Adjustable bend interventional valve delivery system

Abstract

The present application discloses an adjustable bend interventional valve delivery system, comprising an 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, the adjustable bend sheath comprising a tube body and a traction wire, the tube body having a distal end and a proximal end, the distal end of the tube body being pulled and bent by the traction wire, the proximal end of the traction wire being connected to the operating handle, the operating handle comprising: 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; and a control mechanism mounted on the fixed body to drive the adjustable bend sheath to move. The traction wire in the adjustable bend sheath of the present application has a section free from the outside of the sheath body, and has a posture that facilitates force application when pulled, thereby improving the safety and flexibility of the operation.

Description

Technical Field

[0001] The present application belongs to the field of medical device technology, and in particular, relates to an adjustable bend interventional valve delivery system. 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] Based on the tortuous characteristics of the human vascular system and the consideration of long-distance operation, the sheath should usually have sufficient axial and radial support and good compliance. Before reaching the lesion, the sheath itself can be pushed by the doctor, and the compliance of the sheath can make the distal end of the sheath adaptively adjust the bending direction to conform to the human body's veins while moving along the guidewire track. Due to the influence of blood flow in the blood vessels, the sheath usually moves along the blood vessel wall. In the early stage, this does not have much impact on the route of the sheath. However, when releasing drugs and devices, the distal end of the sheath needs to be aligned with the lesion. 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 central position 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 to allow the heart valve replacement device to replace its own valve driving function. Since the sheath moves along the blood vessel wall, when approaching 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, and the diameter of the distal end of the sheath is usually about 7 mm, then 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 shape of the human blood vessels or the human body structure, and customize catheters of different shapes and structures to meet the needs of reaching the lesion site in the circuitous blood vessels. For example, US Pat. No. 2003144657 discloses a catheter assembly, which uses an outer catheter with a preformed distal end and an inner catheter with a preformed distal 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 the positioning through the right atrium and the insertion of the catheter into the coronary sinus. However, this cannot be adapted to the individual physiological and anatomical structure one by one, which can easily affect the surgical results.

[0006] At present, the commonly used solution is to use a sheath with an 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, a Chinese patent document with publication number CN102921089A discloses a catheter with controllable bending head for interventional treatment, wherein the head of the multi-lumen catheter is connected with a main catheter soft head, the tail of the multi-lumen catheter is connected with an extension tube through a connector, a handle is provided outside the extension tube, a handle sliding device is movably connected inside 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 with 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 outside the handle and is connected with 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, and 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, and the main catheter soft head is bent back by the pulling force of the traction wire, thereby realizing the direction adjustment.

[0008] Even if traction wires are used in the prior art, the traction wires are generally threaded and constrained in the pipe or channel in which they are located. Therefore, when large-scale bending is 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. In addition, since the bending is limited by the torque size and the deformation amount of the surrounding area where the traction wire is located, the operation is more laborious. Summary of the invention

[0009] The present application provides an adjustable bend interventional valve delivery system, which is conducive to the adjustment of the distal direction of the sheath, improves the controllability of the bending direction of the distal end of the sheath, and can easily control the distal end of the sheath to bend or move toward a predetermined lesion site.

[0010] An adjustable bending interventional valve delivery system includes an adjustable bending sheath tube, a sheath core placed in the adjustable bending sheath tube, and an operating handle connected to the proximal ends of the adjustable bending sheath tube and the sheath core. The adjustable bending sheath tube includes 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 pulled and bent by the traction wire. The proximal end of the traction wire is connected to the operating handle. The operating handle includes:

[0011] A fixed body of a hollow structure;

[0012] A traction member slidably mounted in the fixed body and connected to the traction wire;

[0013] A driving mechanism mounted on the fixed body to drive the traction member to move;

[0014] A control mechanism installed on a fixed body to drive the bending sheath to move.

[0015] Preferably, 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.

[0016] 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 with the operating handle. The traction wire itself can be made of thinner metal wire or polymer fiber that meets the strength requirements, and its material and processing method can adopt existing technology.

[0017] 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.

[0018] The traction wire is free on the outer wall of the tube body and connected to the distal end of the tube body. The traction wire directly controls the tube body and transmits the traction force more effectively.

[0019] 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.

[0020] The longer the free segment is, the less restraining force the sheath will have, thereby reducing the need for regulating force and lowering the pressure limit requirements for each load-bearing structural component, connector, and connection point.

[0021] Preferably, the free section of the traction wire is located from the proximal end of the tube body to the distal end of the tube body or adjacent to the distal end of the tube body.

[0022] The completely independent traction wire will not be affected by the bending and deformation of the tube body and can directly regulate the distal end.

[0023] Preferably, the free section of the traction wire is located from the proximal end of the tube body to the distal end adjacent to the tube body.

[0024] 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.

[0025] The connection position between the distal end of the traction wire and the sheath is:

[0026] Connected to the end of the sheath; or

[0027] Located proximal to the sheath tip and less than 5 cm away from the sheath tip; or

[0028] 8 to 12 cm (e.g. 10 cm) away from the tip of the sheath.

[0029] The said freedom mainly refers to the extension of the traction wire in the channel or cavity in the prior art. The common way of freedom is to be suspended outside the tube body, at least with a large 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.

[0030] Freedom can also limit the traction wire to a certain extent, such as limiting the distance away from the outer wall of the tube body, or the oblique angle relative to the axial direction of the tube body.

[0031] The sheath tube of the present application can be used for the delivery of vascular stents, heart valve stents or other interventional devices.

[0032] In order to improve safety, the free section is wrapped with a cut-resistant protective layer on the outside.

[0033] The anti-cutting protective layer can be made of a relatively soft material to prevent the traction wire from cutting the internal tissue when it is tightened. The anti-cutting 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 pulling of the tube body.

[0034] In order to enhance the connection between the traction wire and the tube body, preferably, the end of the traction wire is provided with a ring sleeve which is wound around the outer circumference of the tube body.

[0035] The tube body is pulled as a whole by the ring sleeve to avoid local stress concentration.

[0036] Preferably, the ring sleeve is fixed to the outer wall of the tube body, or is rotatably sleeved on the outer wall of the tube body and axially limited.

[0037] The ring sleeve can be fixed to the outer wall of the pipe body by welding or fastening the connecting piece, and the rotatable sleeve is arranged on the pipe body to facilitate the position of the adaptive force point when adjusting the bend.

[0038] As an axial limit, the outer wall of the tube body is provided with an axial limit groove, and the ring sleeve is rotatably sleeved in the axial limit groove.

[0039] As an axial limit, an outer wall of the tube body is provided with an axial limit piece, and the two axial sides of the ring sleeve are respectively blocked by the axial limit piece.

[0040] Preferably, the axial limiter is a blocking hook or a threading ring. The axial position of the limiting ring sleeve can be one or more axial limiters.

[0041] 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.

[0042] In order to match the posture of the sheath during pulling and select a suitable force point, the traction wires are two or more, for example, 2, 3, or 4. In particular, when the traction wire is fixed relative to the tube body, if the traction wire or the ring can change the circumferential position relative to the tube body, then when there is only one traction wire, the force point can be adjusted by pulling to adapt itself.

[0043] The connection parts between each traction wire and the tube body are evenly distributed around the circumference of the tube body.

[0044] 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.

[0045] 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 side wall of the tube body.

[0046] Preferably, the ring sleeve and the traction wire are an integral structure, separate and fixedly connected or detachably connected.

[0047] When it is an integrated structure, the distal end of the traction wire itself is coiled into a ring shape and is sealed and fixed.

[0048] When the structure is not an integral one, 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. After being unfolded, it is roughly in the shape of a flat strip.

[0049] 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.

[0050] A channel is arranged in the side wall of the tube body, and a reinforcing rib runs along the channel to the far end, and the inner wall of the channel and the reinforcing rib are fixed to each other.

[0051] Preferably, there are two reinforcing ribs, and the pulling wire and the reinforcing ribs are spaced apart and distributed in the circumferential direction of the tube body.

[0052] More preferably, 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, and on any cross section of the tube body, the central angle between any reinforcing rib and one of the traction wires is 30 to 150°.

[0053] Preferably, the central angle between any one of the reinforcing ribs and one of the pulling wires is 80-100°.

[0054] Preferably, the pulling wires and reinforcing ribs are evenly distributed in the circumferential direction of the tube body.

[0055] Here, since one section of the traction wire is free, the description of the positional relationship between the traction wire and the reinforcing rib mainly refers to the non-free part. Since the connection part between the traction wire and the tube body may be changeable, the situation where the connection part between the traction wire and the tube body is fixed is specifically referred to.

[0056] If the connection part 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 force point to reach the best traction position and implement the bending adjustment.

[0057] 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 direction of the radial connection line of the two reinforcing ribs, and can only be bent in the direction of the mid-perpendicular line of the 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 bendable (the direction of the traction wire).

[0058] Of course, the two reinforcing ribs may not be arranged opposite to each other. On any cross section of the tube body, the central angle between the two reinforcing ribs is less than 180°, and the traction wire is located on one side of the line connecting any reinforcing rib and the axis of the tube body in the radial direction. In this way, the sheath should not be bent in the direction of the line connecting each reinforcing rib and the axis of the tube body in the radial direction. Therefore, when setting the traction wire, it should be avoided that the traction wire is distributed in the direction of the line connecting any reinforcing rib and the axis of the tube body in the radial direction.

[0059] 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.

[0060] In order to facilitate the threading and binding of the traction wire, the non-free part of the traction wire, except the free section, can be extended toward the proximal end through the guide component. The guide component can be additionally provided or utilize the tube body itself.

[0061] 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.

[0062] Interventional devices such as valves.

[0063] One section of the traction wire adjacent to the distal end is a developing section.

[0064] The developing section may contain developable components in the material, or may be embedded, coated, or wrapped to achieve an effect that can be observed by a medical imaging system.

[0065] The length of the developing section is greater than that of the freeing section.

[0066] The length of the developing section is 12 to 20 cm.

[0067] 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.

[0068] Preferably, the sheath core comprises a core tube, a guide head and an interventional instrument fixing head are fixed at the distal end of the core tube, the portion of the core tube between the guide head and the interventional instrument fixing head is a loading section for placing the interventional instrument, and before release, the expansion section of the bent sheath tube is located outside the loading section.

[0069] The distal end of the traction wire is connected to the proximal end of the expansion section.

[0070] Preferably, a sleeve is provided outside the tube body of the bending adjustment sheath tube, and the sleeve is axially slidably matched with the tube body, and the traction wire extends toward the proximal end through the gap between the tube body and the sleeve.

[0071] The sleeve can slide and tighten around the outer periphery of the tube body, which is beneficial to provide additional radial restraint when the interventional instrument is retrieved, and the interventional instrument is placed and disengaged from the interventional instrument fixing head.

[0072] There may also be a slight gap between the sleeve and the tube body.

[0073] Matching connecting ears and slots are generally provided between the interventional instrument and the interventional instrument fixing head. Once the radial restraint force of the tube body is insufficient, the interventional instrument will be dislocated and the recovery will fail. Therefore, the sheath can provide further safety protection, and the gap between the tube body and the sheath can provide a passage for the traction wire. When using the traction wire, the sheath can be slid to a suitable position to allow the distal end of the traction wire to be free for a while before reaching the connection position with the tube body.

[0074] Especially in areas with large turns, the traction wire is guided and restrained by the sleeve to prevent the traction wire from compressing the body tissue and causing damage after being tightened.

[0075] Preferably, the driving mechanism comprises:

[0076] A moving member that axially resists and applies force to the pulling member;

[0077] The adjusting knob is sleeved on the fixed body and rotates around the axis of the fixed body. The adjusting knob is cylindrical and is located at the outer periphery of the moving part. The adjusting knob and the moving part are threadedly matched.

[0078] 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 part of the movable member extends out of the axial guide groove, an external thread is provided on the extended part, and a matching internal thread is provided inside the adjusting knob.

[0079] Preferably, there are at least two axial guide grooves, which are evenly distributed around the axis of the fixed body.

[0080] Preferably, the driving mechanism is an electric push rod, and is transmission-connected to the traction member.

[0081] Preferably, the control mechanism comprises:

[0082] A control handle is rotatably mounted on the outside of the fixed body, and the inner wall of the control handle has an internal thread;

[0083] A transmission rod is slidably installed in the fixed body along the axis of the fixed body, and a linkage convex tooth matched with the internal thread of the control handle is installed on the transmission rod. The tube body of the bending sheath tube is connected to the transmission rod.

[0084] Preferably, a guide groove for guiding the axial movement of the linkage convex tooth is provided on the fixed body.

[0085] Preferably, the traction member is an annular structure, and the transmission rod slides through the central area of ​​the traction member.

[0086] Preferably, the driving mechanism comprises:

[0087] A moving member that axially resists and applies force to the pulling member;

[0088] An adjusting knob is sleeved on the fixed body and rotates around the axis of the fixed body, the adjusting knob is cylindrical and is located at the periphery of the moving part, and the adjusting knob and the moving part are threadedly matched;

[0089] The moving member is an annular structure and is close to the distal end of the traction member, and the transmission rod slides through the central area of ​​the moving member.

[0090] The traction wire in the bending sheath of the present application 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. In the case of a larger turning radius or when the interventional instrument is long, hard and difficult to bend, the safety and flexibility of the operation are improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0091] Figure 1 It is a structural schematic diagram of the use state of the bending sheath tube in the prior art;

[0092] Figure 2a This is a schematic diagram of the structure of the bending sheath tube in the embodiment of the present application;

[0093] Figure 2b This is a schematic diagram of the structure of another use state of the bending sheath tube in the embodiment of the present application;

[0094] Figure 2c This is a schematic diagram of the structure of another use state of the bending sheath tube in the embodiment of the present application;

[0095] Figure 2d This is a schematic diagram of the structure of another use state of the bending sheath tube in the embodiment of the present application;

[0096] Figure 3 This is a schematic diagram of the structure of the distal end of the bending sheath tube in an embodiment of the present application;

[0097] Figure 4 This is a schematic structural diagram of the distal end side of another method of bending the sheath tube in an embodiment of the present application;

[0098] Figure 5 This is a schematic diagram of the structure of the distal end side of another method of bending the sheath tube in an embodiment of the present application;

[0099] Figure 6 This is a schematic structural diagram of the distal end side of another method of bending the sheath tube in an embodiment of the present application;

[0100] Figure 7 It is a partial schematic diagram of the connection portion between the traction wire and the tube body in the bending sheath in the embodiment of the present application;

[0101] Figure 8 It is a cross-sectional schematic diagram of the connection portion between the traction wire and the tube body in the bending sheath in the embodiment of the present application.

[0102] Fig. 9 This is a schematic diagram of the structure of the adjustable bend interventional valve delivery system in an embodiment of the present application;

[0103] Fig.10 for Fig. 9 Cross-section at AA;

[0104] Fig.11 for Fig. 9 An exploded view of the operating handle of the mid-adjustable curved interventional valve delivery system;

[0105] Fig.12 for Fig. 9 Schematic diagram of the structure of the medium adjustable bend interventional valve delivery system before the bend is adjusted;

[0106] Fig.13 for Fig.12 Enlarged view of part D in the middle;

[0107] Fig.14 for Fig.14Schematic diagram of the structure of the adjustable bend interventional valve delivery system after adjustment;

[0108] Fig.15 for Fig.14 Enlarged view of part E in the middle;

[0109] Fig.16 for Fig. 9 A three-dimensional view of the operating handle of the medium adjustable bend interventional valve delivery system;

[0110] Fig.17 for Fig.16 The schematic diagram after the adjustment knob is omitted;

[0111] Fig.18 for Fig.17 Enlarged view of part F. DETAILED DESCRIPTION

[0112] The present application is further explained below in conjunction with specific embodiments.

[0113] See also Figure 1 In the prior art, taking aortic valve replacement as an example, after the interventional device is loaded, it enters the aorta 1 under the guidance of the guide head 1 of the delivery system, passes through the aortic arch and is located adjacent to the aortic valve 2. Before the interventional device is released, it is wrapped in the tube body 3 of the sheath tube. Figure 1 The figure shows the position and orientation of the aortic valve 2 of a normal physiological structure. By using a sheath tube 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 .

[0114] 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 bending using existing technologies and means. The bending adjustment targeted by this application 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.

[0115] In one embodiment of the present application, there is provided an adjustable bend interventional valve delivery system, comprising an adjustable bend sheath, a sheath core disposed in the adjustable bend sheath, and an operating handle connected to the proximal ends of the adjustable bend sheath and the sheath core.

[0116] The operating handle can be used to drive the relative movement of the bending sheath and the sheath core to achieve the storage or release of the interventional instrument in the bending sheath. The bending sheath in one embodiment includes a tube body 3, which has a distal end and a proximal end. The distal end of the tube body 3 is bent by the traction wire 8, and the proximal end of the traction wire 8 is connected to the operating handle. The operating handle acts on the distal end of the tube body 3 through the transmission of the traction wire 8 to achieve the bending of the tube body 3.

[0117] In order to achieve the relative movement of the bending sheath tube and the sheath core, and to pull the distal end of the tube body 3 via the traction wire 8, the operating handle includes:

[0118] A fixed body of a hollow structure;

[0119] A traction member slidably mounted in the fixed body and connected to the traction wire;

[0120] A driving mechanism mounted on the fixed body to drive the traction member to move;

[0121] A control mechanism installed on a fixed body to drive the bending sheath to move.

[0122] As for the fixed body itself, it is mainly for facilitating holding and providing a connection part for the proximal ends of the tube body 3, the sheath core and the traction wire 8. The hollow structure also facilitates the proximal ends of the above three to be inserted into the fixed body to further provide protection. In conventional technology, axial relative movement is required between the tube body 3 and the sheath core. For example, the proximal end of the sheath core can be fixed to the operating handle, and the proximal end of the tube body 3 is slidably installed on the operating handle. The above-mentioned control mechanism is used to achieve this function. The tube body 3 and the sheath core themselves and how to move relative to each other can also be implemented with reference to the existing technology. Therefore, there is no strict restriction on the control mechanism. At least one component (such as the transmission rod in the embodiment below) is connected to the proximal end of the tube body 3, and the component can move axially relative to the fixed body (or relative to the sheath core).

[0123] In this embodiment, the tube wall of the tube body 3 near the distal end is connected to the traction wire 8, one end of the traction wire 8 extends to the proximal end of the tube body 3, and the other end is near the distal end of the tube body 3, and at least one section of the traction wire 8 is 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 ring sleeve 9, which is wound around the outer circumference of the tube body 3, and the tube body 3 is pulled as a whole through the ring sleeve 9. The tube body 3 near the distal end is an expansion section for accommodating interventional instruments, and the ring sleeve 9 is correspondingly located at the distal side of the expansion section.

[0124] exist Figure 2aIn the present application, since the traction wire 8 has one end free outside the tube body 3, and the traction wire 8 is connected to the end of the sheath tube or is less than 5 cm away from the end, for example, the connection between the traction wire 8 and the sheath tube is less than 3 cm away from the end of the sheath tube. The free part has a large 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 range can be obtained, and the operating feel is also significantly improved.

[0125] In another embodiment, the connection position between the distal end of the traction wire 8 and the sheath is 8 to 12 cm, for example, 10 cm, away from the end of the sheath. This can avoid the site where the interventional instrument is transferred to a certain extent, reducing the difficulty of applying force for bending adjustment. Figure 2b In 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 .

[0126] 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 a 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.

[0127] Relative to Figure 2c ,exist Figure 2d In another embodiment, the traction wire 8 is connected to the proximal side of the expansion section.

[0128] See also Figure 3 The delivery system of the present application 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.

[0129] The sheath core 5 includes a core tube, and the distal end of the core tube is fixed with a guide head 4 and an interventional instrument fixing head 7. The portion of the core tube 5 between the guide head 4 and the interventional instrument fixing head 7 is a loading section for placing interventional instruments. Before release, the expansion section of the tube body 3 is outside the loading section. In this embodiment, the distal end of the traction wire 8 is connected to the proximal end of the expansion section. In this embodiment, the distal end of the traction wire 8 is greater than 10 cm away from the end of the sheath tube.

[0130] A sleeve 12 is disposed outside the tube body 3 , and the sleeve 12 and the tube body 3 are axially slidably matched, and the traction wire 8 extends toward the proximal end through the gap between the tube body 3 and the sleeve 12 .

[0131] The distal end of the sleeve 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.

[0132] See also Figure 4 In another embodiment, a sleeve 12 is provided outside the tube body 3 , and the sleeve 12 and the tube body 3 are axially slidably matched, and the traction wire 8 extends toward the proximal end through the gap between the tube body 3 and the sleeve 12 .

[0133] 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, and the ring itself can be fixed on the outer wall of the tube body or embedded in the side wall of the tube body.

[0134] See also Figure 6 , relative to Figure 4 In 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 after being unfolded.

[0135] 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.

[0136] 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.

[0137] See also Figure 7 and Figure 8 A limiting ring 17 is provided at the distal end of the tube body 3. The limiting ring can be a thickened area of ​​the tube body 3 itself, or it can be additionally fixed on the annular component. An axial limiting groove is provided on the outer periphery of the limiting ring 17. 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 elastic deformation. 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 inner side of the expected turning point, the side ring sleeve 9 is rotated by force until the connection between the traction wire and the ring sleeve 9 rotates to the inner side of the expected bending part. At this time, further force is applied to pull, or an ideal bending effect is obtained.

[0138] See also Fig. 9 , Fig.10 In the delivery system of one embodiment, a sleeve 12 is slidably provided outside the tube body 3 of the bending sheath tube, a sheath core 21 is provided inside the tube body 3, and the distal end of the sheath core 21 extends out of the tube body 3 and is provided with a guide head 4.

[0139] The distal end of the traction wire 8 is freed 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 19 .

[0140] See also Fig.11 The operating handle of one embodiment includes a fixed body 30 with a hollow structure. The fixed body 30 is a split structure formed by buckling two halves. The fixed body 30 is a hollow structure, and the tube body 3 and the sheath core 21 both pass through the fixed body 30.

[0141] In order to drive the traction member 27 to move, in one embodiment, the driving mechanism is an electric push rod (not shown in the figure) and is drivingly connected to the traction member 27. The electric push rod can directly drive the traction member 27 to move along the axial direction of the fixed body.

[0142] In another embodiment, the drive mechanism comprises:

[0143] A moving member 26 that axially resists and applies force to the pulling member 27;

[0144] The adjusting knob 24 is sleeved on the fixed body 30 and rotates around the axis of the fixed body. The adjusting knob 24 is cylindrical and is located at the outer periphery of the moving member 26. The adjusting knob 24 and the moving member 26 are threadedly matched.

[0145] The rotation axis of the adjusting knob 24 is consistent with the axis of the fixed body 30. When the adjusting knob 24 rotates, it can be converted into axial movement of the movable member 26 through the thread. The movable member 26 axially abuts against the distal side of the traction member 27, which can push the traction member 27 to move toward the proximal side, that is, pull the traction wire 8 to achieve bending adjustment.

[0146] The adjusting knob 24 is generally cylindrical and may be formed by buckling two or more petals.

[0147] In order to provide control accuracy, a guiding method for the movable member 26 is provided in a preferred embodiment, that is, the distal side fixing sleeve of the fixed body 30 is provided with a front end handle 23, and the front end handle 23 is provided with a hollow axial guide groove 23a. A part of the movable member 26 extends out of the axial guide groove 23a, and an external thread 26a is provided on the extended part (a full circle is not required, as long as the local radial protrusion is engaged and can be driven by the internal thread), and an internal thread matching the external thread 26a is provided inside the adjusting knob 24.

[0148] The axial guide groove 23a is opened along the axial direction of the fixed body 30, and a part of the movable member 26 is located in the axial guide groove 23a. When the movable member 26 moves axially, it is constrained by the axial guide groove 23a to prevent rotation.

[0149] In a preferred embodiment, there are at least two axial guide grooves 23 that are evenly distributed around the axis of the fixing body 30, which can further improve the guiding effect.

[0150] In order to drive the bending sheath tube to move relative to the sheath core, in one embodiment, the control mechanism includes:

[0151] A control handle 25 rotatably mounted on the outside of the fixed body 30, wherein the inner wall of the control handle 25 has an internal thread;

[0152] A transmission rod 28 is slidably installed in the fixed body 30 along the axis of the fixed body 30 . A linkage convex tooth 28 a matching the internal thread of the control handle is installed on the transmission rod 28 . The tube body 3 of the bending sheath is connected to the transmission rod 28 .

[0153] The rotation of the control handle 25 can drive the transmission rod 28 to move along the axis of the fixed body 30. When the sheath core 21 is stationary relative to the fixed body 30, the transmission rod 28 drives the tube body 3 to slide relative to the sheath core 21, thereby realizing the loading and release of the interventional instrument.

[0154] In order to guide the axial movement of the transmission rod 28 and prevent the transmission rod 28 from rotating, in a preferred embodiment, a guide groove 30 a is provided on the fixing body 30 for guiding the axial movement of the linkage protruding tooth 28 a.

[0155] The side wall of the fixed body 30 has a strip-shaped hollow area extending axially to form a guide groove 30a. The linkage convex tooth 28a fixed to the outer wall of the transmission rod 28 (either an integrated or split structure) extends out of the guide groove 30a, and the movement direction of the linkage convex tooth 28a is limited by the guide groove 30a.

[0156] In a preferred embodiment, there are at least two guide grooves 30a, which are evenly distributed around the axis of the fixed body 30, which can further improve the guiding effect.

[0157] The control handle 25 is a split structure consisting of two parts buckled together, both parts have internal threads and fit together exactly, the linkage protruding teeth 28a are similar in function to external threads but do not require a full circle, as long as the partial radial protrusion is inserted and can be driven by the internal threads.

[0158] The transmission rod 28 is also an axial through structure, through which the sheath core 21 passes, and extends to and is connected to the proximal end of the fixing body 30 .

[0159] The distal end of the front handle 23 is provided with the front cap 22, and the proximal end of the sleeve 12 is connected to the sliding seat 12a, which is movably plugged and matched (axially limited) with the front cap 22. The front handle 23 and the front cap 22 are both split structures formed by buckling two petals.

[0160] The traction member 27 and the moving member 26 are both slidably mounted on the outside of the transmission rod 28 . In one embodiment, the traction member 27 is an annular structure, and the transmission rod 28 slides through the central area of ​​the traction member 27 .

[0161] In one embodiment, the moving member 26 is an annular structure and is attached to the distal end of the traction member 27 , and the transmission rod 28 slides through the central area of ​​the moving member 26 .

[0162] See also Figures 12 to 18 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 Fig.14 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.

[0163] 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, the proximal end of the developing section has at least one step partially extending into the sleeve, so that even if it is slightly bent, the angle can be observed by the medical imaging system.

[0164] The above disclosure is only the specific embodiment of the present application, but the present application is not limited thereto, and those skilled in the art may make various changes and modifications to the present application without departing from the spirit and scope of the present application. Obviously, these changes and modifications should all fall within the scope of protection required by the present application. In addition, although some specific terms are used in this specification, these terms are only for the convenience of explanation and do not constitute any special limitation to the present application.

Claims

1. An adjustable bend interventional valve delivery system, comprising an adjustable bend sheath tube, a sheath core placed in the adjustable bend sheath tube, and an operating handle connected to the proximal ends of the adjustable bend sheath tube and the sheath core, characterized in that: The bending adjustment sheath comprises a tube body and a traction wire, wherein the tube body has a distal end and a proximal end, the distal end of the tube body is pulled and bent by the traction wire, and the proximal end of the traction wire is connected to the operating handle; 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; One end of the traction wire extends to the proximal end of the tube body, and 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. The traction wire has at least one section that is free outside the tube body, and the free section is covered with an anti-cut protective layer.

2. The adjustable bend interventional valve delivery system according to claim 1, characterized in that: The free segment position of the traction wire is: Located at the distal end of the tube; or Located between the middle of the tube and the distal end of the tube; or Located from the proximal end to the distal end of the tube; or adjacent to the distal end of the tube.

3. The adjustable bend interventional valve delivery system according to claim 1, characterized in that: The connection position between the distal end of the traction wire and the sheath is: Connected to the end of the sheath; or Located proximal to the sheath tip and less than 5 cm away from the sheath tip; or The distance from the sheath tip is 8 to 12 cm.

4. The adjustable bend interventional valve delivery system according to claim 1, characterized in that: The operating handle also includes: A control mechanism installed on a fixed body to drive the bending sheath to move.

5. The adjustable bend interventional valve delivery system according to claim 4, characterized in that: At least one component in the control mechanism is connected to the proximal end of the tube body, and the component can move axially relative to the fixed body or relative to the sheath core to drive the bending sheath tube to move.

6. The adjustable bend interventional valve delivery system according to any one of claims 1 to 3, characterized in that: The end of the traction wire is provided with a ring sleeve which is wound around the outer circumference of the tube body.

7. The adjustable bend interventional valve delivery system according to claim 6, 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 axially limited.

8. The adjustable bend interventional valve delivery system according to any one of claims 1 to 3, characterized in that: Reinforcing ribs are also fixed inside the side walls of the tube body.

9. The adjustable bend interventional valve delivery system according to claim 8, characterized in that: There are two reinforcing ribs, and the pulling wire and the reinforcing ribs are spaced apart and distributed in the circumferential direction of the tube body.

10. The adjustable bend interventional valve delivery system according to any one of claims 1 to 3, characterized in that: One section of the traction wire adjacent to the distal end is a developing section.

11. The adjustable bend interventional valve delivery system according to claim 10, characterized in that: The length of the developing section is greater than that of the freeing section.

12. The adjustable bend interventional valve delivery system according to any one of claims 1 to 3, characterized in that: The sheath core comprises a core tube, a guide head and an interventional instrument fixing head are fixed at the distal end of the core tube, the portion of the core tube between the guide head and the interventional instrument fixing head is a loading section for placing interventional instruments, and before release, the expansion section of the bending sheath tube is located at the periphery of the loading section; The distal end of the traction wire is connected to the proximal end of the expansion section.

13. The adjustable bend interventional valve delivery system according to any one of claims 1 to 3, characterized in that: A sleeve is provided outside the tube body of the bending adjustment sheath tube, and the sleeve is axially slidably matched with the tube body, and the traction wire extends toward the proximal end through the gap between the tube body and the sleeve.

14. The adjustable bend interventional valve delivery system according to any one of claims 1 to 3, characterized in that: The driving mechanism comprises: A moving member that axially resists and applies force to the pulling member; The adjusting knob is sleeved on the fixed body and rotates around the axis of the fixed body. The adjusting knob is cylindrical and is located at the outer periphery of the moving part. The adjusting knob and the moving part are threadedly matched.

15. The adjustable bend interventional valve delivery system according to claim 14, characterized in that: The distal fixing sleeve of the fixing body is provided with a front end handle, on which a hollow axial guide groove is provided, a part of the moving part extends out of the axial guide groove, an external thread is provided on the extended part, and a matching internal thread is provided inside the adjusting knob.

16. The adjustable bend interventional valve delivery system according to claim 15, characterized in that: There are at least two axial guide grooves, which are evenly distributed around the axis of the fixed body.

17. The adjustable bend interventional valve delivery system according to any one of claims 1 to 3, characterized in that: The driving mechanism is an electric push rod, and is drivingly connected to the traction member.

18. The adjustable bend interventional valve delivery system according to any one of claims 4 to 5, characterized in that: The control mechanism comprises: A control handle is rotatably mounted on the outside of the fixed body, and 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, and a linkage convex tooth matched with the internal thread of the control handle is installed on the transmission rod. The tube body of the bending sheath tube is connected to the transmission rod.

19. The adjustable bend interventional valve delivery system according to claim 18, characterized in that: The fixed body is provided with a guide groove for guiding the axial movement of the linkage convex tooth.

20. The adjustable bend interventional valve delivery system according to claim 18, characterized in that: The traction member is an annular structure, and the transmission rod slides through the central area of ​​the traction member.

21. The adjustable bend interventional valve delivery system according to claim 20, characterized in that: The driving mechanism comprises: A moving member that axially resists and applies force to the pulling member; An adjusting knob is sleeved on the fixed body and rotates around the axis of the fixed body, the adjusting knob is cylindrical and is located at the periphery of the moving part, and the adjusting knob and the moving part are threadedly matched; The moving member is an annular structure and is close to the distal end of the traction member, and the transmission rod slides through the central area of ​​the moving member.

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