CN118845303A - Control mechanism, delivery system and control method of artificial implant - Google Patents

Abstract

The invention discloses a control mechanism, a conveying system and a control method of an artificial implant, wherein the control mechanism comprises a base, a stay wire and a locking piece, and the base is provided with a locking area; the pull wire has a free end that can be passed through or out of the artificial implant; the locking element is in rotary fit with the base and is provided with a positioning part which enters or moves out of the locking area in the rotation process, and the positioning part is matched with the free end of the stay wire to limit the artificial implant. The locking piece in the control mechanism rotates to unlock the stay wire, so that the device is more suitable for an internal narrow environment compared with the existing structure.

Description

Control mechanism, delivery system and control method of artificial implant

Technical Field

The present application relates to the field of medical device technology, and in particular to a control mechanism, a delivery system and a control method of an artificial implant.

Background Art

With the development of medical conditions, artificial implants have been used to treat heart valve disorders. Common treatment methods generally include repairing or replacing the valve through surgery, or using a flexible catheter to intervene and implant an artificial implant.

In interventional technology, a compressed, loaded artificial implant is installed in the distal portion of a catheter assembly and delivered to a predetermined location, and the catheter assembly is withdrawn from the body after the artificial implant is radially expanded and released.

Regarding the connection between the artificial implant and the catheter assembly, the prior art can adopt a direct snap-fit or wire control method. The wire control method utilizes a flexible member to restrain the artificial implant to the distal end of the catheter assembly and lock the flexible member to maintain the compression state of the artificial implant. When it is necessary to allow the artificial implant to be released, the lock on the flexible member is released, and the flexible member is then loosened until it is separated from the artificial implant to complete the release of the artificial implant. However, the existing locking method for the flexible member still needs to be improved.

Summary of the invention

The present application provides a control mechanism for an artificial implant, which makes the control of the flexible member (including locking and unlocking) more reasonable.

The present application provides a control mechanism for an artificial implant, comprising:

Pedestal;

A pull wire having a free end that can pass through or be removed from the artificial implant;

A locking piece is movably matched with the base, and the locking piece cooperates with the free end of the pull wire to restrict the artificial implant.

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

The present application also provides a control mechanism for an artificial implant, comprising:

a base having a locking area;

A pull wire having a free end that can pass through or be removed from the artificial implant;

A locking member is rotationally matched with the base, and the locking member has a positioning portion that enters or moves out of the locking area during rotation, and the positioning portion cooperates with the free end of the pull wire to limit the artificial implant.

Optionally, the pull wire has a control end opposite to the free end, and the control end can move relative to the base. When the free end is in a first state, the length of the pull wire exposed outside the base is adjusted by operating the control end. When the free end is in a second state, the pull wire is pulled away from the artificial implant by the control end.

Optionally, there are multiple pull wires, the free ends of the pull wires move independently of each other, and the control ends of the pull wires move synchronously.

Optionally, the control mechanism further includes a second shaft, and the control ends of each pull wire are connected to the second shaft.

Optionally, there are multiple locking areas, and the free end of each pull wire corresponds to one of the locking areas in the first state.

Optionally, the free end has a wire loop, and when the free end is in a first state, the positioning portion penetrates into the wire loop, and when the free end is in a second state, the positioning portion pulls out the wire loop.

Optionally, the wire loop is independently configured or formed by winding the pull wire itself.

The present application also provides a control mechanism for an artificial implant, comprising:

a base having a locking area;

A pull wire having a free end that can pass through or be removed from the artificial implant;

A locking member, rotatably matched with the base, the locking member having a positioning portion that enters or moves out of the locking area during rotation, the positioning portion cooperating with the free end of the pull wire to restrict the artificial implant;

The artificial implant has an axial direction in space, one end of which is a wire-controlled end, and the wire-controlled end has an eyelet for the pull wire to pass through. The artificial implant has a relative degree of deformation according to itself:

In the retracted state, the wire control end is radially retracted close to the base;

In an expanded state, the wire control end radially expands away from the base;

The round trip paths of the same pull wire passing through the artificial implant do not overlap.

Optionally, the free end of the pull wire has a first state in which it is restricted to the base and a second state in which the restriction is released, and when the locking element is released from engagement with the free end of the pull wire, the restriction on the artificial implant is released.

Optionally, when the artificial implant is in the contracted state and the expanded state, the free end of the pull wire is in the first state.

Optionally, the artificial implant has a plurality of holes isolated from each other, and in the expanded state, the same pull wire passes through at least two holes.

Optionally, the number of the holes is twice the number of the pull wires, and in the expanded state, the same pull wire corresponds to two holes.

Optionally, the round trip path of the same pull wire through the artificial implant roughly forms a triangle.

Optionally, in the first state, the pull wire extends out of the base through the current locking area, passes through the free end sleeve of the artificial implant and returns to the same locking area.

Optionally, the positioning portion is in a spiral shape with multiple turns, and there is an axial gap between adjacent turns; in the first state, the pull wire extends out of the base through the current axial gap, and the free end after winding around the artificial implant is sleeved to a turn adjacent to the current axial gap.

The base has a distal end and a proximal end opposite to each other, and an axial direction extending between the distal end and the proximal end, the interior of the base has a first cavity, the proximal side of the base has a first opening communicating with the first cavity, and the outer peripheral surface of the base has a second opening communicating with the first cavity;

The pull wire is passed through the first cavity, one end of the pull wire extends proximally out of the base through the first opening, and the other end of the pull wire, ie, the free end, extends out of the base through the second opening to connect to the artificial implant.

Optionally, the locking area is located at the second opening portion.

Optionally, a plurality of locking areas are arranged at intervals along the circumference of the base, and the positioning portion enters or moves out of each locking area in sequence as the locking element moves.

Optionally, the locking element and the base are rotatably matched to drive the positioning portion to enter or move out of each locking area in sequence.

Optionally, a plurality of the second openings are arranged at intervals along the circumference of the base, and ribs are provided between adjacent second openings.

Optionally, in the first state, the free end extends out of the base through the corresponding second opening, passes around the artificial implant, and then returns to the locking area corresponding to the same second opening, or returns to the locking area corresponding to an adjacent second opening.

Optionally, all ribs converge and are fixed to each other at the distal end of the base.

Optionally, all ribs converge to form a ring-shaped structure.

Optionally, the base is provided with a lock hole for the positioning portion to be inserted.

Optionally, the opening of the lock hole is oriented in the circumferential direction of the base.

Optionally, the locking hole is provided on at least one rib.

Optionally, the free end of the pull wire is located in the current locking area in the first state, and the two ends of the positioning portion located in the current locking area are respectively inserted into the locking holes on the corresponding sides.

Optionally, when the positioning portion moves along the first direction, the free end switches from the second state to the first state, the locking hole penetrates the rib along the first direction, and the locking hole has a relative forward opening and a rear opening, wherein the forward opening faces the first direction.

Optionally, there are multiple ribs with locking holes, and the positioning portion as a whole has a relative end and a head end, and the head end is inserted into or separated from each locking hole in sequence as the locking element rotates.

Optionally, all ribs are provided with locking holes.

Optionally, one section of the rib along the axial direction is a bent section extending radially inward, and the locking hole is located at the bent section corresponding to the rib.

Optionally, there are one or more locking holes on the same rib.

Optionally, the plurality of locking holes are arranged in sequence along the extension direction of the ribs.

Optionally, the side of the rib facing the first cavity is the inner side, and the inner side of each rib is respectively provided with a guide groove for the positioning portion to extend.

Optionally, the positioning portion has a curved shape and extends around the axis of the base, and the positioning portion is inserted into or disengaged from the locking hole as the locking element rotates.

Optionally, at least a portion of the locking element is a connecting portion located in the first cavity, and the control mechanism further includes a first shaft in transmission cooperation with the connecting portion to drive the locking element to rotate relative to the base.

Optionally, the pull wire has a control end opposite to the free end, and the control end can move relative to the base. The control mechanism also includes a second shaft connected to the control end, and the second shaft is tubular and movably sleeved outside the first shaft.

Optionally, the positioning portion includes at least one arc-shaped structure that cooperates with the base.

Optionally, the positioning portion is a spiral structure.

Optionally, the spiral structure is coiled at least once.

Optionally, the spiral structure is a multi-turn structure, and the turns are arranged along the axial direction.

Optionally, along the winding direction of the spiral structure, the positioning portion as a whole has an opposite end and a head end, and a portion where one end is located is fixed to the connecting portion.

Optionally, the location where the end of the positioning portion is located is fixed to the connecting portion.

Optionally, the connecting portion is tubular, and the location where the end of the positioning portion is located is wrapped around and fixed to the outer circumference or distal end of the connecting portion.

Optionally, the connecting portion is fixed to the distal end of the first shaft, or is axially separable from the distal end of the first shaft.

Optionally, the positioning portion is a multi-turn spiral structure with an axial gap between adjacent turns. The spiral structure surrounds an internal space. At least one section of the pull wire is a detour section. In the first state, the detour section is in the internal space. Both ends of the detour section extend outside the internal space via corresponding axial gaps.

Optionally, in the first state, the pull wire extends from the control end to the distal end to the outside of the positioning portion, bends to the inside of the positioning portion through the second axial gap, and then extends from the second axial gap to the first axial gap at the distal end and passes through the first axial gap from the inside to the outside and bends to the outside of the positioning portion. After passing through the artificial implant, the free end is sleeved on the positioning portion.

Optionally, the free end is sleeved onto a circle of the positioning portion adjacent to the first axial gap or the second axial gap.

The present application also provides a control mechanism, which has a distal end and a proximal end opposite to each other and an axial direction extending between the proximal end and the distal end, and the control mechanism comprises:

An intervening component, comprising a first intervening component and a second intervening component;

a transmission component, a distal end of which is fixedly connected to the first intervention component;

A control handle connected to and controlling the proximal end of the transmission component;

The linkage structure comprises two selectively linked matching parts, one of which is fixed to the second intervening component and the other is fixed to the transmission component, and the linkage state of the two matching parts is switched during the movement of the transmission component.

Optionally, along the axial direction, the first intervention component is located on one side (which may be the distal end or the proximal end) of the second intervention component.

Optionally, the first intervening component and the second intervening component are partially nested relative to each other.

Optionally, the first intervening component and the second intervening component include the following independent components:

an inner shaft assembly for a prosthetic heart valve prior to load release;

a sheath, which encases the artificial heart valve before release;

A base, connected to the artificial heart valve before release and axially limited to each other;

A locking member, used for restricting the artificial heart valve to the base before release;

The pull wire is connected to the artificial heart valve to control the release process of the artificial heart valve.

Optionally, the control mechanism includes a balloon that loads and expands the artificial heart valve before release.

Optionally, when the transmission component rotates, the two matching parts enter or release a linkage state.

Optionally, when the transmission component slides axially, the two matching parts enter or release a linkage state.

Optionally, the two matching parts drive the second intervention component to perform rotational motion or linear motion in a linkage state.

Optionally, the two matching parts are a linkage key and a linkage groove that can be axially slidably separated, and the linkage key is rotationally linked with each other when inserted into the linkage groove.

Optionally, the two matching parts are a linkage key and a linkage groove that can be separated by relative rotation, and the linkage key is axially linked to each other when inserted into the linkage groove.

Optionally, there are multiple linkage keys, which are connected to each other through a tubular component, and the multiple linkage keys are arranged circumferentially along the tubular component.

Optionally, there are multiple linkage grooves, which are connected to each other through a tubular component, and the multiple linkage grooves are arranged circumferentially along the tubular component.

Optionally, the linkage key is arranged at the proximal end or the distal end of the connecting part.

Optionally, at least a portion of the locking element is a connecting portion, and the control mechanism further includes a transmission component that is in transmission cooperation with the connecting portion, so as to drive the locking element to rotate relative to the base;

The connecting portion is tubular, and the tube wall has a rotation linkage structure that cooperates with the distal end of the transmission component. When the transmission component moves axially relative to the connecting portion, the rotation linkage structure separates or cooperates.

Optionally, the connecting portion is located inside the base.

Optionally, the rotation linkage structure includes:

A linkage key, radially protruding from one of the connecting portion and the transmission component;

The linkage groove cooperates with the linkage key, is arranged on the other of the connecting part and the transmission component, and is located in an open form at the end surface of the other.

Optionally, local deformation of the tube wall of the connecting portion constitutes the linkage key.

Optionally, the tube wall of the connecting portion is partially concave to form the linkage key, and an escape zone is formed on the outer side of the linkage key.

Optionally, the tube wall of the connecting portion is provided with cutouts arranged in pairs adjacent to the proximal end surface, and the portion between the same pair of cutouts is radially folded inward to form the linkage key.

Optionally, there is at least one linkage key, for example, 2 to 4 linkage keys distributed along the circumferential direction.

Optionally, the positioning portion is a multi-turn spiral structure, the spiral structure surrounds an internal space, at least one section of the pull wire is passed through the internal space, and the outer periphery of the connecting portion has a radial concave avoidance area corresponding to the position of the detour section.

Optionally, the transmission component is a first shaft of a tubular structure, and the linkage groove is opened on the tube wall at the distal end of the transmission component.

Optionally, the slot opening of the linkage slot has a flared structure.

The present application also provides a control mechanism having a distal end and a proximal end relative to each other, the control mechanism comprising:

At least three shafts, including a first shaft, a second shaft and a third shaft which are slidably sleeved in sequence from the inside to the outside;

a base connected to the distal end of the third shaft;

A pull wire connected to the distal end of the second shaft, the pull wire having a free end that can pass through or be separated from the artificial implant;

A locking element is connected to the distal end of the first shaft, the locking element is movably matched with the base, and the locking element is matched with the free end of the pull wire to restrict the artificial implant.

The present application also provides a delivery system, comprising a control handle and the aforementioned control mechanism, wherein the proximal ends of the three shafts are respectively connected to and controlled by the control handle.

The present application also provides an artificial implant control method implemented based on a wire control method, comprising:

Providing the aforementioned control mechanism, in which the free end of the pull wire passes through the artificial implant and is bound to the base by the locking element;

The pull wire has a control end opposite to the free end, and when the artificial implant is released, the control end is moved to gradually extend the portion of the pull wire exposed outside the base and allow the artificial implant to deform radially;

When the artificial implant is deformed to a desired extent, the cooperation between the locking element and the base is released and the free end is released;

The control end is moved to pull the free end away from the artificial implant.

The control mechanisms of the present application can cooperate with each other to realize the control of the release or recovery process of the artificial implant in the body, and the structure is further optimized and improved.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1a is a schematic diagram of a control structure restricting an artificial implant according to an embodiment of the present application;

FIG1b is a schematic diagram of the free end of the pull wire in FIG1a being released from restriction;

FIG2a is a schematic diagram of a control structure restricting an artificial implant according to an embodiment of the present application;

FIG2b is a schematic diagram of the free end of the pull wire in FIG2a being released from restriction;

FIG3a is a schematic diagram of a control structure restricting an artificial implant in the prior art;

FIG3b is a schematic diagram of the free end of the pull wire in FIG3a being released from restriction;

FIG4 is a schematic diagram of a control structure with three pull wires in one embodiment of the present application;

FIG5 is a schematic diagram of each pull wire connected to the second shaft in a control structure of an embodiment of the present application;

6a and 6b are schematic structural diagrams of the free end of the pull wire according to an embodiment of the present application;

FIG7 is a schematic structural diagram of an artificial implant according to an embodiment of the present application;

8a to 8c are schematic diagrams of the artificial implant of the present application with the wire-controlled end being folded;

Fig. 9a and Fig. 9b are schematic diagrams of the artificial implant of the present application during threading and folding;

FIG10 is a three-dimensional diagram of the insertion of each pull wire between the artificial implant and the control mechanism of the present application;

FIG11a is a schematic diagram of threading of an artificial implant in the prior art;

FIG. 11 b is a folding route diagram of an artificial implant in the prior art;

FIG11c is a schematic diagram of the artificial implant in FIG11b after being collapsed;

FIG12 is a folding route diagram of the artificial implant of the present application;

13a and 13b are schematic diagrams of the structure of the lock member entering and exiting the lock hole in the control mechanism of the present application;

FIG14 is a schematic diagram of the structure of the base in the control mechanism of the present application;

FIG15 is a half-section schematic diagram of the base portion of the control mechanism of the present application;

16a and 16b are three-dimensional schematic diagrams of the lock element in the control mechanism of the present application being inserted into and removed from the lock hole;

17a to 17c are schematic diagrams showing the locking element in the control mechanism of the present application passing through each pull wire in sequence;

18a and 18b are schematic diagrams of the structure of the lock member entering and exiting the lock hole in the control mechanism of the present application;

18c to 18e are schematic diagrams of the structure of the control mechanism of the present application where the lock element passes through each lock hole in sequence;

FIG19 is a schematic diagram of the structure of the lock and the base in the control mechanism of the present application;

FIG20a is a schematic diagram of the process of inserting a lock element into a lock hole in the control mechanism of the present application;

FIG20b is a schematic diagram of a partial structure of a base in the control mechanism of the present application;

FIG21 is a half-section schematic diagram of the wire control end of the base portion of the control mechanism of the present application;

Figures 22a and 22b are schematic diagrams of the lock structure in the control mechanism of the present application;

FIG23 is a schematic diagram of the path of the pull wire passing through the lock element in the control mechanism of the present application;

24a and 24b are schematic diagrams of the linkage of a control mechanism according to an embodiment of the present application;

25a and 25b are schematic diagrams of linkage of a control mechanism according to another embodiment of the present application;

FIG26 is a schematic structural diagram of a connecting portion of a lock member in a control mechanism of the present application;

FIG27 is a schematic diagram of a portion of the structure at the distal end of the first axis in the control mechanism of the present application;

28a-28b are half-section schematic diagrams showing the separation and combination of the first shaft and the connecting part in the control mechanism of the present application;

FIG29 is a schematic diagram of the first shaft and the connecting part in the control mechanism of the present application rotating after being combined;

FIG30 is a cross-sectional view of the base of the control mechanism of the present application;

31a to 31c are schematic diagrams of releasing the artificial implant in the control mechanism of the present application so that the proximal end gradually expands;

31d to 31g are schematic diagrams of the pull wires in the control mechanism of the present application being released from restriction one by one;

Figures 31h and 31i are schematic diagrams of the pull wire being recovered and withdrawn from the body in the control mechanism of the present application;

The reference numerals in the figures are described as follows:

10. base; 101. locking area; 101a. locking area; 101b. locking area; 103. first cavity; 105. locking hole; 105a. locking hole; 105b. locking hole; 105c. locking hole; 105d. locking hole; 105e. locking hole; 105f. locking hole; 1031. first opening; 1032. annular structure; 1033. second opening; 1034. side wall; 1035. rib; 1035a. rib; 1035b. rib; 1037. bending section; 1039. guide groove;

11, pull wire; 111, free end; 112, forward section; 113, control end; 114, return section; 115, wire loop; 117, detour section; 11a, pull wire; 11b, pull wire; 11c, pull wire; 111a, free end; 111b, free end; 111c, free end;

13, lock; 131, positioning part; 135, connecting part; 1311, end; 1313, head end; 1315, axial gap; 1315a, second axial gap; 1315b, first axial gap; 1317, internal space; 1351, linkage key; 1353, avoidance area; 1355, incision;

2. catheter assembly; 21. first axis; 22. transmission component; 23. second axis; 24. intervention component; 25. third axis; 28. bending adjustment member; 211. linkage groove; 213. flaring structure; 214. first section; 215. transmission sleeve; 216. second section; 217. reinforcement tube; 241. first intervention component; 242. second intervention component; 271. matching part; 2111. limiting part; 2151. slide groove;

301, distal end; 302, proximal end;

40, pipe fitting; 41, inner shaft assembly; 411, second loading section; 413, movable shaft; 415, control unit; 43, sheath; 431, first loading section; 4151, limit block; 45, wire control assembly;

60. artificial implant; 61. inner frame; 63. arm; 601. wire control end; 603. eyelet; 605. connecting ear.

DETAILED DESCRIPTION

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

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

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

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

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

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

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

Depending on the different release modes, the corresponding materials are selected during the processing of the stent, such as nickel-titanium alloy with shape memory that can self-expand in the body, or stainless steel that is released by ball expansion, etc. The stent itself can be formed by cutting tubes or weaving wires, and the leaflets can be connected to the stent by sewing, bonding or integral mold molding.

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

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

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

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

The present application provides a control mechanism for an artificial implant, comprising a base 10, a pull wire 11 and a locking member 13, wherein the pull wire 11 has a free end 111 that can pass through or detach from the artificial implant 60, and the free end 111 has a first state of being restricted to the base 10 (as shown in FIG. 1a) and a second state of being released from the restriction (as shown in FIG. 1b); the locking member 13 is movably matched with the base 10, and the locking member 13 cooperates with the free end 111 of the pull wire 11 to switch the state of the free end 111.

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

In the first state, after the free end 111 is combined with the lock 13, the lock 13 cooperates with the base 10 to limit the pull wire from the lock 13. At this time, the free end 111 can be understood as being relatively fixed to the lock 13. In this state, the pull wire 11 is always connected to the artificial implant 60, and the release process (i.e., the expansion degree) of the artificial implant is adjusted according to the length of the pull wire exposed from the base, and the release/retraction speed of the artificial implant is controlled according to the change rate of the pull wire. If necessary, the pull wire can also be used to recycle the artificial implant.

In the second state, the free end 111 sequentially detaches from the locking element 13 and the artificial implant 60, releasing the interconnection between the artificial implant and the control mechanism, and then the control mechanism as a whole can be withdrawn from the body, leaving the artificial implant at a predetermined position in the body.

In one embodiment, the control mechanism of the artificial implant includes a base 10, a pull wire 11 and a locking member 13, wherein the base 10 has a locking area 101; the pull wire 11 has a free end 111 that can pass through or detach from the artificial implant 60, and the free end 111 has a first state of being restricted in the locking area 101 (as shown in Figures 1a and 2a) and a second state of being released from the restriction (as shown in Figures 1b and 2b); the locking member 13 is rotatably matched with the base 10, and the locking member 13 has a positioning portion 131 that enters or moves out of the locking area 101 during the rotation process, and the positioning portion 131 cooperates with the free end 111 of the pull wire 11 to switch the state of the free end 111.

The locking area 101 may be within the overall outer contour of the base 10 to accommodate the free end in the first state. In addition, the locking area 101 may be open toward the distal end to optimize the extension path of the pull wire 11 .

In conventional technology, for example, FIG. 3 a and FIG. 3 b show that the locking member 13 slides axially so that the positioning portion 131 is separated from the locking area 101 , allowing the pull wire 11 to be separated from the artificial implant.

In this embodiment, the positioning portion 131 has at least circumferential displacement when working as a part of the lock 13, which can reduce or even eliminate the axial stroke change of the lock 13, reduce the axial space occupied by related components and even the proximal control handle, and is more conducive to the configuration of the transmission mechanism.

The pull wire 11 has a control end 113 opposite to the free end 111, and the control end 113 can move relative to the base 10. When the free end 111 is in a first state, the length of the pull wire 11 exposed outside the base 10 is adjusted by the control end 113. When the free end 111 is in a second state, the pull wire 11 is pulled away from the artificial implant 60 by the control end 113. The control end 113 can be extended and controlled by a control handle, and its movement mode can change the length of the pull wire exposed outside the base 10, specifically, it can be axial movement, rotation or winding, etc.

Among them, the artificial implant 60 is a cylindrical structure with a corresponding circumference, and a plurality of pull wires 11 are configured, and the control end 113 of each pull wire 11 can be controlled independently or moved synchronously. The positions where the pull wires 11 interact with the artificial implant 60 are arranged at intervals along the circumference of the artificial implant 60, which can improve the synchronization of the contraction and release of the artificial implant 60. For example, in Figure 4, there are three pull wires 11, and there are three positions where they interact with the artificial implant 60 and they are arranged at intervals around the circumference of the artificial implant.

The control end 113 of each pull wire 11 can be directly extended to the control handle or indirectly transmitted through an intermediate piece to reduce the risk of multiple pull wires 11 being intertwined with each other. For example, as shown in FIG5 , the control mechanism further includes a second shaft 23, and the control end 113 of each pull wire 11 is connected to the second shaft 23. The pull wires 11 are synchronously controlled by operating the second shaft 23.

Correspondingly, there are multiple locking areas 101, and the free end 111 of each pull wire 11 corresponds to one of the locking areas 101 in the first state to avoid interference between the pull wires 11. The multiple locking areas can be separated by the structure of the base itself, or additional separation components can be set on the base.

Regarding the cooperation between the free end 111 and the positioning portion 131, in one embodiment, the free end 111 has a wire loop 115. When the free end 111 is in the first state, the positioning portion 131 penetrates the wire loop 115. When the free end 111 is in the second state, the positioning portion 131 pulls out the wire loop 115. The wire loop 115 can be configured independently (as shown in FIG. 6a) or wound by the pull wire 11 itself (as shown in FIG. 6b). The pull wire 11 is single-strand or multi-strand, for example, a single-strand extending to the control end 113, and for example, two strands extending in parallel to the control end 113, or two strands extending in parallel for a period and then extending to the control end 113 through a parallel strand.

In one embodiment, an embodiment of the present application provides a control mechanism for an artificial implant, including a base 10, a pull wire 11 and a lock 13, wherein the pull wire 11 has a free end 111 that can pass through or detach from the artificial implant 60, and the free end 111 has a first state of being restricted to the base 10 and a second state of being released from the restriction; the lock 13 is movably matched with the base 10, and the lock 13 cooperates with the free end 111 of the pull wire 11 to switch the state of the free end 111.

As shown in FIG7 , the artificial implant 60 has a spatial axial direction, one end of which is a wire control end 601, which can be either the distal end or the proximal end of the artificial implant 60. The wire control end 601 has an eyelet 603 for a pull wire (not shown in the figure for clarity) to pass through.

The eyelets are formed as follows:

The artificial implant includes a hollow portion forming an eyelet, and the hollow portion is a type of structural gap of the artificial implant;

Or directly punch holes to form holes (e.g., FIG. 7 );

Or it can be independently configured in an artificial implant (such as welding, etc.).

The holes 603 are multiple and isolated from each other. In the expanded state, the same pull wire 11 passes through at least two holes 603 .

The free end 111 of the pull wire can limit the complete separation of the artificial implant 60 from the control mechanism in the first state, but the artificial implant can be allowed to deform to a certain extent by adjusting the length of the pull wire exposed outside the base, or it can be understood that the artificial implant changes its position relative to the base. Therefore, when the free end 111 of the pull wire remains in the first state, the artificial implant 60 can still have multiple states according to its own deformation degree, for example, relatively:

In the expanded state, the wire control end 601 radially expands away from the base 10 (as shown in FIG. 8 a ), and the round-trip paths of the same pull wire 11 passing through the artificial implant 60 do not overlap;

In the retracted state, the wire control end 601 is radially retracted and close to the base 10 (as shown in FIG. 8c );

In the intermediate state, the wire control terminal 601 is between the expanded state and the retracted state (as shown in FIG. 8 b ).

As shown in Fig. 7 to Fig. 9a, a plurality of eyelets 603 are arranged in sequence along the circumferential direction. In the expanded state, the same pull wire 11 passes through at least two eyelets 603, that is, one pull wire 11 can act on two locations of the wire control end 601 in the circumferential direction. In a preferred embodiment, the number of eyelets 603 is twice the number of pull wires 11, and the same pull wire 11 corresponds to two eyelets 603. This allows the circumferential contraction and expansion of the wire control end 601 of the artificial implant 60 to be synchronized, and reduces the number of pull wires, avoiding entanglement and friction at the proximal end of the pull wires, and correspondingly reduces the space for accommodating the pull wires.

At least two pull wires are configured for the entire artificial implant 60. In addition, the pull wire is only allowed to be threaded once for the same eyelet to avoid the interference caused by reciprocating threading.

As can be seen from FIG. 9 a , in this state, the extension direction (radial direction) of the pull wire between the artificial implant 60 and the base 10 , i.e. the traction force direction, is perpendicular to the unlocking movement direction (circumferential direction) of the locking element, making unlocking easier.

For example, as shown in Figure 9, the round trip path of the same pull wire 11 through the artificial implant roughly encloses a triangular area, that is, the round trip paths do not overlap, otherwise the return paths overlap, and the extension path of the pull wire 11 is a single straight line or curve, and does not enclose a certain area. The pull wire 11b is the state after the threading is completed, and the bold parts are the forward section 112 and the return section 114 of the pull wire 11b.

As shown in Fig. 9a and Fig. 10, a triangular threading path is specifically formed: in the first state, the pull wire 11a extends out of the base 10 through the current locking area 101, and the free end 111 after winding around the artificial implant 60 is returned to the same locking area 101. After the threading is completed, the pull wire 11 forms a wire loop 115 at the returned position. As shown in Fig. 9a, the pull wire 11b forms two action points (X1, X2) in the locking area 101, and two action points (Y1, Y2) between the pull wire 11b and the artificial implant.

Here is an explanation in combination with the prior art: In FIG11a, three holes 603 are arranged at intervals in the circumferential direction of the artificial implant 60, corresponding to three pull wires, and the specific threading path refers to the pull wire 11c, and their round-trip paths coincide. During the retraction process, the force generated by the pull wire is only radial, and the artificial implant will generate corresponding stress in the circumferential direction and react to the pull wire, so that the force required to be applied to the pull wire gradually increases, affecting the operating feel.

However, the pull wire of this embodiment is in a triangular shape, which generates not only radial force, but also force on the line connecting the two connection points (Y1, Y2) (as shown by the solid arrow in Figure 9a) to directly overcome the stress change during the deformation process of the artificial implant. The change in the overall force of the pull wire is smaller than that of the existing one, and the operation feel is more delicate.

In conventional technology, the interval between two adjacent holes 603 is far apart (i.e., the circumferential span is large), the holes 603 are opened on the connecting ears 605 (as shown in FIG. 11b), and the adjacent connecting ears 605 are independently connected to the pull wire. During the folding process, the adjacent connecting ears 605 may eventually be misaligned and overlapped with each other (as shown in the bold part of FIG. 11c), affecting the subsequent release. However, the threading path of the pull wire in this embodiment makes the connecting ears 605 and the structural gap mostly or completely controlled by the pull wire, reducing or even eliminating the problem of misalignment and overlap during folding (as shown in FIG. 9b).

The two action points (X1, X2) are in the same locking area and adjacent to each other, so the round trip path of the pull line is roughly an equilateral triangle, that is, the lengths of the two bold forward sections 112 and return sections 114 in FIG9a are equal, and the corresponding forward sections 112 and return sections 114 have the same moving speed, which improves the synchronization of the contraction or expansion of the artificial implant 60. If, as shown in FIG12, the circumferential span of the two action points (X1, X2) is large, the corresponding forward sections 112 and return sections 114 have different lengths, and the corresponding different moving speeds lead to abnormal contraction/expansion of the artificial implant.

In order to improve the synchronization of the contraction and expansion of the artificial implant, the prior art needs to configure more pull wires (for example, more than six), but it is necessary to consider whether the space arrangement of each pull wire at the proximal end is allowed, and the pull wires may be too close to each other and rub or entangle. The threading method of this embodiment requires fewer pull wires, thereby meeting the space requirement.

Regarding the positioning portion 131, it has two axial gaps 1315 on both sides of the base along the axial direction, for the radial reciprocating winding and/or free end sleeve of the pull wire 11. In one embodiment, the positioning portion 131 is a spiral with multiple turns, and the axial gap 1315 is between adjacent turns; in the first state, the pull wire 11 extends out of the base through the current axial gap 1315, and the free end 111 after winding around the artificial implant 60 is sleeved to a turn adjacent to the current axial gap 1315 (as shown in FIG. 13a).

As shown in FIG. 14 , the base 10 has a distal end 301 and a proximal end 302 opposite to each other, and an axial direction extending between the distal end 301 and the proximal end 302. The base 10 has a first cavity 103 inside, a first opening 1031 communicating with the first cavity 103 on the proximal side of the base 10, and a second opening 1033 communicating with the first cavity 103 on the outer peripheral surface of the base 10.

As shown in FIG15 , the pull wire 11 is passed through the first cavity 103 , one end of the pull wire 11 (i.e., the control end 113 ) extends proximally out of the base 10 through the first opening 1031 , and the other end of the pull wire 11 (i.e., the free end 111 ) extends out of the base 10 through the second opening 1033 to connect to the artificial implant.

In this embodiment, referring to Figures 16a and 16b, the locking area 101 is located at the second opening. Along the circumference of the base 10, a plurality of locking areas 101 are arranged at intervals, and the positioning portion 131 enters or moves out of each locking area 101 in sequence as the locking element 13 moves.

In one embodiment, as shown in Figure 15, the control mechanism also includes a third axis 25 fixedly connected to the base 10, the third axis 25 extends proximally and can be controlled by the control handle, and the third axis 25 can keep the base 10 relatively fixed in the circumferential direction, so that the positioning portion 131 can rotate relative to the base 10.

In one embodiment, a plurality of partitions are arranged circumferentially on the base 10, and adjacent partitions separate the second opening 1033. Therefore, the second opening 1033 is arranged circumferentially on the base 10 with multiple partitions, and the partitions are ribs 1035 in FIG. 16a and FIG. 16b. The strip structure minimizes its own circumferential span as much as possible, so that the circumferential span of the second opening is maximized, which is convenient for the arrangement of the wire, for example, a wire extends through a locking area and then returns to the same locking area; or a wire extends through a locking area and then returns to the adjacent locking area, so that the two action points can be close enough. At the same time, the ribs also serve as reinforcing ribs to maintain the basic strength requirements required by the base.

In the first state, the free end 111 extends out of the base 10 through the corresponding second opening 1033, passes through the artificial implant 60, and then returns to the locking area 101 corresponding to the same second opening 1033 (as shown in FIG. 17a), or returns to a position circumferentially adjacent to the second opening 1033 (as shown in FIG. 17b).

The position circumferentially adjacent to the second opening 1033 may be another adjacent locking area, or a channel separately configured for threading the pull wire. The formation of the channel may adopt the same structural principle as the locking area. For example, there are six second openings 1033, three of which are spaced apart for the free ends of the pull wires to extend out of the base, and the other three are spaced apart as locking areas, such as Figure 17c. In terms of the circumferential span, the span of the locking area 101 is α, and the span of the second opening 1033 is β, satisfying α/β=1.1~2.

All ribs 1035 converge and fix to each other at the distal end of the base 10, and converge to form an annular structure 1032. All ribs 1035 are continuously distributed in the circumferential direction at the proximal end of the base 10 to form a cylindrical structure.

In one embodiment, the base 10 is provided with a locking hole 105 for the positioning portion 131 to be inserted. The positioning portion 131 has:

In the locked state, the positioning portion 131 is inserted into the lock hole 105 to prevent the free end 111 of the pull wire 11 from being disengaged (as shown in FIG. 18 a );

In the unlocking state, the positioning portion 131 exits the lock hole 105, allowing the free end 111 of the pull wire 11 to be disengaged (as shown in FIG. 18 b );

The locking area 101a is between the two ribs 1035a and 1035b. The free end 111 of the pull wire 11 is located in the current locking area 101 in the first state. Locking holes 105a and 105b are provided on the opposite sides of the two ribs. Of course, the locking holes can also pass through the ribs. One section of the positioning part 131 is in the locking area 101a, and the two ends of the section are respectively inserted into the locking holes 105a and 105b.

Combined with the movement direction of the locking member 13 , the opening of the locking hole 105 faces the circumference of the base 10 .

As shown in Figures 18a to 19, when the positioning portion 131 moves along the first direction (such as X in Figure 19), the free end 111 switches from the second state to the first state, and the locking hole 105 penetrates the rib 1035 along the first direction. The locking hole 105 has a relative forward opening and a rear opening, wherein the forward opening faces the first direction.

In terms of quantity, there are multiple ribs 1035 with locking holes 105, and the positioning portion 131 as a whole has a relatively opposite end 1311 and a head end 1313. The head end 1313 is sequentially inserted into (as shown in FIG. 18a) or sequentially separated from each locking hole 105 (as shown in FIG. 18b) as the locking member 13 rotates. Taking the sequential insertion of the positioning portion as an example, as shown in FIG. 18c to FIG. 18e, the head end 1313 is sequentially combined with the locking hole 105a, the free end 111a, the locking hole 105b, the locking hole 105c, the free end 111b, the locking hole 105d, the locking hole 105e, the free end 111c and the locking hole 105f. The sequential separation is opposite to the sequential combination.

In a preferred embodiment, all ribs 1035 are provided with locking holes 105 for the positioning portion 131 to rotate through in sequence and provide a certain movement guide. During the process of the locking element rotating and inserting into each locking hole, the head end 1313 eventually abuts against the side wall 1034 of one of the ribs 1035 (as shown in FIG. 18 a), or is placed in the corresponding locking hole, playing a role of limiting.

When the positioning portion 131 is a multi-turn spiral, the opening position of the locking hole 105 of each rib 1035 is adapted to the positioning portion 131. There are one or more locking holes 105 on the same rib 1035. The multiple locking holes 105 are arranged in sequence along the extension direction of the rib 1035.

The side of the rib 1035 facing the first cavity 103 is the inner side, and the inner side of each rib 1035 is respectively provided with a guide groove 1039 for the positioning portion 131 to extend. The axial penetration of the guide groove 1039 allows the positioning portion 131 to rotate through, and the proximal side of the guide groove 1039 is open for the positioning portion 131 to be inserted and positioned, and inserted into the first locking hole 105c after the locking member 13 is rotated (as shown in FIG. 20a). In one embodiment, the groove depth (H in FIG. 20b) of the guide groove corresponding to each rib is different, so as to meet the rotation guidance of the spiral positioning portion 131.

Referring to Fig. 20a, in one embodiment, one section of the rib 1035 along the axial direction is a bent section 1037 extending radially inward, and the locking hole 105 is located at the bent section 1037 corresponding to the rib 1035. The bent section 1037 is located at the distal end, and as a whole forms a chamfered or rounded structure on the distal side of the base, which serves as a guide when the artificial implant is folded.

In combination with the rotation characteristics of the lock and the circumferential distribution of each pull wire, the positioning part 131 is in the shape of a rod, which can be a straight rod or a curved rod, and there is only one of them and it matches with the free ends 111 of all the pull wires 11. The axial dimension change of the control mechanism is eliminated, and the original function of the lock to match with the pull wires one by one is retained.

In one embodiment, the base 10 is provided with a locking hole 105, and the opening of the locking hole 105 faces the circumference of the base 10. The positioning portion 131 has a curved shape and extends around the axis of the base, and the positioning portion 131 is inserted into or separated from the locking hole 105 as the locking element 13 rotates. The curvature can make full use of the circumferential space, maintain the necessary length of the locking element, and realize the control of the free ends of all the pull wires with the same locking element.

As shown in Fig. 21, at least a portion of the lock 13 is a connecting portion 135 in the first cavity 103, and the control mechanism further comprises a first shaft 21 in transmission cooperation with the connecting portion 135 to drive the lock 13 to rotate relative to the base 10. The proximal end of the first shaft 21 is connected to and controlled by the control handle.

In one embodiment, the pull wire 11 has a control end 113 opposite to the free end 111, and the control end 113 can move relative to the base 10. The control mechanism also includes a second shaft 23 connected to the control end 113, and the second shaft 23 is tubular and movably sleeved outside the first shaft 21. The movement of the second shaft 23 drives the pull wire 11 to act on the artificial implant to gradually shrink or expand.

In some embodiments, the positioning portion 131 includes at least one arc-shaped structure that cooperates with the base. For example, in Figures 21 to 23, the positioning portion 131 is a spiral structure, and the spiral structure is coiled at least once. For example, the spiral structure is a multi-turn structure, and the turns are arranged along the axial direction (circumferential direction of the base). The generatrix of the spiral structure can be an oblique line (away from or close to the axis of the base) or a straight line. For example, a straight line can avoid increasing the radial dimension or reducing the matching space between the connecting portion 135 and the first shaft 21.

In the winding direction of the spiral structure, the positioning portion 131 has an opposite end 1311 and a head end 1313, wherein one end is fixed to the connecting portion 135. The fixing method includes split connection, such as welding or assembly, or integral molding.

In this embodiment, the head end 1313 of the positioning portion 131 cooperates with the base 10 and the pull wire, and the end 1311 of the positioning portion 131 is fixed to the connecting portion 135, for example, fixed to the outer periphery or distal end of the connecting portion 135. The connection method can be direct welding of the end, or welding and fixing after partial overlap.

The connecting portion 135 is tubular, and other components are inserted into the interior thereof, such as the first shaft 21. In order to improve the connection strength and avoid the extension of the components, the positioning portion 131 can be spirally wound around the outer circumference of the connecting portion 135. The connecting portion 135 and the positioning portion 131 are located in the first cavity 103 near the end 1311 and are welded and fixed to each other.

The connecting portion 135 is fixed to the distal end of the first shaft 21 , or can be axially separated from the distal end of the first shaft 21 .

As shown in Figures 21 to 23, in one embodiment, the positioning portion 131 is a multi-turn spiral structure, with an axial gap 1315 between adjacent turns, and the space surrounded by the spiral structure is an internal space 1317. At least one section of the pull wire 11 is a detour section 117. In the first state, the detour section 117 is in the internal space 1317, and both ends of the detour section 117 extend outside the internal space 1317 through the corresponding axial gap 1315 (as shown in Figure 20). The detour section 117 and the positioning portion 131 form a force point (first force point), and the free end 111 is sleeved to a circle of the positioning portion 131 adjacent to the first axial gap 1315b, and serves as a second force point, so that the second shaft 23 acts on the artificial implant to shrink.

The number of turns of the positioning portion 131 is at least one and a half turns or more than two turns, for example, more than two turns as shown in FIG. 22 a , or approximately one and a half turns as shown in FIG. 22 b .

In conjunction with FIG. 18 and FIG. 20 , in the first state, the pull wire 11 extends from the control end 113 to the distal end to the outside of the positioning portion 131, bends to the inside of the positioning portion 131 through the second axial gap 1315a, and then extends from the second axial gap 1315a to the first axial gap 1315b at the distal end, passes through the first axial gap from the inside to the outside, bends to the outside of the positioning portion 131, and after passing through the artificial implant, the free end 111 is sleeved on the positioning portion 131. The detour section 117 is located between the first axial gap 1315b and the second axial gap 1315a, wherein the portion of the pull wire 11 extending from the control end 113 to the second axial gap 1315a is located between the positioning portion 131 and the base 10, as far away from the first shaft 21 as possible, so as to reduce the influence on the matching between the first shaft 21 and the connecting portion 135, and facilitate the fixed connection between the connecting portion 135 and the positioning portion 131.

In another embodiment, the present application further provides a control mechanism having a distal end and a proximal end opposite to each other and an axial direction extending between the proximal end and the distal end, the control mechanism comprising:

The intervening component 24 includes a first intervening component 241 and a second intervening component 242;

The transmission component 22, the distal end of which is fixedly connected to the first intervention component 241;

A control handle 3 connected to and controlling the proximal end of the transmission component 22;

The linkage structure includes two selectively linked matching parts 271 , one of which is fixed to the second intervening component 242 , and the other is fixed to the transmission component 22 . The linkage state of the two matching parts is switched during the movement of the transmission component 22 .

When the two mating parts are in a linkage state, they drive the second intervening part 242 to rotate or move linearly. For example, when the transmission part 22 slides axially, the two mating parts enter or release the linkage state; as shown in Figure 24a, the two mating parts 271 are in a released linkage state, and the transmission part 22 slides axially so that the two mating parts 271 switch to the linkage state as shown in Figure 24b, and the transmission part 22 can drive the second intervening part 242 to rotate.

Or when the transmission component 22 rotates, the two matching parts enter or release the linkage state; as shown in Figure 25a, the two matching parts 271 are in the release linkage state, and the transmission component 22 rotates so that the two matching parts 271 switch to the linkage state as shown in Figure 25b, and the transmission component 22 can drive the second intervention component 242 to slide.

The two matching parts are a linkage key and a linkage groove that can be axially slidably separated, and the linkage key is rotated and linked with each other when inserted into the linkage groove. The two matching parts can also be a linkage key and a linkage groove that can be relatively rotated and separated, and the linkage key is axially linked with each other when inserted into the linkage groove.

There are multiple linkage keys, a part of an intervening component is tubular, and multiple linkage keys are arranged along the circumference of the tubular part. Correspondingly, there are multiple linkage grooves.

In the figure, along the axial direction, the first intervention component 241 is located on one side (proximal side) of the second intervention component 242. In certain initial or linkage states, the first intervention component 241 and the second intervention component 242 may be partially nested with each other.

In combination with common application scenarios, the first intervention component and the second intervention component include the following independent components:

Inner shaft assemblies for artificial implants (e.g., artificial heart valves) prior to load release;

An outer sheath that wraps around the artificial heart valve before release;

A base, connected to the artificial heart valve before release and axially limited to each other;

A lock for confining the artificial heart valve to the base before release;

A balloon body that is loaded and expanded to hold the artificial heart valve before release;

The pull wire is connected to the artificial heart valve to control the release process of the artificial heart valve.

Referring to FIG. 26 to FIG. 28b, in combination with the above structure of the lock 13, in one embodiment, the lock 13 is used as the second intervening component, and the first shaft 21 is used as the first intervening component. At least a portion of the lock 13 is a connecting portion 135, and the first shaft 21 is in transmission cooperation with the connecting portion 135 and is used to drive the lock 13 to rotate relative to the base 10; the connecting portion 135 is tubular, and the wall of the tube has a rotation linkage structure that cooperates with the distal end of the first shaft. When the first shaft 21 moves axially relative to the connecting portion 135, the rotation linkage structure is separated or combined. Among them, the connecting portion 135 is located inside the base 10, which is conducive to combining with the first shaft 21 in the radial space.

The rotary linkage structure includes two selectively linked matching parts, which are:

A linkage key 1351 is radially protruded from one of the connecting portion 135 and the first shaft 21;

The linkage groove 211, in cooperation with the linkage key 1351, is disposed on the other of the connection portion 135 and the first shaft 21, and is open to the end surface of the other. For example, in FIG28a and FIG28b, the linkage key 1351 is disposed on the connection portion 135, and the linkage groove 211 is disposed on the first shaft 21, and the linkage state is switched by sliding along the axial direction. The rotation linkage of the two is manifested in that the side wall of the linkage groove 211 abuts against the side wall of the linkage key 1351 in the circumferential direction (as shown in FIG29).

Preferably, as shown in FIG30 , the notch of the linkage groove 211 is provided with a flaring structure 213 for guiding the insertion of the linkage key 1351. The linkage groove 211 is provided at the distal end of the first shaft 21, wherein as shown in FIG28a , FIG28b and FIG30 , a pipe 40 extending out of the base is fixed to the distal end of the first shaft 21, and the linkage key 1351 is sleeved and abutted against the outer periphery of the pipe 40, so as to maintain the radial positioning between the locking member 13 and the base 10, and facilitate the insertion of the linkage groove 211.

In one embodiment, as shown in FIG30 , the wall of the connecting portion 135 is partially deformed to form a linkage key 1351. An escape zone 1353 is formed outside the linkage key 1351. The escape zone 1353 exists between the linkage key 1351 and the positioning portion 131, and the detour section 117 of the pull wire 11 can be placed in the escape zone 1353, which facilitates the insertion of the pull wire 11.

The specific formation of the linkage key 1351 is as shown in Figure 26, the tube wall of the connection part 135 is provided with a pair of cutouts 1355 near the proximal end surface, and the portion between the same pair of cutouts 1355 is radially folded inward to form the linkage key 1351. The connection part 135 is a cylindrical structure, and the linkage key 1351 is a sheet.

When the two matching parts are in a linkage state, the proximal end surface of the first shaft 21 abuts against the base 10 , wherein the linkage key 1351 is disposed at the proximal end or the distal end of the connecting part 135 .

In one embodiment, the linkage keys 1351 are distributed at 2 to 4 locations along the circumferential direction. For example, in FIG26 , there are two linkage keys 1351 .

An embodiment of the present application further provides a control mechanism having a distal end and a proximal end opposite to each other, the control mechanism comprising:

At least three shafts, including a first shaft, a second shaft and a third shaft which are slidably sleeved in sequence from the inside to the outside;

a base connected to the distal end of the third axis;

The pull wire is connected to the distal end of the second shaft, and has a free end which can pass through or be separated from the artificial implant, and the free end has a first state in which it is restricted by the base and a second state in which the restriction is released.

The locking element is connected to the far end of the first shaft, and is movably matched with the base. The locking element is matched with the free end of the pull wire to switch the state of the free end.

Other structural details and working methods of the control mechanism of this embodiment can refer to other embodiments. For example, in the first state, the release process of the artificial implant is controlled by adjusting the length of the pull wire exposed outside the base. The number of pull wires can be multiple and controlled by the control handle through the second axis. In the second state after the lock is unlocked, the movement of the second axis drives the pull wire to detach from the artificial implant. In another embodiment, the proximal end of the pull wire extends and is directly controlled by the control handle.

An embodiment of the present application further provides a delivery system, including a control handle and the control mechanisms in the aforementioned embodiments, wherein the proximal ends of the three shafts are respectively connected to and controlled by the control handle.

The control handle includes a support body, and the support body is respectively provided with a driving mechanism for three axes. In order to cooperate with the delivery and retraction of the artificial implant, the control handle is also connected to a sheath that wraps and releases the artificial implant. In order to enhance the positioning effect, in some embodiments, the artificial implant can adopt a similar structure as shown in Figure 10, in which the artificial implant includes an inner frame 61 and an arm 63 fixed to the outer periphery of the inner frame. After release, each arm 63 extends into the corresponding valve sinus to prevent the artificial implant from shifting under the action of blood flow. When releasing, the arm can be released first, and the inner frame can be completely released after it accurately enters the valve sinus. Correspondingly, the distal end of the sheath has a first loading section for wrapping the artificial implant, and the first loading section is open toward the distal end. A second loading section is fixed to the distal end of the first axis, and the second loading section is open toward the proximal end, and is interlocked with the first loading section to wrap the artificial implant.

An embodiment of the present application further provides an artificial implant control method based on a wire control method, comprising:

Providing a control mechanism of the aforementioned embodiment, in which the free end of the pull wire passes through the artificial implant and is bound to the base by the locking member;

The pull wire has a control end opposite to the free end. When the artificial implant is released, the control end is moved distally, so that the portion of the pull wire exposed outside the base gradually stretches and allows the artificial implant to deform radially.

When the artificial implant is deformed to a desired extent, the fit between the locking element and the base is released and each free end is released;

Move the control end proximally to pull the free end away from the artificial implant.

Detailed description is given with reference to the accompanying drawings:

After the artificial implant is delivered to the predetermined position in the body, the components in the sheath are first pushed distally to push the whole forward or the sheath is moved proximally to expose the arm and the control mechanism. At this time, the proximal end of the artificial implant is controlled by the control mechanism and the distal end is constrained by the second loading section 411.

As shown in Figure 31a, the first shaft 21 is pushed again to release the restraint of the second loading section on the artificial implant, that is, the distal end of the artificial implant loses the restraint and expands radially outward. During the distal movement of the first shaft, the coupling with the connecting part is achieved through the rotating linkage structure, that is, it enters a linkage state with the locking element, and is ready to expand the proximal end of the artificial implant.

As shown in Figure 31b, the third axis 25 is kept stationary, and the second axis 23 is pushed toward the distal end, so that the control end 113 of the pull wire 11 moves toward the distal end 301, so that the part of the pull wire 11 exposed outside the base gradually stretches, allowing the artificial implant 60 (mainly the proximal part) to be released gradually, and the pull wire outside the base 10 will gradually stretch in the direction of the arrow; the control end 113 continues to move until Figure 31c, the artificial implant 60 is in an expanded state (i.e., the expected amplitude), and after confirming that it is in the expected fit with the surrounding tissues, the pull wire can be released.

When the pull wire is released, as shown in Figures 31d to 31g, the rotating first axis 21 drives the lock 13 to rotate relative to the base 10, and releases the restrictions of the pull wires 11a, 11b, and 11c in turn. The corresponding free ends 111a, 111b, and 111c in the figure are completely separated from the lock 13.

Then, as shown in Figure 31h, the second shaft 23 is withdrawn toward the proximal end, so that the control end 113 of each pull wire moves toward the proximal end 302, so that the free end is disengaged from the corresponding hole 603, that is, completely disengaged from the artificial implant; finally, as shown in Figure 31i, the second loading section 411 and the first loading section 431 are fastened again, and the control mechanism is withdrawn as a whole to the outside of the body.

In addition, before the pull wire is unlocked, a recovery operation can be performed as needed to facilitate readjustment of the position, and the order can be according to the corresponding operations of Figures 31c, 31b and 31a: drive the control end 113 of the pull wire to move proximally, retract the proximal end of the artificial implant through the pull wire, and then move the remaining components in the sheath proximally back into the sheath as needed, or push the sheath toward the distal end to accommodate the artificial implant.

It should be noted that the position of the axis in the figure has no limiting meaning, and the control end can be very long or very short, or the pull wire can be directly connected to the control handle for direct retraction and extension.

For the control of the pull wire, the control end of the pull wire may be extended and directly controlled by the control handle.

The lock element in the control mechanism of the artificial implant of the present application rotates to unlock the pull wire, which has a smaller axial stroke variation than the existing structure and is more suitable for narrow environments in the body.

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

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

Claims (18)

1. A control mechanism for an artificial implant, characterized in that it comprises: a base having a locking area; A pull wire having a free end that can pass through or be removed from the artificial implant; A locking member is rotationally matched with the base, and the locking member has a positioning portion that enters or moves out of the locking area during rotation, and the positioning portion cooperates with the free end of the pull wire to limit the artificial implant. 2. The control mechanism of the artificial implant according to claim 1 is characterized in that the pull wire has a control end opposite to the free end, and the control end can move relative to the base. When the free end is in a first state, the length of the pull wire exposed outside the base is adjusted by operating the control end, and when the free end is in a second state, the pull wire is pulled away from the artificial implant by the control end. 3. A control mechanism for an artificial implant, characterized in that it comprises: Pedestal; A pull wire having a free end that can pass through or be removed from the artificial implant; A locking member, movably matched with the base, the locking member cooperates with the free end of the pull wire to restrict the artificial implant; The artificial implant has an axial direction in space, one end of which is a wire-controlled end, and the wire-controlled end has an eyelet for the pull wire to pass through. The artificial implant has a relative degree of deformation according to itself: In the retracted state, the wire control end is radially retracted close to the base; In an expanded state, the wire control end radially expands away from the base; The round trip paths of the same pull wire passing through the artificial implant do not overlap. 4. The control mechanism of the artificial implant according to claim 3, characterized in that the free end of the pull wire has a first state in which it is restricted to the base and a second state in which the restriction is released, and when the locking element is released from the engagement with the free end of the pull wire, the restriction on the artificial implant is released; When the artificial implant is in the retracted state and the expanded state, the free end of the pull wire is in the first state. 5. The control mechanism of the artificial implant according to claim 3, characterized in that the artificial implant has a plurality of holes isolated from each other, and in the expanded state, the same pull wire passes through at least two holes. 6. The control mechanism of the artificial implant according to claim 3, characterized in that the round trip path of the same pull wire through the artificial implant roughly forms a triangle. 7. The control mechanism of the artificial implant according to claim 3 is characterized in that the base has a locking area, and the pull wire in the first state extends out of the base through the current locking area, passes through the free end sleeve of the artificial implant and returns to the same locking area. 8. A control mechanism for an artificial implant, characterized in that it comprises: A base having opposite distal and proximal ends and an axial direction extending between the distal and proximal ends, wherein the interior of the base has a first cavity, the proximal side of the base has a first opening communicating with the first cavity, and the outer peripheral surface of the base has a second opening communicating with the first cavity; A pull wire having a free end that can pass through or detach from the artificial implant, the pull wire is passed through the first cavity, one end of the pull wire extends proximally out of the base through the first opening, and the other end of the pull wire, i.e., the free end, extends out of the base through the second opening to connect to the artificial implant; A locking piece is movably matched with the base, and the locking piece cooperates with the free end of the pull wire to restrict the artificial implant. 9. The control mechanism of the artificial implant according to claim 8 is characterized in that the base has a locking area, the locking element has a positioning portion that enters or moves out of the locking area during rotation, the positioning portion cooperates with the free end of the pull wire to limit the artificial implant, and the locking area is located at the second opening. 10. The control mechanism of the artificial implant according to claim 9, characterized in that a plurality of the locking areas are arranged at intervals along the circumference of the base, and the positioning portion enters or moves out of each locking area in sequence as the locking element moves. 11. The control mechanism of the artificial implant according to claim 10, characterized in that the base is provided with a locking hole for the positioning part to be inserted. 12. The control mechanism of an artificial implant according to claim 11, characterized in that the positioning portion has a curved shape and extends around the axis of the base, and the positioning portion is inserted into or disengaged from the locking hole as the locking element rotates. 13. The control mechanism of the artificial implant according to claim 12, characterized in that the positioning portion is a spiral structure. 14. The control mechanism of the artificial implant according to claim 9 is characterized in that the control mechanism includes a linkage structure, and the linkage mechanism includes two selectively linked matching parts, one of the two matching parts is fixed to the positioning part, and the other is fixed to the transmission component, and the linkage state of the two matching parts is switched during the movement of the transmission component. 15. The control mechanism of the artificial implant according to claim 14, characterized in that the two matching parts are a linkage key and a linkage groove that can be axially slidably separated, and the linkage key is rotationally linked with each other when inserted into the linkage groove. 16. The control mechanism of the artificial implant according to claim 15, characterized in that at least a portion of the locking element is a connecting portion located in the first cavity, and the control mechanism includes a first shaft as the transmission component, and after the linkage structure is engaged, the first shaft can drive the locking element to rotate relative to the base. 17. A delivery system, characterized in that it comprises a control handle and a control mechanism of the artificial implant according to any one of claims 1 to 15, The control mechanism comprises: Three shafts, including a first shaft, a second shaft and a third shaft which are slidably sleeved in sequence from the inside to the outside; a base connected to the distal end of the third shaft; a pull wire connected to the distal end of the second shaft; a locking member connected to the distal end of the first shaft; The proximal ends of the three shafts are respectively connected to and controlled by the control handles. 18. A method for controlling an artificial implant based on a wire control method, characterized by comprising: A control mechanism for the artificial implant according to any one of claims 1 to 15 is provided, wherein the free end of the pull wire passes through the artificial implant and is bound to the base by the locking element; The pull wire has a control end opposite to the free end, and when the artificial implant is released, the control end is moved to gradually extend the portion of the pull wire exposed outside the base and allow the artificial implant to deform radially; When the artificial implant is deformed to a desired extent, the cooperation between the locking element and the base is released and the free end is released; The control end is moved to pull the free end away from the artificial implant.