CN113057774B

CN113057774B - Visualization structure, implantation instrument and blood vessel support

Info

Publication number: CN113057774B
Application number: CN201911399312.3A
Authority: CN
Inventors: 李�真; 刘彩萍; 肖本好
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2019-12-30
Filing date: 2019-12-30
Publication date: 2023-03-21
Anticipated expiration: 2039-12-30
Also published as: CN113057774A

Abstract

The invention relates to a developing structure, an implanting apparatus and a blood vessel bracket, wherein the developing structure comprises a first developing unit and a second developing unit which are connected with the implanting apparatus, a developing material is arranged on the first developing unit, the second developing unit is provided with the developing material, the first developing unit and the second developing unit are rotatably connected, and the first developing unit and the second developing unit can rotate relatively around a rotating axis. The developing structure can prevent the first developing unit and the second developing unit from being mutually unfolded when the implantation instrument is sheathed, can increase the developing area of the developing structure and further enhance the developing effect of the developing structure.

Description

Developing structure, implanting instrument and blood vessel support

Technical Field

The invention relates to the field of implanted medical instruments, in particular to a developing structure, an implanting instrument and a vascular stent.

Background

The interventional therapy has the advantages of small wound, short recovery time and the like. Thus, interventional therapies have become accepted by an increasing number of physicians and patients. For example, in treating a vascular tumor (which may be, in particular, an aortic tumor), an implantable device (e.g., a vascular stent) is delivered by interventional means to a neoplastic site of a blood vessel to treat the vascular tumor. It is well known that interventional procedures require the position of the implant instrument within the patient to be observed by means of DSA devices when delivering the implant instrument and when releasing the implant instrument. Specifically, the X-ray opaque visualization structure is arranged on the implantation instrument, so that a doctor can observe the position of the visualization structure in the patient body through a DSA (digital signal amplification) device and further judge the position of the implantation instrument in the patient body, and thus the implantation instrument can be ensured to be accurately released at the expected deployment position.

Referring to fig. 1 and 2 together, in the prior art, an implantation instrument 10 includes a bare stent 11 and a visualization structure 13 attached thereto. The bare stent 11 comprises a plurality of connected bare wave rings 110, each bare wave ring 110 comprises a plurality of wave rods 111 connected end to end, and the plurality of wave rods 111 connected end to end are formed with a plurality of wave crests and wave troughs. The developing structure 13 is 8-shaped, the cross section of the developing structure 13 is circular, and the developing structure 13 includes a circular arc portion 131 along the length direction thereof. When the developing structure 13 is connected to the bare stent 11, the arc portion 131 is attached to the small curved side of the wave crest (or the wave trough), and then the PTFE thread 15 binds the developing structure 13 to the bare blood vessel wave ring 110. The completed implantation device 10 needs to be placed in a delivery sheath for delivery in the blood vessel of the patient, and the radial dimension of the delivery sheath is smaller than the dimension of the implantation device 10 in the natural state (note that the natural state of the implantation device 10 means the state in which the implantation device 10 is naturally expanded without external force). That is, when the implanting device 10 is sheathed, the bare stent 11 needs to be radially compressed, and the angle formed by each wave bar 111 at the wave crest and the wave trough is reduced, thereby causing the wave bars 111 at both sides of the developing structure 13 to press the developing structure 13. In order to avoid the interference between the developing structure 13 and the wave rod 111, which results in the radial compression of the bare stent 11, the developing structure 13 needs to be smaller in size, which results in poor developing effect.

In addition, referring to fig. 3 and fig. 4, the cross sections of the wave bar 111 and the developing structure 13 are circular, and the surfaces of the PTFE wire 15, the wave bar 111, and the developing structure 13 are smooth. Therefore, when the wave bars 111 on both sides of the developing structure 13 press the developing structure 13, the PTFE wires 15, the wave bars 111, and the developing structure 13 slip. Further, the developing structure 13 is caused to slide to the outer side of the bare stent 11, and the developing structure 13 is caused to overlap the bare stent 11 at the outer side of the bare stent 11, further the developing structure 13 occupies the installation space between the vessel wall of the vascular stent 10 and the delivery sheath 10a, and further the delivery sheath 10a with a larger size (the inner diameter size of the delivery sheath 10a referred to herein) is required for sheathing.

Disclosure of Invention

Therefore, it is necessary to provide a developing structure to solve the problem of poor developing effect of the developing structure in the prior art.

The utility model provides a develop the structure, locates on the implanting apparatus, develop the structure and include the first development unit and the second development unit that link to each other with the implanting apparatus, be equipped with development material on the first development unit, be equipped with development material on the second development unit, first development unit and the rotatable linking to each other of second development unit, first development unit can rotate relatively around a rotation axis with the second development unit.

The outer wall of the implantation instrument has a generatrix and the axis of rotation is parallel to or away from the generatrix.

In one embodiment, the first developing unit comprises a framework and a matching piece, the matching piece is arranged on the framework, one end of the matching piece is connected with one end of the framework to form an annular structure together, the other end of the matching piece extends along the framework in a spiral mode, and the first developing unit is rotatably connected with the second developing unit through the annular structure.

In one embodiment, in a projection plane parallel to the axial plane of the implantation instrument, the projection of the matching element in the projection plane is in a wave shape, and a gap is left between two adjacent wave crests or two adjacent wave troughs projected by the matching element.

In one embodiment, the gap is less than 1 millimeter, and the gap is greater than 0.1 millimeter.

In one embodiment, the projection of the engagement element in the projection plane is a wave shape in a projection plane parallel to the axial plane of the implantation instrument, the engagement element projection having a wave height, the wave height being not less than 0.3 mm and the wave height being not more than 1 mm.

In one embodiment, the developing structure further comprises a connecting arm, the connecting arm comprises a first winding part and a second winding part, one end of the first winding part is connected with the first developing unit, the other end of the first winding part is connected with the bare bracket of the implanting instrument, one end of the second winding part is connected with the first developing unit, the other end of the second winding part is connected with the bare bracket of the implanting instrument, and one of the first winding part and the second winding part extends spirally around the other winding part.

In one embodiment, the projection of the connecting arm in a projection plane parallel to the axial plane of the connecting arm comprises a straight line projection and a wave projection, and the height between adjacent peaks and valleys in the wave projection is larger than the projection line width of the straight line projection.

In one embodiment, an implanting instrument is also provided, which includes a bare stent and the above-mentioned visualization structure, wherein the visualization structure is arranged on the bare stent.

In one embodiment, the blood vessel stent comprises a coating and a developing structure, wherein the developing structure is arranged on the coating and comprises a first developing unit and a second developing unit, a developing material is arranged on the first developing unit, the developing material is arranged on the second developing unit, the first developing unit is rotatably connected with the second developing unit, and the first developing unit and the second developing unit can rotate relatively around a rotating axis.

When the developing structure is sheathed along with the implanting instrument, the developing structure is under the action of external force when sheathed, the first developing unit and the second developing unit rotate around the rotation axis, and the first developing unit and the second developing unit are connected and attached; when the implantation instrument is released, the first developing unit and the second developing unit rotate around the rotating axis, the first developing unit and the second developing unit are mutually unfolded, the developing area of the developing structure can be increased, and the developing effect of the developing structure is further enhanced.

Drawings

FIG. 1 is a schematic diagram of a bare stent coupled to a visualization structure in the prior art.

Fig. 2 is an enlarged view of a in fig. 1.

Fig. 3 is a state diagram of radial compression of a bare stent in the prior art.

Fig. 4 is a prior art view of an implantation instrument radially loaded into a delivery sheath.

Fig. 5 is a schematic structural diagram of a blood vessel stent in one embodiment.

Fig. 6 is an enlarged view of B in fig. 5.

Fig. 7-1 is an enlarged view of C in fig. 6.

Fig. 7-2 is a perspective view of fig. 7-1.

Fig. 8-1 is an enlarged view of D in fig. 6.

Fig. 8-2 is a perspective view of fig. 8-1.

FIG. 9 is a schematic diagram of a coupling arm and a wave bar according to an embodiment.

Fig. 10 is a first state diagram of the first developing unit and the connecting arm processing in one embodiment.

Fig. 11 is a second state diagram of the first developing unit and the connecting arm processing in one embodiment.

Fig. 12 is a third state diagram of the first developing unit and the connecting arm processing in one embodiment.

Fig. 13 is a fourth state diagram of the first developing unit and the connecting arm processing in one embodiment.

Fig. 14 is a fifth state diagram of the first developing unit and the connecting arm processing in one embodiment.

Fig. 15 is a sixth state diagram of the first developing unit and the connecting arm processing in one embodiment.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention more comprehensible, embodiments accompanying figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only and do not represent the only embodiments.

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

To more clearly describe the structure of the present invention, the terms "distal" and "proximal" are used as terms of orientation that are conventional in the field of interventional medical devices, wherein "distal" refers to the end that is distal from the operator during the procedure and "proximal" refers to the end that is proximal to the operator during the procedure.

The axial direction refers to the direction parallel to the connecting line of the center of the far end and the center of the near end of the medical instrument; the radial direction means a direction perpendicular to the axial direction.

Referring to fig. 5, the present embodiment provides a visualization structure 23 disposed on the implantation instrument 20. The implantation device 20 can be a vascular stent, a valve prosthesis, or other medical devices implantable in the human body. In particular, in the present embodiment, the implantation instrument 20 is a vascular stent.

The outer wall of the implantation instrument 20 has a generatrix 201, and the generatrix 201 is rotated about a central axis (not numbered) of the implantation instrument 20 to form the outer wall of the implantation instrument 20. The implanting instrument 20 comprises a bare stent 210, the bare stent 210 comprises a plurality of connected bare wave rings 211 along the length direction, the bare wave rings 211 comprise a plurality of

wave rods

211a and 211b which are connected end to end, and the

wave rods

211a and 211b which are connected end to end are formed with a plurality of wave crests 215 and wave troughs 217.

Referring to fig. 6, the developing structure 23 includes a first developing unit 231, a second developing unit 251 and two connecting arms (i.e., connecting arms 271, 291) connected to the implanting apparatus 20. The connection arm 271 is connected to the first developing unit 231, the other connection arm 291 is connected to the second developing unit 251, the first developing unit 231 is connected to the bare stand 210 through the connection arm 271, and the second developing unit 251 is connected to the bare stand 210 through the connection arm 291. Specifically, the first developing unit 231 is connected to one side 211a of one peak 215 by a connecting arm 271, and the second developing unit 251 is connected to the other side 211b of the peak 215 by a connecting arm 291.

The first visualization unit 231 is provided with a visualization material so that the position of the first visualization unit 231 within the patient can be viewed under DSA to thereby determine the position of the implant device 20 within the patient. The second developing unit 251 is provided with a developing material so that the position of the second developing unit 251 in the patient can be observed under DSA, and the position of the implant device 20 in the patient can be further determined, and the first developing unit 231 and the second developing unit 251 develop together, so that the reliability of the developing structure 23 for determining the position of the implant device 20 in the patient can be improved. The first developing unit 231 and the second developing unit 251 are rotatably connected, and the first developing unit 231 and the second developing unit 251 are relatively rotatable about a rotational axis 290, and the rotational axis 290 is parallel to or spaced apart from the bus 201. It should be noted that even if the generatrix 201 of the implantation device 20 intersects the rotation axis 290 at an acute angle or if the generatrix 201 is moved parallel to the acute angle intersecting the rotation axis 290 at an angle of 8 ° or less when the implantation device 20 is in the natural state, the aforementioned case where the rotation axis 290 is parallel to or away from the generatrix 201 applies.

The insertion instrument 20 needs to be loaded into the delivery sheath 10a prior to implantation to facilitate delivery within the lumen of the patient's blood vessel. As will be appreciated by those skilled in the art, the inner diameter of the delivery sheath 10a is smaller than the radial dimension of the insertion instrument 20 in its natural state. Thus, the insertion instrument 20 is radially compressed before being loaded into the lumen of the delivery sheath 10 a. It will be appreciated by those skilled in the art that since the bare stent 210 provides a radially expansive force, the implantation device 20 loaded into the delivery sheath 10a is also a hollow tube structure having a lumen rather than a solid tube structure.

Upon radially compressing the implantation instrument 20, an inward radial force is applied to the visualization structure 23, such that the first visualization unit 231 and the second visualization unit 251 rotate about the rotation axis 290 towards the lumen of the implantation instrument 20, and the portion of the first visualization unit 231 associated with the second visualization unit 251 approaches the central axis of the implantation instrument 20. Further, when the implanting device 20 is sheathed, the developing structure 23 is always accommodated in the compressed lumen of the implanting device 20, and does not need to occupy the installation space between the outer wall of the implanting device 20 and the inner wall of the conveying sheath 10a, thereby avoiding that the implanting device 20 needs the conveying sheath 10a with a larger size (the inner diameter of the conveying sheath 10 a) when sheathed. When the implanting device 20 is sheathed, the developing structure 23 is always accommodated in the compressed lumen of the implanting device 20, and when the implanting device 20 is released from the conveying sheath tube 10a, the frictional resistance when the implanting device 20 is released can be reduced.

In addition, after the implantation instrument 20 is released from the delivery sheath 10a, the first and second developing

units

231 and 251 rotate about the rotation axis under the radial expansion force of the bare stent 210, and the first and second developing

units

231 and 251 move toward the distant central axis about the connected portion. Meanwhile, the first developing unit 231 is unfolded under the traction action of the wave bars (i.e., the wave bar 211a and the wave bar 211 b) on the two sides, so that the developing area and the developing effect of the developing structure 23 are increased, and the identifiability of the developing structure 23 is improved. Meanwhile, the first developing unit 231 and the second developing unit 251 rotate around the rotation axis, and the interference of the developing structure 23 with the

wave bars

211a and 211b can be avoided, thereby preventing the bare stent 210 from being compressed radially.

Referring to fig. 6 and 7-1, the first developing unit 231 includes a frame 233 and a fitting member 235, the fitting member 235 is disposed on the frame 233, and an end of the fitting member 235 is connected to an end of the frame 233 to form a ring structure 237. The first developing unit 231 is rotatably connected to the second developing unit 251 by a ring structure 237. The other end of the engaging member 235 extends helically along the backbone 233. Specifically, the engaging member 235 is helically wound around the backbone 233. In the releasing process of the implanting device 20, if the force applied by the bare stent 210 to the developing structure 23 is too large, and one of the framework 233 and the mating member 235 is broken, if one of the framework 233 and the mating member 235 is not broken, the first developing structure 23 can be prevented from falling, the reliability of the connection between the developing structure 23 and the bare stent 210 is improved, and the safety of the use of the implanting device 20 is further improved. Further, if the force (pulling force) applied by the bare stent 210 to the developing structure 23 is too large, even if the skeleton 233 breaks, the engaging element 235 is pulled into a straight line shape only from the spiral curved shape, and does not break, and the energy generated by the bare stent 210 to the developing structure 23 can be absorbed during the process that the engaging element 235 is straightened and deformed.

The materials of the frame 233 and the engaging member 235 are developing materials, that is, the first developing unit 231 is provided with the developing materials. Specifically, the developing material may be tantalum, platinum, gold, or the like, which has a good developing effect. The other end of the engaging member 235 extends spirally along the frame 233, which can increase the amount of developing material in the developing structure 23, thereby increasing the developing effect of the developing structure 23. In other embodiments, the material of either the frame 233 or the engaging member 235 may be a developing material.

Furthermore, in one embodiment, the material of the frame 233 is a developing material, the first developing unit 231 may only comprise the frame 233, the end of the frame 233 forms a ring structure 237, and the first developing unit 231 is rotatably connected to the second developing unit 251 through the ring structure 237, thereby avoiding the need for a larger-sized delivery sheath 10a for sheathing the implantation device 20.

Of course, in another embodiment, the material of the fitting 235 is a developing material, the first developing unit 231 may include only the fitting 235, the end of the fitting 235 forms an annular structure 237, and the first developing unit 231 is rotatably connected to the second developing unit 251 through the annular structure 237.

In this embodiment, the bobbin 233 is a multi-strand wire, and even if one or some of the multi-strand wires is broken, the bobbin 233 is not broken as long as one or some of the wires in the bobbin 233 is not broken. The fitting 235 is a multi-strand wire, and the fitting 235 may extend helically along the backbone 233. Of course, in other embodiments, the frame 233 could be a single strand of wire, and the engaging member 235 could be a single strand of wire.

Referring to fig. 7-2, in a projection plane parallel to the axial plane of the implantation device 20, a projection 233a of the skeleton 233 in the projection plane is a curve, a projection 235a of the engagement element 235 in the projection plane is a wave shape, the projection 235a extends around the projection 233a wave shape, and a gap is left between two adjacent peaks or two adjacent valleys of the projection 235a of the engagement element 235. When the bare bracket 210 applies a tensile force or a compressive force to the first developing unit 231, the fitting member 235 has a certain telescopic space, and then the bare bracket 210 applies a tensile force or a compressive force to the fitting member 235 to be too large, thereby avoiding the breakage of the fitting member 235.

Specifically, in the present embodiment, a gap is left between two adjacent peaks or two adjacent valleys of the projection 235a of the fitting member 235, the gap is smaller than 1 mm, and the gap is larger than 0.1 mm (i.e. the wave width is smaller than 1 mm, and the wave width is larger than 0.1 mm). It is possible to prevent the bare bracket 210 from applying excessive tensile or compressive force to the first developing unit 231, which may cause the engaging member 235 to break.

In this embodiment, the peak of the projection 235a and the nearest valley have a distance therebetween, that is, the wave height of the projection 235a is not less than 0.3 mm and not more than 1 mm (that is, the wave height is not less than 0.3 mm and not more than 1 mm). Further, a tensile force or a compressive force is applied to the first developing unit 231 on the bare bracket 210, so that the engaging member 235 can be deformed by sliding along the framework 233, and the engaging member 235 is prevented from being broken.

In the present embodiment, the structures of the connecting

arms

271 and 291 are the same, and only the specific structure of the connecting arm 271 of the first developing unit 231 will be described in detail for simplifying the description.

Referring to fig. 6 and 8, the connecting arm 271 includes a first winding member 273 and a second winding member 275, and the materials of the first winding member 273 and the second winding member 275 are developing materials. One end of the first winding member 273 is connected to the first developing unit 231 (for example, one end of the first winding member 273 is connected to the backbone 233 in the first developing unit 231, or one end of the first winding member 273 is connected to the fitting member 235 in the first developing unit 231), and the other end of the first winding member 273 is connected to the bare stent 210 of the implanting device 20. One end of the second winding member 275 is connected to the first developing unit 231 (for example, one end of the second winding member 275 is connected to the backbone 233 in the first developing unit 231, or one end of the second winding member 275 is connected to the mating member 235 in the first developing unit 231), the other end of the second winding member 275 is connected to the bare stent 210 of the implantation device 20, and one of the first winding member 273 and the second winding member 275 extends spirally around the other. In the releasing process of the implanting device 20, if the force applied by the bare stent 210 to the developing structure 23 is too large, even if one of the first winding part 273 and the second winding part 275 is broken, as long as one of the two is not broken, the first developing structure 23 can be prevented from falling, so that the reliability of connection between the developing structure 23 and the bare stent 210 is improved, and the safety of use of the implanting device 20 is further improved. Further, if the force (pulling force) applied by the bare stent 210 to the developing structure 23 is too large, the spirally extending structures of the first winding part 273 and the second winding part 275 are pulled into a linear state from the spiral state without breaking, and the energy generated by the bare stent 210 to the developing structure 23 can be absorbed in the process of being straightened and deformed, so as to prevent the bare stent 210 from breaking other structures of the developing structure 23.

In the present embodiment, in a projection plane parallel to the axial plane of the connecting arm 271, the projection of the connecting arm 271 includes a straight line projection and a wave projection, and the height between adjacent peaks and valleys in the wave projection (i.e., the wave height) is greater than the projection line width of the straight line projection. It is ensured that one of the first and second winding

members

273 and 275 can be slidably deformed along the other to prevent the connecting arm 271 from being completely broken.

In this embodiment, the first winding member 273 is a multi-strand wire, and the first winding member 273 is formed in a straight shape (of course, in other embodiments, the first winding member 273 may be formed in a curved shape or other irregular shapes). Referring to fig. 8-2, in a projection plane parallel to the axial plane of the connecting arm 271, the first winding member 273 forms a first projection 273a in its projection plane, and the first projection 273a is a straight projection. The second winding member 275 is a plurality of strands of wire, the second winding member 275 extends spirally around the first winding member 273, the second winding member 275 forms a second projection 275a in a projection plane parallel to the axial plane of the connecting arm 271, the second projection 275a is a wave projection extending in a wave form around the first projection 273a, and the height between adjacent peaks and valleys in the second projection 275a is greater than the projection line width of the first projection 273 a. In other embodiments, the second winding member 275 may be processed in a straight shape; the first winding part 273 extends spirally around the second winding part 275, the first projection 273a is a waveform projection extending in a waveform around the second projection 275a, and the height between adjacent peaks and valleys in the first projection 273a is greater than the projected line width of the second projection 275 a. Of course, in other embodiments, the first and/or second winding

members

273 and 275 may be a single wire.

A gap (i.e., a wave width) is left between two adjacent wave crests or two adjacent wave troughs, and the gap is greater than the width of the projection of the waveform, i.e., the gap is greater than the width of the projection line of the second winding member 275, so that the second winding member 275 has a sliding deformation space, and the bare stent 210 can be prevented from breaking the second winding member 275.

Referring to fig. 6 again, the connecting arm 271 further includes a first connecting member 277 and a second connecting member 279, the first connecting member 277 is connected to the first winding member 273, the first connecting member 277 is wound around the wave bar 211a of the bare stent 210, the second connecting member 279 is connected to the second winding member 275, and the second connecting member 279 is wound around the wave bar 211a of the bare stent 210.

The first connector 277 may be a multi-strand wire or a single-strand wire. The second connecting member 279 may be a multi-strand wire or a single-strand wire. In this embodiment, the first connecting member 277 is a plurality of wires, the first connecting member 277 is disposed on the wave bar 211a of the bare stent 210 in a grid pattern, the second connecting member 279 is a plurality of wires, and the second connecting member 279 is disposed on the wave bar 211a of the bare stent 210 in a grid pattern.

Along the length direction of the wave rod 211a, the second connecting member 279 is positioned between the wave crest 215 of the bare stent 210 and the first connecting member 277, and the winding density of the first connecting member 277 is greater than that of the second connecting member 279. When the bare stent 210 is compressively deformed or self-expanding deformed, the second connector 279 may slide on the wave lever 211a of the bare stent 210, which may reduce the stress of the wave lever 211a on the connection arm 271. Note that the winding density refers to how much amount of wire is wound on the wave bar 211a per unit length. For example, when the wire is spirally wound, the larger the amount of the wire wound on the wave bar 211a per unit length (i.e., the smaller the pitch), the larger the corresponding winding density, and conversely, the smaller the winding density. When the wire rod is spirally wound and is wound in a grid-shaped staggered manner, the smaller the formed meshes are, the larger the corresponding winding density is, and otherwise, the smaller the winding density is.

In this embodiment, the first connector 277 is a plurality of wires, and the first connector 277 is spirally wound from the proximal side of the wave bar 211a to the distal side of the wave bar 211 a; the second connector 279 is a multi-strand wire, and the second connector 279 is spirally wound from the distal side of the wave bar 211a toward the proximal side of the wave bar 211a, so that the forces applied by the wave bar 211a to the connecting arms 271 are balanced. Of course, in other embodiments, the first connector 277 may be helically wound from the distal side of the wave bar 211a toward the proximal side of the wave bar 211a, and the second connector 279 may be helically wound from the proximal side of the wave bar 211a toward the distal side of the wave bar 211 a. It should be noted that the proximal side of the wave bar 211a refers to the side close to the central axis of the implantation instrument 20 in the radial section of the single wave bar 211 a; the distal side of the wave bar 211a refers to the side of the single wave bar 211a that is distal from the central axis of the implantation instrument 20 in a radial cross-section.

Referring to fig. 9, in another embodiment, the first connecting member 277 is wound on the wave bar 211a in a grid shape, and the second connecting member 279 is wound on the wave bar 211a in a grid shape. The reliability of the connection arm 271 with the wave lever 211a can be increased.

The material of the first and second connecting

members

277 and 279 is a developing material. In other embodiments, the material of one of the first and

second connectors

277 and 279 is a developing material.

As shown in FIG. 9, the first winding element 273 forms an acute angle θ with the radial direction 211a of the straight line segment of the wave rod 211a, and θ is greater than or equal to 0 ° and less than or equal to 45 °, i.e., the straight line projection forms an acute angle θ with the radial direction 211a of the straight line segment of the wave rod 211a, and θ is greater than or equal to 0 ° and less than or equal to 45 °. When θ =0 °, the first winding element 273 is perpendicular to the straight line segment of the wave bar 211a, no component force is generated on the first winding element 273 in the axial direction of the wave bar 211a during the self-expansion of the wave bar 211a, the first connecting element 277 and the second connecting element 279 wound on the wave bar 211a are not easy to slide, and the connection between the developing structure 23 and the wave bar 211a is more stable. And θ =0 ° due to the development of the developing structure 23. If θ is greater than or equal to 45 °, the outer dimensions of the first developing unit 231 and the second developing unit 251 are increased, and further, when the first developing unit 231 and the second developing unit 251 are turned inwards, a larger radial space is required, thereby increasing the frictional resistance when the implantation apparatus 20 is released.

The above-described configurations of the first developing unit 231 and the connecting arm 271 will be briefly described, and more specifically, the method of manufacturing the first developing unit 231 will be described below.

First, a reference point is marked.

Specifically, referring to fig. 10, a multi-strand wire is provided, wherein the number of strands of the multi-strand wire is greater than or equal to 2. Three reference points marked A1, A2, A3 are made on the multi-strand wire. An annular structure 237 is formed around each of the portions A1 and A2, and the position of A3 corresponds to the position where the connecting arm 271 is connected to the frame 233. The positions of A1, A2, A3 may be adjusted according to the size of the developing structure 23.

Second, the first developing unit 231 is formed.

Referring to fig. 11 to 13, a plurality of wires between A1 and A2 are bent to form a bobbin 233, the plurality of wires between A1 and a free end are spirally wound on the bobbin 233, the plurality of wires between A2 and a free end are spirally wound on the bobbin 233, the plurality of wires spirally wound on the bobbin 233 are joined at A3 and the spiral winding is terminated, and the plurality of wires spirally wound on the bobbin 233 form a fitting member 235.

In the third step, the first and second winding

members

273 and 275 are formed.

Specifically, referring to fig. 14, of the two wires merged at A3, one of the wires extends along a straight line toward the wave rod 211a, the wire extending along the straight line toward the wave rod 211a is the first winding member 273, the other wire extends spirally along the first winding member 273 and is close to the wave rod 211a, and the wire spirally extending along the first winding member 273 is the second winding member 275.

Fourth, the first and second connecting

members

277 and 279 are formed.

Specifically, referring to fig. 15, a wire divided from the end of the first winding member 273 is spirally wound around the wave bar 211a to form a first connecting member 277, and the tip of the first connecting member 277 is fixed to the wave bar 211a by spot welding. The wire divided from the end of the second winding member 275 is spirally wound on the wave bar 211a to form a second connecting member 279, and the tip of the second connecting member 279 is fixed to the wave bar 211a by spot welding. It is noted that before the first developing unit 231 is coupled to the wave bar 211a, the angle of the ring structure 237 may be adjusted as needed so that the ring structure 237 is not coplanar with the frame 233, so as to facilitate the rotational coupling of the first developing unit 231 to the second developing unit 251.

The second developing unit 251 in this embodiment has substantially the same structure as the first developing unit 231, and the manufacturing methods thereof are substantially the same. The difference is that the ring structure 237 of the second developing unit 251 is in the same plane as the frame 233, and the ring structure 237 of the first developing unit 231 is not in the same plane as the frame 233.

An embodiment of the present invention further provides a visualization structure 23, which is different from the previous embodiment in that the material of the skeleton 233 is nitinol, and when the bare stent 210 is compressed and deformed, the visualization structure 23 can be deformed simultaneously along the axial direction and the radial direction between the blood vessels, so that when the implantation device 20 is sheathed, the visualization structure 23 does not need to occupy the installation space between the delivery sheath 10a and the implantation device 20. The first developing unit 231 can be fixedly connected with the second developing unit 251, so as to further ensure that when the bare stent 210 is compressed and deformed, the first developing unit 231 and the second developing unit 251 cannot turn over towards the outside of the lumen of the implantation instrument 20, and further avoid the developing structure 23 from occupying the installation space between the delivery sheath 10a and the implantation instrument 20.

An embodiment of the present invention further provides an implanting apparatus 20, which includes a bare stent 210 and the above-mentioned developing structure 23, wherein the developing structure 23 is disposed on the bare stent 210.

In contrast to the above-mentioned embodiment, the implantation device 20 according to another embodiment of the present invention further includes a bare stent 210, a covering film (not shown), and the above-mentioned developing structure 23, wherein the developing structure 23 is disposed on the bare stent 210 or the covering film. For example, the backbone 233 of the first developing unit 231 is sewn to the coating film by a sewing thread, and the backbone 233 of the second developing unit 251 is sewn to the coating film by a sewing thread.

The technical features of the above embodiments can be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the above embodiments are not described, but should be considered as the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above examples only show some embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A developing structure is arranged on an implanting instrument and is characterized in that a wave ring of the implanting instrument comprises a plurality of wave bars which are connected end to end, the developing structure comprises a first developing unit and a second developing unit, the first developing unit and the second developing unit are respectively connected with two adjacent wave bars on the wave ring, a developing material is arranged on the first developing unit, a developing material is arranged on the second developing unit, the first developing unit is rotatably connected with the second developing unit, and the first developing unit and the second developing unit can rotate relatively around a rotating axis; the outer wall of the implantation instrument is provided with a bus, the rotating axis is parallel to or separated from the bus, and the rotating axis is arranged between two adjacent wave bars which are connected with the first developing unit and the second developing unit; when the implantation instrument is radially compressed, inward radial force is applied to the developing structure, so that the first developing unit and the second developing unit rotate around the rotating shaft to the lumen of the implantation instrument, and the part, connected with the first developing unit and the second developing unit, is close to the central axis of the implantation instrument.

2. The developing structure according to claim 1, wherein the first developing unit comprises a framework and a fitting member, the fitting member is arranged on the framework, one end of the fitting member is connected with one end of the framework to form an annular structure together, the other end of the fitting member extends spirally along the framework, and the first developing unit is rotatably connected with the second developing unit through the annular structure.

3. The visualization structure of claim 2, wherein in a projection plane parallel to an axial plane of the implant device, a projection of the mating member in the projection plane is a wave shape, and a gap is left between two adjacent peaks or two adjacent valleys of the projection of the mating member.

4. The developer structure of claim 3, wherein the gap is less than 1 mm and the gap is greater than 0.1 mm.

5. The visualization structure of claim 2, wherein a projection of the engagement element in a projection plane parallel to an axial plane of the implant device has a wave shape, the engagement element projection having a wave height, the wave height being not less than 0.3 mm, and the wave height being not more than 1 mm.

6. The visualization apparatus as recited in claim 1, wherein said visualization apparatus further comprises a connection arm, said connection arm comprising a first winding member and a second winding member, one end of said first winding member being connected to said first visualization unit, the other end of said first winding member being connected to a bare stent of said implantation device, one end of said second winding member being connected to said first visualization unit, the other end of said second winding member being connected to a bare stent of said implantation device, one of said first winding member and said second winding member extending helically around the other.

7. The developer structure of claim 6, wherein said projection of said connecting arm, in a plane of projection parallel to said axial plane of said connecting arm, comprises a straight projection and a wave projection, said wave projection having a height between adjacent peaks and valleys that is greater than a projected line width of said straight projection.

8. An implantation instrument comprising a bare stent and a visualization structure according to any of claims 1 to 7, the visualization structure being provided on the bare stent.

9. A vascular stent is characterized by comprising a wave ring, a covering film and a developing structure, wherein the wave ring comprises a plurality of wave rods which are connected end to end, the developing structure is arranged on the covering film and comprises a first developing unit and a second developing unit, the first developing unit and the second developing unit are respectively connected with two adjacent wave rods on the wave ring, a developing material is arranged on the first developing unit, a developing material is arranged on the second developing unit, the first developing unit is rotatably connected with the second developing unit, and the first developing unit and the second developing unit can relatively rotate around a rotating axis; the outer wall of the blood vessel support is provided with a bus, the rotating axis is parallel to or separated from the bus, and the rotating axis is arranged between two adjacent wave bars which are connected with the first developing unit and the second developing unit; when the vascular stent is radially compressed, inward radial force is applied to the developing structure, so that the first developing unit and the second developing unit rotate around the rotating axis towards the lumen of the vascular stent, and the part, connected with the second developing unit, of the first developing unit is close to the central axis of the vascular stent.