CN113057774B - Visualization structure, implantation instrument and blood vessel support - Google Patents

Abstract

The invention relates to a developing structure, an implant device and a vascular stent. The developing structure includes a first developing unit and a second developing unit connected with the implanting device. The first developing unit is provided with a developing material, and the second developing unit is provided with a There are developing materials, 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 rotation axis. The developing structure of the present invention can prevent the first developing unit and the second developing unit from expanding mutually when the implant device is sheathed, and can increase the developing area of the developing structure, thereby enhancing the developing effect of the developing structure.

Description

Visualize structures, implanted devices and stents

technical field

The invention relates to the field of implanted medical devices, in particular to a developing structure, an implanted device and a blood vessel stent.

Background technique

Interventional therapy has the advantages of less trauma and shorter recovery time. Therefore, interventional therapy has been accepted by more and more doctors and patients. For example, when treating a hemangioma (specifically, the hemangioma may be an aortic aneurysm), an implanted device (for example, a vascular stent) is delivered to the neoplastic site of the blood vessel by means of intervention to treat the hemangioma. It is well known that when delivering and releasing implanted devices, interventional procedures require the use of DSA equipment to observe the position of implanted devices in the patient's body. Specifically, an X-ray-opaque imaging structure is provided on the implant device, and the doctor can observe the position of the imaging structure in the patient's body through the DSA device, and then judge the position of the implant device in the patient's body, so as to ensure that the implant device can Release exactly where it is intended to be deployed.

Please refer to FIG. 1 and FIG. 2 together. In the prior art, an implant device 10 includes a bare stent 11 and a developing structure 13 connected thereto. The bare support 11 includes a plurality of connected bare wave coils 110, and each bare wave coil 110 includes a plurality of end-to-end connected wave rods 111, and the plurality of end-to-end connected wave rods 111 form a plurality of wave peaks and wave troughs. The developing structure 13 is in the shape of 8, the cross section of the developing structure 13 is circular, and the developing structure 13 includes an arc portion 131 along its length. When the imaging structure 13 is connected to the bare stent 11 , the arc portion 131 is in contact with the small curved side of the crest (or trough), and then the PTFE wire 15 binds the imaging structure 13 and the bare vascular coil 110 together. The completed implant device 10 needs to be packed into the delivery sheath before it can be delivered in the patient's blood vessel. The radial size of the delivery sheath is smaller than the size of the implant device 10 in its natural state (it should be pointed out that the implant device 10 is naturally The state refers to the state when the implant device 10 is naturally deployed without external force). That is to say, when the implant instrument 10 is sheathed, the bare stent 11 needs to be radially compressed, and the angles formed by the wave rods 111 at the crests and troughs will decrease, so the wave rods 111 located on both sides of the developing structure 13 will be reduced. 111 squeezes the developing structure 13 . In order to prevent the bare frame 11 from being unable to compress radially due to interference between the developing structure 13 and the wave rod 111 , the size of the developing structure 13 needs to be small, which will result in poor developing effect.

In addition, please refer to FIG. 3 and FIG. 4 together. Since the cross-sections of the wave rod 111 and the developing structure 13 are circular, and the surfaces of the PTFE wire 15 , the wave rod 111 , and the developing structure 13 are relatively smooth. Therefore, when the wave rods 111 on both sides of the developing structure 13 press the developing structure 13 , the PTFE wire 15 , the wave rods 111 , and the developing structure 13 will slip. Further, it will cause the developing structure 13 to slide to the outside of the bare stent 11, and then cause the developing structure 13 to overlap with the bare stent 11 on the outside of the bare stent 11, and further cause the developing structure 13 to occupy the tube wall of the vascular stent 10 and transport The installation space between the sheath tubes 10a further leads to the need for a delivery sheath tube 10a of a larger size (here referred to as the inner diameter of the delivery sheath tube 10a ) to be installed when sheathing.

Contents of the invention

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

A development structure, which is set on the implant device, the development structure includes a first development unit and a second development unit connected with the implant device, the first development unit is provided with a development material, and the second development unit is provided with a development material The first developing unit is rotatably connected to the second developing unit, and the first developing unit and the second developing unit can rotate relatively around a rotation axis.

The outer wall of the implant device has a generatrix with an axis of rotation parallel to or away from the generatrix.

In one of the embodiments, the first developing unit includes a skeleton and a fitting, the fitting is arranged on the skeleton, one end of the fitting is connected to one end of the skeleton to form a ring structure together, and the other end of the fitting extends spirally along the skeleton. A developing unit is rotatably connected with the second developing unit through a ring structure.

In one of the embodiments, in the projection plane parallel to the axial plane of the implant device, the projection of the fitting part in the projection plane is a waveform, and there is a gap between two adjacent peaks or two adjacent troughs of the projection of the fitting part.

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

In one of the embodiments, in a projection plane parallel to the axial plane of the implant device, the projection of the fitting on the projection plane is a waveform, and the projection of the fitting has a wave height, the wave height is not less than 0.3 mm, and the wave height is not greater than 1 mm .

In one of the embodiments, the developing structure further includes a connecting arm, the connecting arm includes a first wrapping part and a second wrapping part, one end of the first wrapping part is connected with the first developing unit, and the other end of the first wrapping part is connected with the implantation unit. The bare frame of the device is connected, 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 frame of the implanted device, and one of the first winding part and the second winding part is wound around the other Spiral extension.

In one of the embodiments, in the projection plane parallel to the axis plane of the connecting arm, the projection of the connecting arm includes linear projection and waveform projection, and the height between adjacent peaks and troughs in the waveform projection is greater than the projection line of the linear projection width.

In one of the embodiments, an implant device is also provided, comprising a bare stent and the above-mentioned developing structure, and the developing structure is arranged on the bare stent.

In one of the embodiments, there is also provided a vascular stent, which includes a film covering and a developing structure, the developing structure is arranged on the covering film, the developing structure includes a first developing unit and a second developing unit, and the first developing unit is provided with The developing material is provided on the second developing unit, the first developing unit and the second developing unit are rotatably connected, and the first developing unit and the second developing unit can relatively rotate around a rotation axis.

When the above-mentioned developing structure follows the sheathing of the implant device, when the sheathing is performed, the developing structure is subjected to an external force, 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 bonded together ; When the implanted device is released, 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 mutually deployed, which can increase the developing area of the developing structure, thereby enhancing the developing effect of the developing structure.

Description of drawings

FIG. 1 is a structural schematic diagram of a bare support connected to a developing 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 state view of an implant instrument being loaded into a delivery sheath in the prior art.

Fig. 5 is a schematic structural diagram of a vascular stent in an embodiment.

FIG. 6 is an enlarged view of B in FIG. 5 .

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

Figure 7-2 is a projection view of Figure 7-1.

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

Figure 8-2 is a projection view of Figure 8-1.

Fig. 9 is a schematic diagram of the connection between the connecting arm and the probe in an embodiment.

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

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

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

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

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

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

Detailed ways

In order to make the above objects, features and advantages of the present invention more comprehensible, specific implementations of the present invention will be described in detail below in conjunction with the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, the present invention can be implemented in many other ways different from those described here, and those skilled in the art can make similar improvements without departing from the connotation of the present invention, so the present invention is not limited by the specific implementations disclosed below.

It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or there may be an intervening element. 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 similar expressions are used herein for purposes of illustration only and are not intended to represent the only embodiments.

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

In order to describe the structure of the present invention more clearly, "distal end" and "proximal end" are used as orientation words, which are commonly used terms in the field of interventional medical equipment, wherein "distal end" means the end away from the operator during the operation, "Proximal" means the end that is closest to the operator during the procedure.

The axial direction refers to the direction parallel to the center of the distal end and the center of the proximal end of the medical device; the radial direction refers to the direction perpendicular to the aforementioned axial direction.

Please refer to FIG. 5 , this embodiment provides a developing structure 23 disposed on the implant device 20 . The implant device 20 may be other implantable medical devices such as a vascular stent, a valve prosthesis, and the like. Specifically, in this embodiment, the implant device 20 is a vascular stent.

The outer wall of the implant device 20 has a generatrix 201 , and the generatrix 201 rotates around the central axis (not labeled) of the implant device 20 to form the outer wall of the implant device 20 . The implant device 20 includes a bare stent 210, the bare stent 210 includes a plurality of connected bare wave coils 211 along the length direction, the bare wave coil 211 includes a plurality of end-to-end connected wave rods 211a and 211b, and the end-to-end connected wave rods 211a and wave rods 211b is formed with a plurality of crests 215 and troughs 217 .

Please refer to FIG. 6 , the developing structure 23 includes a first developing unit 231 , a second developing unit 251 and two connecting arms (ie, connecting arms 271 and 291 ) connected to the implant device 20 . The connecting arm 271 is connected to the first developing unit 231, and the other connecting arm 291 is connected to the second developing unit 251. The first developing unit 231 is connected to the bare support 210 through the connecting arm 271, and the second developing unit 251 is connected to the bare frame through the connecting arm 291. The brackets 210 are connected. Specifically, the first developing unit 231 is connected to the wave bar 211a on one side of the peak 215 through the connecting arm 271 , and the second developing unit 251 is connected to the wave bar 211b on the other side of the wave peak 215 through the connecting arm 291 .

The first developing unit 231 is provided with a developing material, so that the position of the first developing unit 231 in the patient's body can be observed under DSA, so as to determine the position of the implant device 20 in the patient's body. The second development unit 251 is provided with a development material, so that the position of the second development unit 251 in the patient can be observed under DSA, and then the position of the implant device 20 in the patient can be judged. The first development unit 231 and the second development unit 251 can be developed together, which can improve the reliability of the development structure 23 for judging the position of the implant device 20 in the patient's body. The first developing unit 231 is rotatably connected to the second developing unit 251 , and the first developing unit 231 and the second developing unit 251 can rotate relative to each other around a rotation axis 290 . The rotation axis 290 is parallel to or separated from the bus bar 201 . It should be pointed out that, when the implant device 20 is in a natural state, even if the generatrix 201 of the implant device 20 intersects with the rotation axis 290 to form an acute angle, or moves the generatrix 201 in parallel to the acute angle formed by the intersection with the rotation axis 290, as long as the Acute angles less than or equal to 8° belong to the above-mentioned situation where the rotation axis 290 is parallel to or separated from the generatrix 201 .

The implantation instrument 20 needs to be loaded into the delivery sheath 10a before implantation, so as to be delivered in the patient's vascular cavity. Those skilled in the art can understand that the inner diameter of the delivery sheath 10a is smaller than the radial dimension of the implant device 20 when it is in a natural state. Therefore, the implant instrument 20 cannot be loaded into the lumen of the delivery sheath 10a until it is radially compressed. Those skilled in the art can understand that since the bare stent 210 provides radial expansion force, the implant instrument 20 loaded into the delivery sheath 10a is also a hollow tube structure with a lumen instead of a solid tube structure.

When the implant device 20 is radially compressed, an inward radial force is applied to the developing structure 23, so that the first developing unit 231 and the second developing unit 251 rotate around the rotation axis 290 into the lumen of the implant device 20, and the first The connecting part of the developing unit 231 and the second developing unit 251 is close to the central axis of the implant device 20 . Furthermore, when the implant device 20 is sheathed, the developing structure 23 is always accommodated in the compressed lumen of the implant device 20, without occupying the installation space between the outer wall of the implant device 20 and the inner wall of the delivery sheath 10a, and further It is avoided that the delivery sheath 10a with a larger size (here referred to as the inner diameter of the delivery sheath 10a ) is required to be installed when the implant instrument 20 is sheathed. When the implant device 20 is sheathed, the developing structure 23 is always accommodated in the compressed lumen of the implant device 20, and when the implant device 20 is released from the delivery sheath 10a, the friction when the implant device 20 is released can be reduced resistance.

In addition, after the implant instrument 20 is released from the delivery sheath 10a, under the radial expansion force of the bare stent 210, the first developing unit 231 and the second developing unit 251 rotate around the rotation axis, and the first developing unit 231 and the second developing unit 251 rotate around the rotation axis. The second developing unit 251 moves away from the central axis around the connected portion. At the same time, the first developing unit 231 is unfolded under the traction of the two poles (ie, the poles 211 a and 211 b ), thereby increasing the developing area and developing effect of the developing structure 23 , and improving the usability of the developing structure 23 . Recognition. At the same time, the rotation of the first developing unit 231 and the second developing unit 251 around the rotation axis can also prevent the developing structure 23 from interfering with the wave rods 211a and 211b, thereby preventing the bare support 210 from being unable to compress radially.

Please refer to FIG. 6 and FIG. 7-1 together. The first developing unit 231 includes a skeleton 233 and a fitting 235. The fitting 235 is arranged on the skeleton 233. One end of the fitting 235 is connected with one end of the skeleton 233 to form a ring structure together. 237. The first developing unit 231 is rotatably connected to the second developing unit 251 through the ring structure 237 . The other end of the fitting part 235 extends helically along the skeleton 233 . Specifically, the fitting part 235 is helically wound on the skeleton 233 . During the release process of the implant device 20, if the bare stent 210 exerts too much force on the developing structure 23, if one of the skeleton 233 and the matching part 235 is broken, as long as one of the two is not broken, the second can be avoided. A development structure 23 falls, which improves the reliability of the connection between the development structure 23 and the bare stent 210 , thereby improving the safety of the implant device 20 in use. Further, if the bare support 210 exerts too much force (pull) on the developing structure 23, even if the skeleton 233 breaks, the fitting 235 will only be pulled from the helical bending shape to a straight shape without breaking. In addition, during the straightening and deformation process of the fitting part 235 , the energy generated by the bare support 210 on the developing structure 23 can be absorbed.

The materials of the framework 233 and the fitting part 235 are both developing materials, that is, the first developing unit 231 is provided with developing materials. Specifically, the developing material may be materials with good developing effects such as tantalum, platinum, and gold. The other end of the fitting part 235 spirally extends along the skeleton 233 , which can increase the amount of developing material in the developing structure 23 , and further increase the developing effect of the developing structure 23 . In other embodiments, any material of the skeleton 233 and the matching part 235 may be a developing material.

In addition, in one of the embodiments, the material of the skeleton 233 is a developing material, the first developing unit 231 may only include the skeleton 233, and the end of the skeleton 233 forms an annular structure 237, and the first developing unit 231 connects with the second developing unit 237 through its annular structure 237. The two developing units 251 can be rotatably connected to each other, thereby avoiding that the implant instrument 20 needs a larger-sized delivery sheath tube 10a to be inserted when sheathing.

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

In this embodiment, the skeleton 233 is a multi-strand wire, even if one or several strands of the multi-strand wire are broken, as long as there is one wire in the skeleton 233 that is not broken, the skeleton 233 will not break. The fitting part 235 is a multi-strand wire, and the fitting part 235 can extend helically along the skeleton 233 . Of course, in other embodiments, the skeleton 233 can also be a single-strand wire, and the matching part 235 can also be a single-strand wire.

Please refer to Fig. 7-2, in the projection plane parallel to the axial plane of the implant device 20, the projection 233a of the skeleton 233 in the projection plane is a curve, the projection 235a of the fitting 235 in the projection plane is a waveform, and the projection 235a revolves around The projection 233a extends in a waveform, and there is a gap between two adjacent crests or two adjacent troughs of the projection 235a of the matching member 235 . When the bare frame 210 exerts tension or compression force on the first developing unit 231 , the matching part 235 has a certain expansion and contraction space, and then when the bare frame 210 exerts too much tension or compression force on the matching part 235 , the fitting part 235 is prevented from breaking.

Specifically, in this embodiment, there is a gap between two adjacent peaks or two adjacent troughs of the projection 235a of the fitting 235, the gap is less than 1 mm, and the gap is greater than 0.1 mm (that is, the wave width is less than 1 mm, And the wave width is greater than 0.1 mm). This can prevent the bare bracket 210 from exerting too much tension or compression force on the first developing unit 231 , causing the fitting part 235 to break.

In this embodiment, there is a distance between the peak of the projection 235a and its nearest trough, that is, the wave height of the projection 235a, the wave height is not less than 0.3 mm, and the wave height is not greater than 1 mm (that is, the wave height is not less than 0.3 mm, and the wave height is not greater than 1 mm). Furthermore, the bare support 210 exerts too much tension or compression force on the first developing unit 231 , so that the fitting part 235 can slide and deform along the frame 233 , thereby preventing the fitting part 235 from breaking.

In this embodiment, the structures of the connecting arms 271 and 291 are the same, and to simplify the description, only the specific structure of the connecting arm 271 with the first developing unit 231 will be described in detail.

Please refer to FIG. 6 and FIG. 8 together, the connecting arm 271 includes a first wrapping member 273 and a second wrapping member 275 , and the material of the first wrapping member 273 and the second wrapping member 275 is a developing material. One end of the first winding member 273 is connected with the first developing unit 231 (for example, one end of the first winding member 273 is connected with the frame 233 in the first developing unit 231, or one end of the first winding member 273 is connected with the first developing unit 231), the other end of the first wrapping member 273 is connected to the bare stent 210 of the implant device 20. One end of the second winding member 275 is connected with the first developing unit 231 (for example, one end of the second winding member 275 is connected with the framework 233 in the first developing unit 231, or one end of the second winding member 275 is connected with the first developing unit 231), the other end of the second wrapping member 275 is connected to the bare stent 210 of the implant device 20, and one of the first wrapping member 273 and the second wrapping member 275 extends helically around the other. During the release process of the implant device 20, if the bare stent 210 exerts too much force on the developing structure 23, even if one of the first winding member 273 and the second winding member 275 breaks, as long as one of the two does not break , it can prevent the first developing structure 23 from falling, improve the reliability of connecting the developing structure 23 and the bare stent 210 , and further improve the safety of the implant device 20 in use. Furthermore, if the bare support 210 exerts too much force (pull force) on the developing structure 23, the helically extended structures in the first wrapping member 273 and the second wrapping member 275 will not break, but will be pulled in a spiral form. It is in a straight line and can absorb the energy generated by the bare support 210 on the developing structure 23 during the process of being straightened and deformed, so as to prevent the bare support 210 from breaking other structures of the developing structure 23 .

In this embodiment, in the projection plane parallel to the axial plane of the connecting arm 271, the projection of the connecting arm 271 includes linear projection and waveform projection, and the height between adjacent peaks and troughs (ie wave height) in the waveform projection is greater than that of the linear projection The projected line width. It can be ensured that one of the first wrapping member 273 and the second wrapping member 275 can slide and deform along the other, so as to prevent the connecting arm 271 from breaking completely.

In this embodiment, the first winding member 273 is a multi-strand wire, and the first winding member 273 is processed into a straight line (of course, in other embodiments, the first winding member 273 can also be processed into a curve or other irregular shape) . Please refer to FIG. 8-2 , in the projection plane parallel to the axis plane of the connecting arm 271 , the first wrapping member 273 forms a first projection 273a in its projection plane, and the first projection 273a is a linear projection. The second winding part 275 is a multi-strand wire, and the second winding part 275 extends helically around the first winding part 273. The second winding part 275 forms a second projection 275a in a projection plane parallel to the axis plane of the connecting arm 271. The second The projection 275a is a waveform projection that surrounds the first projection 273a and extends in a waveform, and the height between adjacent peaks and troughs in the second projection 275a is larger than the projection line width of the first projection 273a. In other embodiments, the second wrapping member 275 can be processed into a straight line; the first wrapping member 273 spirally extends around the second wrapping member 275, and the first projection 273a is a waveform projection extending in a waveform around the second projection 275a, and the first The height between adjacent peaks and troughs in the projection 273a is greater than the projection line width of the second projection 275a. Of course, in other embodiments, the first wrapping member 273 and/or the second wrapping member 275 can also be a single wire.

There is a gap (i.e. wave width) between two adjacent crests or two adjacent troughs, the gap is greater than the width of the waveform projection, that is, 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 The space can prevent the bare stent 210 from breaking the second wrapping member 275 .

Please refer to FIG. 6 again, the connecting arm 271 further includes a first connecting part 277 and a second connecting part 279, the first connecting part 277 is connected with the first winding part 273, and the first connecting part 277 is wound around the pole 211a of the bare stent 210 Above, the second connecting piece 279 is connected to the second winding piece 275 , and the second connecting piece 279 is wound on the wave rod 211 a of the bare stent 210 .

The first connecting member 277 can be a multi-strand wire or a single-strand wire. The second connecting member 279 can be a multi-strand wire or a single-strand wire. In this embodiment, the first connecting piece 277 is a multi-strand wire, and the first connecting piece 277 is distributed in a grid on the pole 211a of the bare support 210, and the second connecting piece 279 is a multi-strand wire, and the second connecting piece 279 is on The poles 211a of the bare stent 210 are distributed in a grid.

Along the length direction of the wave rod 211 a , the second connecting piece 279 is located between the crest 215 of the bare stent 210 and the first connecting piece 277 , and the winding density of the first connecting piece 277 is greater than that of the second connecting piece 279 . When the bare stent 210 is compressed or deformed by self-expansion, the second connecting member 279 can slide on the wave rod 211 a of the bare stent 210 , which can reduce the stress of the wave rod 211 a on the connecting arm 271 . It should be pointed out that the winding density refers to the amount of wires wound on the probe 211a of unit length. For example, when the wire is helically wound, the more the wire is wound on the wave rod 211a per unit length (ie the smaller the pitch), the greater the corresponding winding density, otherwise the smaller the winding density. When the wire is helically wound and intertwined in a grid shape, the smaller the mesh formed, the greater the corresponding winding density, and vice versa, the smaller the winding density.

In this embodiment, the first connecting member 277 is a multi-strand wire, and the first connecting member 277 is spirally wound from the proximal side of the wave rod 211a to the distal side of the wave rod 211a; the second connecting member 279 is a multi-strand wire, The second connecting member 279 is helically wound from the distal side of the probe 211 a to the proximal side of the probe 211 a, so that the force exerted by the probe 211 a on the connecting arm 271 remains balanced. Of course, in other embodiments, the first connecting member 277 can be spirally wound from the far-center side of the probe rod 211a to the proximal side of the probe rod 211a, and the second connecting member 279 can be wound from the proximal side of the probe rod 211a to the proximal side of the probe rod 211a. The telecentric side of the probe 211a is helically wound. It should be noted that the proximal side of the wave rod 211a refers to the side close to the central axis of the implant device 20 in the radial section of the single wave rod 211a; the far-center side of the wave rod 211a refers to the In the radial section of the single wave rod 211a, the side away from the central axis of the implant device 20 is located.

Please refer to FIG. 9 , in other embodiments, the first connecting member 277 is wound on the wave rod 211a in a grid shape, and the second connecting member 279 is wound on the wave rod 211a in a grid shape. The reliability of the connection between the connecting arm 271 and the probe 211a can be increased.

The material of the first connecting member 277 and the second connecting member 279 is a developing material. In other embodiments, one of the first connecting member 277 and the second connecting member 279 is made of a developing material.

As shown in FIG. 9 , the angle formed between the first winding member 273 and the radial direction 211a of the straight section of the wave rod 211a is an acute angle θ, 0°≤θ≤45°, that is, the straight line projection and the radial direction of the straight section of the wave rod 211a The included angle formed by 211a is an acute angle θ, and 0°≤θ<45°. When θ=0°, the first winding member 273 is perpendicular to the straight line of the wave rod 211a, and the wave rod 211a will not generate a component force along the axial direction of the wave rod 211a during the self-expansion process of the wave rod 211a, and is wound on the wave rod The first connecting member 277 and the second connecting member 279 on the 211a are not easy to slide, and the connection between the developing structure 23 and the wave rod 211a is more stable. And θ=0° due to the unfolding of the developing structure 23 . If θ≥45°, the outer dimensions of the first developing unit 231 and the second developing unit 251 will be increased, further causing the need for a larger The radial space increases the frictional resistance when the implant device 20 is released.

The above is the structure of the first developing unit 231 and the connecting arm 271 , the manufacturing method of the first developing unit 231 will be briefly described below, specifically as follows.

In the first step, mark the reference point.

Specifically, referring to FIG. 10 , a multi-strand wire is provided, and the number of strands of the multi-strand wire is greater than or equal to two. Mark three reference points A1, A2, and A3 on the multi-strand wire. A ring structure 237 is formed around A1 and A2 respectively, and the position of A3 corresponds to the position where the connecting arm 271 is connected to the skeleton 233 . The positions of A1 , A2 and A3 can be adjusted according to the size of the developing structure 23 .

In the second step, the first developing unit 231 is formed.

Please refer to Figures 11 to 13 together, the multi-strand wires between A1 and A2 are bent to form a skeleton 233, the multi-strand wires between A1 and the free end are spirally wound on the skeleton 233, the multi-strand wires between A2 and the free end The wires are helically wound on the skeleton 233 , and the multi-strand wires helically wound on the skeleton 233 meet at A3 and terminate the helical winding.

In the third step, the first wrapping part 273 and the second wrapping part 275 are formed.

Specifically, please refer to FIG. 14 , among the two wires that meet at A3, one of the wires extends straight to the wave bar 211a, the wire extending straight to the wave bar 211a is the first winding member 273, and the other wire The wire extending helically along the first winding member 273 and close to the wave rod 211 a is the second winding member 275 .

The fourth step is to form the first connecting piece 277 and the second connecting piece 279 .

Specifically, please refer to FIG. 15 , the wire separated from the end of the first winding member 273 is helically wound on the wave rod 211a to form a first connecting member 277, and the wire head of the first connecting member 277 is fixed on the wave rod 211a by spot welding. superior. The wire separated from the end of the second winding member 275 is helically wound on the wave rod 211a to form a second connecting member 279, and the wire head of the second connecting member 279 is fixed on the wave rod 211a by spot welding. It should be noted that, before the first developing unit 231 is connected to the pole 211a, the angle of the ring structure 237 can be adjusted according to needs, so that the ring structure 237 and the frame 233 are not in the same plane, so that the first developing unit 231 and the second developing unit Units 251 are rotationally connected.

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

An embodiment of the present invention also provides a developing structure 23, which is different from the above-mentioned embodiments in that the material of the skeleton 233 is nickel-titanium alloy. Simultaneously deforming in the radial direction and the radial direction, so that when the implant device 20 is sheathed, the developing structure 23 does not need to occupy the installation space between the delivery sheath 10a and the implant device 20 . The first developing unit 231 can be fixedly connected with the second developing unit 251 to further ensure that when the bare stent 210 is compressed and deformed, the first developing unit 231 and the second developing unit 251 will not turn over outside the lumen of the implant device 20 , Furthermore, it is avoided that the imaging structure 23 occupies the installation space between the delivery sheath 10 a and the implantation instrument 20 .

An embodiment of the present invention also provides an implant device 20 , including a bare stent 210 and the above-mentioned developing structure 23 , and the developing structure 23 is arranged on the bare stent 210 .

Another embodiment of the present invention also provides an implant device 20. The difference from the above embodiments is that the implant device 20 includes a bare stent 210, a film (not shown) and the above-mentioned development structure 23, the development structure 23 is set on the bare stent 210 or the graft. For example, the framework 233 of the first developing unit 231 is sewed on the covering film by sutures, and the framework 233 of the second developing unit 251 is sewed on the covering film by sutures.

The technical features of the above embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, they should be It is considered to be within the range described in this specification.

The above examples only express several implementation modes of the present invention, and the description thereof is relatively specific and detailed, but it should not be construed as limiting the scope of the patent for the invention. It should be pointed out that those skilled in the art can make several modifications and improvements without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent for the present invention should be based on the appended claims.

Claims (9)

1. A developing structure, which is arranged on an implant device, is characterized in that the wave coil of the implant device comprises a plurality of end-to-end wave rods, and the developing structure comprises a first developing unit and a second developing unit, the The first developing unit and the second developing unit are respectively connected to two adjacent poles on the wave coil, the first developing unit is provided with a developing material, and the second developing unit is provided with a developing material, so The first developing unit is rotatably connected to the second developing unit, and the first developing unit and the second developing unit can rotate relatively around a rotation axis; wherein, the outer wall of the implant instrument has a generatrix, and the The rotation axis is parallel to or away from the generatrix, and the rotation axis is between two adjacent wave rods connecting the first developing unit and the second developing unit; when radially compressing the implant device, applying an inward radial force to the developing structure, so that the first developing unit and the second developing unit rotate around the rotation axis into the lumen of the implant device, and the first developing unit and the second developing unit The part connected with the second developing unit approaches the central axis of the implant device. 2. The developing structure according to claim 1, characterized in that, the first developing unit comprises a skeleton and a fitting, the fitting is arranged on the skeleton, and one end of the fitting is connected to the skeleton. One ends are connected together to form an annular structure, and the other end of the matching member spirally extends along the frame, and the first developing unit is rotatably connected to the second developing unit through the annular structure. 3. The developing structure according to claim 2, characterized in that, in a projection plane parallel to the axial plane of the implant device, the projection of the fitting part in the projection plane is a waveform, and the projection of the fitting part There is a gap between two adjacent peaks or two adjacent troughs. 4. The developing structure according to claim 3, wherein the gap is less than 1 mm, and the gap is larger than 0.1 mm. 5. The developing structure according to claim 2, characterized in that, in a projection plane parallel to the axial plane of the implant device, the projection of the fitting part in the projection plane is a waveform, and the projection of the fitting part It has a wave height, the wave height is not less than 0.3 mm, and the wave height is not greater than 1 mm. 6. The developing structure according to claim 1, characterized in that, the developing structure further comprises a connecting arm, the connecting arm comprises a first wrapping part and a second wrapping part, one end of the first wrapping part is connected to the The first developing unit is connected, the other end of the first wrapping member is connected with the bare support of the implant instrument, one end of the second wrapping member is connected with the first developing unit, and the second wrapping member The other end of the coil is connected to the bare stent of the implant device, and one of the first wrapping member and the second wrapping member extends helically around the other. 7. The developing structure according to claim 6, characterized in that, in the projection plane parallel to the axial plane of the connecting arm, the projection of the connecting arm includes a straight line projection and a waveform projection, and the waveform projection corresponds to The height between the adjacent crests and troughs is greater than the projected line width of the straight line projection. 8. An implant device, characterized by comprising a bare stent and the developing structure according to any one of claims 1 to 7, the developing structure being arranged on the bare stent. 9. A vascular stent, characterized in that it comprises a corrugated coil, a covering film and a developing structure, the corrugating coil comprises a plurality of end-to-end connecting rods, the developing structure is arranged on the covering film, and the developing structure It includes a first developing unit and a second developing unit, the first developing unit and the second developing unit are respectively connected to two adjacent poles on the wave coil, and the first developing unit is provided with a developing material, the second developing unit is provided with developing material, the first developing unit is rotatably connected to the second developing unit, and the first developing unit and the second developing unit can be opposite around a rotation axis Rotation; wherein, the outer wall of the vascular support has a generatrix, the rotation axis is parallel to or separated from the generatrix, and the rotation axis is between the two phases connecting the first developing unit and the second developing unit Between the adjacent wave rods; when the vascular stent is radially compressed, an inward radial force is applied to the developing structure, so that the first developing unit and the second developing unit move toward the The inner cavity of the vascular stent rotates, and the part where the first developing unit and the second developing unit are connected approaches the central axis of the vascular stent.

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