Guide wire
By providing auxiliary support made of phase-changeable material at the distal end of the guide wire, the hardness of the guide wire is adjusted by electrical connection, the problem of restriction of passivity in branched blood vessels is solved, and the guide wire is realized in each blood vessel Dynamic adjustment of flexibility and stiffness.
Patent Information
- Application Number
- CN202323235607.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2023-11-29
- Publication Date
- 2024-12-24
- Estimated Expiration
- 2033-11-29
AI Technical Summary
Existing guidewires are restricted in transit vessels, making it difficult to maintain flexibility and torque transmittance.
The wire guide body including a first support section, a second support section and a transition section whose diameter is reduced in sequence, and a sheath and an auxiliary support made of phase-change material are provided at the distal end of the guide wire to change the hardness through electrical connections to Adjust the softness and stiffness of the guide wire.
When needed, increase the hardness of the distal end of the guidewire to avoid entering the branched blood vessels, reduce the hardness to improve flexibility, and enhance the ability of the guidewire to pass through the branched blood vessels.
Smart Images
Figure CN222218405U_ABST
Abstract
Description
Technical Field
[0001] The present application belongs to the technical field of medical devices, and more specifically, relates to a guide wire. Background Art
[0002] Coronary artery disease is a common clinical problem in the field of coronary interventional treatment. Interventional diagnosis and treatment through guidewire delivery and equipment is one of the fastest-growing treatment methods. When treating stenosis in blood vessels such as coronary arteries surrounding the heart or treating areas of complete occlusion in blood vessels due to the progression of intravascular calcification (for example, chronic total occlusion: CTO (chronic total occlusion)), it is necessary to insert the guidewire used to guide these instruments into the blood vessel before the balloon dilatation catheter and other treatment instruments. The distal part of the guidewire is required to have high softness, good plasticity retention, torque transmission and anti-bending properties.
[0003] In the related art, in order to improve the plasticity and torque transmission of the distal end of the guidewire while maintaining the softness of the distal end of the guidewire, the distal end of the guidewire adopts a double-core shaft design, and a second sheath is also provided at the connection between the two core shafts. In this way, although the rigidity of the distal end of the guidewire is increased, the softness of the distal end of the guidewire is sacrificed to a certain extent, resulting in limited passability of the guidewire in branch vessels. Utility Model Content
[0004] The purpose of the embodiments of the present application is to provide a guidewire to solve the technical problem in the prior art that the guidewire has limited passability in branch blood vessels.
[0005] In order to achieve the above-mentioned purpose, the technical solution adopted in the embodiment of the present application is to provide a guide wire, which includes:
[0006] A guide wire body, on which a first support segment, a second support segment, and a transition segment connecting the first support segment and the second support segment are formed, wherein the second support segment is located at the distal end of the first support segment, and a guide wire is arranged in the guide wire body;
[0007] A sheath, comprising a sleeve and a terminal connected to the distal end of the sleeve, wherein the sleeve is sleeved outside the guide wire body and the terminal is connected to the distal end of the second support segment;
[0008] An auxiliary support member electrically connected to the conductive wire is arranged inside the sheath at the distal end of the guidewire and sleeved on the outside of the guidewire body. The two ends of the auxiliary support member are respectively connected to the sheath and / or the guidewire body. The auxiliary support member is made of a phase-changeable material and can be energized to change its hardness.
[0009] Optionally, both ends of the auxiliary support member are connected with insulating members, and the auxiliary support member is connected to the sheath and / or the guide wire body through the insulating members.
[0010] Optionally, the auxiliary support member is in the shape of a mesh sleeve and is coaxially arranged with the guide wire body.
[0011] Optionally, the auxiliary support member comprises a plurality of alloy wires formed by spiral cross-winding.
[0012] Optionally, the diameter of the distal end of the auxiliary support member is smaller than or equal to the diameter of the proximal end.
[0013] Optionally, the auxiliary support member connects the end head and the transition section.
[0014] Optionally, the sleeve is in the shape of a coil spring.
[0015] Optionally, a hydrophilic coating is applied on the outer side of the sheath.
[0016] Optionally, a connecting structure is provided at the proximal end of the guide wire body, and the connecting structure is used to connect the guide wire body to the distal end of a catheter.
[0017] Optionally, the connection structure includes a connection column coaxially arranged with the guide wire body, and any one of a thread, a snap-in protrusion or a snap-in groove is formed on the outer surface of the connection.
[0018] The guidewire provided in the embodiment of the present application has at least the following beneficial effects:
[0019] By connecting an auxiliary support member at the distal end of the guidewire, located between the sheath and the guidewire body, the guidewire can be electrified in an environment where it needs to maintain plasticity so that its hardness changes, thereby preventing the distal end of the guidewire from easily entering a branch vessel due to insufficient rigidity; and the auxiliary support member can be de-energized when the guidewire needs to enter a branch vessel, thereby reducing its hardness and improving the softness of the distal end of the guidewire. In this way, the rigidity of the distal end of the guidewire can be variably set, which can better improve the passing ability of the guidewire in each branch vessel. BRIEF DESCRIPTION OF THE DRAWINGS
[0020] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.
[0021] Figure 1 Schematic diagram of a guide wire in some embodiments of the present application;
[0022] Figure 2 Schematic diagram of guide wires in other embodiments of the present application;
[0023] Figure 3 This is a schematic diagram of a guide wire in a bent state in some embodiments of the present application;
[0024] Figure 4 A schematic diagram of a mandrel in some embodiments of the present application;
[0025] Figures 5 to 7 Schematic diagram of the connection structure in different embodiments of the present application. DETAILED DESCRIPTION
[0026] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present application more clearly understood, the present application is further described in detail below in conjunction with the accompanying drawings and embodiments.
[0027] It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.
[0028] It should be noted that when an element is referred to as being “fixed to” or “disposed on” another element, it may be directly on the other element or indirectly on the other element.
[0029] When an element is referred to as being “connected to” another element, it can be directly connected to the other element or indirectly connected to the other element.
[0030] It should be understood that the terms "length", "width", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply 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 understood as a limitation on the present application.
[0031] 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 the indicated technical features. Thus, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features.
[0032] In the description of the present application, “plurality” means two or more than two, unless otherwise clearly and specifically defined.
[0033] Please also read Figures 1 to 7 , the guide wire provided in the embodiment of the present application is now described.
[0034] It should be noted that, for the convenience of description, the following definition is used: when the guide wire is inserted into a blood vessel, the end away from the operator is defined as the distal end, and the end close to the operator is defined as the proximal end.
[0035] refer to Figures 1 to 4 The guidewire described in the present application includes a guidewire body 100 , a sheath 200 and an auxiliary support member 300 .
[0036] Specifically, refer to Figure 4 The guide wire body 100 is formed with a first support segment 110 and a second support segment 120 with successively decreasing diameters, and a transition segment 130 connecting the first support segment 110 and the second support segment 120. The second support segment 120 is located at the distal end of the first support segment 110, and the first support segment 110 mainly supports and transports the device.
[0037] It should be understood that the guide wire body 100 is used to be inserted into a blood vessel to guide the implantation of medical devices such as a balloon dilatation catheter. In order to make the guide wire body 100 have good support and pushing force, the material used to make the guide wire body 100 has excellent torque transmission, tracking, support, superelasticity, durability, fatigue resistance and other properties. For example, the guide wire body 100 is made of any one or more materials selected from Ni-Ti alloy, stainless steel, cobalt-based alloy, Fe-Mn alloy, Cu-Zn alloy and Fe-Ni alloy.
[0038] Furthermore, the first support segment 110 and the second support segment 120 are set with equal diameters, and the diameter of the first support segment 110 is greater than the diameter of the second support segment 120. Since the second support segment 120 is located at the distal end of the first support segment 110, the diameter of the first support segment 110 is greater than the diameter of the second support segment 120. In this way, the hardness of the first support segment 110 is greater than the hardness of the second support segment 120, which can provide better support performance for the guidewire body 100, so as to effectively improve the torque transmission and anti-bending properties of the guidewire body 100, so that the guidewire body 100 is not easy to be entangled in the blood vessel. At the same time, the diameter of the second support segment 120 is smaller than the diameter of the first support segment 110, which can make the hardness of the second support segment 120 smaller, and when it is necessary to control the guidewire to enter the branch blood vessel, the second support segment 120 can enter smoothly.
[0039] In addition, a transition section 130 is connected between the first support section 110 and the second support section 120. It can be understood that the contour shape of the transition section 130 can be any one of a conical, parabolic or other streamlined shape, which can gradually reduce the diameter between the first support section 110 and the second support section 120, so that the distal end of the guide wire body 100 has better softness and support.
[0040] refer to Figures 1 to 3The sheath 200 is used to cover the guidewire body 100 therein to prevent the distal end of the guidewire body 100 from damaging the inner wall of the blood vessel when the guidewire moves in the blood vessel. At the same time, the setting of the sheath 200 keeps the overall consistency of the guidewire, increases the support, controllability and tracking of the guidewire, and at the same time, the setting of the sheath 200 enables the operator to obtain good tactile feedback during the operation to achieve more precise control of the guidewire. The sheath 200 can be made of a highly elastic material, such as TPU material, or it can also be made of metal (such as a spring coil). The sheath 200 includes a sleeve 210 and a terminal 220 connected to the distal end of the sleeve 210. Specifically, the sleeve 210 is sleeved on the outside of the guidewire body 100 and the terminal 220 is connected to the distal end of the second support segment 120.
[0041] refer to Figures 1 to 3 The auxiliary support member 300 is arranged inside the sheath 200 at the distal end of the guidewire and is also sleeved outside the guidewire body 100, and its two ends are respectively connected to the sheath 200 and / or the guidewire body 100, and is made of a phase-changeable material. It should be understood that the auxiliary support member 300 should be arranged as close to the distal end of the guidewire as possible.
[0042] It can be understood that the phase-changeable material can be a phase-changeable alloy, such as nitinol (NiTi), doped nickel-titanium alloy, gold-cadmium alloy, silver-cadmium alloy, copper alloy, magnesium alloy, cobalt alloy, titanium and titanium alloy, and dual-phase steel, etc.; the phase-changeable material can also be a polymer-based electrorheological material, melting the polymer material to achieve similar phase-changeable properties.
[0043] By configuring the auxiliary support member 300 to be made of a phase-changeable material, the hardness of such a material decreases as the temperature increases. Therefore, it can be electrically heated to increase its temperature, thereby reducing the hardness of the distal end of the guidewire and enabling it to safely enter each blood vessel branch.
[0044] It is understandable that a wire (not shown in the figure) is provided in the guide wire body 100, and the auxiliary support 300 is connected to the wire. When the wire is energized, the auxiliary support 300 generates heat and undergoes a phase change, thereby changing the hardness. Moreover, it is to be understood that the heating degree of the auxiliary support 300 is different under different current conditions or heating time, and correspondingly, the hardness is also different. It is to be understood that the guide wire is used in human blood vessels. In order to avoid high temperature from causing damage to blood or human organs or tissues, the phase change temperature of the auxiliary support 300 does not exceed 42°C.
[0045] Specifically, both ends of the auxiliary support member 300 can be fixedly connected to the sheath 200, or both can be fixedly connected to the guide wire body 100, or one end can be fixedly connected to the guide wire body 100 and the other end can be fixedly connected to the sheath 200, but this is not limited to the specific embodiment.
[0046] By setting an auxiliary support member 300 between the sheath 200 and the guidewire body 100, during the movement of the guidewire in the blood vessel, when the guidewire does not need to enter the branch blood vessel, the auxiliary support member 300 can be powered off or its current can be reduced, so that its temperature is low and it has a certain hardness, which can effectively increase the height of the distal end of the guidewire to enhance its support, so that it is not easy to bend and accidentally enter the branch blood vessel; when the guidewire needs to enter a branch blood vessel, the current of the auxiliary support member 300 can be increased to heat the auxiliary support member 300 to phase change to a state with lower hardness. At this time, the softness of the distal end of the guidewire is restored, so that it can smoothly enter each branch blood vessel; or, during the movement of the guidewire, the current intensity of the auxiliary support member 300 can be adjusted at any time according to the curvature of the blood vessel, so that the softness of the distal end of the guidewire can be changed in time according to the curvature of the blood vessel, so as to avoid the large rigidity of the distal end of the guidewire damaging the inner wall of the blood vessel.
[0047] It should be understood that in the following descriptions of the embodiments, the phase-changeable material is taken as metal as an example.
[0048] refer to Figure 1 to Figure 2 In some specific embodiments, insulating members 400 are connected to both ends of the auxiliary support member 300 , and the auxiliary support member 300 is connected to the sheath 200 and / or the guide wire body 100 through the insulating member 400 .
[0049] Specifically, the insulating member 400 can be annular or block-shaped. At the same time, the insulating member 400 can be a single-layer insulating structure, in which case the two ends of the auxiliary support member 300 are respectively glued to the insulating member 400, and the insulating member 400 is glued to the sheath 200 and / or the guide wire body 100; the insulating member 400 can also be a multi-layer composite structure, for example, including a first metal layer, a non-metallic layer and a second metal layer in sequence along its thickness direction, wherein the first metal layer is used for welding on the guide wire body 100, and the second metal layer is used for welding and connecting with the auxiliary support member 300. By setting the insulating member 400, the leakage short circuit problem caused by the sheath 200 and the guide wire body 100 being also made of metal can be avoided when the auxiliary support member 300 is energized.
[0050] refer to Figure 1 to Figure 2 In some specific embodiments, the auxiliary support member 300 is in a mesh shape and is coaxially arranged with the guide wire body 100. By coaxially arranging the auxiliary support member 300 and the guide wire body 100, when the guide wire bends and advances in the blood vessel, no matter which side the distal end of the guide wire bends, the auxiliary support member 300 can make the stiffness of the distal end of the guide wire equal in all directions after the same current is passed, so that the torque transmission of the guide wire in each bending direction is consistent, so that the operator can get better tactile feedback.
[0051] More specifically, the auxiliary support member 300 includes a plurality of alloy wires wound in a spiral manner, so that the alloy wires are firmly connected to each other, and after being powered on and heated, the hardness of each part of the auxiliary support member 300 is relatively consistent, thereby further improving the operator's tactile feedback.
[0052] Understandably, reference Figure 1 and Figure 3 In some embodiments, the auxiliary support member 300 is configured with a variable diameter, that is, except for the portion connected to the sheath 200 and the guide wire body 100, other portions of the auxiliary support member 300 are spaced apart from the sheath 200 and the guide wire body 100 by a gap. By configuring the auxiliary support member 300 with a variable diameter, a gap can be left between the inner wall of the sheath 200 and the outer wall of the guide wire body 100 before and after the phase change, so as to avoid the sheath 200, the guide wire body 100, and even the inner wall of the blood vessel due to its greater hardness. Specifically, the variable diameter configuration of the auxiliary support member 300 can have the following several implementations.
[0053] refer to Figure 2 In other embodiments, the auxiliary support member 300 is arranged with equal diameter. Similarly, it should be understood that, except for the portion connected to the sheath 200 and the guide wire body 100 , the other portions of the auxiliary support member 300 are spaced apart from the sheath 200 and the guide wire body 100 by a gap.
[0054] By setting the auxiliary support member 300 in the above two forms, the maneuverability of the guidewire can be effectively improved to improve the tactile feedback of the operator. When powered on, the diameters of the distal ends of the guidewire body 100 and the auxiliary support member 300 are smaller than the diameters of the proximal ends of the guidewire body 100 and the auxiliary support member 300, so that the flexibility of the distal end of the guidewire is better than the flexibility of the proximal end of the guidewire, giving the end of the guidewire flexibility so that it can safely enter each blood vessel branch.
[0055] refer to Figures 1 to 3 In an embodiment where both ends of the auxiliary support member 300 are respectively connected to the sheath 200 and the guide wire body 100 , one end of the auxiliary support member 300 is connected to the end 220 on the sheath 200 , and the other end is connected to the transition section 130 on the guide wire body 100 .
[0056] refer to Figures 1 to 3 In some embodiments, the sleeve 210 is in the shape of a coil spring. By configuring the sleeve 210 in this way, the sleeve 210 can transmit torque well, and also has good performance in terms of support and durability. It should be understood that when the sleeve 210 is in the shape of a spring, the aforementioned auxiliary support member 300 is welded to the sheath 200; at the same time, the connection between the sleeve 210 and the guide wire body 100 can also be welded.
[0057] Furthermore, a hydrophilic coating 500 is coated on the outer side of the sheath 200. The hydrophilic coating 500 can improve the lubricity of the guide wire surface, and its mechanism is that the hydrophilic coating 500 absorbs water molecules to form a gel-like film on the surface of the sheath 200, and the film can reduce the passage resistance of the sheath 200 in the blood vessel and in the relevant matching equipment, so that the sheath 200 has good lubricity and tracking performance, making the guide wire easy to push, effectively improving its passing ability, making it easy for the guide wire to reach the target site in the blood vessel, and at the same time effectively avoiding the formation of blood clots in the blood vessel.
[0058] Preferably, the thickness of the hydrophilic coating 500 at the proximal end of the sheath 200 is greater than that of the hydrophilic coating 500 at the distal end thereof. Specifically, the proximal end portion of the sheath 200 can be spray-processed to make the surface roughness of the proximal end much higher than that of the distal end, so that the hydrophilic coating 500 on the surface of the sheath 200 has different thicknesses, and the tactile feedback capability of the guidewire can be improved.
[0059] refer to Figure 3 , Figures 5 to 7 In some embodiments, a connecting structure 600 is provided at the proximal end of the guidewire body 100, and the connecting structure 600 is used to connect the guidewire body 100 to the distal end of the catheter, so that the guidewire described in the present application can be disassembled from the distal end of the catheter for easy replacement. Specifically, the connecting structure 600 includes a connecting column coaxially arranged with the guidewire body 100, and any one of a thread, a clamping protrusion or a clamping groove is formed on the connected outer surface. Correspondingly, a socket is provided at the distal end of the catheter, and any one of an internal thread, a clamping groove or a clamping protrusion is correspondingly formed on the inner side wall of the socket.
[0060] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present application should be included in the protection scope of the present application.
Claims
1. A guide wire, characterized in that: include: A guide wire body, on which a first support segment, a second support segment, and a transition segment connecting the first support segment and the second support segment are formed, wherein the second support segment is located at the distal end of the first support segment, and a guide wire is arranged in the guide wire body; A sheath, comprising a sleeve and a terminal connected to the distal end of the sleeve, wherein the sleeve is sleeved outside the guide wire body and the terminal is connected to the distal end of the second support segment; An auxiliary support member electrically connected to the conductive wire is arranged inside the sheath at the distal end of the guidewire and sleeved on the outside of the guidewire body. The two ends of the auxiliary support member are respectively connected to the sheath and / or the guidewire body. The auxiliary support member is made of a phase-changeable material and can be energized to change its hardness.
2. The guide wire according to claim 1, characterized in that: Insulating members are connected to both ends of the auxiliary supporting member, and the auxiliary supporting member is connected to the sheath and / or the guide wire body through the insulating members.
3. The guide wire according to claim 1, characterized in that: The auxiliary support member is in the shape of a mesh sleeve and is coaxially arranged with the guide wire body.
4. The guidewire according to any one of claims 1 to 3, characterized in that: The auxiliary support member includes a plurality of alloy wires which are spirally cross-wound.
5. The guide wire according to claim 4, characterized in that: The diameter of the distal end of the auxiliary support member is smaller than or equal to the diameter of the proximal end.
6. The guide wire according to claim 4, characterized in that: The auxiliary support member connects the end head and the transition section.
7. The guide wire according to claim 1, characterized in that: The sleeve is in the shape of a coil spring.
8. The guide wire according to claim 1 or 7, characterized in that: A hydrophilic coating is coated on the outer side of the sheath.
9. The guide wire according to claim 1, characterized in that: A connecting structure is arranged at the proximal end of the guide wire body, and the connecting structure is used to connect the guide wire body to the distal end of the catheter.
10. The guide wire according to claim 9, characterized in that: The connection structure comprises a connection column coaxially arranged with the guide wire body, and any one of a thread, a clamping protrusion or a clamping groove is formed on the outer surface of the connection column.