Delivery system and recovery control method for artificial implant

Abstract

The invention discloses an artificial implant conveying system and a recovery control method.The artificial implant conveying system comprises a catheter sheath, a bending adjusting assembly, an inner shaft assembly and a control handle, the catheter sheath is used for constructing an intervention channel, and a fixing base is arranged at the near end of the catheter sheath; the far end of the bending adjusting assembly can be controlled to change the direction, and the bending adjusting assembly penetrates through the fixing base in a sliding mode and further extends towards the near end. The far end of the inner shaft assembly is provided with a loading section used for being connected with an artificial implant, and the loading section is exposed to the far end of the bending adjusting assembly all the time. The control handle is connected with the bending adjusting assembly and the near end of the inner shaft assembly. The control handle is located on the near end side of the fixing base, and the distance between the control handle and the fixing base is adjustable. When the artificial implant is recycled and the far end of the catheter sheath is close to or in contact with the artificial implant, the far end of the control handle abuts against the near end of the catheter sheath, so that supporting force during recycling is provided, and recycling is facilitated.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a delivery system and a recovery control method for artificial implants. Background Art

[0002] The catheter sheath in the delivery system is used to act as a guide device and limit bleeding during interventional surgery. The catheter sheath is placed in the body and establishes a temporary channel through which the delivery system or other interventional devices can reach the surgical site in the patient's body. The catheter sheath may have multiple inflection points in the body, and its own deflection and structure may affect the delivery and / or retrieval operation. In addition, the adjustment of the relative position of the catheter sheath and other components is also the key to the delivery and / or retrieval operation. The existing delivery system and its control method still need to be further optimized. Summary of the invention

[0003] The present application provides a delivery system for an artificial implant, which facilitates the delivery and / or retrieval of a delivery system or other interventional instruments, and the in vivo and / or delivery retrieval of an artificial implant.

[0004] The present application also provides a delivery system for an artificial implant, comprising:

[0005] A catheter sheath, used for constructing an intervention channel, wherein the proximal end of the catheter sheath is provided with a fixing seat;

[0006] A bending adjustment component, the distal end of which can be controlled to change direction, and the bending adjustment component slides through the fixing seat and further extends toward the proximal end;

[0007] An inner shaft assembly, the distal end of which is provided with a loading section for connecting an artificial implant, the loading section being always exposed to the distal end of the bending adjustment assembly;

[0008] A control handle is connected to the bending adjustment assembly and the proximal end of the inner shaft assembly. The control handle is located on the proximal side of the fixing seat and the distance between the control handle and the fixing seat is adjustable.

[0009] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution, but are merely further supplements or preferences. Under the premise that there are no technical or logical contradictions, each optional method can be combined with the above-mentioned overall solution separately, and multiple optional methods can also be combined.

[0010] Optionally, the catheter sheath has opposite distal and proximal ends and comprises a tubular body, wherein the tubular body comprises:

[0011] A main body section, wherein the fixing seat is connected to the proximal end of the main body section, and the tube wall of the main body section is provided with a structural reinforcement layer at least near the distal end, wherein the reinforcement layer is a metal tube with a hollow structure;

[0012] The deformation section is located at the distal end of the main section, and includes a plurality of elastic sheets arranged at intervals along the circumference of the tube body, the proximal end of each elastic sheet is connected to the metal tube, and each elastic sheet has a relative initial state and an expanded state. In the expanded state, the distal ends of each elastic sheet are relatively far apart and the deformation section as a whole presents a flared structure.

[0013] Optionally, the length of the tube is at least 60 cm.

[0014] Optionally, the length of the tube body ranges from 60 to 90 cm.

[0015] Optionally, the distal end of the tube has a pre-molded shape that matches the shape of the aortic arch.

[0016] Optionally, the metal tube is made of memory alloy.

[0017] Optionally, two adjacent elastic sheets are connected via a connecting piece.

[0018] Optionally, both ends of the connecting member are respectively connected to the elastic sheet on the corresponding side, and the connecting portion is adjacent to the distal end of the elastic sheet;

[0019] When each elastic sheet is in an initial state, the middle portion of the connecting member is folded and stored in the spacing area between adjacent elastic sheets;

[0020] When each elastic sheet is in an expanded state, the middle portion of the connecting member is relatively spread out.

[0021] Optionally, two connecting members are connected between two adjacent elastic sheets, including a first connecting member and a second connecting member arranged along the axial direction.

[0022] Optionally, the first connecting member is connected to the axial distal end of the elastic sheet, and the second connecting member is connected to the axial middle portion of the elastic sheet.

[0023] Optionally, the first connecting member and the second connecting member are V-shaped structures and respectively have a first opening and a second opening, and the first opening and the second opening are opposite to each other.

[0024] Optionally, both sides of the middle portion of the first connecting member have protrusions extending toward the proximal end, and the apex of the second connecting member is located within the two protrusions.

[0025] Optionally, the deformation segment has a grid structure as a whole.

[0026] Optionally, the tube body has a three-layer structure, including an outer membrane layer, the reinforcement layer and an inner membrane layer from the outside to the inside.

[0027] Optionally, the elastic sheet and the metal tube are an integral structure or a separate structure.

[0028] Optionally, the fixed seat is a hemostatic valve.

[0029] Optionally, the hemostatic valve includes a shell, and a sealing member disposed in the shell for preventing fluid leakage.

[0030] Optionally, the fixing seat has a mounting channel connected to the catheter sheath, and a pipe joint connected to the mounting channel is provided at the proximal end of the fixing seat, and the pipe joint has:

[0031] A main interface, wherein a sealing member is disposed at the main interface;

[0032] A branch interface is provided with a one-way valve.

[0033] Optionally, a bending drive mechanism is installed on the control handle;

[0034] Optionally, the bending adjustment component includes:

[0035] The sheath is bent, and the proximal end is fixed to the control handle;

[0036] The bending adjusting member has one end fixedly extending to the distal end of the bending adjusting sheath tube and acting on the sheath tube, and the other end being controlled by the bending adjusting driving mechanism.

[0037] Optionally, the inner shaft assembly includes a first shaft, a second shaft and a third shaft which are sequentially slidably sleeved from the inside to the outside, wherein:

[0038] The distal end of the first shaft is linked with a locking element;

[0039] A pull wire is connected to the distal end of the second shaft;

[0040] A base is fixed at the distal end of the third shaft, the locking element is movably mounted on the base, and a locking hole matching the locking element is provided on the base;

[0041] The pull wire is bound to the base by the locking element after winding around the artificial implant from the second axis, and the second axis and the first axis are slidably matched relative to the third axis.

[0042] Optionally, a push-up mechanism cooperating with the catheter sheath is provided at the distal end of the control handle.

[0043] The present application also provides a control handle, the control handle having a distal end and a proximal end opposite to each other, and an axial direction extending between the proximal end and the distal end, the distal end of the control handle is provided with an axially retractable push-up mechanism, the push-up mechanism comprising:

[0044] A telescopic assembly, with an abutment member at the distal end and an axially movable proximal end connected to the control handle;

[0045] The push-up drive mechanism is installed on the control handle and is linked with the proximal end of the telescopic assembly.

[0046] Optionally, the telescopic assembly is arranged in one or more stages from the distal end to the proximal end, wherein the distal end of the first stage is provided with the abutment member, and the proximal end of the last stage is axially movably connected to the control handle and linked to the ejection drive mechanism.

[0047] Optionally, each stage of the telescopic assembly is a cylindrical structure and is movably connected in sequence.

[0048] Optionally, one of the adjacent stages is an outer cylinder and the other is an inner cylinder, and when the telescopic assembly is extended, the inner cylinder moves toward the distal end relative to the outer cylinder.

[0049] Optionally, mutually cooperating stop structures are provided between adjacent stages.

[0050] Optionally, the anti-retreat structure includes:

[0051] A rack is arranged outside the inner cylinder along the telescopic direction;

[0052] An operating button is swingably mounted on the outer cylinder, wherein the operating button has an operating portion and a clamping portion on both sides of its own swing axis, wherein the clamping portion is engaged with the rack to limit the movement between adjacent stages, and the operating portion is exposed to the outer cylinder to release the engagement between the clamping portion and the rack;

[0053] The elastic member acts on the operating button to drive the engaging portion to maintain engagement with the rack.

[0054] Optionally, the tooth tips of the rack are inclined toward the proximal side, and the tooth surface toward the proximal side drives the engaging portion to self-lock.

[0055] Optionally, the elastic member abuts between the inner wall of the outer tube and the radial outer side of the clamping portion.

[0056] Optionally, the engaging portion has a self-locking surface that cooperates with the rack, and the self-locking surface faces the distal end and is substantially perpendicular to the axial direction of the outer tube.

[0057] Optionally, the ejection drive mechanism includes:

[0058] An external thread section, located at the outer periphery of the final stage;

[0059] The first driving sleeve is rotatably mounted on the control handle and has an internal thread section that matches the external thread section.

[0060] The present application also provides a method for controlling the recovery of an artificial implant, comprising:

[0061] An artificial implant and an interventional delivery system for delivering the artificial implant are provided, wherein the interventional delivery system comprises:

[0062] A catheter sheath, used for constructing an intervention channel, wherein the proximal end of the catheter sheath is provided with a fixing seat;

[0063] An inner shaft assembly having a loading section at the distal end, wherein the artificial implant is at least partially located in the loading section and is releasably connected to the inner shaft assembly before expansion;

[0064] A control handle connected to the proximal end of the inner shaft assembly, the control handle being located at the proximal end side of the fixing seat, and a push mechanism with an adjustable distance between the control handle and the fixing seat being provided at the distal end of the control handle;

[0065] The artificial implant at least partially remains connected to the inner shaft assembly. When being recovered, the catheter sheath is driven to move relative to the inner shaft assembly so that the artificial implant is received in the catheter sheath.

[0066] Optionally, the distal end of the catheter sheath approaches or contacts the artificial implant, driving the pushing mechanism to abut against the fixing seat and further push toward the distal end until the artificial implant is received in the catheter sheath.

[0067] Optionally, the artificial implant is connected to the inner shaft assembly via a pull wire, and during recovery, the pull wire is kept in a tightened state to gather the proximal side of the artificial implant.

[0068] Optionally, before retrieval, the shape of the artificial implant is in an expanded state and is connected to the inner shaft assembly only by a pull wire. Before retrieval, the pull wire is first tightened to gather the proximal side of the artificial implant.

[0069] Optionally, the artificial implant comprises an inner frame defining a blood flow channel, the outer periphery of the inner frame is provided with a plurality of arms, the proximal ends of the arms are fixed to the inner frame, a first gap capable of accommodating native tissue is formed between the distal ends of the arms and the inner frame, and a valve leaflet for controlling the blood flow channel is connected to the inner frame;

[0070] During the retrieval, the proximal end of the arm first enters the catheter sheath, and the distal end of the arm adaptably enters the catheter sheath as the catheter sheath moves relative to the artificial implant.

[0071] Optionally, the method can be used for interventional surgery or for in vitro simulation operations.

[0072] The improvements in the system and method enable the catheter sheath to ensure effective delivery and retrieval of the interventional structure while establishing a pathway. The delivery system of the present application can operate the push-up mechanism at the distal end of the control handle and the proximal end of the catheter sheath to abut against each other when retrieving the artificial implant, so as to provide support force during retrieval, ensure the stability and accuracy of the current relative position of the catheter sheath and other structures and subsequent adjustments, facilitate retrieval, and improve operational convenience and safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0073] Figure 1a A schematic diagram of a control mechanism limiting an artificial implant according to an embodiment of the present application;

[0074] Figure 1b for Figure 1a A schematic diagram of the structure of the pull wire disengaging the lock member in the middle control mechanism;

[0075] Figure 2 A schematic structural diagram of a delivery system for an artificial implant according to an embodiment of the present application;

[0076] Figure 3 for Figure 2 A magnified schematic diagram of the middle part;

[0077] Figure 4 A cross-sectional view of a loading section away from a base in a control mechanism according to an embodiment of the present application;

[0078] Figure 5 It is a partial structural schematic diagram of a loading section in a control mechanism of an embodiment of the present application when loading an artificial implant;

[0079] Figure 6 This is a schematic diagram of the radial relationship between the loading section and the artificial implant arm in the control mechanism of another embodiment of the present application;

[0080] Figure 7 This is a schematic diagram of the radial relationship between the loading section, the artificial implant and the catheter sheath in the control mechanism of one embodiment of the present application;

[0081] Figure 8 This is a structural view of an artificial implant according to an embodiment of the present application;

[0082] Fig. 9 This is a front view of an artificial implant according to an embodiment of the present application;

[0083] Fig.10 A schematic structural diagram of a delivery system for an artificial implant according to an embodiment of the present application;

[0084] Fig.11 This is a schematic structural diagram of a catheter sheath according to an embodiment of the present application;

[0085] Fig.12This is a schematic diagram of the structure of a catheter sheath interventional delivery to the aortic arch according to an embodiment of the present application;

[0086] Fig.13 for Fig.12 Schematic diagram of the structure of the midline catheter sheath assisting in the retrieval of the artificial implant;

[0087] Fig.14 This is a schematic diagram of the structure of the distal end of the catheter sheath when adjusting the bend according to one embodiment of the present application;

[0088] Fig.15 This is a schematic structural diagram of a deformation section in an initial state according to an embodiment of the present application;

[0089] Fig.16 for Fig.15 A partial enlarged schematic diagram;

[0090] Fig.17 for Fig.15 Schematic diagram of the structure of the middle deformation section in the expanded state;

[0091] Fig.18 for Fig.17 A partial enlarged schematic diagram;

[0092] Fig.19 It is a partially enlarged schematic diagram of a deformation segment in an initial state of another embodiment of the present application;

[0093] Fig. 20 for Fig.19 A partial enlarged schematic diagram of the middle deformation segment in the expanded state;

[0094] Fig.21 This is a cross-sectional view of a tube body at a metal tube according to an embodiment of the present application;

[0095] Fig. 22 This is a schematic structural diagram of a deformation section in an expanded state according to another embodiment of the present application;

[0096] Fig.23 This is a schematic structural diagram of a deformation section in an initial state according to another embodiment of the present application;

[0097] Fig.24 for Fig.23 Partial front view of the deformed segment in the initial state.

[0098] Fig.25 This is a schematic structural diagram of a catheter sheath according to another embodiment of the present application;

[0099] Fig.26 for Fig.25 A partial exploded view of the fixing seat of the middle catheter sheath;

[0100] Fig. 27 for Fig.26 Exploded view of the center pipe joint;

[0101] Fig.28 This is a structural schematic diagram of a control handle with respect to a bending adjustment mechanism according to an embodiment of the present application;

[0102] Fig.29 A partial cross-sectional view of a control handle at a ratchet wheel in an embodiment of the present application;

[0103] Fig.30 for Fig.29 A partial cross-sectional view of releasing the restriction on the ratchet;

[0104] Fig.31 This is a schematic diagram of the structure of a limiter in a control handle according to an embodiment of the present application;

[0105] Fig.32 An exploded view of a control handle at a bending adjustment mechanism according to an embodiment of the present application;

[0106] Fig.33 This is a schematic diagram of the structure of a control handle according to an embodiment of the present application;

[0107] Fig.34 for Fig.33 Exploded view of the ejector mechanism;

[0108] Fig.35 for Fig.33 A schematic diagram of the structure in which the first stage of the middle telescopic assembly is extended and abuts against the fixed seat;

[0109] Fig.36 for Fig.35 A schematic diagram of the structure in which the middle push-up driving mechanism drives the telescopic assembly to move toward the far end;

[0110] Fig.37 for Fig.35 A schematic diagram of the structure of the intermediate level in the telescopic component;

[0111] Fig.38 for Fig.35 A schematic diagram of the structure of the first stage in the telescopic component;

[0112] Fig.39 for Fig.34 A half-section view of the final stage;

[0113] Fig.40 A partial half-section view of a telescopic assembly in a control handle according to an embodiment of the present application;

[0114] Fig.41 for Fig.40 A half-section view showing the rack being released after the middle operating part is pressed down.

[0115] The reference numerals in the figures are described as follows:

[0116] 10. base; 101. locking area; 11. pull wire; 111. free end; 113. control end; 13. locking element;

[0117] 21, first axis; 211, loading section; 216, loading section; 217, avoidance;

[0118] 23, second axis; 25, third axis;

[0119] 3. control handle; 31. proximal end; 32. distal end; 330. support body;

[0120] 37, bending drive mechanism; 371, winding wheel; 3711, ratchet; 372, knob; 374, limiter; 3741, ratchet; 375, elastic member; 376, dial button; 351, first drive sleeve;

[0121] 38. Telescopic assembly; 381. First stage; 382. Intermediate stage; 383. Final stage; 3831. External threaded section; 384. Abutment member; 3851. Blocking portion; 3852. Guide groove; 3861. Diameter expansion portion; 3862. Rack; 3863. Elastic buckle; 3864. Guide strip; 387. Operating button; 3871. Operating portion; 3872. Engaging portion; 3873. Self-locking surface; 388. Elastic member; 39. Push-up drive mechanism;

[0122] 4. Catheter assembly; 43. Adjustable sheath tube;

[0123] 501, interval opening; 502, hollow area; 504, middle part; 505, distal side edge; 506, protrusion;

[0124] 51, tube body; 510, main section; 511, metal tube; 513, outer film layer; 514, inner film layer;

[0125] 520, deformation section; 521, elastic sheet; 522, connecting member; 523, first section; 524, second section; 525, second connecting member; 526, first connecting member; 527, first opening; 528, second opening; 529, vertex;

[0126] 551, first connecting channel; 552, second connecting channel; 56, bending adjusting member;

[0127] 581, connecting portion; 582, first opening; 583, third section; 584, fourth section; 585, second gap; 586, third gap; 587, second opening; 588, connector;

[0128] 591, first deformation strip; 592, second deformation strip;

[0129] 60. artificial implant; 601. wire control end; 603. eyelet; 61. inner frame; 63. arm; 631. inflow side; 632. outflow side; 604. blood flow channel; 70. catheter sheath; 720. fixing seat; 721. installation channel; 750. pipe joint; 751. main interface; 752. seal; 753. branch interface; 754. one-way valve. DETAILED DESCRIPTION

[0130] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0131] It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be a central component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be a central component at the same time.

[0132] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0133] In this application, the terms "first", "second", etc. are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number or order of the indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0134] This specification describes an artificial implant and a delivery system for delivering the artificial implant into a subject's body, wherein the delivery system includes a control handle and a catheter assembly, wherein the control handle can be connected to and control the catheter assembly for performing interventional surgery, wherein the catheter assembly includes a plurality of control components, wherein the distal ends of the control components cooperate with each other to operate the artificial implant, such as release, recovery, locking position, adjusting spatial posture, etc., wherein each control component itself can be a hollow tube, a solid rod, a flexible wire, or a combination of multiple forms, wherein there are multiple control components, and at least two of them (taking the proximal end as an example) can slide relative to each other along the axial direction or rotate relative to each other around the axial direction. The force-applying component (the part that the user directly operates and contacts) on the control handle used to operate each control component can be directly fixedly transmitted to the corresponding control component, or can be transmitted by means of threads, gear racks, etc.

[0135] In the following, various improvements on the control handle or local structure can be implemented on the same control handle without obvious technical contradictions, but are not strictly limited to being implemented on the same control handle. For different numbers of controlled components and movement characteristics, or for control handles with further simplified structures, the various embodiments can also be implemented separately or in appropriate combination.

[0136] There are no strict restrictions on the application site and structure of artificial implants. In some drawings or texts, an artificial heart valve is taken as an example. The artificial heart valve generally includes a deformable stent and leaflets connected to the stent. The stent is cylindrical as a whole, and the side wall is a hollow grid structure. Unless otherwise stated, the shape or size of the grid structure is not strictly limited. The inside of the stent is a blood flow channel, and the multiple leaflets cooperate with each other to control the degree of opening and closing of the blood flow channel in the stent. In order to position it in the body, a positioning structure that can interact with the surrounding native tissue, such as anchor spikes, arms, etc., can be set on the periphery of the stent. In order to prevent peripheral leakage, a skirt or anti-peripheral leakage material can be set on the inner and / or outer sides of the stent.

[0137] Depending on the expansion mode, the corresponding material is selected during the processing of the stent, such as nickel-titanium alloy with shape memory that can self-expand in the body, or stainless steel that can expand by balloon expansion, etc. The stent itself can be formed by cutting tubes or weaving wires, and the leaflets can be connected to the stent by sewing, bonding or integral mold molding.

[0138] Taking the self-expanding stent as an example, its expansion and retraction can be controlled by a sheath wrapped around the stent. The position of the stent exposed to the sheath is different and it can be controlled accordingly. It can also be controlled by a pull wire, that is, the pull wire passes through the structural gap (or wire hole structure) of the stent. The expansion degree of the stent can be changed by adjusting the tightness of the pull wire with a control handle. When the pull wire is pulled out of the stent, the stent is allowed to be completely released. Of course, the control of the pull wire is also completed through the various controlled components in the catheter assembly.

[0139] The stent of an artificial implant may generally have a connection structure that cooperates with the catheter assembly to limit the position of each other and prevent unnecessary positional displacement during transportation. The artificial implant is in a radially compressed state, i.e., a loaded state, when input, and is in an expanded state after being released from the constraints of the catheter assembly and radially expanded in the body. Unless otherwise specified, the shape of the artificial implant is understood to be in the expanded state, and the local deformation caused by the pressure of the surrounding tissue is not considered.

[0140] Due to the complexity of the structure in the body, catheter components often need to be bent. The corresponding bending parts can be in the form of tubes or wires, with the distal end acting on the bent part and the proximal end controlling the bending amplitude or direction through a control handle.

[0141] When used to indicate direction, the proximal end in the text generally refers to the side adjacent to the operator (such as a doctor), and the distal end is the relatively distant side. Along the interventional path, each component has a relative distal and proximal end. In theory, when the catheter assembly and the control handle are fully straightened, the straight line between the proximal and distal ends determines the axial direction, and correspondingly, the radial direction perpendicular to the axial direction and the circumferential direction arranged around the axial direction are also determined. When used to refer to a structure, the "end" in the text represents the endpoint of the structure, or a point or area on that side, or a specific structure connected to that point or area.

[0142] An embodiment of the present application also provides a delivery system for an artificial implant, comprising a guide sheath 70, a bending adjustment assembly, an inner shaft assembly and a control handle 3. The delivery system has a proximal end 31 and a distal end 32 relative to each other, and a control mechanism is provided at the distal end of the inner shaft assembly for controlling the expansion and release of the artificial implant 60.

[0143] First, as shown in Figure 1~ Figure 3 The control mechanism includes a base 10, a pull wire 11 and a locking element 13, wherein the base 10 is provided with a locking area 101, the pull wire 11 has a free end 111 that can be passed through or detached from the artificial implant 60, and the locking element 13 is located at the distal end of the base 10 as a whole, and the locking element 13 and the base 10 are rotatably matched to lock the free end 111 of the pull wire 11. The base 10 has a distal end 32 and a proximal end 31 opposite to each other, and an axial direction extending between the distal end 32 and the proximal end 31, and the proximal end, the distal end and the axial direction are also applicable to other components of the control mechanism, and the control handle and the delivery system of the following embodiments without special explanation.

[0144] The free end 111 is the end of the pull wire 11 that first passes through and finally leaves the artificial implant 60, and can also be understood as the farthest end of the pull wire 11 when it is straightened; the other end of the pull wire 11 opposite to the free end 111 is the control end, which can be directly fixed to the base 10, or extend proximally and controllably.

[0145] The free end 111 has a first state (eg, Figure 1a ) and the second state of unrestricted (such as Figure 1b ); the lock 13 is movably matched with the base 10, and the lock 13 is matched with the free end 111 of the pull wire 11 to switch the state of the free end 111. In the first state, the free end 111 is combined with the lock 13 and the lock 13 is matched with the base 10 to limit the pull wire 11 from being separated from the lock 13. At this time, the free end 111 can be understood as being relatively fixed to the lock 13; in this state, the pull wire 11 is always connected to the artificial implant 60, and the expansion process (i.e., the expansion degree) of the artificial implant is adjusted according to the length of the pull wire 11 exposed outside the control mechanism, and the expansion / contraction speed of the artificial implant is controlled according to the change rate of the pull wire. If necessary, the pull wire 11 can also be used to recycle the artificial implant.

[0146] In the second state, the free end 111 is disengaged from the locking element 13. At this time, the free end 111 can be understood to be released, thereby releasing the interconnection between the artificial implant and the control mechanism. Subsequently, the control mechanism can be withdrawn out of the body as a whole, leaving the artificial implant at a predetermined position in the body.

[0147] When the locking element, the base and the pull wire are preassembled in vitro, the pull wire 11 is inserted from the proximal end of the base, and then extends from the distal end of the base to pass through the artificial implant and then combine with the locking element 13 .

[0148] After releasing and detaching from the artificial implant, the control end is driven to move the pull wire 11 toward the proximal end to retract the pull wire; when retracting the artificial implant, the pull wire 11 is in the first state, and the control end 113 is operated to reduce the length exposed outside the control mechanism.

[0149] The lock 13 is located at the distal end of the base 10, which is convenient for observation and operation during pre-assembly in vitro, and convenient for assembly. In particular, the lock 13 and the base 10 are not nested in the radial direction, forming a sufficient radial space for the pull wire to pass through, and making the pull wire move more smoothly. In addition, the maximum radial size of the base 10 and / or the lock 13 can be reduced accordingly, which is convenient for interventional delivery in vivo.

[0150] Of course, the control mechanism of the present application and other embodiments described below including the control mechanism of this embodiment are also suitable for simulation training of interventional delivery operations performed in vitro.

[0151] Secondly, if Figures 4 to 9The artificial implant 60 includes an inner frame 61, and a plurality of arms 63 are provided on the outer periphery of the inner frame. A first gap for accommodating native tissue is formed between each arm 63 and the inner frame 61. A loading section 211 is connected to the distal end of the first shaft 21, and the inner frame 61 is sleeved on the outer periphery of the first shaft 21 in a compressed state; the loading section 211 is tubular and fixed to the distal end of the first shaft 21, and the loading section 211 is open toward the proximal end, and the entire inner frame 61 or at least the distal end portion of the inner frame 61 is accommodated in the loading section 211, and a surrounding wall of the loading section 211 is provided with an avoidance opening 217, and at least a portion of the arm 63 is located at the avoidance opening 217.

[0152] The loading section 211 restrains the distal end of the artificial implant 60, keeps the artificial implant in a folded state, and ensures safe interventional delivery. At the same time, part of the arm 63 enters the avoidance opening 217, which is located in the section with the largest radial space of the loading section 211, that is, on the aforementioned loading section 216. Compared with the existing structure that completely wraps the artificial implant, the radial size of the loading section of this embodiment is smaller, which is conducive to interventional delivery.

[0153] Wherein, when the artificial implant is in a loaded state, the radial relationship between the arm and the loading section and the corresponding method of releasing the restraint on the arm are as follows:

[0154] like Figure 6 , the arm 63 is at least partially in the loading section 211; then the loading section 211 is moved axially to release the restraint of the loading section 211. If there is a catheter sheath wrapped outside the loading section 211, the catheter sheath 70 needs to be moved first.

[0155] Or Figure 6 and Figure 7 As shown, the loading structure includes a guide sheath 70, which is slidably mounted on the outermost side of the inner shaft assembly, and the arm portion 63 is located between the loading section 211 and the guide sheath 70. After the guide sheath 70 is moved, the restraint on the arm portion 63 can be released. In one embodiment, the distal end portion of the artificial implant is located in the loading section, and the proximal end portion is located outside the loading section and in the guide sheath.

[0156] The outflow side 632 of each arm 63 is fixedly connected to the inner frame 61, and the inflow side 631 forms a first gap with the inner frame 61 after expansion, and the inflow side 631 is located at the avoidance port 217. The artificial implant includes an inner frame that defines a blood flow channel, and the outer periphery of the inner frame has a plurality of arms, and a first gap that can accommodate native tissue is formed between each arm and the inner frame, and a leaflet that controls the blood flow channel is connected to the inner frame. The inner frame 61 and the arm 63 are fixed separately or adopt an integral structure. The inner frame 61 and the arm 63 are cut as a whole from a tubular blank, and along the axial direction of the tubular blank, the inflow sides of the inner frame 61 and the arm 63 are away from each other. Among them, the inner frame 61 is a radially deformable cylindrical structure, and the blood flow channel 604 is inside; the leaflet is connected to the inner frame 61 to change the opening degree of the blood flow channel; the arm 63 itself is an integral annular structure, and the outflow side 632 of each arm 63 is fixedly connected to the inner frame 61.

[0157] like Figure 10 to Figure 13 The catheter sheath 70 is used to construct an interventional channel extending from outside the body to the adjacent lesion. The proximal end of the catheter sheath 70 is provided with a fixing seat 720 (located outside the body); the distal end of the bending adjustment component can be controlled to change its direction, and the bending adjustment component slides through the fixing seat 720 and further extends to the proximal end; the distal end of the inner shaft component is provided with a loading section for connecting the artificial implant 60, and the loading section is always exposed to the distal end of the bending adjustment component; the control handle 3 connects the bending adjustment component and the proximal end of the inner shaft component, and the control handle 3 is located at the proximal side of the fixing seat 720 and the distance between the control handle 3 and the fixing seat 720 is adjustable. The catheter sheath 70 of this embodiment is used to assist in the recovery of the artificial implant.

[0158] The catheter sheath is used to establish a temporary channel, and its length can reach a distant surgical site, so that the delivery system can deliver the artificial implant to the surgical site through the channel. The application site and structure of the artificial implant are not strictly limited. In combination with the present application, it at least has a longer axial dimension and is suitable for a longer intervention path.

[0159] like Figure 11 to Figure 22 The present application provides a catheter sheath 70 based on long-distance intervention, having a distal end 32 and a proximal end 31 opposite to each other, and the catheter sheath 70 includes a tube body 51, and the tube body 51 includes a main section 510 and a deformation section 520. The fixing seat 72 is connected to the proximal end of the main section 510, and the tube wall of the main section 510 is provided with a structural reinforcement layer at least adjacent to the distal end, and the reinforcement layer adopts a metal tube 511 with a hollow structure.

[0160] The deformation section 520 is located at the distal end of the main section 510. The deformation section 520 includes a plurality of elastic sheets 521 arranged at intervals along the circumference of the tube body 51. The proximal end of each elastic sheet 521 is connected to the metal tube 511. Each elastic sheet 521 has a relative initial state ( Fig.15 ) and the expansion state ( Fig.17), in the expanded state, the distal ends of the elastic sheets 521 are relatively far away and the deformation section 520 is in an overall flared structure. In the initial state, the elastic sheets 521 are relatively gathered together and the deformation section 520 is in an overall straight tube or radially contracted.

[0161] The hemostatic valve 55 itself can adopt the existing technology including a shell and a seal located in the shell. The seal can be an elastic member or a fluid-driven deformable member. When the catheter component of the delivery system passes through the hemostatic valve, blood leakage is prevented.

[0162] The hemostatic valve 55 has a first connecting passage 551 for injecting fluid to drive the seal and a second connecting passage 552 for exhausting air.

[0163] The catheter sheath of the present application is long enough to reach a remote surgical site, and the deformable section can assist in recovering the artificial implant after switching to the expanded state.

[0164] Taking aortic valve replacement as an example, the catheter sheath 70 enters from the femoral artery of the lower limb until the distal end of the tube body 51 extends to the aortic arch (e.g., the root of the ascending aorta). The catheter sheath of this embodiment can establish a long-distance channel to facilitate the delivery of the catheter assembly and artificial implant of the delivery system. It can also assist in the recovery of the artificial implant.

[0165] Moreover, since the deformation section can assist in recovering the artificial implant after switching to the expanded state, the structure of the catheter assembly can be further simplified. For example, the outermost tube can be omitted compared to a conventional catheter assembly.

[0166] The proximal end of the artificial implant can be connected to the catheter assembly of the delivery system through a conventional T-shaped connecting ear or through a wire control method, and the proximal end of the artificial implant can be kept restrained before the pulling wire is completely released.

[0167] In one embodiment, the length of the tube 51 is at least 60 cm, for example, in the range of 60 to 90 cm.

[0168] In one embodiment, the distal end of the tube body 51 has a pre-molded shape that matches the shape of the aortic arch. This reduces safety hazards of the catheter sheath during interventional delivery and provides better shape matching after it is in place. The pre-molded tube body 51 establishes a delivery channel for the bending adjustment component and the inner shaft component, facilitates the bending of the bending adjustment component and the inner shaft component in the body, and simplifies the structure of the bending adjustment component, for example, eliminating the number of bending parts. The pre-molded tube body 51 can also work in conjunction with the bending adjustment component to achieve more precise bending and centering effects.

[0169] like Fig.21As shown, the distal end of the main body section 510 is a three-layer structure, which includes an outer film layer 513, a reinforcement layer (i.e., a metal tube) and an inner film layer 514 from the outside to the inside. The metal tube 511 is cut from a nickel-titanium alloy tube or woven from nickel-titanium alloy wire to form a hollow structure of the metal tube. The hollow structure can not only increase flexibility and facilitate passing through the turning point, but also make the reinforcement layer better attached to the inner and outer film layers. The outer film layer 513 and the inner film layer 514 can be made of Elasthane, Pe11ethane, Pebax or Grilamide, etc., which have lubricating properties.

[0170] The distal end of the metal tube 511 is aligned with the distal end of the main body section 510, and the length of the metal tube 511 is as follows:

[0171] The artificial implant is retracted into the tube body 51, and the distal end of the artificial implant is aligned with the main body section 510, and the proximal end of the metal tube 511 exceeds or is aligned with the proximal end of the artificial implant;

[0172] Or after the catheter sheath 70 is delivered after intervention, the length of the metal tube 511 is sufficient to cover the aortic arch;

[0173] Alternatively, the metal tube 511 and the main body section 510 may be of the same length.

[0174] like Fig.14 As shown, in one embodiment, the catheter sheath 70 includes a bending adjusting member for driving the tube body 51 to bend, the distal end of the bending adjusting member extends and acts on the distal end of the main section 510 to bend it, the proximal end of the bending adjusting member extends out of the hemostatic valve connected to the extension handle controlled by the extension handle, the extension handle is arranged at the proximal end of the hemostatic valve 55, and a locking mechanism is arranged between the two to limit the axial positioning of the two, and the locking mechanism can be a buckle, etc. The extension handle has a first channel for the delivery system to pass through. The extension handle can also be integrally arranged on the hemostatic valve 55.

[0175] The bending member 56 includes a wire, a tube or a combination of a wire and a tube, for example, the bending member 56 is a traction wire, the distal end of which is extended and fixed to the distal end of the main body segment. The extension handle controls the traction wire to act on the main body segment 510 to bend from a dotted line to a solid line.

[0176] In one embodiment, each elastic sheet 521 is connected to the metal tube 511 in an integrated structure or in separate parts. The integrated structure is convenient for processing and molding, and can also improve the structural strength.

[0177] In one embodiment, two adjacent elastic sheets 521 are connected by a connecting member 522. When the deformation section 520 is switched to the expansion state, the connecting member 522 can make the elastic sheets 521 interact with each other and expand evenly, so that when the artificial implant 60 is recovered, the elastic sheets 521 are evenly stressed, avoiding excessive deformation of the elastic sheets 521.

[0178] like Figure 15 to Figure 18 As shown, in one embodiment, there is one connecting piece 522 between two adjacent elastic sheets, which is roughly V-shaped and has a first opening, and the first opening is arranged toward the distal end. Between the two adjacent elastic sheets is a spacing opening 501, and the spacing opening 501 is widened in the middle and narrowed at both ends. The elastic sheet 521 gradually widens near its proximal end, which can improve the connection strength and ensure the necessary resilience. The spacing opening 501 adopts an arc edge at the most proximal part to disperse the stress and improve safety.

[0179] When each elastic sheet 521 is in the initial state, the middle portion 504 of the connecting member 522 is folded and stored in the interval area between two adjacent elastic sheets; when each elastic sheet 521 is in the expanded state, the middle portion 504 of the connecting member 522 is relatively (relative to the initial state) unfolded.

[0180] The connection portion between the connector 522 and the elastic sheet 521 is adjacent to the distal end of the elastic sheet 521 , eliminating the isolated end or spike structure of the elastic sheet 521 and avoiding poking into the structural gap of the artificial implant.

[0181] Between the end of the connecting piece 522 and the elastic sheet 521 on the corresponding side, the connecting portion adjacent to the distal end of the elastic sheet 521 can be understood as being close to or just at the distal end of the elastic sheet 521. Especially in the expanded state, it can avoid the distal end of the elastic sheet 521 from forming an isolated convex portion, thereby reducing the risk of interference with the artificial implant.

[0182] There is no strict restriction on the shape of the middle part 504. It mainly serves to connect and pull the two connected elastic sheets 521 in the expanded state. In the initial state, the middle part 504 needs to be folded and stored, so a foldable structure is adopted. The folding process can be driven by the elasticity of the elastic sheet 521, or the middle part 504 itself can use a predetermined elastic material to assist in driving the folding. After folding, it is stored between the two adjacent elastic sheets and extends accordingly to the proximal end.

[0183] The connection method between the elastic sheet 521 and the connecting member 522 affects the stress distribution and the folding effect of the connecting member 522. In one embodiment, the distal side edge 505 of each elastic sheet 521 is arc-shaped, and the two ends of the connecting member extend roughly along the tangent direction of the arc to connect to the distal side edge of the corresponding elastic sheet. Fig.18 The connecting piece 522 has a first section 523 and a second section 524 forming a V-shaped structure, wherein the first section 523 extends along the X1 direction toward the distal side edge 505 of the elastic sheet 521, and the second section 524 extends along the X2 direction toward the distal side edge 505 of the elastic sheet 521, and the first section 523 and the second section 524 merge into one.

[0184] The arc shape of the distal side edge 505 only expresses the general trend or overall shape characteristics, and is not a strict limitation. The connecting parts extend and intersect in a tangential direction, which provides a better radial contraction force and a more reasonable stress distribution.

[0185] In another embodiment, the first section 523 and the second section 524 of two adjacent connecting members 522 are butt-jointed to the distal side edge of the same elastic sheet, and the distal side edge of the butt-jointed portion is smoothly transitioned. The smooth outer edge can avoid safety hazards. For example, the first section 523 and the second section 524 are butt-jointed to the distal side edge 505 of the same elastic sheet 521. Since they are integrated after butt-jointing, the butt-jointed portion is relatively smooth, avoiding the interference of spikes or protruding portions on the artificial implant 1.

[0186] Furthermore, all the connectors 522 extend continuously in the circumferential direction of the tube body. As can be seen in the figure, since the adjacent connectors 522 are smoothly connected, all the connectors 522 are connected to form a ring. Although the middle part 504 has a slight bend and undulation, it does not affect the overall trend.

[0187] In the initial state, each elastic sheet has two corners on both sides of the middle portion 504 of the connecting member 522, and each corner is provided with a protrusion 506 extending toward the proximal end. The protrusion 506 can strengthen the structure of the corner to avoid fatigue damage caused by repeated bending.

[0188] When each elastic sheet is in the expanded state, the two protrusions corresponding to the same U-shape are adjacent to or abut against each other. The two protrusions are adjacent to or abut against each other, which can limit the expansion angle of the connecting member 522 so that it will not fold in the opposite direction under extreme or abnormal conditions.

[0189] There is a spacing opening 501 between two adjacent elastic sheets. In the initial state, the first section 523 and the second section 524 of each elastic sheet extend from its two ends along an arc path into the spacing opening 501. That is, the connector 522 is arc-shaped at the distal side edge 505 adjacent to the elastic sheet 521, which conforms to the shape characteristics of the elastic sheet 521, extends close to the edge of the elastic sheet 521, and occupies less space. When the arc structure is unfolded, there will be no excessive stress concentration, reducing the safety hazard of fatigue fracture.

[0190] In the initial state of each elastic sheet, the proximal end side of the connecting member 522a is axially adjacent to the middle of the spacing opening 501. In the initial state of each elastic sheet, the spacing opening 501 is a roughly strip-shaped notch, and the distal end is closed by the connecting member 522. Each elastic sheet 521 can expand radially outwards to adapt to the gradual deformation of the artificial implant when expanding the artificial implant, and prevent the artificial implant from suddenly bursting out at the end of expansion. In addition, when recovery is required, each elastic sheet 521 expands radially outwards to form a trumpet to guide the recovery of the artificial implant.

[0191] When each elastic sheet is in the expanded state, the top angle of the V-shape of the connecting member 522 is greater than or equal to 120 degrees. Of course, in combination with the above, the top angle of the V-shape adopts a rounded structure, which is roughly U-shaped.

[0192] Each elastic sheet has a hollow area, and the elastic sheets are arranged along the circumferential direction, with a number of 3 to 6, for example, 5.

[0193] The hollow area 502 of the elastic sheet 521 facilitates the deformation of the elastic sheet and reduces the resistance to outward expansion. In one embodiment, the hollow area 502 is a strip hole, a circular hole, an ellipse or a water drop lamp shape. On the same elastic sheet, the hollow area 502 is one or multiple places isolated from each other. The inner edge of each hollow area is smooth, which can avoid cracking caused by excessive stress concentration during deformation. The total area of ​​the hollow areas on the same elastic sheet is less than 50% of the area of ​​the elastic sheet. The hollow area 502 is a plurality of through holes, and the through holes on the same elastic sheet can be arranged at intervals along the axial direction or circumferential direction of the tube body.

[0194] The outer film layer 513 and the inner film layer 514 can further extend distally to cover the inner and outer sides of the deformation section 520. To reduce the risk of tearing, the film layer between two adjacent elastic sheets can be cut to release the deformation stress.

[0195] In another embodiment, if Fig.19 and Fig. 20 As shown, two connecting members 522 are connected between two adjacent elastic sheets 521 , and the two connecting members 522 are respectively a first connecting member 526 and a second connecting member 525 arranged along the axial direction.

[0196] The specific structure of the first connecting member 526 can refer to the above embodiment. In this embodiment, the second connecting member 525 is connected to the axial middle part (hereinafter referred to as the waist) of the elastic sheet 521. The second connecting member 525 is a V-shaped structure and has a second opening 528, wherein the first opening 527 and the second opening 528 are separated from each other.

[0197] The V-shaped inflection point of the second connecting member 525 has a relatively obvious inflection trend, and the second opening 528 faces the proximal end, which can reduce the resistance and hidden dangers caused by the outward warping of the inflection point during withdrawal. The first connecting member 526 and the second connecting member 525 have different deformation amounts, which limit the different radial deformation amounts of the part connected to the elastic sheet, so that the deformation section 520 as a whole presents a cone with an arc-shaped generatrix, which reduces the bending angle of the turning part between the deformation section and the main section.

[0198] The waist of the elastic sheet 521 is circumferentially retracted inwardly compared to the distal and proximal ends thereof, and the root of the second connecting member 525 transitions to the waist in an arc shape.

[0199] When the catheter assembly and the artificial implant are pushed toward the distal end in the catheter sheath, in order to avoid potential resistance caused by the two protrusions 506, the apex 529 of the second connecting member 525 is located inside the two protrusions 506, which can play a guiding role.

[0200] In another embodiment, if Fig. 22 , which is different from the above-mentioned embodiment, the deformation section 520 is a grid structure as a whole, and the elastic sheet 521 can be understood as a partial grid structure in the circumferential direction. The deformation of the grid structure can adapt to the switching of the state of the elastic sheet.

[0201] like Figure 23-24 As shown, in another embodiment, adjacent elastic sheets 521 are connected at their middle parts to form a connecting portion 581, and the connecting portion 581 is provided with a first opening 582, and the first opening 582 can be used to release stress when the deformation section 520 expands or contracts. The first opening is a circular hole, and there are multiple first openings 582, which are arranged at intervals along the axial extension of the deformation section and have the same size.

[0202] In one embodiment, the elastic sheet 521 extends from the connecting portion 581 to the distal end and gradually gathers to form a third section 583, and the distal end of the elastic sheet 521 is an arc structure. The elastic sheet 521 extends from the connecting portion 581 to the proximal end and gradually gathers to form a fourth section 584. The gathering trend of the fourth section is greater than that of the third section.

[0203] In one embodiment, a second gap 585 is provided between adjacent third sections 583 , and a third gap 586 is provided between adjacent fourth sections 584 . In an initial state, the second gap 585 and the third gap 586 form a V shape.

[0204] In one embodiment, a second opening 587 is provided on the same elastic sheet 521 for releasing stress during deformation. The second opening 587 extends along the axial direction of the deformation section and its two ends extend to the third section 583 and the fourth section 584 respectively, and the extension distances are equal. The second opening 587 is relatively itself, and its middle part gradually converges to the two ends of the axial direction to form a V-shaped structure.

[0205] The proximal end of the fourth section 584 is provided with a connector 588 for connecting with the main section, and the connector 588 is a T-shaped structure. Referring to the above embodiment, the proximal end of the fourth section 584 is connected with the main section, that is, the deformation section and the main section are formed in one piece.

[0206] The two ends of the second opening 587 overlap with the second gap 585 and the third gap 586 in the axial direction, so that the third section 583 and the fourth section 584 respectively have two first deformation strips 591 and two second deformation strips 592 arranged in a V shape. When expanding outward, the first deformation strips 591 and the second deformation strips 592 are away from each other in the circumferential direction.

[0207] In one embodiment, at least one elastic sheet has a different length from the other elastic sheets, or the lengths of the elastic sheets are all different, wherein the length of the elastic sheet is the length between the two ends along the axial direction, and the proximal ends of the elastic sheets are at the same axial position.

[0208] In a preferred embodiment, the elastic sheet includes a first elastic sheet and a second elastic sheet adjacent to each other in the circumferential direction, wherein the length of the first elastic sheet is greater than the length of the second elastic sheet.

[0209] This embodiment has a simple structure, is mechanically stable, and is easy to manufacture and install.

[0210] like Figure 25 to Figure 27 In one embodiment, the fixing seat 720 is a hemostatic valve, and the hemostatic valve can adopt the existing technology. In another embodiment, the fixing seat 720 has a mounting channel 721 connected to the catheter sheath 70, and the proximal end of the fixing seat 720 is provided with a pipe joint 750 connected to the mounting channel 721, and the pipe joint 750 has:

[0211] A main interface 751, where a sealing member 752 is disposed;

[0212] The branch interface 753 is provided with a one-way valve 754. In one embodiment, the control handle 3 is provided with a bending drive mechanism 7, and the bending adjustment assembly includes:

[0213] The proximal end of the bending sheath tube 43 is fixed to the control handle 3;

[0214] The bending adjusting member has one end fixedly extending to the distal end of the bending adjusting sheath tube 43 and acting on the catheter sheath, and the other end being controlled by the bending adjusting driving mechanism 37 .

[0215] The distal end of the bending member can be fixed to the distal end of the bending sheath 43, or can be relatively movable. The bending member can be a wire, a tube, or a combination of a wire and a tube. For example, the bending member is a bending wire fixed to the sheath, so that the bending sheath is bent, or the bending member includes a bending tube and a bending wire connected to the bending tube, and the bending wire drives the bending tube to drive the bending sheath to bend.

[0216] The distal end of the bending member is fixed to the bending sheath 43, and the proximal end is controlled by the bending drive mechanism 37 and moves relative to it, so that the distal end drives the bending sheath 43 to bend, thereby bending the catheter sheath 70, changing the travel path of the distal end of the delivery system.

[0217] like Figure 28 to Figure 32 , the bending drive mechanism includes:

[0218] The winding wheel 371 is rotatably mounted on a support body of the control handle 3 (see the following embodiment for details), and the proximal end of the bending member 56 is made of a flexible material and is wound around the winding wheel 371;

[0219] The knob 372 is linked with the winding wheel 371;

[0220] The one-way engaging structure interacts with the winding wheel 371 and / or the knob 372 and has a relative limiting state and a released state. In the limiting state, the winding wheel 371 is only allowed to rotate in one direction.

[0221] The bending amplitude is related to the change amount of the bending member 56. The bending member 56 is rotated and wound at the proximal end to reduce the axial length of the control handle 3 and increase the bending amplitude. When no force is applied manually, the one-way clamping structure is in a limited position to avoid accidental contact with the knob and limit the rotation of the knob to maintain the direction of the bending sheath 43.

[0222] The rotation axis of the winding wheel 371 is perpendicular to the axial direction of the control handle, wherein the winding wheel 371 has a first direction of bending when rotating, and a second direction of being reset by the bending member 56. The direction of unidirectional rotation is the first direction, and the unidirectional locking structure can limit the rotation of the winding wheel 371 in the second direction before being released.

[0223] In one embodiment, as shown in the figure, the one-way engaging structure includes:

[0224] The ratchet 3711 is coaxially fixed to the winding wheel 371, for example, adopting an integrated structure;

[0225] A stopper 374 is movably mounted on the support body 330 and has a pawl 3741 that cooperates with the ratchet wheel;

[0226] The elastic member 375 acts on the limiting member 374 to make the pawl 3741 mesh with the ratchet wheel 3711;

[0227] The dial button 376 is movably mounted on the support body 330 and cooperates with the limiting member 374 to drive the limiting member 374 to move so that the one-way engaging structure is in a limited state or a released state.

[0228] The dial button 376 at least partially extends out of the support body 330 to the control handle for operation by an operator.

[0229] As shown in the figure, the limiter 374 is rotatably mounted on the support body 330, and the limiter 374 and the dial button 376 are an integral structure or are fixed separately. In normal operation, the dial button 376 is turned to switch the one-way engaging structure to the released state, and after the dial button 376 is released, it is reset to the limited state under the action of the elastic member 375.

[0230] If the limiter 374 cannot be reset normally, for example, the elastic member 375 fails, the out-of-control state can also be judged from the fact that after the dial button 376 is released, the dial button cannot be reset and is in a free motion state. At this time, it is necessary to control the dial button 376 to directly act on the limiter 374 to control the state of the one-way engaging structure. As an emergency relief measure, the safety of the operation is improved.

[0231] In one embodiment, the inner shaft assembly includes a first shaft 21, a second shaft 23 and a third shaft 25 which are slidably sleeved in sequence from the inside to the outside, wherein the distal end of the first shaft 21 is linked with a locking member 13, the distal end of the second shaft 23 is connected with a pull wire 11, the distal end of the third shaft 25 is fixed with a base 10, the locking member 13 is movably mounted on the base 10, and the base 10 is provided with a locking hole 105 which matches the locking member 13; the pull wire 11 is bound to the base 10 by the locking member 13 after winding around the artificial implant 60 from the second shaft 23, and the proximal ends of the second shaft 23 and the first shaft 21 are slidably matched with respect to the third shaft 25. The corresponding control method refers to the following embodiment.

[0232] The present application also provides a delivery system, including a catheter assembly with an artificial implant loaded at the distal end, a control handle connected to the proximal end of the catheter assembly to control the catheter assembly, and the catheter sheath 70 of the above embodiment. The catheter assembly can be inserted into the tube body of the catheter sheath via the hemostatic valve, and the specific structure of the catheter assembly and the control handle can adopt the existing technology. In addition, since the deformation section can assist in recovering the artificial implant after switching to the expanded state, the structure of the catheter assembly can be further simplified. For example, the outermost pipe can be omitted relative to the conventional catheter assembly.

[0233] The length of the catheter sheath of the present application can reach a more distant surgical site, for example, the length of the tube body extends to the ascending aorta, constructing a longer channel to facilitate the delivery of the catheter assembly and the artificial implant.

[0234] An embodiment of the present application also provides a control method of a delivery system, the system is used for interventional delivery of the artificial implant of the above embodiment, the delivery system also includes the control mechanism and control handle of the above embodiment, and an inner shaft assembly connecting the control handle and the control mechanism and the loading section. The control method includes:

[0235] First, expanding at least a portion of the arm to align the first gap with the native tissue;

[0236] Driving the loading section to the far end to separate from the inner frame, so that the far end of the inner frame expands;

[0237] The proximal portion of the expanded inner frame is partially expanded by releasing the pull wires exposed to the base, so that the inner frame is deformed as a whole to a desired extent, and the pull wires are always kept controlling the inner frame during the process;

[0238] Moving the loading section proximally to allow the loading section to enter the blood flow channel;

[0239] Disconnect the guy wire from the inner frame.

[0240] After the artificial implant is delivered to the predetermined position in the body, the loading section or the guide sheath or its internal structure is driven distally to make the two move axially in opposite directions (according to the different settings of the arm) until at least a part of the arm is released and expanded, the distal end of the inner frame is still bound by the loading section, and the first gap is aligned with the native tissue. This embodiment takes the solution in which the arm is set between the loading section and the guide sheath as an example and is explained in conjunction with the accompanying drawings:

[0241] The catheter sheath is driven to move proximally or the internal structure of the catheter sheath is driven to move distally to release the restraint of the catheter sheath on the arm, so that the arm expands radially outward.

[0242] The first axis is then pushed distally to release the restraint of the loading section on the artificial implant, that is, the distal end of the inner frame loses restraint and expands radially outward, and then the proximal end of the inner frame is prepared to expand.

[0243] Keep the third axis stationary and push the second axis distally to move the control end of the pull wire distally, so that the part of the pull wire exposed outside the base gradually stretches, allowing the artificial implant (mainly the proximal part) to gradually expand, and the pull wire outside the base will gradually stretch in the direction of the arrow; the control end continues to move, and the artificial implant is in an expanded state (i.e., the expected amplitude). After confirming that it is in line with the expected fit with the surrounding tissues, the pull wire can be released.

[0244] When the pull wire is released, the first axis moves proximally until the loading section enters the blood flow channel and the loading section is combined with the locking element through a linkage assembly. The first axis is rotated to drive the locking element to rotate relative to the base, and all pull wires are released in turn until all free ends are completely separated from the locking element.

[0245] Then, the second axis is withdrawn toward the proximal end, so that the control end of each pull wire moves toward the proximal end, and the free end is separated from the corresponding hole, that is, completely separated from the artificial implant, which can also be understood as releasing the artificial implant.

[0246] The entire delivery system is withdrawn from the body.

[0247] During the process of retracting the loading section into the blood flow channel, the pull wire remains in the first state to keep the components of the control mechanism and the artificial implant in a relatively fixed spatial posture, thereby guiding the loading section to be smoothly retracted into the blood flow channel, and reducing or eliminating the safety risk of the loading section being mounted on the distal end of the artificial implant during retraction.

[0248] In addition, before the pull wire is unlocked, a recovery operation can be performed as needed. The recovery operation generally needs to be combined with other components, such as the catheter sheath of the aforementioned embodiment. The specific operation is: when the pull wire is in the first state, the control end of the pull wire is driven to move proximally, and the proximal end of the artificial implant is retracted by the pull wire. Then, as needed, the remaining components in the catheter sheath are moved proximally back into the catheter sheath, or the catheter sheath is pushed distally to accommodate the artificial implant.

[0249] In the early stage of recovery, there is a certain gap between the distal end of the catheter sheath and the proximal end of the artificial implant or they are in a state of mutual abutment. In this state, there is a large force between the catheter sheath and the artificial implant, and this force is fed back to the control handle so that the operator feels obvious operation damping force. In this state, the artificial implant is recovered by referring to the telescopic assembly and the push-up drive mechanism of the following embodiment.

[0250] If there is a certain gap between the distal end of the catheter sheath and the proximal end of the artificial implant, the telescopic assembly can be used to directly drive the catheter sheath to move toward the distal end to quickly eliminate the gap; the following method can also be used to drive the inner shaft assembly to move toward the proximal end to eliminate the gap; or the above two methods can be combined to eliminate the gap until the operator clearly feels the operational damping force, proving that the catheter sheath and the artificial implant are abutting against each other.

[0251] It should be noted that the position of the axis in the figure is not limiting, the control end can be very long or very short, or the cable can be directly connected to the control handle for direct retraction. For the control of the cable, the control end of the cable can also be extended and directly controlled by the control handle.

[0252] The above control handle can be a conventional control handle. The present application provides another control handle, such as Figure 34 to Figure 37 The control handle has relative distal and proximal ends, and an axial direction extending between the proximal and distal ends. The distal end of the control handle 3 is provided with an axially retractable push-up mechanism, which includes a telescopic component 38 and a push-up drive mechanism 39. The distal end of the telescopic component 38 has a stop member 384, and the proximal end is axially movably connected to the control handle 3. The push-up drive mechanism 39 is installed on the control handle 3 and linked with the proximal end of the telescopic component 38.

[0253] The telescopic assembly 38 is used to adjust the distance between the abutment member 384 and the catheter sheath in the aforementioned embodiment, and can keep the abutment member at any position. The telescopic assembly 38 can maintain the distance between the abutment member 384 and the catheter sheath, which is convenient for interventional delivery operations. When retrieving the artificial implant, the abutment member 384 is driven to move distally until it abuts against the proximal end of the catheter sheath, and then the inner shaft assembly is driven to move proximally relative to the catheter sheath 70 until the artificial implant is retrieved into the catheter sheath 70;

[0254] Alternatively, the push-up drive mechanism 39 acts on the final stage 383 to drive the telescopic assembly 38 to move further distally, and drives the catheter sheath to move distally relative to the inner shaft assembly until the artificial implant is recovered into the catheter sheath 70.

[0255] Alternatively, the artificial implant recovery operation can only be completed in a certain area in the body, therefore, the telescopic assembly 38 is first extended to the area, and at this time, the distal end of the catheter sheath 70 is close to the control mechanism, reducing the distance between the catheter sheath and the artificial implant, and then the inner shaft assembly is withdrawn until the artificial implant is also located in the area, and finally the push-up drive mechanism 39 completes the recovery of the artificial implant according to the above operation. By operating the push-up mechanism at the distal end of the control handle, the telescopic assembly and the proximal end of the catheter sheath are abutted to provide support during recovery, ensuring the stability and accuracy of the current relative position of the catheter sheath and other structures and subsequent adjustments, facilitating recovery, and improving operational convenience and safety.

[0256] The telescopic assembly 38 can move quickly to eliminate the distance between the abutment member 384 and the catheter sheath, which is a rough adjustment. The push-up drive mechanism 39 can control and accurately adjust the axial movement distance of the telescopic assembly 38, which is a fine adjustment.

[0257] In one embodiment, the telescopic assembly 38 is arranged in one or more stages from the distal end to the proximal end, the distal end of the first stage 381 is provided with a stop member 384 , and the proximal end of the final stage 383 is linked to the ejection drive mechanism 39 .

[0258] like Figure 35 to Figure 41 In one embodiment, each stage of the telescopic assembly 38 is a cylindrical structure and is movably connected in sequence. While ensuring the adjustment distance, the axial space is saved and the axial size of the control handle is reduced. One of the adjacent stages is an outer cylinder and the other is an inner cylinder. When the telescopic assembly 38 is extended, the inner cylinder moves toward the distal end relative to the outer cylinder. Conversely, when the telescopic assembly 38 is shortened, the inner cylinder moves toward the proximal end relative to the outer cylinder. The telescopic assembly 38 has a first limit of maximum length and a second limit of minimum length. The telescopic assembly 38 includes a first stage 381, an intermediate stage 382 and a final stage 383 from the inside to the outside.

[0259] In one embodiment, mutually cooperating stop structures are provided between adjacent stages, which at least restrict the proximal movement of the inner cylinder relative to the outer cylinder, and the restriction of the stop structure needs to be released during operation; and for the distal movement of the inner cylinder relative to the outer cylinder, the stop mechanism can restrict or only provide a certain resistance, for example, the restriction of the stop mechanism can be released under the action of artificial external force.

[0260] The anti-retreat structure includes:

[0261] The rack 3862 is arranged outside the inner cylinder along the telescopic direction;

[0262] The operating button 387 is swingably mounted on the outer tube. The operating button 387 has an operating portion 3871 and a clamping portion 3872 on both sides of its own swing axis. The clamping portion 3872 is engaged with the rack 3862 to limit the movement between adjacent stages. The operating portion 3871 is exposed to the outer tube where it is located and is used to release the engagement between the clamping portion 3872 and the rack 3862.

[0263] The elastic member 388 acts on the operating button 387 to drive the engaging portion 3872 to maintain engagement with the rack 3862 .

[0264] Pressing the operating part 3871 releases the restriction of the stop structure (i.e., unlocks it). After release, the operating button 387 is reset by the elastic member 388 and meshes with the rack 3862 (i.e., locked). The elastic member 388 abuts between the inner wall of the outer cylinder and the radial outer side of the clamping part 3872. The clamping part 3872 has a self-locking surface 3873 that cooperates with the rack 3862. The self-locking surface 3873 faces the distal end and is roughly perpendicular to the axial direction of the outer cylinder. Among them, the first stage 381 and the middle stage 382 are provided with racks, and the middle stage 382 and the final stage 383 are provided with operating buttons 387 and elastic members 388, and the elastic member 388 is a spring.

[0265] In a preferred embodiment, two operating buttons 387 are symmetrically arranged, and the two buttons move toward each other to perform unlocking and locking operations. There are two corresponding racks 3862 arranged accordingly, and the locking effect is better.

[0266] In one embodiment, the tooth tip of the rack 3862 is inclined toward the proximal side, and the tooth surface toward the proximal side drives the clamping part 3872 to self-lock. Therefore, the stop structure is only a one-way clamping structure, allowing the operator to quickly operate the telescopic assembly 38 to extend without unlocking the stop structure. Among them, when the inner tube is extended to the first limit position, it is limited by the outer tube and stops extending. Specifically, the proximal end of the inner tube is provided with an elastic buckle 3863, and the inner cavity of the outer tube is provided with a blocking part 3851 that abuts against the elastic buckle 3863 to limit the inner tube from coming out. During assembly, the elastic buckle 3863 is deformed to allow the inner tube to be inserted into the outer tube and extended to the first limit position, and the blocking part 3851 abuts against the elastic buckle 3863.

[0267] In one embodiment, the elastic buckle 3863 is disposed at the proximal end of the inner tube, and the blocking portion 3851 is disposed at the distal end of the outer tube. The blocking portion 3851 is the inner cavity wall of the outer tube.

[0268] In one embodiment, a sliding guide structure is provided between the inner tube and the outer tube, specifically including a guide groove 3852 extending along the axial direction provided in one of them, and a guide strip 3864 in the other that cooperates with the guide groove 3852. In one embodiment, an elastic buckle 3863 is provided at the proximal end of the guide strip, and the bottom wall of the distal end of the guide groove is a blocking portion 3851.

[0269] In one embodiment, the distal end of each inner cylinder has an expanded diameter portion 3861 exposed to the distal end of the adjacent outer cylinder at the second limit, and the operator can hold the expanded diameter portion to quickly move the corresponding stage to the distal end. At the second limit, the inner cylinder abuts against the distal end of the adjacent outer cylinder through its own expanded diameter portion 3861. Among them, the abutment member 384 also serves as the expanded diameter portion 3861 of the first stage (i.e., the inner cylinder). The distal end of the final stage (i.e., the outer cylinder) has an expanded diameter portion 3861 exposed to the distal end of the control handle at the second limit. The operating button 387 and the elastic member 388 are installed on the expanded diameter portion 3861.

[0270] In one embodiment, the ejection drive mechanism comprises:

[0271] The external thread section 3831 is located on the outer periphery of the final stage 383;

[0272] The first driving sleeve 351 is rotatably mounted on the control handle 3 and has an internal thread segment meshing with the external thread segment.

[0273] In one embodiment, a method for controlling the recovery of an artificial implant is provided, comprising:

[0274] Provided are an artificial implant and a delivery system for delivering the artificial implant, the delivery system comprising:

[0275] A catheter sheath is used to construct an intervention channel, and the proximal end of the catheter sheath is provided with a fixing seat;

[0276] An inner shaft assembly having a loading section at the distal end, wherein the artificial implant is at least partially located in the loading section and is releasably connected to the inner shaft assembly before expansion;

[0277] A control handle connected to the proximal end of the inner shaft assembly, the control handle is located on the proximal side of the fixing seat, and the distance between the distal end of the control handle and the fixing seat is adjustable;

[0278] The artificial implant at least partially remains connected to the inner shaft assembly. When it is recovered, the catheter sheath is driven to move relative to the inner shaft assembly so that the artificial implant is received in the catheter sheath.

[0279] The proximal end and the distal end of this embodiment are not strictly limited to installation positions, but may also be orientation indications.

[0280] The relative movement of the catheter sheath and the inner shaft assembly can be the catheter sheath moving toward the distal end, or the inner shaft assembly moving toward the proximal end, or the inner shaft assembly moving toward the proximal end and the catheter sheath moving toward the distal end until the distal end of the catheter sheath approaches or contacts the artificial implant, eliminating the gap mentioned above, and waiting for the next operation.

[0281] The method for eliminating the gap can adopt the aforementioned push-up mechanism. During recovery, the push-up mechanism or other components can be pressed against the proximal end of the fixed seat to provide sufficient force transmission to facilitate the recovery operation. The artificial implant, the catheter sheath, the inner shaft assembly and the control handle refer to the structure of the aforementioned embodiment. Specifically, in one embodiment, the distal end of the catheter sheath approaches or contacts the artificial implant, and the push-up mechanism is driven to press against the fixed seat. The telescopic assembly is first extended to the distal end until the head is pressed against the fixed seat, and then the push-up drive mechanism is controlled to drive the telescopic assembly as a whole to move to the distal end and act on the catheter sheath through the fixed seat to make it move to the distal end until the recovery of the artificial implant is completed.

[0282] The expansion of at least a portion of the artificial implant relative to the inner shaft component is understood to be deformation and outward expansion or expansion after the distal end is separated from the loading section or the catheter sheath, etc.

[0283] In one embodiment, the artificial implant is connected to the inner shaft assembly by a pull wire. When the artificial implant is recovered, the pull wire is kept in a tightened state to gather the proximal side of the artificial implant, which is conducive to the smooth entry of the proximal end of the artificial implant into the catheter sheath during recovery. Before recovery, the shape of the artificial implant may be in an expanded state, and the pull wire needs to be tightened first to gather the proximal side of the artificial implant. During recovery, the proximal end of the arm of the artificial implant enters the catheter sheath first, and the distal end of the arm enters the catheter sheath as the catheter sheath adapts to the movement of the artificial implant.

[0284] The length of the catheter sheath in the delivery system can reach a distant surgical site, for example, the length of the tube body extends to the root of the aortic arch, which is convenient for the delivery of the delivery system and other interventional devices. And after the deformation section is switched to the expanded state, it is conducive to the recovery of the artificial implant. During recovery, the distal end of the control handle and the proximal end of the catheter sheath are pressed against each other to provide support force during recovery, which is convenient for recovery.

[0285] It should be noted that the methods mentioned in this application can be used for interventional surgery as well as for in vitro simulation training.

[0286] The technical features of the above embodiments can be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification. When the technical features in different embodiments are embodied in the same figure, it can be regarded that the figure also discloses the combination examples of the various embodiments involved.

[0287] The above embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the patent application. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application.

Claims

1. A delivery system for an artificial implant, characterized in that: include: A catheter sheath, used for constructing an intervention channel, wherein the proximal end of the catheter sheath is provided with a fixing seat; A bending adjustment component, the distal end of which can be controlled to change direction, and the bending adjustment component slides through the fixing seat and further extends toward the proximal end; An inner shaft assembly, the distal end of which is provided with a loading section for connecting an artificial implant, the loading section being always exposed to the distal end of the bending adjustment assembly; A control handle is connected to the bending adjustment assembly and the proximal end of the inner shaft assembly. The control handle is located on the proximal side of the fixing seat and the distance between the control handle and the fixing seat is adjustable.

2. The delivery system of artificial implant according to claim 1, characterized in that: The catheter sheath has opposite distal and proximal ends and includes a tubular body, the tubular body comprising: A main body section, wherein the fixing seat is connected to the proximal end of the main body section, and the tube wall of the main body section is provided with a structural reinforcement layer at least near the distal end, wherein the reinforcement layer is a metal tube with a hollow structure; The deformation section is located at the distal end of the main section, and includes a plurality of elastic sheets arranged at intervals along the circumference of the tube body, the proximal end of each elastic sheet is connected to the metal tube, and each elastic sheet has a relative initial state and an expanded state. In the expanded state, the distal ends of each elastic sheet are relatively far apart and the deformation section as a whole presents a flared structure.

3. The delivery system of artificial implant according to claim 2, characterized in that: The length of the tube is at least 60 cm.

4. The delivery system of artificial implant according to claim 3, characterized in that: The length of the tube body ranges from 60 to 90 cm.

5. The delivery system of artificial implant according to claim 2, characterized in that: The distal end of the tube has a pre-molded shape matching the shape of the aortic arch.

6. The delivery system of artificial implant according to claim 2, characterized in that: The metal tube is made of memory alloy.

7. The delivery system of artificial implant according to claim 2, characterized in that: Two adjacent elastic sheets are connected via a connecting piece.

8. The delivery system of artificial implant according to claim 7, characterized in that: Both ends of the connecting member are respectively connected to the elastic sheet on the corresponding side, and the connecting portion is adjacent to the distal end of the elastic sheet; When each elastic sheet is in an initial state, the middle portion of the connecting member is folded and stored in the spacing area between adjacent elastic sheets; When each elastic sheet is in an expanded state, the middle portion of the connecting member is relatively spread out.

9. The delivery system of artificial implant according to claim 7, characterized in that: Two connecting pieces are connected between two adjacent elastic sheets, including a first connecting piece and a second connecting piece arranged along the axial direction.

10. The delivery system of artificial implant according to claim 9, characterized in that: The first connecting member is connected to the distal end of the elastic sheet in the axial direction, and the second connecting member is connected to the middle part of the elastic sheet in the axial direction.

11. The delivery system of artificial implant according to claim 10, characterized in that: The first connecting member and the second connecting member are V-shaped structures and respectively have a first opening and a second opening, and the first opening and the second opening are opposite to each other.

12. The delivery system of artificial implant according to claim 11, characterized in that: Both sides of the middle part of the first connecting member have protrusions extending toward the proximal end, and the apex of the second connecting member is located inside the two protrusions.

13. The delivery system of artificial implant according to claim 1, characterized in that: The fixing seat has a mounting channel connected to the catheter sheath, and a pipe joint connected to the mounting channel is arranged at the proximal end of the fixing seat, and the pipe joint has: A main interface, wherein a sealing member is disposed at the main interface; A branch interface is provided with a one-way valve.

14. The delivery system of artificial implant according to claim 1, characterized in that: The fixing seat is a hemostatic valve.

15. The delivery system of artificial implant according to claim 1, characterized in that: The control handle is provided with a bending drive mechanism, and the bending adjustment assembly comprises: The sheath is bent, and the proximal end is fixed to the control handle; The bending adjusting member has one end fixedly extending to the distal end of the bending adjusting sheath tube and acting on the sheath tube, and the other end being controlled by the bending adjusting driving mechanism.

16. The delivery system of artificial implant according to claim 1, characterized in that: The inner shaft assembly comprises a first shaft, a second shaft and a third shaft which are sequentially slidably sleeved from the inside to the outside, wherein: The distal end of the first shaft is linked with a locking element; A pull wire is connected to the distal end of the second shaft; A base is fixed at the distal end of the third shaft, the locking element is movably mounted on the base, and a locking hole matching the locking element is provided on the base; The pull wire is bound to the base by the locking element after winding around the artificial implant from the second axis, and the second axis and the first axis are slidably matched relative to the third axis.

17. A method for controlling the recovery of an artificial implant, characterized in that: include: An artificial implant and a delivery system for delivering the artificial implant are provided, the delivery system comprising: A catheter sheath, used for constructing an intervention channel, wherein the proximal end of the catheter sheath is provided with a fixing seat; An inner shaft assembly having a loading section at the distal end, wherein the artificial implant is at least partially located in the loading section and is releasably connected to the inner shaft assembly before expansion; A control handle connected to the proximal end of the inner shaft assembly, the control handle being located at the proximal end side of the fixing seat, and a push mechanism with an adjustable distance between the control handle and the proximal end of the fixing seat being provided at the distal end; The artificial implant at least partially remains connected to the inner shaft assembly. When being recovered, the catheter sheath is driven to move relative to the inner shaft assembly so that the artificial implant is received in the catheter sheath.

18. The recycling control method according to claim 17, characterized in that: The distal end of the catheter sheath approaches or contacts the artificial implant, driving the pushing mechanism to abut against the fixing seat, and further pushing toward the distal end until the artificial implant is received in the catheter sheath.

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