Guide wire with adjustable flexibility

Abstract

The utility model provides a guide wire with adjustable flexibility, which relates to the technical field of medical instruments, and comprises a mandrel assembly, a plurality of springs and a control assembly, the mandrel assembly at least comprises three sections of mandrels, namely a front section mandrel, a middle section mandrel and a rear section mandrel, the hardness of the front section mandrel is lower than that of the rear section mandrel, adjacent mandrels are connected through the springs, and the springs are connected with the control assembly. The control assembly comprises a plurality of traction wires which are connected with the spring. The guide wire meets the clinical requirement of'hard pushing-soft navigation 'through the differentiated design of different sections of mandrels, and mechanical property differentiated configuration of different sections is achieved on the single guide wire; by arranging the traction wire, the flexibility of the guide wire can be dynamically adjusted, the flexibility can be adjusted in a real-time and segmented mode in an operation, the pushing stability of the guide wire is maintained, the adaptability of the guide wire in the operation is enhanced, and sudden anatomical variation in the operation can be coped with.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical equipment technical field especially a kind of guide wire of adjustable compliance. BACKGROUND

[0002] At present, in clinical intervention treatment, such as the examination and treatment in the lumen of blood vessel, bile duct, ureter, guide wire is one of important medical instruments. The traditional guide wire is usually composed of single or a small number of mandrels, and its structure is relatively simple. The compliance, support force and pushing performance of the guide wire are improved mainly by changing the elasticity and surface treatment of the material.

[0003] However, the guide wire with single structure has the following problems in actual use: 1) structural rigidity contradiction: the overall rigidity of the guide wire is fixed, and the single mandrel needs to compromise between support force and compliance. For example, the guide wire for urinary system needs high support force to pass through the narrow ureter, but the hard material can easily cause damage to the ureter wall. The guide wire with too high compliance is difficult to maintain the stability of pushing, and cannot flexibly adjust its compliance according to the specific application scene. 2) When operating in complex lumen, the guide wire is prone to excessive bending or pushing obstruction, and the in-situ adaptability is insufficient. The compliance parameter of the existing guide wire depends on preoperative selection, and cannot cope with sudden anatomical variations during operation, such as lumen stenosis caused by digestive tract spasm, which affects the operation effect. 3) There is no effective structure design to realize real-time adjustment of the compliance of the guide wire in the prior art, and it is difficult to meet the specific needs of different patients and different lumens.

[0004] In view of the above defects, the present application is proposed. UTILITY MODEL CONTENTS

[0005] The utility model aims at providing a kind of guide wire of adjustable compliance, can realize the effect of real-time, segmented adjustment of compliance in situ, solve the problem that guide wire compliance cannot be dynamically adjusted at present.

[0006] To solve the above problems, the utility model provides a kind of guide wire of adjustable compliance, including mandrel assembly, several springs and control assembly, the mandrel assembly at least includes three mandrels, is respectively front section mandrel, middle section mandrel and rear section mandrel, the hardness of front section mandrel is lower than that of rear section mandrel, guarantees the compliance and advancing performance of guide wire, adjacent the mandrel is connected by spring, compared with mandrel, can reduce hardness to the maximum, realizes the different section mechanical property differentiation configuration on single guide wire, the control assembly includes several traction wires, the traction wire is connected with spring, preferably connected with the distal end of spring, can be connected with the middle section position of spring, the traction wire is used for adjusting spring pitch, realizes the compliance adjustment of guide wire by controlling the displacement of traction wire to adjust spring pitch, can be adjusted in real time to the compliance of guide wire, to adapt to complex lumen in situ, and operator can quantitatively adjust compliance.

[0007] Preferably, the length of the front mandrel is 80-120mm, the length of the middle mandrel is 200-300mm, and the length of the rear mandrel is 1-2m. In addition to the above length range, the required length can be set according to the actual use of the product.

[0008] According to one embodiment of the present invention, the hardness of the front mandrel, the middle mandrel and the rear mandrel increases sequentially. The flexible design of the front mandrel can adapt to sharp-angle bending, the hard material of the rear mandrel provides propulsion support, and the middle mandrel is connected by a spring to balance the overall mechanical properties, thereby meeting the clinical needs of hard push-soft navigation, improving the clinical use effect during operation and significantly improving clinical benefits.

[0009] According to one embodiment of the present invention, the diameter of the front mandrel gradually increases from the distal end to the proximal end, and its distal end is set with a rounded head structure to prevent the tip from damaging human cavity tissues.

[0010] According to one embodiment of the present invention, the ends of the front mandrel, middle mandrel and rear mandrel that cooperate with the spring are all provided as tapered joints to facilitate connection with the spring.

[0011] According to one embodiment of the present invention, the proximal end of the rear mandrel is configured as a polygonal prism structure, which is used to cooperate with the push handle. The design of the polygonal prism structure can play a foolproof confirmation role.

[0012] According to one embodiment of the present invention, a polytetrafluoroethylene layer is provided on the outer surface of the rear mandrel to reduce the friction coefficient of the guide wire.

[0013] Alternatively, the polytetrafluoroethylene layer can be achieved by covering the rear mandrel with a polytetrafluoroethylene tube.

[0014] According to one embodiment of the present invention, the front mandrel and / or the middle mandrel are coated with a polyurethane coating and a hydrophilic lubricating coating to reduce the coefficient of friction of the guide wire.

[0015] According to one embodiment of the present invention, a developing material is provided at at least a portion of the spring.

[0016] Preferably, all springs are made of radiopaque material. Using such radiopaque material can enhance the positioning accuracy during guidewire surgery and allow for spring pitch adjustment based on radiopaque findings.

[0017] According to one embodiment of the present invention, the traction wire is wound around one or more spring coils of a spring and then fixed, which can be done by welding or applying adhesive.

[0018] According to one embodiment of the present invention, the control component further includes an operating mechanism connected to the traction wire for controlling the displacement of the traction wire.

[0019] The beneficial effects of this invention are that the differentiated design of different mandrel segments enables the guidewire to meet the clinical requirements of "hard pushing - soft navigation," improving the clinical effectiveness during surgery and significantly enhancing clinical benefits. The different mandrel segments are connected by springs, which minimizes stiffness compared to a standard mandrel. Different mechanical properties are configured for different sections on a single guidewire, allowing it to pass through anatomical structures that traditional guidewires cannot, such as hairpin bends. By setting a traction wire, the flexibility of the guidewire can be dynamically adjusted, enabling real-time, segmented adjustment of flexibility during surgery, maintaining guidewire pushing stability, enhancing intraoperative adaptability, and responding to sudden intraoperative anatomical variations. Attached Figure Description

[0020] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0021] Figure 1 This is a schematic diagram of the overall structure of the guidewire with adjustable flexibility. Detailed Implementation

[0022] The following description is only intended to disclose the present invention so that those skilled in the art can implement it. The embodiments in the following description are merely examples, and those skilled in the art will conceive of other obvious modifications. The basic principles of the present invention defined in the following description can be applied to other embodiments, modifications, improvements, equivalents, and other solutions that do not depart from the spirit and scope of the present invention.

[0023] Example 1:

[0024] A guidewire with adjustable flexibility, such as Figure 1 It includes a spindle assembly, several springs, and control components.

[0025] The mandrel assembly includes at least three mandrel sections: a front mandrel 1, a middle mandrel 2, and a rear mandrel 3. In other embodiments, the number of mandrel sections can be further increased, and the corresponding springs and traction wires are adjusted synchronously.

[0026] In the example: the end closer to the doctor is the posterior / proximal end, and the end closer to the patient is the anterior / distal end.

[0027] The length of the front mandrel 1 can be selected from 80-120mm. It is made of flexible material wire, such as super-elastic nickel-titanium alloy wire, which can be subjected to shape memory heat treatment (water quenching) in a vacuum environment at 500℃. The front mandrel adopts a gradual diameter, with the smallest diameter at the far end of the mandrel. The far end is rounded to prevent the tip from damaging human body cavity tissues. The proximal end is machined into a tapered opening to facilitate connection with the spring.

[0028] The length of the middle section mandrel 2 can be selected as 200-300mm. It is made of materials such as 316L stainless steel or 304 stainless steel. The surface hardness is improved by low-temperature ion nitriding treatment, which can play a balancing and supporting role. For example, after the stainless steel wire is electrolytically polished, it is placed in a nitrogen-hydrogen mixed atmosphere furnace for low-temperature ion nitriding treatment to generate a hardened layer on the surface and improve the hardness. The far end and near end of the middle section stainless steel mandrel need to be processed into tapered joints so that they can be matched with the spring.

[0029] The length of the rear mandrel 3 can be selected as 1-2m. It is made of rigid support material, such as cobalt-chromium alloy. This material needs to have high hardness to provide support and also needs to be biocompatible. The far end of the rear mandrel is machined into a tapered opening to cooperate with the spring, while the near end can be machined into a polygonal structure to fit the push handle. At the same time, the polygonal structure can play a foolproof confirmation role when the handle is inserted. The rear mandrel mainly plays a supporting and pushing role.

[0030] It should be noted that, in addition to the length range mentioned above, the length of each mandrel section can be set according to the actual use of the product.

[0031] The hardness of the front mandrel 1 is lower than that of the rear mandrel 3, ensuring the flexibility and propulsion performance of the guide wire.

[0032] Preferably, the hardness of the front mandrel 1, the middle mandrel 2, and the rear mandrel 3 increases sequentially. The flexible design of the front mandrel 1 can adapt to sharp-angle bending, the hard material of the rear mandrel 3 provides propulsion support, and the middle mandrel 2 balances the overall mechanical properties through spring connection, thus meeting the clinical needs of hard push-soft navigation. This improves the clinical use effect during the operation and has significant clinical benefits.

[0033] The differentiated design of the three-segment mandrel enables the guidewire to meet the clinical needs of "hard pushing and soft navigation," improving the clinical effectiveness during the procedure and resulting in significant clinical benefits.

[0034] The spring includes a first spring 4 and a second spring 5. The spring wire can be made of a material with a radiopaque quality, such as platinum-tungsten wire or platinum wire. Using such a radiopaque material can enhance the positioning accuracy during the guidewire procedure and allow for adjustment of the spring pitch based on the radiopaque results.

[0035] The spring can be fixed to the mandrel after being pre-wound according to the set parameters, or it can be fixed after being wound on the mandrel. The part where the adjacent mandrel section connects to the spring is processed into a tapered opening. The two ends of the spring are fixed to the tapered surface by laser welding, glue application, or other methods.

[0036] Preferably, the tapered end of the mandrel section is inserted into the inner cavity of the spring, and a laser is used to perform circumferential welding to form a continuous sealed weld for fixation.

[0037] Because the guidewire is supported only by springs, its stiffness can be minimized compared to the mandrel, allowing it to pass through anatomical structures that traditional guidewires cannot, such as hairpin bends.

[0038] The control assembly includes a first spring traction wire 6 and a second spring traction wire 7.

[0039] The traction wire is preferably made of braided steel wire rope made of multiple strands of stainless steel wire. The braided structure can enhance the tensile strength and avoid the risk of breakage during the operation. Two traction wires are arranged parallel to the long axis of the guide wire and are connected to the distal end of the first spring and the distal end of the second spring respectively. They are fixed by welding to the outer surface of the spring or by inserting them between the spring coils and then welding them.

[0040] Preferably, the traction wire is wound around the surface of the spring at a 30° helix angle, with a 2mm interval between each turn, and fixed using a miniature resistance spot welding machine; or the tensile stability is increased by winding the traction wire around multiple coils of the spring.

[0041] By controlling the displacement of the traction wire and adjusting the spring pitch, the bending stiffness of the guide wire can be affected, thereby adapting to the complex cavities during the operation. The surgeon can quantitatively adjust the compliance.

[0042] During operation, the traction wire can be manually pulled or mechanically assisted to pull the distal end of the spring, forcing the spring pitch to decrease or increase. The decrease and increase of the spring pitch correspond to the decrease and increase of compliance, respectively. The change in pitch directly changes the radial stiffness and axial bending radius of the spring, thereby achieving local adjustment of the guide wire's compliance.

[0043] Before the operation, the doctor can set the initial compliance parameters according to the characteristics of the target cavity. If a sudden change in the bending angle occurs during the operation, the compliance of the guide wire can be adjusted by adjusting the traction wire and changing the spring pitch. After the guide wire passes the target position, the position of the traction wire can be fixed to keep the pitch stable.

[0044] Example 2:

[0045] Based on Example 1, in this example, the front mandrel 1 and the middle mandrel 2 are coated with a polyurethane (TPU) coating and a hydrophilic lubricating coating to reduce the guide wire friction coefficient.

[0046] The rear mandrel 3 is covered with a polytetrafluoroethylene (PTFE) tube to reduce the friction coefficient of the guide wire.

[0047] Example 3:

[0048] Based on embodiment 1 or 2, the control component further includes an operating mechanism connected to the traction wire for controlling the displacement of the traction wire.

[0049] The operating mechanism can be a structure capable of rotating and winding the traction wire, such as a reel structure.

[0050] In this embodiment, a handle linkage mechanism is used to control the traction wire. The handle has a built-in common gear transmission system, which transmits the knob action to the position of the winding drum through the gear transmission system, precisely controlling the displacement of the traction wire to adjust the spring pitch. For example, each turn of the knob corresponds to a pitch change of 0.5mm. The built-in locking mechanism can fix the adjusted wire to prevent accidental changes in the spring during the operation.

[0051] Those skilled in the art should understand that the embodiments of the present invention described above and shown in the accompanying drawings are merely examples and do not limit the present invention. The purpose of the present invention has been fully and effectively achieved. The functional and structural principles of the present invention have been shown and explained in the embodiments. Without departing from the stated principles, the implementation of the present invention may have any variations and modifications.

Claims

1. A guidewire with adjustable flexibility, characterized in that: The device includes a spindle assembly, several springs, and a control assembly. The spindle assembly includes at least three spindle sections: a front spindle (1), a middle spindle (2), and a rear spindle (3). The front spindle (1) has a lower hardness than the rear spindle (3). Adjacent spindles are connected by springs. The control assembly includes several traction wires connected to the springs. The traction wires are used to adjust the spring pitch. By controlling the traction wires, the flexibility of the guide wire can be adjusted.

2. The adjustable flexibility guidewire according to claim 1, characterized in that: The hardness of the front mandrel (1), the middle mandrel (2) and the rear mandrel (3) increases sequentially.

3. The adjustable flexibility guidewire according to claim 1 or 2, characterized in that: The diameter of the front mandrel (1) gradually increases from the distal end to the proximal end, and its distal end is set with a round head structure.

4. The adjustable flexibility guidewire according to claim 3, characterized in that: The ends of the front mandrel (1), middle mandrel (2) and rear mandrel (3) that mate with the spring are all set as tapered joints.

5. The adjustable flexibility guidewire according to claim 4, characterized in that: The proximal end of the rear mandrel (3) is configured as a polygonal prism structure.

6. The adjustable flexibility guidewire according to claim 1 or 2, characterized in that: The outer surface of the rear mandrel (3) is provided with a polytetrafluoroethylene layer.

7. The adjustable flexibility guidewire according to claim 6, characterized in that: The front mandrel (1) and / or the middle mandrel (2) are covered with a polyurethane coating and a hydrophilic lubricating coating.

8. The adjustable flexibility guidewire according to claim 1 or 2, characterized in that: The spring is provided with a developing material at at least a portion of its location.

9. The adjustable flexibility guidewire according to claim 1, characterized in that: The traction wire is wound around one or more spring coils and fixed to the spring.

10. The adjustable flexibility guidewire according to claim 1, characterized in that: The control component also includes an operating mechanism connected to the traction wire for controlling the displacement of the traction wire.

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