A slow closing and opening guidewire

Abstract

The present invention provides a slow-closing opening guidewire, which relates to the technical field of interventional medical devices, comprising an outer sleeve with a hollow cavity; an opening wire, which is arranged in the outer sleeve; a guide wire, which is arranged in the outer sleeve; a twist control assembly, which is respectively connected to the proximal ends of the opening wire and the guide wire, and can respectively drive the opening wire and the guide wire to move along the axial direction of the outer sleeve; wherein the opening wire is made of hard alloy, and the hardness of the distal end of the opening wire is greater than that of the distal end of the guide wire. The present invention arranges the opening wire and the guide wire in the outer sleeve, and independently controls the advancement or retreat of the opening wire and the guide wire through the twist control assembly. First, the harder opening wire is used to open the vascular occlusion, and then the guide wire with a softer distal end is passed through the vascular occlusion, which greatly reduces the difficulty of the guide wire passing. After the guide wire passes through, the outer sleeve is pushed forward to allow the outer sleeve to also pass through the vascular occlusion, and successfully reach the position.

Description

Technical Field

[0001] The present invention belongs to the technical field of interventional medical devices, and in particular relates to a slow-closing and opening guidewire. Background Art

[0002] Most patients with intracranial and extracranial large artery occlusions may be asymptomatic or have mild symptoms due to the presence of extensive compensatory vessels, making it difficult to determine the exact onset of cerebral vascular occlusion. Therefore, there is currently no strict definition of non-acute intracranial and extracranial large vessel occlusion. To distinguish the time window for treatment of acute intracranial arterial occlusion, some studies define middle cerebral artery occlusions lasting more than 24 hours as non-acute middle cerebral artery occlusion, while those lasting more than four weeks are termed chronic occlusion. There are numerous causes of intracranial and extracranial arterial occlusion, including atherosclerosis, cardioembolism, vascular dissection, moyamoya disease, and cerebral vasculitis.

[0003] The most common site of intracranial arterial occlusion is the anterior circulation, with the middle cerebral artery being the most common, and the basilar artery being the most common in the posterior circulation. Selection of cases for interventional treatment: For non-acute occlusion of intracranial and extracranial arteries, if symptoms fluctuate or worsen despite standard drug treatment, and imaging assessment shows hypoperfusion in the responsible vascular area, interventional recanalization may be considered. Timing and success rate assessment of intravascular recanalization: As the occlusion time increases, the thrombus becomes fibrotic and forms calcified plaques, which increases the difficulty of microguidewire passage and greatly reduces the success rate of vascular recanalization. For intracranial vascular occlusion, some researchers have suggested that intravascular recanalization is feasible for patients with an occlusion time of ≤3 months.

[0004] In the existing technology, the biggest challenge of intravascular opening is whether the guidewire can pass through the occluded segment smoothly. The guidewire is a common interventional medical device. When used, the guidewire is first inserted into the lesion site in the blood vessel to guide the entry of subsequent surgical instruments. The use requirements of the guidewire are proximal support and distal flexibility. The distal hardness of this guidewire is insufficient, and it is difficult for the guidewire to pass smoothly through the vascular occlusion. If the distal end of the guidewire is hardened, there will be a risk of the guidewire puncturing the blood vessel. You cannot have both. Therefore, it is difficult for the existing guidewire to pass smoothly through the intracranial vascular occlusion area.

[0005] Therefore, it is necessary to provide an improved technical solution to the above-mentioned deficiencies in the prior art. Summary of the Invention

[0006] The purpose of the present invention is to provide a slow-closing and recanalizing guidewire to solve the problem that the distal end hardness of the existing guidewire is insufficient, the guidewire is difficult to pass through the vascular occlusion smoothly, and the guidewire is difficult to pass through the intracranial vascular occlusion area.

[0007] In order to achieve the above object, the present invention provides the following technical solutions:

[0008] A slow closing and opening guidewire comprises an outer sleeve with a hollow cavity;

[0009] An opening wire is arranged in the outer sleeve;

[0010] A guide wire is arranged in the outer sleeve;

[0011] The torque control assembly is connected to the proximal end of the opening wire and the guide wire respectively, and is used to independently drive the opening wire or the guide wire to move axially along the outer sleeve;

[0012] Wherein, the opening wire is made of hard alloy, and the hardness of the distal end of the opening wire is greater than the hardness of the distal end of the guide wire.

[0013] Preferably, the distal end of the opening wire is ground, and a first developing wire is provided near the distal end of the opening wire, and the distance between the first developing wire and the distal end of the opening wire is 20-30 mm.

[0014] Preferably, both the opening wire and the guide wire are wound with springs as a whole, and the spring spacing of the opening wire gradually increases from the proximal end to the distal end, so that the distal end of the opening wire is flexible, and the spring spacing of the guide wire remains consistent with that of the opening wire.

[0015] Preferably, the torque control assembly includes a connector connected to the opening wire and the guide wire, the proximal end of the connector is provided with an internal thread groove, and the connector is threadedly connected to the rotating handle through the internal thread groove.

[0016] Preferably, the opening wire is made of stainless steel.

[0017] Preferably, the guide wire is made of nickel-titanium alloy, and the distal end of the guide wire is shaped into an ellipse.

[0018] Preferably, the outer diameter of the outer sleeve gradually decreases from the proximal end to the distal end, the distal end of the outer sleeve is a flexible section, and the proximal end is a supporting section.

[0019] Preferably, the compliant section is made of a tube through dense cutting, and the supporting section is cut from a tube with a uniform outer diameter, and the cutting gap of the supporting section is larger than the cutting gap of the compliant section.

[0020] Preferably, a developing ring is provided at the distal end of the outer sleeve.

[0021] Preferably, a second imaging wire is provided at the distal end of the guide wire.

[0022] Beneficial effects:

[0023] (1) The present invention provides a torque control assembly to independently drive the opening wire and the guide wire located in the outer cannula. First, the harder opening wire is used to open the vascular occlusion, and then the softer guide wire at the distal end is passed through the vascular occlusion. The difficulty of passing the guide wire is greatly reduced. After the guide wire passes through, the outer cannula is pushed forward to allow the outer cannula to pass through the vascular occlusion and successfully reach its position, thus overcoming the difficulty of the guide wire passing through the intracranial vascular occlusion area.

[0024] (2) The present invention provides a developing ring, a first developing wire, and a second developing wire to determine the positions of the outer tube, the opening wire, and the guide wire, thereby facilitating the operator's judgment and improving the success rate of the operation.

[0025] (3) The present invention provides a twist control assembly that independently controls the opening wire and the guide wire. The rotating handle is held and the connector is rotated to allow the connector to perform axial linear motion and radial rotational motion along the rotating handle, thereby allowing the opening wire and the guide wire to rotate forward or backward, thereby stably achieving control over the opening wire and the guide wire. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The drawings and the accompanying drawings, which constitute part of this application, are intended to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are intended to explain the present invention and do not constitute an undue limitation of the present invention. Among them:

[0027] Figure 1 Schematic diagram of the cross-sectional structure of the slow closing and opening guidewire in Example 1 of the present invention;

[0028] Figure 2 Schematic diagram of the cross-sectional structure of the slow closing and opening guidewire in Examples 2 and 3 of the present invention;

[0029] Figure 3 This is a schematic cross-sectional structural diagram of an outer sleeve in an embodiment of the present invention;

[0030] Figure 4 Schematic diagram of the structure of the opening wire in an embodiment of the present invention;

[0031] Figure 5 Schematic diagram of the structure of the guide wire in an embodiment of the present invention;

[0032] Figure 6 This is a schematic diagram of the main structure of the torque control assembly according to an embodiment of the present invention;

[0033] Figure 7 2 is a schematic diagram of the right side structure of the torque control assembly according to an embodiment of the present invention;

[0034] Figure 8 Schematic diagram of the opening wire passing through the occluded area of ​​the blood vessel;

[0035] Figure 9 Schematic diagram of the guide wire passing through the vascular occlusion area.

[0036] In the figure: 1. outer sleeve; 11. flexible section; 12. support section; 2. opening wire; 21. first developing wire; 3. guide wire; 31. second developing wire; 4. twist control assembly; 41. connector; 42. rotating handle; 43. anti-slip strip; 5. developing ring. DETAILED DESCRIPTION

[0037] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention are within the scope of protection of the present invention.

[0038] In the description of the present invention, it should be understood that descriptions involving orientations, such as up, down, front, back, left, right, etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the guidewire or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0039] In the description of the present invention, "several" means one or more, "many" means more than two, "greater than," "less than," and "exceed" are understood to exclude the number itself, while "above," "below," and "within" are understood to include the number itself. The use of "first" and "second" in the description is solely for the purpose of distinguishing technical features and should not be construed as indicating or implying relative importance, implicitly specifying the number of the indicated technical features, or implicitly specifying the order of the indicated technical features.

[0040] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be understood to indicate or imply relative importance or to implicitly indicate the quantity of the technical features indicated. Thus, features defined as "first" and "second" may explicitly or implicitly include one or more features.

[0041] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the term "connection" should be understood in a broad sense. For example, it can be a fixed connection or a movable connection, a detachable connection or a non-detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection, or mutual communication; it can be a direct connection, or an indirect connection through an intermediate medium, and it can be internal communication between two elements, indirect communication, or an interactive relationship between two elements.

[0042] In the description of the present invention, "before use" refers to the state in which the slow closing and opening guide wire has not been used, has not entered the human body, or has not come into contact with body fluids such as blood, tissue fluid, etc. in the human body; and "during use" refers to the state in which the slow closing and opening guide wire has entered the human body or has come into contact with body fluids such as blood, tissue fluid, etc. in the human body.

[0043] In the description of the present invention, the "gathered state" refers to a state in which the "branch conduits" are attached to each other within a partial length range or the entire length range.

[0044] In the description of the present invention, the "in vivo environment" refers to the environment below the epidermis of the skin where body fluids exist, such as the dermis and subcutaneous tissue, or the inside of blood vessels and organs.

[0045] In the description of the present invention, "proximal end" refers to the end close to the operator during surgery, and "distal end" refers to the end far away from the operator during surgery.

[0046] The present invention will be described in detail below with reference to the embodiments. It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments can be combined with each other.

[0047] The present invention addresses existing guidewire technology, which requires proximal support and distal flexibility. However, the distal end of such guidewires is insufficiently stiff, making it difficult for the guidewire to pass smoothly through vascular occlusions. Furthermore, stiffening the distal end of the guidewire increases the risk of puncturing the vessel. This compromise between the two makes it difficult for the guidewire to pass through intracranial vascular occlusions.

[0048] The present invention discloses a slow closing and opening guide wire, referring to Figure 2 and Figure 3 , including an outer sleeve 1 with a hollow cavity; the outer sleeve 1 is made of stainless steel, has a certain hardness, and is not easy to break. In a preferred embodiment, the outer sleeve 1 is made of stainless steel as the core material, and the outer layer is coated with PTFE. The PTFE coating has good chemical stability and has little impact on the environment inside the blood vessel. The outer sleeve 1 is cut in a dense manner at the distal end and sparse at the proximal end, so that the distal end has good flexibility and reduces the possibility of puncturing the blood vessel. Preferably, the hollow cavity of the outer sleeve 1 is set to pass through along its own axial direction.

[0049] refer to Figure 2 、 Figure 3 and Figure 4 The opening wire 2 is arranged in the outer sleeve 1; the opening wire 2 is forward along the hollow cavity and passes through the hollow cavity. The opening wire 2 is in the shape of a spring. The opening wire 2 is used to first pass through the occluded part of the intracranial artery.

[0050] refer to Figure 2 、 Figure 3 and Figure 5The guide wire 3 is preferably made of nickel-titanium alloy and is also passed through the hollow cavity. The shape of the guide wire 3 is consistent with that of the opening wire 2.

[0051] refer to Figure 2 、 Figure 6 and Figure 7 The torque control assembly 4 is connected to the proximal ends of the opening wire 2 and the guide wire 3, respectively, and is used to independently drive the opening wire 2 or the guide wire 3 to move axially along the outer tube 1. The torque control assembly 4 comprises two groups: one group is welded, bonded, or hot-melted to the opening wire 2, and the other group is welded, bonded, or hot-melted to the guide wire 3. Each group of torque control assemblies 4 independently controls the opening wire 2 or the guide wire 3. Specifically, the torque control assembly 4 comprises a connector 41 with a threaded groove at its proximal end and a rotating handle 42 with an external thread at its distal end. The rotating handle 42 and the connector 41 are threadedly connected. The distal end of the connector 41 is welded to the opening wire 2 or the guide wire 3. In a preferred embodiment, the connector 41 is connected to the opening wire 2 or the guide wire 3 by hot-melt. During use, the rotating handle 42 is grasped and rotated. The connector 41 rotates along the external thread and moves forward along the axial direction of the rotating handle 42, thereby driving the opening wire 2 or the guide wire 3 to move axially along the outer tube 1. It should be noted that the opening wire 2 or the guide wire 3 rotates with the rotation of the rotating handle 42, radially rotating relative to the outer sleeve 1, and also axially moving with the connector 41. By providing the torque control component 4, the position of the opening wire 2 or the guide wire 3 can be adjusted easily and quickly.

[0052] The opening wire 2 is made of hard alloy, and the hardness of the distal end of the opening wire 2 is greater than that of the distal end of the guide wire 3. In a preferred embodiment, the opening wire 2 is cut from stainless steel. Stainless steel has strong hardness and corrosion resistance, which can ensure a certain degree of punctureability.

[0053] In another embodiment of the present invention, the opening wire 2 is made of cobalt-chromium alloy, which has high strength and hardness, strong ability to penetrate the occluded parts of intracranial blood vessels, and can withstand the external forces exerted on the instrument during interventional surgery. It will not produce harmful substances due to chemical reactions under the physiological environment of the human body.

[0054] In another embodiment of the present invention, the opening wire 2 is made of nickel-titanium alloy. In this embodiment, the front end of the opening wire 2 is ground to enhance its penetrating ability. Nickel-titanium alloy also has good biocompatibility and causes relatively little immune and inflammatory response in the body.

[0055] refer to Figure 8 and Figure 9The working principle of the present invention is as follows: After the outer sleeve 1 is close to the occluded part, hold the rotating handle 42 and rotate the connector 41. The connector 41 rotates along the external thread and moves forward along the axial direction of the rotating handle 42, thereby driving the opening wire 2 to move axially along the outer sleeve 1, while the outer sleeve 1 and the guide wire 3 remain in place. The distal end of the opening wire 2 is relatively sharp. At the same time, the connector 41 drives the opening wire 2 to move axially back and forth and radially rotate along the outer sleeve 1, allowing the opening wire 2 to open the occluded blood vessel by rotating and advancing. After the opening wire 2 opens the occluded blood vessel, the opening wire 2 is withdrawn by rotating the connector 41 in the opposite direction. Until the opening wire 2 is completely retracted into the outer sleeve 1. At this time, the opening wire 2 with a relatively hard distal end is located as a whole inside the outer sleeve 1, which can reduce the risk of the opening wire 2 puncturing the blood vessel. Rotating the connector 41 connected to the guide wire 3 causes the guide wire 3 to move axially forward and backward, as well as radially rotate, along the outer sleeve 1. Since the occluded segment of the blood vessel has been initially opened, the distal end of the guide wire 3 can easily pass through the occluded segment. The outer sleeve 1 is then pushed through the occluded vessel to secure the guide wire in place.

[0056] By setting the opening wire 2 and the guide wire 3 in the outer sleeve 1, and independently controlling the forward or backward movement of the opening wire 2 and the guide wire 3 through the twist control component 4, the harder opening wire 2 is used to open the vascular occlusion, and then the guide wire 3 with a softer distal end is passed through the vascular occlusion. The difficulty of the guide wire 3 passing through is greatly reduced. After the guide wire 3 passes through, the outer sleeve 1 is pushed forward to allow the outer sleeve 1 to pass through the vascular occlusion and achieve successful placement. This overcomes the problem in the prior art that the distal end hardness of the guide wire is insufficient and the guide wire is difficult to pass through the vascular occlusion smoothly. By combining soft and hard guide wires, the problem of the difficulty of the guide wire passing through the intracranial vascular occlusion area is overcome.

[0057] refer to Figure 4 and Figure 5 In a preferred embodiment of the present invention, both the opening wire 2 and the guide wire 3 are wound with springs. By configuring the opening wire 2 and the guide wire 3 to be wound with springs, the forward and backward movement of the opening wire 2 and the guide wire 3 can be controlled by rotating the twist control assembly 4, thereby achieving the purpose of convenient operation.

[0058] In a preferred embodiment of the present invention, the spring spacing of the cannula filament 2 gradually increases from the proximal end to the distal end, making the distal end of the cannula filament 2 flexible and maintaining the same spring spacing as the guide wire 3. Specifically, the proximal spring spacing of the cannula filament 2 and the guide wire 3 is small, resulting in high structural strength and stability. The distal spring spacing of the cannula filament 2 and the guide wire 3 gradually increases, making the distal end more flexible and smoother, allowing the distal end to more easily pass through the vascular occlusion.

[0059] refer to Figure 2 、 Figure 6 and Figure 7In a preferred embodiment of the present invention, the torque control assembly 4 includes a connector 41 connected to the opening wire 2 and the guide wire 3. The proximal end of the connector 41 is provided with an internal thread groove, and the connector 41 is threadedly connected to a rotating handle 42 through the internal thread groove. The connector 41 and the opening wire 2 and the guide wire 3 can be fixed by welding or hot-melt connection. The surface of the rotating handle 42 is integrally formed with an external thread, and the external thread is adapted to the internal thread groove. By setting a threaded connection between the connector 41 and the rotating handle 42, the rotating connector 41 can achieve axial and radial movement, allowing the connector 41 to drive the opening wire 2 and the guide wire 3 to achieve axial and radial movement.

[0060] In another embodiment of the present application, a claw-shaped connection groove is provided at the distal end of the connector 41 , and the through wire and the guide wire 3 are inserted into the connection groove and fixed together with the connector 41 by friction.

[0061] Furthermore, the cross-section of the connector 41 along its own axis is T-shaped, and the surface of the connector 41 is provided with an anti-slip strip 43. The anti-slip strip 43 is bonded to the outer peripheral surface of the connector 41. The anti-slip strip 43 is in the shape of a strip and is preferably made of a rubber material. It is used to increase the contact area between the connector 41 and the user's palm, thereby increasing friction and achieving an anti-slip effect.

[0062] refer to Figure 4 In a preferred embodiment of the present invention, the opening wire 2 is made of stainless steel, and the distal end of the opening wire 2 is ground. Stainless steel has a high hardness, and grinding further increases the hardness of the opening wire 2, allowing for efficient opening of vascular occlusions.

[0063] refer to Figure 5 In a preferred embodiment of the present invention, the guide wire 3 is made of nickel-titanium alloy, and the distal end of the guide wire 3 is shaped into an elliptical shape. The guide wire 3 made of nickel-titanium alloy has good biocompatibility and reduces the impact on the in vivo environment. The distal end of the guide wire 3 is set to an elliptical shape to reduce the sharpness of the distal end of the guide wire 3 and reduce damage to the blood vessel wall. Since the solution of allowing the opening wire 2 to open the occluded section first is adopted, the guide wire 3 can pass through the occluded section that has been opened more easily, and the relatively flexible guide wire 3 can also be easily put into place.

[0064] refer to Figure 2 In a preferred embodiment of the present invention, the outer diameter of the outer sleeve 1 gradually decreases from the proximal end to the distal end, the distal end of the outer sleeve 1 is a flexible section 11, and the proximal end is a supporting section 12.

[0065] In a preferred embodiment of the present invention, the flexible section 11 is made of a tube through dense cutting, and the support section 12 is cut from a tube with a uniform outer diameter. The cutting gap of the support section 12 is larger than the cutting gap of the flexible section 11.

[0066] In a preferred embodiment of the present invention, a developing ring 5 is provided at the distal end of the outer sleeve 1. The developing ring 5 is a ring wound around the distal end of the outer sleeve 1. The developing ring 5 may be made of a platinum-iridium alloy. The position of the developing ring 5 can be easily seen during surgery, thereby assisting in determining the specific position of the outer sleeve 1.

[0067] In a preferred embodiment of the present invention, a first developing wire 21 is provided at the distal end of the opening wire 2, and a second developing wire 31 is provided at the distal end of the guide wire 3. By providing the first developing wire 21 at the distal end of the opening wire 2 and a developing ring 5 at the distal end of the outer sleeve 1, the relative positions of the first developing wire 21 and the developing ring 5 can be observed to determine whether the opening wire 2 is fully retracted into the outer sleeve 1. The first developing wire 21 and the second developing wire 31 are provided to assist in determining the positions of the opening wire 2 and the guide wire 3. Preferably, the first developing wire 21 and the second developing wire 31 are platinum-iridium alloy wires. The first developing wire 21 is connected to the opening wire 2 20-30 mm from the distal end by a winding method. The second developing wire 31 is connected to the elliptical portion of the guide wire 3 by a winding method. The distal end of the opening wire 2 protrudes beyond the first developing wire 21. Because the distal end of the opening wire 2 is thin and sharpened after grinding, the opening wire 2 has a stronger opening capability than conventional guide wires with developing rings at the distal end.

[0068] The following describes in detail a slow closing and opening guidewire of the present invention through specific embodiments.

[0069] Example 1

[0070] refer to Figure 1 This embodiment provides a slow-closing and recanalizing guidewire comprising an outer sleeve 1. The outer sleeve 1 is made of stainless steel and has a hollow cavity extending axially through the middle of the outer sleeve 1. The outer sleeve 1 is cut into two sections using a denser cutting pattern. The distal end is a compliant section 11, and the proximal end is a support section 12. The support section 12 has a larger cutting gap, while the compliant section 11 has a smaller cutting gap.

[0071] The outer diameter of the outer sleeve 1 gradually decreases from the proximal end to the distal end. It should be understood that the outer diameter refers to the distance from the outer circumference of the outer sleeve 1 to the central axis. The diameter of the hollow cavity remains unchanged, so the wall thickness of the outer sleeve 1 gradually decreases. The compliant section 11 has a smaller outer diameter and higher compliance. The support section 12 has a larger outer diameter, greater rigidity, and stronger support.

[0072] The distal end of the outer sleeve 1 is connected to a developing ring 5 by laser welding. The developing ring 5 is ring-shaped and is preferably made of platinum-iridium alloy. During surgery, the position of the developing ring 5 can be clearly observed through the developing equipment, thereby assisting in determining the position of the outer sleeve 1.

[0073] refer to Figure 3 、 Figure 4 、 Figure 5、 Figure 8 and Figure 9 The outer sleeve 1 is provided with an opening wire 2 and a guide wire 3 passing through the hollow inner cavity. The opening wire 2 and the guide wire 3 are both spring-wound, and the spring spacing gradually increases from the proximal end to the distal end, so that the proximal end structure of the opening wire 2 and the guide wire 3 has high strength and strong stability, and the distal end of the opening wire 2 and the guide wire 3 has better flexibility.

[0074] The opening wire 2 is made of stainless steel, which has high hardness and can improve the penetration ability of the opening wire 2 into the vascular occlusion. In addition, stainless steel has good corrosion resistance and can adapt to the environment inside the blood vessel.

[0075] In other embodiments of the present application, the opening wire 2 is made of cobalt-chromium alloy, which has high strength and hardness, strong ability to penetrate the occluded parts of intracranial blood vessels, and can withstand the external forces exerted on the instrument during interventional surgery.

[0076] The distal end of the opening wire 2 is ground to increase the hardness of the distal end of the opening wire 2 .

[0077] The opening wire 2 is provided with a first imaging wire 21 near the distal position, and the distal distance between the first imaging wire 21 and the opening wire 2 is 20-30mm (for example, 20mm, 22mm, 23.5mm, 25mm, 26.5mm, 28mm, 30mm). In a specific embodiment, the distal distance between the first imaging wire 21 and the opening wire 2 is 20mm. In another embodiment of the present application, the distal distance between the first imaging wire 21 and the opening wire 2 is 30mm. The first imaging wire 21 is wound around the opening wire 2 in a self-encircling manner. During surgery, the position of the first imaging wire 21 can be easily observed by the imaging device, thereby facilitating the operator to judge the position of the distal end of the opening wire 2 and reducing the probability of the distal end of the opening wire 2 going off track and injuring the blood vessel wall. Compared with the guide wire of the prior art, the distal end of the opening wire 2 protrudes from the first imaging wire 21, and the distal end of the opening wire 2 is relatively sharp, and has a stronger puncture ability when contacting the vascular occlusion, and has a stronger opening ability.

[0078] The guide wire 3 is made of nickel-titanium. The distal end of the guide wire 3 is shaped into an ellipse. The ellipse-shaped distal end is more flexible, which reduces damage to the blood vessel during the penetration process.

[0079] Preferably, a second developing wire 31 is wound around the distal end of the guide wire 3 , and the position of the second developing wire 31 can be easily observed through a developing device, thereby facilitating the operator to determine the position of the distal end of the opening wire 2 .

[0080] Preferably, the first developing wire 21 and the second developing wire 31 are both made of platinum-iridium alloy, which can display a bright area different from the surrounding tissue on the developing device, thereby facilitating the operator to determine the specific positions of the opening wire 2 and the guide wire 3.

[0081] refer to Figure 1 、 Figure 8 and Figure 9 When in use, rotate the opening wire 2 at the proximal end and push the opening wire 2 toward the distal end, so that the opening wire 2 moves axially forward along the outer sleeve 1, while the guide wire 3 remains in place. The distal end of the opening wire 2 is relatively sharp, and during the forward rotation process, the opening wire 2 is allowed to open the occluded blood vessel in a rotational and forward manner. After the opening wire 2 opens the occluded blood vessel, rotate it in the opposite direction and pull the opening wire 2 toward the proximal end until the distal end of the opening wire 2 enters the outer sleeve 1. The auxiliary judgment method is that the first developing wire 21 is located at the rear end of the developing ring 5. Rotate the guide wire 3 at the proximal end and push the guide wire 3 toward the distal end, so that the guide wire 3 moves axially forward along the outer sleeve 1, while the opening wire 2 remains in place. Because the opening wire 2 has preliminarily opened the occluded blood vessel, it is easier for the guide wire 3 to pass through the occluded part of the blood vessel. Then, push the outer sleeve 1 toward the distal end so that the outer sleeve 1 also passes through the occluded blood vessel, thereby achieving the position of the guide wire.

[0082] By providing an overtube 1, a cannulation wire 2, and a guide wire 3, the advancement or retraction of the cannulation wire 2 and guide wire 3 can be manually and independently controlled. First, the harder cannulation wire 2 is used to open the occluded blood vessel, reducing the penetration difficulty of the guide wire 3. The guide wire 3 is then passed through the blood vessel, overcoming the difficulty of penetration caused by the flexible distal end of the guide wire 3. The overtube 1 is then guided distally through the occluded blood vessel using the guide wire 3, securing the guide wire in place and overcoming the difficulty of the guide wire passing through the occluded intracranial blood vessel.

[0083] Example 2

[0084] refer to Figure 2 、 Figure 6 and Figure 7 The difference between this embodiment and embodiment 1 lies in the driving method of the opening wire 2 and the guide wire 3.

[0085] The proximal ends of the opening wire 2 and guide wire 3 are each mounted with a torque control assembly 4. This assembly comprises a connector 41 welded to the opening wire 2 and guide wire 3, and a rotating handle 42 threadedly connected to the connector 41. Specifically, an internal thread groove is axially provided in the middle of the proximal end of the connector 41, and an external thread is provided on the distal outer circumference of the rotating handle 42, which mates with the internal thread groove.

[0086] When in use, the user holds the rotating handle 42 and rotates the connector 41 to allow the opening wire 2 and the guide wire 3 to move axially and rotate radially, and the driving method is more stable and reliable.

[0087] In another embodiment of the present application, the twist control assembly 4 is a Luer adapter. The opening wire 2 and the guide wire 3 are driven by rotating the twist control assembly 4 .

[0088] Example 3

[0089] refer to Figure 2 、 Figure 6 and Figure 7 The difference between this embodiment and embodiment 2 lies in the torque control component 4.

[0090] The torque control assembly 4 includes a T-shaped connector 41, the distal end of which is hot-melt-connected to the opening wire 2 and the guide wire 3. The proximal end of the connector 41 protrudes outward, and a rubber anti-slip strip 43 is bonded to the outer circumference of the connector 41. The anti-slip strip 43 is made of a rubber material and provides a non-slip effect, facilitating the operator's application of force.

[0091] In summary, the present invention provides a twist control assembly 4 to independently drive the opening wire 2 and the guide wire 3 located in the outer sleeve 1. First, the harder opening wire 2 is used to open the vascular occlusion, and then the softer guide wire 3 at the distal end is passed through the vascular occlusion. The difficulty of passing the guide wire 3 is greatly reduced. After the guide wire 3 passes, the outer sleeve 1 is pushed forward to allow the outer sleeve 1 to pass through the vascular occlusion and achieve successful positioning.

[0092] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the present invention.

Claims

1. A slow closing and opening guidewire, characterized in that: It comprises an outer sleeve (1) having a hollow cavity; An opening wire (2) is arranged in the hollow cavity of the outer sleeve (1); A guide wire (3) is arranged in the hollow cavity of the outer sleeve (1); The twist control assembly (4) is connected to the proximal ends of the opening wire (2) and the guide wire (3), respectively, and is used to independently drive the opening wire (2) or the guide wire (3) to move axially along the outer sleeve (1); Wherein, the opening wire (2) is made of hard alloy, and the hardness of the distal end of the opening wire (2) is greater than the hardness of the distal end of the guide wire (3); The opening wire (2) and the guide wire (3) are both wound with springs. The spring spacing of the opening wire (2) gradually increases from the proximal end to the distal end, so that the distal end of the opening wire (2) is flexible. The spring spacing of the guide wire (3) is consistent with that of the opening wire (2). The twist control assembly (4) includes a connector (41) connected to the opening wire (2) and the guide wire (3), the proximal end of the connector (41) is provided with an internal thread groove, and the connector (41) is threadedly connected to a rotating handle (42) through the internal thread groove; The distal end of the opening wire (2) is ground, and a first developing wire (21) is provided near the distal end of the opening wire (2), and the distance between the first developing wire (21) and the distal end of the opening wire (2) is 20-30 mm; The opening wire (2) is made of stainless steel; The guide wire (3) is made of nickel-titanium alloy, and the distal end of the guide wire (3) is shaped into an ellipse; The outer diameter of the outer sleeve (1) gradually decreases from the proximal end to the distal end, the distal end of the outer sleeve (1) is a flexible section (11), and the proximal end is a support section (12); the flexible section (11) is made of a tube through dense cutting, and the support section (12) is cut from a tube with a uniform outer diameter, and the cutting gap of the support section (12) is larger than the cutting gap of the flexible section (11).

2. A slow closing and opening guidewire according to claim 1, characterized in that: A developing ring (5) is provided at the distal end of the outer sleeve (1).

3. The slow closing and opening guidewire according to claim 1, characterized in that: A second developing wire (31) is provided at the distal end of the guide wire (3).

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