Slowly-closed opening guide wire

Abstract

The invention provides a slow-closing opening guide wire, and relates to the technical field of interventional medical instruments. The opening wire is arranged in the outer sleeve; the guide wire is arranged in the outer sleeve; the twisting control assembly is connected to the near ends of the opening wire and the guide wire and can drive the opening wire and the guide wire to move in the axial direction of the outer sleeve; the opening wire is made of hard alloy, and the hardness of the far end of the opening wire is larger than that of the far end of the guide wire. The opening wire and the guide wire are arranged in the outer sleeve, advancing or retreating of the opening wire and the guide wire is independently controlled through the twisting control assembly, firstly, the hard opening wire is used for opening a blood vessel occlusion position, then the guide wire with the soft far end penetrates through the blood vessel occlusion position, and the passing difficulty of the guide wire is greatly reduced; and after the guide wire passes through, the outer sleeve is pushed forwards, so that the outer sleeve also penetrates through a blood vessel occlusion part, and successful in-place is realized.

Description

Technical Field

[0001] The 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 occlusion may be asymptomatic or have mild symptoms due to the presence of extensive compensatory vessels, and it is difficult to determine the specific time of cerebral vascular occlusion. Therefore, there is currently no strict definition for non-acute intracranial and extracranial large vessel occlusion. In order to distinguish the time window for the treatment of acute intracranial artery occlusion, some studies have called middle cerebral artery occlusion with an onset of more than 24 hours as non-acute middle cerebral artery occlusion, and those with an occlusion time of more than 4 weeks as chronic occlusion. There are many causes of intracranial and extracranial artery occlusion, including atherosclerosis, cardiogenic embolism, vascular dissection, moyamoya disease, and cerebral vasculitis.

[0003] The most common site of intracranial artery occlusion is the anterior circulation, among which the middle cerebral artery occlusion is the most common, and the basilar artery occlusion is the most common in the posterior circulation. Selection of cases for interventional treatment: Non-acute occlusion of intracranial and extracranial arteries, symptoms still fluctuate or worsen after standardized drug treatment, and imaging assessment shows low perfusion in the responsible vascular area, and interventional recanalization can 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 passing, greatly reducing the success rate of vascular recanalization. For intracranial vascular occlusion, some researchers have suggested that intravascular recanalization is feasible for patients with occlusion time ≤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, and the two cannot be achieved at the same time. Therefore, it is difficult for the guidewire of the existing technology to pass smoothly through the occluded area of ​​the intracranial blood vessel.

[0005] Therefore, it is necessary to provide an improved technical solution to address 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 opening guidewire to solve the problems 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 having 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 along the axial direction of the outer sleeve;

[0012] Wherein, the opening wire is made of cemented carbide, 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 arranged 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 is 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 a rotating handle via 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 developing wire is provided at the distal end of the guide wire.

[0022] Beneficial effects:

[0023] (1) The present invention sets a twist control component to independently drive the opening wire and the guide wire located in the outer sleeve. 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, the outer sleeve is pushed forward to allow the outer sleeve to pass through the vascular occlusion and successfully reach the 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 determination and improving the success rate of the operation;

[0025] (3) The present invention provides a twist control assembly which independently controls the opening wire and the guide wire. The rotating handle is held and the connecting head is rotated to allow the connecting head 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 constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper 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 It is a schematic cross-sectional structure diagram of the slow closing and opening guidewire in Examples 2 and 3 of the present invention;

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

[0030] Figure 4 It is a structural schematic diagram 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 It is a right side structural schematic diagram 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] Fig. 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 belong to the scope of protection of the present invention.

[0038] In the description of the present invention, it should be understood that the descriptions involving orientations, such as up, down, front, back, left, right, etc., and the orientations or positional relationships indicated 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, and do not indicate or imply that the guidewire or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0039] In the description of the present invention, "several" means one or more, "more" means more than two, "greater than", "less than", "exceed" etc. are understood as not including the number itself, and "above", "below", "within" etc. are understood as including the number itself. If there is a description of "first" or "second", it is only used for the purpose of distinguishing the technical features, and cannot be understood as indicating or implying the relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features.

[0040] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, the 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 stipulated 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 connection between two elements, indirect connection, 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 guidewire 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 guidewire 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 the state in which the "branch conduits" are attached to each other within a partial length range or within the entire length range.

[0044] In the description of the present invention, "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, the "proximal end" refers to the end close to the operator during surgery, and the "distal end" refers to the end far away from the operator during surgery.

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

[0047] The present invention aims at the prior art, which requires the use of guide wires to have proximal support and distal flexibility. The distal end of such guide wires is not hard enough, and it is difficult for the guide wire to pass smoothly through the vascular occlusion. If the distal end of the guide wire is hardened, there will be a risk of the guide wire puncturing the blood vessel. The two cannot be achieved at the same time, so it is difficult for the guide wire to pass through the intracranial vascular occlusion area.

[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 effect on the intravascular environment. The outer sleeve 1 is cut in a dense distal end and sparse 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 penetrate 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, and the opening wire 2 is in a coiled spring shape. 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 arranged in the outer sleeve 1; the guide wire 3 is preferably made of nickel-titanium alloy wire, and the guide wire 3 also passes 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 twist control assembly 4 is respectively connected to the proximal end of the opening wire 2 and the guide wire 3, and is used to independently drive the opening wire 2 or the guide wire 3 to move along the axial direction of the outer sleeve 1; the twist control assembly 4 has two groups, one group is welded, bonded or hot-melted with the opening wire 2, and the other group is welded, bonded or hot-melted with the guide wire 3, and each group of twist control assembly 4 controls the opening wire 2 or the guide wire 3 separately. Specifically, the twist control assembly 4 includes a connector 41 with a thread groove at the proximal end and a rotating handle 42 with an external thread at the distal end, and the rotating handle 42 is connected to the connector 41 by a thread. The distal end of the connector 41 is welded to the opening wire 2 or the guide wire 3; in a preferred embodiment, the connection method of the connector 41 and the opening wire 2 or the guide wire 3 is a hot-melt connection. When in use, hold the rotating handle 42, 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 or the guide wire 3 to move along the axial direction of the outer sleeve 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 rotates relative to the outer sleeve 1, and also moves axially with the connector 41. By providing the twist control assembly 4, the position of the opening wire 2 or the guide wire 3 can be adjusted separately and conveniently 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 the hardness 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, and can ensure a certain puncture performance.

[0053] In another embodiment of the present invention, the opening wire 2 is a cobalt-chromium alloy, which has high strength and hardness, strong ability to penetrate the occluded part of the intracranial blood vessels, and can withstand the external force exerted on the instrument during the 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 required to be ground to have stronger penetration ability. Nickel-titanium alloy also has good biocompatibility and causes relatively small immune and inflammatory reactions in the body.

[0055] refer to Figure 8 and Fig. 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, 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 forward and backward and radially rotate along the outer sleeve 1, so that the opening wire 2 can 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 piercing the blood vessel. The connector 41 connected to the guide wire 3 is rotated, and the connector 41 drives the guide wire 3 to move forward and backward axially and rotate radially along the outer sleeve 1. Since the occluded section of the blood vessel has been initially opened, the distal end of the guide wire 3 can easily pass through the occluded section of the blood vessel. Then, the outer sleeve 1 is pushed through the occluded blood vessel to achieve the position of the guide wire.

[0056] By setting the opening wire 2 and the guide wire 3 in the outer sleeve 1, and independently controlling the advancement or retreat of the opening wire 2 and the guide wire 3 through the twist control component 4, the vascular occlusion is first opened with the harder opening wire 2, and then the guide wire 3 with a softer distal end is passed through the vascular occlusion, and 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. The problem of insufficient hardness of the distal end of the guide wire in the prior art and the difficulty of the guide wire passing through the vascular occlusion is overcome. By combining soft and hard guide wires, the problem of difficulty in the guide wire passing through the intracranial vascular occlusion area is overcome.

[0057] refer to Figure 4 and Figure 5 In the preferred embodiment of the present invention, both the opening wire 2 and the guide wire 3 are wound with springs. By setting 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, so as to achieve the purpose of convenient operation.

[0058] In a preferred embodiment of the present invention, the spring spacing of the opening wire 2 gradually increases from the proximal end to the distal end, making the distal end of the opening wire 2 flexible, and the spring spacing of the guide wire 3 is consistent with the opening wire 2. Specifically, the proximal spring spacing of the opening wire 2 and the guide wire 3 is small, the structural strength is high, and the stability is strong. The distal spring spacing of the opening wire 2 and the guide wire 3 gradually increases, making the distal end highly flexible and smooth, so that the distal end can more conveniently 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, and an internal thread groove is provided at the proximal end of the connector 41, 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 the connector 41 and the rotating handle 42 to be threadedly connected, 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 an anti-slip strip 43 is provided on the surface of the connector 41. The anti-slip strip 43 is bonded to the outer peripheral surface of the connector 41, and the anti-slip strip 43 is in a strip shape and is preferably made of rubber material, which is used to increase the contact area between the connector 41 and the palm of the user, thereby increasing the friction force 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. The hardness of the stainless steel material is relatively high, and after the distal end of the opening wire 2 is ground, the hardness is further improved, and the occluded part of the blood vessel can be opened efficiently.

[0063] refer to Figure 5 In a preferred embodiment of the present invention, the guide wire 3 is a nickel-titanium alloy, and the distal end of the guide wire 3 is shaped into an ellipse. 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 ellipse 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 letting the opening wire 2 open the occluded section first is adopted, it is easier for the guide wire 3 to pass through the occluded section that has been opened, and the relatively flexible guide wire 3 can also be easily put in 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, and 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 providing the developing ring 5 at the distal end of the outer sleeve 1, it is judged whether the opening wire 2 is completely retracted into the outer sleeve 1 by observing the relative positions of the first developing wire 21 and the developing ring 5. The first developing wire 21 and the second developing wire 31 are provided to assist in judging 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 at a distance of 20-30 mm from the distal end by winding. The second developing wire 31 is connected to the elliptical part of the guide wire 3 by winding. The distal end of the opening wire 2 protrudes from the first developing wire 21. Since the distal end of the opening wire 2 is thin, it becomes sharper after grinding. Compared with the guide wire with a developing ring at the distal end in the prior art, the opening wire 2 has a stronger opening ability.

[0068] The slow closing and opening guidewire of the present invention is described in detail below through specific embodiments.

[0069] Example 1

[0070] refer to Figure 1 The present embodiment provides a slow closing and opening guidewire, including an outer sleeve 1, which is a tube made of stainless steel material, and a hollow cavity penetrating along its own axial direction is arranged in the middle of the outer sleeve 1. The outer sleeve 1 is processed into two sections by cutting in a far-close and near-sparse manner. Among them, the distal end is a flexible section 11, and the proximal end is a support section 12. The cutting gap of the support section 12 is larger, and the cutting gap of the flexible section 11 is smaller.

[0071] The outer diameter of the outer sleeve 1 gradually decreases from the proximal end to the distal end. It can 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 outer diameter of the flexible section 11 is small and the flexibility is high. The outer diameter of the support section 12 is large, the hardness is large, and the support is strong.

[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 Fig. 9 The outer sleeve 1 is provided with an opening wire 2 and a guide wire 3 passing through the hollow inner cavity. Both the opening wire 2 and the guide wire 3 are 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 a high hardness and can improve the penetration ability of the opening wire 2 into the occluded part of the blood vessel. 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 developing wire 21 near the distal position, and the distal distance between the first developing wire 21 and the opening wire 2 is 20-30mm (e.g., 20mm, 22mm, 23.5mm, 25mm, 26.5mm, 28mm, 30mm). In a specific embodiment, the distal distance between the first developing wire 21 and the opening wire 2 is 20mm. In another embodiment of the present application, the distal distance between the first developing wire 21 and the opening wire 2 is 30mm. The first developing wire 21 is wound around the opening wire 2 in a self-encircling manner. During surgery, the position of the first developing wire 21 can be easily observed by the developing 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 and stabbing the blood vessel wall. Compared with the guide wire of the prior art, the distal end of the opening wire 2 protrudes the first developing wire 21, and the distal end of the opening wire 2 is sharper, and the puncture ability is stronger when contacting the vascular occlusion, and has a stronger opening ability.

[0078] The guide wire 3 is made of nickel-titanium, and the distal end of the guide wire 3 is shaped into an ellipse, which is more flexible and 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 an 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 Fig. 9 When in use, the opening wire 2 is rotated at the proximal end and pushed toward the distal end, so that the opening wire 2 moves forward axially along the outer sleeve 1, while the guide wire 3 remains in place. The distal end of the opening wire 2 is sharper, and the opening wire 2 is allowed to open the occluded blood vessel by rotating and pushing in the process of rotating forward. After the opening wire 2 opens the occluded blood vessel, it rotates in the opposite direction and pulls 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. The guide wire 3 is rotated at the proximal end and pushed toward the distal end, so that the guide wire 3 moves forward axially 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, the outer sleeve 1 is pushed toward the distal end, so that the outer sleeve 1 also passes through the occluded blood vessel, so that the guide wire is in place.

[0082] By setting the outer sleeve 1, the opening wire 2 and the guide wire 3, the opening wire 2 and the guide wire 3 can be manually and independently controlled to advance or retreat. First, the harder opening wire 2 is used to open the occluded part of the blood vessel to reduce the penetration difficulty of the guide wire 3, and then the guide wire 3 is passed through the blood vessel, overcoming the problem of difficult penetration caused by the flexibility of the distal end of the guide wire 3. Afterwards, the outer sleeve 1 is guided to the distal end through the occluded part of the blood vessel by the guide wire 3 to achieve the position of the guide wire, overcoming the problem of difficulty in passing the guide wire through the occluded area of ​​the 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 the guide wire 3 are respectively installed with a torque control assembly 4. The torque control assembly 4 includes a connector 41 welded to the opening wire 2 and the guide wire 3, and a rotating handle 42 threadedly connected to the connector 41. Specifically, an internal thread groove is axially arranged at the middle of the proximal end of the connector 41, and an external thread is arranged on the outer peripheral surface of the distal end of the rotating handle 42, and the external thread and the internal thread groove are adapted.

[0086] When in use, the rotating handle 42 is held and the connector 41 is rotated 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 twist control assembly 4 includes a T-shaped connector 41, the distal end of which is connected to the opening wire 2 and the guide wire 3 by hot melting. The proximal end of the connector 41 is protruding outward, and an anti-slip strip 43 is bonded to the outer circumferential surface of the connector 41. The anti-slip strip 43 is made of rubber material and can play an anti-slip role, making it convenient for the operator to exert force.

[0091] In summary, the present invention sets a twist control component 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 above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope 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 outer sleeve (1); A guide wire (3) is arranged in the outer sleeve (1); The twist control assembly (4) is respectively connected to the proximal end of the opening wire (2) and the guide wire (3), and is used to independently drive the opening wire (2) or the guide wire (3) to move along the axial direction of 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).

2. A slow closing and opening guidewire according to claim 1, characterized in that: The distal end of the opening wire (2) is ground, and a first developing wire (21) is arranged 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.

3. A slow closing and opening guidewire according to claim 1, characterized in that: The opening wire (2) and the guide wire (3) are both wound with springs as a whole, and 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, and the spring spacing of the guide wire (3) is consistent with that of the opening wire (2).

4. A slow closing and opening guidewire according to claim 1, characterized in that: The torque control assembly (4) comprises a connector (41) connected to the opening wire (2) and the guide wire (3); an internal thread groove is provided at the proximal end of the connector (41); and the connector (41) is threadedly connected to a rotating handle (42) via the internal thread groove.

5. The slow closing and opening guidewire according to claim 1, characterized in that: The opening wire (2) is made of stainless steel.

6. A slow closing and opening guidewire according to claim 1, characterized in that: The guide wire (3) is made of nickel-titanium alloy, and the distal end of the guide wire (3) is shaped into an ellipse.

7. The slow closing and opening guidewire according to claim 1, characterized in that: 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).

8. A slow closing and opening guidewire according to claim 7, characterized in that: The flexible section (11) is made by densely cutting a tube, the support section (12) is cut by 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).

9. A slow closing and opening guidewire according to any one of claims 1 to 8, characterized in that: A developing ring (5) is provided at the distal end of the outer sleeve (1).

10. A slow closing and opening guidewire according to any one of claims 1 to 8, characterized in that: A second developing wire (31) is arranged at the distal end of the guide wire (3).

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