Delivery device and delivery system for an implant

Abstract

The application provides an implant delivery device and a delivery system, the implant delivery device comprising: a wire control assembly, a driving wire and a removal wire; the wire control assembly is used to drive a wire control stent to expand or contract through a pull wire; the driving wire is used to be connected with the pull wire; the removal wire is used to be detachably connected with the pull wire; when the removal wire is connected with the pull wire, the removal wire limits the axial position of the driving wire relative to the wire control assembly through the pull wire; when the removal wire is detached from the pull wire, the limitation on the axial position of the driving wire is released. In this way, when the removal wire is detached from the pull wire, the limitation on the driving wire can be released, and when the driving wire is pulled to the proximal end, the pull wire can be pulled to the proximal end together, so that the wire removal is realized. The structure of the delivery device is simple, the wire removal action is simple, the surgical process can be simplified, the success rate of surgery can be improved, and the friction stroke of the pull wire is small.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an implant delivery device and delivery system. BACKGROUND

[0002] Transcatheter aortic valve replacement (TAVR) is a technique in which a valve prosthesis is delivered to the aortic root through a catheter for positioning and release, replacing the native valve. It is a hot front technology in the field of valve heart disease treatment, which has created a milestone in the minimally invasive treatment of aortic valve disease. This technology can treat aortic valve disease without opening the chest and stopping the heart, eliminating the great trauma caused by previous open chest surgery and cardiopulmonary bypass.

[0003] Currently, the artificial valve prosthesis used in transcatheter aortic valve replacement mainly includes two categories: balloon-expandable aortic valve prosthesis and self-expanding aortic valve prosthesis. These two types of valve prostheses are almost equally effective in clinical practice. The balloon-expandable aortic valve prosthesis can provide stable support and stability during release. The advantage of the self-expanding aortic valve prosthesis mainly lies in its less impact on hemodynamics during implantation and its certain degree of adjustability and recoverability during release. With the development of interventional surgery technology, the valve prosthesis has the function of adjustment or re-recovery after release, which increases the reliability and safety of the valve prosthesis implantation process and is considered in more and more product design concepts.

[0004] The existing transcatheter aortic valve recovery system product can achieve recovery before the valve prosthesis is completely released (part of the valve prosthesis is covered by the delivery sheath). However, after the valve prosthesis is completely separated from the delivery sheath, it cannot be recovered or repositioned. Therefore, how to achieve the recovery, repositioning and release of the self-expanding aortic valve prosthesis after complete release is still a problem to be solved in the prior art. More and more researches show that the wire control technology is the key to achieve the recovery of the aortic valve prosthesis after complete release. However, the existing wire control technology still has problems such as easy displacement of the valve prosthesis and complex operation. SUMMARY

[0005] The purpose of the present application is to provide an implant delivery device and delivery system to solve the problem of easy displacement of the valve prosthesis and complex operation of the existing delivery device.

[0006] To solve the above technical problems, the present application provides an implant delivery device, which comprises a wire control assembly, a driving wire and a removal wire.

[0007] The wire control assembly is used to expand or contract the wire control support through the pull wire; the removal wire is detachably connected with the wire control assembly; the driving wire is used to be connected with the pull wire; the removal wire is used to be detachably connected with the pull wire;

[0008] When the removal wire is connected with the pull wire, the removal wire limits the axial position of the driving wire relative to the wire control assembly through the pull wire.

[0009] When the removal wire is disconnected with the pull wire, the limitation on the axial position of the driving wire is released.

[0010] Optionally, the driving wire is connected with the pull wire in a first direction, and the removal wire is connected with the pull wire in a second direction, and the first direction is arranged at an angle with the second direction.

[0011] Optionally, when the removal wire is connected with the pull wire, the removal wire is also used to limit the axial position of the pull wire relative to the wire control assembly.

[0012] Optionally, the removal wire comprises a surrounding segment, the surrounding segment is initially connected with the pull wire; when a preset condition is met, the surrounding segment is disconnected with the pull wire.

[0013] When the removal wire is connected with the pull wire, the surrounding segment is circumferentially surrounded at least part of the wire control assembly, and the surrounding segment is limited in the axial position relative to the wire control assembly.

[0014] When the removal wire is disconnected with the pull wire, the limitation on the axial position of the surrounding segment is released.

[0015] Optionally, the distal end of the surrounding segment has an open pin-shaped part, the pin-shaped part is used to be inserted into the wire buckle of the pull wire to be connected with the pull wire; the preset condition comprises that the pin-shaped part moves away from the pull wire to be disconnected from the wire buckle.

[0016] Optionally, the wire control assembly comprises a mandrel, the mandrel is used for the removal wire to surround.

[0017] Optionally, the wire control assembly comprises a first limiting part, the first limiting part is connected with the distal end of the mandrel; the radial outer dimension of the first limiting part is greater than the radial outer dimension of the mandrel.

[0018] The first limiting part comprises a first through structure which is opened through in the axial direction; the first through structure is used for the pull wire to pass through.

[0019] Optionally, the wire control assembly comprises a second limiting part, the second limiting part is connected with the proximal end of the mandrel; the radial outer dimension of the second limiting part is greater than the radial outer dimension of the mandrel.

[0020] The second limiting member comprises a second through structure which is axially through; the second through structure is used for the driving line and / or the removal line to pass through.

[0021] Optionally, the distal end of the driving line has a pull ring, the pull ring is used for the pull line to pass through; the pull ring can pass through the second through structure.

[0022] Optionally, the wire control assembly comprises a driving tube, the distal end of the driving tube is connected with the second limiting member; when the removal line is connected with the pull line, the driving line moves towards the proximal end to drive the driving tube to bend, so as to drive the delivery device to bend on the side of the proximal end of the wire control assembly.

[0023] Optionally, the first limiting member comprises at least two first through structures; the at least two first through structures are arranged in the circumferential direction of the first limiting member; the at least two first through structures are respectively used for different pull lines to pass through.

[0024] Optionally, the removal line is arranged around the mandrel and is respectively used for being connected with different pull lines.

[0025] Optionally, the delivery device comprises an inner tube, the wire control assembly is movably sleeved on the inner tube in the axial direction of the inner tube.

[0026] Optionally, the delivery device comprises a wire deployment component, the wire deployment component is connected with the inner tube, and the wire deployment component is used for changing the extension direction of the pull line from the axial extension to the radial extension.

[0027] Optionally, the delivery device comprises two or more wire deployment components, the two or more wire deployment components are arranged in the axial direction of the inner tube at intervals; and / or the delivery device comprises two or more wire control assemblies, the two or more wire control assemblies are arranged in the axial direction of the inner tube at intervals.

[0028] To solve the above technical problems, the present application further provides a delivery system of an implant, which comprises a wire control valve prosthesis and the delivery device of the implant as described above; the wire control valve prosthesis comprises a wire control stent and at least one group of pull lines; the wire control stent is detachably loaded on the delivery device of the implant, and a part of the pull lines is arranged in the circumferential direction of the wire control stent and is used for driving the wire control stent to expand or contract under the driving of the wire control assembly.

[0029] Optionally, at least one end of the pull line has a wire buckle, and the wire buckle is detachably passed through by the removal line.

[0030] In summary, in the implant delivery device and delivery system provided by the present application, the implant delivery device comprises a wire control assembly, a driving wire and a removal wire; the wire control assembly is used to expand or contract the wire control stent by pulling the driving wire; the driving wire is used to be connected with the pull wire; the removal wire is used to be detachably connected with the pull wire; when the removal wire is connected with the pull wire, the removal wire limits the axial position of the driving wire relative to the wire control assembly through the pull wire; when the removal wire is detached from the pull wire, the limitation on the axial position of the driving wire is released.

[0031] In this way, when the removal wire is detached from the pull wire, the limitation on the driving wire is released, and when the driving wire is pulled towards the proximal end, the pull wire can be pulled towards the proximal end together, so as to realize the removal of the wire. The structure of the delivery device is simple, the removal action is simple, the surgical process can be simplified, the success rate of the surgery can be improved, the friction stroke of the pull wire is small, the stability of the wire control stent is less affected during the removal process, and the success rate of the surgery is effectively improved. Further, since the position of the driving wire relative to the wire control assembly is limited towards the proximal end when the removal wire is connected with the pull wire, when the driving wire is pulled towards the proximal end, the wire control assembly can also be bent on the proximal side of the wire control assembly, so as to realize the bending control function. BRIEF DESCRIPTION OF DRAWINGS

[0032] Those skilled in the art will understand that the provided drawings are for better understanding of the present application, and do not constitute any limitation on the scope of the present application. Among them:

[0033] Figure 1 is a schematic diagram of an example of a wire control valve prosthesis according to an embodiment of the present application;

[0034] Figure 2 is a schematic diagram of another example of a wire control valve prosthesis according to an embodiment of the present application;

[0035] Figure 3a is a schematic diagram of an implant delivery device according to an embodiment of the present application, which comprises a wire deployment component;

[0036] Figure 3b is a schematic diagram of an implant delivery device according to an embodiment of the present application, which comprises two wire deployment components;

[0037] Figure 3c is a schematic diagram of an implant delivery device and a wire control valve prosthesis according to an embodiment of the present application;

[0038] Figure 4 is a schematic diagram of an inner tube and a wire deployment assembly according to an embodiment of the present application;

[0039] Figure 5 is a schematic diagram of a wire control assembly and an inner tube according to an embodiment of the present application;

[0040] Figure 6 is a schematic diagram of the outer tube, the wire control assembly and the inner tube of an embodiment of the present application;

[0041] Figure 7a 、 Figure 7b is a schematic diagram of the wire control assembly, the driving wire and the removal wire of an embodiment of the present application;

[0042] Figures 8a-8c is a schematic diagram of the connection between the removal wire and the pull wire of an embodiment of the present application;

[0043] Figures 9a-9c is a schematic diagram of the bending control of the delivery device of an embodiment of the present application;

[0044] Figures 10a-10c is a schematic diagram of several preferred examples of the first through structure of an embodiment of the present application;

[0045] Figures 11a-11d is a schematic diagram of several preferred examples of the first through hole, the second through hole and the third through hole of an embodiment of the present application;

[0046] Figure 12 is a perspective view of the wire control assembly, the driving wire and the removal wire of an embodiment of the present application;

[0047] Figure 13a 、 Figure 13b is a schematic diagram of several preferred examples of the wire deployment component of an embodiment of the present application;

[0048] Figures 14a-14c is a schematic diagram of the steps of using the delivery system of an embodiment of the present application.

[0049] In the drawings:

[0050] 01-wire control bracket; 02-pull wire; 021-fixed wire; 022-detaching wire; 022a-fixed end; 022b-detaching end; 023-wire buckle;

[0051] 11-inner tube; 12-outer tube; 13-wire deployment component; 131- conversion piece; 131a-third through hole; 131b-third groove; 131c- hole; 132-second fixed ring; 133-fourth through hole; 14-conical head; 15- operating component;

[0052] 20-wire control assembly; 21-first limiting piece; 211a-first through hole; 211b-first groove; 213-first fixed ring; 22-second limiting piece; 221a-first through hole; 23-core shaft; 24-driving tube;

[0053] 31-driving wire; 311-pull ring; 32-removal wire; 321-encircling segment; 322-pin-shaped piece. DETAILED DESCRIPTION

[0054] The objects, advantages and features of the present application will become more apparent from the following detailed description, taken in conjunction with the accompanying drawings in which:

[0055] As used in the present disclosure, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise. The term "plurality" is generally employed in its sense including "at least one" unless the content clearly dictates otherwise. The term "at least two" is generally employed in its sense including "two or more" unless the content clearly dictates otherwise. In addition, the terms "first," "second," "third," etc. are used only to describe a particular name for ease of identification, and are not intended to indicate or imply relative importance or a specific number of the technical features indicated. Thus, the features defined with "first," "second," "third" can explicitly or implicitly include one or at least two of the features. The terms "one end" and "the other end" and "proximal end" and "distal end" generally refer to two parts corresponding to each other, which include not only the end points. The terms "proximal end" and "distal end" are defined herein with respect to a delivery device having one end for intervention into a human body and a control end extending out of the body. The term "proximal end" refers to a position of an element closer to the control end of the delivery device extending out of the body, and the term "distal end" refers to a position of an element closer to the end of the delivery device for intervention into the human body and thus farther away from the control end of the delivery device. Alternatively, in the application scenario of manual or hand operation, the terms "proximal end" and "distal end" are defined herein with respect to an operator such as a surgeon or a clinician. The term "proximal end" refers to a position of an element closer to the operator, and the term "distal end" refers to a position of an element closer to the delivery device and thus farther away from the operator. In addition, as used in the present disclosure, "mounting", "connecting", "connecting", an element "provided" in another element should be broadly understood, generally only indicates that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the connection, coupling, cooperation or transmission between the two elements can be direct or indirect through intermediate elements, and cannot be understood as indicating or implying the spatial positional relationship between the two elements, i.e. one element can be in any orientation inside, outside, above, below or one side of another element, unless the content is otherwise explicitly indicated. For those skilled in the art, the specific meaning of the above terms in the present disclosure can be understood according to the specific circumstances. In addition, directional terms such as above, below, up, down, upward, downward, left, right, etc. are used with respect to the exemplary embodiments as they are shown in the figures, upward or upward direction is towards the top of the corresponding figure, and downward or downward direction is towards the bottom of the corresponding figure.

[0056] The purpose of the present disclosure is to provide a delivery device and delivery system for an implant to solve the problems of easy displacement and complex operation of the existing delivery device valve prosthesis.

[0057] The following is described with reference to the accompanying drawings.

[0058] Figure 1 and Figure 2An implant is shown, in particular a wire-controlled valve prosthesis, which comprises a wire-controlled stent 01 and a pull wire 02. The wire-controlled stent 01 is preferably a self-expandable stent, which is radially expandable or contractible. A portion of the pull wire 02 is arranged circumferentially around the wire-controlled stent 01, and by driving the pull wire 02, the expansion or contraction of the wire-controlled stent 01 can be controlled. In some embodiments, the wire-controlled valve prosthesis comprises at least two pull wires 02. The at least two pull wires 02 can be divided into fixed wires 021 and disengaging wires 022 according to different functions. The fixed wire 021 can be understood as a pull wire 02 with both ends being fixed ends 022a, both of which are fixedly connected with a delivery device, thereby forming a loop. If there are more than two fixed wires 021, the latter fixed wire 021 passes through the loop of the former fixed wire 021, forming a sequentially pinned relationship; the disengaging wire 022 has a fixed end 022a and a disengaging end 022b, the fixed end 022a is used to be fixedly connected with the delivery device, and the disengaging end 022b is used to be detachably connected with the delivery device. Further, the disengaging wire 022 passes through the loop of the last fixed wire 021 to pin the last fixed wire 021. In this way, after the delivery device is separated from the disengaging end 022b, the disengaging wire 022 is equivalent to releasing the pinning of the last fixed wire 021, and the fixed wires 021 are also sequentially released from the pinning relationship, so that the pull wire 02 and the wire-controlled stent 01 are disconnected from each other, at this time, the pull wire 02 can be driven to move towards the proximal end by the delivery device to complete the withdrawal of the pull wire 02 (withdrawal refers to the disengagement of the pull wire 02 from the wire-controlled stent 01 and the withdrawal towards the proximal end). Figure 1 In the shown exemplary embodiment, the disengaging wire 022 forms a single loop. As shown in other embodiments, Figure 2 In other embodiments, the pull wire 02 is used for disengagement without distinction between the fixed wire 021 or the disengaging wire 022, or all the pull wires 02 can be considered as disengaging wires 022. In these embodiments, each pull wire 02 has a fixed end 022a and a disengaging end 022b, the fixed end 022a of the pull wire 02 is fixedly connected with the delivery device, and the disengaging end 022b of the pull wire 02 is detachably connected with the delivery device. In this way, after the delivery device is separated from the disengaging end 022b of the pull wire 02, the disengaging end 022b of the pull wire 02 is relaxed, so that the pull wire 02 and the wire-controlled stent 01 are disconnected from each other to further complete the withdrawal of the pull wire 02.

[0059] Based on the wire-controlled valve prosthesis as described above, the pull wire 02 can be extended towards the proximal end for operation, which makes the pull wire 02 easy to cross and entangle with each other, affecting the operation. Therefore, please refer to Figures 3a to 6The embodiment of the present application provides a kind of delivery device of implant, it includes: wire control component 20, drive line 31 and removal line 32;The wire control component 20 is used to drive wire control support 01 expansion or contraction by pull wire 02;The removal line 32 is detachably connected with the wire control component 20;The drive line 31 is used to be connected with the pull wire 02;The removal line 32 is used to be detachably connected with the pull wire 02;Wherein, when the removal line 32 is connected with the pull wire 02, the removal line 32 limits the axial position of the drive line 31 relative to the wire control component 20 by the pull wire 02;When the removal line 32 is disconnected with the pull wire 02, the axial position of the drive line 31 is released from the limitation.It needs to be explained, limit the axial position of drive line 31 relative to wire control component 20 is that the connection of both is relatively fixed.And release the axial position of drive line 31 is that the fixed relationship of drive line 31 relative to wire control component 20 is released, the axial movement of both is decoupled, i.e. if pull drive line 31 to proximal end, wire control component 20 will not be pulled to proximal end.The axial position relationship of pull wire 02 and surrounding section 321 relative to wire control component 20 can also be understood by referring to the axial position relationship of drive line 31 relative to wire control component 20.

[0060] So configured, when the removal line 32 is disconnected with the pull wire 02, the drive line 31 can be released from the limitation, and when the drive line 31 is pulled to proximal end, the pull wire 02 can be pulled to proximal end together, so as to realize wire removal.The structure of delivery device is simple, and the wire removal action is simple, which can simplify the operation process, improve the operation success rate, and the friction stroke of pull wire 02 is small, the stability of wire control support 01 is little affected during wire removal process, and the operation success rate is effectively improved.Further, since the position of drive line 31 relative to wire control component 20 is limited towards proximal end when the removal line 32 is connected with the pull wire 02, when the drive line 31 is pulled to proximal end, wire control component 20 can also be bent on the proximal end side of delivery device, so as to realize bending control function.

[0061] Further, the delivery device comprises an inner tube 11, and the wire control assembly 20 is movably sleeved on the inner tube 11 along the axial direction of the inner tube 11. The inner tube 11 is used for passing a guide wire, and the extending direction of the inner tube 11 is the axial direction, i.e. the axial direction of the whole delivery device. It can be understood that, since the inner tube 11 is bendable, the axial direction is not a straight line, but follows the bending of the inner tube 11. The proximal end of the inner tube 11 is connected with the handle 15. Further, the delivery device further comprises an outer tube 12 movably sleeved on the wire control assembly 20 and the inner tube 11 along the axial direction, and the implant is accommodated in the outer tube 12 after being folded or contracted. Optionally, the distal end of the inner tube 11 is provided with a tapered head 14 to facilitate the delivery of the delivery device, and the proximal end of the delivery device is provided with an operating part 15 (such as a handle). The specific structure of other parts of the delivery device can be understood and configured by those skilled in the art according to the prior art, and the present application does not make a detailed description here.

[0062] Further, the delivery device comprises a wire deployment part 13 connected with the inner tube 11, and the wire deployment part 13 is used for changing the extending direction of the pull wire 02 from the axial direction to the radial direction. The wire deployment part 13 is mainly used for changing the extending direction of the pull wire 02. Preferably, the position of the wire deployment part 13 along the axial direction is matched with the loading position of the wire control stent 01, and more preferably, the distal end of the wire deployment part 13 is matched with the position of the pull wire 02 around the wire control stent 01, so as to minimize the angle of the pull wire 02 between the wire deployment part 13 and the wire control stent 01 relative to the radial direction of the wire control stent 01, and preferably make the part of the pull wire 02 parallel to the radial direction of the wire control stent 01. Figure 3a In the shown exemplary embodiment, the delivery device comprises one wire deployment part 13. Optionally, referring to 3b, the delivery device comprises two or more wire deployment parts 13, and the two or more wire deployment parts 13 are distributed along the axial direction of the inner tube 11. Preferably, the wire control stent 01 has a certain length along the axial direction, and at least one wire deployment part 13 is arranged at the position corresponding to the proximal end and the distal end of the wire control stent 01 respectively, so as to enable the pull wire 02 to uniformly apply force to the wire control stent 01 at the proximal end and the distal end, and make the wire control stent 01 more uniform in contraction and expansion. Figure 3c The delivery device and the wire control valve prosthesis are shown in the assembled state.

[0063] The structure and principle of the wire control assembly 20, the driving wire 31, the removal wire 32 and the pull wire 02 will be further described below with reference to the accompanying drawings. Figure 7a Figure 7b The structure and principle of the wire control assembly 20, the driving wire 31, the removal wire 32 and the pull wire 02 will be further described below with reference to the accompanying drawings.

[0064] ​Optionally, the driving line 31 is connected with the pull line 02 along a first direction, the removing line 32 is connected with the pull line 02 along a second direction, and the first direction is arranged at an angle with the second direction. In the exemplary embodiment shown in FIG. 7a, the first direction is the horizontal direction in Figure 7a , and the second direction is the vertical direction in Figure 7a . In other embodiments, the first direction and the second direction are not limited to be perpendicular, as long as they are at an angle. In an alternative exemplary embodiment, the removing line 32 comprises a looped segment 321, which is initially connected with the pull line 02, and the looped segment 321 is circumferentially looped around at least part of the wire control assembly 20. In this way, the looped segment 321 is initially connected with the pull line 02 along the second direction. Thus, when the pull line 02 is moved along the first direction, it is limited by the removing line 32 along the second direction.

[0065] Since the driving line 31 is connected with the pull line 02, and the looped segment 321 of the removing line 32 is connected with the pull line 02, the position of the pull line 02 is limited by the removing line 32, and at this time the removing line 32 is also connected with the wire control assembly 20, so the axial position of the driving line 31 relative to the wire control assembly 20 is also limited, that is, the removing line 32 limits the axial position of the driving line 31 relative to the wire control assembly 20 through the pull line 02. It can be understood that when the removing line 32 is connected with the pull line 02, the removing line 32 is also used to limit the axial position of the pull line 02 relative to the wire control assembly 20.

[0066] Further, the looped segment 321 is disconnected from the pull line 02 when a preset condition is met. The preset condition can be different according to different connection modes of the looped segment 321 and the pull line 02. For example, in some embodiments, the looped segment 321 and the pull line 02 are mechanically connected, and the preset condition can be that the looped segment 321 mechanically moves, expands, or is unlocked relative to the pull line 02; in other embodiments, the looped segment 321 and the pull line 02 can be electrolytically separated, and the preset condition can be that electricity is supplied; in other embodiments, the looped segment 321 and the pull line 02 can be separated by dissolution, and the preset condition can be that a certain period of time is waited, and the like. Those skilled in the art can set the specific preset condition according to the different connection modes of the looped segment 321 and the pull line 02.

[0067] Please refer to Figure 7b , after the looped segment 321 is disconnected from the pull line 02, the axial position of the pull line 02 is no longer limited, and at this time the driving line 31 is pulled towards the proximal end, thereby dragging the pull line 02 towards the proximal end, and the wire removal is completed. It can be understood that the pull line 02 connected with the driving line 31 can be regarded as a disconnection line 022, and the end of the pull line 02 connected with the driving line 31 can be regarded as a disconnection end 022b. Combined with Figure 1 andFigure 2 In the shown example, if there are other fixation lines 021, both ends of the fixation line 021 can be fixed to the wire control assembly 20. In this configuration, after the looped segment 321 is connected to the pull line 02, the wire control assembly 20, the driving line 31, the removal line 32, and the pull line 02 form a combined body that can move together in the axial direction of the inner tube 11, thereby achieving control of the deployment and retraction of the wire control stent 01. When the preset condition is met, the looped segment 321 is disconnected from the pull line 02, and the driving line 31 is pulled proximally, thereby completing the removal of the wire.

[0068] Preferably, when the pull line 02 is connected to the removal line 32, the axial distance between the wire control assembly 20 and the distal end of the delivery device (understood as the axial distance between the distal end of the wire control assembly 20 and the distal end of the delivery device) is not greater than 300 mm. In this configuration, the wire control assembly 20 is integrated into the distal end portion of the delivery device, simplifying the wire control structure of the delivery device. In addition, the pulling and disconnecting actions of the pull line 02 are simple, the friction stroke is small, the stability of the wire control stent 01 during the removal process is less affected, the success rate of the operation is improved, and the problems of long removal path and complex operation of the existing delivery device are overcome.

[0069] Figure 7a and Figure 7b In the shown example, at least one end of the pull line 02 has a wire buckle 023, which is preferably a closed loop. After the looped segment 321 passes through the wire buckle 023, the position of the wire buckle 023 can be limited, at which time the removal line 32 can be considered to be connected to the pull line 02. It can be understood that the wire buckle 023 can be considered as the disconnection end 022b. In some embodiments, the wire buckle 023 can be formed by one end of the pull line 02 itself, such as coiled knotting, bonding, or welding, at which time the other end of the pull line 02 can be fixed to the wire control assembly 20 to form the fixed end 022a. This is suitable for, for example, Figure 1 The wire control valve prosthesis shown. In other embodiments, both ends of the pull line 02 can be formed together. This is suitable for, for example, Figure 2 The wire control valve prosthesis shown. Optionally, the distal end of the driving line 31 has a pull ring 311, and the wire buckle 023 is arranged therein, so that the driving line 31 and the wire buckle 023 are connected.

[0070] Preferably, please refer to Figures 8a-8c The distal end of the looped segment 321 has an open pin 322, which is used to pass through the wire buckle 023 to connect with the pull line 02; the preset condition includes moving the pin 322 away from the pull line 02 to disengage from the wire buckle 023. This embodiment does not limit the specific form of the pin 322, Figures 8a-8cThe pin-shaped member 322 is shown in helical, L-shaped and hook-shaped respectively, which have the common feature of having an opening instead of being closed. When the pin-shaped member 322 moves away from the wire buckle 023, the pin-shaped member 322 can be deformed by force, so that the wire buckle 023 is slipped off the pin-shaped member 322. In an alternative example, the pin-shaped member 322 is in a helical shape, and the number of turns of the helix is between 1 and 3. The pin-shaped member 322 can be made of metal or non-metal materials. It is understood that the force that deforms the pin-shaped member 322 should be less than the tensile limit of the pull wire 02. It should be noted that Figures 8a-8c Only the connection mode of the pin-shaped member 322 and the wire buckle 023 is shown, and it is not intended to limit the extension direction of the removal wire 32.

[0071] Please continue to refer to Figure 7a Optionally, the wire control assembly 20 includes a mandrel 23, which is used for the removal wire 32 to surround, specifically for the surrounding section 321 of the removal wire 32 to surround.

[0072] Optionally, when the removal wire 32 is connected with the pull wire 02, the surrounding section 321 circumferentially surrounds at least part of the wire control assembly 20 (such as the mandrel 23), and the axial position of the surrounding section 321 is limited relative to the wire control assembly 20; when the removal wire 32 is disconnected from the pull wire 02, the limitation on the axial position of the surrounding section 321 is released. It should be noted that the surrounding section 321 circumferentially surrounds at least part of the wire control assembly 20, and the surrounding section 321 can surround part or the entire circumference of the wire control assembly 20. The axial position of the surrounding section 321 relative to the wire control assembly 20 can be limited in various ways, for example, in some embodiments, the axial position of the surrounding section 321 relative to the wire control assembly 20 can be limited by the friction between the surrounding section 321 and the mandrel 23. When the pin-shaped member 322 is connected to the wire buckle 023, slightly pulling the removal wire 32 towards the proximal end, the surrounding section 321 and / or the wire buckle 023 will generate friction with the mandrel 23, so that the surrounding section 321 will not easily move along the axial direction of the wire control assembly 20. In other embodiments, a ring-shaped groove can also be formed circumferentially on the mandrel 23, and the surrounding section 321 is partially embedded in the groove, which also has the effect of limiting the axial position of the surrounding section 321.

[0073] Optionally, the wire control assembly 20 comprises a first limiting member 21, which is connected to the distal end of the mandrel 23; the radial outer dimension of the first limiting member 21 is larger than that of the mandrel 23. It is to be noted that the radial outer dimension of the first limiting member 21 refers to the largest radial outer dimension of the first limiting member 21. If the outer periphery of the first limiting member 21 is circular, the radial outer dimension of the first limiting member 21 is the outer diameter thereof. If the outer periphery of the first limiting member 21 is polygonal, the radial outer dimension of the first limiting member 21 is the diameter of the circumscribed circle thereof. The radial outer dimension of the mandrel 23 is the same as well. The radial outer dimension of other components described below can be understood in the same way as the definition of the radial outer dimension of the first limiting member 21. Since the radial outer dimension of the first limiting member 21 disposed at the distal end of the mandrel 23 is large, it can limit the position of the surrounding segment 321 towards the distal end. Thus, when the wire control assembly 20 is driven to move towards the proximal end, the first limiting member 21 can drive the surrounding segment 321 to move towards the proximal end by abutting against the surrounding segment 321.

[0074] Optionally, the wire control assembly 20 comprises a second limiting member 22, which is connected to the proximal end of the mandrel 23; the radial outer dimension of the second limiting member 22 is larger than that of the mandrel 23. Further, the wire control assembly 20 comprises a driving tube 24, the distal end of which is connected to the second limiting member 22; when the removal wire 32 is connected to the pull wire 02, the driving wire 31 drives the driving tube 24 to bend towards the proximal end, thereby driving the delivery device to bend on the proximal side of the wire control assembly. Since the radial outer dimension of the second limiting member 22 disposed at the proximal end of the mandrel 23 is large, it can limit the position of the surrounding segment 321 towards the proximal end. Thus, please refer to Figures 9a-9c When the driving wire 31 is pulled towards the proximal end, the driving wire 31 drives the surrounding segment 321 to move towards the proximal end by the wire buckle 023, which will be blocked by the second limiting member 22, so that the driving wire 31 drives the driving tube 24 to bend when it is pulled towards the proximal end. It can be understood that the bending of the driving tube 24 will drive the inner tube 11, the outer tube 12, etc. of the delivery device to bend together, thereby realizing the control bending function.

[0075] Preferably, the first limiting member 21 comprises a first through structure axially through; the first through structure is used for the pull wire 02 to pass through. Each first through structure can accommodate one or more pull wires 02 to pass through. The first through structure defines the circumferential position of the pull wire 02, thereby avoiding the pull wires 02 from crossing each other to produce scratching or winding.

[0076] In some embodiments, as shown in Figure 10a and Figure 10b the first through structure is a first through hole 211a axially through, and the first through hole 211a is arranged in the first limiting member 21.Figure 10a and Figure 10b In the exemplary embodiment shown, the first limiting member 21 is a multi-cavity tube, which includes a plurality of first through holes 211a, whereby the first through holes 211a limit the circumferential position of the pull wires 02. The cross-sectional shape and number of the first through holes 211a are not limited in this embodiment, Figure 11a Fig. 11d exemplarily shows several preferred cross-sectional shapes of the first through holes 211a. It should be understood that, Figures 11a-11d these are merely examples of the cross-sectional shape and number of the first through holes 211a, and are not limitations on the cross-sectional shape and number of the first through holes 211a. For example, in some embodiments, if there is only one disconnection line 022, the first limiting member 21 can only include one first through structure.

[0077] Further, the first limiting member 21 includes at least two first through structures; the at least two first through structures are circumferentially arranged around the first limiting member 21; and the at least two first through structures are respectively used for passing the different pull wires 02. Preferably, the disconnection lines 022 in the two groups of pull wires 02 at the proximal end and the distal end of the wire control support 01 are respectively passed through different first through structures.

[0078] In other embodiments, as Figure 10c shown, the first through structure is a first groove 211b axially opened on the outer periphery of the first limiting member 21. In Figure 10c the exemplary embodiment shown, the first limiting member 21 is a gear-like structure, and the outer periphery thereof has a plurality of first grooves 211b, each of which can accommodate one or more pull wires 02 to pass through, which can also limit the circumferential position of the pull wires 02. Further, the outer periphery of the first limiting member 21 can also be provided with a first fixing ring 213 to further limit the position of the pull wires 02, or to be wound around the pull wires 02.

[0079] It should be noted that, Figures 10a-10c only exemplary examples of the first through holes 211a and the first grooves 211b are shown, and the passing mode of the pull wires 02 is not limited, and the wire buckle 023, Figure 10a and Figure 10c the circumferential segment 321 of the removal wire 32 are not shown in the first limiting member 21.

[0080] Optionally, the removal line 32 is looped around the mandrel 23 for connecting with different pull lines 02 respectively. In an exemplary embodiment, the first limiting member 21 comprises at least two first penetrating structures, and n different pull lines 02 pass through the different first penetrating structures respectively to form n line buckles 023. The same removal line 32 sequentially passes through the line buckles 023 of n-1 different pull lines 02, and then connects with the line buckle 023 of the nth pull line 02 by using a pin-shaped member 322, wherein n is a natural number greater than 1. In this way, after the pin-shaped member 322 is separated from the line buckle 023 of the nth pull line 02, and the removal line 32 is pulled to withdraw from the line buckles 023 of the pull lines 02, the disengagement ends 022b of the pull lines 02 can be simultaneously untied. Then, the pull lines 02 can be withdrawn. It should be noted that the line buckles 023 of the plurality of pull lines 02 can be connected with different driving lines 31 respectively, or the same driving line 31 can be connected with the line buckles 023 of two or more pull lines 02, that is, pulling one driving line 31 can simultaneously withdraw two or more pull lines 02.

[0081] Further, the second limiting member 22 comprises a second penetrating structure axially penetratingly provided; the second penetrating structure is used for penetrating the driving line 31 and / or the removal line 32. The provision of the second penetrating structure limits the circumferential position of the driving line 31 and / or the removal line 32, so as to avoid mutual crossing and scratching or winding between the driving line 31 and / or the removal line 32.

[0082] Please refer to Figure 12 In an exemplary embodiment, the second penetrating structure is a second through hole 221a axially penetratingly provided, and the present embodiment does not limit the cross-sectional shape and number of the second through hole 221a, Figures 11a-11d Exemplarily, the cross-sectional shapes of several preferred second through holes 221a are shown. It should be understood that Figure 11a Fig. 11d is only an example of the cross-sectional shape and number of the second through hole 221a, but not a limitation on the cross-sectional shape and number of the second through hole 221a. In other embodiments, the second penetrating structure is a second groove axially provided on the outer periphery of the second limiting member 22, which can be specifically referred to the first groove 211b on the first limiting member 21, and will not be repeated here.

[0083] Preferably, the pull ring 311 of the driving line 31 can pass through the second penetrating structure. In this way, when the driving line 31 is pulled towards the proximal end, the withdrawal of the line can be completed by passing through the second penetrating structure. For example, the inner diameter of the second through hole 221a is greater than the outer diameter of the pull ring 311.

[0084] Optionally, the driving line 31, the removal line 32 and the pull line 02 are wire materials with a certain tensile strength, which can be high polymer material wires or metal wires, and those skilled in the art can select appropriate materials according to actual needs.

[0085] Optionally, the wire deployment component 13 comprises a conversion piece 131, the conversion piece 131 is provided with a second limiting structure for limiting the circumferential position of the pull wire 02 around the support bracket unit 10. The provision of the second limiting structure can limit the circumferential position of each pull wire 02, avoiding the interlacing and entangling of each other.

[0086] Preferably, the second limiting structure comprises a plurality of third through holes 131a which are axially through the conversion piece 131; or, the second limiting structure comprises a plurality of third grooves 131b which are axially opened on the outer periphery of the conversion piece 131; the third through holes 131a or the third grooves 131b are used for the pull wire 02 to pass through. The structure and setting principle of the third through holes 131a and the third grooves 131b are similar to the first through holes 211a and the first grooves 211b on the first limiting piece 21, the cross-sectional shape of the third through holes 131a and the third grooves 131b is not limited in the embodiment, the third through holes 131a can be Figure 11a Figure 11d as shown.

[0087] Preferably, the wire deployment component 13 further comprises a transition structure for gradually changing the extension direction of the pull wire 02. It should be noted that the gradual change of the extension direction of the pull wire 02 here refers to that the pull wire 02 has a certain turning radius at the transition structure, rather than a sharp angle. Optionally, the gradual change can be a smooth change in the form of an arc, or a multi-fold change formed by a plurality of fold lines. The provision of the transition structure can effectively reduce the wear of the pull wire 02.

[0088] Please refer to Figure 13a In an alternative exemplary embodiment, the transition structure comprises a second fixed ring 132; the second fixed ring 132 is fixedly arranged relative to the conversion piece 131, and the second fixed ring 132 is used for the pull wire 02 to pass around to change the extension direction. Figure 13a In the shown exemplary embodiment, the conversion piece 131 has a third groove 131b which is axially opened on the outer periphery, and the second fixed ring 132 is connected with the conversion piece 131 by welding, bonding, mechanical limiting or the like, and the inner periphery of the second fixed ring 132 and the third groove 131b form a closed hole which can be used for the pull wire 02 to pass around to change the extension direction, which not only limits the circumferential position of the pull wire 02, but also makes the second fixed ring 132 as a transition structure to make the pull wire 02 change the extension direction smoothly. Of course, in other embodiments, the conversion piece 131 with the third through holes 131a can also be used in cooperation with the second fixed ring 132 to change the extension direction of the pull wire 02, and the present application is not limited thereto.

[0089] ​Please refer to Figure 13b In another alternative exemplary embodiment, the conversion member 131 has a hole 131c opened along the axial direction of the delivery tube assembly 10, and the second limiting structure includes a plurality of fourth through holes 133 opened along the radial direction of the conversion member 131 and in communication with the hole 131c; the transition structure includes the fourth through holes 133; the hole 131c and the fourth through holes 133 are used for the pull wire 02 to pass through to change the extension direction. The hole 131c can be in various forms such as a through hole, a blind hole, or a ring groove, and the pull wire 02 can pass through the hole 131c and then pass through the fourth through hole 133 to change the extension direction. In Figure 13b In the exemplary embodiment shown, the hole 131c is annular and open towards the proximal end along the axial direction of the conversion member 131, and the side wall of the fourth through hole 133 serves as the transition structure. Preferably, the intersection between the side wall of the fourth through hole 133 and the hole 131c is a circular arc surface to form a smooth transition. In this configuration, the outer periphery of the conversion member 131 can no longer be provided with an additional second fixing ring 132, thereby reducing the radial outer dimension of the wire deployment component 13, reducing the contact height of the wire deployment component 13 with the wire-controlled stent 01, and reducing the interference when the wire-controlled stent 01 is pressed.

[0090] Optionally, the delivery device includes two or more wire-controlled assemblies 20, which are spaced apart along the axial direction of the inner tube 11 and can be respectively connected to different pull wires 02 to control the extension and retraction of different pull wires 02.

[0091] Based on the delivery device of the implant as described above, the present embodiment also provides a delivery system of an implant, which includes a wire-controlled valve prosthesis and the delivery device as described above; the wire-controlled valve prosthesis includes a wire-controlled stent 01 and at least one set of pull wires 02; the wire-controlled stent 01 is detachably loaded on the delivery device of the implant, and a portion of the pull wires 02 is arranged circumferentially around the wire-controlled stent 01 and is used to drive the wire-controlled stent 01 to expand or contract under the drive of the wire-controlled assembly 20. For the specific structures of other components of the delivery system of the implant, those skilled in the art can understand and configure them according to the prior art, and the present application does not make a detailed description of this.

[0092] The use steps of the delivery system of the implant provided in the present embodiment will be exemplarily described below. Figure 3c , and Figures 14a-14c The use steps of the delivery system of the implant provided in the present embodiment will be exemplarily described below.

[0093] Step S1: Please refer to Figure 3c After the delivery and preliminary release of the wire-controlled valve prosthesis are completed, the relationship between the delivery device and the wire-controlled valve prosthesis is as shown in Figure 3cAs shown, the wire-controlled stent 01 of the wire-controlled valve prosthesis is in an expanded (or semi-expanded due to the limitation of the implantation site) state due to self-expansion. The wire-controlled stent 01 drives the pull wire 02 to move towards the distal end, and the wire-controlled assembly 20 is located at the distal end Figure 3c position (right side in the figure).

[0094] Step S2: If the release position of the wire-controlled valve prosthesis is appropriate at this time, and the position of the wire-controlled valve prosthesis does not need to be adjusted, the withdrawal wire 32 can be pulled towards the proximal end to separate the withdrawal wire 32 from the pull wire 02, and then the driving wire 31 is pulled towards the proximal end to complete the withdrawal, as shown in Figure 14a .

[0095] Step S3: If the release position of the wire-controlled valve prosthesis is not appropriate at this time, and the position of the wire-controlled valve prosthesis needs to be adjusted, the wire-controlled valve prosthesis can be retrieved. In the state shown in Figure 3c , the wire-controlled assembly 20 is driven by the driving tube 24 to move towards the proximal end. At this time, the driving wire 31, the withdrawal wire 32, the pull wire 02, and the wire-controlled assembly 20 form a combined body and move towards the proximal end together, so that the wire-controlled stent 01 is compressed until it is in a contracted state, as shown in Figure 14b .

[0096] Step S4: Further, the outer tube 12 moves towards the distal end to cover the wire-controlled stent 01, as shown in Fig. 14c. At this time, the retrieval of the wire-controlled valve prosthesis is completed, and the wire-controlled valve prosthesis can be moved together by driving the entire delivery device until it reaches the intended adjustment position, and the wire-controlled valve prosthesis is released. It can be understood that the step of moving the outer tube 12 towards the distal end to cover the wire-controlled stent 01 is an optional step. In some cases, for example, only the position of the wire-controlled valve prosthesis needs to be fine-tuned, the wire-controlled stent 01 can be directly moved after being compressed.

[0097] Step S5: Release process of the wire-controlled valve prosthesis: optionally, the outer tube 12 is moved towards the proximal end until the compressed wire-controlled stent 01 is completely exposed, as shown in Figure 14b . It can be understood that this step is an optional step.

[0098] Step S6: Further, the wire-controlled assembly 20 is driven by the driving tube 24 to move towards the distal end, the tension on the pull wire 02 is released, and the wire-controlled stent 01 expands based on its self-expansion performance, as shown in Figure 3c .

[0099] Step S7: If the release position of the wire-controlled valve prosthesis is appropriate at this time, return to execute the aforementioned step S2 to complete the withdrawal.

[0100] Step S8: If the release position of the wire-controlled valve prosthesis is not appropriate at this time, return to execute the aforementioned steps S3-S6 to adjust the position of the wire-controlled valve prosthesis again.

[0101] To sum up, in the implant delivery device and delivery system provided by the application, the implant delivery device comprises a wire control assembly, a driving wire and a removal wire; the wire control assembly is used to drive the expansion or contraction of the wire control stent by a pull wire; the driving wire is used to be connected with the pull wire; the removal wire is used to be detachably connected with the pull wire; when the removal wire is connected with the pull wire, the removal wire limits the axial position of the driving wire relative to the wire control assembly through the pull wire; when the removal wire is detached from the pull wire, the limitation on the axial position of the driving wire is released. In this way, when the removal wire is detached from the pull wire, the limitation on the driving wire can be released, and when the driving wire is pulled towards the proximal end, the pull wire can be pulled towards the proximal end together, so as to realize the removal of the wire. The structure of the delivery device is simple, the removal action is simple, the surgical process can be simplified, the success rate of surgery can be improved, the friction stroke of the pull wire is small, the stability of the wire control stent is less affected during the removal process, and the success rate of surgery is effectively improved. Further, since the position of the driving wire relative to the wire control assembly is limited towards the proximal end when the removal wire is connected with the pull wire, when the driving wire is pulled towards the proximal end, the wire control assembly can also be bent on the proximal side of the wire control assembly, so as to realize the bending control function.

[0102] It should be noted that the above several embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the application, and does not limit the scope of the application in any way. Any modification or modification made by a person skilled in the art according to the above disclosure is within the protection scope of the claims.

Claims

1. An implant delivery device, characterized by, The application relates to a wire control assembly, a driving wire and a removal wire. The wire control assembly is used for driving a wire control support to expand or contract through a pulling wire; the pulling wire comprises a fixed wire and a detachable wire, both ends of the fixed wire are fixed to the wire control assembly, the detachable wire has a separation end and a fixed end, the fixed end is fixed to the wire control assembly, the removal wire is detachably connected with the wire control assembly; the driving wire is used for being connected with the separation end of the pulling wire; the removal wire is used for being detachably connected with the pulling wire. When the removal wire is connected with the pulling wire, the removal wire limits the axial position of the driving wire relative to the wire control assembly through the pulling wire. When the removal wire is disconnected with the pulling wire, the limitation on the axial position of the driving wire is released. The driving wire is connected with the pulling wire in a first direction, the removal wire is connected with the pulling wire in a second direction, and the first direction is arranged at an angle with the second direction.

2. The implant delivery device of claim 1, wherein, When the removal wire is connected with the pulling wire, the removal wire is also used for limiting the axial position of the pulling wire relative to the wire control assembly.

3. The implant delivery device of claim 1, wherein, The removal wire comprises a surrounding segment, the surrounding segment is initially connected with the pulling wire; when a preset condition is met, the surrounding segment is disconnected with the pulling wire.

4. The implant delivery device of claim 1, wherein, When the removal wire is connected with the pulling wire, the surrounding segment is circumferentially surrounded on at least part of the wire control assembly, and the surrounding segment is limited in the axial position relative to the wire control assembly. When the removal wire is disconnected with the pulling wire, the limitation on the axial position of the surrounding segment is released. A distal end of the surrounding segment has an open pin-shaped part, the pin-shaped part is used for penetrating into a wire buckle of the pulling wire to be connected with the pulling wire; the preset condition comprises that the pin-shaped part moves away from the pulling wire to be disconnected from the wire buckle.

5. The implant delivery device of claim 4, wherein, The wire control assembly comprises a mandrel, the mandrel is used for surrounding the removal wire.

6. The implant delivery device of claim 1, wherein, The wire control assembly comprises a first limiting part, the first limiting part is connected with a distal end of the mandrel; the radial outer dimension of the first limiting part is larger than the radial outer dimension of the mandrel; 7. The implant delivery device of claim 6, wherein, The first limiting part comprises a first penetrating structure which is opened through in the axial direction; the first penetrating structure is used for penetrating the pulling wire. The wire control assembly comprises a second limiting part, the second limiting part is connected with a proximal end of the mandrel; the radial outer dimension of the second limiting part is larger than the radial outer dimension of the mandrel; 8. The implant delivery device of claim 6, wherein, The second limiting part comprises a second penetrating structure which is opened through in the axial direction; the second penetrating structure is used for penetrating the driving wire and / or the removal wire. A distal end of the driving wire has a pull ring, the pull ring is used for penetrating the pulling wire; the pull ring can pass through the second penetrating structure.

9. The implant delivery device of claim 8, wherein, The wire control assembly comprises a driving tube, a distal end of the driving tube is connected with the second limiting part; when the removal wire is connected with the pulling wire, the driving tube is bent towards the proximal end driven by the driving wire, so that the conveying device is bent on the proximal end side of the wire control assembly.

10. The implant delivery device of claim 8, wherein, ​ 11. The delivery device of an implant according to claim 7, characterized in that The first limiting member comprises at least two first through structures; the at least two first through structures are arranged circumferentially around the first limiting member; and the at least two first through structures are respectively used for threading different pull wires.

12. The implant delivery device of claim 11, wherein, The removal wire is arranged around the mandrel and is respectively used for connecting different pull wires.

13. The delivery device of an implant according to claim 1, characterized in that The delivery device comprises an inner tube, and the wire control assembly is movably sleeved on the inner tube along the axial direction of the inner tube.

14. The implant delivery device of claim 13, wherein, The delivery device comprises a wire deployment component connected with the inner tube, and the wire deployment component is used for changing the extension direction of the pull wire from the axial extension to the radial extension.

15. The implant delivery device of claim 14, wherein, The delivery device comprises two or more wire deployment components which are distributed along the axial direction of the inner tube; and / or the delivery device comprises two or more wire control assemblies which are distributed along the axial direction of the inner tube.

16. A delivery system for an implant, characterized by The delivery device comprises: a wire control valve prosthesis and an implant according to any one of claims 1-15; the wire control valve prosthesis comprises a wire control stent and at least one group of pull wires; the wire control stent is detachably loaded on the delivery device of the implant, and a part of the pull wire is arranged circumferentially around the wire control stent and is used for driving the wire control stent to expand or contract under the drive of the wire control assembly.

17. The implant delivery system of claim 16, wherein, At least one end of the pull wire is provided with a wire buckle, and the wire buckle is detachably threaded by the removal wire.

Images