Vascular reconstruction device, pusher device and medical system

Abstract

The present application provides a kind of vascular reconstruction device, pusher and medical system, the vascular reconstruction device includes: first braided wire, second braided wire and third braided wire, the first braided wire and second braided wire are interwoven in different directions and form tubular structure, the third braided wire is arranged along the axial direction of the tubular structure, and is fixedly connected with the first braided wire and the second braided wire.The introduction of the third braided wire can define the axial extension length of the vascular reconstruction device after delivery, to facilitate the doctor to judge the specific implantable length when implanting.The pusher is used to push the vascular reconstruction device to the target position, the pusher includes a connecting structure, the distal end of the connecting structure is detachably connected with the vascular reconstruction device, and the delivery of the pusher can be repeatedly recycled and released to the vascular reconstruction device, compared with the design of horn mouth and the design of barb structure, it will not cause damage to the vascular wall.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a blood vessel reconstruction device, a pushing device and a medical system. BACKGROUND

[0002] Coronary aneurysm refers to local expansion of the coronary artery, and the diameter of the lesion site is 1.5-2 times the diameter of the original normal blood vessel, with an incidence of about 0.3%-5.3%, which can be seen in patients of any age. The most common cause of coronary aneurysm is atherosclerosis, followed by Kawasaki disease, coronary revascularization, inflammatory arterial disease, etc.

[0003] Currently, there is no expert consensus or guideline for the treatment of coronary aneurysm in clinical practice. The existing treatment methods include interventional therapy, medical drug therapy and surgical operation therapy. Drug therapy requires patients to use antithrombotic therapy for a long time, and lifelong medication. Surgical operation is suitable for patients with severe complications, and its occlusion rate is high, but the process of open chest surgery is complex, the risk for high age group is high, and the recovery time is long. Interventional therapy is widely used in clinical treatment due to its small surgical incision, short recovery time and economy.

[0004] The instruments used in interventional therapy mainly include covered stents, stent-assisted coil embolization, filling embolic agents, blood flow reconstruction devices, etc. The covered stent can completely isolate the aneurysm and reconstruct the blood flow channel, but the small diameter covered stent has always existed problems of stent restenosis, thrombosis and branch vessel occlusion. Stent-assisted coil embolization has the risk of spring coil falling off to the distal end of the coronary artery and coronary aneurysm rupture. There are many reports of filling embolic agent leakage, so it is less used in clinical practice at present. The blood flow reconstruction device is generally a dense mesh stent, which changes the hemodynamics at the lesion site by means of dense mesh, that is, by increasing the mesh density to form turbulent flow, to form thrombus, reduce the blood flow supply in the aneurysm, and then induce the intimal hyperplasia at the neck of the coronary aneurysm to restore normal morphology.

[0005] According to relevant patents and literature review, the problems to be solved for the blood vessel reconstruction device for coronary aneurysm at present are:

[0006] (1) Not easy to withdraw and reposition: the current two-end trumpet-shaped opening design of the blood vessel reconstruction device and the microspike design mentioned in the related patents make the device end or the whole achieve good wall adhesion performance during transportation, but it is not easy to reposition during the operation process after fixation, and the surface microspike structure is more likely to pierce the blood vessels in the lesion area to cause false aneurysm.

[0007] (2) Poor axial length stability: the woven blood vessel reconstruction device has good compliance, but the axial length change rate is large after being affected by external force, causing the doctor to have difficulty in determining the implant length and area during actual implantation. SUMMARY

[0008] The present application aims to provide a vascular reconstruction device, a pushing device and a medical system to solve one or more problems of the prior art.

[0009] To solve the above technical problems, the present application provides a vascular reconstruction device, comprising: a first braided wire, a second braided wire and a third braided wire, the first braided wire and the second braided wire are interwoven in different directions to form a tubular structure, and the third braided wire is arranged along the axial direction of the tubular structure and is fixedly connected with the first braided wire and the second braided wire.

[0010] Optionally, in the vascular reconstruction device, the first braided wire and the second braided wire are interwoven in opposite spiral directions around the same axis to form the tubular structure.

[0011] Optionally, in the vascular reconstruction device, the third braided wire at least extends out of the tubular structure from the proximal end of the tubular structure, and the part of the third braided wire extending out of the tubular structure is used for detachable connection with a pushing device.

[0012] Optionally, in the vascular reconstruction device, the vascular reconstruction device comprises at least two third braided wires.

[0013] Optionally, in the vascular reconstruction device, the at least two third braided wires are uniformly distributed along the circumferential direction of the tubular structure.

[0014] Optionally, in the vascular reconstruction device, the first braided wire, the second braided wire and the third braided wire are all made of degradable high molecular material wires.

[0015] The present application also provides a pushing device for pushing the vascular reconstruction device as claimed in any one of the above to a target position, the pushing device comprising a connecting structure, the distal end of the connecting structure being detachably connected with the vascular reconstruction device, the vascular reconstruction device having an inner cavity, when the pushing device is partially accommodated in the inner cavity, the distal end of the connecting structure is kept connected with the vascular reconstruction device under the action of the circumferential constraint force of the vascular reconstruction device, and when the pushing device is separated from the inner cavity of the vascular reconstruction device, the distal end of the connecting structure is in a detachable state with the vascular reconstruction device under the action of the circumferential constraint force of the vascular reconstruction device.

[0016] Optionally, in the pusher device, the connecting structure has an open state and a compressed state, when the connecting structure is switched from the compressed state to the open state, the connecting structure is subjected to the circumferential constraining force of the vascular reconstruction device, and when the connecting structure is switched from the open state to the compressed state, the connecting structure is released from the circumferential constraining force of the vascular reconstruction device.

[0017] Optionally, in the pusher device, the connecting structure comprises a fixing member, at least two connecting rods and a separation component connected to the distal end of each connecting rod, the at least two connecting rods are uniformly distributed along the circumference of the fixing member, and the separation component is used for separable connection with the vascular reconstruction device.

[0018] Optionally, in the pusher device, the connecting rod is a heat memory treated nickel-titanium alloy rod.

[0019] Optionally, in the pusher device, the separation component comprises a separation structure and a guide member, the guide member is used for connection with the vascular reconstruction device or guiding the vascular reconstruction device to connect with the separation member, and the separation member is used for disconnecting the connection between the guide member and the vascular reconstruction device or disconnecting the connection between itself and the vascular reconstruction device.

[0020] Optionally, in the pusher device, the separation structure comprises a physical separation structure or a mechanical separation structure.

[0021] Optionally, in the pusher device, the physical separation structure comprises a spiral-shaped electric resistance wire, and the electric resistance wire is used for melting the part of the vascular reconstruction device connected thereto by electrification.

[0022] Optionally, in the pusher device, the physical separation structure comprises a metal spiral coil and a separation wire, the separation wire is used for connecting with the vascular reconstruction device and is at least partially arranged in the metal spiral coil, and the metal spiral coil and the separation wire are used for breaking the connection point between the separation wire and the vascular reconstruction device by applying a voltage with opposite polarity.

[0023] Optionally, in the pusher device, the mechanical separation structure comprises a delivery tube, a balloon, a cutting member and an outer tube, the cutting member is arranged on the outer surface of the balloon, the delivery tube is used for pressurizing the balloon to drive the balloon to expand, so that the cutting member cuts the part of the vascular reconstruction device connected to the inner wall of the outer tube.

[0024] Optionally, in the pusher device, the guide member is a radiopaque body, and the guide member has a through hole arranged along the axial direction.

[0025] Optionally, in the pushing device, the pushing device further comprises a pushing rod, the pushing rod is detachably connected with the connecting structure, and the pushing rod pushes the vascular reconstruction device to the target position by pushing the connecting structure.

[0026] The present application also provides a medical system, comprising the vascular reconstruction device according to any one of the preceding and the pushing device according to any one of the preceding.

[0027] In summary, the present application provides a vascular reconstruction device, a pushing device and a medical system, the vascular reconstruction device comprises a first braided wire, a second braided wire and a third braided wire, the first braided wire and the second braided wire are interwoven in different directions to form a tubular structure, and the third braided wire is arranged along the axial direction of the tubular structure and is fixedly connected with the first braided wire and the second braided wire. The introduction of the third braided wire can limit the axial extension length of the vascular reconstruction device after delivery, which facilitates the doctor to determine the specific implantable length during implantation. The pushing device is used to push the vascular reconstruction device to the target position, and the pushing device comprises a connecting structure, the distal end of the connecting structure is detachably connected with the vascular reconstruction device, the vascular reconstruction device has an inner cavity, when the pushing device is partially accommodated in the inner cavity, the distal end of the connecting structure is subjected to the circumferential constraint force of the vascular reconstruction device to maintain the connection state with the vascular reconstruction device, and when the pushing device is separated from the inner cavity of the vascular reconstruction device, the distal end of the connecting structure is released from the circumferential constraint force of the vascular reconstruction device to be in a detachable state with the vascular reconstruction device. The pushing device is detachably connected with the vascular reconstruction device, and the vascular reconstruction device can be repeatedly recovered and released by using the delivery of the pushing device, and compared with the horn mouth design and the barb structure design, the vascular reconstruction device does not cause damage to the vascular wall. BRIEF DESCRIPTION OF DRAWINGS

[0028] Figure 1a A perspective structural schematic view of the vascular reconstruction device provided by the embodiment of the present application is shown in the figure;

[0029] Figure 1b A cross-sectional structural schematic view of the vascular reconstruction device provided by the embodiment of the present application is shown in the figure;

[0030] Figure 2 A structural schematic view of the connecting structure in the embodiment of the present application is shown in the figure;

[0031] Figure 3 A structural schematic view of one of the hot-melt separation components in the embodiment of the present application is shown in the figure;

[0032] Figure 4 Another structural schematic view of the hot-melt separation component in the embodiment of the present application is shown in the figure;

[0033] Figure 5A schematic view of a released state of the blood vessel reconstruction device in the guide catheter in the embodiment of the present application;

[0034] Figure 6 A schematic view of a releasing process of the blood vessel reconstruction device in the embodiment of the present application;

[0035] Figure 7 A schematic view of a released state of the blood vessel reconstruction device in the embodiment of the present application;

[0036] Figure 8 A schematic view of a structure of the electric separation assembly in the embodiment of the present application;

[0037] Figure 9 A schematic view of a structure of the balloon separation assembly in the embodiment of the present application;

[0038] In the drawings, the following reference signs are used:

[0039] 100 - blood vessel reconstruction device;

[0040] 101 - first braided wire; 102 - second braided wire; 103 - third braided wire;

[0041] 200 - pushing device;

[0042] 201 - fixing member; 202 - connecting rod; 203 - separation assembly;

[0043] 301 - first guide member; 302 - helical resistance wire;

[0044] 3011 - through hole;

[0045] 400 - pushing rod;

[0046] 500 - guide catheter; 600 - blood vessel;

[0047] 701 - second guide member; 702 - metal spiral; 703 - separation wire; 704 - positioning member;

[0048] 801 - third guide member; 802 - delivery tube; 803 - balloon; 804 - cutting member; 805 - outer tube. DETAILED DESCRIPTION

[0049] In order to make the objects, advantages and features of the present application more clearly, the present application will be described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that all the drawings are very simplified and not drawn according to scale, and are only used to facilitate and clearly assist the purpose of describing the embodiments of the present application. In addition, the structures shown in the drawings are often part of the actual structures. In particular, different scales are sometimes used to show the different emphasis of each drawing. It should also be understood that, unless specifically described or indicated, the terms "first", "second", "third" and the like in the description are only used to distinguish the components, elements, steps and the like in the description, and are not used to represent the logical relationship or sequence relationship between the components, elements, steps and the like.

[0050] In the present application, "proximal end" and "distal end" are the relative orientation, relative position and direction of elements or actions relative to each other from the perspective of a doctor using the medical device. Although "proximal end" and "distal end" are not restrictive, "proximal end" generally refers to the end of the medical device that is close to the doctor during normal operation, and "distal end" generally refers to the end that enters the patient's body first.

[0051] See Figure 1a The embodiments of the present application provide a vascular reconstruction device, which comprises a first braided wire 101, a second braided wire 102 and a third braided wire 103. The first braided wire 101 and the second braided wire 102 are interwoven in different directions to form a tubular structure. The third braided wire 103 is arranged along the axial direction of the tubular structure and is fixedly connected with the first braided wire 101 and the second braided wire 102, so as to limit the axial extension length of the tubular structure.

[0052] It can be understood that the vascular reconstruction device provided by the embodiments of the present application meets the basic radial support force and compliance requirements of the vascular reconstruction device. The tubular structure formed by the first braided wire 101 and the second braided wire 102 can contract or expand according to the implanted vascular diameter, and can maintain adhesion with the blood vessel. However, as described above, the braided vascular reconstruction device has good compliance, but the axial length change rate is large due to external force (such as being squeezed and contracted by blood pressure), which causes the doctor to have difficulty in determining the implantation length and area during actual implantation. The vascular reconstruction device provided by the embodiments of the present application introduces the third braided wire 103 on the basis of the tubular structure formed by the first braided wire 101 and the second braided wire 102. The third braided wire 103 is fixedly connected with the first braided wire 101 and the second braided wire 102 along the axial direction of the tubular structure, so that the extension length of the tubular structure in the axial direction is limited by the third braided wire 103, and can only change within a relatively fixed extension length interval. Therefore, it is beneficial for the doctor to make a judgment during actual implantation.

[0053] The present application does not make specific restrictions on the organizational form of the tubular structure, for example, the tubular structure can be a plain weave formed by the first braided wire 101 and the second braided wire 102 in 1-1, 1-2, 1-3, 2-3, etc., or other variations, which can be selected according to the radial support force and compliance required by different lesion areas.

[0054] In the present embodiment, preferably, the first braided wire 101 and the second braided wire 102 are interwoven around the same axis in opposite spiral directions to form a tubular structure, thereby making the vascular reconstruction device have a plurality of left-handed spiral structures and a plurality of right-handed spiral structures, and the spiral structures in the same spiral direction do not intersect each other. Although "left and right" are non-restrictive descriptions, it should be understood that "left and right" are relative to the central axis of the formed spiral structure, and left-handed and right-handed indicate two spiral directions opposite to the central axis rotation direction, in addition, left-handed and right-handed indicate the spiral direction of the braided wire from one end to the other end of the axial direction after the vascular reconstruction device is formed, and do not represent the path direction of the braided wire during the braiding process.

[0055] The wire diameters of the first braided wire 101 and the second braided wire 102 can be the same or different, for example, one of the first braided wire 101 and the second braided wire 102 can be a thin wire, and the other is a thick wire, so that the first braided wire 101 and the second braided wire 102 interwoven around the same axis in opposite spiral directions to form a tubular structure has good mechanical properties, large radial force, resistance to deformation, and at the same time has high compliance, which can expand the narrow part of the blood vessel.

[0056] During specific braiding, the first braided wire 101 can be used as a counterclockwise wire, the second braided wire 102 can be used as a clockwise wire, and the third braided wire 103 can be used as an axial direction wire, which are placed on the carrier of the braiding machine according to a certain rule, so that the counterclockwise wire and the clockwise wire are wound around each other in counterclockwise and clockwise directions respectively, and the axial direction wire can be passed out from the center hole of the carrier of the braiding machine, thereby forming an integrally braided and formed vascular reconstruction device. In addition, the first braided wire 101 and the second braided wire 102 can be fixed on the surface of the first braided wire 101 and the second braided wire 102 by heat melting, gluing and other methods after integrally braided and formed.

[0057] Specifically, the tubular structure provided by the embodiment has an outer diameter of 1 mm to 5 mm, the first braided wire 101 and the second braided wire 102 have a helix angle of 30° to 75°, the braiding density (the number of interlacing points of the first braided wire 101 and the second braided wire 102 within 1 inch) is 50 to 500, the first braided wire 101 and the second braided wire 102 have a diameter of 0.01 mm to 1 mm, and the first braided wire 101 and the second braided wire 102 have a number of 24 to 128, but the application is not limited thereto.

[0058] In the embodiment, the third braided wire 103 extends out of the tubular structure at least at the proximal end of the tubular structure, and the part of the third braided wire 103 extending out of the tubular structure is used for detachable connection with the pushing device. Thus, the introduction of the third braided wire 103 facilitates the connection between the blood vessel reconstruction device and the pushing device, and can be used to define the axial extension length of the tubular structure.

[0059] The researchers of the application prepared three kinds of blood vessel reconstruction device samples with the following structures:

[0060] (1) The blood vessel reconstruction device named BS-1 includes 12 first braided wires 101, 12 second braided wires 102, and 0 third braided wires 103;

[0061] (2) The blood vessel reconstruction device named BS-2 includes 12 first braided wires 101, 12 second braided wires 102, and 3 third braided wires 103;

[0062] (3) The blood vessel reconstruction device named BS-3 includes 12 first braided wires 101, 12 second braided wires 102, and 6 third braided wires 103.

[0063] The outer diameter of the above three kinds of blood vessel reconstruction device samples is 5 mm, the braiding density is 80, the wire diameter is 0.2 mm, and the length is 40 mm.

[0064] The axial dimensional stability is verified by using anti-parallel plate extrusion performance experiment and finite element calculation method. In the experimental part, the axial dimensional stability of the vascular reconstruction device is tested according to the anti-parallel plate extrusion performance test method in YY / T 0663.1-2016 "Cardiovascular implants - Intravascular endoprostheses - Part 2: Vascular stents". The test is carried out on an Instron 5543 universal material testing machine, using a compression clamp, the compression speed is 0.1 mm / s, the compression displacement is 50% of the sample outer diameter, and the length of the sample after compression to 50% of the outer diameter is measured. The results are as follows: the length of BS-1 after compression is 41.5 mm, the length of BS-2 after compression is 40.8 mm, and the length of BS-3 after compression is 40.2 mm. In the finite element calculation part, the vascular reconstruction device and the compression clamp model are established in the three-dimensional modeling software and imported into the finite element analysis software for numerical simulation calculation. The boundary conditions are set as follows: the freedom of the vascular reconstruction device is not limited; the compression direction of the compression clamp to the vascular reconstruction device is the sample radial direction, the compression speed is 0.1 mm / s, the compression displacement is 50% of the sample outer diameter, and the freedom in other directions is limited. The length of the sample after compression to 50% of the outer diameter is exported, and the results are as follows: the length of BS-1 after compression is 41.4 mm, the length of BS-2 after compression is 40.7 mm, and the length of BS-3 after compression is 40.3 mm, which is consistent with the results of the experimental part. With the introduction of the third braided wire 103, the equivalent stress of the first braided wire 101 and the second braided wire 102 is reduced, and the equivalent stress of the first braided wire 101 and the second braided wire 102 of BS-2 and BS-3 is reduced to 0.83 times and 0.79 times of BS-1 respectively. The stress is mainly concentrated in the third braided wire 103, which proves that the introduction of the third braided wire 103 can limit the axial deformation of the stent after stress and is beneficial to the doctor to judge the actual implant length.

[0065] In summary, by introducing the third braided wire 103 in the axial direction, the mutual sliding of the second braided wire 102 and the first braided wire 101 in the axial direction can be inhibited, the axial dimensional stability of the vascular reconstruction device can be improved, the doctor can select the appropriate length of the vascular reconstruction device according to the actual lesion area, and the introduction of the degradable material can eliminate the space-occupying effect and be completely absorbed in the body.

[0066] Preferably, the vascular reconstruction device 100 includes at least two third braided wires 103, which are uniformly distributed along the circumference of the tubular structure. In this way, the length variation rate of the vascular reconstruction device 100 at different positions during transportation can be reduced. Further preferably, the number of the first braided wire 101 and the second braided wire 102 is the same, and the number of the third braided wire 103 is not greater than the number of the first braided wire 101 or the second braided wire 102. Figure 1bAs shown in the middle, the first braided wire 101, the second braided wire 102, and the third braided wire 103 are equal in number, i.e., the first braided wire 101 and the second braided wire 102 are braided to form a 2-over-2 tubular structure, and the third braided wire 103 is fixed between the first braided wire 101 and the second braided wire 102 along the axial direction of the tubular structure, but the present application is not limited thereto.

[0067] In addition, preferably, the first braided wire 101, the second braided wire 102, and the third braided wire 103 are all made of degradable polymer material, including but not limited to: poly-lactide (PLA), poly-glycolide (PGA), poly-p-dioxanone (PPDO), polycaprolactone (PCL), polyhydroxyalkanoate (PHA), silk fibroin wire, collagen protein wire, and copolymers, mixtures, etc. of the above-mentioned materials. The introduction of degradable materials can eliminate the space-occupying effect, so that the vascular reconstruction device 100 is completely absorbed in the body.

[0068] Please refer to Figure 2 , and in combination with Figures 5 to 7 , the present application also provides a pushing device 200 for pushing a vascular reconstruction device to a target position, which may be the vascular reconstruction device 100 provided by the present application, or other existing vascular reconstruction devices with a lumen. In the following description, the pushing device 200 is described in combination with the vascular reconstruction device 100 provided by the present application, but it should be understood that the present application is not limited thereto.

[0069] The pushing device 200 comprises a connecting structure, the distal end of the connecting structure is detachably connected with the vascular reconstruction device 100, when the pushing device 200 is partially accommodated in the lumen, the distal end of the connecting structure is connected with the vascular reconstruction device 100 under the action of the circumferential constraint force of the vascular reconstruction device 100, and when the pushing device 200 is separated from the lumen of the vascular reconstruction device 100, the distal end of the connecting structure is in a detachable state with the vascular reconstruction device 100 under the action of the circumferential constraint force of the vascular reconstruction device 100.

[0070] Specifically, the connecting structure has an open state and a compressed state, when the connecting structure is transported to the lumen of the vascular reconstruction device 100 from the compressed state and then switches to the open state, the connecting structure is under the action of the circumferential constraint force of the vascular reconstruction device 100, and when the connecting structure switches from the open state to the compressed state, the circumferential constraint force of the vascular reconstruction device 100 is removed.

[0071] In this embodiment, the connection structure may include a fixing member 201, at least two connecting rods 202, and a separation component 203 connected to the distal end of each connecting rod. The at least two connecting rods 202 are evenly distributed circumferentially along the fixing member 201. The separation component 203 is used to be detachably connected to the vascular reconstruction device 100, specifically, to be detachably connected to the third braided wire 103.

[0072] The connecting rod 202 can be made of a nickel-titanium alloy rod that has undergone heat memory treatment. The heat treatment process memorizes the corresponding dimensions to allow the vascular reconstruction device to fully adhere to the vessel wall. The heat treatment conditions can be: temperature 400℃~600℃, time 15min~120min. The connecting rod 202 can also be made of other materials that can be heat-treated to memorize corresponding dimensions; these will not be elaborated upon here.

[0073] The fixing member 201 and at least two connecting rods 202 can be integrally formed by cutting, or they can be fixed by welding, gluing, or other methods. The separation component 203 can be fixedly connected to the corresponding connecting rod 202 by heat shrink tubing.

[0074] In other embodiments, the connection structure may also employ other structures having an open state and a pressed state, such as an umbrella-shaped woven structure formed by woven metal wires, which will not be described in detail here.

[0075] In this embodiment, the pushing device 200 further includes a pushing rod 400, which is detachably connected to the connecting structure. Specifically, the pushing rod 400 is detachably connected to the fixing member 201. The pushing rod 400 pushes the vascular reconstruction device 100 to the target position by pushing the connecting structure.

[0076] like Figure 2 As shown, in a preferred embodiment, the fixing member 201 has an inner diameter that matches the outer diameter of the push rod 400, so that it can be sleeved on the push rod 400 and further fixed to the surface of the push rod 400 by welding, gluing, or interference fit. In other embodiments, the fixing member 201 may be block-shaped, such as round or square, and fixed to the distal end of the push rod 400, specifically by welding, gluing, or other methods.

[0077] In this embodiment, the separation component includes a separation structure and a guide. The guide is used to connect with the vascular reconstruction device or guide the vascular reconstruction device to connect with the separation component. The separation component is used to disconnect the connection between the guide and the vascular reconstruction device or disconnect itself from the vascular reconstruction device.

[0078] Optionally, the separation structure comprises a physical separation structure or a mechanical separation structure. In addition, preferably, the guide is a radiopaque body for observing the release of the distal end of the vascular reconstruction device 100. The radiopaque body can be made of platinum, platinum-iridium alloy, platinum-tungsten alloy, gold, tantalum, tungsten, etc., preferably platinum-iridium alloy, and the guide has a through hole arranged along the axial direction for the third braided wire to pass through.

[0079] In an optional embodiment, the separation assembly is a thermal melting separation assembly, i.e., the separation structure is a physical separation structure of thermal melting separation, and the guide is a first guide 301.

[0080] Specifically, as shown in Figure 3 The physical separation structure comprises a spiral-shaped resistance wire 302, the proximal end portion of the spiral-shaped resistance wire 302 is sleeved on the first guide 301, and the two are fixed by glue or welding. The third braided wire 103 is fixed on the surface of the spiral-shaped resistance wire 302 after passing through the through hole 3011 of the first guide 301, and the fixing mode can be knotting or glue bonding. The spiral-shaped resistance wire 302 is powered on to heat and melt the third braided wire 103, and the separation is completed.

[0081] As shown in Figure 4 The third braided wire 103 can also be fixed on the surface of the first guide 301 after passing through the through hole, and the fixing mode can be, for example, glue fixing, etc. The spiral-shaped resistance wire 302 is powered on to heat and melt the third braided wire 103, and the separation is completed.

[0082] When the separation assembly 203 is a thermal melting separation assembly, the working process of pushing the vascular reconstruction device 100 is as follows:

[0083] As shown in Figure 5 The connecting rod 202 is pressed and held to the surface of the pushing rod 400 and is withdrawn into the guide catheter 500 to complete the assembly. When the vascular reconstruction device 100 is pushed out of the guide catheter 500, since one end thereof is fixed with the connecting rod 202, there is no sudden unloading phenomenon in the guide catheter 500. As shown in Figure 6As shown, when the vascular reconstruction device 100 is gradually pushed out of the guide catheter 500 by the push rod 400, the connection vascular reconstruction device 100 proximal end and the connecting rod 202 gradually open to the memorized size due to the shape memory function, and in addition, the release of the vascular reconstruction device 100 distal end can be observed by the visualization body inside the separation assembly 203. If the placement position is not good, since the push rod 400 and the vascular reconstruction device 100 are fixedly connected, the push rod 400 can be gradually withdrawn, the connecting rod is compressed by the guide catheter 500 to drive the vascular reconstruction device 100 to be compressed and withdrawn into the guide catheter 500 and released again. As shown in the figure, Figure 7 As shown, after the release is completed, the additional voltage makes the resistance wire inside the separation assembly 203 heat and fuse the third braided wire 103 of the vascular reconstruction device 100 provided therein, and the separation is completed. Finally, the push rod 400 and the guide catheter 500 are withdrawn.

[0084] In another optional embodiment, the separation assembly adopts an electrically induced separation assembly, that is, the separation structure adopts an electrically induced separation physical separation structure, and at this time, the guide is a second guide 701.

[0085] Specifically, as shown in the figure, Figure 8 As shown, the physical separation structure includes a metal spiral 702 and a separation wire 703, and the separation wire 703 is at least partially provided in the metal spiral 702. The second guide 701 is coaxial with the metal spiral 702, and the separation wire 203 is distributed in the axial direction of the metal spiral 702. The third braided wire 103 is also distributed in the axial direction of the metal spiral 702, so that the third braided wire 103 and the separation wire 703 can cross each other to form a connection point. After a voltage with opposite polarities is applied to the metal spiral 702 and the separation wire 703, the connection point of the separation wire 703 and the third braided wire 103 breaks.

[0086] The material of the metal spiral 702 can be 304 stainless steel, 304L stainless steel, 316 stainless steel, 316L stainless steel, nickel-titanium alloy, platinum-iridium alloy, platinum-tungsten alloy, gold, etc., and is preferably 304 stainless steel.

[0087] The separation wire 703 can adopt an enameled wire, and the core wire material can be 304 stainless steel, 304L stainless steel, 316 stainless steel, 316L stainless steel, iron-nickel alloy, iron, etc., and is preferably 316 stainless steel. The enameled material can be polytetrafluoroethylene, polyurethane, polyester, polyamide, etc., and is preferably polytetrafluoroethylene.

[0088] Preferably, the separation assembly 203 further comprises a positioning member 704, which is arranged in the metal spiral 702 and is used to connect the separation wire 703, so that the separation wire 703 and the metal spiral 702 are coaxially arranged. Specifically, the positioning member 704 can be a spiral body, which is coaxial with the metal spiral, penetrates into the metal spiral 702, and is fixed with the metal spiral 702 by adhesion. The material of the positioning member 704 can be 304 stainless steel, 304L stainless steel, 316 stainless steel, 316L stainless steel, nickel-titanium alloy, platinum-iridium alloy, platinum-tungsten alloy, gold, etc., and is preferably 304 stainless steel.

[0089] When the separation assembly 203 is an electroseparation assembly, the pushing process of the vascular reconstruction device 100 is as follows:

[0090] When the vascular reconstruction device 100 is pushed out of the introduction sheath, since one end thereof is fixed with the connecting rod 202, there is no sudden unloading phenomenon in the guide catheter 500. When the degradable vascular reconstruction device 100 is gradually pushed out of the guide catheter 500 by the pushing rod 400, the connecting rod 202 and the connecting degradable vascular reconstruction device 100 gradually expand to the memorized size due to the shape memory function, and in addition, the release of the distal end of the vascular reconstruction device 100 can be observed through the radiopaque body at the distal end of the metal spiral 702. If the placement position is not good, since the pushing rod 400 and the vascular reconstruction device 100 are fixedly connected, the pushing rod 400 can be gradually withdrawn, the connecting rod is compressed by the guide catheter 500 to drive the vascular reconstruction device 100 to be compressed and withdrawn into the guide catheter 500 and then be released again. After the release is completed, an anode voltage and a cathode voltage are respectively applied to the separation wire 703 and the metal spiral 702, so that the separation point is broken, and the separation is completed. Finally, the pushing rod 400 and the guide catheter 500 are withdrawn.

[0091] In yet another optional embodiment, the separation assembly adopts a balloon separation assembly, that is, the separation structure adopts a mechanical separation structure of balloon separation, and at this time, the guide member is a third guide member 801.

[0092] Specifically, as shown in Figure 9 The mechanical separation structure comprises a delivery tube 802, a balloon 803, a cutting member 804, and an outer tube 805. The guide member 801 can be adhesively fixed in the outer tube 805 at the distal end of the outer tube 805. The cutting member 804 is arranged on the outer surface of the balloon 803, and the delivery tube 802 is used to pressurize the balloon 803 to drive the balloon 803 to expand, so that the cutting member 804 can cut the third braided wire 103 connected to the inner wall of the outer tube 805 after penetrating out of the guide member 801.

[0093] The delivery tube 802 has a gas inlet in communication with the interior of the balloon 803, through which the balloon 803 is pressurized, and the delivery tube material can be silicone rubber, polyurethane, polyamide and block copolymer thereof, polyester, polyamide 66, polyamide 6, polyethylene, polypropylene, polymethyl methacrylate, polycarbonate, etc., preferably polyamide.

[0094] The material of the balloon 803 can be polyamide and block copolymer thereof, polyurethane, polyester, etc., preferably polyurethane.

[0095] The material of the cutting member 804 can be 304 stainless steel, 304L stainless steel, 316 stainless steel, 316L stainless steel, pure titanium, titanium alloy, etc., preferably 304 stainless steel.

[0096] When the separation assembly 203 adopts a balloon separation assembly, the pushing process of the vascular reconstruction device 100 is as follows:

[0097] When the vascular reconstruction device 100 is pushed out of the introduction sheath, since one end thereof is fixed with the connecting rod 202, there is no sudden unloading phenomenon in the guide catheter 500. When the degradable vascular reconstruction device 100 is gradually pushed out of the guide catheter 500 by the push rod 400, the connecting rod connecting the proximal end of the degradable vascular reconstruction device 100 and the distal end of the push rod 400 is gradually expanded to the memory size due to the shape memory function, and in addition, the release of the distal end of the vascular reconstruction device 100 can be observed by the developer. If the placement position is not good, since the push rod 400 and the vascular reconstruction device 100 are fixedly connected, the push rod 400 can be gradually withdrawn, the connecting rod is compressed by the guide catheter 500 to drive the vascular reconstruction device 100 to be compressed and withdrawn into the guide catheter 500 and then released again. After the release is completed, the balloon 803 is pressurized, the balloon 803 is expanded to cut the third braided wire 103 with the surface cutting member 804, and the separation is completed. Finally, the push rod 400 and the guide catheter 500 are withdrawn.

[0098] The embodiment of the present application also provides a medical system, which comprises the vascular reconstruction device 100 and the push device 200 provided by the embodiment of the present application.

[0099] In summary, the vascular reconstruction device, the pushing device and the medical system provided by the present application, the vascular reconstruction device comprises a first braided wire, a second braided wire and a third braided wire, the first braided wire and the second braided wire are interwoven in different directions to form a tubular structure, and the third braided wire is arranged along the axial direction of the tubular structure and is fixedly connected with the first braided wire and the second braided wire. The introduction of the third braided wire can limit the axial extension length of the vascular reconstruction device after delivery, so as to facilitate the doctor to judge the specific implantable length during implantation. The pushing device is used for pushing the vascular reconstruction device to the target position, and the pushing device comprises a connecting structure, the distal end of the connecting structure is detachably connected with the vascular reconstruction device, and the vascular reconstruction device has an inner cavity; when the pushing device is partially accommodated in the inner cavity, the distal end of the connecting structure is connected with the vascular reconstruction device under the action of the circumferential constraint force of the vascular reconstruction device; when the pushing device is separated from the inner cavity of the vascular reconstruction device, the distal end of the connecting structure is in a detachable state with the vascular reconstruction device under the action of the circumferential constraint force of the vascular reconstruction device. The pushing device and the vascular reconstruction device are detachably connected, and the vascular reconstruction device can be repeatedly recovered and released by using the delivery of the pushing device, compared with the horn mouth design and the barb structure design, the vascular wall will not be damaged.

[0100] In addition, it should be appreciated that, although the present application has been disclosed as above with preferred embodiments, the above embodiments are not intended to limit the present application. For any skilled person in the art, many possible changes and modifications or equivalent embodiments of the above disclosed technical content can be made without departing from the scope of the present application. Therefore, any simple modification, equivalent change and modification of the above embodiments made according to the technical essence of the present application without departing from the content of the present application shall still fall within the scope of protection of the present application.

Claims

1. A medical system, characterized in that, The medical system includes a pushing device and a vascular reconstruction device, wherein the pushing device is used to push the vascular reconstruction device to a target location; The pushing device includes a connecting structure, the distal end of which is detachably connected to the vascular reconstruction device. The vascular reconstruction device has an inner cavity. When the pushing device is partially housed in the inner cavity, the distal end of the connecting structure is subjected to the circumferential constraint force of the vascular reconstruction device and remains connected to the vascular reconstruction device. When the pushing device is detached from the inner cavity of the vascular reconstruction device, the distal end of the connecting structure is released from the circumferential constraint force of the vascular reconstruction device and is in a detachable state from the vascular reconstruction device. The connection structure includes a distally located separation component for detachable connection with the vascular reconstruction device; the separation component includes a separation structure and a guide, the guide for connecting with or guiding the vascular reconstruction device to the separation structure, and the separation structure for disconnecting the guide from the vascular reconstruction device or disconnecting itself from the vascular reconstruction device.

2. The medical system as described in claim 1, characterized in that, The connecting structure has an open state and a gripping state. When the connecting structure is input into the inner cavity of the vascular reconstruction device from the gripping state and then switched to the open state, it is subjected to the circumferential constraint force of the vascular reconstruction device. When the connecting structure is switched from the open state to the gripping state, the circumferential constraint force of the vascular reconstruction device is released.

3. The medical system as described in claim 2, characterized in that, The connection structure further includes a fixing member and at least two connecting rods, the at least two connecting rods being evenly distributed along the circumference of the fixing member; the distal end of each connecting rod is connected to the separation component.

4. The medical system as described in claim 3, characterized in that, The connecting rod is a nickel-titanium alloy rod that has undergone heat memory treatment.

5. The medical system as described in claim 1, characterized in that, The separation structure includes a physical separation structure or a mechanical separation structure.

6. The medical system as described in claim 5, characterized in that, The physical separation structure includes a spiral resistance wire, which melts the portion of the vascular reconstruction device connected to it by passing an electric current through it.

7. The medical system as described in claim 5, characterized in that, The physical separation structure includes a metal spiral coil and a separation wire, the separation wire being used to connect to the vascular reconstruction device and being at least partially inserted through the metal spiral coil, the metal spiral coil and the separation wire being used to break the connection point between the separation wire and the vascular reconstruction device by applying a voltage of opposite polarity.

8. The medical system as described in claim 5, characterized in that, The mechanical separation structure includes: a delivery tube, a balloon, a cutting element, and an outer tube. The cutting element is disposed on the outer surface of the balloon. The delivery tube is used to pressurize the balloon and drive the balloon to expand, so that the cutting element cuts off the portion of the vascular reconstruction device connected to the inner wall of the outer tube.

9. The medical system as described in claim 1, characterized in that, The guide is a developing body, and the guide has a through hole that extends through the body along the axial direction.

10. The medical system as claimed in claim 1, characterized in that, The pushing device also includes a pushing rod, which is detachably connected to the connecting structure. The pushing rod pushes the vascular reconstruction device to the target position by pushing the connecting structure.

11. The medical system as claimed in claim 1, characterized in that, The vascular reconstruction device includes a first braided wire, a second braided wire, and a third braided wire. The first and second braided wires are interwoven in different directions to form a tubular structure. The third braided wire is arranged along the axial direction of the tubular structure and is fixedly connected to the first and second braided wires.

12. The medical system as described in claim 11, characterized in that, The first and second braided filaments interweave around the same axis in opposite spiral directions to form the tubular structure.

13. The medical system as described in claim 11, characterized in that, The third braided filament extends at least proximal to the outside of the tubular structure along the proximal end of the tubular structure, and the portion of the third braided filament extending outside the tubular structure is detachably connected to the pushing device.

14. The medical system as described in claim 11, characterized in that, The vascular reconstruction device includes at least two of the third braided wires.

15. The medical system as described in claim 14, characterized in that, At least two of the third braided filaments are evenly distributed along the circumference of the tubular structure.

16. The medical system as claimed in claim 11, characterized in that, The first braided filament, the second braided filament, and the third braided filament are all biodegradable polymer filaments.

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