meet the bending requirements. Moreover, since the bending is limited by the torque size and the deformation of the surrounding parts of the traction wire, the operation is relatively laborious. Summary of the Invention

[0009] The present invention provides a bending-adjustable sheath tube, which is beneficial to the adjustment of the distal direction of the sheath tube, improves the controllability of the bending direction of the distal end of the sheath tube, and can easily control the distal end of the sheath tube to bend or move toward a predetermined lesion site.

[0010] A bending adjustment sheath comprises a tube body and a traction wire. The tube body has a distal end and a proximal end. The distal end of the tube body is bent by the traction wire. One end of the traction wire extends toward the proximal end of the tube body. The connection between the other end of the traction wire and the tube body is located at or adjacent to the distal end of the tube body, and at least one section of the traction wire is a free section that is free outside the tube body.

[0011] The distal end of the traction wire is fixed and adjacent to the distal end of the tube body, and the proximal end of the traction wire extends out of the tube body for connection to the operating handle. The traction wire itself can be made of a relatively thin metal wire or polymer fiber that meets the strength requirements, and its material and processing method can adopt existing technologies.

[0012] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution. They are merely further supplements or optimizations. Under the premise that there are no technical or logical contradictions, each optional method can be combined separately for the above-mentioned overall solution, or multiple optional methods can be combined.

[0013] Preferably, a guide member is further provided, which acts between the tube body and the free section and is used to limit the gap between the tube body and the free section when adjusting the bend.

[0014] Preferably, a plurality of the guide members are distributed at intervals along the axial direction of the tube body, forming a plurality of guide points for defining the gap between the tube body and the free section.

[0015] The guide member is a radially expandable structure, and has a pre-deformation state in which the free segment is tightened to the outer wall of the tube body, and a post-deformation state in which the free segment is partially separated from the tube body.

[0016] Preferably, the guide members are continuously distributed along the axial direction of the tube body to form a guide channel for defining the gap between the tube body and the free section.

[0017] Preferably, the guide member is a guide sleeve connected to the outer periphery of the tube body and wrapping the free segment.

[0018] The guide sleeve is made of elastic material and has a pre-deformation state in which the free section is driven to stick to the outer wall of the tube body; and a post-deformation state in which the free section partially separates from the tube body.

[0019] The guide sleeve is a rolled wall structure, which has a deformed state in which the free segment is partially separated from the tube body and the rolled wall structure of the corresponding part is unfolded; and a deformed state in which the rolled wall structure is restored by itself and the free segment is pressed against the outer wall of the tube body.

[0020] The rolled wall structure in the state before deformation is rolled up over a circle, and the part beyond the 360-degree circumference overlaps with the part within the 360-degree circumference.

[0021] The starting side and the ending side of the rolled-up wall structure wound in the circumferential direction are connected by a flexible envelope film.

[0022] The guide sleeve in the state before deformation wraps the free section tightly against the outside of the tube body.

[0023] Preferably, at least a portion of the guide sleeve is fixed to the tube body.

[0024] Preferably, the distal end and the proximal end of the guide sleeve are fixed to the outer periphery of the tube body, and the portion between the distal end and the proximal end of the guide sleeve is suspended outside the tube body.

[0025] Preferably, at least a portion of the free segment is located in the radial gap between the tube body and the guide sleeve. More preferably, the entire free segment is located in the radial gap between the tube body and the guide sleeve.

[0026] Preferably, the free segment is suspended in a radial gap between the tube body and the guide sleeve.

[0027] Preferably, a portion of the free segment is slidably attached to the inner side of the guide sleeve. Further, the guide sleeve has a sandwich structure and a portion of the free segment is passed through the sandwich structure; or the free segment is movably sewn onto the guide sleeve.

[0028] Preferably, the guide sleeve wraps around a portion of the tube body in the circumferential direction; or the guide sleeve is cylindrical and wraps around the tube body in the circumferential direction.

[0029] Preferably, the tube body includes an expansion section at the distal end for accommodating an interventional instrument, and a connecting section connected to the expansion section and extending toward the proximal end, and the distal end of the guide sleeve is located at:

[0030] fixed on the connecting section adjacent to the expansion section; or

[0031] fixed at the junction of the connecting section and the expansion section; or

[0032] The expansion section is fixed on the expansion section and is adjacent to the proximal end of the expansion section.

[0033] Preferably, the side wall of the guide sleeve is provided with a reinforcement area that contacts and cooperates with the free section.

[0034] Preferably, the reinforced area has a greater thickness than other peripheral areas.

[0035] Preferably, a reinforcement layer is provided in the side wall of the reinforcement area.

[0036] Preferably, the tube body includes an expansion section at the distal end for accommodating an interventional instrument, and a connecting section connected to the expansion section and extending toward the proximal end, and the distal end position of the free section is:

[0037] fixed on the connecting section adjacent to the expansion section; or

[0038] fixed at the junction of the connecting section and the expansion section; or

[0039] Fixed on the expansion section.

[0040] Preferably, the distal end of the free segment is fixed on the expansion segment and is adjacent to the proximal end of the expansion segment, or adjacent to the distal end of the expansion segment, or between the proximal end and the distal end of the expansion segment.

[0041] Preferably, the distal end of the free segment is fixedly connected to at least one of the outer wall, inner wall, and interlayer of the tube body.

[0042] Preferably, the tube body includes an expansion section at the distal end for accommodating the interventional instrument, and a connecting section connected to the expansion section and extending toward the proximal end.

[0043] A metal reinforcement structure is provided in the interlayer of the expansion section, and the distal end of the free section enters the interlayer of the expansion section and is fixedly connected to the metal reinforcement structure.

[0044] Preferably, the distal end of the free segment is fixed to the tube body by knotting, welding or bonding.

[0045] Preferably, the distal end of the free segment enters the inner cavity of the tube body from the outer wall of the tube body along the first penetration point, and then passes through the inner cavity along the second penetration point to exit the tube body, and is tied with the portion outside the tube body after passing through.

[0046] Preferably, the first penetration point is closer to the distal end of the tubular body, or closer to the proximal end of the tubular body, or the first penetration point is at the same axial position on the tubular body as the second penetration point.

[0047] Preferably, the free segment is one segment or multiple segments arranged at intervals.

[0048] Preferably, the traction wire forms a transition section between two adjacent free sections, and the transition section passes through the tube body.

[0049] Preferably, the tube body is provided with a reinforcement frame at least at the transition section.

[0050] Preferably, a sleeve is provided on the outside of the tube body, the sleeve and the tube body are axially slidably fitted together, and the sleeve is closer to the proximal end of the tube body than the guide member.

[0051] Preferably, the tube body includes an expansion section at the distal end for accommodating an interventional instrument, and a connecting section connected to the expansion section and extending toward the proximal end, and the sleeve is located on the periphery of the connecting section.

[0052] Preferably, the portion of the traction wire connected to the proximal end of the free segment is an extension segment, and the extension segment extends toward the proximal end in the gap between the tube body and the sleeve.

[0053] Preferably, the portion of the traction wire connected to the proximal end of the free segment is an extension segment, the connection between the free segment and the extension segment passes through the wall of the tube body, and the extension segment extends toward the proximal end inside the tube body.

[0054] Preferably, the proximal end side of the guide sleeve and the distal end side of the sleeve are adjacent to or butted against each other.

[0055] Preferably, the proximal end side of the guide sleeve and the distal end side of the sleeve are butted against each other and form an integral structure.

[0056] Preferably, the free section of the traction wire is located at the distal end of the tube body or adjacent to the distal end of the tube body.

[0057] The traction wire is free on the outer wall of the tube and connected to the distal end of the tube. The traction wire directly controls the tube and transmits the traction force more effectively.

[0058] Preferably, the traction wire is connected to the distal end of the tube or is less than 5 cm from the distal end. More preferably, it is less than 3 cm. Too far a distance will affect the pulling and bending effect.

[0059] Preferably, the free section of the traction wire is located from the middle of the tube body to the distal end of the tube body or adjacent to the distal end of the tube body.

[0060] The longer the free segment is, the less restraining force the sheath will exert, which will reduce the need for regulatory force and lower the pressure limit requirements for each load-bearing structural component, connector, and connection point.

[0061] Preferably, the free section of the traction wire is located from the proximal end to the distal end of the tube body or adjacent to the distal end of the tube body.

[0062] The completely independent traction wire is not affected by the bending deformation of the tube and directly controls the distal end.

[0063] Different sheaths have different distal structures. When the distal structure is not suitable for loading the pull wire, the connection point with the pull wire can be moved to a suitable position, and then the distal end can be driven to move in a linked manner.

[0064] The freeness mentioned above is mainly relative to the prior art in which the traction wire extends in a channel or cavity. The common way of freeness is to be suspended outside the tube body, at least with a greater degree of freedom, and to a certain extent can be separated from the outer wall of the tube body to maintain the pulling and tightening effect.

[0065] Freedom can also limit the traction wire to a certain extent, such as limiting the distance it leaves the outer wall of the tube body, or the angle relative to the axial direction of the tube body.

[0066] The sheath tube of the present invention can be used for delivering vascular stents, heart valve stents or other interventional devices.

[0067] In order to improve safety, the free section is covered with an anti-cutting protective layer.

[0068] The anti-cut protective layer can be made of a relatively soft material to prevent the traction wire from cutting the internal tissue when tightening. The anti-cut protective layer and the traction wire can be relatively fixed or can slide relative to each other, at least without causing adverse effects on the traction of the tube body.

[0069] Preferably, there are two or more traction wires. More preferably, the connection parts between the two or more traction wires and the tube body are evenly distributed around the circumference of the tube body.

[0070] In order to improve the connection between the traction wire and the tube body, preferably, the end of the traction wire is provided with a ring sleeve, and the ring sleeve is wound around the outer circumference of the tube body.

[0071] The tube body is pulled as a whole by the ring sleeve to avoid local stress concentration.

[0072] The ring sleeve is fixed on the outer wall of the tube body, or is rotatably sleeved on the outer wall of the tube body and is axially limited.

[0073] The ring sleeve can be fixed to the outer wall of the pipe body by welding or fastening the connector, etc. The rotating sleeve is arranged on the pipe body to facilitate the position of the adaptive force point when adjusting the bend.

[0074] For axial limitation, an axial limiting groove is provided on the outer wall of the tube body, and the ring sleeve is rotatably sleeved in the axial limiting groove.

[0075] For axial limitation, an axial limiting piece is provided on the outer wall of the tube body, and both axial sides of the ring sleeve are respectively blocked by the axial limiting piece.

[0076] Preferably, the axial limiter is a blocking hook or a threading ring to limit the axial position of the ring sleeve. There can be one or more axial limiters.

[0077] Preferably, the axial limiting member is a limiting step located on the outer wall of the tube body, or a limiting ring fixed on the tube body.

[0078] To facilitate matching the sheath's posture during traction and selecting an appropriate traction point, the traction wires may be two or more, for example, two, three, or four. In particular, if the traction wires are fixed relative to the tubular body, and if the traction wires or loops can change their circumferential position relative to the tubular body, then with only one traction wire, its traction point can be adjusted and adapted by traction.

[0079] Preferably, the ring sleeve is fixed to the outer wall of the tube body, and the ring sleeve is evenly distributed and connected with 2 to 4 traction wires in the circumferential direction.

[0080] When the ring sleeve is fixedly connected to the tube body, the ring sleeve can be fixed on the outer wall of the tube body or embedded in the inner side wall of the tube body.

[0081] Preferably, the ring sleeve and the traction wire are an integral structure, separate and fixedly connected or detachably connected.

[0082] When it is an integrated structure, the distal end of the traction wire is coiled into a ring and sealed and fixed. That is, the distal end of the traction wire is coiled to form the ring.

[0083] In the case of a non-integrated structure, the ring sleeve may be slightly wider in the axial direction in order to improve the strength, for example, the width of the ring sleeve in the axial direction is 1 to 5 mm.

[0084] In order to further control the posture of the sheath tube during delivery in the body to coordinate with the bending adjustment, preferably, reinforcing ribs are fixed inside the side wall of the tube body.

[0085] Preferably, a channel is provided in the side wall of the tube body, and a reinforcing rib extends along the entire body of the channel to the distal end, and the inner wall of the channel and the reinforcing rib are fixed to each other.

[0086] Preferably, there are two reinforcing ribs, and the pulling wire and the reinforcing ribs are spaced apart in the circumferential direction of the tube body.

[0087] More preferably, there are two traction wires and two reinforcing ribs, and the two reinforcing ribs are located on opposite sides of the axis of the tube body. On any cross section of the tube body, the angle between any reinforcing rib and the center of one of the traction wires is 30 to 150°.

[0088] Preferably, the central angle between any one of the reinforcing ribs and one of the traction wires is 80-100°.

[0089] Preferably, the pulling wires and reinforcing ribs are evenly distributed in the circumferential direction of the tube body.

[0090] Here, since one section of the traction wire is free, the position of the traction wire can be regarded as the connection part of the tube body. Since the connection part of the traction wire and the tube body may be changeable, the connection part of the traction wire and the tube body is fixed.

[0091] If the connection portion between the traction wire and the tube body is variable, for example, the ring sleeve is rotatably installed, then when the traction wire is pulled, the traction wire will adaptively change the fulcrum to reach the optimal traction position and implement bending adjustment.

[0092] The two reinforcing ribs are located on opposite sides of the axis of the tube body, that is, the two reinforcing ribs are located on two opposite sides of the tube body. In this way, the sheath is not easy to bend in the radial direction of the line connecting the two reinforcing ribs, and can only be bent in the direction of the mid-perpendicular line connecting the two reinforcing ribs. When the traction wire is pulled, the distal end of the sheath will inevitably and more easily bend in the direction that is most easily bent (the direction of the traction wire).

[0093] Of course, the two reinforcing ribs do not need to be arranged opposite each other. At any cross-section of the tube, the angle between the centers of the two reinforcing ribs is less than 180°, and the pull wire is located on one side of the radial line connecting any of the reinforcing ribs and the axis of the tube. This prevents the sheath from bending in the radial direction of the line connecting any of the reinforcing ribs and the axis of the tube. Therefore, when placing the pull wire, avoid distributing it in the radial direction of the line connecting any of the reinforcing ribs and the axis of the tube.

[0094] The distal end of the tubular body is an expansion section for accommodating an interventional device. Of course, the connection portion of the traction wire is located near the distal end of the expansion section.

[0095] In order to facilitate the threading and binding of the traction wire, in addition to the free section, the non-free part of the traction wire can be extended to the proximal end through a guide component. The guide component can be additionally provided or utilize the tube body itself.

[0096] The distal end of the tube body is an expansion section for accommodating an interventional instrument, and the traction wire is connected to the proximal side of the expansion section.

[0097] Interventional devices such as valves.

[0098] A section of the traction wire adjacent to the distal end is a developing section.

[0099] The developing section may contain developable components in the material, or be embedded, coated, or wrapped to achieve an effect that can be observed by a medical imaging system.

[0100] The length of the developing section is greater than that of the freeing section.

[0101] The length of the developing section is 12 to 20 cm.

[0102] The developing section has a sufficient length to indicate the turning position when the sheath is bent, so as to determine the approximate turning angle and direction.

[0103] The developing section has developing areas distributed continuously or a plurality of developing points distributed at intervals.

[0104] The present invention also provides an adjustable bend interventional valve delivery system, comprising the adjustable bend sheath, a sheath core placed in the adjustable bend sheath, and an operating handle connected to the proximal ends of the adjustable bend sheath and the sheath core, wherein the proximal end of the traction wire is connected to the operating handle.

[0105] The sheath core comprises a core tube, the distal end of which is provided with a loading section for placing interventional instruments. Before release, the expansion section of the bending sheath tube is located outside the loading section.

[0106] A guide head and an interventional instrument fixing head adjacent to the guide head are fixed at the distal end of the core tube, and the loading section is located between the guide head and the interventional instrument fixing head.

[0107] Preferably, the operating handle comprises:

[0108] A fixed body of a hollow structure;

[0109] a traction member slidably mounted in the fixed body and connected to the traction wire;

[0110] A driving mechanism mounted on the fixed body to drive the traction member to move;

[0111] A control mechanism installed on the fixed body to drive the bending sheath to move.

[0112] Preferably, the driving mechanism comprises:

[0113] A moving member that applies axial force against the pulling member;

[0114] An adjusting knob is sleeved on the fixed body and rotates around the axial direction of the fixed body. The adjusting knob is cylindrical and is located on the outer periphery of the moving part. The adjusting knob and the moving part are threadedly matched.

[0115] Preferably, the distal side fixing sleeve of the fixed body is provided with a front end handle, a hollow axial guide groove is provided on the front end handle, a portion of the movable part extends out of the axial guide groove, an external thread is provided on the extended portion, and a matching internal thread is provided inside the adjusting knob.

[0116] Preferably, there are at least two axial guide grooves, which are evenly distributed around the axis of the fixed body.

[0117] Preferably, the driving mechanism is an electric push rod, and is transmission-connected to the traction member.

[0118] Preferably, the control mechanism includes:

[0119] A control handle is rotated and mounted on the outside of the fixed body, wherein the inner wall of the control handle has an internal thread;

[0120] A transmission rod is slidably installed in the fixed body along the axis of the fixed body. The transmission rod is provided with linkage convex teeth matched with the internal thread of the control handle. The tube body of the bending sheath is connected to the transmission rod.

[0121] Preferably, a guide groove for guiding the axial movement of the linkage cam is provided on the fixed body.

[0122] Preferably, the traction member is an annular structure, and the transmission rod slides through the central area of ​​the traction member.

[0123] Preferably, the moving member is an annular structure and abuts against the distal end of the traction member, and the transmission rod slides through the central area of ​​the traction member.

[0124] Preferably, the control handle is provided with a limiting component for limiting the axial displacement of the transmission rod.

[0125] Preferably, the limiting component is movably mounted on the control handle, and has a limiting state in which it abuts against the linkage convex teeth, and a releasing state in which it avoids the linkage convex teeth.

[0126] Preferably, a mounting opening is provided on the side wall of the control handle, and the limiting component is movably embedded in the mounting opening.

[0127] Preferably, the limiting component is a rotatably mounted adjusting wheel;

[0128] The axial end surface of the adjusting wheel serves as a limiting surface, and in the limiting state, the limiting surface blocks the movement path of the linkage convex tooth;

[0129] The outer edge of the adjusting wheel is provided with an avoidance groove, and in the unlocked state, the avoidance groove corresponds to the movement path position of the linkage convex tooth.

[0130] Preferably, at least a portion of the outer edge of the adjusting wheel is located outside the installation opening, and an anti-slip structure is provided on the portion.

[0131] Preferably, the adjusting wheel is provided with an indicator indicating the state of the limiting component.

[0132] The traction wire in the bending sheath of the present invention has a section that is free outside the sheath body. It has a posture that is convenient for applying force when pulling. Through relative movement with the tube body, it can also adaptively change the point of force, which improves the safety and flexibility of operation when dealing with a larger turning radius or interventional instruments that are long, hard and difficult to bend. BRIEF DESCRIPTION OF THE DRAWINGS

[0133] Figure 1 This is a structural diagram of the use status of the bending sheath tube in the prior art;

[0134] Figure 2a This is a schematic structural diagram of the bending sheath tube of the present invention in use;

[0135] Figure 2b This is a structural schematic diagram of another usage state of the bending sheath tube of the present invention;

[0136] Figure 2c This is a structural schematic diagram of another usage state of the bending sheath tube of the present invention;

[0137] Figure 2d This is a structural schematic diagram of another usage state of the bending sheath tube of the present invention;

[0138] Figure 3 This is a schematic structural diagram of the distal end of the bending sheath tube of the present invention;

[0139] Figure 4 This is a schematic structural diagram of the distal end of another method of bending the sheath tube of the present invention;

[0140] Figure 5 This is a schematic structural diagram of the distal end of another method of bending the sheath tube of the present invention;

[0141] Figure 6 This is a schematic structural diagram of the distal end of another method of bending the sheath tube of the present invention;

[0142] Figure 7 A partial schematic diagram of the connection between the traction wire and the tube body in the bending adjustment sheath of the present invention;

[0143] Figure 8 Schematic cross-sectional view of the connection between the traction wire and the tube body in the bending adjustment sheath of the present invention;

[0144] Figure 9 Schematic diagram of the spacing distribution of the traction wire and the reinforcing ribs in the bending sheath of the present invention;

[0145] Figure 10 Schematic diagram of another spacing distribution of the traction wire and the reinforcing rib in the bending adjustment sheath of the present invention;

[0146] Figure 11 Schematic diagram of the structure of the adjustable bend interventional valve delivery system of the present invention;

[0147] Figure 12 for Figure 11 Cross-section at AA;

[0148] Figure 13 for Figure 11 Exploded view of the operating handle of the mid-adjustable interventional valve delivery system;

[0149] Figure 14 for Figure 11 Schematic diagram of the structure of the adjustable interventional valve delivery system before adjustment;

[0150] Figure 15 for Figure 14 Enlarged view of part D in the middle;

[0151] Figure 16 for Figure 11 Schematic diagram of the structure of the adjustable interventional valve delivery system after adjustment;

[0152] Figure 17 for Figure 16 Enlarged view of part E in the middle;

[0153] Figure 18 for Figure 11 A three-dimensional view of the operating handle of the mid-adjustable interventional valve delivery system;

[0154] Figure 19 for Figure 18 The diagram after the adjustment knob is omitted;

[0155] Figure 20 for Figure 19 Enlarged view of part F;

[0156] Figure 21 This is a schematic diagram of the structure of the operating handle of the bending sheath tube of the present invention after removing half of the control handle;

[0157] Figure 22 for Figure 21 A top view of

[0158] Figure 23 This is a schematic structural diagram of the adjusting wheel in the bending adjustment sheath tube of the present invention.

[0159] Figure 24 This is a schematic diagram of the structure of the adjustable bend interventional valve delivery system of the present invention after adding a guide member;

[0160] Figure 25 for Figure 24 Cross-section at the middle BB;

[0161] Figure 26 This is a schematic diagram of the structure of the free section and the tube body of the bending sheath tube before bending;

[0162] Figure 27 This is a schematic diagram of the structure of the free section and the tube body of the bending-adjusting sheath tube after bending;

[0163] Figure 28 This is a schematic diagram of the structure of the free section and the tube body after the bending is adjusted when a guide piece is added to the bending adjustment sheath tube of the present invention;

[0164] Figure 29 This is another structural schematic diagram of the free section and the tube body after the bending is adjusted when a guide piece is added to the bending adjustment sheath tube of the present invention;

[0165] Figure 30 This is another structural schematic diagram of the free section and the tube body after the bending is adjusted when a guide piece is added to the bending adjustment sheath tube of the present invention;

[0166] Figure 31 This is a schematic structural diagram of a bending sheath tube according to the present invention, in which a plurality of guide members are distributed at intervals along the axial direction of the tube body;

[0167] Figure 32This is a schematic structural diagram of a guide sleeve in a bending sheath tube of the present invention;

[0168] Figure 33 Schematic cross-sectional view of the guide sleeve in the bending sheath of the present invention having a rolled wall structure (state before deformation);

[0169] Figure 34 Schematic cross-sectional view of the guide sleeve in the bending sheath of the present invention having a rolled wall structure (in a deformed state);

[0170] Figure 35 This is a cross-sectional schematic diagram of a guide sleeve in a bending adjustment sheath according to the present invention provided with a flexible envelope membrane;

[0171] Figure 36 This is a schematic structural diagram of the present invention in which the free section of the bending sheath is restricted by a limiting ring on the inner side of the guide sleeve;

[0172] Figure 37 This is a schematic diagram of the structure in which the free section of the bending adjustment sheath is sewn onto the inner side of the guide sleeve;

[0173] Figure 38 This is a cross-sectional schematic diagram of a case where the guide sleeve in the bending sheath of the present invention is a cylindrical structure;

[0174] Figure 39a This is a schematic diagram of the connection between the distal end of the guide sleeve and the tube body in the bending sheath of the present invention;

[0175] Figure 39b This is another schematic diagram of the connection between the distal end of the guide sleeve and the tube body in the bending sheath of the present invention;

[0176] Figure 39c This is another schematic diagram of the connection between the distal end of the guide sleeve and the tube body in the bending sheath of the present invention;

[0177] Figure 39d for Figure 39c Enlarged view of part C;

[0178] Figure 40a Schematic diagram of the connection position between the distal end of the free segment and the tube body in the bending adjustment sheath of the present invention;

[0179] Figure 40b Another schematic diagram of the connection position between the distal end of the free segment and the tube body of the bending adjustment sheath of the present invention;

[0180] Figure 40c Another schematic diagram of the connection position between the distal end of the free segment and the tube body of the bending adjustment sheath of the present invention;

[0181] Figure 41 This is a schematic diagram of the structure in which the distal end of the free segment of the bending sheath is fixed to the tube body of the present invention;

[0182] Figure 42This is another structural schematic diagram of the present invention in which the distal end of the free segment of the bending sheath is fixed to the tube body;

[0183] Figure 43 Schematic diagram of the structure of the adjustable bend interventional valve delivery system of the present invention;

[0184] Figure 43a for Figure 38 Enlarged view of part a;

[0185] Figure 43b This is a schematic diagram of another knotting method at the distal end of the free segment;

[0186] Figure 43c This is a schematic diagram of another knotting method at the distal end of the free segment;

[0187] Figure 44 This is a structural diagram of the welding of the distal end of the free segment and the pipe body;

[0188] Figure 45 This is another structural diagram of the free segment distal end being welded to the tube body;

[0189] Figure 46 Schematic diagram of the distribution of multiple free segments;

[0190] Figure 47 This is a schematic diagram of the structure of the adjustable bend interventional valve delivery system of the present invention after adding a guide sleeve;

[0191] Figure 48 for Figure 47 Cross-section at AA;

[0192] Figure 49 for Figure 47 Enlarged view of part I. DETAILED DESCRIPTION

[0193] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0194] It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be an intermediate component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be an intermediate component.

[0195] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains. The terms used herein in the specification of the present invention are for the purpose of describing specific embodiments only and are not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0196] See also Figure 1 In the prior art, taking aortic valve replacement as an example, the interventional device is transferred and guided by the guide head 4 of the delivery system into the aorta 1, passing through the aortic arch and adjacent to the aortic valve 2. Before being released, the interventional device is wrapped in the sheath tube 3. Figure 1 The figure shows the position and orientation of the aortic valve 2 in a normal physiological structure. By using a sheath that can be bent at the distal end in the prior art, the distal end of the delivery system can be bent and the guide head 4 can be directed to the aortic valve 2.

[0197] See also Figure 2a ,Due to the lesions, some special occasions may require the delivery system to bend more at the distal end, e.g. Figure 2a The direction of the middle aortic valve 2 changes, and the bending amplitude of the distal end of the delivery system is close to 270 degrees. In this state, since the distal aortic valve stent is long and rigid and difficult to bend, it is difficult to adjust the bend using existing technologies and means. The bending adjustment targeted by the present invention does not necessarily emphasize the degree of bending. The focus is on making the bending adjustment more labor-saving and convenient through structural improvements, and the adjustable amplitude range is larger.

[0198] The present invention adopts a bending adjustment sheath, which includes a tube body 3, which has a distal end and a proximal end. A traction wire 8 is further connected to the tube wall of the tube body 3 near the distal end. One end of the traction wire 8 extends toward the proximal end of the tube body 8, and the other end is near the distal end of the tube body 3, with at least a section free outside the tube body 3. In order to improve the connection strength between the traction wire 8 and the tube body 3 and avoid local stress concentration, the end of the traction wire 8 is provided with a collar 9, which is wrapped around the outer circumference of the tube body 3. The tube body 3 is pulled as a whole by the collar 9. The tube body 3 near the distal end is an expansion section for accommodating interventional instruments, and the collar 9 is correspondingly located on the distal side of the expansion section.

[0199] exist Figure 2a In the present invention, since the traction wire 8 has one end free outside the tube body 3, and the traction wire is connected to the end portion of the sheath or is less than 3 cm away from the end portion, the free portion has a greater degree of freedom and can be separated from the outer wall of the tube body to a certain extent to maintain the pulling and tightening effect, a larger bending adjustment range can be obtained, and the operating feel is also significantly improved.

[0200] Figure 2bIn another embodiment, a sleeve 12 is provided on the outer wall of the tube body 3 , and the non-free section 8d extends along the gap between the sleeve 12 and the tube body 3 , and transitions to the free section 8c at the opening of the sleeve 12 .

[0201] Relative to Figure 2a ,exist Figure 2c In another embodiment, a sleeve 12 is provided on the outer wall of the tube body 3, and the traction wire 8 extends along the gap between the sleeve 12 and the tube body 3, transitioning to a free section at the opening of the sleeve 12. The tube body 3 is an expansion section for loading interventional instruments near the distal end, and the traction wire 8 is connected to the middle of the expansion section.

[0202] Relative to Figure 2c ,exist Figure 2d In another embodiment, the traction wire 8 is connected to the proximal side of the expansion section.

[0203] See also Figure 3 The delivery system of the present invention includes a bending adjustment sheath, a sheath core 5 placed in the tube body 3 of the bending adjustment sheath, and an operating handle fixed to the proximal ends of the bending adjustment sheath and the sheath core, and the proximal end of the traction wire 8 is connected to the operating handle.

[0204] The sheath core 5 comprises a core tube, to which a guide head 4 and an interventional instrument fixing head 7 are fixed. The portion of the core tube between the guide head 4 and the interventional instrument fixing head 7 serves as a loading section for placing the interventional instrument. Before release, the expanded section of the tube body 3 is located outside the loading section. A cannula 12 is provided on the outside of the tube body 3, which slides axially with the tube body 3. A traction wire 8 extends proximally through the gap between the tube body 3 and the cannula 12.

[0205] The distal end of the cannula 12 is an open mouth, and the traction wire 8 is free outside the tube body 3 after extending out of the open mouth until it is connected to the ring sleeve 9 at the distal end of the tube body 3. In order to improve the strength of the open mouth, a reinforcing ring 11 can be provided to prevent the open mouth from being partially torn when the traction wire 8 is tightened.

[0206] See also Figure 4 In another embodiment, a sleeve 12 is provided on the outside of the tube body 3 , and the sleeve 12 and the tube body 3 are axially slidably fitted together, and the traction wire 8 extends toward the proximal end through the gap between the tube body 3 and the sleeve 12 .

[0207] See also Figure 5 , relative to Figure 4 In another embodiment, there are two traction wires, namely traction wire 8a and traction wire 8b, which are connected to each other at the distal end to a ring structure. The ring itself can be fixed on the outer wall of the tube body or embedded in the side wall of the tube body.

[0208] See also Figure 6 , relative to Figure 4In another embodiment, the ring sleeve 9 is slightly closer to the proximal end to prevent the distal end of the tube body 3 from splitting. The axial width of the ring sleeve 9 is 1 to 5 mm, and it is roughly a flat strip when unfolded.

[0209] In another embodiment, the annulus and the traction wire are an integral structure, that is, the distal end of the traction wire itself is coiled into a ring shape and is sealed and fixed.

[0210] Figure 6 The middle ring sleeve 9 is rotatably sleeved on the outer wall of the tube body 3 and is axially limited. The axial limitation method can adopt an axial limiting groove or an axial limiting piece on the outer wall of the tube body.

[0211] See also Figure 7 and Figure 8 The distal end of the tube body 3 is provided with a limiting ring 17, which can be a thickened area of ​​the tube body 3 itself, or an additional annular component fixed to the tube body 3. An axial limiting groove is provided on the outer periphery of the limiting ring 17, and the ring sleeve 9 is rotatably installed and fitted in the axial limiting groove. During installation, the ring sleeve 9 can be directly inserted into the axial limiting groove by means of elastic deformation, and the traction wire is connected to the ring sleeve 9. When the traction wire is pulled, if the posture of the tube body 3 is not ideal, that is, the fulcrum is not on the inside of the desired turning part, the ring sleeve 9 is rotated after being subjected to force until the connection part between the traction wire and the ring sleeve 9 rotates to the inside of the expected bending part. At this time, further force is applied to pull to obtain an ideal bending effect.

[0212] See also Figure 9 In another embodiment, in order to further control the posture of the sheath tube when being delivered in the body to coordinate with the bending adjustment, a reinforcing rib 32 is further provided in the side wall of the tube body 3.

[0213] The reinforcing ribs 32 can be directly attached to the inner wall of the tube body 3; alternatively, a channel can be provided in the side wall of the tube body 3, with the reinforcing ribs 32 extending along the channel to the distal end. Furthermore, when the reinforcing ribs 32 extend along the channel, they can be free from the inner wall of the channel or fixed to the inner wall of the channel.

[0214] In the figure, two reinforcing ribs 32 are provided axially within the tubular body 3. These ribs 32 are fixed to the sidewalls of the tubular body 3 to enhance the axial propulsion force of the sheath. The two ribs 32 are arranged opposite each other within the tubular body 3, such that the line connecting the two ribs 32 passes approximately through the axis of the tubular body 3. In one embodiment, two traction wires are provided, namely, traction wire 8a and traction wire 8b. The two traction wires and the two reinforcing ribs 32 are spaced apart and evenly distributed circumferentially around the tubular body 3.

[0215] The non-free section of the traction wire is guided inside the sheath (ie, is located in the radial gap between the sheath core 21 and the tube body 3). The figure only illustrates the cross-sectional area of ​​the portion of the traction wire guided inside the sheath.

[0216] like Figure 10 As shown, in one embodiment, two pull wires are located near the same reinforcement rib. The central angle A corresponding to the span between the pull wire 8a and the adjacent reinforcement rib is less than 90 degrees. However, the central angle A should not be too small to avoid affecting the bending adjustment. On any cross section of the tube body, the central angle between any reinforcement rib and one of the pull wires should be greater than 30 degrees, and is generally set to be greater than 60 degrees.

[0217] Regardless of how the traction wire is arranged, it should be spaced apart from the reinforcing ribs 32. Since one section of the traction wire is free, the position of the traction wire can be considered the connection point with the tube body 3. If the connection point between the traction wire and the tube body 3 is variable, such as by a rotatable loop, the position of the traction wire can be considered the traction position that is adaptively reached when the traction wire is pulled tight.

[0218] When the delivery system needs to be bent, the traction wire can be pulled, and the tension of the traction wire can cause the distal end of the tube body 3 to bend. Since two reinforcing ribs 32 are arranged opposite to each other in the tube wall of the sheath tube, the reinforcing ribs 32 enhance the radial force of the tube body 3. The cross section of the reinforcing rib 32 is a strip. The tube body 3 cannot bend in the length direction of the reinforcing rib cross section, but can only bend in the thickness direction of the reinforcing rib 32. In other words, the bending direction of the tube body 3 is limited. Since the traction wire and the reinforcing rib 32 are spaced apart in the circumferential direction, when the traction wire is pulled, the distal end of the sheath tube will inevitably and easily bend in the direction of the traction wire. Through pulling and rotating operations, the distal end of the sheath tube is more easily bent in the target direction.

[0219] Of course, the two reinforcing ribs 32 do not need to be arranged opposite each other. At any cross-section of the tubular body 3, the central angle between the two reinforcing ribs 32 is less than 180°. However, it should be noted that when placing the traction wire, since the sheath is not easily bent in the radial direction of the line connecting each reinforcing rib 32 and the axis of the tubular body 3, it is necessary to avoid distributing the traction wire in the radial direction of the line connecting any one reinforcing rib 32 and the axis of the tubular body 32.

[0220] In another embodiment, a developing section is provided at one section of the traction wire adjacent to the distal end. The developing section may contain a developable component in a material, or be embedded, coated, or wrapped to achieve an effect that can be observed by a medical imaging system.

[0221] Since there is a free section in the traction wire that is free outside the tube body, in the bending state, the extension path of the free section is different from that of the tube body 3. Therefore, in order to avoid misjudgment of the direction of the tube body 3, the length of the developing section is set to be greater than the length of the free section.

[0222] According to the general use length of the sheath tube, the length of the developing section is set to be greater than 12 cm.

[0223] It's easy to understand that the longer the developing segment on the traction wire, the more helpful it is in indicating the turning point during sheath bending, thereby helping to determine the approximate turning angle and direction. Therefore, the developing segment is provided with continuously distributed developing areas, forming a continuous indicating route. In another embodiment, the developing segment is provided with multiple developing points spaced apart, and the extension direction of the tube body 3 can be roughly determined by using these spaced developing points.

[0224] See also Figure 11 , Figure 12 The delivery system of the present invention also includes an operating handle 19, a sleeve 12 is slidably provided on the outside of the tube body 3 of the bending sheath tube, a sheath core 21 is provided inside the tube body 3, the distal end of the sheath core 21 extends out of the tube body 3 and is provided with a guide head 4.

[0225] The distal end of the traction wire 8 moves free for a while, enters the gap between the sleeve 12 and the tube body 3, and extends toward the proximal end to the operating handle.

[0226] See also Figure 13 The operating handle includes a fixed body 30 with a hollow structure. The fixed body 30 is a split structure composed of two petals buckled together. The fixed body 30 is a hollow structure. The tube body 3 and the sheath core 21 both pass through the inside of the fixed body 30.

[0227] The side wall of the fixed body 30 has a hollow guide groove, and a transmission rod 28 is slidably installed in the fixed body 30. A linkage convex tooth is fixed on the outer wall of the transmission rod 28, and the linkage convex tooth extends out of the guide groove. A control handle 25 is rotatably sleeved on the outside of the fixed body 30. The control handle 25 is a split structure composed of two petals that are buckled together. The control handle 25 has an internal thread and cooperates with the linkage convex tooth. The rotation of the control handle 25 can drive the transmission rod 28 to move axially. The tube body 3 is connected to the transmission rod 28 through a sheath connector, and is then driven by the transmission rod 28.

[0228] The transmission rod 28 is also an axially through-hole structure, through which the sheath core 21 passes, extending and connecting to the proximal end of the fixed body 30. The distal end of the fixed body 30 is fixedly mounted with a front handle 23, and the distal end of the front handle 23 is mounted with the front cap 22. The proximal end of the cannula 12 is connected to a sliding seat 12a, which is movably connected to the front cap 22. Both the front handle 23 and the front cap 22 are split structures, consisting of two snap-fitting halves.

[0229] The outside of the transmission rod 28 is respectively slidably covered with a traction member 27 and a moving member 26, wherein the traction member 27 is connected to the traction wire 8, and the moving member 26 is abutted against the distal side of the traction member. A hollow axial guide groove is provided on the front end handle 23, and a part of the moving member 26 extends out of the axial guide groove, and an external thread is provided on the extended part. An adjusting knob 24 is rotatably installed on the front end handle 23. The adjusting knob 24 is a split structure composed of two petals buckled together, and the inner wall of the adjusting knob 24 is provided with an internal thread that matches the external thread of the moving member 26.

[0230] See also Figures 14 to 20 When the bend needs to be adjusted, the adjusting knob 24 is rotated to drive the moving member 26 to move axially, and then the traction wire 8 is driven by the traction member 27 to move. The distal end of the tube body 3 is driven by the traction wire 8 to present Figure 16 In the bending state shown, the angle M can be adjusted between 52 and 180 degrees, and the axial stroke of the traction member 27 can be between 1 and 30 mm. That is, when the maximum stroke is reached, the angle M is the smallest.

[0231] In order to indicate the turning point when the sheath is bent, the traction wire 8 is divided into a developing section near the distal end. The length of the developing section is 12 to 20 cm, for example, 15 cm. In the unbent state, at least a part of the proximal end of the developing section extends into the sleeve, so that even with a slight bend, the angle can be observed by the medical imaging system.

[0232] After the interventional device is delivered to the predetermined position, the sheath is driven to retreat by the control handle 25. As the sheath retreats, the interventional device is gradually released. In the early stage of release, if it is found that the posture or position of the interventional device needs to be adjusted, the sheath can be pushed forward to retract the interventional device, that is, to recover the interventional device. The closer to the end point of release, the more difficult it is to recover.

[0233] After the release begins, the free section of the traction wire will gradually relax as the tube body 3 retreats. The force exerted by the relaxed free section on the tube body 3 will decrease, and the bending angle will change accordingly. This will cause the position of the expanded end of the tube body 3 to change after the initial bending. The limiting component can prompt the operator to adjust the tightness of the traction wire when the interventional instrument can still be recovered during the release process, so as to drive the sheath to return to the previous bending state and maintain the position and posture of the interventional instrument.

[0234] See also Figure 21 In another embodiment, the control handle 25 is provided with a limiter to restrict the axial displacement of the transmission rod 28. As previously mentioned, the transmission rod 28 is connected to the tubular body 3 via the sheath connector. Therefore, limiting the axial displacement of the transmission rod 28 limits the retraction of the tubular body 3, thereby prompting the operator to further confirm the posture or position of the interventional instrument during the release process.

[0235] Of course, in order to continue to retract the tube body 3, a limiting component is movably installed on the control handle 25, and the limiting component has a limiting state of abutting against the linkage convex tooth 281, and a releasing state of avoiding the linkage convex tooth 281.

[0236] When the limiting component is in the limiting state, the limiting component blocks the path of the linkage protruding tooth 281 moving along the guide groove 301 of the fixed body 30, so as to limit the transmission rod 28 from continuing to drive the tube body 3 to retreat; when the limiting component is in the unlocking state, the limiting component avoids the path of the linkage protruding tooth 281 moving along the guide groove 301 of the fixed body 30, so as to allow the transmission rod 28 to continue to drive the tube body 3 to retreat until the bracket is released.

[0237] In another embodiment, two linkage protruding teeth 281 are arranged opposite to each other on the transmission rod 28 . In order to achieve the best limiting effect, two limiting components are also arranged opposite to each other on the control handle 25 .

[0238] The limiting component must not only rotate with the control handle 25, but also pass through the side wall of the control handle 25 and cooperate with the linkage protruding teeth 281. In order to facilitate the movable installation of the limiting component, an installation opening is opened on the side wall of the control handle 25, and the limiting component is movably embedded in the installation opening.

[0239] Combine Figure 22 As shown, in one embodiment, a pivot is provided at the mounting opening of the control handle 25, and the limiting component is an adjustment wheel 33 rotatably mounted on the pivot. The adjustment wheel 33 fits tightly against the pivot and does not rotate in the absence of external interference. However, upon application of a certain external force, the adjustment wheel 33 can rotate to a specified angle.

[0240] When driving the adjusting wheel 33 to rotate, an external force can be applied directly to the adjusting wheel 33, or a transmission component can be used to drive the adjusting wheel 33 to rotate. In order to simplify the structure of the control handle 25, at least a portion of the outer edge of the adjusting wheel 33 is arranged outside the mounting opening to facilitate direct application of rotational force to the adjusting wheel 33.

[0241] Furthermore, in another embodiment, an anti-slip structure is provided on the exposed portion of the adjustment wheel 33 to prevent slipping during rotation of the adjustment wheel 33. The anti-slip structure may be stripes, grooves, etc. provided on the adjustment wheel 33, or an anti-slip material, such as an anti-slip pad, may be added to the adjustment wheel 33 by embedding, coating, or covering the adjustment wheel 33.

[0242] Since the adjusting wheel 33 switches between the limit state and the unlock state by rotation, the portion of the adjusting wheel 33 outside the mounting opening changes relative to the adjusting wheel 33 as a whole. In other words, the portion of the adjusting wheel 33 outside the mounting opening is called the exposed portion, and the exposed portion is provided with an anti-slip structure.

[0243] See also Figure 23The axial end face of the adjusting wheel 33 serves as a limiting surface 331, which blocks the movement path of the linkage convex tooth 281 in the limiting state; an avoidance groove 332 is provided on the outer edge of the adjusting wheel 33, which corresponds to the movement path of the linkage convex tooth 281 in the unlocking state, allowing the linkage convex tooth 281 to continue to move through the avoidance groove 332.

[0244] Rotation of the adjusting wheel 33 switches the position of the avoidance groove 332 or the limiting surface 331. Because both the avoidance groove 332 and the interlocking protruding tooth 281 have a certain width, the interlocking protruding tooth 281 can only pass through when the avoidance groove 332 is in the correct position. In another embodiment, to quickly locate the correct position of the avoidance groove 281, a marking is provided on the adjusting wheel 33. This marking indicates the current state of the limiting component, facilitating rapid switching between the limiting and unlocking states of the adjusting wheel 33.

[0245] See also Figure 24 and Figure 25 In another embodiment, in order to prevent the free segment of the traction wire 8 from cutting the aorta and improve safety, the bending adjustment sheath used in the present invention is also provided with a guide 13, which acts between the tube body 3 and the free segment and is used to limit the gap between the tube body 3 and the free segment during bending.

[0246] The guide member 13 acts between the tube body 3 and the free section, which can be understood as applying a force on both.

[0247] The free segment, as part of the traction wire 8, is located outside the tube body 3 and creates a radial gap between it and the tube body 3 during bending. When subjected to force, the radial gap between the free segment and the tube body 3 changes, maintaining the pulling and tightening effect to achieve the desired bending range. The force exerted by the guide member to limit the gap between the free segment and the tube body 3 is controlled to a level that at least does not adversely affect the pulling of the tube body 3.

[0248] See also Figure 26 , the distance between points A and B on the tube 3 is set to L0, and the traction wire 8 passes through the tube 3 at points A and B, forming a free segment 8c with a length of M0. At this time, the free segment 8c and the tube 3 are both in the initial state, and L0 ≈ M0.

[0249] See also Figure 27 In order to intuitively reflect the bending state of the tube body 3 and facilitate subsequent qualitative analysis, the thickness of the tube body 3 is omitted in the figure.

[0250] As can be seen from the figure, when the free segment 8c is tightened by force, it drives the AB segment of the tube body 3 to bend. Assuming that the arc formed by the bending of the AB segment of the tube body 3 is a semicircle, according to the formula for the circumference of a circle: C = 2πr, it can be calculated that the distance by which the free segment is shortened relative to the initial length in order to maintain the arc segment AB in a semicircular state can be calculated.

[0251] The calculation process is: Since the chord of the semicircle is the diameter, the line segment AB is the diameter. Let the length of the line segment AB be M1, then have to

[0252] It can be obtained that the distance shortened by the free section 8c is M0-M1≈L0-0.64L0=0.36L0.

[0253] It can be seen that when the arc formed by the AB section of the tube body needs to be bent into a semicircular state, the distance that the free section 8c needs to be shortened by pulling is 0.36L0, that is, the length of the traction wire 8 that needs to be pulled at the operating handle is 0.36L0.

[0254] Relative to Figure 27 In terms of Figure 28 In the figure, a guide member 13 is provided between the free section 8c and the tube body 3. For the convenience of calculation, the guide member 13 is provided on the center line of the line segment AB and at point C where it intersects with the arc AB.

[0255] For the convenience of calculation, the thickness of the tube body 3 is still ignored in this figure, and it is known that the central angle corresponding to the arc AB is still 180 degrees, the length is L0, and the line segment AB is still the diameter of the circle where the arc AB is located, and the length is M1.

[0256] The guide member 13 limits the gap between the free segment 8c and the tubular body 3, keeping the radial gap between them small. Under the restraining action of the guide member 13, the free segment 8c forms a line segment ACB. To facilitate qualitative deduction of the shortened distance of the free segment 8c, assume that at point C, the free segment 8c is infinitely close to the tubular body 3.

[0257] Then ΔABC is an inscribed triangle, ∠ACB = 90°, and line segment AC is equal to line segment CB.

[0258] Therefore, the length of the free segment 8c in the tensioned state is

[0259] Since it has been proved above that M1≈0.64L0, then M2≈1.41M1=1.41×0.64L0≈0.90L0.

[0260] It can be seen that, under the action of the guide member 13, the distance that the free section 8c is shortened is M0-M2≈L0-0.90L0=0.10L0.

[0261] It can be seen that when the arc formed by the AB section of the tube body needs to be bent into a semicircular state, the distance that the free section 8c needs to be shortened by pulling is 0.10L0, that is, the length of the traction wire 8 that needs to be pulled at the operating handle is 0.10L0.

[0262] compared to Figure 27 and Figure 28According to the derivation result, when the AB segments of the tube body 3 are driven to bend to the same arc, when a guide member 13 is provided for bending adjustment, the shortening distance of the free segment 8c is smaller, that is, the operating handle needs to pull a smaller length of the traction wire 8, which not only facilitates the bending operation, but also can further improve the bending sensitivity and enhance the bending effect.

[0263] Further, see Figure 29 , two guide members 13 are provided between the free section 8c and the tube body 3. The same as above is that: the central angle corresponding to the known arc AB is 180 degrees, the length is L0, and the line segment AB is still the diameter of the circle where the arc AB is located, and the length is M1.

[0264] For ease of calculation, the thickness of the tube 3 is still neglected in this figure, and it is assumed that at points C and D, the free section 8c is infinitely close to the tube 3. The guide members 13 are arranged at points C and D so that the resulting ΔACO, ΔCOD, and ΔOBD form an equilateral triangle, with point O being the center of the circle containing arc AB.

[0265] Based on the above settings, it can be obtained that when the two guide members 13 are limited, the length M2 of the free section 8c is:

[0266] Since it has been proved above that M1≈0.64L0, then M2=1.5M1≈1.5×0.64L0≈0.96L0.

[0267] It can be seen that, under the action of the two guide members 13, the distance M0-M2 shortened by the free section 8c is M0-M2≈L0-0.96L0=0.04L0.

[0268] It can be seen that when the arc formed by the AB section of the tube body needs to be bent into a semicircular state, the distance that the free section 8c needs to be shortened by pulling is 0.04L0, that is, the length of the traction wire 8 that needs to be pulled at the operating handle is 0.04L0.

[0269] Compared to Figure 27 and Figure 28 The derivation results, in Figure 29 When the AB sections of the tube body 3 are bent to the same arc and a guide member 13 is provided for bending adjustment, the shortening distance of the free section 8c is smaller, that is, the length of the traction wire 8 that the operating handle needs to pull is smaller.

[0270] Overview Figures 27 to 29 When a guide member 13 is set between the free section 8c and the tube body 3, the distance the traction wire 8 is pulled becomes smaller when the tube body 3 reaches the same bending degree, and the more guide members 13 are set, the greater the degree to which the pulling distance of the traction wire 8 becomes smaller.

[0271] See also Figure 30It can be seen that when more guide members 13 are set between the free section 8c and the tube body 3, the more significant the limiting effect of the guide members 13 on the extension direction of the free section 8c is, that is, the better the sensitivity of the bending adjustment is.

[0272] See also Figure 31 To better utilize the guide member 13, in one embodiment, multiple guide members 13 are spaced apart along the axial direction of the tube body, forming multiple guide points for defining the gap between the tube body 3 and the free section 8c. These multiple guide points restrict the extension direction of corresponding portions of the free section 8c, thereby defining the gap between the free section 8c and the tube body 3.

[0273] As can be seen from the figure, the three guide members arranged at intervals outside the tube body 3 are guide member AB, guide member CD, and guide member EF. The spacing between these three guide members can be set to be the same or different, that is, when multiple guide members 13 are distributed outside the tube body 3, the spacing between two adjacent guide members 13 can be the same, different, or partially the same, and the freedom of setting of the guide members 13 is relatively large.

[0274] Not only that, the lengths of the guide members AB, CD and EF can be the same or different or partially the same, that is, when multiple guide members 13 are distributed outside the tube body 3, the lengths of each guide member 13 can be the same or different or partially the same, and the freedom of setting the specifications of the guide members 13 is relatively large.

[0275] Furthermore, if the guide member EF is the most distal guide member, the distal end of the free segment 8c may be within the range where the guide member EF is located, or may extend beyond the guide member EF to a more distal end.

[0276] If the guide member AB is the most proximal guide member, the proximal end of the free segment 8c may be within the range where the guide member AB is located, or may extend out of the guide member AB to a more proximal end.

[0277] In order to adapt to the change of the gap between the tube body 3 and the free section 8c, the guide member 13 adopts a radially expandable structure, which has a pre-deformation state in which the free section 8c is tightened to the outer wall of the tube body, and a post-deformation state in which the free section 8c is partially separated from the tube body.

[0278] When the free segment 8c is not pulled, the guide member 13 tightens the free segment to the outer wall of the tube body, which on the one hand prevents the free segment from being exposed and cutting or scratching the aorta, and on the other hand makes the overall structure compact, making it easier for the delivery system to enter the aorta.

[0279] When the free section 8c is pulled, the gap between it and the tube body 3 changes, generating a radially outward force on the guide member 13 that tightens it. Since there is a constraint structure between the guide member 13 itself and the tube body 3, after being subjected to the force of the free section 8c, the constraint structure still has a constraint effect on the guide member 13. Therefore, the guide member 13 is partially separated from the tube body after being acted upon by the free section, forming a spatial structure with multiple intervals that limit the gap between the free section and the tube body.

[0280] See also Figure 32 , relative to Figure 31 In another embodiment, the guide members 13 are continuously distributed along the axial direction of the tube body to form a guide channel for defining the gap between the tube body 3 and the free section. The guide channel constituting the guide channel limits the extension direction of the free section 8c as a whole.

[0281] It should be noted that when the guide member 13 forms a continuous guide channel, the guide channel can be formed by one guide member 13 extending and distributed along the axial direction of the tube body, or can be formed by multiple guide members continuously spliced ​​and distributed.

[0282] In order to better guide the free section 8c, the guide member 13 adopts a guide sleeve 14 connected to the outer periphery of the tube body and wrapping the free section.

[0283] As can be seen from the figure, the guide sleeve 14 is provided with two ends A and B. Assuming A is the proximal end of the guide sleeve 14 and B is the distal end of the guide sleeve 14, the distal end of the free segment 8c can be located in the area of ​​the guide sleeve 14, or it can extend to the distal end through the B end. The proximal end of the free segment 8c can be located in the area of ​​the guide sleeve 14, or it can extend to the proximal end through the A end.

[0284] The guide sleeve 14 itself is configured as a radially expandable structure to better define the gap between the tube body 3 and the free section.

[0285] To simplify the structure of the guide sleeve 14, in one embodiment, the guide sleeve 14 is made of an elastic material, partially or entirely. The elastic material is sufficiently elastic to satisfy both a pre-deformation state in which the free segment is forced to abut against the outer wall of the tube body, and a post-deformation state in which the free segment partially separates from the tube body.

[0286] When the guide sleeve 14 is in the deformed state, it needs to be continuously acted upon by the free section 8c to maintain this state. When the action of the free section 8c changes, the degree of partial separation between the guide sleeve 14 and the tube body 3 will also change accordingly. When the action of the free section 8c disappears, the guide sleeve 14 will, under the action of the elastic force of the elastic material, drive the free section 8c against the outer wall of the tube body 3 to restore to the state before deformation.

[0287] See also Figure 33In another embodiment, the guide sleeve 14 has a coiled wall structure, i.e., the cross-section of the guide sleeve 14 is coiled. The coiled wall structure causes the guide sleeves 14 to partially overlap in the circumferential direction. The guide sleeves 14 can have a deformed state in which the free segments partially separate from the tube body and the coiled wall structure at the corresponding portion is deployed; and a pre-deformed state in which the coiled wall structure self-restores, forcing the free segments to abut against the outer wall of the tube body.

[0288] The guide sleeve 14 in the pre-deformation state wraps the free section tightly against the outside of the tube body.

[0289] In order to drive the free section to stick to the outer wall of the tube body, the rolled wall structure in the state before deformation is rolled around more than a circle, and the part beyond the 360-degree circumference overlaps with the part within 360 degrees.

[0290] That is, in the same cross-section of the guide sleeve 14 before deformation, the tube wall extends circumferentially over 360 degrees from the winding starting side 14a to the winding ending side 14b, and the areas extending over 360 degrees overlap. As can be seen from the figure, the trailing side 14b of the guide sleeve 14 extends beyond the starting side 14a by one circumference and overlaps the outer circumference of the starting side 14a, forming a complete channel within the guide sleeve 14.

[0291] Since the guide sleeve 14 is required to restore the pre-deformation state of the rolled wall structure when not affected by the free section, the overlapping parts have smooth contact surfaces, that is, there are no shapes or components that block each other and affect the restoration.

[0292] like Figure 34 As shown, when the rolling wall structure is subjected to the radial force of the free section 8c, the overlapping parts of the rolling wall structure unfold accordingly, but the winding of the rolling wall structure is still greater than or equal to 360 degrees, that is, when the guide sleeve 14 is in the pre-deformation state or the post-deformation state, the rolling wall structure always has partial overlap to maintain a complete channel, prevent the free section 8c from being exposed, and ensure safety.

[0293] See also Figure 35 In order to enable the rolled wall structure to switch more smoothly between the deformed state and the pre-deformed state, the starting side 14a and the ending side 14b of the rolled wall structure wound in the circumferential direction are connected by a flexible envelope membrane 15, ensuring that it can recover by itself after the external force is removed and maintain a certain strength and compliance.

[0294] The flexible envelope 15 primarily provides radial support, preventing the rolled wall structure from over-expanding under the radial force of the free section 8c and thereby losing the effectiveness of the guide sleeve 14. It also enhances the sealing properties of the guide channel formed by the guide sleeve 14, preventing the free section 8c from slipping out of the guide sleeve 14 through the gap between the overlapping start side 14a and the end side 14b.

[0295] Since the flexible envelope 15 needs to be folded or twisted when the guide sleeve 14 switches states, its wall thickness and rigidity are lower than those of the guide sleeve 14. In this embodiment, the flexible envelope 15 is made of PTFE material with a wall thickness of 0.25-0.5 mm.

[0296] No matter what state the guide sleeve 14 is in, the flexible envelope 15 can keep the guide sleeve 14 closed. The flexible envelope 15 can be fixed to the guide sleeve 14 by welding or other methods.

[0297] To accommodate the flexible envelope 15, it is positioned in the middle layer of the overlapping portion of the guide sleeve 14. The flexible envelope 15 can extend somewhat circumferentially, meaning it does not completely enclose the entire inner cavity of the guide sleeve 14. Before the guide sleeve 14 is deformed, the flexible envelope 15 is stretched taut between the starting and ending sides 14a, 14b of the guide sleeve 14. The attachment points of the flexible envelope 15 to the guide sleeve 14 are not strictly required to be at the starting and ending sides 14a, 14b and can be adjusted as appropriate.

[0298] In another embodiment, in order to establish a constraint structure between the guide sleeve 14 and the tubular body 3 , at least a portion of the guide sleeve 14 is fixed to the tubular body 3 .

[0299] Since the guide sleeve 14 needs to partially follow the free section 8c away from the tube body 3 when limiting the tube body 3 and the free section 8c, in order to adapt to the changes in the gap between the guide sleeve 14 and the tube body, the distal end and the proximal end of the guide sleeve 14 are fixed on the outer periphery of the tube body 3, and the part between the distal end and the proximal end of the guide sleeve 14 is suspended on the outer periphery of the tube body 3.

[0300] The guide sleeve 14 can be connected and fixed to the tube body 3 by welding or bonding, and the portion between the distal end and the proximal end of the guide sleeve 14 is suspended on the outer periphery of the tube body 3. Its suspension can be understood as there is no additional constraint or connection between the guide sleeve 14 and the tube body 3, and the relative position with the tube body 3 is maintained only by the strength or elasticity of the guide sleeve 14 itself. For example, when the guide sleeve 14 is made of elastic material, it can be tightened to the outer periphery of the tube body 13.

[0301] The distal end and the proximal end of the free segment 8c are constrained by the tube body 3 or are constrained by external force to be attached to the tube body 3. Therefore, after the free segment 8c is subjected to a pulling force, the free segment 8c is in a taut state, and the corresponding position of the tube body 3 is in a naturally bent state. The guide sleeve 14 can achieve a limiting effect on the overall gap between the tube body 3 and the free segment by limiting the gap between the tube body 3 and the free segment at any position in the axial direction. Therefore, in one embodiment, at least a portion of the free segment 8c is in the radial gap between the tube body 3 and the guide sleeve 14, and the free segment 8c is partially guided by the guide sleeve 14, that is, the gap between the free segment 8c and the tube body 3 is partially limited by the guide sleeve 14, so that the gap is limited as a whole, so as to achieve the expected limiting effect.

[0302] Of course, in order to obtain the best limiting effect and the best safety performance, in another embodiment, the free section 8c is entirely located in the radial gap between the tube body 3 and the guide sleeve 14. In this case, the distal end and the proximal end of the free section 8c can be located at the ends of the guide sleeve 14, or in the range between the proximal end and the distal end of the guide sleeve 14.

[0303] When the free segment 8c is partially or entirely located in the radial gap between the tubular body 3 and the guide sleeve 14, the free segment can extend in the radial gap in various ways. For example, in one embodiment, the free segment 8c is suspended in the radial gap between the tubular body 3 and the guide sleeve 14. Suspension can be understood as meaning that there is no additional restraint or connection between the free segment 8c, the guide sleeve 14, and the tubular body 3. The free segment 8c is located in the radial gap between the tubular body 3 and the guide sleeve 14 solely by its own structure. When the free segment 8c is in a relaxed state, it freely resides in the radial gap between the tubular body 3 and the guide sleeve 14. When the free segment 8c is pulled taut, it exerts a force on the guide sleeve 14.

[0304] In another embodiment, a portion of the free segment 8c is slidably attached to the inner side of the guide sleeve 14. The free segment 8c is partially radially restrained by the inner side of the guide sleeve but is axially movable relative to the inner side of the guide sleeve. This radial restraint of the free segment 8c prevents the free segment 8c from becoming excessively disorganized and tangled when not stretched and tightened. The axial relative movement of the free segment 8c ensures that the free segment 8c does not interfere with the restraint of the guide sleeve 14 when stretched.

[0305] See also Figure 36 One method for achieving partial sliding fit of the free segment 8c on the inner side of the guide sleeve 14 is as follows: the guide sleeve 14 has a sandwich structure 31, and a portion of the free segment 8c is passed through the sandwich structure 31 to achieve sliding fit on the inner side of the guide sleeve 14.

[0306] The sandwich structure 31 can be a plurality of interspaced locations, and the free segment 8c passes through the sandwich structures 31 in sequence, so as to restrict the free segment 8c at multiple locations; the sandwich structure 31 can also be a continuously distributed section, so as to continuously restrict the free segment 8c.

[0307] The outer layer of the sandwich structure 31 is regarded as a complete guide sleeve, and the inner layer can be circumferentially non-closed as shown in the figure, or can be tubular, and the free section 8c is guided through the inner layer.

[0308] The free segment 8c is guided through the sandwich structure 31 and is restricted by the inner side of the guide sleeve 14, but the restricted position relative to the specific position of the free segment 8c is not fixed and changes with the movement of the free segment 8c.

[0309] The second method for achieving the partial sliding fit of the free section 8 c on the inner side of the guide sleeve 14 is: the free section 8 c is partially sliding fit on the inner side of the guide sleeve 14 in a sewing manner.

[0310] In this manner, the free segment 8 c itself can be used as a suture, and the free segment 8 c itself can be sewn onto the guide sleeve 14 , so that the free segment 8 c can partially slide and fit on the inner side of the guide sleeve 14 .

[0311] See also Figure 37 Alternatively, other sutures 29 may be used to sew the free segment 8 c onto the guide sleeve 14 , so that the free segment 8 c can partially slide and fit onto the inner side of the guide sleeve 14 .

[0312] When a part of the free segment 8c is slidably fitted on the inner side of the guide sleeve 14 in a sewing manner, the local part of the free segment 8c that is fitted with the inner side of the guide sleeve 14 is a dynamically changing part, that is, when the free segment 8c is in a stretched or relaxed state, the specific part of the aforementioned part relative to the free segment 8c can change.

[0313] The guide sleeve 14 wraps around the free segment to prevent the free segment 8c from cutting or scratching the aorta. When the guide sleeve 14 wraps around the free segment, the guide sleeve 14 and the tubular body 3 can be arranged side by side, and the free segment 8c extends inside the guide sleeve 14. The guide sleeve 14 itself is fixed to the outer wall of the tubular body 3. The fixation can be continuous at the contact position or multiple fixed points at intervals.

[0314] When the free section 8c is pulled and tightened, a radial force is generated on the guide sleeve 14, and the guide sleeve 14 partially follows the movement of the free section to limit the gap between the tube body 3 and the free section 8c.

[0315] When the guide sleeve 14 wraps the free section, the tube body 3 and the guide sleeve 14 may overlap in the circumferential direction, that is, the guide sleeve 14 wraps around a portion of the tube body 3. That is, the free section 8c is in the overlapping space between the two and is limited by the portion where the guide sleeve 14 wraps around the tube body 3.

[0316] When the guide sleeve 14 itself has no elasticity, the guide sleeve 14 can be made to fit as close to the outer wall of the tube body 3 as possible by tightening the traction wire 8, making the product compact and easy to store. It should be noted that the purpose of properly tightening the traction wire 8 is not to adjust the bend, but to close the guide sleeve 14.

[0317] See also Figure 38 In another embodiment, in order to give the guide sleeve 14 the greatest degree of freedom and to facilitate the adjustment of the point of action of the traction wire 8 on the tube body 3 during bending, in another embodiment, the guide sleeve 14 is a tubular structure and circumferentially wraps around the tube body 3.

[0318] Both ends of the guide sleeve 14 can be movably mounted on the outside of the tube body, and at least one end can be fixed by bonding or other means and restricted by the tube body 3. However, since a gap will be generated between the middle part of the guide sleeve 14 and the tube body 3 when the free section is tightened, there is no need for an additional constraint structure.

[0319] When the guide sleeve 14 is a cylindrical structure, the free section 8c can be located at any position in the radial gap between the guide sleeve 14 and the tube body 3 in a relaxed state. When the free section 8c is in a taut state, the free section 8c runs from the original arbitrary position to the path formed by the distal end and the proximal end of the free section 8c, driving the tube body 3 to bend along a preset angle.

[0320] See also Figure 39a The tubular body 3 includes an expansion section 3a at the distal end for accommodating an interventional instrument, and a connecting section 3b connected to the expansion section 3a and extending toward the proximal end. A guide sleeve 14 is attached to the outer periphery of the tubular body 3. More precisely, the entire guide sleeve 14 is connected to the connecting section 3b of the tubular body 3, with the distal end of the guide sleeve 14 fixed on the connecting section 3b adjacent to the expansion section 3a. This ensures that the free section 8c is largely enclosed while preventing the expansion section 3a from interfering with the release of the interventional instrument.

[0321] The proximal end of the guide sleeve 14 extends toward the proximal end of the tubular body 3 so that the guide sleeve 14 wraps a part or the whole of the free section 8c.

[0322] Relative to Figure 39a ,exist Figure 39b In another embodiment, the distal end of the guide sleeve 14 is fixed at the junction of the connecting section 3b and the expansion section 3a to reduce the number of connecting parts of the outer wall of the tube body and improve the aesthetics.

[0323] The proximal end of the guide sleeve 14 is connected to the connecting section 3b of the tubular body 3 and extends toward the proximal end of the tubular body 3 to wrap a part or the whole of the free section 8c.

[0324] Relative to Figure 39a ,exist Figure 39c In another embodiment, in order for the guide sleeve 14 to largely wrap the free section 8c, the distal end of the guide sleeve 14 is fixed to the expansion section 3a and adjacent to the proximal end of the expansion section 3a. The proximal end of the guide sleeve 14 is connected to the connecting section 3b of the tubular body 3 and extends toward the proximal end of the tubular body 3.

[0325] exist Figures 39a to 39c In the embodiment, the tube body 3 is in a bent state, and the free section 8c is in close contact with the inner wall of the guide sleeve 14. The guide sleeve 14 is partially separated from the tube body 3 by the radial action of the free section 8c, thereby constituting a spatial range that limits the tube body 3 and the free section 8c.

[0326] See also Figure 39dThe guide sleeve 14 wraps the tube body 3 and the free section 8c. When the free section 8c is pulled and tightened, the free section 8c is partially or completely pressed against the inner side of the guide sleeve 14, and a gap of a distance d is created between the free section 8c and the tube body 3. The size of the gap d is limited by the guide sleeve 14 to improve the bending sensitivity.

[0327] Since the free section 8c exerts a large force on the guide sleeve 14 when it is pulled and tightened, and the specifications of the free section 8c itself are small, the contact area between the free section 8c and the guide sleeve 14 is small, and the pressure at the interaction point between the guide sleeve 14 and the free section 8c is large. Therefore, it is necessary to strengthen the structure of the guide sleeve 14 locally or as a whole. At least the side wall of the guide sleeve should be provided with a reinforced area that contacts and cooperates with the free section.

[0328] The specific structure of the reinforced area is not limited as long as the strength is sufficient. For example, the reinforced area can be thicker than other surrounding areas.

[0329] The other areas around refer to other areas around the guide sleeve 14 in the reinforcement area, that is, other areas outside the reinforcement area of ​​the guide sleeve 14. Increasing the thickness to enhance the support strength of the free section 8c is also a relatively simple way to achieve this.

[0330] The method of increasing the thickness can be to reserve a reinforcement area with a larger thickness during the production design of the guide sleeve 14. At this time, the reinforcement area is an integrated structure and is an integrated structure with the guide sleeve 14; it can also be to form a reinforcement area by stacking reinforcement materials on the guide sleeve 14 at a later stage. At this time, the reinforcement area is composed of a multi-layer structure, and part of it has a connection structure with the guide sleeve body.

[0331] The reinforcing material can be connected to the guide sleeve 14 by welding or bonding, and the reinforcing material can be connected to the inner wall or outer wall of the guide sleeve. At the same time, the reinforcing material can cover a part or the whole of the guide sleeve 14.

[0332] In another embodiment, sufficient strength can be achieved by providing a reinforcement layer in the side wall of the reinforcement area. The reinforcement layer should be added in such a way that it does not adversely affect the limiting function of the guide sleeve 14.

[0333] Different from the method of stacking a reinforcement layer on the inner wall or outer wall of the guide sleeve 14, the reinforcement layer in this embodiment is arranged in the side wall of the reinforcement area and is integral to the inner wall or outer wall surface of the guide sleeve 14, that is, the reinforcement layer is embedded in the guide sleeve 14, which is not easily affected by the outside world and can achieve a higher degree of coordination with the guide sleeve 14's own structure.

[0334] See also Figure 40a The tubular body 3 includes an expansion section 3a at the distal end for accommodating the interventional instrument, and a connecting section 3b connected to the expansion section 3a and extending toward the proximal end.

[0335] In order to conveniently express the position of the free section 8c in the figure and avoid interference, the guide sleeve is omitted in the accompanying drawings corresponding to this embodiment. Of course, the guide sleeve can be provided as required, and the structure and connection method of the guide sleeve can be combined with the aforementioned embodiments.

[0336] The free section 8c of the traction wire 8 is outside the tube body. There is a radial gap between the free section 8c and the tube body 3, which can guide the tube body 3 to bend when the free section 8c is pulled and tightened. Therefore, the axial position of the free section 8c in the tube body 3 has a greater influence on the bending part of the tube body 3.

[0337] As can be seen in the figure, the free segment 8c is entirely located on the connecting segment 3b, with its distal end fixed on the connecting segment 3b adjacent to the expansion segment 3a. This minimizes the impact on the expansion segment 3a while ensuring optimal bending control. The remainder of the traction wire 8, excluding the free segment 8c, extends within the tubular body 3 or is secured against the outer wall of the tubular body 3 by a restraining structure, such as an elastic sleeve, located outside the tubular body 3.

[0338] Relative to Figure 40a ,exist Figure 40b In another embodiment, the distal end of the free segment 8c is fixed at the junction of the connecting segment 3b and the expansion segment 3a. The presence of a connecting structure at the junction can reduce the difficulty of fixing the free segment 8c to a certain extent.

[0339] Relative to Figure 40a ,exist Figure 40c In another embodiment, the distal end of the free segment 8c is fixed on the expansion segment 3a. When fixed on the expansion segment 3a, the distal end of the free segment 8c is closer to the distal end of the tube body 3, thereby improving the sensitivity of the tube body 3 to the bending.

[0340] When the distal end position of the free segment 8c is fixed on the expansion segment 3a, it can be fixed on the expansion segment 3a and adjacent to the proximal side of the expansion segment 3a; or fixed on the expansion segment 3a and adjacent to the distal side of the expansion segment 3a; or fixed on the expansion segment 3a and between the proximal and distal ends of the expansion segment 3a.

[0341] See also Figure 41 The free segment 8c of the traction wire 8, which is free outside the tube body, changes in total length when pulled, thereby driving the tube body 3 to bend. To achieve this bending effect, the proximal end of the free segment 8c is a dynamic position relative to the tube body 3, while the distal end of the free segment 8c is a fixed position relative to the tube body 3.

[0342] That is, the distal end of the free segment 8c is fixedly connected to the tube body 3 , and the distal end of the free segment 8c is fixedly connected to at least one of point A-outer wall, point B-interlayer, and point C-inner wall of the tube body 3 .

[0343] See also Figure 42 In another embodiment, the tube body 3 includes an expansion segment 3a at the distal end for accommodating the interventional instrument, and a connecting segment 3b connected to the expansion segment 3a and extending toward the proximal end.

[0344] When the distal end of the free segment 8c is fixed in the interlayer of the tube body 3, the fixing method of this embodiment is: the expansion segment 3a of the tube body 3 is provided with an interlayer, and a metal reinforcement structure 16 is provided in the interlayer of the expansion segment 3a, and the distal end of the free segment 8c enters the interlayer of the expansion segment 3a and is fixedly connected to the metal reinforcement structure 16.

[0345] The free section 8c is fixedly connected to the metal reinforcement structure 16, which can reduce the requirements for the structural strength of the tube body itself. At the same time, the effective area of ​​the metal reinforcement structure 16 on the tube body 3 is larger than the effective area of ​​the far end of the free section on the tube body 3, making bending adjustment more labor-saving and convenient, and the bending effect is good.

[0346] In the fixing method of this embodiment, the metal reinforcement structure 16 can be provided in the interlayer of the expansion section 8c. That is, the free section 8c is not limited to being fixed to the metal reinforcement structure 16. Any reinforcement structure provided in the interlayer of the expansion section 3a can be connected to the free section 8c. Of course, the free section 8c itself can also be connected to the interlayer of the expansion section 8c by welding or bonding.

[0347] The free segment 8c can guide the distal end of the tube body to bend after being pulled. It can be imagined that the proximal end of the free segment 8c must be movable, and the distal end of the free segment 8c is best fixedly connected to the tube body 3 to clarify the force position when the tube body bends, thereby obtaining an ideal bending angle.

[0348] There are many ways to fix the distal end of the free segment 8c to the tube body 3. For example, the distal end of the free segment 8c is fixed to the tube body 3 by knotting, welding or bonding. Relatively speaking, welding and bonding can make the distal end of the free segment 8c and the tube body 3 have a larger bonding area, which is conducive to improving the connection strength, while the knotting method is more flexible to operate and has a large degree of freedom.

[0349] See also Figure 43 and Figure 43a In one embodiment, when the distal end of the free segment 8c is connected to the tube body 3 in a knotted manner, the distal end of the free segment 8c can enter the inner cavity of the tube body along the first penetration point 18 from the outer wall of the tube body, and then pass through the tube body 3 along the second penetration point 20 from the inner cavity. After passing through, it is knotted with the part outside the tube body to form a node 21.

[0350] The penetration point refers to the position where the free segment 8c penetrates the tube wall.

[0351] Compared with the method in which the distal end of the free segment 8c enters the inner cavity of the tube body along the first penetration point 18 and then ties itself, the knotting method of this embodiment is more reliable. The distal end of the free segment 8c roughly surrounds a part of the tube body to prevent the knotted part from breaking away from the restriction of the tube body 3 when the pulling force on the free segment 8c is too large.

[0352] Moreover, the distal end of the free segment 8c surrounds a portion of the tube body 3 therein, and when pulled and tightened, there is not only one point of action between the free segment 8c and the tube body, thereby avoiding local stress concentration on the traction wire.

[0353] Furthermore, it can be seen from the figure that in the knotting method at the distal end of the free segment, the first penetration point 18 is closer to the distal end of the tube body than the second penetration point 20.

[0354] Relative to Figure 43a ,exist Figure 43b In another embodiment, the first penetration point 18 is closer to the proximal end of the tube body than the second penetration point 20. Specifically, after the distal end of the free segment 8c penetrates the tube body 3 along the first penetration point 18, it moves a distance within the lumen of the tube body 3 toward the distal end of the tube body 3 before exiting the tube body 3 along the second penetration point 20. The exiting portion then moves a distance along the proximal end of the tube body 3 before being tied to the portion of the free segment 8c outside the tube body 3, forming a knot 21.

[0355] Relative to Figure 43a , Figure 43c In another embodiment, the first penetration point 18 and the second penetration point 20 are located at the same axial position on the tubular body 3. That is, after the distal end of the free segment 8c enters the inner cavity of the tubular body 3 along the first penetration point 18, it moves a certain distance along the circumference of the tubular body 3, and then passes out of the tubular body 3 along the second penetration point. The exiting portion then moves back along the axial direction of the tubular body 3 and becomes knotted with the portion of the free segment 8c outside the tubular body 3, forming a knot 21.

[0356] Compared with the manner in which the first penetration point 18 and the second penetration point 20 are spaced apart in the axial direction of the tube body 3, in this embodiment, the free segment 8c is located between the first penetration point 18 and the second penetration point 20. When the free segment is tightened, the free segment 8c can be better shared with the pulling force exerted on the free segment 8c, thereby preventing the free segment 8c from breaking due to excessive pulling force.

[0357] When the distal end of the free segment 8c is connected to the tube body 3 by welding, the distal end of the free segment 8c can be welded to the inner wall or outer wall of the tube body 3. It is easy to understand that welding to the inner wall of the tube body 3 can avoid the influence of the external environment on the welding point, thereby improving the reliability of the connection between the two.

[0358] See also Figure 44 The distal end of the free segment 8c enters the interior of the tube body 3 through the first penetration point 18 and is welded and fixed at the penetration portion.

[0359] Relative to Figure 44 ,exist Figure 45 In another embodiment, the distal end of the free segment 8c enters the interior of the tube body 3 through the first penetration point 18, and is welded at the welding point 31 after extending a certain path inside the tube body 3. Relatively speaking, extending a certain path before welding can reduce the impact of the penetration portion on the welding point.

[0360] The portion of the traction wire 8 that is free outside the tube body is the free segment 8c, and the bending is achieved through the free segment. In order to achieve a variety of bending effects, the free segment 8c can be one or more segments.

[0361] If the free section 8c is a section, a local position on the tube body 3 can be driven to bend, thereby controlling the guiding path of the guiding head 4 of the conveying system.

[0362] If multiple free segments 8c are provided, and these segments are spaced apart, then after the traction wire is pulled, the multiple free segments will cause multiple locations on the tube to bend, resulting in the final bending effect. Relatively speaking, the bending range achievable with multiple free segments 8c is greater, but the uncertainty of achieving the desired effect increases with multiple free segments. Therefore, the number of free segments should be selected based on the needs.

[0363] It should be noted that, unless otherwise specified, when there are multiple free segments, the proximal end of the most proximal segment is understood as the proximal end of the entire free segment; the distal end of the most distal segment is understood as the distal end of the entire free segment.

[0364] When there are multiple free segments 8c, the traction wire 8 is a transition segment between two adjacent free segments, and the transition segment passes through the tube body, or at least the transition segment is tightly attached to the outer wall of the tube body under the action of external force.

[0365] See also Figure 46 This embodiment is further explained by taking two free sections 8c as an example. Each free section 8c corresponds to a part of the tube body 3, and the transition section 8d is between the two free sections 8c. The transition section 8d passes through the tube body.

[0366] As can be seen from the figure, when the free segments 8c are pulled and tightened, the corresponding portion of the tube body 3 corresponding to each free segment 8c bends, resulting in two bends in the entire tube body 3, causing the distal end of the tube body to bend nearly 180 degrees. It is easy to understand that the more free segments 8c are provided, the more parts of the tube body 3 are forced to bend during bending adjustment, and the overall bending angle of the tube body 3 will also increase accordingly.

[0367] Compared with having only one free section, when multiple free sections are provided, the tube body can be driven to produce a larger bending amplitude, and the operation is simpler when achieving the same bending amplitude.

[0368] When the free segment 8c is pulled and tightened, the transition segment exerts a force on the tube body or the component applying the external force to break free. If the transition segment breaks free, the bending performance of the free segment will be severely affected. Therefore, the tube body 3 is provided with a reinforcement frame at least at the transition segment, or on the component applying the external force to the transition segment, to ensure the bending performance of the free segment.

[0369] See also Figure 47 A sleeve 12 is provided on the outside of the proximal end of the tube body 3, and the sleeve 12 and the tube body 3 are axially slidably matched. A guide member 13 is provided on the outside of the distal end of the tube body 3. As can be seen from the figure, the sleeve 12 is closer to the proximal end of the tube body 3 than the guide member 13.

[0370] More specifically, the distal end of the tubular body 3 comprises an expansion section 3a for accommodating an interventional instrument, a connecting section 3b connected to the expansion section 3a and extending proximally, and a cannula 12 disposed around the connecting section 3b of the tubular body 3. The provision of the cannula 12 not only enhances protection for the tubular body 3 but also provides a new path for the traction wire 8 to extend proximally.

[0371] An important reason why the free segment 8c of the traction wire 8 is restricted by the guide sleeve is to prevent the free segment from cutting or scratching the aorta. Similarly, the part of the traction wire other than the free segment cannot cause damage to the aorta.

[0372] See also Figure 48 In one embodiment, the portion of the traction wire 8 that is free outside the tube body is the free segment, and the portion connected to the proximal side of the free segment is the extension segment. The extension segment extends proximally in the gap between the tube body 3 and the sleeve 12, which can avoid the extension segment penetrating the tube body and affecting the structure of the tube body. In order to achieve the ideal effect, it is emphasized here that the entire extension segment is in the gap between the tube body 3 and the sleeve 12.

[0373] See also Figure 49 In another embodiment, different from the previous embodiment, the connection between the free section and the extension section passes through the outer wall of the tube body 3, and the extension section extends proximally inside the tube body 3. In order to achieve the ideal effect, it is emphasized here that the entire extension section extends proximally inside the tube body 2.

[0374] It should be noted that the connection between the free segment and the extension segment is not a fixed location on the traction wire; the connection is referred to in relation to other components. For example, if the connection between the free segment and the extension segment penetrates the tube wall, more accurately, the portion of the traction wire that penetrates the tube wall is the connection between the free segment and the extension segment.

[0375] It is easy to understand that the guide sleeve 14 and the sleeve 12 are provided on the pipe body, and the state between the two is that the proximal end of the guide sleeve 14 and the distal end of the sleeve 12 are adjacent to each other or butted against each other. If the two are adjacent to each other, there is no constraint between the two, the relative freedom is large, and the arrangement is easy.

[0376] If the proximal end of the guide sleeve 14 and the distal end of the sleeve 12 are butted together to form an integral structure, although the relative degree of freedom is reduced, the overall aesthetics is improved. When the two are butted together, they can be connected by welding or detachable means, and the butt joints can be continuous or spaced.

[0377] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0378] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A bending sheath, comprising a tube body and a traction wire, wherein the tube body has a distal end and a proximal end, and the distal end of the tube body is bent by the traction wire, characterized in that: One end of the traction wire extends toward the proximal end of the tube body, the connection portion between the other end of the traction wire and the tube body is located at or adjacent to the distal end of the tube body, and at least one section of the traction wire is a free section outside the tube body; The bending adjustment sheath is further provided with a guide member, which acts between the tube body and the free section and is used to limit the gap between the tube body and the free section during bending adjustment; The guide member is a guide sleeve connected to the outer periphery of the tube body and wrapping the free segment. The guide sleeve has a sandwich structure and a part of the free segment is guided through the sandwich structure.

2. The bending adjustment sheath according to claim 1, characterized in that: The guide members are distributed in plurality along the axial direction of the tube body at intervals, forming a plurality of guide points for defining the gap between the tube body and the free section.

3. The bending adjustment sheath according to claim 1, characterized in that: The guide members are continuously distributed along the axial direction of the tube body to form a guide channel for defining the gap between the tube body and the free section.

4. The bending adjustment sheath according to any one of claims 1 to 3, characterized in that: The guide member is a radially expandable structure, and has a pre-deformation state in which the free segment is tightened to the outer wall of the tube body, and a post-deformation state in which the free segment is partially separated from the tube body.

5. The bending adjustment sheath according to claim 3, characterized in that: The guide sleeve is made of elastic material and has a pre-deformation state in which the free section is driven to abut against the outer wall of the tube body.

6. The bending adjustment sheath according to claim 5, characterized in that: The guide sleeve is in a deformed state where it is partially separated from the tube body by the action of the free segment.

7. The bending adjustment sheath according to claim 5, characterized in that: The guide sleeve is a rolled wall structure, which is partially separated from the tube body by the free section and has a deformed state in which the rolled wall structure of the corresponding part is unfolded.

8. The bending adjustment sheath according to claim 7, characterized in that: The guide sleeve has a self-recovering wall-rolling structure that drives the free section to be close to the outer wall of the tube body before deformation.

9. The bending adjustment sheath according to claim 8, characterized in that: The rolled wall structure in the state before deformation is rolled up over a circle, and the part beyond the 360-degree circumference overlaps with the part within the 360-degree circumference.

10. The bending adjustment sheath according to claim 7, 8 or 9, characterized in that: The starting side and the ending side of the rolled-up wall structure wound in the circumferential direction are connected by a flexible envelope film.

11. The bending adjustment sheath according to claim 7, 8 or 9, characterized in that: The guide sleeve in the state before deformation wraps the free section tightly against the outside of the tube body.

12. The bending adjustment sheath according to any one of claims 5 to 9, characterized in that: At least a portion of the guide sleeve is fixed to the tube body.

13. The bending adjustment sheath according to claim 12, characterized in that: The distal end and the proximal end of the guide sleeve are fixed to the outer periphery of the tube body, and the portion between the distal end and the proximal end of the guide sleeve is suspended on the outer periphery of the tube body.

14. The bending adjustment sheath according to any one of claims 5 to 9, characterized in that: At least a portion of the free section is located in a radial gap between the tube body and the guide sleeve.

15. The bending adjustment sheath according to any one of claims 5 to 9, characterized in that: The guide sleeve wraps a part of the tube body in the circumferential direction.

16. The bending adjustment sheath according to any one of claims 5 to 9, characterized in that: The guide sleeve is cylindrical and wraps around the tube body in the circumferential direction.

17. The bending adjustment sheath according to any one of claims 5 to 9, characterized in that: The tube body includes an expansion section at the distal end for accommodating an interventional instrument, and a connecting section connected to the expansion section and extending toward the proximal end. The distal end of the guide sleeve is located at: The expansion section is fixed to the connecting section adjacent to the expansion section.

18. The bending adjustment sheath according to any one of claims 5 to 9, characterized in that: The tube body includes an expansion section at the distal end for accommodating an interventional instrument, and a connecting section connected to the expansion section and extending toward the proximal end. The distal end of the guide sleeve is located at: The expansion section is fixed at the junction of the connection section and the expansion section.

19. The bending adjustment sheath according to any one of claims 5 to 9, characterized in that: The tube body includes an expansion section at the distal end for accommodating an interventional instrument, and a connecting section connected to the expansion section and extending toward the proximal end. The distal end of the guide sleeve is located at: The expansion section is fixed on the expansion section and is adjacent to the proximal end of the expansion section.

20. The bending adjustment sheath according to any one of claims 5 to 9, characterized in that: The side wall of the guide sleeve is provided with a reinforcement area which contacts and cooperates with the free section.

21. The bending adjustment sheath according to claim 20, characterized in that: The reinforced area has a greater thickness than other areas of the periphery.

22. The bending adjustment sheath according to claim 20, characterized in that: A reinforcement layer is provided in the side wall of the reinforcement area.

23. The bending adjustment sheath according to claim 1, wherein: The tube body includes an expansion section at the distal end for accommodating an interventional instrument, and a connecting section connected to the expansion section and extending toward the proximal end. The distal end of the free section is located at: fixed on the connecting section adjacent to the expansion section; or fixed at the junction of the connecting section and the expansion section; or Fixed on the expansion section.

24. The bending adjustment sheath according to claim 23, characterized in that: The distal end of the free segment is fixed on the expansion segment and is adjacent to the proximal end of the expansion segment, or adjacent to the distal end of the expansion segment, or located between the proximal end and the distal end of the expansion segment.

25. The bending adjustment sheath according to claim 1, characterized in that: The tube body includes an expansion section at the distal end for accommodating interventional instruments, and a connecting section connected to the expansion section and extending toward the proximal end. A metal reinforcement structure is provided in the interlayer of the expansion section, and the distal end of the free section enters the interlayer of the expansion section and is fixedly connected to the metal reinforcement structure.

26. The bending adjustment sheath according to any one of claims 1 or 23 to 25, characterized in that: The distal end of the free segment is fixedly connected to at least one of the outer wall, the inner wall, and the interlayer of the tube body.

27. The bending adjustment sheath according to any one of claims 1 or 23 to 25, characterized in that: The distal end of the free segment is fixed to the tube body by knotting, welding or bonding.

28. The bending adjustment sheath according to any one of claims 1 or 23 to 25, characterized in that: The distal end of the free segment enters the inner cavity of the tube body along the first penetration point from the outer wall of the tube body, and then passes through the inner cavity along the second penetration point to exit the tube body, and is tied with the portion outside the tube body after passing through.

29. The bending adjustment sheath according to claim 28, wherein: The first penetration point is closer to the distal end of the tubular body, or closer to the proximal end of the tubular body, relative to the second penetration point, or they are at the same axial position on the tubular body.

30. The bending adjustment sheath according to any one of claims 1 to 3, 5 to 9, and 23 to 25, characterized in that: The free segment is one segment or multiple segments arranged at intervals.

31. The bending adjustment sheath according to claim 30, wherein: The traction wire forms a transition section between two adjacent free sections, and the transition section passes through the tube body.

32. The bending adjustment sheath according to claim 31, characterized in that: The tube body is provided with a reinforcement frame at least at the transition section.

33. The bending adjustment sheath according to any one of claims 1 to 3, characterized in that: A sleeve is provided on the outside of the tube body. The sleeve and the tube body are axially slidably matched, and the sleeve is closer to the proximal end of the tube body relative to the guide member.

34. The bending adjustment sheath according to claim 33, wherein: The tube body comprises an expansion section at the distal end for accommodating an interventional instrument, and a connecting section connected to the expansion section and extending toward the proximal end. The sleeve is located on the outer periphery of the connecting section.

35. The bending adjustment sheath according to claim 33, characterized in that: The portion of the traction wire connected to the proximal end of the free segment is an extension segment, and the extension segment extends toward the proximal end in the gap between the tube body and the sleeve.

36. The bending adjustment sheath according to claim 33, wherein: The portion of the traction wire connected to the proximal end of the free segment is the extension segment. The connection between the free segment and the extension segment passes through the wall of the tube body, and the extension segment extends toward the proximal end inside the tube body.

37. The bending adjustment sheath according to claim 33, characterized in that: The proximal end side of the guide sleeve and the distal end side of the sleeve are adjacent to or butted against each other.

38. The bending adjustment sheath according to claim 37, characterized in that: The proximal end side of the guide sleeve and the distal end side of the sleeve are butted against each other and form an integral structure.

39. The bending adjustment sheath according to any one of claims 1 to 3, 5 to 9, and 23 to 25, wherein: The free section of the traction wire is located at the distal end of the tube body or adjacent to the distal end of the tube body.

40. The bending adjustment sheath according to any one of claims 1 to 3, 5 to 9, and 23 to 25, wherein: The traction wire is connected to the distal end of the tube body or is less than 5 cm away from the end.

41. The bending adjustment sheath according to any one of claims 1 to 3, 5 to 9, and 23 to 25, wherein: The free section of the traction wire is located from the middle of the tube body to the distal end of the tube body or adjacent to the distal end of the tube body.

42. The bending adjustment sheath according to any one of claims 1 to 3, 5 to 9, and 23 to 25, wherein: The free section of the traction wire is located between the proximal end of the tube body and the distal end of the tube body or adjacent to the distal end of the tube body.

43. The bending adjustment sheath according to any one of claims 1 to 3, 5 to 9, and 23 to 25, wherein: The exterior of the free section is covered with a cut-resistant protective layer.

44. The bending adjustment sheath according to any one of claims 1 to 3, 5 to 9, and 23 to 25, wherein: There are two or more traction wires.

45. The bending adjustment sheath according to claim 44, characterized in that: The connection parts between the two or more traction wires and the tube body are evenly distributed around the circumference of the tube body.

46. ​​The bending adjustment sheath according to any one of claims 1 to 3, 5 to 9 or 23 to 25, wherein: The end of the traction wire is provided with a ring sleeve which is wound around the outer circumference of the tube body.

47. The bending adjustment sheath according to claim 46, characterized in that The ring sleeve is fixed on the outer wall of the tube body, or is rotatably sleeved on the outer wall of the tube body and is axially limited.

48. The bending adjustment sheath according to claim 46, wherein: An axial limiting groove is provided on the outer wall of the tube body, and the ring sleeve is rotatably sleeved in the axial limiting groove.

49. The bending adjustment sheath according to claim 46, wherein: An axial limiter is provided on the outer wall of the tube body, and both axial sides of the ring sleeve are respectively blocked by the axial limiter.

50. The bending adjustment sheath according to claim 48, wherein: The axial limiting member is a limiting step located on the outer wall of the tube body, or a limiting ring fixed on the tube body.

51. The bending adjustment sheath according to claim 46, wherein: The ring sleeve is fixed on the outer wall of the tube body, and the ring sleeve is evenly distributed and connected with 2 to 4 traction wires in the circumferential direction.

52. The bending adjustment sheath according to claim 46, wherein: The ring sleeve and the traction wire are an integral structure, separate and fixedly connected or detachably connected.

53. The bending adjustment sheath according to claim 52, characterized in that: The width of the ring sleeve in the axial direction is 1~5mm.

54. The bending adjustment sheath according to claim 53, characterized in that The distal end of the pull wire is coiled upon itself to form the loop.

55. The bending adjustment sheath according to any one of claims 1 to 3, 5 to 9 or 23 to 25, wherein: Reinforcing ribs are also fixed inside the side walls of the tube body.

56. The bending adjustment sheath according to claim 55, characterized in that A channel is provided in the side wall of the tube body, and a reinforcing rib extends along the entire body of the channel to the distal end, and the inner wall of the channel and the reinforcing rib are fixed to each other.

57. The bending adjustment sheath according to claim 56, characterized in that: There are two reinforcing ribs, and the drawing wire and the reinforcing ribs are spaced apart and distributed in the circumferential direction of the tube body.

58. The bending adjustment sheath according to claim 57, characterized in that: There are two traction wires and two reinforcing ribs. The two reinforcing ribs are located on opposite sides of the axis of the tube body. On any cross section of the tube body, the angle between any reinforcing rib and the center of one of the traction wires is 30~150°.

59. The bending adjustment sheath according to any one of claims 1 to 3, 5 to 9 or 23 to 25, wherein: A section of the traction wire adjacent to the distal end is a developing section.

60. The bending adjustment sheath according to claim 59, wherein: The length of the developing section is greater than that of the freeing section.

61. The bending adjustment sheath according to claim 60, characterized in that: The length of the developing section is 12 to 20 cm.

62. The bending adjustment sheath according to claim 61, characterized in that: The developing section has developing areas distributed continuously or a plurality of developing points distributed at intervals.

63. An adjustable bend interventional valve delivery system, characterized in that: It comprises the bending adjustment sheath as described in any one of claims 1 to 62, a sheath core placed in the bending adjustment sheath, and an operating handle connected to the proximal ends of the bending adjustment sheath and the sheath core, and the proximal end of the traction wire is connected to the operating handle.

64. The adjustable bend interventional valve delivery system according to claim 63, wherein: The sheath core comprises a core tube, the distal end of which is provided with a loading section for placing interventional instruments. Before release, the expansion section of the bending sheath tube is located outside the loading section.

65. The adjustable bend interventional valve delivery system according to claim 64, wherein: A guide head and an interventional instrument fixing head adjacent to the guide head are fixed at the distal end of the core tube, and the loading section is located between the guide head and the interventional instrument fixing head.

66. The adjustable bend interventional valve delivery system according to claim 63, wherein: The operating handle comprises: A fixed body of a hollow structure; a traction member slidably mounted in the fixed body and connected to the traction wire; A driving mechanism mounted on the fixed body to drive the traction member to move; A control mechanism installed on the fixed body to drive the bending sheath to move.

67. The adjustable bend interventional valve delivery system according to claim 66, wherein: The driving mechanism comprises: A moving member that applies axial force against the pulling member; An adjusting knob is sleeved on the fixed body and rotates around the axial direction of the fixed body. The adjusting knob is cylindrical and is located on the outer periphery of the moving part. The adjusting knob and the moving part are threadedly matched.

68. The adjustable bend interventional valve delivery system according to claim 67, wherein: The distal end fixing sleeve of the fixing body is provided with a front end handle, and a hollow axial guide groove is provided on the front end handle. A part of the moving part extends out of the axial guide groove, and an external thread is provided on the extended part, and a matching internal thread is provided inside the adjusting knob.

69. The adjustable bend interventional valve delivery system according to claim 68, wherein: There are at least two axial guide grooves, which are evenly distributed around the axis of the fixed body.

70. The adjustable bend interventional valve delivery system according to claim 67, wherein: The driving mechanism is an electric push rod and is transmission-connected with the traction member.

71. The adjustable bend interventional valve delivery system according to claim 67, wherein: The control mechanism includes: A control handle is rotated and mounted on the outside of the fixed body, wherein the inner wall of the control handle has an internal thread; A transmission rod is slidably installed in the fixed body along the axis of the fixed body. The transmission rod is provided with linkage convex teeth matched with the internal thread of the control handle. The tube body of the bending sheath is connected to the transmission rod.

72. The adjustable bend interventional valve delivery system according to claim 71, wherein: The fixed body is provided with a guide groove for guiding the axial movement of the linkage convex teeth.

73. The adjustable bend interventional valve delivery system according to claim 71, wherein: The traction member is an annular structure, and the transmission rod slides through the central area of ​​the traction member.

74. The adjustable bend interventional valve delivery system according to claim 73, wherein: The moving member is an annular structure and is abutted against the distal end of the pulling member, and the transmission rod slides through the central area of ​​the pulling member.

75. The adjustable bend interventional valve delivery system according to claim 71, wherein: The control handle is provided with a limiting component for limiting the axial displacement of the transmission rod.

76. The adjustable bend interventional valve delivery system according to claim 75, wherein: The limiting component is movably mounted on the control handle and has a limiting state in which it abuts against the linkage convex teeth, and a releasing state in which it avoids the linkage convex teeth.

77. The adjustable bend interventional valve delivery system according to claim 76, wherein: A mounting opening is provided on the side wall of the control handle, and the limiting component is movably embedded in the mounting opening.

78. The adjustable bend interventional valve delivery system according to claim 77, wherein: The limiting component is a rotatably mounted adjusting wheel; The axial end surface of the adjusting wheel serves as a limiting surface, and in the limiting state, the limiting surface blocks the movement path of the linkage convex tooth; The outer edge of the adjusting wheel is provided with an avoidance groove, and in the unlocked state, the avoidance groove corresponds to the movement path position of the linkage convex tooth.

79. The adjustable bend interventional valve delivery system according to claim 78, wherein: At least a portion of the outer edge of the adjusting wheel is located outside the installation opening, and an anti-slip structure is provided on the portion.

80. The adjustable bend interventional valve delivery system according to claim 78, wherein: The regulating wheel is provided with a mark indicating the state of the limiting component.

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