Delivery equipment, systems and manufacturing methods for implantable prostheses

Abstract

This invention relates to the field of medical device technology and discloses a delivery device for implantable prostheses. This invention also discloses a method for manufacturing an implantable prosthesis system and an implantable prosthesis delivery device. In the process of delivering the implantable prosthesis into the human body, the delivery device utilizes the cooperation of a limiting member and a limiting structure to control the rotation direction of the rotating shaft, thereby adjusting the rotation direction of the drive wire. The above design simplifies the structure of the implantable prosthesis system and gives the implantable prosthesis system strict unidirectional actuation.

Description

TECHNICAL FIELD

[0001] The embodiments of the present application relate to the technical field of medical devices, in particular to a delivery device for implanting a prosthesis, a system and a manufacturing method. BACKGROUND

[0002] Interventional therapy is an effective and safe treatment method. In interventional therapy, a delivery device is often used to deliver and implant a prosthesis in the human body, and the special function of the prosthesis is used to restore the normal physiological function of the patient.

[0003] In some cases, a one-way rotating delivery device is needed to complete the implantation of the prosthesis. The existing delivery device uses a one-way bearing to achieve the function of one-way rotation. However, the delivery device using the one-way bearing has many problems, such as the one-way bearing is inconvenient to install due to its structural design in the delivery device, and non-standard parts are needed, increasing the cost. For example, the one-way bearing is fixed by rotating into the containing member through the threaded fixing member, and when the rotating shaft rotates, the friction torque is transmitted to the one-way bearing, and further transmitted to the threaded fixing member, which will cause the threaded fixing member and the containing member to be disengaged, causing the delivery device to fail. For example, the one-way bearing is generally a needle bearing, and the rotation damping is too small, and a slight torque will cause an undesirable effect, such as premature decoupling with the prosthesis.

[0004] Therefore, it is necessary to provide a delivery device for implanting a prosthesis to solve one or more of the above problems. SUMMARY

[0005] The purpose of the embodiments of the present application is to provide a delivery device for implanting a prosthesis, a system and a manufacturing method, which simplifies the structure of the implanting prosthesis system and makes the implanting prosthesis system have strict one-way actuation.

[0006] To solve one or more of the above technical problems, the present application provides a delivery device for implanting a prosthesis, comprising:

[0007] The accommodation part is provided with an inner cavity through in the axial direction; the rotating shaft is rotatably accommodated in the inner cavity; the driving wire is fixedly connected with the rotating shaft and is used for detachable connection with the implanted prosthesis; and the limiting piece is movably arranged on the accommodation part, and the limiting structure is arranged on the rotating shaft in the circumferential direction, wherein the limiting piece and the limiting structure are configured such that when the rotating shaft rotates relative to the accommodation part in a first direction, the limiting structure drives the limiting piece to move to allow the rotating shaft to rotate the driving wire in the first direction; when the rotating shaft rotates relative to the accommodation part in a second direction, the limiting piece abuts against the limiting structure to prevent the rotating shaft from rotating the driving wire in the second direction, and the first direction and the second direction are opposite.

[0008] The application also provides an implanted prosthesis system, comprising:

[0009] The implanted prosthesis and the delivery device of the implanted prosthesis are detachably connected.

[0010] The application also provides a manufacturing method of the delivery device of the implanted prosthesis, comprising:

[0011] The accommodation part is provided with an inner cavity through in the axial direction; the rotating shaft is rotatably accommodated in the inner cavity; the driving wire is fixedly connected with the rotating shaft and is used for detachable connection with the implanted prosthesis; and the limiting piece is movably arranged on the accommodation part, and the limiting structure is arranged on the rotating shaft in the circumferential direction, wherein the limiting piece and the limiting structure are configured such that when the rotating shaft rotates relative to the accommodation part in a first direction, the limiting structure drives the limiting piece to move to allow the rotating shaft to rotate the driving wire in the first direction; when the rotating shaft rotates relative to the accommodation part in a second direction, the limiting piece abuts against the limiting structure to prevent the rotating shaft from rotating the driving wire in the second direction, and the first direction and the second direction are opposite.

[0012] The application comprises a containing part, a rotating shaft, a driving wire and a limiting part. The containing part has an inner cavity through in the axial direction. At least part of the rotating shaft is rotatably contained in the inner cavity. The driving wire is fixedly connected with the rotating shaft and is used for detachable connection with an implanted prosthesis. The limiting part is movably arranged on the containing part. The rotating shaft is circumferentially provided with a limiting structure. When the rotating shaft rotates relative to the containing part in a first direction, the limiting structure drives the limiting part to move to allow the rotating shaft to drive the driving wire to rotate in the first direction. When the rotating shaft rotates relative to the containing part in a second direction, the limiting part abuts against the limiting structure to prevent the rotating shaft from driving the driving wire to rotate in the second direction. The first direction is opposite to the second direction. In this way, the rotation direction of the rotating shaft is controlled by the cooperation of the limiting part and the limiting structure, and the rotation direction of the driving wire is adjusted. The above design simplifies the structure of the implanted prosthesis system and makes the implanted prosthesis system have strict one-way actuation.

[0013] Optionally, the limiting part is arranged on the containing part in a radially movable manner. When the rotating shaft rotates in the first direction, the limiting structure exerts a first force on the limiting part to move the limiting part in a radial direction of the containing part and away from the rotating shaft. When the rotating shaft rotates in the second direction, the second force exerted by the limiting part on the limiting structure is perpendicular to the radial direction. The limiting part is arranged on the containing part in a radially movable manner. When the rotating shaft rotates in the first direction, the limiting part is moved in a radial direction of the containing part and away from the rotating shaft by the first force of the limiting structure. At this time, the rotating shaft rotates in the first direction. When the rotating shaft rotates in the second direction, the second force exerted by the limiting part on the limiting structure is perpendicular to the radial direction of the rotating shaft. The reaction force of the limiting structure on the limiting part is also perpendicular to the radial direction of the rotating shaft, so the limiting part cannot be moved in the radial direction of the containing part. At this time, the limiting part prevents the rotating shaft from rotating in the second direction.

[0014] Optionally, the limiting part and the limiting structure are both a plurality of limiting parts and limiting structures. The plurality of limiting parts are arranged on the containing part in a spaced manner around the axis of the rotating shaft. The limiting structure is circumferentially arranged on the rotating shaft. The limiting part and the limiting structure are both a plurality of limiting parts and limiting structures. The plurality of limiting parts are arranged on the containing part in a spaced manner around the axis of the rotating shaft. The limiting structure is circumferentially arranged on the rotating shaft. In this way, the rotating shaft can be subjected to the action of the spaced limiting parts during rotation, and the stress is uniform, thereby improving the stability of the delivery device of the implanted prosthesis.

[0015] Optionally, each limiting structure extends in the axial direction of the rotating shaft. The size of the limiting structure in the axial direction of the rotating shaft is greater than the size of the limiting part in the axial direction of the rotating shaft. Each limiting structure extends in the axial direction of the rotating shaft. The size of the limiting structure in the axial direction of the rotating shaft is greater than the size of the limiting part in the axial direction of the rotating shaft. In this way, when the rotating shaft is inserted into the inner cavity, it can be ensured that the limiting part and the limiting structure can abut each other.

[0016] Optionally, the accommodation part is provided with a receiving hole for accommodating the limiting piece, and the receiving hole extends along the radial direction of the accommodation part. The accommodation part is provided with a radially extending receiving hole, and the limiting piece is movably accommodated in the receiving hole. Furthermore, the plurality of limiting pieces correspond to the plurality of receiving holes one by one and pass through the receiving holes to cooperate with the limiting structure. The limiting piece is arranged between the limiting structures through the receiving hole. In this way, the limiting piece can move radially under the action of a force in the radial direction of the rotating shaft. When the limiting piece moves away from the rotating shaft, the limiting piece moves away from the limiting structure, and the rotating shaft can rotate in the first direction. In addition, the limiting piece and the accommodation part are detachably connected through the receiving hole. When the limiting piece is damaged, the limiting piece can be removed and replaced with a new one, which facilitates the maintenance of the delivery device of the implanted prosthesis.

[0017] Optionally, the side wall of the receiving hole is provided with a first foolproof part, and the side wall of the limiting piece is provided with a second foolproof part. The second foolproof part is configured to allow the limiting piece to be completely accommodated in the receiving hole when the limiting piece is inserted into the receiving hole in a preset direction, and to prevent the limiting piece from being completely accommodated in the receiving hole when the limiting piece is not inserted into the receiving hole in the preset direction. The first foolproof part is arranged on the side wall of the receiving hole, and the second foolproof part is arranged on the limiting piece. When the limiting piece is arranged in the receiving groove, the second foolproof part cooperates with the first foolproof part to achieve foolproofing, which can ensure that the limiting piece is installed in the correct installation direction.

[0018] Optionally, the cross-sectional shape of the receiving hole at the first foolproof part is a convex shape, and the cross-sectional shape of the limiting piece at the second foolproof part is also a convex shape. When the limiting piece is accommodated in the receiving groove in the preset direction, the cross sections of the two convex shapes overlap. The cross-sectional shape of the receiving hole at the first foolproof part is a convex shape, and the cross-sectional shape of the limiting piece at the second foolproof part is also a convex shape. When the limiting piece is accommodated in the receiving groove in the preset direction, the cross sections of the two convex shapes overlap.

[0019] Optionally, each limiting piece is provided with a limiting block part at an end away from the rotating shaft, and each receiving hole is provided with a limiting boss part. The limiting block part and the limiting boss part are configured such that when the limiting block part abuts against the limiting boss part, a gap is left between the end of the limiting piece close to the axis of the rotating shaft and the bottom of the limiting structure. Each limiting piece is provided with a limiting block part at an end away from the rotating shaft, and each receiving hole is provided with a limiting boss part. When the limiting piece abuts against the limiting structure through the receiving hole, the limiting block part abuts against the limiting boss part to prevent the limiting piece from moving further towards the rotating shaft. In this way, the limiting piece can be prevented from entering the inner cavity to avoid damage to the delivery device of the implanted prosthesis.

[0020] Optionally, the size of the limiting block part of the limiting member is greater than the size of the rest of the limiting member, and the size of the accommodating hole at the position of the limiting member is smaller than the size of the accommodating hole at the rest of the limiting member. The size of one end of the limiting block part of the limiting member is greater than the size of the rest of the limiting member, thus forming a first blocking shoulder, and the limiting boss part protrudes relative to the side wall of the accommodating hole, thus forming a second blocking shoulder, and the limiting block part and the limiting boss part are in abutment through the contact between the first blocking shoulder and the second blocking shoulder.

[0021] Optionally, the elastic member is arranged in the accommodating part to provide elastic force for the limiting member to move along the radial direction of the accommodating part and towards the rotating shaft. The delivery device for the implantable prosthesis further comprises an elastic member arranged in the accommodating part, and after the limiting structure moves the limiting member away from the rotating shaft in the first direction, the elasticity of the elastic member can automatically reset the limiting member to abut against the limiting structure again.

[0022] Optionally, the elastic member is an elastic ring arranged on the outer wall of the accommodating part and covering the end of the plurality of limiting members away from the rotating shaft. The elastic member is an elastic ring arranged on the outer wall of the accommodating part and covering the end of the plurality of limiting members away from the rotating shaft, so as to ensure that the finger-shaped members do not fall off the accommodating part and ensure the integrity and stability of the delivery device for the implantable prosthesis.

[0023] Optionally, the outer wall of the accommodating part is circumferentially provided with an annular limiting groove, and the elastic ring is located in the limiting groove. The outer wall of the accommodating part is circumferentially provided with an annular limiting groove, and the elastic member is located in the limiting groove, so as to ensure that the elastic member does not fall off the accommodating part and ensure the continuous effect of the elastic member on the finger-shaped members.

[0024] Optionally, the elastic member is a compression spring compressed by the limiting member when the limiting member moves away from the limiting structure, or the elastic member is a tension spring stretched by the limiting member when the limiting member moves away from the limiting structure. The elastic member can be a compression spring or a tension spring, so that it can be selected according to actual needs during manufacturing, thereby reducing the manufacturing difficulty.

[0025] Optionally, the limiting member is a finger-shaped member, and the limiting structure is a one-way tooth. The limiting member is arranged as a simple finger-shaped member, and the limiting structure is arranged as a simple one-way tooth, thereby reducing the manufacturing difficulty of the delivery device for the implantable prosthesis, and thus reducing the manufacturing cost of the delivery device for the implantable prosthesis.

[0026] Optionally, the one-way tooth comprises a first quasi-rotation surface and a first rotation-stopping surface arranged oppositely, and the finger comprises a second quasi-rotation surface and a second rotation-stopping surface arranged oppositely; when the rotation shaft rotates in the first direction, the first quasi-rotation surface contacts the second quasi-rotation surface and pushes the finger away from the rotation shaft, and when the rotation shaft rotates in the second direction, the first rotation-stopping surface contacts the second rotation-stopping surface to prevent the rotation shaft from rotating in the second direction. The one-way tooth comprises a first quasi-rotation surface and a first rotation-stopping surface arranged oppositely, and the finger comprises a second quasi-rotation surface and a second rotation-stopping surface arranged oppositely; when the rotation shaft rotates in the first direction, the first quasi-rotation surface contacts the second quasi-rotation surface and pushes the finger away from the rotation shaft, and when the rotation shaft rotates in the second direction, the first rotation-stopping surface contacts the second rotation-stopping surface to prevent the rotation shaft from rotating in the second direction. In this way, different surfaces are arranged directly on the one-way tooth and the finger to limit the rotation direction of the rotation shaft, without the need for additional components, so that the structure of the delivery device for the implanted prosthesis is simple and the reliability is higher.

[0027] Optionally, the first quasi-rotation surface, the first rotation-stopping surface, the second quasi-rotation surface and the second rotation-stopping surface are all planes; when the finger interacts with the one-way tooth, the planes where the first quasi-rotation surface and the second quasi-rotation surface are located intersect the movement direction of the finger, and the planes where the first rotation-stopping surface and the second rotation-stopping surface are located are parallel to the movement direction of the finger. The first quasi-rotation surface, the first rotation-stopping surface, the second quasi-rotation surface and the second rotation-stopping surface are all planes; the planes where the first quasi-rotation surface and the second quasi-rotation surface are located intersect the movement direction of the finger, and the planes where the first rotation-stopping surface and the second rotation-stopping surface are located are parallel to the movement direction of the finger. The quasi-rotation surfaces and the rotation-stopping surfaces are designed as planes, which has low processing difficulty and reduces the manufacturing cost of the delivery device for the implanted prosthesis.

[0028] Optionally, the rotating shaft is also axially movable relative to the accommodating portion, the rotating shaft comprises a first coordination surface extending from a distal end surface of the rotating shaft to an outer circumferential surface of the limiting structure; each of the fingers comprises a matching portion adjacent to the one-way tooth, the matching portion is provided with a second coordination surface at a position corresponding to the first coordination surface; the first coordination surface and the second coordination surface are configured to interact with each other when the rotating shaft passes through the inner cavity and extends towards the distal end of the accommodating portion, and the fingers and the one-way tooth at least partially overlap, so as to drive the fingers to move radially in a direction away from the one-way tooth. The rotating shaft is axially movable relative to the accommodating portion, the rotating shaft comprises a first coordination surface extending from a distal end surface of the rotating shaft to an outer circumferential surface of the limiting structure, each of the fingers comprises a matching portion adjacent to the one-way tooth, the matching portion is provided with a second coordination surface corresponding to the first coordination surface, when the rotating shaft passes through the inner cavity and extends towards the distal end of the accommodating portion, and the fingers and the one-way tooth at least partially overlap, the first coordination surface and the second coordination surface interact with each other to drive the fingers to move radially in a direction away from the rotating shaft, so that the rotating shaft can be inserted into the inner cavity at any angle, and the fingers and the one-way tooth can smoothly abut each other through the cooperation of the first coordination surface and the second coordination surface.

[0029] The rotating shaft is in the shape of a circular truncated cone at the position of the first coordination surface, and the outer diameter increases from the distal end to the proximal end along the axial direction of the rotating shaft, the second coordination surface is a plane, and the distance from the second coordination surface to the axis of the rotating shaft increases from the distal end to the proximal end along the axial direction of the rotating shaft, or the second coordination surface is a curved surface complementary to the first coordination surface. The rotating shaft is in the shape of a circular truncated cone at the position of the first coordination surface, the outer diameter increases from the distal end to the proximal end along the axial direction of the rotating shaft, the second coordination surface is a plane, and the distance from the second coordination surface to the side surface of the rotating shaft increases from the distal end to the proximal end, or the second coordination surface is a curved surface complementary to the first coordination surface. The part of the rotating shaft at the position of the first coordination surface is in the shape of a circular truncated cone, which is simple in structure and can reduce the manufacturing difficulty of the delivery device of the implanted prosthesis.

[0030] Optionally, the rotating shaft comprises a first step portion at the proximal end and a main body portion at the distal end, the first step portion is coaxially connected with the main body portion, the diameter of the first step portion is larger than the diameter of the main body portion, so as to form a third stop shoulder; the inner cavity comprises a second step portion at the proximal end and a receiving portion at the distal end, the diameter of the second step portion is larger than the diameter of the receiving portion, so as to form a fourth stop shoulder; the diameter of the first step portion is not larger than the diameter of the second step portion and is larger than the diameter of the receiving portion, so as to prevent the rotating shaft from being separated from the receiving portion at the distal end of the receiving portion. The rotating shaft comprises a first step portion at the proximal end and a main body portion at the distal end, the first step portion is coaxially connected with the main body portion, the diameter of the first step portion is larger than the diameter of the main body portion, so as to form a third stop shoulder; the inner cavity comprises a second step portion at the proximal end and a receiving portion at the distal end, the diameter of the second step portion is larger than the diameter of the receiving portion, so as to form a fourth stop shoulder; the diameter of the first step portion is not larger than the diameter of the second step portion and is larger than the diameter of the receiving portion, so as to prevent the rotating shaft from being separated from the receiving portion at the distal end of the receiving portion.

[0031] Optionally, the receiving portion comprises a receiving hole extending in the radial direction, the limiting member is movably received in the receiving hole; the receiving portion further comprises a first mounting through hole extending in the axial direction, the first mounting through hole passes through the receiving hole, the limiting member comprises a second mounting through hole extending in the axial direction of the receiving portion; movably arranging the limiting member on the receiving portion comprises: receiving the limiting member in the receiving hole and passing the elongated member through the first mounting through hole and the second mounting through hole, so as to place the limiting member at a radially pre-set position; placing the rotating shaft in the inner cavity of the receiving portion, so that the limiting structure is adjacent to the limiting member, comprises: after the rotating shaft is placed in the inner cavity of the receiving portion, the elongated member is withdrawn, so that the limiting structure is adjacent to the limiting member. After the fingers are adjacent to the one-way teeth, the elongated member is passed through the first mounting through hole and the second mounting through hole to fix each finger. The elongated member can prevent the fingers from being separated from the receiving portion when the elastic member is arranged. BRIEF DESCRIPTION OF DRAWINGS

[0032] One or more embodiments are illustrated by way of example in the figures that form a part of this disclosure and which are shown by way of example, not limitation, in the figures of the accompanying drawings in which like references indicate similar elements and in which:

[0033] Figure 1 is a cross-sectional side view of a delivery device for an implantable prosthesis according to a first embodiment of the present invention;

[0034] Figure 2 is a perspective view of a delivery device for an implantable prosthesis according to a first embodiment of the present application;

[0035] Figure 3a is a force diagram of a stopper and a stop structure when a rotating shaft is rotated in a first direction in a delivery device for an implantable prosthesis according to the first embodiment of the present application;

[0036] Figure 3b is a force diagram of a stopper and a stop structure when a rotating shaft is rotated in a second direction in a delivery device for an implantable prosthesis according to the first embodiment of the present application;

[0037] Figure 4 is a perspective view of a distal end of a rotating shaft of a delivery device for an implantable prosthesis according to the first embodiment of the present application;

[0038] Figure 5 is a perspective view of a fool-proof structure of a delivery device for an implantable prosthesis according to the first embodiment of the present application;

[0039] Figure 6 is a cross-sectional front view of a distal end of a rotating shaft of a delivery device for an implantable prosthesis according to the first embodiment of the present application;

[0040] Figure 7a is a cross-sectional side view of a distal end of a rotating shaft of a delivery device for an implantable prosthesis according to the first embodiment of the present application;

[0041] Figure 7b is a force diagram of a stopper when assembling a rotating shaft in a delivery device for an implantable prosthesis according to the first embodiment of the present application;

[0042] Figure 8 is a cooperation diagram of a delivery device for an implantable prosthesis and a mitral valve clip according to the first embodiment of the present application;

[0043] Figure 9 is a cross-sectional side view of an implantable prosthesis system according to a second embodiment of the present application;

[0044] Figure 10 is a step diagram of a manufacturing method of a delivery device for an implantable prosthesis according to a third embodiment of the present application;

[0045] Figure 11 is a diagram of an elongated member and a positioning hole of a delivery device for an implantable prosthesis according to the third embodiment of the present application. DETAILED DESCRIPTION

[0046] In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the various embodiments of the present application will be described in detail below with reference to the drawings. However, those skilled in the art can understand that, in the various embodiments of the present application, many technical details are presented in order to make the readers better understand the present application. However, the technical solutions claimed by the present application can be implemented even without these technical details and based on various changes and modifications of the following embodiments.

[0047] In the embodiments of the present application, the terms "upper", "lower", "left", "right", "front", "back", "top", "bottom", "inner", "outer", "middle", "vertical", "horizontal", "lateral", "longitudinal", and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings. These terms are mainly used to better describe the present application and its embodiments, and are not used to limit the indicated devices, elements or components to have a specific orientation, or to be constructed and operated in a specific orientation.

[0048] In addition, in addition to being used to indicate the orientation or positional relationship, the above-mentioned partial terms can also be used to indicate other meanings, for example, the term "upper" can also be used to indicate a certain dependent relationship or connection relationship in some cases. For those skilled in the art, the specific meaning of these terms in the present application can be understood according to the specific circumstances.

[0049] In addition, the terms "mount", "set", "provided with", "open", "connect", "connect" should be broadly understood. For example, it can be fixedly connected, detachably connected, or integrally constructed; it can be mechanically connected, or electrically connected; it can be directly connected, or indirectly connected through an intermediate medium, or it can be internal communication between two devices, elements or components. For those skilled in the art, the specific meaning of the above-mentioned terms in the present application can be understood according to the specific circumstances.

[0050] In addition, the terms "first", "second", and the like are mainly used to distinguish different devices, elements or components (the specific types and structures can be the same or different), and are not used to indicate or imply the relative importance and quantity of the indicated devices, elements or components. Unless otherwise specified, the meaning of "multiple" is two or more.

[0051] The present application provides a delivery device for implanting a prosthesis, having a proximal end and a distal end arranged oppositely, comprising: a housing provided with an inner cavity axially through; a rotating shaft, at least part of the rotating shaft is rotatably accommodated in the inner cavity; a driving wire, the driving wire is fixedly connected with the rotating shaft, for detachable connection with the prosthesis; and a limiting member, the limiting member is movably arranged on the housing, and the rotating shaft is circumferentially provided with a limiting structure, wherein the limiting member and the limiting structure are configured such that, when the rotating shaft rotates relative to the housing in a first direction, the limiting structure drives the limiting member to move to allow the rotating shaft to rotate the driving wire in the first direction; when the rotating shaft rotates relative to the housing in a second direction, the limiting member abuts against the limiting structure to prevent the rotating shaft from rotating the driving wire in the second direction, the first direction and the second direction being opposite.

[0052] The present application does not have special restrictions on the type of implanted prosthesis, for example, it can be a valve clip for repairing a valve using the "rim-to-rim" technology, it can be a spring coil for treating an aneurysm, it can be a left atrial appendage occluder, etc. The present application does not have special restrictions on the purpose of first direction rotation and second direction rotation, for example, coupling between the delivery device and the implanted prosthesis is achieved by relative rotation in the first direction, decoupling between the delivery device and the implanted prosthesis is achieved by relative rotation in the second direction, for example, decoupling between the delivery device and the implanted prosthesis is achieved by relative rotation in the first direction, coupling between the delivery device and the implanted prosthesis is achieved by relative rotation in the second direction.

[0053] The following will take the delivery device in the environment for delivering a mitral valve clip as an example to specifically describe the implementation details of the present application, the following content is only provided for the convenience of understanding, and is not necessary for implementing the present application scheme.

[0054] The first specific embodiment of the present application relates to a delivery device for implanting a prosthesis, such as Figures 1 to 2As shown, the implantable prosthesis system comprises a housing 100, a rotating shaft 200, a driving wire 300 and a limiting member 400, wherein the housing 100 has an inner cavity 110 penetrating in the axial direction, at least part of the rotating shaft 200 is rotatably accommodated in the inner cavity 110, the driving wire 300 is fixedly connected with the rotating shaft 200 and is used for detachable connection with the implantable prosthesis, the limiting member 400 is movably arranged on the housing 100, the rotating shaft 200 is circumferentially provided with a limiting structure 210, when the rotating shaft 200 rotates relative to the housing 100 along a first direction P1, the limiting structure 210 drives the limiting member 400 to move to allow the rotating shaft 200 to drive the driving wire 300 to rotate along the first direction P1, when the rotating shaft 200 rotates relative to the housing 100 along a second direction P2, the limiting member 400 abuts against the limiting structure 210 to prevent the rotating shaft 200 from driving the driving wire 300 to rotate along the second direction P2, wherein the first direction P1 is opposite to the second direction P2.

[0055] For reference Figure 8 In the embodiment, before being implanted into the human body, the distal end of the driving wire 300 is threadedly connected with the mitral valve clip 900, and the driving wire 300 rotates relative to the mitral valve clip 900 along the second direction P2 to realize coupling with the mitral valve clip 900. Therefore, during the implantation process, it is necessary to prohibit the driving wire 300 from rotating relative to the mitral valve clip 900 along the second direction P2 again, so as to prevent excessive coupling between the driving wire 300 and the mitral valve clip 900, and avoid that, after the mitral valve clip 900 clamps the mitral valve leaflet 1000, the driving wire 300 cannot rotate relative to the mitral valve leaflet 1000 along the first direction P1 to realize decoupling with the mitral valve clip 900.

[0056] Compared with the prior art, the first embodiment of the present application utilizes the cooperation between the limiting member 400 and the limiting structure 210 to realize control of the rotating direction of the rotating shaft 200, thereby limiting the rotating direction of the driving wire 300. The above technical solution simplifies the structure of the implantable prosthesis system, reduces the production cost, and enables the implantable prosthesis system to have strict one-way actuation, thereby improving the use safety.

[0057] Preferably, the limiting member 400 is arranged to be movable along the radial direction of the housing 100, when the rotating shaft 200 rotates along the first direction P1, as shown in Figure 3a at this time, the limiting member 400 is subjected to a first force F1 of the limiting structure 210, which has a radial component F1' that drives the limiting member 400 to move outward along the radial direction of the housing 100 (i.e. away from the rotating shaft), so that the rotating shaft 200 rotates along the first direction P1; when the rotating shaft 200 rotates along the second direction P2, as shown in Figure 3bAs shown, the second force F2 of the limiting structure 210 on the limiting member 400 is perpendicular to the radial direction, and the limiting member 400 cannot move along the radial direction of the accommodating portion 100, at this time, the limiting structure 210 and the limiting member 400 form an abutment, and the limiting member 400 prevents the rotating shaft 200 from rotating in the second direction P2.

[0058] Optionally, the accommodating portion 100 can be cylindrical, polygonal, elliptical cylindrical or other shapes, as long as it has an inner cavity 110 for accommodating the rotating shaft 200, and meets the requirements of the rotating shaft 200 rotating in the inner cavity. The driving wire 300 can be made of metal, or other materials that meet the requirements of the operation. The present embodiment does not make specific limitations on this.

[0059] In some embodiments, the limiting structure 210 is a plurality of limiting structures, and the limiting structures 210 are circumferentially arranged at the distal end of the rotating shaft 200. Preferably, the limiting structures 210 are uniformly circumferentially arranged on the rotating shaft 200. The diameter of the portion of the rotating shaft 200 where the limiting structure 210 is arranged is less than or equal to the inner diameter of the inner cavity 110.

[0060] In some embodiments, the limiting member 400 is provided as a plurality of limiting members, and the plurality of limiting members 400 are arranged at intervals around the axis of the rotating shaft 200 in the accommodating portion 100. As shown in the drawings, Figure 4 As shown, the limiting member 400 is three, and is arranged at an interval of 120° at the distal end of the accommodating portion 100. Each limiting member 400 cooperates with the adjacent limiting structure 210. In this way, the rotating shaft 200 can be subjected to the action of the limiting structure 210 arranged at intervals during rotation, and the force is uniform, thereby improving the stability of the delivery device of the implanted prosthesis.

[0061] Optionally, the limiting member 400 can also be provided as two, four or more, as long as the limiting member 400 can cooperate with the limiting structure 210 to limit the rotating direction of the rotating shaft 200, and the present embodiment does not make specific limitations on this.

[0062] In some embodiments, each limiting structure 210 extends in the axial direction of the rotating shaft 200, and the size of the limiting structure 210 in the axial direction of the rotating shaft 200 is greater than the size of the limiting member 400 in the axial direction of the rotating shaft 200. In this way, when the rotating shaft 200 is inserted into the inner cavity 110, it can be ensured that the limiting member 400 and the limiting structure 210 can cooperate.

[0063] In some embodiments, the accommodating portion 100 is provided with a receiving hole 130 for accommodating the limiting member 400, and the receiving hole 130 extends along the radial direction of the accommodating portion 100. As shown in the drawings, Figure 6As shown, the limiting member 400 is movably accommodated in the accommodating hole 130, and the end of the limiting member 400 close to the rotating shaft 200 extends out of the end of the accommodating hole 130 close to the rotating shaft 200 and abuts against the limiting structure 210. Since the accommodating hole 130 is arranged along the radial direction of the accommodating portion 100, the limiting member 400 can move along the radial direction of the accommodating portion 100. In this way, the limiting member 400 can move along the radial direction under the action of the force along the radial direction of the rotating shaft 200. When the rotating shaft 200 rotates along the first direction P1, the limiting structure 210 contacts the limiting member 400 and applies a force along the radial direction of the rotating shaft 200 to the limiting member 400 to move the limiting member 400 away from the rotating shaft 200 until the limiting structure 210 no longer provides the limiting member 400 with the force to move the limiting member 400 away from the rotating shaft 200 along the radial direction of the rotating shaft 200. Thus, the limiting structure 210 smoothly passes through the limiting member 400 as the rotating shaft 200 rotates along the first direction P1.

[0064] In the present embodiment, the limiting member 400 is detachably connected with the accommodating portion 100 through the accommodating hole 130. When the limiting member 400 is damaged, the limiting member 400 can be removed and replaced with a new one, which facilitates the maintenance of the delivery device for the implanted prosthesis.

[0065] Further, when there are multiple limiting members 400, the number of the accommodating holes 130 matches the number of the limiting members 400, and the positions of the multiple accommodating holes 130 one-to-one correspond to the positions of the limiting members 400.

[0066] In some embodiments, a first foolproof portion 131 is arranged on the sidewall of the accommodating hole 130, and a second foolproof portion 410 is arranged on the sidewall of the limiting member 400. In this way, when the limiting member 400 is arranged in the accommodating hole 130 in a preset direction, the second foolproof portion 410 cooperates with the first foolproof portion 131 to allow the limiting member 400 to be completely accommodated in the accommodating hole 130. In this way, the end of the limiting member 400 close to the rotating shaft 200 can extend out of the accommodating hole 130 and abut against the limiting structure 210. When the limiting member 400 is not inserted into the accommodating hole 130 in the preset direction, the first foolproof portion 131 and the second foolproof portion 410 can prevent the limiting member 400 from being completely accommodated in the accommodating hole 130. In this way, the end of the limiting member 400 close to the rotating shaft 200 cannot abut against the limiting structure 210. Therefore, the cooperation between the first foolproof portion 131 and the second foolproof portion 410 can achieve a foolproof effect and ensure that the limiting member 400 is assembled in the correct installation direction.

[0067] As Figure 5As shown, the cross-sectional shape of the accommodation hole 130 at the first fool-proof portion 131 is a convex shape, and correspondingly, the cross-sectional shape of the limiting member 400 at the second fool-proof portion 410 is also a convex shape. When the limiting member 400 is installed in the accommodation hole 130 according to the preset direction, the two convex cross-sections overlap.

[0068] Specifically, in the embodiment, the first fool-proof portion 131 is a shallow groove arranged on the side of the accommodation hole 130 away from the rotating shaft 200, and arranged on the left side wall (from the perspective of the distal end of the delivery device to the proximal end). Figure 5 Correspondingly, the second fool-proof portion 410 is a protrusion arranged on the side of the limiting member 400 away from the rotating shaft 200, and arranged on the left side wall. Further, in the embodiment, the first fool-proof portion 131 is a circular arc shape, and correspondingly, the second fool-proof portion 410 is also a circular arc shape. Figure 5 Obviously, the position of the first fool-proof portion 131 can also be arranged on other side walls of the accommodation hole 130, or arranged at other axial positions of the accommodation hole 130; the shape of the first fool-proof portion 131 can also be other shapes, as long as it can cooperate with the second fool-proof portion 410.

[0069] Further, the cross-sectional shape of the limiting member 400 is not specifically limited in the embodiment, as long as the limiting member 400 can cooperate with the limiting structure 210 to limit the rotation direction of the rotating shaft 200. For example, the cross-section of the limiting member 400 can be a triangular shape, a circular shape, a rectangular shape, or other shapes.

[0070] In some embodiments, each limiting member 400 is provided with a limiting block portion 420 at the end away from the rotating shaft 200, and each accommodation hole 130 is provided with a limiting boss portion 132, when the limiting member 400 passes through the accommodation hole 130 and abuts against the limiting structure 210, the limiting block portion 420 abuts against the limiting boss portion 132 to prevent the limiting member 400 from continuing to move towards the rotating shaft 200. In this way, the limiting member 400 can be prevented from hitting the rotating shaft 200, causing damage such as eccentricity, loosening, etc. of the rotating shaft 200.

[0071] Specifically, as shown in FIG. 4, the limiting member 400 is provided with a limiting block portion 420 at the end away from the rotating shaft 200, and the accommodation hole 130 is provided with a limiting boss portion 132. Figure 6As shown, the size of the limiting block portion 420 of the limiting member 400 is greater than the size of the rest of the limiting member 400, thus forming a first stop shoulder, and the size of the accommodating hole 130 at the position of the limiting boss portion 132 is smaller than the size of the rest of the accommodating hole 130, thus forming a second stop shoulder. The limiting block portion 420 and the limiting boss portion 132 abut against each other through the contact between the first stop shoulder and the second stop shoulder. In addition, according to the clearance requirement between the limiting member 400 and the bottom of the limiting structure 210, i.e., the surface of the distal end of the rotating shaft body, the axial length of the limiting block portion 420 and the rest of the finger-shaped member, and the axial length of the limiting boss portion 132 and the rest of the accommodating hole 130 are determined.

[0072] In some embodiments, the limiting member 400 is a finger-shaped member, and the limiting structure 210 is a one-way tooth. By setting the limiting member 400 as a simple finger-shaped member and the limiting structure 210 as a simple one-way tooth, the manufacturing difficulty of the delivery device of the implanted prosthesis can be reduced, thereby reducing the manufacturing cost of the delivery device of the implanted prosthesis.

[0073] Further, as shown, each finger-shaped member has a matching portion 430 at one end close to the rotating shaft 200, which is used to cooperate with the one-way tooth to control the rotation direction of the rotating shaft 200. Figure 6

[0074] Specifically, each finger-shaped member is located between two one-way teeth. The one-way tooth includes a first quasi-rotation surface 211 and a first rotation-stopping surface 212 arranged oppositely. Similarly, the matching portion 430 includes a second quasi-rotation surface 431 and a second rotation-stopping surface 432 arranged oppositely. The second quasi-rotation surface 431 of the matching portion 430 is adjacent to the first quasi-rotation surface 211 of one one-way tooth, and the second rotation-stopping surface 432 of the matching portion 430 is adjacent to the first rotation-stopping surface 212 of the other one-way tooth. When the rotating shaft 200 rotates in the first direction P1, the first quasi-rotation surface 211 contacts the second quasi-rotation surface 432, and the force exerted by the first quasi-rotation surface 211 on the finger-shaped member can push the finger-shaped member away from the rotating shaft 200, and when the rotating shaft 200 rotates in the second direction P2, the first rotation-stopping surface 212 abuts against the second rotation-stopping surface 432, and the force exerted by the second rotation-stopping surface 432 on the one-way tooth is perpendicular to the direction of movement of the finger-shaped member, and the second rotation-stopping surface 432 prevents the rotating shaft 200 from rotating in the second direction P2. In this way, by directly setting different surfaces on the one-way tooth and the finger-shaped member, the rotation direction of the rotating shaft 200 is limited, without the need for additional components, so that the structure of the delivery device of the implanted prosthesis is simple and the reliability is higher.

[0075] ​Preferably, the first quasi-cylindrical surface 211, the first stop-cylindrical surface 212, the second quasi-cylindrical surface 431 and the second stop-cylindrical surface 432 are all planar surfaces, wherein the planes in which the first quasi-cylindrical surface 211 and the second quasi-cylindrical surface 431 are located are arranged at an angle to the direction of movement of the finger, and the planes in which the first stop-cylindrical surface 212 and the second stop-cylindrical surface 432 are located are parallel to the direction of movement of the finger. By arranging the quasi-cylindrical surface and the stop-cylindrical surface as planar surfaces, the processing difficulty is low, and the manufacturing cost of the delivery device for the implanted prosthesis is reduced. Preferably, the angle between the planes in which the first quasi-cylindrical surface 211 and the second quasi-cylindrical surface 431 are located and the direction of movement of the finger is 30°-60°, and more preferably 45°.

[0076] Alternatively, the first quasi-cylindrical surface 211 and the second quasi-cylindrical surface 431 can also be curved surfaces. As long as the contact between the first quasi-cylindrical surface 211 and the second quasi-cylindrical surface 431 can drive the finger to move in the direction away from the rotation axis 200 by the force exerted by the one-way tooth on the finger, the same applies to the first stop-cylindrical surface 212 and the second stop-cylindrical surface 432. As long as the contact between the first stop-cylindrical surface 212 and the second stop-cylindrical surface 432 can exert a force on the one-way tooth by the force exerted by the finger on the one-way tooth, the force is perpendicular to the direction of movement of the finger.

[0077] In some embodiments, the rotation axis 200 is configured to also be axially movable within the inner cavity 110 relative to the housing 100, so as to increase the freedom of movement of the driving wire 300. The rotation axis 200 comprises a first coordination surface 232 extending from the distal end surface 231 of the rotation axis 200 to the outer circumferential surface of the limiting structure 210. Correspondingly, the limiting member 400 is provided with a second coordination surface 433 matching the first coordination surface 232. Through the cooperation of the first coordination surface 232 and the second coordination surface 433, the rotation axis 200 provides a force to drive the limiting member 400 to move radially along the housing 100. When the distal end of the rotation axis 200 is accommodated in the inner cavity 110 and extends towards the distal end of the housing 100, if the fitting part 430 of the finger at least partially overlaps with the one-way tooth, through the interaction of the first coordination surface 232 and the second coordination surface 433, the rotation axis 200 drives the finger to move radially in the direction away from the rotation axis 200 while extending towards the distal end. In this way, the rotation axis 200 can extend into the inner cavity 110 at any angle, and the cooperation of the first coordination surface 232 and the second coordination surface 433 can make the finger and the one-way tooth cooperate smoothly.

[0078] Specifically, the shape of the first coordination surface 232 at the position of the rotating shaft 200 is a circular truncated cone, and the outer diameter increases from the distal end to the proximal end along the axial direction of the rotating shaft 200, that is, the diameter of the distal end of the first coordination surface 232 is smaller than that of the proximal end. In this way, the first coordination surface 232 has a simple structure, reducing the processing difficulty. Correspondingly, the second coordination surface 433 is a plane, and along the axial direction of the rotating shaft 200 from the distal end to the proximal end, the distance between the surface of the second coordination surface 433 and the axis of the rotating shaft 200 increases. Thus, the first coordination surface 232 and the second coordination surface 433 form a line contact. Alternatively, the second coordination surface 433 is a curved surface complementary to the first coordination surface 433. In this way, the first coordination surface 232 and the second coordination surface 433 form a surface contact, increasing the contact stability. Similarly, the first coordination surface 232 and the second coordination surface 433 can also have other shapes in addition to the above-mentioned shapes, as long as the rotating shaft 200 provides the force for driving the limiting piece 400 to move along the radial direction of the accommodating portion 100 through the cooperation of the first coordination surface 232 and the second coordination surface 433.

[0079] As shown in Figure 7a and Figure 7b , when the rotating shaft 200 moves along the axis in the inner cavity 110 towards the distal end of the accommodating portion 100 (in the X direction in the figure), when the first coordination surface 232 of the rotating shaft 200 contacts the second coordination surface 433 of the limiting piece 400, the first coordination surface 232 exerts a force F3 on the limiting piece 400, which is perpendicular to the second coordination surface 433 and in the direction away from the rotating shaft 200. At this time, F3 can be divided into a component force F3' in the X direction, and a component force F3" perpendicular to the X direction and in the direction away from the rotating shaft 200. The limiting piece 400 is constrained by the side wall of the accommodating hole 130 and cannot move in the X direction, but under the action of the component force F3", the limiting piece 400 moves towards the direction away from the rotating shaft 200, at the same time promoting the deformation of the elastic ring 600, generating elastic potential energy. When the rotating shaft 200 rotates, the limiting piece 400 moves towards the rotating shaft 200 under the elastic force of the elastic ring 600 to be located between the two limiting structures 210, so that the limiting piece 400 abuts against the limiting structure 210.

[0080] Further, as shown in Figure 2As shown, the rotating shaft 200 includes a first stepped portion 220 at the proximal end and a main body portion 230 at the distal end, the first stepped portion 220 is coaxially connected with the main body portion 230, the diameter of the first stepped portion 220 is larger than that of the main body portion 230 to form a third stop shoulder. Correspondingly, the inner cavity 110 includes a second stepped portion at the proximal end and a receiving portion 120 at the distal end. Similarly, the diameter of the second stepped portion is larger than that of the receiving portion 120 to form a fourth stop shoulder. Meanwhile, the diameter of the first stepped portion 220 is not larger than that of the second stepped portion and is larger than that of the receiving portion 120. In this way, when the rotating shaft 200 is moved to a preset position in the inner cavity 110 of the receiving portion 100, the third stop shoulder abuts against the fourth stop shoulder to prevent the rotating shaft 200 from continuously moving to the distal end of the receiving portion 100, and to prevent the rotating shaft 200 from being separated from the receiving portion 100 at the distal end of the receiving portion 100.

[0081] In some embodiments, as shown in FIG. 1, the delivery device further includes a driving member 500 at the proximal end of the rotating shaft 200 for an operator to operate to drive the rotating shaft 200 to move. The driving member 500 can be a knob or other structure. The driving member 500 can be connected with the rotating shaft 200 by welding, screwing, gluing or other connection methods. The driving member 500 and the rotating shaft 200 can also be integrally formed. Figures 1-2

[0082] In this embodiment, the delivery device for implanting the prosthesis further includes an elastic member arranged in the receiving portion 100 for providing the limiting member 400 with an elastic force in the radial direction of the receiving portion 100 and moving towards the rotating shaft 200. Specifically, when the rotating shaft 200 rotates in the first direction P1 and the limiting structure 210 drives the limiting member 400 to move in the direction away from the rotating shaft 200, i.e. in the radial direction of the receiving portion 100 and outward, the elastic member stores elastic potential energy under the action of the limiting member 400. After the limiting member 400 is no longer acted on by the limiting structure 210, the elastic member applies an elastic force to the limiting member 400 to automatically reset the limiting member 400.

[0083] It can be understood that in addition to the above effects, under the action of the elastic member, when the operator rotates the driving member 500 in the first direction P1 to drive the rotating shaft 200 to rotate, the operator needs to exert a larger force to rotate the rotating shaft 200 in order to overcome the elastic force of the elastic member, i.e. the elastic member causes larger damping to the rotation of the rotating shaft 200, which can prevent the operator from inadvertently rotating the rotating shaft 200 during the delivery of the implanting prosthesis, resulting in the implanting prosthesis being unwound in advance. In addition, during the rotation process, the limiting member 400 will be driven to the original position under the action of the elastic member, and a slight collision occurs between the limiting block portion 420 and the limiting boss portion 131 in this process, and the sound generated by the collision can remind the operator that the current is in the unwinding process.​

[0084] In some embodiments, the elastic member is an elastic ring 600, which is sleeved on the outer wall of the accommodating portion 100 and covers the end of the finger away from the rotation shaft 200. That is, the accommodating hole 130 is provided with an open end on the outer wall of the accommodating portion 100, the finger can be inserted into the accommodating hole 130 from the open end, and the elastic ring 600 covers the open end of the accommodating hole 130. In this way, the elastic ring 600 is easy to be stretched and sleeved on the accommodating portion 100, and the assembly is simple. Moreover, the axial length of the elastic ring 600 can be much larger than the open end, which can ensure that the finger will not be separated from the accommodating portion 100 and ensure the stability of the delivery device of the implanted prosthesis. The elastic ring 600 is preferably a ring-shaped rubber ring.

[0085] In some embodiments, an annular limiting groove 140 is circumferentially provided on the outer wall of the accommodating portion 100, and the elastic member 600 is located in the limiting groove 140. In this way, it can be ensured that the elastic member 600 will not move axially out of the accommodating portion 100, and the safety of the delivery device is ensured.

[0086] In some alternative embodiments, the elastic member can also be a compression spring, which is compressed by the limiting member 400 when the limiting member 400 is away from the limiting structure 210. For example, the compression spring is arranged at the end of the finger away from the rotation shaft 200, and the other end of the compression spring is in abutment with a covering member provided at the open end of the accommodating hole 130. In some other alternative embodiments, the elastic member can also be a tension spring, which is stretched by the limiting member 400 when the limiting member 400 is away from the limiting structure 210. For example, the tension spring is arranged between the limiting block portion 420 and the limiting boss portion 131.

[0087] The second embodiment of the present application relates to an implanted prosthesis system, as shown in Figure 1 、 Figure 8 and Figure 9 , which comprises an implanted prosthesis 700 and the delivery device of the implanted prosthesis in the above-mentioned first embodiment, and the implanted prosthesis 700 is detachably connected to the delivery device of the implanted prosthesis.

[0088] The advantages of the second embodiment of the present application over the prior art have been described in the above-mentioned embodiments and will not be repeated here.

[0089] Specifically, the end of the driving wire 300 away from the accommodating portion 100 is provided with a thread 310, and the driving wire 300 is threadedly connected with the implanted prosthesis 700 through the thread 310.

[0090] Optionally, the implantable prosthesis 700 can be a valve clip, a spring coil for treating aneurysm, a left atrial appendage occluder or other implant, which are not specifically limited in the present embodiment. In the present embodiment, before implanting into the human body, the distal end of the drive wire 300 is screwed with the mitral valve clip 900, and the drive wire 300 is rotated relative to the mitral valve clip 900 in the second direction P2 to achieve coupling with the mitral valve clip 900. Thus, during the implantation process, it is necessary to prohibit the drive wire 300 from rotating relative to the mitral valve clip 900 in the second direction P2, so as to prevent excessive coupling between the drive wire 300 and the mitral valve clip 900, and to avoid that when the mitral valve clip 900 needs to be decoupled from the drive wire 300 after clamping the mitral valve leaflet 1000, the drive wire 300 cannot be rotated relative to the mitral valve leaflet 1000 in the first direction P1 to achieve decoupling with the mitral valve clip 900.

[0091] The third embodiment of the present application relates to a manufacturing method of a delivery device of an implantable prosthesis, as shown in Figure 10 and Figure 11 , comprising:

[0092] providing a containing part 100 with an axial through inner cavity 110, a rotating shaft 200 with a limiting structure 210 arranged circumferentially, a drive wire 300 and a limiting part 400, the limiting part 400 and the limiting structure 210 are configured to, when the rotating shaft 200 rotates relative to the containing part 100 in a first direction P1, the limiting structure 210 drives the limiting part 400 to move to allow the rotating shaft 200 to rotate the drive wire 300 in the first direction P1; when the rotating shaft 200 rotates relative to the containing part 100 in a second direction P2, the limiting part 400 abuts against the limiting structure 210 to prevent the rotating shaft 200 from rotating the drive wire 300 in the second direction P2, the first direction P1 and the second direction P2 are opposite; movably arranging the limiting part 400 on the containing part 100, placing the rotating shaft 200 into the inner cavity 110 of the containing part 100, making the limiting structure 210 on the rotating shaft 200 abut against the limiting part 400, and fixedly connecting the drive wire 300 to the rotating shaft 200.

[0093] The third embodiment of the present application provides a limiting part 400 and a limiting structure 210, when the rotating shaft 200 rotates relative to the accommodating part 100 along the first direction P1, the limiting structure 210 drives the limiting part 400 to move to allow the rotating shaft 200 to drive the driving wire 300 to rotate along the first direction P1, when the rotating shaft 200 rotates relative to the accommodating part 100 along the second direction P2, the limiting part 400 abuts against the limiting structure 210 to prevent the rotating shaft 200 from driving the driving wire 300 to rotate along the second direction P2, the first direction P1 and the second direction P2 are opposite, the limiting part 400 is movably arranged on the accommodating part 100, the rotating shaft 200 is arranged in the inner cavity 110 of the accommodating part 100, the limiting structure 210 on the rotating shaft 200 abuts against the limiting part 400, and the driving wire 300 is fixedly connected with the rotating shaft 200. In this way, the limiting part 400 and the limiting structure 210 are matched to realize the control of the rotating direction of the rotating shaft 200, and the rotating direction of the driving wire 300 is limited. The above technical scheme simplifies the structure of the implanted prosthesis system, reduces the production cost, and makes the implanted prosthesis system have strict one-way actuation, and improves the use safety.

[0094] Further, the accommodating part 100 is provided with a containing hole 130 extending along the radial direction of the accommodating part 100. The limiting part 400 is movably arranged in the containing hole 130, so that the limiting part 400 can move along the radial direction of the accommodating part 100. The accommodating part 100 further comprises an axially arranged first mounting hole 233, and the limiting part 400 further comprises a second mounting hole 440.

[0095] Further, the step of movably arranging the limiting part 400 on the accommodating part 100 comprises: arranging the limiting part 400 in the containing hole 130, and passing the elongated part 800 through the first mounting hole 233 and the second mounting hole 440 to fix the limiting part 400.

[0096] Further, the step of arranging the rotating shaft 200 in the inner cavity 110 of the accommodating part 100 to abut the limiting structure 210 against the limiting part 400 comprises: after the rotating shaft 200 is arranged in the inner cavity 110 of the accommodating part 100, the elongated part 800 is withdrawn to abut the limiting structure 210 against the limiting part 400.

[0097] The delivery device, system and manufacturing method of the implanted prosthesis provided by the embodiments of the present application are introduced in detail, specific examples are applied in this paper to explain the principles and embodiments of the present application, the above embodiments are only used to help understand the idea of the present application, and there will be changes in specific embodiments and application range, and the content of the specification should not be understood as a limitation of the present application.

Claims

1. A delivery apparatus for an implantable prosthesis, characterized by, The application relates to a rotating device for a medical implant, comprising: a housing provided with an inner cavity extending axially; a rotating shaft rotatably accommodated in the inner cavity; a driving wire fixedly connected with the rotating shaft and used for detachable connection with an implant prosthesis; a limiting member movably arranged on the housing and provided with a limiting structure arranged circumferentially on the rotating shaft; and an elastic member arranged on the housing and used for providing the limiting member with an elastic force moving radially along the housing and towards the rotating shaft; wherein the limiting member and the limiting structure are configured as follows: the limiting member is arranged radially along the housing and movably arranged on the housing; when the rotating shaft rotates relative to the housing along a first direction, the limiting structure applies a first acting force to the limiting member, drives the limiting member to move radially along the housing and away from the rotating shaft, so as to allow the rotating shaft to drive the driving wire to rotate along the first direction; when the rotating shaft rotates relative to the housing along a second direction, the limiting member applies a second acting force to the limiting structure, and a second acting force perpendicular to the radial direction, so that the limiting member abuts against the limiting structure, thereby preventing the rotating shaft from driving the driving wire to rotate along the second direction, and the first direction and the second direction are opposite. The limiting member and the limiting structure are both multiple, the multiple limiting members are arranged on the housing at intervals around the axis of the rotating shaft, and the limiting structure is arranged circumferentially on the rotating shaft. Each limiting structure extends along the axis of the rotating shaft, and the size of the limiting structure in the axial direction of the rotating shaft is greater than the size of the limiting member in the axial direction of the rotating shaft. The housing is provided with a receiving hole for accommodating the limiting member, and the receiving hole extends radially along the housing. The side wall of the receiving hole is provided with a first foolproof part, the side wall of the limiting member is provided with a second foolproof part, and the second foolproof part and the first foolproof part are configured as follows: when the limiting member is inserted into the receiving hole in a preset direction, the limiting member is allowed to be completely accommodated in the receiving hole; and when the limiting member is not inserted into the receiving hole in the preset direction, the limiting member is prevented from being completely accommodated in the receiving hole. The cross-sectional shape of the receiving hole at the first foolproof part is a convex shape, the cross-sectional shape of the limiting member at the second foolproof part is also a convex shape, and when the limiting member is accommodated in the receiving hole in the preset direction, the cross sections of the two convex shapes overlap. Each limiting member is provided with a limiting block part at one end away from the rotating shaft, and each receiving hole is provided with a limiting boss part, The limiting block part and the limiting boss part are configured as follows: when the limiting block part abuts against the limiting boss part, a gap is left between the end of the limiting member close to the axis of the rotating shaft and the bottom of the limiting structure. The size of the limiting member at the limiting block part is greater than the size of the remaining part of the limiting member, and the size of the receiving hole at the position of the limiting member part is smaller than the size of the remaining part of the receiving hole.

2. The delivery apparatus of an implant prosthesis of claim 1, wherein, ​ 3. The delivery apparatus of an implant prosthesis of claim 1, wherein, ​ 4. The delivery apparatus of an implant prosthesis of claim 1, wherein, ​ 5. The delivery apparatus of an implant prosthesis of claim 4, wherein, ​ 6. The delivery apparatus of an implant prosthesis of claim 5, wherein, ​ 7. The delivery apparatus of an implant prosthesis of claim 4, wherein, ​ ​ 8. The delivery apparatus of an implant prosthesis of claim 7, characterized in that ​ 9. The delivery apparatus of an implant prosthesis of claim 1, wherein, The elastic member is an elastic ring, which is sleeved on the outer wall of the accommodating portion and covers the end of the limiting member away from the rotating shaft.

10. The delivery apparatus of an implant prosthesis of claim 9, characterized in that The outer wall of the accommodating portion is circumferentially provided with an annular limiting groove, and the elastic ring is located in the limiting groove.

11. The delivery apparatus of an implant prosthesis of claim 9, wherein, The elastic member is a compression spring, which is compressed by the limiting member when the limiting member is away from the limiting structure; or the elastic member is a tension spring, which is stretched by the limiting member when the limiting member is away from the limiting structure.

12. The delivery apparatus of an implant prosthesis according to any one of claims 1-11, characterized in that, The limiting member is a finger-shaped member, and the limiting structure is a one-way tooth.

13. The delivery apparatus of an implant prosthesis of claim 12, characterized in that The one-way tooth comprises a first quasi-rotation surface and a first rotation-stopping surface arranged oppositely, and the finger-shaped member comprises a second quasi-rotation surface and a second rotation-stopping surface arranged oppositely. When the rotating shaft rotates in the first direction, the first quasi-rotation surface contacts the second quasi-rotation surface and lifts the finger-shaped member away from the rotating shaft, and when the rotating shaft rotates in the second direction, the first rotation-stopping surface contacts the second rotation-stopping surface to prevent the rotating shaft from rotating in the second direction.

14. The delivery device of claim 13, wherein the implantable prosthesis is a stent-graft. The first quasi-rotation surface, the first rotation-stopping surface, the second quasi-rotation surface and the second rotation-stopping surface are all planes, and when the finger-shaped member interacts with the one-way tooth, the plane where the first quasi-rotation surface and the second quasi-rotation surface are located intersects the movement direction of the finger-shaped member, and the plane where the first rotation-stopping surface and the second rotation-stopping surface are located is parallel to the movement direction of the finger-shaped member.

15. The delivery apparatus of an implant prosthesis of claim 12, wherein, The rotating shaft can also axially move relative to the accommodating portion, and the rotating shaft comprises a first coordination surface, which extends from the distal end surface of the rotating shaft to the outer circumferential surface of the limiting structure. Each finger-shaped member comprises a matching portion adjacent to the one-way tooth, and the matching portion is provided with a second coordination surface at a position corresponding to the first coordination surface. The first coordination surface and the second coordination surface are configured to, when the rotating shaft passes through the inner cavity and extends to the distal end of the accommodating portion, and the finger-shaped member and the one-way tooth at least partially overlap, the first coordination surface interacts with the second coordination surface to drive the finger-shaped member to move radially away from the one-way tooth.

16. The delivery apparatus of an implant prosthesis of claim 15, wherein, The rotating shaft is in the shape of a circular truncated cone at the position of the first coordination surface, and the outer diameter increases from the distal end to the proximal end along the axial direction of the rotating shaft. The second coordination surface is a plane, and the distance from the second coordination surface to the axis of the rotating shaft increases from the distal end to the proximal end along the axial direction of the rotating shaft, or the second coordination surface is a curved surface complementary to the first coordination surface.

17. The delivery apparatus of an implant prosthesis according to any one of claims 1-11, characterized in that, The rotating shaft comprises a first stepped portion at the proximal end and a main body portion at the distal end, the first stepped portion is coaxially connected with the main body portion, the diameter of the first stepped portion is greater than the diameter of the main body portion to form a third stopping shoulder, the inner cavity comprises a second stepped portion at the proximal end and an accommodating portion at the distal end, the diameter of the second stepped portion is greater than the diameter of the accommodating portion to form a fourth stopping shoulder, and the diameter of the first stepped portion is not greater than the diameter of the second stepped portion and is greater than the diameter of the accommodating portion to prevent the rotating shaft from separating from the accommodating portion at the distal end of the accommodating portion.

18. An implanted prosthetic system, comprising: The rotating shaft comprises a first stepped portion at the proximal end and a main body portion at the distal end, the first stepped portion is coaxially connected with the main body portion, the diameter of the first stepped portion is greater than the diameter of the main body portion to form a third stopping shoulder, the inner cavity comprises a second stepped portion at the proximal end and an accommodating portion at the distal end, the diameter of the second stepped portion is greater than the diameter of the accommodating portion to form a fourth stopping shoulder, and the diameter of the first stepped portion is not greater than the diameter of the second stepped portion and is greater than the diameter of the accommodating portion to prevent the rotating shaft from separating from the accommodating portion at the distal end of the accommodating portion. The rotating shaft comprises a first stepped portion at the proximal end and a main body portion at the distal end, the first stepped portion is coaxially connected with the main body portion, the diameter of the first stepped portion is greater than the diameter of the main body portion to form a third stopping shoulder, the inner cavity comprises a second stepped portion at the proximal end and an accommodating portion at the distal end, the diameter of the second stepped portion is greater than the diameter of the accommodating portion to form a fourth stopping shoulder, and the diameter of the first stepped portion is not greater than the diameter of the second stepped portion and is greater than the diameter of the accommodating portion to prevent the rotating shaft from separating from the accommodating portion at the distal end of the accommodating portion. An implantable prosthesis, and a delivery device for the implantable prosthesis as claimed in any one of claims 1-17, the implantable prosthesis being detachably connected to the delivery device for the implantable prosthesis.

19. A method of manufacturing a delivery apparatus for an implantable prosthesis, characterized by, Comprise: Providing a containing part with an axial through inner cavity, a rotating shaft with a limiting structure circumferentially arranged, a driving wire, a limiting member and an elastic member; The elastic member is configured to be arranged in the containing part, for providing the limiting member with an elastic force along the radial direction of the containing part and moving towards the rotating shaft; the limiting member and the limiting structure are configured such that, when the rotating shaft rotates relative to the containing part in a first direction, the limiting structure exerts a first acting force on the limiting member, driving the limiting member to move radially along the containing part and in a direction away from the rotating shaft, to allow the rotating shaft to drive the driving wire to rotate in the first direction; when the rotating shaft rotates relative to the containing part in a second direction, a second acting force perpendicular to the radial direction is exerted on the limiting structure, so that the limiting member abuts the limiting structure to prevent the rotating shaft from driving the driving wire to rotate in the second direction, the first direction and the second direction being opposite; Movable arrangement of the limiting member on the containing part; Arrangement of the elastic member in the containing part; Placing the rotating shaft into the inner cavity of the containing part, so that the limiting structure abuts the limiting member; Fixed connection of the driving wire to the rotating shaft.

20. The manufacturing method of claim 19, wherein The containing part comprises a containing hole arranged in the radial direction, and the limiting member is movably contained in the containing hole; The containing part further comprises a first mounting through hole arranged in the axial direction, and the first mounting through hole passes through the containing hole; the limiting member comprises a second mounting through hole arranged in the axial direction of the containing part; Movable arrangement of the limiting member on the containing part comprises: Containing the limiting member in the containing hole, and passing the elongated member through the first mounting through hole and the second mounting through hole to place the limiting member at a radially pre-set position; Placing the rotating shaft into the inner cavity of the containing part, so that the limiting structure abuts the limiting member, comprises: After the rotating shaft is placed in the inner cavity of the containing part, the elongated member is withdrawn, and the limiting structure abuts the limiting member.

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