Valve prosthesis delivery system and method of operating the same

Abstract

The present application relates to the technical field of medical devices, in particular to a valve prosthesis delivery system and an operating method thereof, which can efficiently, accurately and conveniently deliver a valve prosthesis. The valve prosthesis delivery system comprises: a multi-lumen tube; a control unit at the proximal end of the multi-lumen tube; a cartridge at the distal end of the multi-lumen tube; a bending assembly comprising a snake tube connected to the distal end of the multi-lumen tube and located in the cartridge, opposite straight sides and bending sides of the snake tube forming a bending angle, so that the cartridge is oriented at the bending angle; a connecting tube extending in the central lumen to the inside of the snake tube; a tip assembly comprising a tip head, which is detachably arranged at the distal end of the cartridge; a guide wire line in the connecting tube connected to the proximal end of the tip head; a circumferential rotation assembly comprising: a valve seat connected to the valve prosthesis and connected to the connecting tube; a circumferential transmission mechanism connected to the control unit and connected to the connecting tube and the cartridge, rotation of the circumferential control causes rotation of the circumferential transmission mechanism and circumferential rotation of the valve seat and the cartridge.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a valve prosthesis delivery system and an operation method thereof. BACKGROUND

[0002] Minimally invasive transcatheter treatment of cardiovascular diseases has gradually become the main treatment method, such as coronary stents, artificial valve prostheses, occluders or large vessel stents, etc. The valve prosthesis needs to be delivered to the desired position in the human body by a delivery device. The position accuracy of the heart valve prosthesis is particularly important.

[0003] However, due to the complex anatomical structure of the mitral valve and the tricuspid valve, for minimally invasive transcatheter products, especially when using a transjugular approach, limited by the diameter of the catheter and the performance of the catheter, during the process of delivering the valve prosthesis to the target position by the delivery system, the outer sheath tube (or the cartridge tube) of the delivery system and the inner core tube inside it cannot achieve suitable movement or linkage at different stages as needed, resulting in that the artificial valve is difficult to be accurately delivered to the target position; in addition, due to the lack of a circumferential adjustment mechanism / device, the fixing device of the artificial valve cannot be adjusted in the circumferential position, resulting in that the fixing point is prone to deviation. SUMMARY

[0004] Embodiments of the present application provide a valve prosthesis delivery system and an operation method thereof, which can efficiently, accurately and conveniently deliver the valve prosthesis.

[0005] According to an aspect of the present application, a valve prosthesis delivery system is provided, comprising:

[0006] a multi-lumen tube comprising a central lumen extending in an axial direction;

[0007] a control unit arranged at a proximal end of the multi-lumen tube;

[0008] a cartridge arranged at a distal side of the multi-lumen tube, the cartridge being fixed by a cartridge fixing seat, the cartridge fixing seat being sleeved on the periphery of the multi-lumen tube and being capable of rotating around the multi-lumen tube;

[0009] a bending assembly comprising a bendable snake tube, the snake tube being connected to a distal end of the multi-lumen tube and being located in the cartridge, a straightened side and a bending side of the snake tube being connected to the control unit respectively, the snake tube forming a suitable bending angle under the control of the control unit, so that the cartridge sleeved outside the snake tube is oriented at the bending angle;

[0010] a connecting tube arranged in the central lumen and extending distally into the snake tube;

[0011] a circumferential rotation assembly comprising: a valve seat connected to a head end of a valve prosthesis, the valve seat connected to the connecting tube; a circumferential transmission mechanism connected to a circumferential control of the control unit, the circumferential transmission mechanism connected to the connecting tube and connected to the cartridge fixing seat, rotation of the circumferential control causing rotation of the circumferential transmission mechanism, driving the connecting tube and the cartridge fixing seat, thereby causing circumferential rotation of the valve seat and the cartridge.

[0012] Preferably, in any embodiment,

[0013] the straightening side of the serpentine tube is connected to the bending adjuster of the control unit by a straightening pull wire;

[0014] the bending side of the serpentine tube is connected to the bending adjuster via a guide body after being turned 180 degrees, such that when the bending adjuster moves, the straightening pull wire and the bending pull wire respectively tighten or release the straightening side and the bending side in opposite directions, thereby causing the serpentine tube to form a suitable bending angle.

[0015] Preferably, in any embodiment,

[0016] the bending adjuster moves axially to cause the serpentine tube to form a suitable bending angle.

[0017] Preferably, in any embodiment,

[0018] the bending adjuster comprises a bending wheel, the bending wheel being connected to a bending control of the control unit by a thread and moving axially with rotation of the bending control.

[0019] Preferably, in any embodiment,

[0020] the multi-lumen tube comprises: a passage lumen surrounding the central lumen and extending axially;

[0021] the straightening pull wire and the bending pull wire respectively extend through the respective passage lumens.

[0022] Preferably, in any embodiment,

[0023] the bending angle of the serpentine tube is 0-90 degrees.

[0024] Preferably, in any embodiment, further comprising:

[0025] a tip assembly comprising: a tip head detachably arranged at a distal end of the cartridge; and a guide wire line within the connecting tube, the guide wire line connected to a proximal end of the tip head and connected to the control unit.

[0026] Preferably, in any embodiment,

[0027] The tip head comprises a first guide portion having a shape tapering in a proximal-to-distal direction and a second guide portion having a shape enlarging in the proximal-to-distal direction.

[0028] Preferably, in any embodiment,

[0029] The circumferential rotation assembly comprises a first transmission member connecting the circumferential rotation control and the connecting tube, and a second transmission member connecting between a distal end of the first transmission member and the cartridge fixing base;

[0030] Rotation of the circumferential rotation control causes the first transmission member to rotate, which in turn causes the connecting tube and the cartridge fixing base to rotate, thereby causing the valve seat and the cartridge to circumferentially rotate.

[0031] Preferably, in any embodiment,

[0032] The circumferential rotation assembly allows the cartridge to circumferentially rotate within a range of ±90 degrees.

[0033] According to another aspect of the present application, there is provided a method for operating the valve prosthesis delivery system as claimed in any one of the preceding aspects, comprising:

[0034] Bringing the cartridge to a predetermined delivery port;

[0035] Forming the serpentine tube into a suitable bending angle, thereby orienting the cartridge at the bending angle and into the delivery port to a predetermined depth;

[0036] While the serpentine tube maintains the bending angle unchanged, rotating the circumferential rotation control while keeping the extension axis of the cartridge unchanged, driving the connecting tube and the cartridge fixing base to rotate, and causing the valve seat connected with the valve prosthesis and the cartridge to circumferentially rotate by a predetermined circumferential rotation angle.

[0037] The valve prosthesis delivery system and the method for operating the same provided by the embodiments of the present application can efficiently, accurately and conveniently deliver the valve prosthesis. BRIEF DESCRIPTION OF DRAWINGS

[0038] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the drawings needed to be used in the embodiments or prior art description will be described below. Obviously, the technical solutions described in the description in conjunction with the drawings are only some embodiments of the present application, and for those skilled in the art, other embodiments and drawings can be obtained without creative labor on the basis of these drawings shown in the embodiments.

[0039] Figure 1- Figure 5 is a schematic view showing a process of delivering a valve prosthesis to a predetermined position in a predetermined posture and safely withdrawing the valve prosthesis delivery system according to an embodiment of the present application.

[0040] Figure 6 Figure 6 is a schematic view of the structure of a bending assembly according to an embodiment of the present application.

[0041] Figure 7 Figure 7 is a schematic view of the structure of a valve prosthesis delivery system according to an embodiment of the present application.

[0042] Figure 8 Figure 8 is a schematic view of the structure of a valve prosthesis delivery system according to an embodiment of the present application.

[0043] Figure 9 Figure 9 is a schematic view of the structure of a distal portion of a valve prosthesis delivery system according to an embodiment of the present application. DETAILED DESCRIPTION

[0044] The technical solutions of the embodiments of the present application will be clearly and completely described below with reference to the drawings. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments. Based on the embodiments described in the present application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present application.

[0045] The embodiments of the present application provide a valve prosthesis delivery system and an operating method thereof, which can efficiently, accurately and conveniently deliver a valve prosthesis.

[0046] According to an aspect of the present application, a valve prosthesis delivery system is provided, comprising:

[0047] a multi-lumen tube comprising a central lumen extending in an axial direction;

[0048] a control unit arranged at a proximal end of the multi-lumen tube;

[0049] a cartridge arranged at a distal side of the multi-lumen tube, the cartridge being fixed by a cartridge fixing seat, the cartridge fixing seat being sleeved on an outer periphery of the multi-lumen tube and being rotatable around the multi-lumen tube;

[0050] a bending assembly comprising a bendable snake tube, the snake tube being connected to a distal end of the multi-lumen tube and being located in the cartridge, a straight side and a bending side of the snake tube being connected to the control unit respectively, the snake tube being formed with a suitable bending angle under the control of the control unit, so that the cartridge sleeved outside the snake tube is oriented at the bending angle;

[0051] a connecting tube arranged in the central lumen and extending distally into the snake tube;

[0052] A circumferential rotation assembly includes: a valve seat connected to the head end of a valve prosthesis and connected to the connecting tube; a rotation transmission mechanism connected to a rotation control of the control unit, and connected to the connecting tube and the cartridge holder, wherein rotation of the rotation control causes rotation of the rotation transmission mechanism, driving the connecting tube and the cartridge holder, thereby causing the valve seat and the cartridge to rotate circumferentially.

[0053] Thus, after the valve prosthesis-carrying cartridge is delivered to a predetermined position (e.g., above the tricuspid valve between the right atrium and right ventricle) via the valve prosthesis delivery system (hereinafter referred to as the delivery system), for example, as Figure 1 As shown), the control unit causes the serpentine tube of the bending assembly to form a suitable bending angle, thereby orienting the cartridge at such a bending angle and inserting it into the delivery port (e.g., at the valve annulus) (e.g., into the right ventricle) to a predetermined depth (e.g., as shown). Figure 2 (as shown); then, while the snake-bone tube maintains its bending angle (so that the magazine, which is fitted outside the snake-bone tube, also maintains its orientation at the bending angle), the magazine is rotated circumferentially around the extension axis by a predetermined circumferential rotation angle while maintaining its extension axis (corresponding to the bending angle) using the rotation control of the control unit. Simultaneously, the valve seat (i.e., the valve prosthesis fixation seat, which is connected to the connecting tube and rotation control via a rotation transmission mechanism) connected to the valve prosthesis head rotates by the predetermined circumferential rotation angle, thereby allowing the valve prosthesis to adjust its posture before release to adapt to the native tissue in the in vivo application environment (e.g., as shown). Figure 3 (as shown); then, the valve prosthesis can be released from the magazine (e.g., as shown). Figure 4 As shown in the figure, since the release port of the magazine is already accurately positioned in a predetermined position (which may correspond to the predetermined depth mentioned above) and in a predetermined orientation (which may correspond to the predetermined circumferential rotation angle mentioned above) and in a suitable posture before release, the hollow part of the valve prosthesis released at this time can perfectly overlap with the original tissue that needs to be avoided in the in vivo application environment, thereby avoiding damage to human tissue by the interventional valve prosthesis and ensuring that the valve prosthesis is fixed in place in the human body to achieve its predetermined function.

[0054] It should be emphasized that after the snake tube is bent to a suitable bending angle by the bending assembly, the snake tube maintains its position and bending degree (bending angle) in subsequent operations (especially in the process of circumferential rotation by the circumferential rotation assembly), on the one hand, to ensure that the cartridge placed outside the snake tube maintains the orientation (for example, the orientation along its extension direction) adjusted in place, and on the other hand, to effectively limit the movement of the connecting tube inside it during subsequent circumferential rotation, to constrain the connecting tube to rotate circumferentially along its own extension direction, so that the valve prosthesis fixing seat connected to the connecting tube can be circumferentially rotated in a predetermined manner, thereby achieving the circumferential rotation adjustment of the valve prosthesis to a predetermined posture (position / angle) before release, to correspond to the position of the native tissue in the in-vivo application environment.

[0055] Therefore, the valve prosthesis delivery system provided by the embodiments of the present application can efficiently, accurately and conveniently deliver the valve prosthesis. Moreover, the valve prosthesis can be safely and reliably delivered to the site in a more convenient and efficient manner by operating the proximal control unit (for example, including a control handle), thereby reducing the adverse effects on the patient caused by long-term surgery.

[0056] Optionally, in an embodiment, the proximal end of the cartridge is connected to the outer tube, and the multi-lumen tube is arranged in the outer tube.

[0057] Optionally, in an embodiment, the connecting tube passes through the multi-lumen tube.

[0058] Optionally, in an embodiment, the straightening side and the bending side of the snake tube are respectively located on opposite sides of the snake tube (for example, as shown in the embodiment shown in the figure). Figure 6

[0059] Preferably, in any embodiment,

[0060] The straightening side of the snake tube is connected to the bending member of the control unit by a straightening pull wire;

[0061] The bending side of the snake tube is connected to the bending member via a bending pull wire after being turned by 180 degrees via a guide body, so that when the bending member moves, the straightening pull wire and the bending pull wire respectively tighten or release the straightening side and the bending side in opposite directions, thereby forming a suitable bending angle of the snake tube.

[0062] ​Thus, one of the straightening pulling wire and the bending pulling wire is directly connected to the bending member, while the other one is turned by 180 degrees after passing through the guide body and connected to the bending member in the opposite direction. By means of the design of the guide body, when the bending member moves, the straightening pulling wire and the bending pulling wire have opposite effects on the corresponding straightening side and the bending side (for example, the straightening side is loosened, while the bending side is tightened), so that the serpentine tube is bent in a controllable manner to form a suitable bending angle, thereby orienting the cartridge outside the serpentine tube at the bending angle.

[0063] Figure 6 is a structural schematic diagram of the bending assembly according to an embodiment of the present application. In Figure 6 It can be seen in the embodiment shown that the straightening side (the upper side in Figure 6 ) of the serpentine tube is connected to the bending member (the embodiment of Figure 6 is shown as a bending wheel) of the control unit; the bending side (the lower side in Figure 6 ) of the serpentine tube is connected to the bending member after being turned by 180 degrees after passing through the guide body (the embodiment of Figure 6 is shown as a fixed pulley), so that when the bending member moves, the straightening pulling wire and the bending pulling wire respectively tighten or release the straightening side and the bending side in opposite directions, so that the serpentine tube forms a suitable bending angle.

[0064] For example, when the bending member moves to the left, the straightening side pulling wire of the straightening side (the upper side in Figure 6 ) of the serpentine tube is loosened, while the connection point of the bending side pulling wire of the bending side (the lower side in Figure 6 ) connected to the bending member also moves to the left with the bending member, so that the left part of the bending side pulling wire connected to the bending member after being turned by 180 degrees after passing through the guide body moves to the right, thereby pulling the bending side to the right, so that the straightening side (the upper side in Figure 6 ) of the serpentine tube is loosened, while the bending side (the lower side in Figure 6 ) is pulled to the right, so that the serpentine tube is bent, that is, the bending operation of the serpentine tube is realized.

[0065] It should be understood that Figure 6 is only a schematic diagram according to one embodiment of the present application, which is used to illustrate one principle of the bending operation of the serpentine tube by means of the bending assembly, and is not used to limit the protection scope of the present application.

[0066] Optionally, in any embodiment, the guide body comprises a guide wheel, one of the straightening pulling wire and the bending pulling wire is turned by 180 degrees after passing through the round sliding surface of the guide wheel and connected to the bending member in the opposite direction.

[0067] Optionally, in any embodiment, the guide body comprises a fixed pulley, one of the straightening pulling wire and the bending pulling wire is turned by 180 degrees after passing through the round sliding surface of the fixed pulley and connected to the bending member in the opposite direction.

[0068] Optionally, in any of the embodiments, the guide body comprises a guide post, and one of the straightening pull wire and the bending adjustment pull wire is connected to the bending adjustment member in opposite direction after being turned 180 degrees around the cylindrical surface of the guide post.

[0069] Optionally, in any of the embodiments, the guide body has a smooth curved portion, and one of the straightening pull wire and the bending adjustment pull wire is connected to the bending adjustment member in opposite direction after being turned 180 degrees around the curved portion.

[0070] Optionally, in any of the embodiments, the curved portion of the guide body is provided on the edge of the guide body.

[0071] Optionally, in any of the embodiments, the guide body is fixed to the inner wall of the control unit.

[0072] Optionally, in any of the embodiments, the guide body is fixed or provided on the bending adjustment member (e.g. on the outer surface of the bending adjustment member).

[0073] Optionally, in any of the embodiments, the guide body is a guide protrusion extending from the bending adjustment member. That is, the guide body and the bending adjustment member are in one-piece structure.

[0074] It should be understood that the guide body can be movable (e.g. a fixed pulley) or stationary when the straightening pull wire or the bending adjustment pull wire is moved during the bending operation.

[0075] Preferably, in any of the embodiments, the bending adjustment member is moved axially to form a suitable bending angle of the serpentine tube.

[0076] Optionally, in any of the embodiments, the bending adjustment member is rotated to form a suitable bending angle of the serpentine tube.

[0077] Preferably, in any of the embodiments, the bending adjustment member comprises a bending adjustment wheel, which is threadedly connected to a bending control of the control unit and moved axially with the rotation of the bending control. In this way, the axial movement of the bending adjustment member is achieved by the rotational movement, which can be finely adjusted to achieve a predetermined bending angle of the serpentine tube.

[0078] Optionally, in any of the embodiments, the bending adjustment wheel has an external thread, which is engaged with an internal thread of the bending control to achieve the threaded connection.

[0079] Optionally, in any of the embodiments, the bending wheel has a central through hole for the connection tube to pass through in the axial direction. It should be understood that in addition to the connection tube, other pipeline structures (such as multi-lumen tubes) can also pass through the central through hole as needed to achieve a compact structure. In this way, on the one hand, a compact structure is achieved without hindering the mutual connection of the connection tube and related components, and on the other hand, material can be saved to reduce weight.

[0080] Preferably, in any of the embodiments, the multi-lumen tube comprises: a passage lumen surrounding the central lumen and extending in the axial direction; the straightening pull wire and the bending pull wire respectively extend through the respective passage lumens. In this way, it is ensured that the serpentine tube bending operation by the straightening pull wire and the bending pull wire is not disturbed by external factors (such as influence from other components).

[0081] Preferably, in any of the embodiments, the bending angle of the serpentine tube is 0-90 degrees.

[0082] Preferably, in any of the embodiments, further comprising:

[0083] a tip assembly comprising: a tip head which is detachably arranged at the distal end of the cartridge; and a guide wire pipeline within the connection tube, which is connected to the proximal end of the tip head and to the control unit.

[0084] In this way, after the valve prosthesis is released, the control unit can be operated to move the guide wire pipeline proximally to pull the tip head (TIP head) proximally (i.e. towards the cartridge) until it closes on the cartridge, without the risk of operating the TIP head distally of the cartridge as in the prior art, which can cause the cartridge to mistakenly touch the released valve prosthesis (which can cause the already deployed valve prosthesis to move out of the intended position, thereby affecting the effect of the valve prosthesis). In this way, by pulling the TIP head alone proximally through the guide wire pipeline and closing it on the cartridge, and then safely exiting (for example, as shown in Figure 5

[0085] Preferably, in any of the embodiments, (for example, as shown in Figure 9 the tip head comprises a first guide portion and a second guide portion, the first guide portion has a tapered shape in the direction from proximal to distal, and the second guide portion has an enlarged shape in the direction from proximal to distal. When the tip head advances distally along the blood vessel, the tapered shape of the first guide portion can smoothly contact the blood vessel wall, reducing damage to the blood vessel. When the tip head is pulled proximally by the guide wire pipeline to close towards the cartridge, the shape of the second guide portion makes it easier for the tip head to move proximally without being blocked, and is less likely to collide with the already released valve prosthesis to cause it to dislodge or be damaged.

[0086] ​Optionally, in any of the embodiments, the first guide portion of the tip head is outside the cartridge, and the second guide portion is inside the cartridge.

[0087] Optionally, in any of the embodiments, the first guide portion has a conical shape, i.e. a tapering conical shape towards the distal end.

[0088] Optionally, in any of the embodiments, the second guide portion has a water-drop shape. That is, the outer contour shape of the tip head is not a straight line shape of a conical structure, but a convex curved shape. In this way, the axial length can be effectively saved while ensuring a smooth surface, which is particularly suitable for the compact structure of the valve prosthesis delivery system.

[0089] Optionally, in any of the embodiments, the tip head has an annular step on the outer peripheral surface and is mounted to the distal end of the cartridge through the annular step.

[0090] Preferably, in any of the embodiments, the circumferential transmission mechanism can include a first transmission member connected between the circumferential control and the connecting tube, and a second transmission member connected between the distal end of the first transmission member and the cartridge fixing seat. Through the connection of the second transmission member, the first transmission member, the second transmission member and the cartridge fixing seat form a transmission structure of, for example, 1:1, i.e. the rotation of the circumferential control causes the rotation of the first transmission member, and the second transmission member and the cartridge fixing seat rotate accordingly. The rotation of the first transmission member can drive the rotation of the connecting tube and the valve seat fixedly connected with the connecting tube; thus, the valve seat connected with the valve prosthesis and the cartridge connected with the cartridge fixing seat can be rotated circumferentially by 1:1 through the first transmission member and the second transmission member, so as to control the valve seat and the cartridge to complete circumferential rotation by the same circumferential rotation angle.

[0091] Optionally, in any of the embodiments, the above-mentioned 1:1 transmission structure is a rigid transmission structure. In the case of substantially rigid transmission, substantially synchronous real-time rotation can be achieved, so that there is no time difference in rotation between the valve prosthesis and the cartridge, no friction between the valve prosthesis and the cartridge, and the valve prosthesis can be prevented from being damaged.

[0092] It should be noted that 1:1 synchronous real-time transmission means that the circumferential rotation of the two objects starts at the same time and ends at the same time.

[0093] From the above analysis, the synchronous real-time circumferential rotation of the valve seat (to which the valve prosthesis is connected) and the cartridge fixing seat (to which the cartridge for accommodating the valve prosthesis is connected) can be achieved through the main control rotation of the circumferential control, so that the valve prosthesis can be adjusted in a lossless circumferential rotation before being released.

[0094] Optionally, in any embodiment, the valve seat connected to the valve prosthesis is connected to the distal end of the connecting tube, extending distally into the cartridge and not connected or in contact with the cartridge to avoid collision and damage or affect the posture of the valve prosthesis during operation, which is not conducive to the release of the valve.

[0095] Optionally, in any embodiment, the outer peripheral surface of the valve seat is separated from the inner wall of the cartridge by a predetermined distance.

[0096] Preferably, in any embodiment, the circumferential rotation assembly allows the circumferential rotation angle of the cartridge to be ±90 degrees (e.g., ±60 degrees).

[0097] Optionally, in any embodiment, the control unit comprises: a control knob, circumferential rotation of the control knob causes the first transmission member to rotate.

[0098] Optionally, in any embodiment, the control unit comprises: a handle disposed at the proximal end; and a control knob that can rotate axially around the axis of the handle.

[0099] Optionally, in any embodiment, the control knob can comprise a bending control knob, and the bending control comprises or is connected to the bending control knob, such that rotation of the bending control knob causes axial movement of the bending wheel.

[0100] Optionally, in any embodiment, the control knob can comprise a circumferential rotation control knob, and the circumferential rotation control comprises or is connected to the circumferential rotation control knob, such that rotation of the circumferential rotation control knob causes the circumferential rotation transmission mechanism to rotate and cause the connecting tube, the valve seat, and the cartridge to circumferentially rotate.

[0101] Optionally, in any embodiment, the control unit comprises a forward and backward assembly, which comprises:

[0102] a forward and backward control connected to the connecting tube through a threaded structure, causing the connecting tube to move axially along with the rotation of the forward and backward control.

[0103] Optionally, in any embodiment, the control unit can comprise a forward and backward control knob, and the forward and backward control comprises or is connected to the forward and backward control knob, such that rotation of the forward and backward control knob causes axial movement of the connecting tube.

[0104] Optionally, in any of the embodiments, the plurality of control knobs (e.g., the bending control knob, the circumferential control knob, or the advancing / retracting control knob) are disposed on the handle and are axially separated. That is, the different control knobs are arranged axially separately (e.g., sequentially along the axial direction) and can be operated independently of each other. In this way, during the bending step, only the rotation of the bending control knob can be performed; during the circumferential step, only the rotation of the circumferential control knob can be performed while keeping the bending control knob stationary (e.g., locked by a suitable locking mechanism), thereby ensuring that the cartridge is circumferentially rotated around its extension axis to adapt to the position of the native tissue in the in-vivo application environment while keeping the bending angle unchanged, and thus enabling the bending and circumferential rotation operations to be achieved in a compact structure.

[0105] Optionally, in any of the embodiments, the circumferential control knob is disposed proximally of the bending control knob.

[0106] Optionally, in any of the embodiments, the advancing / retracting control knob is disposed proximally of the circumferential control knob.

[0107] By disposing a plurality of control knobs (e.g., the bending control knob, the circumferential control knob, or the advancing / retracting control knob) on the handle of the control unit at the proximal end, the operations are performed by the rotation of the control knobs on the outer peripheral surface of the handle, and the different control knobs are operated by corresponding transmission or linkage components, which can significantly simplify the step-by-step operations of the valve prosthesis delivery system.

[0108] Optionally, in any of the embodiments, the control unit comprises a circumferential locking mechanism for the circumferential control, which, when in the locked state, prohibits the rotation of the circumferential control or prohibits the rotation of the circumferential control from being transmitted to the first transmission component. In this way, the effects of the circumferential rotation can be prevented from being affected by a misoperation.

[0109] Optionally, in any of the embodiments, the control unit comprises a bending locking mechanism for the bending control, which, when in the locked state, prohibits the rotation of the bending control or prohibits the rotation of the bending control from being transmitted to the bending wheel. In this way, the bending angle of the serpentine tube can be prevented from being affected by a misoperation.

[0110] It should be understood herein that the control knobs (e.g., the bending control knob or the advancing / retracting control knob) described in the foregoing embodiments can convert the rotational motion into linear motion through a threaded structure as needed, and the self-locking function can be achieved by the self-locking angle of the threaded structure itself and the damping present in the threaded structure itself. However, further selective enabling or disabling of the effective operation of the control knobs (e.g., the bending control knob or the advancing / retracting control knob) by the locking mechanism (e.g., the bending locking mechanism or the advancing / retracting locking mechanism) can be further provided, thereby better enabling or disabling the bending operation or the advancing / retracting operation.

[0111] Optionally, in any embodiment, the control unit comprises a push-pull assembly, the push-pull assembly comprising:

[0112] a push-pull control connected to the connecting tube by a threaded structure, such that rotation of the push-pull control causes axial movement of the connecting tube.

[0113] Optionally, in any embodiment, the push-pull control comprises a fine push-pull control knob and a fine push-pull block threadedly connected to the fine push-pull control knob, rotation of the fine push-pull control knob causing axial movement (e.g. distal axial movement) of the fine push-pull block, which pushes the first transmission member distally and in turn pushes the second transmission member distally, thereby causing the distal movement of the cartridge for fine adjustment. After the bending operation and before the turning operation, the cartridge enters the delivery port (e.g. into the right ventricle) at a predetermined bending angle, at which point the fine adjustment operation is required to advance the cartridge to a predetermined depth to reach a predetermined position, in preparation for the subsequent valve release operation; after the fine adjustment operation is completed to reach the predetermined position, the turning operation can be performed.

[0114] According to another aspect of the present application, there is provided a method for operating a valve prosthesis delivery system as claimed in any preceding claim, comprising:

[0115] causing the cartridge to reach a predetermined delivery port;

[0116] causing the serpentine tube to form a suitable bending angle, thereby causing the cartridge to be oriented at the bending angle and enter the delivery port to a predetermined depth;

[0117] while the serpentine tube maintains the bending angle unchanged, causing the cartridge to rotate around the extension axis by a predetermined circumferential rotation angle while maintaining the direction of the extension axis unchanged, and causing the valve seat connected to the valve prosthesis to rotate synchronously by the predetermined circumferential rotation angle.

[0118] Preferably, in any embodiment, further comprising:

[0119] after releasing the valve prosthesis from the cartridge, pulling the tip head proximally through the guide wire line to close on the cartridge.

[0120] Figure 7 is a structural schematic diagram of a valve prosthesis delivery system according to an embodiment of the present application.

[0121] In Figure 7 an embodiment, a valve prosthesis delivery system is seen to comprise:

[0122] a multi-lumen tube 8 comprising a central lumen extending axially;

[0123] a control unit 10 disposed at the proximal end of the multi-lumen tube;

[0124] Magazine 6 is located on the distal side of the multi-chamber tube;

[0125] A bending assembly includes a flexible snake tube connected to the distal end of the multi-cavity tube and located within the magazine. A straightening side and a bending side of the snake tube are respectively connected to the control unit. Under the control of the control unit, the snake tube forms a suitable bending angle, thereby orienting the magazine, which is fitted outside the snake tube, at the bending angle.

[0126] A connecting tube 7 is disposed within the central cavity and extends distally into the snake-bone tube;

[0127] A circumferential rotation assembly includes: a valve seat connected to the head end of a valve prosthesis and connected to the connecting tube 7; a rotation transmission mechanism connected to the rotation control of the control unit, and connected to the connecting tube and the cartridge, wherein rotation of the rotation control causes rotation of the rotation transmission mechanism and causes circumferential rotation of the connecting tube, the valve seat, and the cartridge.

[0128] Figure 8 This is a schematic diagram of the valve prosthesis delivery system according to an embodiment of the present invention.

[0129] Figure 9 This is a schematic diagram of the distal portion of a valve prosthesis delivery system according to an embodiment of the present invention.

[0130] exist Figure 8 The illustrated embodiment shows a valve prosthesis delivery system in which, after the bending operation is completed, the cartridge enters the delivery port (e.g., at the valve annulus) to a predetermined depth (e.g., as shown in the diagram) according to the orientation defined by the bending angle of the serpentine tube. Figure 2 (as shown); then, while the snake-bone tube maintains its bending angle (so that the magazine, which is fitted outside the snake-bone tube, also maintains its orientation at the bending angle), the magazine is rotated circumferentially around its extension axis by a predetermined circumferential rotation angle while maintaining its extension axis (corresponding to the bending angle) using the rotation control of the control unit. Simultaneously, the valve seat 30 (i.e., the valve prosthesis fixation seat, which is connected to the connecting tube and the rotation control via a rotation transmission mechanism) connected to the valve prosthesis head rotates by the predetermined circumferential rotation angle, thereby allowing the valve prosthesis to adjust its posture before release to adapt to the native tissue in the in vivo application environment (e.g., as shown). Figure 3 (as shown); then, retract magazine 6 to release the valve prosthesis from magazine 6 (e.g., as shown). Figure 4As shown in the figure, since the cartridge release port has been accurately positioned in a predetermined position (which can correspond to the above-mentioned predetermined depth) and in a predetermined orientation (which can correspond to the above-mentioned predetermined circumferential rotation angle) in a suitable posture before release, the hollowed-out portion of the valve prosthesis released at this time can perfectly coincide with the native tissue that needs to be avoided in the in-vivo application environment, so as to avoid damage to the human tissue by the interventional valve prosthesis, and to ensure that the valve prosthesis is fixed in place in the human body to achieve its predetermined function.

[0131] In combination Figure 8 and 9 In the embodiment shown in the figure, the circumferential rotation mechanism can include: a first transmission member 12 connected to the circumferential rotation control and the connecting tube 7; and a second transmission member 11 connected between the distal end of the first transmission member 12 and the cartridge 6.

[0132] The second transmission member 11 is connected to the first transmission member 12, the second transmission member 11 is connected to the cartridge fixing seat 10, the cartridge fixing seat 10 is fixed with the cartridge 6, and the connecting tube fixing seat 14 is connected with the connecting tube 7. The head end of the valve prosthesis is connected to the valve seat 30, the valve seat 30 is connected with the connecting tube 7, the outside of the valve prosthesis is the cartridge 6, and the cartridge 6 and the connecting tube 7 need to be circumferentially rotated by the same circumferential rotation angle (for example, can be substantially synchronous circumferential rotation) across the multi-lumen tube 8 and the serpentine tube fixing seat 13.

[0133] Since the stent of the valve prosthesis will expand and generate a large friction force with the cartridge 6 when the temperature in the body rises, in order to achieve the circumferential rotation adjustment of the valve prosthesis, the cartridge 6 and the valve seat 30 and the valve prosthesis need to move together. The cartridge 6 is outside the serpentine tube, the connecting tube 7 is inside the serpentine tube, and the cartridge 6 and the connecting tube 7 need to be circumferentially rotated by the same circumferential rotation angle (for example, can be synchronous real-time circumferential rotation) while ensuring that the bending degree and position of the serpentine tube remain unchanged.

[0134] The rotation of the circumferential rotation control causes the rotation of the first transmission member 12. The rotation of the first transmission member 12 causes the corresponding rotation (for example, synchronous real-time rotation) of the connecting tube fixing seat 14, the second transmission member 11 and the cartridge fixing seat 10. Correspondingly, the connecting tube 7, the valve seat 30 fixedly connected with the connecting tube, and the cartridge 6 fixedly connected with the cartridge fixing seat are circumferentially rotated by the same circumferential rotation angle (for example, synchronous real-time circumferential rotation).

[0135] As can be seen from the above, through the connection of the second transmission member 11, the first transmission member 12, the second transmission member 11, and the magazine fixing seat 10 form a transmission structure in a ratio of, for example, 1:1. That is, the rotation of the rotation control causes the first transmission member 12 to rotate, and the second transmission member 11 and the magazine fixing seat 10 rotate accordingly. The rotation of the first transmission member 12 can drive the connecting tube 7 and the valve seat 30 fixedly connected to the connecting tube to rotate; thereby enabling the valve seat 30 connected to the valve prosthesis and the magazine 6 connected to the magazine fixing seat 10 to achieve corresponding circumferential rotation in a ratio of, for example, 1:1 (e.g., real-time rotation). In this way, there will be no time difference in rotation between the valve prosthesis and the magazine, and the magazine 6, the valve seat 30, and the valve prosthesis can achieve coordinated movement (i.e., synchronous circumferential rotation). Therefore, there will be no friction between the valve prosthesis and the magazine, and damage to the valve prosthesis can be avoided.

[0136] exist Figure 8 and Figure 9 In the illustrated embodiment, the magazine 6 and connecting tube 7 need to achieve the same circumferential rotation angle across the multi-cavity tube 8 and the snake-bone tube fixing seat 13. With the snake-bone tube remaining bent, the rotation control (e.g., the circumferential adjustment knob 4 shown in the figure) can be rotated to rotate the first transmission member 12. The first transmission member 12 is connected to the second transmission member 11 and the connecting tube fixing seat 14, thereby achieving circumferential rotation of the second transmission member 11 and the connecting tube fixing seat 14, which in turn achieves circumferential rotation of the connecting tube 7. The second transmission member 11 is connected to the first transmission member 12 and to the magazine fixing seat 10, which is fixed to the magazine 6. The connecting tube fixing seat 14 is connected to the connecting tube 7, thus driving the magazine 6 and connecting tube 7 to rotate circumferentially, thereby achieving synchronous circumferential rotation of the magazine 6 and connecting tube 7.

[0137] In the context of turnover controls (e.g.) Figure 8 During the circumferential rotation operation initiated by the circumferential adjustment knob 4), the first transmission component 12, which is connected to the circumferential control, plays a crucial role. The first transmission component 12 is connected to both the second transmission component 11 and the connecting tube fixing seat 14. Therefore, on the one hand, the rotational motion of the circumferential control can be transmitted to the magazine 6 installed in the magazine fixing seat 10 through the first transmission component 12, the second transmission component 11, and the magazine fixing seat 10, causing the magazine 6 to rotate circumferentially. On the other hand, the rotational motion of the circumferential control is also transmitted through the first transmission component 12, the second transmission component 11, and the magazine fixing seat 10, causing the magazine 6 to rotate circumferentially. The actuator 12, the connecting tube fixing seat 14, and the connecting tube 7 installed in the connecting tube fixing seat 14 transmit the power to the valve seat 30 fixedly connected to the distal end of the connecting tube 7, causing the valve seat 30 to rotate. This causes the magazine 6 on the distal side of the valve prosthesis delivery system and the valve seat 30 to rotate circumferentially at the same circumferential rotation angle (e.g., synchronous circumferential rotation). This allows the valve prosthesis to be pre-adjusted relative to the original tissue in the body before release, so as to avoid damage to human tissue caused by the interventional valve prosthesis.

[0138] The valve prosthesis delivery system and the operation method thereof provided by the embodiments of the present application can efficiently, accurately and conveniently deliver the valve prosthesis.

[0139] It should be noted that the relational terms herein such as first and second are used only to differentiate one entity or operation from another entity or operation, without necessarily requiring or implying any such actual relationship or order between or among the entities or operations. Moreover, the terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but can include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by "comprises a... " does not, without more constraints, exclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.

[0140] In the description of multiple elements in this document, multiple parallel features connected by "and / or" mean to include one or more (or one or more kinds) of the parallel features. For example, the meaning of "a first element and / or a second element" is one or more of the first element and the second element, i.e., only the first element, or only the second element, or both the first element and the second element (both exist at the same time).

[0141] The embodiments provided in the present application can be combined with each other as needed, for example, the features in any two, three or more embodiments are combined to construct a new embodiment of the present application, which is also within the protection scope of the present application, unless otherwise specified or technically contradictory and unimplementable.

[0142] The above only describes exemplary embodiments of the present application and is not intended to limit the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A valve prosthesis delivery system, characterized in that, include: A multi-lumen tube (8) includes a central cavity extending axially; A control unit is disposed at the proximal end of the multi-lumen tube; The magazine (6) is located on the far side of the multi-cavity tube; the magazine (6) is fixed by a magazine fixing seat, which is sleeved around the periphery of the multi-cavity tube and can rotate around the multi-cavity tube. A bending assembly includes a flexible snake tube connected to the distal end of the multi-cavity tube and located within the magazine. A straightening side and a bending side of the snake tube are respectively connected to the control unit. Under the control of the control unit, the snake tube forms a suitable bending angle, thereby orienting the magazine, which is fitted outside the snake tube, at the bending angle. A connecting tube (7) is disposed within the central cavity and extends distally into the snake-bone tube; A circumferential rotation assembly includes: a valve seat connected to the head end of a valve prosthesis, which is connected to the connecting tube (7); a rotation transmission mechanism connected to the rotation control of the control unit, and connected to the connecting tube and the magazine fixing seat, wherein rotation of the rotation control causes the rotation transmission mechanism to rotate, driving the connecting tube and the magazine fixing seat, thereby causing the valve seat and the magazine to rotate circumferentially; The turnover transmission mechanism includes: a first transmission component, which connects the turnover control and the connecting pipe; and a second transmission component, which connects the distal end of the first transmission component between the magazine fixing seat; The rotation of the rotation control causes the first transmission component to rotate, which in turn causes the connecting tube and the magazine fixing seat to rotate accordingly, thereby causing the valve seat and the magazine to rotate circumferentially.

2. The valve prosthesis delivery system as described in claim 1, characterized in that, The straightening side of the snake-bone tube is connected to the bending adjustment component of the control unit via a straightening traction wire; The bending side of the snake tube is connected to the bending member via a bending traction wire that is rotated 180 degrees through a guide body. When the bending member moves, the straightening traction wire and the bending traction wire tighten or release the straightening side and the bending side in opposite directions, thereby forming a suitable bending angle for the snake tube.

3. The valve prosthesis delivery system as described in claim 2, characterized in that, The bending element moves axially to allow the snake-bone tube to form a suitable bending angle.

4. The valve prosthesis delivery system as described in claim 2, characterized in that, The bending component includes a bending wheel, which is threadedly connected to the bending control of the control unit and moves axially as the bending control rotates.

5. The valve prosthesis delivery system as described in claim 2, characterized in that, The multi-lumen tube includes: a channel cavity surrounding the central cavity and extending axially; The straightening traction wire and the bending traction wire extend through their respective channel cavities.

6. The valve prosthesis delivery system as described in claim 1, characterized in that, The bending angle of the snake-bone tube is 0-90 degrees.

7. The valve prosthesis delivery system as described in claim 1, characterized in that, Further includes: The tip assembly includes: a tip head that is detachably disposed at the distal end of the magazine; and a guidewire located within the connecting tube, the guidewire being connected to the proximal end of the tip and to the control unit.

8. The valve prosthesis delivery system as described in claim 7, characterized in that, The tip includes a first guide portion and a second guide portion, the first guide portion having a shape that tapers from near to far, and the second guide portion having a shape that enlarges from near to far.

9. The valve prosthesis delivery system as described in claim 1, characterized in that, The circumferential rotation assembly allows the magazine to rotate circumferentially within a range of ±90 degrees.

10. An operating method for operating the valve prosthesis delivery system as described in any one of claims 1-9, characterized in that, include: To bring the magazine to the predetermined delivery port; The snake-bone tube is made to form a suitable bending angle, thereby orienting the magazine at the bending angle and allowing it to enter the delivery port to a predetermined depth; While keeping the bending angle of the snake tube unchanged, the magazine is rotated while keeping its extension axis direction unchanged. The rotation control drives the connecting tube and the magazine fixing seat to rotate, so that the valve seat and the magazine connected to the valve prosthesis rotate circumferentially by a predetermined circumferential rotation angle.

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