CN116407381A

CN116407381A - Delivery guidewire, delivery system, and blood flow guide device system

Info

Publication number: CN116407381A
Application number: CN202111661051.5A
Authority: CN
Inventors: 任静; 马腾达; 张敏瑶; 王永胜
Original assignee: Hangzhou Deno Brain Neurology Medical Technology Co ltd
Current assignee: Hangzhou Deno Brain Neurology Medical Technology Co ltd
Priority date: 2021-12-30
Filing date: 2021-12-30
Publication date: 2023-07-11

Abstract

The invention relates to a conveying guide wire, a conveying system and a blood flow guiding device system, wherein the conveying guide wire comprises a mandrel and a conveying member, the conveying member is sleeved on the mandrel, the outer peripheral surface of the conveying member is a non-smooth surface, and at least part of the outer peripheral surface of the conveying member is in fit connection with the proximal end of the blood flow guiding device so as to drive the blood flow guiding device to synchronously advance or retreat along with the mandrel along the axial direction. When performing the operation, make carry the dense net support of seal wire drive blood flow guider remove in the microcatheter, and then make transmission piece and microcatheter cooperation, through mutual friction's mode, reach the effect that makes the dense net support of blood flow guider realize pushing or withdrawing, be favorable to realizing the accurate location to blood flow guider in the transportation, be convenient for the doctor simultaneously and control.

Description

Delivery guidewire, delivery system, and blood flow guide device system

Technical Field

The invention relates to the technical field of medical equipment, in particular to a conveying guide wire, a conveying system and a blood flow guiding device system.

Background

In recent years, more and more methods are related to interventional therapy for treating intracranial aneurysms, wherein a blood flow guiding device is a novel and effective treatment method for treating intracranial aneurysms, and has good treatment effects on intracranial large-sized, huge-sized, wide-necked, fusiform and saccular aneurysms.

The blood flow guiding device is implanted into the parent artery through the delivery system, and blood inflow into the aneurysm is slowly reduced by changing the blood flow dynamics of the neck of the aneurysm, and the aneurysm is reduced until the blood flow guiding device is fused with the parent artery, so that the effect of treating the aneurysm is achieved. Wherein the delivery system can smoothly and effectively deliver the blood flow guiding device to the parent artery accurately. However, the current delivery systems generally suffer from operability problems, which are inconvenient for pushing or retracting operations, and thus, poor positioning.

Disclosure of Invention

The invention aims to provide a conveying guide wire, a conveying system and a blood flow guiding device system of a blood flow guiding device, which can be accurately positioned and are convenient to operate.

In order to solve the technical problems, the invention adopts the following technical scheme:

according to one aspect of the present invention, there is provided a delivery guidewire comprising: a mandrel; and the transmission piece is sleeved on the mandrel, the outer peripheral surface of the transmission piece is a non-smooth surface, and at least part of the outer peripheral surface of the transmission piece is used for being attached and connected with the proximal end of the blood flow guiding device so as to drive the blood flow guiding device to synchronously advance and/or retreat along with the mandrel in the axial direction.

In some embodiments of the present application, the delivery guidewire further comprises a proximal stop; the proximal limiting part is sleeved on the mandrel and arranged on the proximal side of the transmission part.

In some embodiments of the present application, the proximal stop has a diameter greater than the diameter of the delivery member and is configured to stop the proximal end of the blood flow guiding device.

In some embodiments of the present application, the delivery guidewire further comprises a distal stop; the distal end limiting part is sleeved on the mandrel and arranged on the distal end side of the transmission part.

In some embodiments of the present application, the delivery guidewire further comprises a positioning member; the locating piece is sleeved on the mandrel and is arranged on the far end side of the far end limiting piece at intervals.

In some embodiments of the present application, the delivery guidewire further comprises a developing element; the distal end of the mandrel is provided with a developing part, and the distal end of the developing part is in a hook shape; the developing element is wound on the developing part; the positioning member is provided at a proximal end of the developing member.

In some embodiments of the present application, the delivery guidewire further comprises a push tube; the pushing tube is sleeved on the mandrel and arranged on the proximal side of the proximal limiting piece, and the distal end of the pushing tube abuts against the proximal limiting piece.

In some embodiments of the present application, the push tube comprises a flexible section and a push section integrally connected to a proximal end of the flexible section; the proximal end of the soft section is connected with the distal end of the pushing section, and the distal end of the soft section abuts against the proximal end limiting piece.

According to some embodiments of the present application, a plurality of cutting holes are densely distributed on the peripheral wall of the soft section, and a plurality of the cutting holes are circumferentially spaced and arranged at intervals and sequentially spaced along the axial direction.

In some embodiments of the present application, the cutting hole is an elongated hole and extends along a circumferential direction of the soft segment.

According to some embodiments of the present application, the cutting hole includes a plurality of U-shaped structural units extending in a continuous bending manner or a plurality of Ω -shaped structural units bending in a continuous bending manner, and the plurality of U-shaped structural units or the plurality of Ω -shaped structural units are sequentially connected along a circumferential direction.

In some embodiments of the present application, the cutting holes are elongated holes, and among a plurality of the cutting holes arranged at intervals along the axis, adjacent cutting holes are arranged in parallel and in a staggered manner.

In some embodiments of the present application, one or more marking points are disposed on the peripheral wall of the pushing section, where the marking points are used to prompt the release progress of the blood flow guiding device.

According to another aspect of the present invention, there is also provided a delivery system for delivering a blood flow guiding device, the delivery system comprising a delivery guidewire and a loader; the conveying guide wire adopts the conveying guide wire; the loader is hollow and provided with a loading space; the blood flow guiding device can be contracted and installed in the loading space; the conveying guide wire is positioned in the loading space and penetrates through the blood flow guiding device, and the conveying guide wire pushes and/or withdraws the blood flow guiding device.

In some embodiments of the present application, the peripheral wall of the loader is provided with a protruding portion.

According to yet another aspect of the present invention, there is also provided a blood flow guiding device system comprising a blood flow guiding device and a delivery system; the conveying system adopts the conveying system; the blood flow guiding device is a dense net support formed by braiding a plurality of braiding wires, the dense net support is sleeved on the mandrel, the proximal end of the dense net support is sleeved on the transmission piece, and the braiding wires comprise at least two of nickel-titanium alloy wires, platinum-nickel alloy wires and platinum-tungsten alloy wires.

In some embodiments of the present application, the braided wire comprises a nickel-titanium alloy wire and a platinum-nickel alloy wire.

In some embodiments of the present application, the platinum-nickel alloy wire comprises a core and a nickel-titanium wire; the nickel titanium wire is wrapped on the periphery of the core; the core is a platinum wire with the purity of more than or equal to 99.99%, and the specific gravity of the nickel-titanium wire accounts for 30% of the platinum-nickel wire.

In some embodiments of the present application, the braided wire comprises at least four alloy wires with a developing function.

According to some embodiments of the present application, the plurality of braided wires includes a plurality of first braided wires and a plurality of second braided wires, diameters of the first braided wires and the second braided wires are different, and a ratio of the number of the first braided wires to the number of the second braided wires is 1:1-1:1.5.

In some embodiments of the present application, the first braided wires are nickel-titanium alloy wires, the number of the first braided wires is 20, and the diameter of the first braided wires is 0.03mm; the second braided wires are the platinum nickel alloy wires, the number of the second braided wires is 28, and the diameter of the second braided wires is 0.04mm.

In some embodiments of the present application, the surface of the dense mesh scaffold is provided with a polymer coating for preventing clotting and/or reducing friction.

According to the technical scheme, the invention has at least the following advantages and positive effects:

in the conveying guide wire, the transmission piece is arranged on the mandrel, and the transmission piece is attached to the proximal end of the blood flow guiding device by utilizing the non-smooth characteristic of at least part of the peripheral surface of the transmission piece, so that the blood flow guiding device is driven to synchronously advance or retreat along the axial direction along with the transmission piece and the mandrel. When performing the operation, make the dense net support that carries the guide wire to drive blood flow guider remove in the microcatheter, and then make transmission piece and microcatheter cooperation, through mutual friction's mode, reach the effect that makes blood flow guider's dense net support realize pushing or withdrawing, be favorable to in the transportation, be convenient for the doctor to control to realize the accurate location to blood flow guider.

Drawings

Fig. 1 is a schematic diagram of a blood flow guiding device system according to an embodiment of the present invention.

Fig. 2 is a schematic view of the structure of fig. 1 in another state.

Fig. 3 is a schematic view of the blood flow catheter device of fig. 1.

Fig. 4 is a schematic view of the delivery guidewire of fig. 1.

Fig. 5 is a schematic view of the mandrel of fig. 4.

Fig. 6 is a schematic view of the structure of the developing portion, developing member and positioning member at the distal end of the spindle of fig. 4.

Fig. 7 is a schematic view of the mandrel, distal stop, transmission, proximal stop, and push tube of fig. 4.

Fig. 8 is a schematic view of a structure of the push tube of fig. 7.

Fig. 9 is a schematic view of another construction of the push tube of fig. 7.

Fig. 10 is a schematic view of the structure of the cut hole in fig. 9.

Fig. 11 is a schematic view of yet another construction of the push tube of fig. 7.

Fig. 12 is a schematic view of the structure of the loader of fig. 1.

The reference numerals are explained as follows: 100. a blood flow guiding device; 110. a connecting cylinder; 120. a proximal flare; 130. a distal flare; 200. delivering a guidewire; 300. a loader; 310. a boss; 1. a mandrel; 11. a pushing part; 12. an intermediate portion; 13. a developing section; 2. a developing member; 3. a positioning piece; 4. a transmission member; 5. a distal stop; 6. a proximal stop; 7. a pushing tube; 71. a soft section; 711. cutting the hole; 72. a pushing section; 721. the points are marked.

Detailed Description

Exemplary embodiments that embody features and advantages of the present invention will be described in detail in the following description. It will be understood that the invention is capable of various modifications in various embodiments, all without departing from the scope of the invention, and that the description and illustrations herein are intended to be by way of illustration only and not to be construed as limiting the invention.

In the description of the present application, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the terms in this application will be understood by those of ordinary skill in the art in a specific context.

It is also noted that in the description of the present application, the terms "proximal" and "distal" refer to the relative orientation, relative position, orientation of elements or actions with respect to one another from the perspective of the operator using the medical device, although "proximal", "distal" are not intended to be limiting, and "proximal" generally refers to the end of the medical device that is proximate to the operator during normal operation, and "distal" generally refers to the end that is first introduced into the patient.

Fig. 1 is a schematic diagram of a blood flow guiding device system according to an embodiment of the present invention. Fig. 2 is a schematic view of the structure of fig. 1 in another state.

Referring to fig. 1 and 2, a blood flow guiding device system according to an embodiment of the present invention is mainly applied to an operation for endovascular intervention treatment of intracranial aneurysms, and the blood flow guiding device system mainly includes a blood flow guiding device 100 and a delivery system. The blood flow guiding device 100 is mainly used for being implanted into an aneurysm-carrying artery, and blood flowing into the aneurysm is slowly reduced by changing the blood flow dynamics of the neck of the aneurysm, and the aneurysm is reduced until the aneurysm is fused with the aneurysm-carrying artery, so that the effect of treating the aneurysm is achieved. The delivery system can smoothly and efficiently deliver the blood flow guiding device 100 to the parent artery with accuracy.

The delivery system generally includes a delivery guidewire 200 and a loader 300. The blood flow guiding device 100 is tethered to the delivery guidewire 200 and is preloaded into the loader 300 along with the delivery guidewire 200.

In surgical delivery, a microcatheter (not shown) is first introduced into the vicinity of the parent artery, the loader 300 is then connected to the microcatheter via a connector (not shown), and an axial force is applied to the delivery guidewire 200 by the operator to deliver the blood flow guiding device 100 tethered to the delivery guidewire 200 from the loader 300 into the microcatheter, and the loader 300 is removed; continuing to apply an axially directed force to continue advancing the blood flow direction device 100 until the blood flow direction device 100 is moved to the parent artery, releasing the blood flow direction device 100; the reconstruction of the tumor-bearing vessel is completed by the blood flow guiding device 100, and the treatment of the intracranial aneurysm is realized.

Fig. 3 is a schematic view of the blood flow catheter device of fig. 1.

Referring to fig. 1-3, a blood flow guiding device 100 includes a dense mesh stent having a mesh structure formed by interweaving braided filaments. The dense net support can be contracted along the radial direction or expanded along the radial direction under the action of self elasticity, namely the dense net support is of a self-expanding net structure.

Specifically, the braided wire can be made of alloy wires with better toughness, such as nickel-titanium alloy wires, platinum-nickel alloy wires, platinum-tungsten alloy wires and the like.

In some embodiments, the dense mesh stent is formed by mixed and staggered braiding of at least two alloy wires of nickel-titanium alloy wires, platinum-nickel alloy wires and platinum-tungsten alloy wires. The platinum-nickel alloy wire comprises a core and a nickel-titanium wire. The core is arranged at the axle center, and the nickel titanium wire is wrapped on the periphery of the core. The core is a platinum wire with the purity of more than or equal to 99.99 percent, and the specific gravity of the nickel-titanium wire accounts for 30 percent of the platinum-nickel wire.

In some embodiments, the dense mesh stent is formed by mixed and staggered braiding of braided wires of different diameters so that the dense mesh stent has sufficient radial support. The ratio of the number of the first braided wires to the number of the second braided wires is 1:1-1:1.5, and the diameter of the first braided wires can be smaller than the diameter of the second braided wires or larger than or equal to the diameter of the second braided wires, which is not limited herein.

Referring to fig. 3, in the present embodiment, the dense mesh stent is woven from 48 cylindrical alloy wires. The 48 alloy wires comprise 20 nickel-titanium alloy wires and 28 platinum-nickel alloy wires, the diameter of the nickel-titanium alloy wires is 0.03mm, the diameter of the platinum-nickel alloy wires is 0.04mm, and the nickel-titanium alloy wires and the platinum-nickel alloy wires are mixed and interweaved to form the dense net support. The platinum-nickel alloy wire comprises a core and a nickel-titanium wire, wherein the diameter of the core is 0.01mm, and the core is wrapped in the middle by the nickel-titanium wire. The core is a platinum wire with the purity of more than or equal to 99.99%, and the specific gravity of the nickel-titanium wire accounts for 30% of the platinum-nickel wire.

The blood flow guiding device 100 formed by braiding the braided filaments has a radial compression ratio of between one half and one tenth, and can be loaded into the loader 300 or into the microcatheter after compression. The blood flow guiding device 100 formed by braiding with the braiding wires has high flexibility and high flexibility, so that the blood flow guiding device 100 can be bent or twisted in space, and the blood flow guiding device 100 can be released into a blood vessel to be more similar to the shape of a natural blood vessel, can conform to a tortuous cerebral blood vessel, and can also support the lumen shape of the blood vessel.

In some embodiments, the multiple alloy wires of the dense mesh stent at least comprise four alloy wires with a developing function, so that the dense mesh stent after mixed braiding can realize a whole body developing function, and the adhesion of the blood flow guiding device 100 after intravascular release can be better presented and judged.

In some embodiments, the surface of the dense mesh scaffold is provided with a polymer coating for preventing clotting. The polymer coating is insoluble in water and not easy to degrade, and the thickness of the coating is 5-1000nm. The polymer coating can be used for promoting vascular endothelialization, reducing thrombosis and reducing friction force when pushed in liquid.

The polymer coating may be sprayed or coated on the surface of each alloy wire or on the surface of the whole dense net support.

Referring to fig. 3, in some embodiments, the blood flow guiding device 100 is generally cylindrical, and the blood flow guiding device 100 includes a proximal flare 120, a connecting barrel 110, and a distal flare 130 disposed in sequence from proximal to distal along its own axis.

The connecting cylinder 110 is cylindrical, and diameters of the connecting cylinder 110 are the same along the axial direction.

The proximal flare 120 and the distal flare 130 are disposed at two ends of the connecting tube 110, i.e., the proximal flare 120 is connected to the proximal end of the connecting tube 110, and the distal flare 130 is connected to the distal end of the connecting tube 110.

The proximal flare 120 increases in diameter from distal to proximal, giving it a flare-shaped configuration. The distal flare 130 increases in diameter from the proximal end to the distal end, giving it a flare-shaped flare. The configuration of the proximal flare 120 and the distal flare 130 may be used to enhance the anchoring properties and radial support of the dense mesh stent in the vessel.

It will be appreciated that in other embodiments, the proximal flare 120 may be provided only at the proximal end of the connector barrel 110, or the distal flare 130 may be provided only at the distal end of the connector barrel 110.

In some embodiments, the length of the proximal flare 120 and the distal flare 130 may be 1.5mm, with the flaring angle of the proximal flare 120 and the flaring angle of the distal flare 130 both being between 30 ° -35 °. The relatively small flaring angles of the proximal 120 and distal 130 flare facilitate reducing irritation of the dense mesh stent to the vessel wall.

Fig. 4 is a schematic structural view of the delivery guidewire 200 of fig. 1.

Referring to fig. 4, a delivery guidewire 200 is used to deliver the blood flow guiding device 100 to a predetermined location within a patient, i.e., at a parent artery. The delivery guidewire 200 of this embodiment mainly includes a mandrel 1, a developing element 2, a positioning member 3, a transmission member 4, a distal end limiter 5, a proximal end limiter 6, and a push tube 7.

The mandrel 1 is used to advance and/or retract the blood flow guiding device 100 and to support the blood flow guiding device 100. The blood flow guiding device 100 is compressively bound to the mandrel 1, and the mandrel 1 may drive the blood flow guiding device 100 to axially advance and/or retract.

Fig. 5 is a schematic view of the structure of the mandrel 1 in fig. 4.

Referring to fig. 4 and 5, in some embodiments, the mandrel 1 includes a pushing portion 11, an intermediate portion 12, and a developing portion 13 disposed in order from a proximal end to a distal end along its own axis.

The proximal end of the pushing portion 11 is close to the operator. The pushing portion 11 has a columnar shape and a uniform diameter. The diameter of the pushing portion 11 is 0.3 to 0.5mm, for example, 0.41mm. In some embodiments, the surface of the pushing part 11 is coated or sprayed with a PTEE (polytetrafluoroethylene) coating.

The intermediate portion 12 continues distally in the axial direction from the distal end of the push portion 11. The blood flow guiding device 100 is fitted around and bound to the peripheral side of the intermediate portion 12. The diameter of the proximal end of the intermediate portion 12 is the same as the diameter of the pushing portion 11, the intermediate portion 12 has a tapered shape as a whole, and the diameter of the intermediate portion 12 gradually decreases from the proximal end to the distal end, for example, from 0.41mm to 0.1mm. Thus, the intermediate portion 12 becomes progressively more deformable from the proximal end to the distal end, and is better able to accommodate the curvature of the intracranial vessel, and more readily conforms to the vessel's structure to the diseased parent artery.

The proximal end of the developing portion 13 is connected to the distal end of the intermediate portion 12, and continues distally in the axial direction from the distal end of the intermediate portion 12. The proximal end of the developing portion 13 has a proximal end diameter larger than the distal end diameter of the intermediate portion 12. The proximal end of the developing portion 13 is columnar, the distal end of the developing portion 13 is hooked, and the diameters of the proximal end and the distal end of the developing portion 13 are the same.

It should be noted that, the developing portion 13 may be integrally formed into a hook shape by adopting a bending process, and has a good guiding effect on the mandrel 1, and meanwhile, damage to a blood vessel in the advancing process may be avoided. In some embodiments, the distal end of the developing portion 13 has a bend angle of between 40 ° and 45 ° and a length of between 10mm and 20mm, for example 15mm.

The diameter of the developing portion 13 is smaller than that of the pushing portion 11, ensuring that the pushing portion 11 is thicker in diameter, so that a sufficient pushing force can be provided. In some embodiments, the diameter of the developing portion 13 is 0.21 to 0.23mm.

In some embodiments, the material of the mandrel 1 may be at least one of stainless steel, nickel-titanium alloy, copper alloy, or aluminum alloy. Specifically, the mandrel 1 may be formed by grinding any one of the above materials, or may be formed by bonding or welding any two of the above materials.

Fig. 6 is a schematic view of the developing portion 13, developing member 2 and positioning member 3 of the distal end of the spindle 1 of fig. 4.

Referring to fig. 4 to 6, the developing element 2 is covered on the developing portion 13 of the mandrel 1, for example, the developing element 2 is wound around the outer periphery of the developing portion 13 in a winding manner to form a developing spring. The visualization element 2 is used for visualization, thereby showing the position of the blood flow catheter device within the blood vessel.

Specifically, the developing element 2 may be made of platinum-tungsten, platinum-iridium, cobalt-chromium, gold, platinum or other metal filaments with developing effect, or may be made of polymer materials with developing effect. The metal filament may be fixed to the developing part 13 by a tightly wound manner and by a welding process.

Referring to fig. 4 to 6, the positioning member 3 is sleeved on the mandrel 1 and disposed at the proximal end of the middle portion 12, i.e. at the connection between the middle portion 12 and the developing portion 13. The positioning piece 3 can be fixed on the mandrel 1 by adopting bonding, welding or the like. In some embodiments, the positioning member 3 is located at the proximal edge of the developing element 2.

In some embodiments, the positioning member 3 may be made of stainless steel, gold, platinum, or other developable and easily processed metal materials, or other developable and easily processed polymer materials.

The positioning member 3 is used to prevent the blood flow guiding device 100 from falling off the mandrel 1 during the delivery of the blood flow guiding device 100. Since the positioning element 3 can also play a role in developing, when the positioning element 3 is seen to be exposed from the microcatheter in the DSA image during the delivery process, the dense mesh stent starts to be released, so that the release position of the blood flow guiding device 100 in the blood vessel can be accurately adjusted.

Fig. 7 is a schematic view of the structure of the mandrel 1, distal limiter 5, transmission member 4, proximal limiter 6 and push tube 7 of fig. 4.

Referring to fig. 4 and 7, the transmission member 4 is sleeved on the mandrel 1 and disposed at the proximal end of the pushing portion 11. The transmission member 4 can be fixed on the mandrel 1 by bonding, hot melting, welding, etc.

The transmission piece 4 is at least partially attached to the proximal end of the dense mesh stent, and the outer peripheral surface of the transmission piece 4 is a non-smooth surface. When the dense net support is bound on the mandrel 1 and is loaded in the loader 300 or the micro-catheter, the dense net support can be clamped and driven to advance or retreat synchronously along the axial direction along with the mandrel 1 by applying a pushing force or a pulling force to the mandrel 1 in the axial direction and by friction force between the transmission piece 4 and the loader 300 or the micro-catheter, so that the release position of the dense net support can be accurately adjusted, and an operator can operate conveniently.

In some embodiments, the transmission member 4 has a tubular structure, and the transmission member 4 may be made of a polymer material with certain hardness and friction properties, such as Pebax (polyether block polyamide) tube, silica gel, or rubber. The effect of precisely controlling the advancing or retracting of the dense net support is achieved by the mutual friction of the surface of the transmission member 4 and the inner wall of the loader 300 or the micro-catheter.

Still referring to fig. 4 and 7, the proximal end stopper 6 is sleeved on the mandrel 1 and disposed at the proximal end of the transmission member 4. The proximal stop 6 may be fixed to the mandrel 1 by means of adhesive or welding. The proximal stopper 6 serves to prevent the transmission member 4 from sliding off the mandrel 1 and to prevent the transmission member 4 from moving proximally relative to the mandrel 1 in the axial direction.

In some embodiments, the proximal limiter 6 and the transmission member 4 are disposed at intervals, and the gap between the proximal limiter 6 and the transmission member 4 may be filled with glue to enhance the firmness of the transmission member 4 on the mandrel 1.

In some embodiments, the proximal stopper 6 may be made of the same material as the positioning member 3, i.e., the proximal stopper 6 may be made of a metal material that can be developed and processed easily, such as stainless steel, gold, platinum, etc., or other polymer materials that can be developed and processed easily.

In some embodiments, the diameter of the proximal stop 6 is greater than the diameter of the delivery member 4, and the outer diameter of the proximal stop 6 is matched with the inner diameter of the microcatheter or loader 300 for stopping the proximal end of the dense mesh stent such that the dense mesh stent is stopped on the distal side of the proximal stop 6, preventing the dense mesh stent from sliding off the mandrel 1.

Referring to fig. 4 and 7, the distal limiting member 5 is sleeved on the mandrel 1, is disposed on the distal side of the transmission member 4, and is disposed on the proximal side of the positioning member 3 at intervals. The distal limiter 5 may be fixed to the mandrel 1 by means of adhesion or welding. The distal stopper 5 serves to prevent the transmission member 4 from sliding off the spindle 1 and to prevent the transmission member 4 from moving in the axial direction toward the distal side with respect to the spindle 1.

In some embodiments, the distal limiter 5 and the transmission member 4 are arranged at intervals, and the gap between the distal limiter 5 and the transmission member 4 may be filled with glue to enhance the firmness of the transmission member 4 on the mandrel 1.

In some embodiments, the distal limiter 5 may be made of the same material as the positioning element 3 and the proximal limiter 6, i.e. the distal limiter 5 may also be made of a metal material that is developable and easy to process, such as stainless steel, gold, platinum, or other polymer materials that are developable and easy to process.

Referring to fig. 4 and 7, a pushing tube 7 is sleeved on the mandrel 1 and disposed at a proximal side of the proximal limiting member 6, and a distal end of the pushing tube 7 abuts against the proximal limiting member 6. The pushing tube 7 can be connected with the mandrel 1 into a whole by adopting an adhesive bonding or welding mode. The pushing tube 7 is used to provide a sufficient pushing force for the mandrel 1, thereby enabling a better delivery of the delivery guidewire 200.

In some embodiments, the push tube 7 includes a flexible section 71 and a push section 72 integrally connected. The soft segment 71 is located at the distal end of the pushing segment 72, and the proximal end of the soft segment 71 is integrally connected with the distal end of the pushing segment 72. The flexible section 71 has flexible properties to allow the distal end of the push tube 7 to better accommodate intracranially curved blood vessels, facilitating compliance of the blood vessel into the lesion at the distal end. The pushing section 72 has a degree of rigidity to provide sufficient delivery force to facilitate one-handed operation by an operator to facilitate more precise control of the advancement or retraction of the blood flow guiding device 100, and to more precise position and release of the blood flow guiding device 100.

Referring to fig. 4 and 7, in some embodiments, one or more marker points 721 are provided on the outer peripheral wall of the push segment 72 near the proximal end of the push tube 7, the marker points 721 being used to alert the operator during the procedure, to the progress of release of the dense stent, such as indicating that release is about to begin, or indicating that release is about to complete, etc. The marking points 721 may be formed on the outer circumferential wall of the push section 72 using a carving, spraying, or the like process.

Specifically, during delivery, as the push tube 7 drives the mandrel 1 and blood flow guiding device 100 forward within the microcatheter, the marker 721 at the proximal end of the push tube 7 will gradually approach the microcatheter. When the marker 721 is examined into the microcatheter, the blood flow guiding device 100 is about to be pushed out of the microcatheter for release. The marker 721 can then alert the operator that slow advancement or retraction of the microcatheter can begin, allowing the blood flow guiding device 100 to be precisely released.

In some embodiments, the pushing tube 7 is a hypotube, the diameter of the hypotube is in the range of 0.5-0.6 mm, a cutting line is formed at the distal end of the hypotube, and the portion with the cutting line is the soft segment 71, so as to increase the bending performance of the soft segment 71, wherein the length of the cutting line is in the range of 50-100 mm.

Fig. 8 is a schematic view of a structure of the push tube 7 in fig. 7. Fig. 9 is a schematic view of another construction of the push tube 7 of fig. 7. Fig. 10 is a schematic view of the structure of the cutting hole 711 of fig. 9. Fig. 11 is a schematic view of a further construction of the push tube 7 of fig. 7.

Referring to fig. 7 to 10, in some embodiments, the cutting lines of the soft segment 71 are a plurality of cutting holes 711 densely distributed on the peripheral wall of the soft segment 71. The plurality of cutting holes 711 are arranged at intervals in the circumferential direction of the soft segment 71, and are arranged at intervals in the axial direction of the soft segment 71. The cutting holes 711 of the soft segment 71 are formed into a hollowed-out structure by a cutting process, and the hollowed-out structure is uniformly distributed in the circumferential direction and the axial direction of the soft segment 71.

When the soft section 71 of the pushing tube 7 is subjected to external force in the radial direction, the soft section 71 can be bent and deformed at the cutting holes 711 of each hollowed part, so that the flexible bending performance of the pushing tube 7 at the soft section 71 is improved, and the pushing tube can be further adapted to intracranial bent blood vessels.

Referring to fig. 8, in some embodiments, the cutting hole 711 of the soft segment 71 is a long hole, which extends along the circumferential direction of the soft segment 71, and the long hole may be a long waist hole. A plurality of elongated holes of different lengths are formed in the circumferential direction of the soft segment 71, and the plurality of elongated holes are arranged at intervals in the circumferential direction. In the axial direction of the soft segment 71, a plurality of elongated holes are formed in a spaced arrangement, and the plurality of elongated holes are arranged in parallel and offset.

Referring to fig. 9 and 10, in some embodiments, the cutting hole 711 of the flexible section 71 is a curved long hole, and the cutting hole 711 includes a plurality of U-shaped structural units extending in a continuous bending manner or a plurality of Ω -shaped structural units continuously bending in a continuous bending manner, and the plurality of U-shaped structural units or the plurality of Ω -shaped structural units are sequentially connected in a circumferential direction. In the present embodiment, two U-shaped or Ω -shaped structural units are included in each of the cutting holes 711. It will be appreciated that in other embodiments, each of the cutting holes 711 may include only one U-shaped or omega-shaped structural element, or more than three U-shaped or omega-shaped structural elements may be provided.

Referring to fig. 11, the cutting holes 711 of the present embodiment are similar to the cutting holes 711 of the embodiment of fig. 8 in structure and are elongated. The cutting hole 711 of the present embodiment is different from the cutting hole 711 of the embodiment of fig. 8 in that the length and arrangement of the cutting holes 711 are different.

In the present embodiment, the lengths of the respective cutting holes 711 are the same. In the circumferential direction of the soft segment 71, only one cutting hole 711 or a plurality of cutting holes 711 arranged at intervals in the circumferential direction may be provided. Among the plurality of cutting holes 711 of the soft segment 71, which are arranged at intervals along the axis, adjacent cutting holes 711 are arranged in parallel and offset, and are arranged in equidistant spirals. And the plurality of cutting holes 711 are alternately arranged in turn along the forward spiral and the reverse spiral in the axial direction, so that the area where the cutting holes 711 are not distributed forms a continuously bent cutting gap in the axial direction of the soft segment 71.

It should be noted that, in other embodiments, the plurality of cutting holes 711 are arranged in the axial direction only in a forward spiral or in a reverse spiral.

Fig. 12 is a schematic view of the structure of the loader 300 in fig. 1.

Referring to fig. 1, 2 and 12, the loader 300 has a cylindrical shape, and is hollow in the interior thereof to have a loading space. The loading space is used to load the blood flow guiding device 100 and the delivery guidewire 200. Referring to the configuration shown in fig. 1 and 2, the delivery guidewire 200 and the blood flow guiding device 100 are preloaded into the loader 300.

The shuttle 300 is made of a transparent material to facilitate the operator's view of the blood flow guiding device 100 positioned within the loading space and to clearly see when the blood flow guiding device 100 is delivered into the microcatheter.

The interior of the cartridge 300 has a smooth interior cavity with a low coefficient of friction. The cartridge 300 may employ tubing having a smooth lumen. Or a smooth inner film material is provided on the inner layer of the cartridge 300 and a moderate hardness material is provided on the outer layer of the cartridge 300. The inner layer may be made of, for example, PTFE (polytetrafluoroethylene), HDPE (High Density Polyethylene ), or FEP (Fluorinated ethylene propylene, perfluoroethylene propylene copolymer). The outer layer is made of heat-shrinkable tubes made of FEP or PTFE and the like through hot melting.

Referring to fig. 2, in some embodiments, the length of the loader 300 needs to cover the flexible section 71 of the pushing tube 7, so that the pushing tube 7 has enough pushing force, and thus, an operator can perform a one-hand operation.

Referring to fig. 12, in some embodiments, a protrusion 310 is protruding from the outer peripheral wall of the loader 300. The boss 310 is provided with one or more, and the plurality of bosses 310 are arranged at intervals in the axial direction. The protruding portion 310 can provide pushing force for assisting an operator, so that the operator can conveniently realize one-hand operation.

Based on the technical scheme, the invention has at least the following advantages and positive effects:

in the delivery guidewire 200 of the present invention, the transmission member 4 is provided on the mandrel 1, and the proximal end of the blood flow guiding device 100 is bonded and connected by utilizing the non-smooth characteristic of the outer peripheral surface of the transmission member 4, so that the blood flow guiding device 100 is driven to advance or retreat in synchronization with the transmission member 4 and the mandrel 1 in the axial direction. When in operation, the conveying guide wire 200 drives the dense net support of the blood flow guiding device 100 to move in the micro-catheter, so that the transmission piece 4 is matched with the micro-catheter, the effect of pushing or retracting the dense net support of the blood flow guiding device 100 is achieved in a mutual friction mode, the accurate positioning of the blood flow guiding device 100 is facilitated in the conveying process, and meanwhile, the operation of a doctor is facilitated.

While the invention has been described with reference to several exemplary embodiments, it is to be understood that the terminology used is intended to be in the nature of words of description and of limitation. As the present invention may be embodied in several forms without departing from the spirit or essential characteristics thereof, it should also be understood that the above-described embodiments are not limited by any of the details of the foregoing description, but rather should be construed broadly within its spirit and scope as defined in the appended claims, and therefore all changes and modifications that fall within the meets and bounds of the claims, or equivalences of such meets and bounds are therefore intended to be embraced by the appended claims.

Claims

1. A delivery guidewire for delivering a blood flow guiding device, comprising:

a mandrel; a kind of electronic device with high-pressure air-conditioning system

The transmission piece is sleeved on the mandrel, the outer peripheral surface of the transmission piece is a non-smooth surface, and at least part of the outer peripheral surface of the transmission piece is in fit connection with the proximal end of the blood flow guiding device so as to drive the blood flow guiding device to advance and/or retreat synchronously along with the mandrel in the axial direction.

2. The delivery guidewire of claim 1, further comprising a proximal stop;

the proximal limiting part is sleeved on the mandrel and arranged on the proximal side of the transmission part.

3. The delivery guidewire of claim 2, wherein the proximal stop has a diameter greater than the diameter of the delivery member and is configured to stop the proximal end of the blood flow guide device.

4. The delivery guidewire of claim 2, further comprising a distal stop;

the distal end limiting part is sleeved on the mandrel and arranged on the distal end side of the transmission part.

5. The delivery guidewire of claim 4, further comprising a positioning member;

the locating piece is sleeved on the mandrel and is arranged on the far end side of the far end limiting piece at intervals.

6. The delivery guidewire of claim 5, wherein the delivery guidewire further comprises a visualization element;

the distal end of the mandrel is provided with a developing part, and the distal end of the developing part is in a hook shape;

the developing element is wound on the developing part;

the positioning member is provided at a proximal end of the developing member.

7. The delivery guidewire of claim 2, further comprising a push tube;

the pushing tube is sleeved on the mandrel and arranged on the proximal side of the proximal limiting piece, and the distal end of the pushing tube abuts against the proximal limiting piece.

8. The delivery guidewire of claim 7, wherein the push tube comprises a flexible segment and a push segment integrally connected to a proximal end of the flexible segment;

the proximal end of the soft section is connected with the distal end of the pushing section, and the distal end of the soft section abuts against the proximal end limiting piece.

9. The delivery guidewire of claim 8, wherein the flexible segment has a plurality of circumferentially spaced apart cutting openings disposed in a circumferential array and sequentially spaced apart axially.

10. The delivery guidewire of claim 9, wherein the cutting aperture is an elongate aperture and extends circumferentially of the flexible segment.

11. The delivery guidewire of claim 9, wherein the cutting bore comprises a plurality of U-shaped structural units extending in a continuous bend or a plurality of Ω -shaped structural units continuously bent, the plurality of U-shaped structural units or the plurality of Ω -shaped structural units being sequentially connected in a circumferential direction.

12. The delivery guidewire of claim 9, wherein said cutting bores are elongated bores and adjacent ones of said cutting bores are arranged in parallel and offset relation with respect to one another in a plurality of said cutting bores spaced along the axis.

13. The delivery guidewire of claim 8, wherein the outer peripheral wall of the push segment is provided with one or more marker points for prompting a release profile of the blood flow guiding device.

14. A delivery system for delivering a blood flow guiding device, comprising a delivery guidewire and a loader; the use of a delivery guidewire according to any one of claims 1-13; the loader is hollow and provided with a loading space; the blood flow guiding device can be contracted and installed in the loading space; the conveying guide wire is positioned in the loading space and penetrates through the blood flow guiding device, and the conveying guide wire pushes and/or withdraws the blood flow guiding device.

15. The delivery system of claim 14, wherein the peripheral wall of the cartridge is provided with a raised portion.

16. A blood flow direction device system comprising a blood flow direction device and a delivery system; the delivery system employing the delivery system of claim 14 or 15;

the blood flow guiding device is a dense net support formed by braiding a plurality of braiding wires, the dense net support is sleeved on the mandrel, the proximal end of the dense net support is sleeved on the transmission piece, and the braiding wires comprise at least two of nickel-titanium alloy wires, platinum-nickel alloy wires and platinum-tungsten alloy wires.

17. The blood flow guiding device system of claim 16, wherein the braided wire comprises a nickel-titanium alloy wire and a platinum-nickel alloy wire.

18. The blood flow guiding device system of claim 16 or 17, wherein the platinum-nickel alloy wire comprises a core and a nickel-titanium wire; the nickel titanium wire is wrapped on the periphery of the core; the core is a platinum wire with the purity of more than or equal to 99.99%, and the specific gravity of the nickel-titanium wire accounts for 30% of the platinum-nickel wire.

19. The blood flow guiding device system of claim 16, wherein the braided wire comprises at least four alloy wires having a visualization function.

20. The blood flow guiding device system of claim 16, wherein the plurality of braided wires comprises a plurality of first braided wires and a plurality of second braided wires, the first braided wires and the second braided wires being different in diameter, and a ratio of the number of first braided wires to the number of second braided wires is 1:1 to 1:1.5.

21. The blood flow guiding device system of claim 20, wherein the first braided wire is the nitinol wire, the number of first braided wires is 20, and the diameter of the first braided wire is 0.03mm; the second braided wires are the platinum nickel alloy wires, the number of the second braided wires is 28, and the diameter of the second braided wires is 0.04mm.

22. The blood flow guiding device system of claim 16, wherein a surface of the dense mesh scaffold is provided with a polymer coating for preventing clotting and/or reducing friction.