CN119488386A - Artificial implant delivery system and recovery control method - Google Patents

Abstract

The present invention discloses a delivery system and recovery control method for an artificial implant, wherein the delivery system for the artificial implant includes a catheter sheath, a bending adjustment component, an inner shaft component and a control handle, wherein the catheter sheath is used to construct an intervention channel, and the proximal end of the catheter sheath is provided with a fixing seat; 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 and further extends toward the proximal end; the distal end of the inner shaft component is provided with a loading section for connecting the artificial implant, and the loading section is always exposed to the distal end of the bending adjustment component; the control handle connects the bending adjustment component and the proximal end of the inner shaft component, and 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. When recovering the artificial implant, when the distal end of the catheter sheath approaches and contacts the artificial implant, the distal end of the control handle and the proximal end of the catheter sheath are pressed against each other to provide a supporting force during recovery, so as to facilitate recovery.

Description

Delivery system for artificial implant and recovery control method

Technical Field

The application relates to the technical field of medical instruments, in particular to a conveying system and a recovery control method of an artificial implant.

Background

The catheter sheath in the delivery system is used to act as an introducer and limit bleeding during interventional procedures. The catheter sheath is placed into the body and a temporary passageway is established through which a delivery system or other interventional instrument can be passed to a surgical site within the patient. The catheter sheath may present multiple inflection points in the body and its own deflection and structure may affect the delivery and/or retrieval procedure, and further adjustment of the relative position of the catheter sheath to other components is critical to the delivery and/or retrieval procedure. Existing conveying systems and methods for controlling the same still need further optimization.

Disclosure of Invention

The present application provides a delivery system for an artificial implant that facilitates delivery and/or retrieval of the delivery system or other interventional instrument, and retrieval of the artificial implant in vivo and/or delivered.

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

A catheter sheath for constructing an interventional channel, the proximal end of the catheter sheath having a fixed seat;

A bending component, the distal end of which can change the direction in a controlled way, and the bending component extends to the proximal end further through the fixing seat in a sliding way;

an inner shaft assembly having a distal end with a loading segment for attachment of a prosthetic implant, the loading segment being always exposed at a distal end of the bending assembly;

The control handle is connected with the bending adjusting assembly and the proximal end of the inner shaft assembly, and is positioned at the proximal end side of the fixing seat and is adjustable in distance with the fixing seat.

The following provides several alternatives, but not as additional limitations to the above-described overall scheme, and only further additions or preferences, each of which may be individually combined for the above-described overall scheme, or may be combined among multiple alternatives, without technical or logical contradictions.

Optionally, the catheter sheath has opposite distal and proximal ends and comprises a tube comprising:

the main body section, the said fixing base is connected to the proximal end of the said main body section, there is structural reinforcement in the tube wall of the said main body section at least near the distal end, the said reinforcement adopts the metal tube with hollowed-out structure;

The deformation section is located the distal end of main part section, the deformation section includes a plurality of elastic pieces of following body circumference interval arrangement, the proximal end of each elastic piece with the tubular metal resonator links to each other, and each elastic piece has relative initial state and expansion state under the expansion state, the distal end of each elastic piece is kept away from relatively just the deformation section is flaring structure on the whole.

Optionally, the length of the tube body is at least 60cm.

Optionally, the length range of the pipe body is 60-90 cm.

Optionally, the distal portion of the tube has a preformed shape that matches the arcuate shape of the aorta.

Optionally, the metal tube is made of memory alloy.

Optionally, two adjacent elastic sheets are connected through a connecting piece.

Optionally, two ends of the connecting piece are respectively connected to the elastic sheets on the corresponding sides, and the connection part is adjacent to the distal ends of the elastic sheets;

In the initial state, the middle part of each elastic sheet is folded and accommodated in the interval area of the adjacent elastic sheets;

In the expanded state, the middle parts of the connecting pieces are relatively unfolded.

Optionally, two connecting pieces are connected between two adjacent elastic pieces, and each connecting piece comprises a first connecting piece and a second connecting piece which are axially arranged.

Optionally, 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 of the elastic sheet in the axial direction.

Optionally, the first connecting piece and the second connecting piece are V-shaped structures, and have first opening and second opening respectively, first opening with the second opening deviates from each other.

Optionally, two sides of the middle part of the first connecting piece are provided with protruding parts extending towards the proximal end, and the vertex of the second connecting piece is positioned in the two protruding parts.

Optionally, the deformation section is in a grid structure as a whole.

Optionally, the pipe body has three-layer structure, from outside to inside includes outer membrane layer, enhancement layer and internal film layer in proper order.

Optionally, the elastic sheet and the metal tube are in an integral structure or a split structure.

Optionally, the fixed seat is a hemostatic valve.

Optionally, the hemostatic valve includes a housing and a seal disposed within the housing for preventing fluid leakage.

Optionally, the fixing base is provided with an installation channel communicated with the catheter sheath, the proximal end of the fixing base is provided with a pipe joint connected with the installation channel, and the pipe joint is provided with:

a primary interface at which a seal is disposed;

and a branch interface, wherein a one-way valve is arranged at the branch interface.

Optionally, a bending driving mechanism is installed on the control handle;

optionally, the bending adjustment assembly includes:

the proximal end of the bending regulating sheath tube is fixed on the control handle;

One end of the bending adjusting piece is fixedly extended to the distal end part of the bending adjusting sheath tube and acts on the sheath tube, and the other end of the bending adjusting piece is controlled by the bending adjusting driving mechanism.

Optionally, the inner shaft assembly includes first axle, second axle and the third axle of sliding sleeve in proper order from inside to outside, wherein:

A lock is linked at the distal end of the first shaft;

the distal end of the second shaft is connected with a stay wire;

The far end of the third shaft is fixedly provided with a base, the lock piece is movably arranged on the base, and the base is provided with a lock hole matched with the lock piece;

The pull wire is bound to the base by the lock after passing around the artificial implant from the second shaft, and the second shaft and the first shaft are in sliding fit relative to the third shaft.

Optionally, the distal end of the control handle is provided with an ejector mechanism cooperating with the catheter sheath.

The present application also provides a control handle having opposed distal and proximal ends, and an axial direction extending therebetween, the distal end of the control handle being provided with an axially retractable ejector mechanism comprising:

The telescopic component is provided with an abutting piece at the far end, and the near end is movably connected to the control handle along the axial direction;

And the ejection driving mechanism is arranged on the control handle and is linked with the proximal end of the telescopic component.

Optionally, the telescopic component is sequentially provided with one or more stages from the distal end to the proximal end, wherein the abutting piece is arranged at the distal end of the first stage, and the proximal end of the last stage is movably connected to the control handle along the axial direction and is linked with the ejection driving mechanism.

Optionally, each stage of the telescopic component is of a cylindrical structure and is movably spliced in sequence.

Alternatively, one of the adjacent stages is an outer barrel and the other is an inner barrel, and when the telescopic component is extended, the inner barrel moves distally relative to the outer barrel.

Optionally, mutually matched retaining structures are arranged between adjacent stages.

Optionally, the retaining structure includes:

A rack arranged outside the inner cylinder in the telescoping direction;

The operation button is arranged on the outer cylinder in a swinging way, an operation part and a clamping part are respectively arranged on two sides of the swinging axis of the operation button, the clamping part is meshed with the rack to limit the movement between the adjacent stages, and the operation part is exposed to the outer cylinder and used for releasing the meshing of the clamping part and the rack;

and an elastic member acting on the operation knob to drive the engagement portion to maintain engagement with the rack.

Optionally, the tooth tip of the rack is inclined towards the proximal side, and the tooth surface towards the proximal side drives the clamping part to self-lock.

Optionally, the elastic element is abutted between the inner wall of the outer cylinder and the radial outer side of the clamping part.

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

Optionally, the ejector driving mechanism includes:

an external thread section located at the outer periphery of the final stage;

The first driving sleeve is rotatably arranged on the control handle and provided with an internal thread section matched with the external thread section.

The application also provides a recovery control method of the artificial implant, which comprises the following steps:

providing an artificial implant and an interventional delivery system for delivering the artificial implant, the interventional delivery system comprising:

The catheter sheath is used for constructing an interventional channel, and the proximal end of the catheter sheath is provided with a fixed seat;

An inner shaft assembly having a loading section at a distal end thereof, the artificial implant being at least partially disposed in the loading section and releasably coupled to the inner shaft assembly prior to expansion;

The control handle is connected with the proximal end of the inner shaft assembly, the control handle is positioned at the proximal end side of the fixed seat, and the distal end of the control handle is provided with an ejection mechanism with adjustable distance with the fixed seat;

The prosthetic implant remains at least partially connected to the inner shaft assembly and, upon retrieval, the catheter sheath is driven into relative movement with the inner shaft assembly such that the prosthetic implant is received within the catheter sheath.

Optionally, the distal end of the catheter sheath approaches or contacts the artificial implant, drives the ejection mechanism against the fixed seat, and further ejects the artificial implant distally until the artificial implant is received into the catheter sheath.

Optionally, the artificial implant is connected to the inner shaft assembly by a pull wire, which is held in a tightened state to gather the proximal side of the artificial implant when recovered.

Optionally, the shape of the artificial implant is in an expanded state, and the shape is connected with the inner shaft assembly only by a pull wire, and the proximal side of the artificial implant is gathered by tightening the pull wire before the recovery.

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 arm parts, the proximal ends of the arm parts are fixed to the inner frame, a first gap which can contain the native tissue is formed between the distal ends of the arm parts and the inner frame, and the inner frame is connected with valve blades for controlling the blood flow channel;

Upon retrieval, the proximal end of the arm first enters the catheter sheath and the distal end of the arm is adapted to enter the catheter sheath as the catheter sheath moves relative to the prosthetic implant.

Alternatively, the method may be used for interventional procedures, as well as in vitro simulation procedures.

The improvement of the system and the method ensures that the catheter sheath can ensure the effective delivery and recovery of the interventional structure when establishing a passage, and the conveying system can operate the pushing mechanism at the distal end of the control handle to prop against the proximal end of the catheter sheath when recovering the artificial implant so as to provide supporting force during recovery, ensure the stability and accuracy of the relative positions of the current catheter sheath and other structures and the subsequent adjustment, and is convenient for recovery and improves the operation convenience and safety.

Drawings

FIG. 1a is a schematic illustration of a control mechanism for limiting an artificial implant according to an embodiment of the present application;

FIG. 1b is a schematic diagram of the control mechanism of FIG. 1a showing the pull wire disengaged from the lock;

FIG. 2 is a schematic view of a delivery system for an artificial implant according to an embodiment of the present application;

FIG. 3 is an enlarged schematic view of portion A of FIG. 2;

FIG. 4 is a cross-sectional view of a loading section of a control mechanism away from a base in accordance with one embodiment of the present application;

FIG. 5 is a schematic view of a portion of the control mechanism of an embodiment of the present application when the loading section is loaded with an artificial implant;

FIG. 6 is a schematic view of the radial relationship of the loading section and the prosthetic implant arm in a control mechanism according to another embodiment of the present application;

FIG. 7 is a schematic view of the radial relationship between the loading section, the prosthetic implant, and the catheter sheath in a control mechanism according to an embodiment of the present application;

FIG. 8 is a structural view of an artificial implant according to an embodiment of the present application;

FIG. 9 is a front view of an artificial implant according to an embodiment of the present application;

FIG. 10 is a schematic view of a delivery system for an artificial implant according to an embodiment of the present application;

FIG. 11 is a schematic view of a catheter sheath according to an embodiment of the present application;

FIG. 12 is a schematic view of the catheter sheath intervention delivery to the aortic arch in accordance with one embodiment of the present application;

FIG. 13 is a schematic view of the structure of the catheter sheath of FIG. 12 to assist in retrieving an artificial implant;

FIG. 14 is a schematic view of a distal end bending adjustment of a catheter sheath according to an embodiment of the present application;

FIG. 15 is a schematic view of a deformed segment in an initial state according to an embodiment of the present application;

FIG. 16 is an enlarged partial schematic view of FIG. 15;

FIG. 17 is a schematic view of the deformed segment of FIG. 15 in an expanded state;

FIG. 18 is an enlarged partial schematic view of FIG. 17;

FIG. 19 is an enlarged partial schematic view of a deformed segment in an initial state according to another embodiment of the present application;

FIG. 20 is an enlarged partial schematic view of the deformed segment of FIG. 19 in an expanded state;

FIG. 21 is a cross-sectional view of a tube body at a metal tube in accordance with an embodiment of the present application;

FIG. 22 is a schematic view of a deformed segment in an expanded state according to another embodiment of the present application;

FIG. 23 is a schematic view showing a deformed segment in an initial state according to another embodiment of the present application;

fig. 24 is a partial front view of the deformed segment of fig. 23 in an initial state.

FIG. 25 is a schematic view showing the structure of a catheter sheath according to another embodiment of the present application;

FIG. 26 is a partially exploded view of the catheter sheath of FIG. 25 at the anchor mount;

FIG. 27 is an exploded view of the pipe joint of FIG. 26;

FIG. 28 is a schematic view of a control handle related to a bending mechanism according to an embodiment of the present application;

FIG. 29 is a partial cross-sectional view of the control handle at the ratchet wheel in accordance with one embodiment of the present application;

FIG. 30 is a partial cross-sectional view of the release of the ratchet constraint of FIG. 29;

FIG. 31 is a schematic view showing the structure of a limiting member in a control handle according to an embodiment of the present application;

FIG. 32 is an exploded view of a control handle at a turn down mechanism according to an embodiment of the present application;

FIG. 33 is a schematic view of a control handle according to an embodiment of the present application;

FIG. 34 is an exploded view of the ejector mechanism of FIG. 33;

FIG. 35 is a schematic view of the telescoping assembly of FIG. 33 in a first stage extended and abutting configuration against a mounting bracket;

FIG. 36 is a schematic view of the push drive mechanism of FIG. 35 driving the retraction assembly distally;

FIG. 37 is a schematic view of an intermediate stage of the telescoping assembly of FIG. 35;

FIG. 38 is a schematic view of the structure of the first stage of the telescoping assembly of FIG. 35;

FIG. 39 is a half cross-sectional view of the final stage of FIG. 34;

FIG. 40 is a partial cross-sectional view of a telescoping assembly in a control handle according to an embodiment of the present application;

fig. 41 is a half sectional view showing the release of the restriction on the rack after the depression of the operation part in fig. 40.

Reference numerals in the drawings are described as follows:

10. The base, 101, a locking area, 11, a stay wire, 111, a free end, 113, a control end, 13 and a lock;

21. A first shaft, 211, a loading section, 216, a loading part, 217, and an avoidance port;

23. second shaft, 25, third shaft;

3. Control handle, 31, proximal end, 32, distal end, 330, support body;

37. bending driving mechanism 371, reel 3711, ratchet wheel 372, knob 374, limiting piece 3741, pawl 375, elastic piece 376, pulling button 351, first driving sleeve;

38. The telescopic component 381, the first stage 382, the middle stage 383, the last stage 383, the external thread section 384, the abutting piece 3851, the blocking part 3852, the guide groove 3861, the diameter expanding part 3862, the rack 3863, the elastic buckle 3864, the guide bar 387, the operation button 3871, the operation part 3872, the clamping part 3873, the self-locking surface 388, the elastic piece 39 and the pushing driving mechanism;

4. 43, bending the sheath tube;

501. spaced openings 502, hollowed-out areas 504, middle portions 505, distal side edges 506, protrusions;

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

520. Deformation section 521, elastic sheet 522, connecting piece 523, first section 524, second section 525, second connecting piece 526, first connecting piece 527, first opening 528, second opening 529, vertex;

551. first connecting channel 552, second connecting channel 56, bending piece;

581. Joint part 582, first opening 583, third segment 584, fourth segment 585, second gap 586, third gap 587, second opening 588, connector;

591. 592, second deformation strips;

60. artificial implant 601, drive-by-wire end 603, eyelet 61, inner frame 63, arm 631, inflow side 632, outflow side 604, blood flow channel 70, catheter sheath 720, anchor 721, mounting channel 750, tube connector 751, main interface 752, seal 753, branch interface 754, one-way valve.

Detailed Description

The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When an element is referred to as being "disposed on" another element, it can be directly on the other element or intervening elements may also be present.

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

In the present disclosure, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or as implicitly indicating the number, order of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present application, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.

The present specification describes an artificial implant and a delivery system for delivering the artificial implant into a subject, the delivery system comprising a control handle and a catheter assembly, wherein the control handle is connectable to and controls the catheter assembly for performing an interventional procedure, the catheter assembly comprising a plurality of controlled elements, the distal ends of each controlled element being cooperatively operable with the artificial implant, such as releasing, retrieving, locking, adjusting spatial pose, etc., each controlled element itself being a hollow tube, a solid rod, a flexible wire, or a combination of forms, the controlled elements being a plurality of controlled elements, and at least two of them (as examples proximal ends) being relatively slidable in an axial direction or relatively rotatable about an axial direction. The force application part (the part which is directly operated and contacted by a user) for operating each controlled piece on the control handle can be directly fixed for transmission with the corresponding controlled piece, or can be transmitted in a mode of threads, gears, racks and the like.

In the following, many modifications to the control handle or the partial structure may be implemented on the same control handle without obvious technical contradictions, but are not strictly limited to be implemented on the same control handle, and the embodiments may be implemented separately or combined appropriately for different controlled numbers and movement characteristics, or for a control handle with a further simplified structure.

The application site and structure of the artificial implant are not strictly limited, in some figures or texts, an artificial heart valve is taken as an example, the artificial heart valve generally comprises a deformable bracket and valve blades connected in the bracket, the bracket is in a cylindrical shape as a whole, the side wall of the bracket is in a hollowed grid structure, the shape or the size of the grid structure is not strictly limited unless specifically stated, a blood flow channel is arranged in the bracket, a plurality of valve blades are mutually matched to control the opening and closing degree of the blood flow channel in the bracket, a positioning structure which can act with peripheral primary tissues, such as anchor thorns, arm parts and the like, can be arranged on the periphery of the bracket for positioning in vivo, and a skirt edge or a peripheral leakage prevention material can be arranged on the inner side and/or the outer side of the bracket for preventing peripheral leakage.

According to different expansion modes, the stent is made of corresponding materials, such as nickel-titanium alloy with shape memory capable of self-expanding in vivo, stainless steel material expanded by ball expansion, and the like, the stent can be formed by cutting a tube or weaving wires, and the valve blades can be connected to the stent by stitching, bonding or integral die forming.

Taking a self-expanding stent as an example, the expansion and recovery of the self-expanding stent can be controlled by a sheath tube wrapped on the periphery of the stent, the positions of the stent exposed to the sheath tube are different, and the stent can be correspondingly controlled, and the stent can also be controlled by a stay wire, namely the stay wire passes through a structural gap (or a wire hole structure) of the stent, the expansion degree of the stent can be changed by adjusting the tightness of the stay wire through a control handle, after the stay wire is pulled out of the stent, the stent is allowed to be completely released, and the control of the stay wire is also completed through each controlled part in a catheter assembly.

The stent of the artificial implant may be generally provided with a coupling structure cooperating with the catheter assembly to define positions with each other, preventing an unnecessary positional deviation from occurring at the time of delivery, and the artificial implant may be in a radially compressed state, i.e., a loaded state, upon input, in an in vivo unconstrained and radially expanded state of the catheter assembly, and the shape expression of the artificial implant is understood as the expanded state without specific explanation, and does not consider local deformation caused by the surrounding tissue pressure.

Because of the complexity of the in vivo structure, the catheter assembly often requires a bending operation, the corresponding bending member may be in the form of a tube or wire, the distal end acts on the bent member, and the proximal end is operated to bend the extent or direction by the control handle.

Proximal end, when used in reference to a direction, generally refers to the side adjacent the operator (e.g., physician) and distal end is the side that is relatively far from, along the interventional path, each component itself having opposite distal and proximal ends, the straight line between the proximal and distal ends theoretically defining the axial direction when the catheter assembly is fully straightened with the control handle, and correspondingly defining the radial direction perpendicular to the axial direction and the circumferential direction disposed about the axial direction, and "end" when used in reference to a structure means the end point of the structure or a point or region on the side or a particular structure attached to the point or region.

An embodiment of the present application also provides a delivery system for an artificial implant comprising a catheter sheath 70, a bending assembly, an inner shaft assembly and a control handle 3. The delivery system has opposite proximal 31 and distal 32 ends, the distal end of the inner shaft assembly being provided with a control mechanism for controlling the expansion, release, etc. of the prosthetic implant 60.

First, as shown in fig. 1-3, the control mechanism comprises a base 10, a pull wire 11 and a locking member 13, wherein the base 10 is provided with a locking area 101, the pull wire 11 is provided with a free end 111 capable of being wound around or separated from the artificial implant 60, the locking member 13 is integrally located at the distal end of the base 10, and the locking member 13 is in rotating fit with the base 10 to lock the free end 111 of the pull wire 11. The base 10 has opposite distal and proximal ends 32, 31 and an axial direction extending between the distal and proximal ends 32, 31, which are equally applicable to other components of the control mechanism, as well as to the control handles and delivery systems of the embodiments described below, without specific reference thereto.

The free end 111 is the end of the pull wire 11 that passes through and finally out of the artificial implant 60, and can be understood as the most distal end when the pull wire 11 is straightened, and the other end of the pull wire 11 opposite to the free end 111 is a control end, wherein the control end can be directly fixed on the base 10 or can be controlled to extend proximally.

The free end 111 has a first state (fig. 1 a) in which it is restrained to the base 10 and a second state (fig. 1 b) in which it is released, the lock 13 is movably engaged with the base 10, and the lock 13 is engaged with the free end 111 of the 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 engaged with the base 10 to limit the pull wire 11 from being separated from the lock 13, so that the free end 111 can be understood as being relatively fixed to the lock 13, and in this state, the pull wire 11 is always connected with 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 out of 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 may also be used for retrieval of the artificial implant.

In the second state, the free end 111 is disengaged from the locking element 13, at which point the free end 111 is understood to be released, thereby releasing the interconnection between the artificial implant and the control mechanism, and the control mechanism as a whole may then be withdrawn from the body, leaving the artificial implant in the body in a predetermined position.

Wherein the locking element, the base and the stay wire are assembled outside the body, the penetrating path of the stay wire 11 extends from the proximal end of the base, and then extends from the distal end of the base to penetrate around the artificial implant and then be combined with the locking element 13.

When the artificial implant is recovered, the control end 113 is operated to reduce the length of the pull wire 11 exposed outside the control mechanism in the first state.

The lock 13 is located the distal end of base 10, is favorable to the observation and the operation when external pre-installation, and convenient equipment especially lock 13 and base 10 do not have the nestification in radial, forms sufficient radial space that supplies the stay wire to wear to establish, and makes the stay wire more smooth and easy at the motion process. In addition, the radial maximum dimension of the base 10 and/or lock 13 may be correspondingly reduced to facilitate in vivo interventional delivery.

Of course, the control mechanism of the present application and other embodiments described below including the control mechanism of the present embodiment are also applicable to simulated training of interventional delivery procedures outside of the body.

Next, as shown in fig. 4 to 9, the artificial implant 60 includes an inner frame 61, the outer periphery of the inner frame has a plurality of arm portions 63, a first gap for accommodating the native tissue is formed between each arm portion 63 and the inner frame 61, the distal end of the first shaft 21 is connected with a loading section 211, 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 on the distal end of the first shaft 21, the loading section 211 is opened towards the proximal end, the whole of the inner frame 61 or at least the distal end portion of the inner frame 61 is accommodated in the loading section 211, the peripheral wall of the loading section 211 is provided with an avoiding opening 217, and at least a part of the arm portions 63 is located at the avoiding opening 217.

The loading section 211 restrains the distal portion of the implant 60, maintains the implant in a collapsed state, and allows the arm 63 to enter the relief opening 217 while ensuring delivery of the safety intervention, the relief opening 217 being located in a region of the maximum radial space of the loading section 211, i.e., the loading section 216 described above. The loading segment of this embodiment is smaller in radial dimension than prior art designs that completely encapsulate the prosthetic implant, facilitating interventional delivery.

The method for releasing the arm part from the radial relation between the arm part and the loading section in the loading state of the artificial implant comprises the following steps:

As shown in fig. 6, the arm 63 is at least partially disposed within the loading section 211, and the loading section 211 is moved axially to un-bind the loading section 211, and if there is a sheath wrapped around the loading section 211, the sheath 70 is moved.

Alternatively, as shown in fig. 6 and 7, the loading structure includes a catheter sheath 70 slidably mounted on the outermost side of the inner shaft assembly with the arm 63 between the loading section 211 and the catheter sheath 70. The restriction of the arm 63 can be released by moving the catheter sheath 70. In one embodiment, the distal portion of the prosthetic implant is within the loading segment and the proximal portion is outside the loading segment and within the catheter sheath.

The outflow side 632 of each arm 63 is fixedly connected to the inner frame 61, the inflow side 631 is expanded to form a first gap with the inner frame 61, and the inflow side 631 is positioned at the escape opening 217. The artificial implant comprises an inner frame defining a blood flow channel, the periphery of the inner frame is provided with a plurality of arm parts, a first gap which can contain the primary tissue is formed between each arm part and the inner frame, and the inner frame is connected with valve blades for controlling the blood flow channel. The inner frame 61 and the arm 63 are fixed in a split or integrated structure, the inner frame 61 and the arm 63 are cut integrally by a pipe blank, and the inflow sides of the inner frame 61 and the arm 63 are far away from each other along the axial direction of the pipe blank. The inner frame 61 is a radially deformable tubular structure, a blood flow channel 604 is arranged in the inner frame, the valve blades are connected to the inner frame 61 to change the opening degree of the blood flow channel, the arm portions 63 are of an integral annular structure, and the outflow side 632 of each arm portion 63 is fixedly connected to the inner frame 61.

Referring to fig. 10-13, the catheter sheath 70 is used to construct an interventional channel extending from outside the body to adjacent a lesion, the proximal end of the catheter sheath 70 is provided with a fixed seat 720 (outside the body), the distal end of the bending assembly can be controlled to change the direction, the bending assembly slides to extend further proximally through the fixed seat 720, the distal end of the inner shaft assembly is provided with a loading section for connecting the artificial implant 60, the loading section is always exposed to the distal end of the bending assembly, the control handle 3 is connected with the bending assembly and the proximal end of the inner shaft assembly, and the control handle 3 is positioned at the proximal side of the fixed seat 720 and has an adjustable distance from the fixed seat 720. The catheter sheath 70 of the present embodiment is used to assist in retrieval of an artificial implant.

The catheter sheath is used to establish a temporary channel of a length that is capable of reaching a remote surgical site for the delivery system to deliver the artificial implant through the channel intervention to the surgical site. Wherein the site of application and the structure of the artificial implant are not strictly limited, are incorporated in the present application, have at least a longer axial dimension and are suitable for longer interventional routes.

Referring to fig. 11-22, the present application provides a long-gauge intervention-based catheter sheath 70 having opposite distal and proximal ends 32, 31, the catheter sheath 70 comprising a tube 51, the tube 51 comprising a main body section 510 and a deformation section 520. The fixing base 72 is connected to the proximal end of the main body section 510, and a structural reinforcing layer is provided in the pipe wall of the main body section 510 at least near the distal end, wherein the reinforcing layer is a metal pipe 511 with a hollow structure.

The deformation section 520 is located at the distal end of the main body section 510, and the deformation section 520 includes a plurality of elastic pieces 521 circumferentially spaced along the tube body 51, the proximal end of each elastic piece 521 being connected to the metal tube 511, each elastic piece 521 having an opposite initial state (fig. 15) and an expanded state (fig. 17) in which the distal end of each elastic piece 521 is relatively far away and the deformation section 520 is in a flared structure as a whole. The elastic pieces 521 are relatively gathered in an initial state and the deformed section 520 is integrally formed as a straight cylinder or is contracted radially inward.

The hemostatic valve 55 itself may comprise a housing and a seal within the housing, which may be an elastomeric member or a deformable member driven by a fluid, to prevent blood leakage when the catheter assembly of the delivery system is passed through the hemostatic valve.

The hemostatic valve 55 has a first connecting channel 551 for the injection fluid to drive the seal and a second connecting channel 552 for venting.

The catheter sheath of the application can reach a remote operation site and the deformation section can assist in recovering the artificial implant after being switched to an expanded state.

Taking aortic valve replacement as an example, the catheter sheath 70 is advanced from the femoral artery of the lower limb until the distal end of the tubular body 51 extends to the aortic arch (e.g., the root of the ascending aorta). The catheter sheath of the present embodiment may establish a long-distance passageway that facilitates delivery of the catheter assembly and the prosthetic implant of the delivery system. And may also assist in retrieving the artificial implant.

Furthermore, the deformation section can assist in recovering the artificial implant after being switched to the expanded state, so that the structure of the catheter assembly can be further simplified. For example, the outermost tube member may be omitted relative to conventional catheter assemblies.

The manner in which the proximal end of the artificial implant remains attached to the catheter assembly of the delivery system may be by way of conventional T-shaped lugs or by way of a wire control, which may remain attached to the proximal end of the artificial implant until the pull wire is completely released.

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

In one embodiment, the distal portion of the tube 51 has a preformed shape that matches the arcuate shape of the aorta. Reducing the safety hazards of the catheter sheath during interventional delivery and better shape matching after placement. The pre-molded tube 51 establishes a delivery channel for the bending assemblies and the inner shaft assembly, facilitates the bending assemblies and the inner shaft assembly to be over-bent in the body, and simplifies the structure of the bending assemblies, e.g., omits the number of bending members, etc. The pre-molded tube 51 can also cooperate with the bending adjustment assembly to achieve more precise bending adjustment and centering.

As shown in fig. 21, the distal end of the main body section 510 has a three-layer structure including an outer film layer 513, a reinforcing layer (i.e., a metal tube), and an inner film layer 514 in this order from the outside to the inside. The metal tube 511 is formed by cutting a nickel-titanium alloy tube or weaving a nickel-titanium alloy wire, so that a hollow structure of the metal tube is formed, the hollow structure not only can increase flexibility and facilitate passing through turning sites, but also can enable the reinforcing layer to be better adhered to the inner and outer membrane layers. The outer film layer 513 and the inner film layer 514 may be ELASTHANE, PE ethane, pebax, GRILAMIDE, or the like, respectively, having lubricating properties.

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

The prosthetic implant is retrieved into the tubular body 51 with the distal end of the prosthetic implant aligned with the main body section 510 and the proximal end of the metal tube 511 beyond or aligned with the proximal end of the prosthetic implant;

Or after the catheter sheath 70 is completed with the interventional delivery, the length of the metal tube 511 is sufficient to cover the aortic arch;

or the metal tube 511 is of equal length to the body section 510.

As shown in FIG. 14, in one embodiment, the catheter sheath 70 includes a deflection member that drives the bending of the body 51, the distal end of the deflection member extending and acting on the distal end of the body section 510 to bend the same, the proximal end of the deflection member extending beyond the hemostatic valve connection being controlled by an extension handle disposed at the proximal end of the hemostatic valve 55 with a locking mechanism therebetween that limits axial positioning of the two, which may be a buckle or the like. The extension handle has a first passageway for the delivery system to pass through. The extension handle may also be integrally provided to the hemostatic valve 55.

The deflection member 56 comprises a wire, a tube, or a combination of wires and tubes, for example, the deflection member 56 is a pull wire with a distal end extending secured to a distal end of the body segment. The extension handle controls the change in traction wire applied to the body segment 510 from dotted to solid curve.

In one embodiment, each resilient tab 521 is integrally or separately connected to the metal tube 511. Wherein, the integral structure is convenient for machine-shaping, also can structural strength.

In one embodiment, two adjacent elastic pieces 521 are connected by a connecting member 522. When the deformed segment 520 is switched to the expanded state, the connecting members 522 can cause the elastic pieces 521 to interact and expand uniformly, so that when the artificial implant 60 is recovered, the elastic pieces 521 are uniformly stressed, and excessive deformation of the elastic pieces 521 is avoided.

In one embodiment, as shown in fig. 15-18, the connecting member 522 between two adjacent elastic sheets is one, has a generally V-shaped structure and has a first opening disposed toward the distal end. Between two adjacent elastic sheets are interval openings 501, the middle part of the interval opening 501 is widened, and two ends are narrowed. The elastic piece 521 is gradually widened near the proximal end thereof, so that the connection strength can be improved, the necessary resilience force can be ensured, and the spacing opening 501 adopts an arc-shaped edge at the proximal-most position to disperse stress, thereby improving the safety.

In the initial state, each elastic piece 521 is folded and accommodated in the space between two adjacent elastic pieces, and in the expanded state, each elastic piece 521 is unfolded relative to the central portion 504 of the connecting piece 522 (relative to the initial state).

The connection of the connecting member 522 to the resilient tab 521 is adjacent the distal end of the resilient tab 521, eliminating the need for an isolated resilient tab 521 tip or spike structure, avoiding snagging structural gaps in the artificial implant.

The connection point between the end of the connecting element 522 and the elastic piece 521 on the respective side, adjacent to the distal end of the elastic piece 521, is understood to be close to or just at the distal end of the elastic piece 521, in particular in the expanded state, avoiding the formation of an isolated convex portion of the distal end of the elastic piece 521, reducing the risk of interference with the artificial implant.

The shape of the middle part 504 is not strictly limited, and the middle part 504 mainly plays a role in connecting and pulling two connected elastic sheets 521 in an expanded state, and the middle part 504 needs to be folded and stored in an initial state, so that a foldable structure is adopted, the folding process can be driven by the elasticity of the elastic sheets 521, or can be combined with the middle part 504 to adopt a preset elastic material, the folding is driven in an auxiliary mode, and the folded middle part is stored between two adjacent elastic sheets and extends towards the proximal end correspondingly.

The manner in which the elastic tabs 521 are connected to the attachment member 522 affects the distribution of stresses and the folding effect of the attachment member 522, and in one embodiment the distal edge 505 of each elastic tab 521 is arcuate and the ends of the attachment member are connected to the distal edge of the respective elastic tab in a generally tangential extension of the arcuate shape. Referring to fig. 18, the connecting member 522 has a first section 523 and a second section 524 constituting a V-shaped structure, wherein the first section 523 extends in the X1 direction toward the distal side edge 505 of the elastic sheet 521, the second section 524 extends in the X2 direction toward the distal side edge 505 of the elastic sheet 521, and the first section 523 and the second section 524 meet each other as a single body.

The arcuate shape of the distal edge 505 merely represents a general trend or overall shape and is not strictly limiting, as the connectors meet in a tangential extension, providing a more effective radial gathering force and more reasonable stress distribution.

In another embodiment, the first section 523 and the second section 524 of two adjacent connectors 522 are butted against the distal side edges of the same elastic sheet, and the distal side edges of the butted portions are smoothly transitioned. The smooth outer edges avoid safety hazards, such as the first section 523 and the second section 524 abutting the distal edge 505 of the same elastic tab 521, and the abutting portions are relatively smooth due to the integration of the abutting portions, thereby avoiding interference of the artificial implant 1 by the sharp or abrupt portions.

Further, all of the connectors 522 extend continuously in the circumferential direction of the tube. As can be seen, since the adjacent connectors 522 are smoothly butted, all of the connectors 522 are connected in a loop, although the middle portion 504 may be slightly bowed up and down, without affecting the overall trend,

In the initial state, the two sides of the middle portion 504 of the connecting member 522 are provided with two corner portions, and each corner portion is provided with a protrusion 506 extending proximally. The protrusion 506 can structurally reinforce the corner portion, and can prevent fatigue damage caused by repeated bending.

In the expanded state, the two corresponding protruding parts of the same U shape are adjacent to or abutted against each other. The two protrusions being adjacent or abutting each other may define the angle of deployment of the connector 522 so as not to fold back in extreme or abnormal situations.

The adjacent elastic sheets are provided with a spacing opening 501, and in the initial state, the first section 523 and the second section 524 extend from the two ends of the elastic sheets along the arc-shaped path into the spacing opening 501. That is, the attachment member 522 is arcuate adjacent the distal edge 505 of the resilient tab 521, and preferably conforms to the shape characteristics of the resilient tab 521, extending proximate the edge of the resilient tab 521, with less space. The arc structure does not have the condition of too concentrated stress during unfolding, and the potential safety hazard of fatigue fracture is reduced.

In the initial state, the proximal side of the connecting member 522a is axially adjacent to the middle of the spaced apart openings 501. In the initial state, the spacing openings 501 are substantially bar-shaped openings, the distal ends of the elastic pieces are closed by the connecting pieces 522, the elastic pieces 521 can be expanded radially outwards, the elastic pieces can adapt to gradual deformation of the artificial implant when the artificial implant is expanded, the artificial implant is prevented from suddenly collapsing out at the end of expansion, and when the artificial implant needs to be recovered, the elastic pieces 521 are expanded radially outwards to form a horn-shaped opening for guiding the recovery of the artificial implant.

In the expanded state, each elastic tab has a V-shape with a vertex angle of 120 degrees or more. Of course, in combination with the foregoing, the apex angle of the V-shape adopts a rounded corner structure, and is approximately U-shaped.

Each elastic sheet is provided with a hollow area, and the elastic sheets are circumferentially distributed in 3-6, for example 5.

The hollowed-out area 502 of the elastic sheet 521 is convenient for deformation of the elastic sheet, and reduces the outward expansion resistance, in one embodiment, the hollowed-out area 502 is in the shape of a bar hole, a round hole, an ellipse or a water drop lamp, and on the same elastic sheet, the hollowed-out area 502 is one or a plurality of mutually isolated parts, and the inner edge of each hollowed-out area is smooth, so that the cracking caused by too concentrated stress during deformation can be avoided. The total area of the hollowed-out 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 along the axial direction or the circumferential direction of the tube body at intervals.

The outer membrane layer 513 and the inner membrane layer 514 may further extend distally to cover the inner and outer sides of the deformation section 520, and in order to reduce the risk of tearing, the membrane layer between two adjacent elastic sheets may be subjected to a notch treatment to release the deformation stress.

In another embodiment, as shown in fig. 19 and 20, two connecting members 522 are connected between two adjacent elastic pieces 521, and the two connecting members 522 are a first connecting member 526 and a second connecting member 525 respectively arranged in the axial direction.

For a specific structure of the first connecting member 526, reference is made to the foregoing embodiment, in which the second connecting member 525 is connected to the axial middle portion (hereinafter referred to as waist portion) of the elastic member 521. The second connecting member 525 has a V-shaped structure and has a second opening 528, wherein the first opening 527 and the second opening 528 face away from each other.

The V-shaped inflection point of the second connecting element 525 has a relatively obvious turning trend, and the second opening 528 faces the proximal end, so that the resistance and hidden trouble caused by the outward warping of the inflection point part during the retraction can be reduced. The deformation of the first connecting element 526 and the deformation of the second connecting element 525 are different, so that the positions, connected with the elastic pieces, of the elastic pieces are limited to generate different radial deformation, the whole deformation section 520 presents an arc-shaped cone shape, and the bending angle of the turning positions between the deformation section and the main body section is slowed down.

The waist portion of the elastic tab 521 is circumferentially inwardly received at the distal and proximal ends thereof, and the root portion of the second connecting member 525 is arcuately transited with the waist portion.

In order to avoid potential drag caused by the two protrusions 506 when pushing the catheter assembly and the artificial implant distally within the catheter sheath, the apex 529 of the second connector 525 is positioned within the two protrusions 506, which may provide a guiding effect.

In another embodiment, as shown in fig. 22, unlike the previous embodiment, the deformation section 520 is in a lattice structure as a whole, and the elastic sheet 521 can be understood as a partial lattice structure in the circumferential direction. The deformation of the lattice structure can be adapted to the switching of the states of the elastic sheets.

In another embodiment, as shown in fig. 23 to 24, the adjacent elastic sheets 521 are connected at their middle portions and form a connecting portion 581, and the connecting portion 581 is provided with a first opening 582, where the first opening 582 can release stress when the deformation section 520 expands or contracts. The first openings are circular holes, the number of the first openings is a plurality of the first openings 582 are arranged at intervals along the axial extension of the deformation section, and the sizes of the first openings 582 are the same.

In one embodiment, the elastic piece 521 extends distally from the engagement portion 581 and gradually tapers as the third segment 583, and the distal end of the elastic piece 521 has a circular arc structure. The elastic piece 521 extends proximally from the engagement portion 581 and gradually gathers as the fourth segment 584. Wherein the gathering trend of the fourth section is greater than the gathering trend of the third section.

In one embodiment, a second gap 585 is disposed between adjacent third segments 583, a third gap 586 is disposed between adjacent fourth segments 584, and in an initial state, the second gap 585 and the third gap 586 are V-shaped.

In one embodiment, the same elastic piece 521 is provided with a second opening 587 for releasing stress during deformation. Wherein the second opening 587 extends in the axial direction of the deformed segment and extends to the third segment 583 and the fourth segment 584 by equal distances. The second opening 587 is, with respect to itself, gradually folded in a V-shape toward both axial ends.

The proximal end of the fourth segment 584 is provided with a connector 588 for connection with the main body segment, the connector 588 being shown as a T-shaped structure. Reference is also made to the previous embodiments in which the proximal end of the fourth segment 584 is connected to the main body segment, i.e. the deformation segment is integrally formed with the main body segment.

The second aperture 587 has two ends that overlap the second gap 585 and the third gap 586, respectively, in axial position such that the third segment 583 and the fourth segment 584 have two first deformation strips 591 and two second deformation strips 592, respectively, in a V-shaped arrangement. When flared, the first deformation strip 591 and the second deformation strip 592 are circumferentially spaced apart from one another.

In one embodiment, there is at least one elastic sheet having a different length than the remaining elastic sheets, or different lengths between the elastic sheets. Wherein the length of the elastic sheet is the length between two ends along the axial direction, and the proximal ends of the elastic sheet are positioned at the same axial position.

In a preferred embodiment, the elastic sheet comprises 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.

The embodiment has simple structure, stable mechanics and convenient manufacture and installation.

In one embodiment, as shown in fig. 25-27, the holder 720 is a hemostatic valve, which may be implemented by using the prior art. In another embodiment, the holder 720 has a mounting channel 721 communicating with the catheter sheath 70, and the proximal end of the holder 720 is provided with a fitting 750 connected to the mounting channel 721, the fitting 750 having:

A primary interface 751, the primary interface 751 being configured with a seal 752;

A branch port 753, and a check valve 754 is provided at the branch port 753. In one embodiment, the control handle 3 is provided with a bending driving mechanism 7, and the bending adjusting assembly comprises:

a bending sheath 43, the proximal end of which is fixed to the control handle 3;

one end of the bending member fixedly extends to the distal end part of the bending sheath tube 43 and acts on the catheter sheath, and the other end is controlled by the bending driving mechanism 37.

The distal end of the deflection member may be fixed to the distal end of the deflection sheath 43 or may be relatively movable. The deflection member may be a wire, a tube or a combination of wire and tube. For example, the bending adjusting piece is a bending adjusting wire fixed with the sheath tube, so that the bending adjusting sheath tube bends, or the bending adjusting piece comprises a bending adjusting pipe and a bending adjusting wire connected with the bending adjusting pipe, and the bending adjusting wire drives the bending adjusting pipe to drive the bending adjusting sheath tube to bend.

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

As shown in fig. 28 to 32, the bending driving mechanism includes:

a reel 371 rotatably mounted to a support body (see the embodiment described below) of the control handle 3, and a proximal end of the bending piece 56 is made of a flexible material and wound around the reel 371;

A knob 372 coupled to the reel 371;

The one-way engagement structure interacts with the reel 371 and/or the knob 372 and has opposite limit states and release states in which only one-way rotation of the reel 371 is allowed.

The amount of deflection is related to the amount of deflection of the deflection member 56, the deflection member 56 proximally being rotationally displaced to reduce the axial length of the control handle 3 and increase the amount of deflection. The one-way engagement structure is in a limited state when no force is applied by a person, thereby avoiding the error touching the knob and limiting the knob to rotate to maintain the orientation of the bending sheath 43.

The rotation axis of the reel 371 is perpendicular to the axial direction of the control handle, wherein the reel 371 has a first direction for bending when rotating and a second direction for resetting by the bending member 56, the unidirectional rotation direction is the first direction, and the unidirectional engagement structure can limit the rotation of the reel 371 in the second direction before being released.

In one embodiment, as shown in the figure, the one-way locking structure includes:

ratchet 3711, coaxially fixed to reel 371, for example in an integral structure;

A limiting member 374 movably mounted on the support 330 and having a pawl 3741 engaged with the ratchet;

an elastic member 375 acting on the stop member 374 to engage the pawl 3741 with the ratchet 3711;

the pulling button 376 is movably mounted on the supporting body 330 and cooperates with the limiting member 374 to drive the limiting member 374 to move so that the unidirectional engaging structure is in a limiting state or a releasing state.

The toggle 376 extends at least partially out of the support 330 to the control handle for manipulation by the operator.

As shown, the limiting member 374 is rotatably mounted on the support 330, and the limiting member 374 and the toggle 376 are integrally or separately fixed. During normal operation, toggle 376 is toggled to switch the one-way engagement structure to a release state, and after toggle 376 is released, the toggle is reset and switched to a limit state under the action of elastic piece 375.

If the stop 374 fails to return normally, such as if the elastic member 375 fails, the out of control condition may also be determined from the fact that the toggle 376 is released and cannot return to a free movement condition. At this time, the control knob 376 is required to directly act on the stopper 374 to control the state of the one-way engagement structure. As an emergency relief measure, the safety of the operation is improved.

In one embodiment, the inner shaft assembly comprises a first shaft 21, a second shaft 23 and a third shaft 25 which are sequentially sleeved in a sliding mode from inside to outside, wherein a locking piece 13 is linked at the distal end of the first shaft 21, a pull wire 11 is connected at the distal end of the second shaft 23, a base 10 is fixed at the distal end of the third shaft 25, the locking piece 13 is movably arranged on the base 10, a lock hole 105 matched with the locking piece 13 is arranged on the base 10, the pull wire 11 is bound to the base 10 by the locking piece 13 after passing through the artificial implant 60 from the second shaft 23, and the proximal ends of the second shaft 23 and the first shaft 21 are in sliding fit relative to the third shaft 25. The corresponding control method is referred to the following examples.

The present application also provides a delivery system comprising a catheter assembly distally loaded with an artificial implant, a control handle coupled to the proximal end of the catheter assembly for controlling the catheter assembly, and the catheter sheath 70 of the above-described embodiments. The catheter assembly may be threaded into the body of the catheter sheath via a hemostatic valve, and the specific construction of the catheter assembly and control handle may employ prior art techniques. Furthermore, the deformation section can assist in recovering the artificial implant after being switched to the expanded state, so that the structure of the catheter assembly can be further simplified. For example, the outermost tube member may be omitted relative to conventional catheter assemblies.

The catheter sheath length of the present application is capable of reaching a remote surgical site, such as with the length of the tube extending into the ascending aorta, creating a longer passageway for delivery of the catheter assembly as well as the artificial implant.

An embodiment of the present application also provides a method of controlling a delivery system for interventional delivery of the prosthetic implant of the previous embodiments, the delivery system further comprising the control mechanism of the previous embodiments, a control handle, and an inner shaft assembly connecting the control handle and the control mechanism, and a loading segment. The control method comprises the following steps:

expanding at least a portion of the arm portion to register the first gap with the native tissue;

driving the loading section to depart from the inner frame to expand the distal end part of the inner frame;

Expanding the proximal portion of the inner frame by releasing the portion of the pull wire exposed to the base to deform the inner frame as a whole to a desired extent and maintaining control of the pull wire over the inner frame throughout the process;

Moving the loading segment proximally into the blood flow path;

and (5) the connection between the pull wire and the inner frame is released.

After the artificial implant is delivered to the predetermined location in the body, the loading segment or the catheter sheath or its internal structure is driven distally to move the two axially in opposite directions (depending on the different arrangement of the arms) until at least a portion of the arms are unbound and expanded, the distal end of the inner frame remains bound by the loading segment, and the first gap is registered with the native tissue. The present embodiment will be described with reference to the drawings by taking an example of a scheme in which an arm portion is provided between a loading section and a catheter sheath:

the catheter sheath is driven to move towards the proximal end or the internal structure of the catheter sheath is driven to move towards the distal end, the restraint of the catheter sheath to the arm part is relieved, and the arm part expands outwards in the radial direction.

The first shaft is then advanced distally to un-tie the loading segment to the artificial implant, i.e., the distal end of the inner frame is radially expanded out of tie, and the proximal end of the inner frame is then ready for expansion.

The third shaft is kept still, the second shaft is pushed to the distal end, the control end of the stay wire is moved to the distal end, the portion of the stay wire exposed out of the base is gradually elongated, the artificial implant (mainly the proximal end portion) is allowed to be gradually expanded, the stay wire located out of the base is gradually elongated along the arrow direction, the control end continues to move, the artificial implant is in an expanded state (namely the expected amplitude), and the stay wire can be released after confirming that the artificial implant is in accordance with expected fit with peripheral tissues.

When the pull wires are released, the first shaft moves proximally until the loading section enters the blood flow channel and is combined with the locking piece through the linkage assembly, the first shaft is rotated to drive the locking piece to rotate relative to the base, and all the pull wires are sequentially released until all the free ends are completely separated from the locking piece.

The second shaft is then retracted proximally, causing the control end of each pull wire to move proximally, causing the free end to disengage from the corresponding eyelet, i.e., completely from the artificial implant, which may also be understood as releasing the artificial implant.

The delivery system is withdrawn entirely outside the body.

In the process of retracting the loading section into the blood flow channel, the stay wire is still in the first state so as to keep the components of the control mechanism and the artificial implant in a relatively fixed space posture, the loading section is guided to retract smoothly into the blood flow channel, and the safety risk of the loading section hanging on the far end of the artificial implant during retraction is reduced or eliminated.

In addition, before the pull wire is unlocked, a retrieval operation may be performed as needed, which generally requires the incorporation of other components, such as the catheter sheath of the foregoing embodiments, with the particular operation being to drive the control end of the pull wire proximally while the pull wire is in the first state, to retract the proximal end of the artificial implant by the pull wire, and then to move the remaining components within the catheter sheath proximally back into the catheter sheath, or to push the catheter sheath distally to receive the artificial implant, as needed.

In the initial stage of recovery, a certain gap exists between the distal end of the catheter sheath and the proximal end of the artificial implant or the catheter sheath and the proximal end of the artificial implant are in a mutually abutted state, and in the state, a large acting force exists between the catheter sheath and the artificial implant, and the acting force is fed back to the control handle so that an operator can feel obvious operation damping force. In this state, the artificial implant is recovered with reference to the use of the telescopic assembly and the ejector driving mechanism of the following embodiments.

If a certain gap exists between the distal end of the catheter sheath and the proximal end of the artificial implant, the telescopic component can be directly driven to enable the catheter sheath to move distally to quickly eliminate the gap, or the following method can be adopted to drive the inner shaft component to move proximally to eliminate the gap, or the two methods are combined to eliminate the gap until an operator obviously senses an operation damping force, so that mutual abutting action of the catheter sheath and the artificial implant is proved.

It should be noted that the position of the shaft in the drawing is not limited, and the control end may be long or short or the wire may be directly connected to the control handle for receiving and releasing. For the control of the stay wire, the control end of the stay wire can also extend and be directly controlled by the control handle.

The control handle may be a conventional control handle, and the present application provides another control handle, as shown in fig. 34-37, where the control handle has opposite 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 ejection mechanism, and the ejection mechanism includes a retraction assembly 38 and an ejection driving mechanism 39, the distal end of the retraction assembly 38 is provided with an abutment 384, the proximal end is movably connected to the control handle 3 in the axial direction, and the ejection driving mechanism 39 is mounted on the control handle 3 and is linked with the proximal end of the retraction assembly 38.

The telescoping assembly 38 is used to adjust the distance of the abutment 384 from the catheter sheath of the previous embodiment and can maintain the abutment in either position. The telescoping assembly 38 may maintain a distance between the abutment 384 and the catheter sheath, facilitating the interventional delivery procedure. Upon retrieval of the artificial implant, the abutment 384 is driven distally until it abuts the proximal end of the catheter sheath, and the inner shaft assembly is then driven proximally relative to the catheter sheath 70 until the artificial implant is retrieved into the catheter sheath 70;

or the final stage 383 is acted upon by the ejector drive mechanism 39 to drive the telescoping assembly 38 distally further and to drive the catheter sheath distally relative to the inner shaft assembly until the prosthetic implant is retrieved into the catheter sheath 70.

Or the artificial implant recovery operation can only be completed in a certain area in the body, so that the telescopic component 38 is firstly extended to the area, and the distal end of the catheter sheath 70 is close to the control mechanism, so that the distance between the catheter sheath and the artificial implant is reduced, the inner shaft component is then retracted until the artificial implant is also positioned in the area, and finally the push-push driving mechanism 39 is used for completing the recovery of the artificial implant according to the operation. The telescopic assembly is propped against the proximal end of the catheter sheath by operating the pushing mechanism at the distal end of the control handle, so that the supporting force during recovery is provided, the stability and the accuracy of the relative position of the current catheter sheath and other structures and subsequent adjustment are ensured, and the operation convenience and the safety are convenient to recover and improve.

Wherein the telescoping assembly 38 is rapidly movable to eliminate the distance between the abutment 384 and the catheter sheath, which is a rough adjustment. The push drive mechanism 39 can control and precisely adjust the axial movement distance of the telescoping assembly 38, which is a fine adjustment.

In one embodiment, retraction assembly 38 has one or more stages arranged in sequence from distal to proximal, with abutment 384 at the distal end of first stage 381 and with ejector drive mechanism 39 at the proximal end of last stage 383.

35-41, In one embodiment, each stage of the telescopic assembly 38 is a cylindrical structure and is movably inserted in sequence. The axial space is saved while the adjustment distance is ensured, and the axial size of the control handle is reduced. One of the adjacent stages is an outer barrel and the other is an inner barrel, which moves distally relative to the outer barrel as the retraction assembly 38 is extended. Conversely, as the retraction assembly 38 shortens, the inner barrel moves proximally relative to the outer barrel. And telescoping assembly 38 has a first limit of maximum length and a second limit of minimum length. Wherein retraction assembly 38 includes a top end 381, an intermediate end 382, and a final end 383 from inside to outside.

In one embodiment, a cooperating backstop structure is provided between adjacent stages. At least the inner cylinder is limited to move towards the proximal end relative to the outer cylinder, and the limit of the stop structure is required to be released during operation, and the stop mechanism can be limited or only provide a certain resistance to the movement of the inner cylinder towards the distal end relative to the outer cylinder, for example, the limit of the stop mechanism can be released under the action of manually applied external force.

Wherein, the stopping structure includes:

A rack 3862 disposed outside the inner tube in a telescoping direction;

An operation button 387 mounted on the outer cylinder in a swinging manner, wherein the operation button 387 is provided with an operation part 3871 and an engagement part 3872 at two sides of a swinging axis of the operation button 387, the engagement part 3872 is engaged with the rack 3862 to limit the movement between the adjacent stages, and the operation part 3871 is exposed to the outer cylinder for releasing the engagement of the engagement part 3872 with the rack 3862;

The elastic member 388 acts on the operation knob 387 to drive the engagement portion 3872 to maintain engagement with the rack 3862.

Pressing the operating portion 3871 releases the restriction of the retaining structure (i.e., unlocking), and after release, the operating knob 387 is reset by the elastic member 388 and engaged with (i.e., locked with) the rack 3862. The elastic member 388 abuts between the inner wall of the outer cylinder and the radially outer side of the engagement portion 3872. The engagement portion 3872 has a self-locking surface 3873 which cooperates with the rack 3862, and the self-locking surface 3873 faces the distal end side and is substantially perpendicular to the outer cylinder axial direction. Wherein the first and intermediate stages 381, 382 are provided with racks, the intermediate and final stages 382, 383 are provided with an operating knob 387 and an elastic member 388, and the elastic member 388 is a spring.

In a preferred embodiment, the operating buttons 387 are symmetrically arranged in two, and the two are moved towards each other to perform unlocking and locking operations. The corresponding racks 3862 are two in corresponding arrangement, and the locking effect is better.

In one embodiment, the tips of the racks 3862 are inclined toward the proximal side and the tooth surface drive engagement portion 3872 toward the proximal side is self-locking. The backstop structure is therefore merely a one-way snap-fit structure, allowing the operator to quickly operate extension of retraction assembly 38 without unlocking the backstop structure. When the inner cylinder is extended to the first limit position, the inner cylinder is limited by the outer cylinder and the extension is stopped. Specifically, the proximal end of the inner cylinder is provided with an elastic buckle 3863, the inner cavity of the outer cylinder is provided with a blocking part 3851 which abuts against the elastic buckle 3863 to limit the inner cylinder from falling out, and when the inner cylinder is assembled, the elastic buckle 3863 deforms to allow the inner cylinder to be inserted into the outer cylinder and extend to a first limit position, and the blocking part 3851 abuts against the elastic buckle 3863.

In one embodiment, the elastic buckle 3863 is disposed at the proximal end of the inner cylinder, and the blocking portion 3851 is disposed at the distal end of the outer cylinder. The blocking portion 3851 is the inner lumen wall of the outer barrel.

In one embodiment, a sliding guide structure is disposed between the inner and outer cylinders, and specifically includes an axially extending guide slot 3852 disposed in one of the guide slots, and a guide bar 3864 engaged with the guide slot 3852. In one embodiment, the proximal end of the guide bar is provided with an elastic buckle 3863, and the bottom wall of the distal slot of the guide slot is a blocking portion 3851.

In one embodiment, the distal end of each inner barrel has an enlarged diameter portion 3861 exposed at a second limit to the distal end of an adjacent outer barrel, which the operator can grasp to rapidly move the corresponding stage distally. At the second limit, the inner cylinder abuts against the distal end of the adjacent outer cylinder through its own enlarged diameter portion 3861. The abutting piece 384 serves as the diameter-enlarged portion 3861 of the first stage (i.e., the inner tube). The distal end of the final stage (i.e., the outer barrel) has an enlarged diameter portion 3861 exposed at a second limit to the distal end of the control handle. The operation knob 387 and the elastic member 388 are attached to the enlarged diameter portion 3861.

In one embodiment, the ejector drive mechanism includes:

an external thread segment 3831 located on the outer periphery of the final stage 383;

the first driving sleeve 351 is rotatably mounted to the control handle 3 and has an internally threaded section which engages with the externally threaded section.

In one embodiment, a method for controlling the retrieval of an artificial implant is provided, comprising:

Providing an artificial implant and a delivery system for delivering the artificial implant, the delivery system comprising:

the catheter sheath is used for constructing an interventional channel, and the proximal end of the catheter sheath is provided with a fixed seat;

an inner shaft assembly having a loading section at a distal end thereof, the loading section being at least partially positioned and releasably connectable to the inner shaft assembly prior to expansion of the artificial implant;

The control handle is connected with the proximal end of the inner shaft assembly, is positioned at the proximal end side of the fixed seat, and the distance between the distal end of the control handle and the fixed seat can be adjusted;

the prosthetic implant remains at least partially connected to the inner shaft assembly and, upon retrieval, the catheter sheath is driven into relative movement with the inner shaft assembly to allow the prosthetic implant to be received within the catheter sheath.

The proximal and distal ends of the present embodiment are not strictly limited to the mounting positions, and may be azimuth indicators.

The relative movement of the sheath and the inner shaft assembly may be such that the sheath moves distally, or the inner shaft assembly moves proximally and the sheath moves distally until the distal end of the sheath approaches or contacts the artificial implant, eliminating the aforementioned gap, waiting for the next procedure.

The method for eliminating the gap can adopt the ejection mechanism, and when the device is recovered, the ejection mechanism or other components can be propped against the proximal end of the fixed seat to provide enough force transmission, so that the recovery operation is facilitated. Wherein the artificial implant, catheter sheath, inner shaft assembly and control handle are referenced to the structure of the previous embodiments. Specifically, in one embodiment, the distal end of the catheter sheath approaches or contacts the artificial implant, the pushing mechanism is driven to abut against the fixed seat, the telescopic assembly is firstly adopted to extend distally until the first stage abuts against the fixed seat, and the pushing driving mechanism is controlled to drive the telescopic assembly to integrally move distally and act on the catheter sheath through the fixed seat to move distally until the recovery of the artificial implant is completed.

Expansion of at least a portion of the prosthetic implant relative to the inner shaft assembly is understood to mean deformation expansion or expansion after the distal side has been removed from the loading segment or catheter sheath, etc.

In one embodiment, the artificial implant is connected to the inner shaft assembly by a pull wire, and when the artificial implant is recovered, the pull wire is kept in a tightened state to gather the proximal side of the artificial implant, so that the proximal end of the artificial implant smoothly enters the catheter sheath when the artificial implant is recovered. Before the artificial implant is recovered, the shape of the artificial implant may be in an expanded state, and the pull wire is required to be tightened to gather the proximal side of the artificial implant. Wherein, when the artificial implant is recovered, the proximal end of the arm of the artificial implant is advanced into the catheter sheath, and the distal end of the arm is adapted to enter the catheter sheath along with the movement of the catheter sheath relative to the artificial implant.

The length of the catheter sheath in the delivery system is capable of reaching a remote surgical site, e.g., the length of the tube extends to the root of the aortic arch, facilitating delivery of the delivery system and other interventional instruments. And the deformation section is favorable for recovering the artificial implant after being switched to the expansion state. When in recovery, the distal end of the control handle is propped against the proximal end of the catheter sheath, so that the supporting force during recovery is provided, and the recovery is convenient.

It should be noted that the methods of the present application may be used for interventional procedures as well as in vitro simulation training.

The technical features of the above embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description. When technical features of different embodiments are embodied in the same drawing, the drawing can be regarded as a combination of the embodiments concerned also being disclosed at the same time.

The foregoing examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the claims. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application.

Claims (18)

1. A delivery system for an artificial implant, comprising:

A catheter sheath for constructing an interventional channel, the proximal end of the catheter sheath having a fixed seat;

A bending component, the distal end of which can change the direction in a controlled way, and the bending component extends to the proximal end further through the fixing seat in a sliding way;

an inner shaft assembly having a distal end with a loading segment for attachment of a prosthetic implant, the loading segment being always exposed at a distal end of the bending assembly;

The control handle is connected with the bending adjusting assembly and the proximal end of the inner shaft assembly, and is positioned at the proximal end side of the fixing seat and is adjustable in distance with the fixing seat.

2. The delivery system of an artificial implant of claim 1 wherein the catheter sheath has opposite distal and proximal ends and comprises a tube comprising:

the main body section, the said fixing base is connected to the proximal end of the said main body section, there is structural reinforcement in the tube wall of the said main body section at least near the distal end, the said reinforcement adopts the metal tube with hollowed-out structure;

The deformation section is located the distal end of main part section, the deformation section includes a plurality of elastic pieces of following body circumference interval arrangement, the proximal end of each elastic piece with the tubular metal resonator links to each other, and each elastic piece has relative initial state and expansion state under the expansion state, the distal end of each elastic piece is kept away from relatively just the deformation section is flaring structure on the whole.

3. The delivery system of an artificial implant of claim 2, wherein the length of the tube is at least 60cm.

4. A delivery system for an artificial implant according to claim 3, wherein the length of the tube body ranges from 60 to 90cm.

5. The prosthetic implant delivery system of claim 2, wherein the distal end portion of the tube has a pre-molded shape that matches the arcuate shape of the aorta.

6. The delivery system for an artificial implant of claim 2, wherein the metal tube is a memory alloy.

7. The delivery system of an artificial implant of claim 2, wherein two adjacent elastic sheets are connected by a connector.

8. The artificial implant delivery system of claim 7, wherein the connector is connected at both ends to the respective side elastic pieces, respectively, with the connection points being adjacent to distal ends of the elastic pieces;

In the initial state, the middle part of each elastic sheet is folded and accommodated in the interval area of the adjacent elastic sheets;

In the expanded state, the middle parts of the connecting pieces are relatively unfolded.

9. The artificial implant delivery system of claim 7, wherein two connectors are connected between adjacent ones of the elastic sheets, including a first connector and a second connector disposed in an axial direction.

10. The prosthetic implant delivery system of claim 9, wherein the first connector is coupled to an axially distal end of the flexible sheet and the second connector is coupled to an axially central portion of the flexible sheet.

11. The prosthetic implant delivery system of claim 10, wherein the first and second connectors are V-shaped structures and have first and second openings, respectively, the first and second openings facing away from each other.

12. The prosthetic implant delivery system of claim 11, wherein the first connector has a proximally extending protrusion on each side of the middle portion and wherein the apex of the second connector is located within both of the protrusions.

13. The delivery system of an artificial implant according to claim 1, wherein the holder has a mounting channel in communication with the catheter sheath, the proximal end of the holder being provided with a tube connector connected to the mounting channel, the tube connector having:

a primary interface at which a seal is disposed;

and a branch interface, wherein a one-way valve is arranged at the branch interface.

14. The delivery system of an artificial implant of claim 1, wherein the holder is a hemostatic valve.

15. The prosthetic implant delivery system of claim 1, wherein the control handle has a bend-adjusting drive mechanism mounted thereon, the bend-adjusting assembly comprising:

the proximal end of the bending regulating sheath tube is fixed on the control handle;

One end of the bending adjusting piece is fixedly extended to the distal end part of the bending adjusting sheath tube and acts on the sheath tube, and the other end of the bending adjusting piece is controlled by the bending adjusting driving mechanism.

16. The prosthetic implant delivery system of claim 1, wherein the inner shaft assembly comprises a first shaft, a second shaft, and a third shaft slidably nested in sequence from inside to outside, wherein:

A lock is linked at the distal end of the first shaft;

the distal end of the second shaft is connected with a stay wire;

The far end of the third shaft is fixedly provided with a base, the lock piece is movably arranged on the base, and the base is provided with a lock hole matched with the lock piece;

The pull wire is bound to the base by the lock after passing around the artificial implant from the second shaft, and the second shaft and the first shaft are in sliding fit relative to the third shaft.

17. A method for controlling the retraction of an artificial implant, comprising:

Providing an artificial implant and a delivery system for delivering the artificial implant, the delivery system comprising:

The catheter sheath is used for constructing an interventional channel, and the proximal end of the catheter sheath is provided with a fixed seat;

An inner shaft assembly having a loading section at a distal end thereof, the artificial implant being at least partially disposed in the loading section and releasably coupled to the inner shaft assembly prior to expansion;

the control handle is connected with the proximal end of the inner shaft assembly, the control handle is positioned at the proximal end side of the fixed seat, and the distal end of the control handle is provided with an ejection mechanism with adjustable distance between the control handle and the proximal end of the fixed seat;

The prosthetic implant remains at least partially connected to the inner shaft assembly and, upon retrieval, the catheter sheath is driven into relative movement with the inner shaft assembly such that the prosthetic implant is received within the catheter sheath.

18. The retrieval control method of claim 17, wherein the distal end of the introducer sheath is brought into proximity with or contact with the prosthetic implant, the ejector mechanism is driven against the anchor seat, and is further ejected distally until the prosthetic implant is received within the introducer sheath.