Head end pre-bent micro guide wire assembly

Abstract

The utility model provides a head end pre-bending micro guide wire assembly, which comprises a micro guide wire and a leading-in device, the micro guide wire comprises a core wire, a spring and a safety net, the far end of the core wire is provided with a first bending part, the spring is sleeved on the surface of the far end of the core wire and is fixed with the core wire, the safety net is sleeved on the surface of the far end of the core wire, and the leading-in device is arranged on the micro guide wire. The safety net is arranged on the inner side of the spring and is fixed with the core wire and the spring; the introducer comprises a first valve body and a second valve body which are hinged to each other, the first valve body and the second valve body are closed to form the whole introducer with a through hole, the far end of the micro guide wire is arranged in the through hole in a penetrating mode, and the first bent part is located on the outer side of the through hole. According to the micro guide wire assembly with the pre-bent head end, only the far-end section of the micro guide wire is in contact with the inner wall of the introducer in the whole operation process, the friction distance between the micro guide wire and the introducer is greatly reduced, the coating damage condition is reduced, and meanwhile the operation time and difficulty of an operator are further reduced by adopting a pre-loading mode.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, and particularly relates to a micro-guide wire assembly with a pre-bent head end. Background Art

[0002] Neurovascular lesions are common clinical problems in the field of neurointerventional therapy. Interventional therapy by delivering and cooperating with instruments through a micro-guide wire is one of the rapidly developing treatment methods at present. Micro-guide wires have been widely used in medical interventional surgeries, such as percutaneous transluminal angioplasty (PTA) of neurovascular vessels and other surgeries. Micro-guide wires provide a basic track for interventional instruments such as catheters, stents, and balloons during interventional diagnosis and treatment, and are an essential supporting product in interventional surgeries. For example, in percutaneous transluminal angioplasty (PTA) of neurovascular vessels, first, a sheath is inserted through puncture of the radial artery or femoral artery, and the cerebrovascular lesion condition is determined by digital subtraction angiography (DSA). Then, a micro-guide wire is inserted. By controlling the proximal end of the micro-guide wire, the head end of the micro-guide wire is driven to rotate, and the micro-guide wire is placed near the diseased blood vessel to establish a passage from the outside of the body to the diseased blood vessel. According to the blood vessel lesion condition, such as aneurysm, stenosis / occlusion, or arteriovenous fistula / arteriovenous malformation, a catheter, stent, or balloon is selected to reach near the diseased blood vessel along the passage established by the micro-guide wire to treat the blood vessel.

[0003] Currently, the micro-guide wires sold on the market have a structure of a core wire + a spring + a surface hydrophilic coating + a J-shaped head end design. The J-shaped bend at the head end can prevent the head end of the guide wire from directly piercing the blood vessel wall, protect the blood vessel, reduce complications in interventional surgeries, and improve the success rate of surgeries.

[0004] However, due to the J-shaped bend design at the head end, it is inconvenient for the head end of the micro-guide wire to enter the catheter. Accessories such as introducers are required. The proximal end of the micro-guide wire is inserted through the head end of the introducer, and the guide wire is continuously pulled back until the J-shaped bend at the head end is pulled back into the introducer tube body. At this time, the bent shape becomes straight, and then the micro-guide wire is pushed into the catheter along the introducer tube body. Finally, the introducer is withdrawn proximally along the micro-guide wire. The introducer tube body is made of stainless steel, and the micro-guide wire passes through the introducer twice. As a result, the introducer tube body is likely to scratch and damage the coating of the micro-guide wire, and the operation time is relatively long. Summary of the Utility Model

[0005] Therefore, the technical problem to be solved by the present utility model is that in the prior art, due to the J-shaped bend design at the head end of the micro-guide wire, it is inconvenient for the head end of the micro-guide wire to enter the catheter. Accessories such as introducers are required. The proximal end of the micro-guide wire is inserted through the head end of the introducer, and the guide wire is continuously pulled back until the J-shaped bend at the head end is pulled back into the introducer tube body. At this time, the bent shape becomes straight, and then the micro-guide wire is pushed into the catheter along the introducer tube body. Finally, the introducer is withdrawn proximally along the micro-guide wire. The introducer tube body is made of stainless steel, and the micro-guide wire passes through the introducer twice. As a result, the introducer tube body is likely to scratch and damage the coating of the micro-guide wire, and the operation time is relatively long.

[0006] For this reason, the present utility model provides a head-end pre-bent micro-guide wire assembly, including a micro-guide wire and an introducer:

[0007] The micro-guide wire includes:

[0008] A core wire, with a first bending portion provided at its distal end;

[0009] A spring, sleeved on the surface of the distal end of the core wire and fixed to the core wire;

[0010] A safety net, sleeved on the surface of the distal end of the core wire, the safety net being provided inside the spring and fixed to the core wire and the spring;

[0011] The introducer includes a first flap and a second flap that are hinged to each other. The first flap and the second flap are closed to form an integral introducer with a through hole. The distal end of the micro-guide wire is inserted through the through hole and the first bending portion is outside the through hole.

[0012] Optionally, a locking structure is provided between the first flap and the second flap to keep the first flap and the second flap in a closed state.

[0013] Optionally, the locking structure includes a buckle provided on the first flap and a buckle adapter provided on the second flap, or

[0014] A buckle provided on the second flap and a buckle adapter provided on the first flap.

[0015] Optionally, the distal end of the introducer is conical or parabolic.

[0016] Optionally, the diameter of the first bending portion is 1.5 - 5 mm.

[0017] Optionally, the diameter of the first bending portion is 1.5 mm, 3 mm or 5 mm.

[0018] Optionally, a second bending portion is provided at the proximal end of the first bending portion, and the second bending portion bends towards the first bending portion.

[0019] Optionally, the bending angle of the second bending portion is 15 - 45 degrees.

[0020] Optionally, the distal end of the core wire and the surface of the spring are coated with a hydrophilic coating.

[0021] Optionally, the surface of the spring is provided with a PTFE coating or a second hydrophilic coating or a silicone oil coating.

[0022] The head-end pre-bent micro-guide wire assembly provided by the present utility model has the following advantages:

[0023] 1. The present utility model provides a head-end pre-bent micro-guide wire assembly, which includes a micro-guide wire and an introducer. The micro-guide wire includes a core wire, a spring and a safety net. A first bending portion is provided at the distal end of the core wire. The spring is sleeved on the surface of the distal end of the core wire and fixed to the core wire. The safety net is sleeved on the surface of the distal end of the core wire, and the safety net is arranged inside the spring and fixed to the core wire and the spring. The introducer includes a first flap and a second flap which are hinged to each other. The first flap and the second flap are closed to form an integral introducer with a through hole. The distal end of the micro-guide wire is inserted into the through hole and the first bending portion is located outside the through hole.

[0024] For the head-end pre-bent micro-guide wire assembly with this structure, during the whole operation process, only the distal segment of the micro-guide wire contacts the inner wall of the introducer, greatly reducing the friction distance between the micro-guide wire and the introducer, reducing the coating damage situation. At the same time, the pre-loading method further reduces the operation time and difficulty of the operator.

[0025] 2. The present utility model provides a head-end pre-bent micro-guide wire assembly. The unique design of multiple sizes of head-end bends can adapt to different clinical lesions, improve the success rate of the operation, shorten the operation time, reduce the damage to the blood vessel wall, reduce surgical complications, facilitate the operator to select the direction in the blood vessel, and reduce the irradiation time of the ray to the patient and the operator.

[0026] 3. The present utility model provides a head-end pre-bent micro-guide wire assembly. The pre-loaded introducer design is convenient for doctors to operate and shortens the operation time. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the specific embodiments of the present utility model or the technical solutions in the prior art, the following will briefly introduce the drawings required to be used in the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present utility model. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0028] Figure 1 It is a schematic structural view of the head-end pre-bent micro-guide wire provided in the embodiment of the present utility model;

[0029] Figure 2 For Figure 1 the enlarged view of the structure at the circled A in

[0030] Figure 3 For Figure 1 the sectional view at the Z-Z section line in

[0031] Figure 4 It is a schematic structural view of the introducer in the head-end pre-bent micro-guide wire provided in the embodiment of the present utility model;

[0032] Figure 5 Side view of the introducer in the head-end pre-bent micro-guide wire provided in the embodiment of the present utility model;

[0033] Figure 6 Schematic structural diagram of the first bending portion and the second bending portion in the head-end pre-bent micro-guide wire provided in the embodiment of the present utility model;

[0034] Figure 7 Schematic structural diagram of the safety net in the head-end pre-bent micro-guide wire provided in the embodiment of the present utility model.

[0035] Explanation of reference numerals:

[0036] 1 - Core wire;

[0037] 2 - Spring;

[0038] 3 - Safety net;

[0039] 4 - Hydrophilic coating;

[0040] 5 - Introducer;

[0041] 6 - Locking structure;

[0042] 7 - First bending portion;

[0043] 8 - Second bending portion; Detailed implementation manners

[0044] Next, the technical solution of the present utility model will be clearly and completely described in conjunction with the drawings. Obviously, the described embodiments are part of the embodiments of the present utility model, rather than all of them. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present utility model without creative efforts shall fall within the protection scope of the present utility model.

[0045] In the description of the present utility model, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present utility model and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present utility model. In addition, the terms "first", "second", "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance. In addition, the technical features involved in different embodiments of the present utility model described below can be combined with each other as long as they do not conflict with each other.

[0046] In this embodiment, for the convenience of description, the end close to the operator is set as the proximal end, and the end far from the operator is set as the distal end.

[0047] Embodiment

[0048] This embodiment provides a head-end pre-bent micro-guide wire assembly, as Figures 1 to 6 shown, which includes a micro-guide wire and an introducer 5. The micro-guide wire includes a core wire 1, a spring 2, a safety net 3, and an introducer 5.

[0049] As Figures 1 to 3 shown, the spring 2 is sleeved on the distal surface of the core wire 1 and fixed to the core wire 1. The safety net 3 is sleeved on the distal surface of the core wire 1. The safety net 3 is arranged inside the spring 2 and fixed to the core wire 1 and the spring 2.

[0050] Specifically, in this embodiment, the diameter of the core wire 1 gradually decreases from the proximal end to the distal end. The distal part of the core wire 1 can be conical, parabolic, streamlined or any other structure, so that the distal end of the core wire 1 has good flexibility. The material for preparing the core wire 1 should have excellent durability, torsional controllability, tracking performance, etc., and provide good supporting force and pushing force for the micro-guide wire. The surface of the core wire 1 should be smooth and clean, without defects harmful to patients such as scars, cracks, scratches, etc. The core wire 1 is made of any one or more materials of Ni-Ti alloy, stainless steel, cobalt-based alloy, Fe-Mn alloy, Cu-Zn alloy, Fe-Ni alloy. Of course, other suitable materials for preparing the core wire 1 can also be used. Preferably, the distal end of the core wire 1 uses a high-elastic Ni-Ti alloy, and the proximal end uses high-strength stainless steel. The distal end and the proximal end are welded by dissimilar metal butt welding technology. The core wire 1 can be made by using physical grinding or chemical etching and other methods or techniques, and physical grinding method is preferred. When the distal end of the core wire 1 is a Ni-Ti alloy, the head-end double-bend shape can be formed by controlling the heat treatment temperature. For example, the heat treatment temperature is controlled at 400-750 °C and heat treatment is carried out for a specified time, so as to obtain the double-bend shape at the distal end of the core wire 1 and the distal softness.

[0051] In this embodiment, the spring 2 covers the distal part surface of the core wire 1 and the entire safety net 3. The material of the spring 2 can be stainless steel wire, pre-coated PTFE-coated stainless steel wire, platinum-tungsten or platinum-nickel wire. Of course, other appropriate materials can also be used. In this embodiment of Figure 1Among them, preferably, the material of the spring 2 is platinum-tungsten alloy and stainless steel. The spring 2 is coaxially connected to the safety net 3 and the core wire 1, and the connection method is brazing, and the welding temperature is 200°C - 500°C. The spring 2 is wound by a spring machine. Preferably, the wire diameter of the winding is 0.001 - 0.01", the rotation speed of the spring machine is about 1 - 30 n / s, the pitch is 0.025 - 0.25 mm, and the total length of the spring 2 is 1 - 400 cm. Optionally, in order to optimize the use effect of the micro-guide wire, in one embodiment, the surface of the spring 2 is provided with a PTFE coating or a second hydrophilic coating or a silicone oil coating. Specifically, the coating provided on the spring 2 extends from the proximal end to the distal end of the spring 2, thereby further reducing the pushing resistance of the micro-guide wire.

[0052] In this embodiment, the safety net 3 is sleeved on the distal end of the core wire 1 and connected thereto. Preferably, the safety net 3 is made of metal wire braiding or metal tube cutting, and can be braided into a safety net 3 with different mesh densities (PPI) or different wire sizes according to the different softness and hardness requirements of the distal end of the core wire 1. When a harder distal end of the core wire 1 is required, the number of braiding heads and the cross-sectional size of the metal wire of the safety net 3 can be increased. The number of metal wire heads of the safety net 3 is preferably 6 - 20, the diameter of the round metal wire is 0.0005 - 0.002", and the size of the flat metal wire is 0.0005" * 0.0005" - 0.0005 * 0.002". Preferably, the length range of the safety net 3 is 10 - 50 mm. And, the safety net 3 can be connected to any position at the head end of the core wire 1 according to requirements. In this embodiment Figure 1 of, the distal end of the safety net 3 is welded parallel to the distal ends of the core wire 1 and the spring 2 together. The material, number of heads, size and position of the metal wire of the safety net 3 can be customized according to requirements such as the flexibility, safety and tip shaping ability of the guide wire. The setting of the safety net 3 at the tip of the guide wire increases the cross-sectional area at the tip of the guide wire, improves the breaking force of the guide wire, and at the same time reduces the tip diameter of the core wire 1, so that the core wire 1 maintains good flexibility. In this embodiment, the safety net 3 is braided by at least 4 metal wires, and the diameter of a single metal wire is very small (about 1 / 4 of the diameter of the tip core wire 1) and is in the shape of a hollow cylinder. Radially, the safety net 3 is very flexible. At the same time, since the shape of the safety net 3 is cross-overlapped, it has a high breaking force axially. As Figure 7 shown, therefore the safety net 3 can effectively avoid the danger of the core wire 1 breaking or falling off, and ensure the tip safety. While making the tip of the core wire 1 soft, it has a high breaking force.

[0053] In this embodiment, the distal end of the core wire 1 and the surface of the spring 2 are coated with a hydrophilic coating 4, and the hydrophilic coating 4 is a polyvinylpyrrolidone coating, a polyethylene oxide coating, a transparent acrylate coating, or a polymethyl vinyl ether maleic anhydride coating. The hydrophilic coating 4 makes the surface of the micro-guide wire smoother. It absorbs water molecules to form a gel-like surface on the micro-guide wire, reducing the passing resistance of the micro-guide wire, so that the micro-guide wire has good lubricity and tracking performance, reducing the passing resistance of the micro-guide wire in the blood vessel, making the micro-guide wire easy to push, and improving its passing ability.

[0054] In this embodiment, as Figure 6 shown, the distal end of the core wire 1 is provided with a first bending portion 7, and the first bending portion 7 is in a J shape. Currently, the distal end of the micro-guide wire is often straight. During the advancement of the micro-guide wire, the distal end of the micro-guide wire will pierce the blood vessel wall, causing damage to the blood vessel wall. In this embodiment, the design of the first bending portion 7 at the distal end can enable the micro-guide wire to advance safely in the blood vessel, avoiding direct contact between the distal end of the micro-guide wire and the blood vessel wall and causing damage to the blood vessel wall. Due to the existence of the first bending portion 7, there is no need to worry about the distal end of the micro-guide wire directly piercing the blood vessel wall and causing blood vessel damage, allowing the operator to perform blind insertion of the guide wire (pushing the micro-guide wire directly without imaging) during the interventional operation, reducing the time of angiography and the exposure time of the patient and the operator to radiation.

[0055] Among them, as Figure 6 shown, the diameter D of the first bending portion 7 is 1.5 - 5 mm. In this embodiment, it is preferably 1.5 mm, 3 mm, or 5 mm. Among them, the 1.5 mm J-shaped micro-guide wire can be deeply inserted into the blood vessel in lesions such as vascular malformations, ensuring that the guide wire advances in a larger blood vessel, effectively avoiding entering small-sized collateral blood vessels, causing blood vessel damage or prolonging the operation time; the 3 mm J-shaped micro-guide wire can smoothly pass through the existing stent in the blood vessel, avoiding the guide wire entering the stent mesh, and facilitating the guide wire to continue to move forward in the blood vessel after passing through the stent; the 5 mm J-shaped micro-guide wire can be used for intravascular stent massage, improving the vascular wall apposition of the stent and achieving a better treatment effect.

[0056] Furthermore, in this embodiment, a second bending portion 8 is provided at the proximal end of the first bending portion 7, and the second bending portion 8 bends towards the first bending portion 7. The bending angle A0 of the second bending portion 8 is 15 - 45 degrees. In this embodiment, it is preferably 15°, 30°, or 45° to adapt to different branch blood vessel angles. The design of the second bending portion 8 can help the operator enter the target blood vessel faster in the branch blood vessel, reduce the operation time, reduce the exposure time of the patient and the operator to radiation, and reduce the damage to the blood vessel wall caused by repeated operations.

[0057] In this embodiment, as Figure 4 and Figure 5As shown, the introducer 5 includes a first flap and a second flap that are hinged to each other. The first flap and the second flap are closed to form the overall introducer 5 with a through-hole. The distal end of the micro-guidewire is inserted through the through-hole, and the first bending portion 7 is located outside the through-hole.

[0058] Due to the J-bend design at the tip, it is inconvenient for the tip of the micro-guidewire to enter the catheter. Accessories such as the introducer 5 are required. The proximal end of the micro-guidewire is inserted through the tip of the introducer 5, and the guidewire is pulled back until the J-bend at the tip is pulled back into the tube body of the introducer 5. At this time, the bend becomes straight, and then the micro-guidewire is pushed into the catheter along the tube body of the introducer 5. Finally, the introducer 5 is withdrawn proximally along the micro-guidewire. The tube body of the introducer 5 is made of stainless steel, and the micro-guidewire passes through the introducer 5 twice. It can be seen that the tube body of the introducer 5 is likely to scratch and damage the coating of the micro-guidewire, and the operation time is relatively long.

[0059] The introducer 5 provided in this embodiment is pre-loaded with a micro-guidewire, which can omit the operation of the operator loading the micro-guidewire and shorten the operation time. After the tip of the guidewire is pushed into the catheter, the introducer 5 is opened and removed to complete the operation of the micro-guidewire entering the catheter. The improved introducer 5 is pre-loaded with a micro-guidewire in the factory. During the operation, after only a small section of the micro-guidewire passes through the introducer 5 and enters the catheter, the introducer 5 can be opened and removed, which can avoid the whole micro-guidewire passing through the introducer 5 twice and increasing the friction and damage of the coating of the guidewire, and shorten the operation time. The introducer 5 in this embodiment is made of high-molecular HDPE soft material, which is different from the conventional stainless steel material introducer 5, and further reduces the probability of the coating being damaged.

[0060] As an implementation manner, as Figure 4 and Figure 5 , a locking structure 6 is provided between the first flap and the second flap to keep the first flap and the second flap in a closed state. Specifically, the locking structure 6 includes a buckle provided on the first flap and a buckle adapter provided on the second flap, or a buckle provided on the second flap and a buckle adapter provided on the first flap.

[0061] In this embodiment, the distal end of the introducer 5 is conical or parabolic.

[0062] In this embodiment, the introducer 5 assists the micro-guidewire with a bent tip to enter the catheter. The usage steps are as follows:

[0063] First, take out the introducer 5 pre-loaded with the micro-guidewire, then pull back the tip of the micro-guidewire into the introducer 5, the tip of the guidewire becomes straight, then push the micro-guidewire into the catheter, then remove the introducer 5, and finally continue to push the guidewire into the catheter.

[0064] The traditional introducer 5 is a closed type. During use, the entire micro-guide wire needs to be inserted into the introducer 5 from the proximal end to the distal end, and then the entire micro-guide wire is pushed from the distal end to the proximal end into the catheter, and the entire micro-guide wire rubs against the introducer 5 twice. In this embodiment, the openable introducer 5 is designed so that during the entire operation process, only the distal segment of the micro-guide wire contacts the inner wall of the introducer 5, greatly reducing the friction distance between the micro-guide wire and the introducer 5, reducing the coating damage situation, and at the same time, the pre-loading method is adopted to further reduce the operation time and difficulty of the operator.

[0065] As an alternative, the head-end bend can be replaced by a cold-setting bending process, the spring 2 welding can be replaced by glue bonding, and the material of the introducer 5 can be replaced by other materials with similar hardness.

[0066] Obviously, the above embodiments are only examples given for clear illustration and are not limitations on the implementation manners. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation manners here. And the obvious changes or modifications derived therefrom are still within the protection scope of the present utility model.

Claims

1. A head-end pre-bent micro-guidewire assembly, comprising a micro-guidewire and an introducer (5), characterized in that: The micro-guidewire includes: A core wire (1) with a first bending portion (7) provided at its distal end; A spring (2) sleeved on the distal surface of the core wire (1) and fixed to the core wire (1); A safety net (3) sleeved on the distal surface of the core wire (1), the safety net (3) being disposed inside the spring (2) and fixed to the core wire (1) and the spring (2); The introducer (5) includes a first flap and a second flap that are hinged to each other. The first flap and the second flap are closed to form an integral introducer with a through-hole. The distal end of the micro-guidewire is inserted through the through-hole and the first bending portion (7) is outside the through-hole.

2. The head-end pre-bent micro-guide wire assembly according to claim 1, characterized in that, A locking structure (6) is provided between the first flap and the second flap to keep the first flap and the second flap in a closed state.

3. The head-end pre-bent micro-guide wire assembly according to claim 2, characterized in that, The locking structure (6) includes a buckle provided on the first flap and a buckle adapter provided on the second flap, or A buckle provided on the second flap and a buckle adapter provided on the first flap.

4. The proximal pre-bent micro-guidewire assembly according to any one of claims 1-3, characterized in that The distal end of the introducer (5) is conical or parabolic.

5. The head-end pre-bent micro-guide wire assembly according to claim 1, wherein The diameter of the first bending portion (7) is 1.5 - 5 mm.

6. The head-end pre-bent micro-guide wire assembly according to claim 5, characterized in that, The diameter of the first bending portion (7) is 1.5 mm, 3 mm or 5 mm.

7. The head-end pre-bent micro-guide wire assembly according to claim 1, wherein A second bending portion (8) is provided at the proximal end of the first bending portion (7), and the second bending portion (8) bends towards the first bending portion (7).

8. The head-end pre-bent micro-guide wire assembly according to claim 7, characterized in that, The bending angle of the second bending portion (8) is 15 - 45 degrees.

9. The head-end pre-bent micro-guide wire assembly according to claim 1, wherein, The distal end of the core wire (1) and the surface of the spring (2) are coated with a hydrophilic coating (4).

10. The head-end pre-bent micro-guide wire assembly according to claim 9, characterized in that, The surface of the spring (2) is provided with a PTFE coating or a second hydrophilic coating or a silicone oil coating.

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