Stent introduction device and stent introduction method

Abstract

The present invention belongs to the technical field of medical devices, and discloses a stent introduction device and a stent introduction method. The crimping assembly of the stent introduction device is provided with a crimping cavity for accommodating the stent, and the stent is formed into a crimping state; the tube body docking assembly clamps the delivery sheath; the displacement assembly can reciprocate the crimping assembly and / or the tube body docking assembly along the first direction and / or the second direction and / or the third direction to connect the delivery sheath to the crimping assembly; when the stent is in the crimping state, the delivery guide wire is arranged in the stent and extends axially along the crimping cavity, and the first limiter and the second limiter of the delivery guide wire are respectively located on both sides of the distal end of the stent to form a limit state, and the first limiter and the second limiter can drive the distal end to reciprocate axially and introduce the stent into the delivery sheath. The stent introduction device of the present invention has a simple structure, is easy to operate, reduces production costs, and has good introduction consistency. The stent introduction method uses the above-mentioned stent introduction device to introduce the stent and the delivery guide wire into the delivery sheath.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a stent introduction device and a stent introduction method. Background Art

[0002] Cerebral vascular stenosis and cerebral aneurysm are common cerebrovascular diseases, and the resulting cerebral stroke is a disease with a high morbidity and mortality rate. Compared with traditional treatment methods, self-expanding stents have become an important means of treating cerebrovascular diseases. Self-expanding stents usually use nickel-titanium shape memory alloy, have a large expansion ratio and are small in size. The microcatheter that delivers the self-expanding stent to the lesion site generally has an inner diameter of 0.021 inches or 0.027 inches. Therefore, the manufacturer needs to first press the self-expanding stent into an introduction sheath with the same inner diameter as the microcatheter, and then use the introduction sheath to introduce the stent into the microcatheter. Finally, the operator uses the microcatheter to deliver the self-expanding stent to the lesion site.

[0003] However, since the inner diameter of the microcatheter is much smaller than the size of the self-expanding stent after expansion, this process requires either the use of a crimping machine with a complex structure and inconvenient operation to shrink and crimp the stent for introduction, or manual introduction, a process that has the problems of high production costs and poor consistency of manual introduction. Summary of the invention

[0004] The purpose of the present invention is to provide a stent introduction device and a stent introduction method, which are used to solve the problems that the existing crimping machine for shrinking and crimping the stent is complex in structure and inconvenient to use, or that manual introduction is used, resulting in high production costs and poor introduction consistency.

[0005] To achieve this object, the present invention adopts the following technical solutions:

[0006] In a first aspect, a stent introduction device is provided, which is used to introduce a stent and a delivery guide wire into a delivery sheath, wherein the stent introduction device has a proximal end and a distal end along the introduction direction of the stent, and the stent introduction device comprises:

[0007] A crimping assembly, wherein the crimping assembly is provided with a crimping cavity, wherein the crimping cavity is used to accommodate the bracket and to make the bracket form a crimping state;

[0008] A tube body docking assembly, the tube body docking assembly is used to clamp the delivery sheath tube;

[0009] a displacement assembly, the displacement assembly being connected to the crimping assembly and / or the tube body docking assembly, the displacement assembly being capable of reciprocating the crimping assembly and / or the tube body docking assembly along a first direction and / or a second direction and / or a third direction, so that the delivery sheath is connected to the crimping assembly, and the delivery sheath and the crimping cavity are coaxially arranged, and the first direction, the second direction and the third direction are not in the same plane and are arranged at an angle to each other;

[0010] Among them, when the stent is in the crimping state, the delivery guide wire is arranged in the stent and extends along the axial direction of the crimping cavity. The first limit member and the second limit member of the delivery guide wire are respectively located on both sides of the distal end of the stent to form a limiting state. When the delivery guide wire moves along the axial direction, the first limit member and the second limit member can drive the distal end to move back and forth along the axial direction and enable the stent to be introduced into the delivery sheath.

[0011] In one embodiment, the crimping cavity includes a pre-expansion section and a straight section that are interconnected, the pre-expansion section is trumpet-shaped with a large diameter end located at the proximal end and a small diameter end located at the distal end, and the small diameter end is connected to the straight section.

[0012] In one embodiment, the inner diameter of the straight section is larger than the outer diameter of the first limit member and the outer diameter of the second limit member, and a mounting groove is provided at the distal end of the straight section, and the delivery sheath can be snapped into the mounting groove so that the inner tube wall of the delivery sheath does not protrude from the inner tube wall of the straight section.

[0013] In one embodiment, the distal end portion is provided with a plurality of developing rings, and the developing rings are sleeved on the mesh of the bracket. The plurality of developing rings are arranged at intervals along the circumference of the distal end portion. When the bracket is in the crimping state, the developing rings abut against the inner tube wall of the crimping cavity, and the inner aperture formed by the plurality of developing rings is smaller than the outer diameter of the first limit member and the outer diameter of the second limit member.

[0014] In one embodiment, the crimping assembly further includes a position capture member capable of sensing the developing ring and confirming the axial position of the bracket.

[0015] In one embodiment, the crimping assembly includes a first crimping block and a second crimping block, the first crimping block is provided with a first crimping groove, the second crimping block is provided with a second crimping groove, the first crimping block and the second crimping block are detachably connected so that the first crimping groove and the second crimping groove surround the crimping cavity; and / or,

[0016] The tube body docking assembly is provided with a clamping groove opening upward, and the delivery sheath can be clamped in the clamping groove; and / or,

[0017] The stent introduction device also includes a traction wire and a traction member, the traction wire can pass through the mesh of the stent, the traction member is connected to one end of the traction wire away from the stent, and the traction member can pull the traction wire to guide the stent to reciprocate axially along the crimping cavity to form the crimping state.

[0018] In one embodiment, the material of the bracket includes shape memory alloy; and / or,

[0019] The stent introduction device further includes a traction wire, the traction wire is used to pass through the mesh of the stent to pull the stent, and the material of the traction wire includes metal or polymer material; and / or,

[0020] The material of the crimping assembly includes metal or polymer material.

[0021] In one of the embodiments, the crimping assembly is made of a transparent polymer material.

[0022] In one embodiment, the displacement assembly includes a first displacement mechanism and a second displacement mechanism, the first displacement mechanism is detachably connected to the crimping assembly, the second displacement mechanism is detachably connected to the tube docking assembly, the first displacement mechanism can reciprocate the crimping assembly along the first direction, the second direction and the third direction respectively, and the second displacement mechanism can reciprocate the tube docking assembly along the first direction, the second direction and the third direction respectively; and / or,

[0023] The first direction, the second direction and the third direction are arranged perpendicular to each other.

[0024] In one embodiment, the displacement assembly also includes a guide rail, the length of which extends along the first direction, the first direction and the axial direction of the crimping cavity are parallel to each other, the first displacement mechanism and the second displacement mechanism are respectively slidably connected to the guide rail, and when the delivery sheath and the crimping cavity are coaxially arranged, the first displacement mechanism and / or the second displacement mechanism slide along the guide rail to connect the delivery sheath to the crimping cavity.

[0025] In one embodiment, the displacement assembly includes a base mechanism and a first adjusting knob, a second adjusting knob and a third adjusting knob respectively rotatably connected to the base mechanism, the base mechanism is connected to the crimping assembly and / or the tube body docking assembly, when the first adjusting knob is rotated, the base mechanism drives the crimping assembly and / or the tube body docking assembly to move along the first direction; when the second adjusting knob is rotated, the base mechanism drives the crimping assembly and / or the tube body docking assembly to move along the second direction; when the third adjusting knob is rotated, the base mechanism drives the crimping assembly and / or the tube body docking assembly to move along the third direction.

[0026] In a second aspect, a stent introduction method is provided, wherein the stent and the delivery guide wire are introduced into the delivery sheath using the stent introduction device as described above, and the stent introduction method comprises the following steps:

[0027] Step S1, inserting the distal end of the stent from the proximal end of the crimping cavity of the crimping assembly and moving along the axial direction of the crimping cavity until the distal end of the stent passes through the distal end of the crimping cavity;

[0028] Step S2, passing the delivery guide wire through the crimping cavity and moving along the axial direction until the first stopper and the second stopper of the delivery guide wire are located on both sides of the distal end of the stent;

[0029] Step S3, moving the stent and the delivery guide wire simultaneously from the distal end to the proximal end along the axial direction until the distal end portion enters the crimping cavity to form a crimping state, and the delivery guide wire forms a limited state;

[0030] Step S4, the displacement assembly moves to adjust the position of the crimping assembly and / or the tube body docking assembly along the first direction and / or the second direction and / or the third direction, so that the delivery sheath is connected to the crimping assembly, and the delivery sheath and the crimping cavity are coaxially arranged;

[0031] Step S5, moving the delivery guide wire from the proximal end to the distal end along the axial direction, and the first limit member and the second limit member drive the stent to move back and forth along the axial direction until the stent is separated from the crimping cavity and introduced into the delivery sheath.

[0032] In one embodiment, the traction wire includes a plurality of first traction wires and a second traction wire, the stent is provided with a first mesh and a second mesh, the first mesh is located at the distal end of the stent, along the axial direction, the second mesh and the first mesh are arranged in parallel, and the second mesh is arranged on the proximal side of the first mesh, and before the step S1, the following steps are also included:

[0033] S101, passing the first traction wire through two first mesh holes arranged opposite to each other and folding the first traction wire in half;

[0034] S102, sequentially passing through the plurality of first traction wires until the first traction wires pass through all the first mesh holes of the distal end portion;

[0035] S103, passing the second traction wire through the second mesh and folding the second traction wire in half, with the free end of the second traction wire extending toward the proximal end of the stent;

[0036] Furthermore, in the step S1, the first traction wire is pulled at the distal end of the crimping assembly, and the stent is pulled by the first traction wire to move along the axial direction from the proximal end to the distal end;

[0037] In the step S3, the second traction wire is pulled on the proximal side of the crimping assembly, and the second traction wire pulls the stent to move along the axial direction from the distal end to the proximal end.

[0038] Beneficial effects of the present invention:

[0039] The stent introduction device provided by the present invention comprises a crimping assembly, a tube body docking assembly and a displacement assembly. The crimping assembly is provided with a crimping cavity, which is used to accommodate the stent and make the stent form a crimping state. The stent in the crimping state is compressed to facilitate the introduction of the delivery sheath. The tube body docking assembly is used to clamp the delivery sheath. The displacement assembly is connected to the crimping assembly and / or the tube body docking assembly, and the displacement assembly can reciprocate the crimping assembly and / or the tube body docking assembly along the first direction and / or the second direction and / or the third direction so that the delivery sheath is connected to the crimping assembly, and the delivery sheath and the crimping cavity are coaxially arranged, and the first direction, the second direction and the third direction are arranged at an angle to each other. The displacement assembly can be arranged only in one of the crimping assembly and the tube body docking assembly, or the crimping assembly and the tube body docking assembly are simultaneously provided with the displacement assembly. Wherein, when the stent is in the crimping state, the delivery guide wire is arranged in the stent and extends along the axial direction of the crimping cavity, and the first limiter and the second limiter of the delivery guide wire are respectively located on both sides of the distal end of the stent to form a limit state. When the stent reciprocates to form a gripping state, and the delivery guide wire reciprocates to form a limiting state, the displacement component drives the gripping component and / or the tube body docking component to connect the delivery sheath to the gripping component, which will not affect the position adjustment and state adjustment of the stent and the delivery guide wire in the gripping cavity. The structure is simple, the operation is convenient, and the production cost is reduced. When the delivery guide wire moves axially, the first limiting member and the second limiting member can drive the distal end to reciprocate axially and guide the stent into the delivery sheath, thereby accurately controlling the introduction position and avoiding the problem of poor consistency in manual introduction.

[0040] The stent introduction method provided by the present invention uses the above-mentioned stent introduction device to introduce the stent and the delivery guide wire into the delivery sheath. First, the crimping state of the stent and the limiting state of the delivery guide wire are synchronously adjusted by the crimping assembly. Then, the tube body docking assembly and the displacement assembly are actuated to realize the connection of the delivery sheath to the crimping assembly, thereby avoiding affecting the position adjustment and state adjustment of the stent and the delivery guide wire in the crimping cavity. The operation is convenient and the production cost is reduced. Finally, the first limiting member and the second limiting member of the delivery guide wire drive the distal end to move back and forth axially and introduce the stent into the delivery sheath, thereby accurately controlling the introduction position and achieving good introduction consistency. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 is a schematic structural diagram of a stent introduction device provided in an embodiment of the present invention;

[0042] Figure 2 is a schematic structural diagram of a stent threading traction wire provided in an embodiment of the present invention;

[0043] Figure 3 The working diagram of the stent introduction device provided in the embodiment of the present invention is as follows Figure 1 ;

[0044] Figure 4 The working diagram of the stent introduction device provided in the embodiment of the present invention is as follows Figure 2 ;

[0045] Figure 5 is a schematic end view of a stent and a delivery guide wire in a crimped state provided by an embodiment of the present invention;

[0046] Figure 6 The working diagram of the stent introduction device provided in the embodiment of the present invention is as follows Figure 3 ;

[0047] Figure 7 It is a partial structural schematic diagram of a stent introduction device provided in an embodiment of the present invention.

[0048] In the figure:

[0049] 1. Crimping assembly; 11. Crimping cavity; 111. Pre-expansion section; 112. Straight section; 1121. Mounting groove; 12. Position capture member; 2. Pipe body docking assembly; 21. Clamping groove; 3. Displacement assembly; 31. First displacement mechanism; 32. Second displacement mechanism; 33. Guide rail; 34. First adjustment knob; 35. Second adjustment knob; 36. Third adjustment knob;

[0050] 100, support; 101, distal end; 102, developing ring; 200, delivery guide wire; 201, first stopper; 202, second stopper; 300, delivery sheath; 400, traction wire; 401, first traction wire; 402, second traction wire; 500, traction member. DETAILED DESCRIPTION

[0051] The present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. It is to be understood that the specific embodiments described herein are only used to explain the present invention, rather than to limit the present invention. It is also necessary to explain that, for ease of description, only the parts related to the present invention, rather than all structures, are shown in the accompanying drawings.

[0052] In the description of the present invention, unless otherwise clearly specified and limited, the terms "connected", "connected", and "fixed" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0053] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0054] In the description of this embodiment, the terms "upper", "lower", "left", "right" and other directions or positional relationships are based on the directions or positional relationships shown in the drawings, and are only for the convenience of description and simplification of operation, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operate in a specific direction, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are only used to distinguish in the description and have no special meaning.

[0055] like Figures 1 to 7As shown, this embodiment first provides a stent introduction device, which is used to introduce the stent 100 and the delivery guide wire 200 into the delivery sheath 300. Along the introduction direction of the stent 100, the stent introduction device has a proximal end and a distal end. The stent introduction device includes a crimping assembly 1, a tube body docking assembly 2 and a displacement assembly 3. The crimping assembly 1 is provided with a crimping cavity 11, which is used to accommodate the stent 100 and make the stent 100 form a crimping state. The stent 100 in the crimping state is compressed to facilitate introduction into the delivery sheath 300. The tube body docking assembly 2 is used to clamp the delivery sheath 300. The displacement assembly 3 is connected to the crimping assembly 1 and / or the tube body docking assembly 2. The displacement assembly 3 can reciprocate the crimping assembly 1 and / or the tube body docking assembly 2 along the first direction and / or the second direction and / or the third direction so that the delivery sheath 300 is connected to the crimping assembly 1, and the delivery sheath 300 and the crimping cavity 11 are coaxially arranged, and the first direction, the second direction and the third direction are arranged at an angle to each other. The displacement assembly 3 may be provided in only one of the crimping assembly 1 and the pipe body docking assembly 2 , or the crimping assembly 1 and the pipe body docking assembly 2 may be provided with the displacement assembly 3 at the same time.

[0056] Among them, when the stent 100 is in the crimping state, the delivery guide wire 200 is arranged in the stent 100 and extends along the axial direction of the crimping cavity 11, and the first limiter 201 and the second limiter 202 of the delivery guide wire 200 are respectively located on both sides of the distal end 101 of the stent 100 to form a limited state. When the stent 100 reciprocates to form a crimping state, the delivery guide wire 200 reciprocates with it and forms a limited state with the stent 100, and the displacement component 3 drives the crimping component 1 and / or the tube body docking component 2 to connect the delivery sheath 300 to the crimping component 1, which will not affect the position adjustment and state adjustment of the stent 100 and the delivery guide wire 200 in the crimping cavity 11. The structure is simple, the operation is relatively convenient, and the production cost is reduced. When the delivery guide wire 200 moves axially, the first limiter 201 and the second limiter 202 can drive the distal end 101 to move back and forth axially and introduce the stent 100 into the delivery sheath 300, thereby accurately controlling the introduction position and avoiding the problem of poor consistency in manual introduction.

[0057] It should be noted that during the introduction process, the reciprocating movement along the axial direction includes movement from the proximal end to the distal end, and also includes movement from the distal end to the proximal end. This reciprocating movement facilitates accurate adjustment of the introduction position. When the delivery guide wire 200 moves axially from the proximal end to the distal end, the distal end 101 is driven to move by the second stopper 202; when the delivery guide wire 200 moves axially from the distal end to the proximal end, the distal end 101 is driven to move by the first stopper 201.

[0058] In order to achieve effective crimping of the stent 100, the crimping cavity 11 includes a pre-expansion section 111 and a straight section 112 that are interconnected. The pre-expansion section 111 is trumpet-shaped, with the large diameter end located at the proximal end and the small diameter end located at the distal end, and the small diameter end is connected to the straight section 112. That is, the inner diameter of the pre-expansion section 111 gradually decreases from the large diameter end to the small diameter end until it is reduced to the same as the inner diameter of the straight section 112. In this way, the stent 100 enters the crimping cavity 11 from the large diameter end of the pre-expansion section 111. During the axial movement, as the inner diameter of the pre-expansion section 111 gradually decreases, the stent 100 is also gradually crimped until it enters the straight section 112 to form a crimping state. The provision of the pre-expansion section 111 is conducive to the gradual crimping of the stent 100, avoiding damage to the stent 100 caused by sudden size changes; the provision of the straight section 112 is conducive to maintaining a stable crimping state.

[0059] The overall length of the crimping cavity 11 is 20 mm to 100 mm, preferably 80 mm. The inner diameter of the straight section 112 is 0.3 mm to 1 mm, preferably 0.5 mm. The inner diameter of the large diameter end of the pre-expansion section 111 is 1 mm to 2 mm, for example, 1 mm, or 1.2 mm, or 1.5 mm, or 2 mm, and the inner diameter of the large diameter end is always larger than the inner diameter of the straight section 112. The above dimensions can be adaptively adjusted according to the size of the stent 100.

[0060] In order to facilitate the conveying guide wire 200 to form a limited state, the inner diameter of the straight section 112 is larger than the outer diameter of the first limiting member 201 and the outer diameter of the second limiting member 202. In this way, the first limiting member 201 and the second limiting member 202 can enter the straight section 112 to avoid the conveying guide wire 200 from getting stuck.

[0061] The far end of the straight section 112 is provided with a mounting groove 1121, and the delivery sheath 300 can be snapped into the mounting groove 1121 so that the inner tube wall of the delivery sheath 300 does not protrude from the inner tube wall of the straight section 112. This snap-on structure is relatively simple and can prevent the delivery sheath 300 from falling off. Preferably, the inner diameter of the delivery sheath 300 is equal to the inner diameter of the straight section 112. When the delivery sheath 300 is snapped into the mounting groove 1121, the inner tube wall of the delivery sheath 300 and the inner tube wall of the straight section 112 are smoothly connected. In this way, when the stent 100 is introduced into the delivery sheath 300 from the crimping cavity 11 along the axial direction, it is relatively smooth and no scratches will occur.

[0062] In one embodiment, the distal end portion 101 is provided with a plurality of developing rings 102, which are sleeved on the mesh of the support 100, and the plurality of developing rings 102 are arranged at intervals along the circumference of the distal end portion 101. When the support 100 is in a crimping state, the developing rings 102 abut against the inner tube wall of the crimping cavity 11, and the inner aperture formed by the plurality of developing rings 102 is smaller than the outer diameter of the first stopper 201 and the outer diameter of the second stopper 202. Figure 4 and Figure 6 As shown, the inner aperture formed by the plurality of developing rings 102 is H1, the outer diameter of the first stopper 201 and the outer diameter of the second stopper 202 are both H2, H1<H2, so that the distal end portion 101 is always located between the first stopper 201 and the second stopper 202. The developing rings 102 make the shape of the stent 100 in the gripping state more stable at the distal end portion 101, and can accurately maintain the relative position with the delivery guide wire 200 in the limiting state. When the delivery guide wire 200 moves axially toward the delivery sheath 300, the first limit member 201 and the second limit member 202 can abut and apply the push-pull force of the axial movement to the developing ring 102, and then the developing ring 102 drives the bracket 100 to move. This not only makes it easy to introduce the bracket 100 into the delivery sheath 300, but also, after the delivery sheath 300 drives the bracket 100 and the delivery guide wire 200 to the vicinity of the treatment position, the delivery guide wire 200 can drive the bracket 100 to move back and forth, so as to control the bracket 100 to accurately reach the treatment position.

[0063] In order to ensure the reliability of the limit, the outer diameter H2 of the first limit member 201 and the second limit member 202 are 0.2mm to 0.4mm, preferably 0.3mm. The spacing between the first limit member 201 and the second limit member 202 is 1mm to 5mm, so that there is enough space to accommodate the developing ring 102. For example, the spacing can be 1mm, or 2mm, or 4mm, or 5mm. The spacing between the first limit member 201 and the second limit member 202 is preferably 2mm. In this way, when the conveying guide wire 200 uses the first limit member 201 and the second limit member 202 to push and pull the developing ring 102 axially, it can ensure that the spacing is sufficient to accommodate the developing ring 102, and the push and pull direction of the developing ring 102 can be quickly switched.

[0064] In order to capture the axial position of the bracket 100 and the delivery guide wire 200, the crimping assembly 1 also includes a position capture member 12, which can sense the developing ring 102 and confirm the axial position of the bracket 100. When the bracket 100 forms a crimping state, the position capture member 12 can send a signal, and the movement of the bracket 100 can be stopped at this time. Of course, the position capture member 12 can also capture the position of the delivery guide wire 200. The first limit member 201 and the second limit member 202 are made of developing materials. The position capture member 12 can capture the first limit member 201 and the second limit member 202, and then send a signal when the delivery guide wire 200 forms a limiting state. At this time, the movement of the delivery guide wire 200 can be stopped to ensure the relative position of the bracket 100 and the delivery guide wire 200 is accurate.

[0065] The specific structure and working principle of the position capture member 12 can be set with reference to the prior art, which is not the focus of this application and will not be described in detail in this embodiment.

[0066] In one embodiment, the crimping assembly 1 includes a first crimping block and a second crimping block, the first crimping block is provided with a first crimping groove, the second crimping block is provided with a second crimping groove, and the first crimping block and the second crimping block are detachably connected so that the first crimping groove and the second crimping groove surround and form a crimping cavity 11. This split structure is convenient for processing, and the first crimping block and the second crimping block can be connected by fasteners such as nuts. Preferably, the first crimping block and the second crimping block are symmetrical structures, and the first crimping block and the second crimping block can be arranged left and right or up and down, which is not specifically limited in this embodiment.

[0067] In one embodiment, the tube body docking assembly 2 is provided with a clamping groove 21 with an opening facing upward, and the delivery sheath 300 can be clamped in the clamping groove 21. The cross-sectional shape of the clamping groove 21 can be set according to the outer diameter and size of the delivery sheath 300, and is not limited to the drawings of this embodiment. Such a clamping groove 21 with an opening facing upward is convenient for placing the delivery sheath 300, and is easy to take and put.

[0068] In one embodiment, the stent introduction device further includes a traction wire 400 and a traction member 500. The traction wire 400 can pass through the mesh of the stent 100. The traction member 500 is connected to the end of the traction wire 400 away from the stent 100. The traction member 500 can be pulled by the traction wire 400, and the traction wire 400 guides the stent 100 to reciprocate along the axial direction of the crimping cavity 11 to form a crimping state. The arrangement of the traction wire 400 and the traction member 500 facilitates the control of the movement of the stent 100 from the proximal end to the distal end to enter the crimping cavity 11, and the movement of retreating from the distal end to the proximal end to form a crimping state.

[0069] The specific structure of the traction member 500 can be set with reference to the prior art, which is not the focus of this application and will not be described in detail in this embodiment.

[0070] The material of the stent 100 includes a shape memory alloy, such as a nickel-titanium alloy. The material of the traction wire 400 includes a metal or a polymer material. The material of the crimping assembly 1 includes a metal or a polymer material.

[0071] In one embodiment, the crimping assembly 1 is made of a transparent polymer material, such as organic glass, so that the crimping cavity 11 is visible, and the operator can directly see the inside of the crimping assembly 1 and observe the status of the stent 100 and the delivery sheath 300. When it is observed that the stent 100 and the delivery sheath 300 form a limited position state, the axial movement of the stent 100 and the delivery sheath 300 can be stopped in time to maintain the limited position state.

[0072] In one embodiment, the displacement assembly 3 includes a first displacement mechanism 31 and a second displacement mechanism 32, the first displacement mechanism 31 is detachably connected to the crimping assembly 1, the second displacement mechanism 32 is detachably connected to the tube body docking assembly 2, the first displacement mechanism 31 can reciprocate the crimping assembly 1 along the first direction, the second direction and the third direction, respectively, and the second displacement mechanism 32 can reciprocate the tube body docking assembly 2 along the first direction, the second direction and the third direction, respectively. The first direction, the second direction and the third direction are arranged perpendicular to each other. Through the first displacement mechanism 31 and the second displacement mechanism 32, the crimping assembly 1 and the tube body docking assembly 2 can act simultaneously, and the adjustment speed is faster.

[0073] In one embodiment, the displacement assembly 3 also includes a guide rail 33, the length of which extends along a first direction, and the first direction and the axial direction of the crimping cavity 11 are parallel to each other. The first displacement mechanism 31 and the second displacement mechanism 32 are respectively slidably connected to the guide rail 33. When the delivery sheath 300 and the crimping cavity 11 are coaxially arranged, the first displacement mechanism 31 and / or the second displacement mechanism 32 slide along the guide rail 33 to connect the delivery sheath 300 to the crimping cavity 11.

[0074] The displacement assembly 3 includes a base mechanism and a first adjusting knob 34, a second adjusting knob 35 and a third adjusting knob 36 which are rotatably connected to the base mechanism respectively. When the displacement assembly 3 includes a first displacement mechanism 31 and a second displacement mechanism 32, the first displacement mechanism 31 and the second displacement mechanism 32 have a base mechanism, a first adjusting knob 34, a second adjusting knob 35 and a third adjusting knob 36 respectively.

[0075] The base mechanism is slidably disposed on the guide rail 33, and the base mechanism is connected to the crimping assembly 1 and / or the tube docking assembly 2. When the first adjustment knob 34 is rotated, the base mechanism drives the crimping assembly 1 and / or the tube docking assembly 2 to move in the first direction; when the second adjustment knob 35 is rotated, the base mechanism drives the crimping assembly 1 and / or the tube docking assembly 2 to move in the second direction; when the third adjustment knob 36 is rotated, the base mechanism drives the crimping assembly 1 and / or the tube docking assembly 2 to move in the third direction. This method of controlling the movement of the crimping assembly 1 and the tube docking assembly 2 by rotating the knob is relatively simple, and is convenient for controlling the movement position accuracy.

[0076] Specifically, the specific structure of the first displacement mechanism 31 is as follows: the axial direction of the first adjustment knob 34 extends along the first direction, and the axial directions of the second adjustment knob 35 and the third adjustment knob 36 extend along the second direction. When the first adjustment knob 34 is screwed, the first adjustment knob 34 moves along the first direction; when the second adjustment knob 35 and the third adjustment knob 36 are screwed, the second adjustment knob 35 and the third adjustment knob 36 move along the second direction. A transmission structure is provided in the base mechanism, and the transmission structure converts the movement of the first adjustment knob 34 in the first direction into the movement of the base mechanism on the guide rail 33, converts the movement of the second adjustment knob 35 in the second direction into the movement of the base mechanism in the second direction, and converts the movement of the third adjustment knob 36 in the second direction into the movement of the base mechanism in the third direction. The transmission structure has a variety of implementation structures, and the movement direction can be converted by rotating the size rack or driving the screw nut.

[0077] The structure of the second displacement mechanism 32 may be set with reference to the first displacement mechanism 31 described above.

[0078] The present embodiment also provides a stent introduction method, using the above-mentioned stent introduction device to introduce the stent 100 and the delivery guide wire 200 into the delivery sheath 300, and the stent introduction method includes the following steps:

[0079] Step S1: insert the distal end of the stent 100 from the proximal end of the crimping cavity 11 of the crimping assembly 1 and move along the axial direction of the crimping cavity 11 until the distal end of the stent 100 passes through the distal end of the crimping cavity 11. Figure 3 As shown;

[0080] Step S2, passing the delivery guide wire 200 through the crimping cavity 11 and moving it axially until the first stopper 201 and the second stopper 202 of the delivery guide wire 200 are located on both sides of the distal end portion 101 of the stent 100;

[0081] Step S3, the stent 100 and the delivery guide wire 200 are simultaneously moved axially from the distal end to the proximal end until the distal end 101 enters the crimping cavity 11 to form a crimping state, and the delivery guide wire 200 forms a limited state, such as Figure 4 As shown; through the above steps S2 and S3, the crimping state of the stent 100 and the limiting state of the delivery guide wire 200 are completed at the same time;

[0082] Step S4, the displacement assembly 3 is actuated to adjust the position of the crimping assembly 1 and / or the tube docking assembly 2 along the first direction and / or the second direction and / or the third direction, so that the delivery sheath 300 is connected to the crimping assembly 1, and the delivery sheath 300 and the crimping cavity 11 are coaxially arranged, such as Figure 6 As shown;

[0083] Step S5, the delivery guide wire 200 is moved axially from the proximal end to the distal end, and the first limiter 201 and the second limiter 202 drive the stent 100 to reciprocate along the axial direction until the stent 100 is separated from the crimping cavity 11 and introduced into the delivery sheath 300.

[0084] The stent introduction method provided in the embodiment of the present invention uses the above-mentioned stent introduction device to introduce the stent 100 and the delivery guide wire 200 into the delivery sheath 300, and the crimping state of the stent 100 and the limiting state of the delivery guide wire 200 are synchronously adjusted by the crimping assembly 1. Then, the tube body docking assembly 2 and the displacement assembly 3 are actuated to realize the connection of the delivery sheath 300 to the crimping assembly 1, so as to avoid affecting the position adjustment and state adjustment of the stent 100 and the delivery guide wire 200 in the crimping cavity 11. The structure is simple, the operation is convenient, and the production cost is reduced. Finally, the first limiting member 201 and the second limiting member 202 of the delivery guide wire 200 drive the stent 100 to move back and forth axially and introduce it into the delivery sheath 300, and the introduction position is accurately controlled, and the introduction consistency is good.

[0085] In one embodiment, if Figure 2 As shown, the traction wire 400 includes a plurality of first traction wires 401 and a second traction wire 402, and the stent 100 is provided with a first mesh and a second mesh, the first mesh is located at the distal end 101 of the stent 100, and the second mesh is arranged in parallel with the first mesh along the axial direction, and the second mesh is arranged on the proximal side of the first mesh. Before step S1, the following steps are also included:

[0086] S101, passing the first traction wire 401 through two first meshes arranged opposite to each other and folding the first traction wire 401 in half;

[0087] S102, sequentially passing through a plurality of first traction wires 401 until all the first meshes of the distal portion 101 are passed through by the first traction wires 401, so that the plurality of first traction wires 401 can gather the distal portion 101, making it easier for the stent 100 to enter the pre-expansion section 111;

[0088] S103, passing the second traction wire 402 through the second mesh and folding it in half, with the free end of the second traction wire 402 extending toward the proximal end of the stent 100; the free end of the second traction wire 402 can be inserted into the interior of the stent 100, or can be located outside the stent 100.

[0089] Furthermore, in step S1, the first traction wire 401 is pulled by the traction member 500 at the distal end of the crimping assembly 1, and the stent 100 is pulled by the first traction wire 401 to move axially from the proximal end to the distal end to enter the crimping cavity 11 until the distal end of the stent 100 passes through the distal end of the crimping cavity 11, and then the plurality of first traction wires 401 can be removed. The stent 100 with the distal end 101 gathered by the plurality of first traction wires 401 can enter the pre-expansion section 111 relatively easily, and the operation is convenient.

[0090] In step S3, the second traction wire 402 is pulled by the traction member 500 at the proximal side of the crimping assembly 1, and the second traction wire 402 pulls the stent 100 to move axially from the distal end to the proximal end until the stent 100 retreats to the distal end 101 and enters the crimping cavity 11 to form a crimping state, and then the second traction wire 402 can be removed. Since the second mesh through which the second traction wire 402 passes is close to the distal end 101, during the retraction process of the stent 100, the second traction wire 402 can apply traction force to the distal end 101, so that the distal end 101 performs the retraction action first, and the stent 100 can be quickly adjusted to the crimping state. Moreover, the second traction wire 402 will not affect the proximal end of the stent 100, so as to prevent the proximal end of the stent 100 from being separated from the crimping cavity 11.

[0091] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. For those skilled in the art, various obvious changes, readjustments and substitutions can be made without departing from the protection scope of the present invention. It is not necessary and impossible to list all the embodiments here. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. A stent introduction device, used for introducing a stent (100) and a delivery guide wire (200) into a delivery sheath (300), wherein along the introduction direction of the stent (100), the stent introduction device has a proximal end and a distal end, and is characterized in that: The stent introduction device comprises: A crimping assembly (1), the crimping assembly (1) being provided with a crimping cavity (11), the crimping cavity (11) being used to accommodate the support (100) and to put the support (100) into a crimping state; A tube body docking assembly (2), the tube body docking assembly (2) being used to clamp the delivery sheath tube (300); a displacement assembly (3), the displacement assembly (3) being connected to the crimping assembly (1) and / or the tube body docking assembly (2), the displacement assembly (3) being capable of reciprocating the crimping assembly (1) and / or the tube body docking assembly (2) along a first direction and / or a second direction and / or a third direction, so that the delivery sheath tube (300) is connected to the crimping assembly (1), and the delivery sheath tube (300) and the crimping cavity (11) are coaxially arranged, and the first direction, the second direction and the third direction are not in the same plane and are arranged at an angle to each other; Wherein, when the stent (100) is in the crimping state, the delivery guide wire (200) is arranged in the stent (100) and extends along the axial direction of the crimping cavity (11), and the first limiting member (201) and the second limiting member (202) of the delivery guide wire (200) are respectively located on both sides of the distal end portion (101) of the stent (100) to form a limiting state, and when the delivery guide wire (200) moves along the axial direction, the first limiting member (201) and the second limiting member (202) can drive the distal end portion (101) to reciprocate along the axial direction and enable the stent (100) to be introduced into the delivery sheath (300); The distal end portion (101) is provided with a plurality of developing rings (102), the developing rings (102) being sleeved on the mesh of the bracket (100), and the plurality of developing rings (102) being arranged at intervals along the circumference of the distal end portion (101).

2. The stent introduction device according to claim 1, characterized in that: The crimping cavity (11) comprises a pre-expansion section (111) and a straight section (112) which are interconnected, the pre-expansion section (111) being trumpet-shaped with a large diameter end located at a proximal end and a small diameter end located at a distal end, the small diameter end being connected to the straight section (112).

3. The stent introduction device according to claim 2, characterized in that: The inner diameter of the straight section (112) is larger than the outer diameter of the first limiting member (201) and the outer diameter of the second limiting member (202), and a mounting groove (1121) is provided at the distal end of the straight section (112), and the delivery sheath tube (300) can be snap-fitted into the mounting groove (1121) so that the inner tube wall of the delivery sheath tube (300) does not protrude from the inner tube wall of the straight section (112).

4. The stent introduction device according to claim 1, characterized in that: When the bracket (100) is in the pressing and gripping state, the developing ring (102) abuts against the inner tube wall of the pressing and gripping cavity (11), and the inner hole diameter formed by the plurality of developing rings (102) is smaller than the outer diameter of the first limiting member (201) and the outer diameter of the second limiting member (202).

5. The stent introduction device according to claim 4, characterized in that: The pressing and gripping assembly (1) further comprises a position capturing member (12), wherein the position capturing member (12) is capable of sensing the developing ring (102) and confirming the axial position of the bracket (100).

6. The stent introduction device according to any one of claims 1 to 5, characterized in that: The crimping assembly (1) comprises a first crimping block and a second crimping block, the first crimping block is provided with a first crimping groove, the second crimping block is provided with a second crimping groove, the first crimping block and the second crimping block are detachably connected so that the first crimping groove and the second crimping groove surround the crimping cavity (11); and / or, The tube body docking assembly (2) is provided with a clamping groove (21) with an opening facing upward, and the delivery sheath tube (300) can be clamped in the clamping groove (21); and / or, The stent introduction device further comprises a traction wire (400) and a traction member (500), wherein the traction wire (400) is capable of passing through the mesh of the stent (100), and the traction member (500) is connected to one end of the traction wire (400) away from the stent (100), and the traction member (500) is capable of traction of the traction wire (400) to guide the stent (100) to reciprocate along the axial direction of the crimping cavity (11) to form the crimping state.

7. The stent introduction device according to any one of claims 1 to 5, characterized in that: The material of the bracket (100) includes shape memory alloy; and / or, The stent introduction device further comprises a traction wire (400), the traction wire (400) being used to pass through the mesh of the stent (100) to pull the stent (100), the material of the traction wire (400) comprising metal or polymer material; and / or, The material of the crimping assembly (1) includes metal or polymer material.

8. The stent introduction device according to claim 7, characterized in that: The crimping assembly (1) is made of a transparent polymer material.

9. The stent introduction device according to any one of claims 1 to 5, characterized in that: The displacement assembly (3) comprises a first displacement mechanism (31) and a second displacement mechanism (32); the first displacement mechanism (31) is detachably connected to the crimping assembly (1); the second displacement mechanism (32) is detachably connected to the tube docking assembly (2); the first displacement mechanism (31) is capable of reciprocating the crimping assembly (1) along the first direction, the second direction and the third direction respectively; and the second displacement mechanism (32) is capable of reciprocating the tube docking assembly (2) along the first direction, the second direction and the third direction respectively; and / or, The first direction, the second direction and the third direction are arranged perpendicular to each other.

10. The stent introduction device according to claim 9, characterized in that: The displacement assembly (3) further comprises a guide rail (33), the length of the guide rail (33) extending along the first direction, the first direction and the axial direction of the crimping cavity (11) being parallel to each other, the first displacement mechanism (31) and the second displacement mechanism (32) being respectively slidably connected to the guide rail (33), and when the delivery sheath tube (300) and the crimping cavity (11) are coaxially arranged, the first displacement mechanism (31) and / or the second displacement mechanism (32) slide along the guide rail (33) to connect the delivery sheath tube (300) to the crimping cavity (11).

11. The stent introduction device according to any one of claims 1 to 5, characterized in that: The displacement assembly (3) comprises a base mechanism and a first adjusting knob (34), a second adjusting knob (35) and a third adjusting knob (36) which are rotatably connected to the base mechanism respectively; the base mechanism is connected to the crimping assembly (1) and / or the tube body docking assembly (2); when the first adjusting knob (34) is rotated, the base mechanism drives the crimping assembly (1) and / or the tube body docking assembly (2) to move along the first direction; when the second adjusting knob (35) is rotated, the base mechanism drives the crimping assembly (1) and / or the tube body docking assembly (2) to move along the second direction; when the third adjusting knob (36) is rotated, the base mechanism drives the crimping assembly (1) and / or the tube body docking assembly (2) to move along the third direction.

12. A stent introduction method, characterized in that: The stent introduction device according to any one of claims 1 to 11 is used to introduce the stent (100) and the delivery guide wire (200) into the delivery sheath (300), wherein the stent introduction method comprises the following steps: Step S1, inserting the distal end of the stent (100) from the proximal end of the crimping cavity (11) of the crimping assembly (1) and moving along the axial direction of the crimping cavity (11) until the distal end of the stent (100) passes through the distal end of the crimping cavity (11); Step S2, passing the delivery guide wire (200) through the crimping cavity (11) and moving along the axial direction until the first stopper (201) and the second stopper (202) of the delivery guide wire (200) are located on both sides of the distal end portion (101) of the stent (100); Step S3, moving the stent (100) and the delivery guide wire (200) simultaneously along the axial direction from the distal end to the proximal end until the distal end (101) enters the crimping cavity (11) to form a crimping state, and the delivery guide wire (200) forms a limited state; Step S4, the displacement component (3) is actuated to adjust the position of the crimping component (1) and / or the tube body docking component (2) along the first direction and / or the second direction and / or the third direction, so that the delivery sheath (300) is connected to the crimping component (1), and the delivery sheath (300) and the crimping cavity (11) are coaxially arranged; Step S5, moving the delivery guide wire (200) from the proximal end to the distal end along the axial direction, and the first limit member (201) and the second limit member (202) drive the distal end (101) to move back and forth along the axial direction until the stent (100) is separated from the crimping cavity (11) and introduced into the delivery sheath (300).

13. The stent introduction method according to claim 12, characterized in that: When the stent introduction device further comprises a traction wire (400), the traction wire (400) comprises a plurality of first traction wires (401) and a second traction wire (402), the stent (100) is provided with a first mesh and a second mesh, the first mesh is located at the distal end (101) of the stent (100), and along the axial direction, the second mesh is arranged in parallel with the first mesh, and the second mesh is arranged at the proximal side of the first mesh, and before the step S1, the following steps are further included: S101, passing the first traction wire (401) through two first mesh holes arranged opposite to each other and folding the first traction wire in half; S102, sequentially passing through the plurality of first traction wires (401) until the first traction wires (401) pass through all the first meshes of the distal portion (101); S103, passing the second traction wire (402) through the second mesh and folding it in half, with the free end of the second traction wire (402) extending toward the proximal end of the stent (100); Furthermore, in the step S1, the first traction wire (401) is pulled at the distal end of the crimping assembly (1), and the stent (100) is pulled by the first traction wire (401) to move along the axial direction from the proximal end to the distal end; In the step S3, the second traction wire (402) is pulled on the proximal side of the crimping assembly (1), and the second traction wire (402) pulls the stent (100) to move along the axial direction from the distal end to the proximal end.

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