Pre-shaping guide wire

Abstract

The utility model belongs to the technical field of medical instruments, and particularly relates to a pre-shaping guide wire which comprises a guide wire body, the guide wire body comprises a rigid section and a flexible section, the near end of the flexible section is connected with the far end of the rigid section, the flexible section comprises a plurality of bending parts, at least two bending parts are not located in the same plane, a plurality of grooves are formed in the bending parts, and the grooves are matched with the rigid section and the flexible section. The position of the groove is consistent with the bending direction of the bending part; the sheath comprises a sheath body and an end head, the sheath body is in an elastic net shape and wraps the peripheral side of the flexible section, the near end of the end head is connected with the far end of the sheath body, and the end head is an X-ray visible end head; and the developing ring is arranged in the sheath and surrounds the peripheral side of the flexible section. And by arranging the X-ray visible end and the developing ring, the movement track of the guide wire body is effectively tracked, and the controllability is better. The groove is formed in the bending part, so that the flexibility of the guide wire is enhanced, the bending part is more flexible, and the passing ability of the sheath penetrating through a blood vessel is effectively improved by arranging the sheath body to be in an elastic net shape.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a pre-shaped guide wire. Background Art

[0002] Vascular interventional surgery is a minimally invasive surgical technique that uses catheters and guidewires to reach distant lesions in the body and complete the corresponding medical process. It can effectively shorten the operation time, greatly reduce the patient's pain and shorten the recovery time, and has been widely used at home and abroad.

[0003] The blood vessels in the human body are complex, with thin walls and many branches, which greatly increases the difficulty of delivery. Therefore, doctors are required to operate flexibly and move reliably, which undoubtedly places high demands on the operator. The inevitable shaking of human hands and fatigue from long-term operation greatly reduce the reliability of the operation.

[0004] Since existing guidewires are all straight structures or single arc-shaped curved structures, doctors often shape the guidewires according to the shapes of branch vessels. However, guidewires are relatively soft and shaping depends on the doctor's experience. They cannot reach the target shape in one go and often get damaged.

[0005] The Chinese patent with the authorization announcement number CN217187415U discloses a medical pre-shaped guide wire, including a guide wire body and a sheath, wherein the guide wire body includes a rigid section at the proximal end and a flexible section at the distal end with an arc-shaped curved structure, wherein the flexible section includes at least two curved portions, and at least two of the curved portions are not in the same plane, wherein the sheath is sleeved on the flexible section, and the proximal end of the sheath is connected to the distal end of the rigid section. The sheath is composed of a spring coil wound around the guide wire body, and the guide wire has a large friction coefficient, is troublesome to use, and has a general anti-bending ability.

[0006] The guide wire body is pre-shaped to adapt to complex blood vessels, but the pre-shaped guide wire has poor maneuverability when entering the blood vessel. Therefore, it is necessary to improve the existing technology to solve the above problems. Utility Model Content

[0007] The purpose of the present application is to provide a pre-shaped guide wire, aiming to solve the technical problem in the prior art that the pre-shaped guide wire has poor maneuverability when entering a blood vessel.

[0008] In order to achieve the above object, the present application provides a pre-shaped guide wire, comprising:

[0009] A guidewire body, the guidewire body comprising a rigid section and a flexible section, the proximal end of the flexible section being connected to the distal end of the rigid section, the flexible section comprising a plurality of curved portions, and at least two of the curved portions are not in the same plane, the curved portions are provided with a plurality of grooves, and the positions of the grooves are consistent with the bending directions of the curved portions;

[0010] A sheath, the sheath comprising a sheath body and a terminal, the sheath body is in the shape of an elastic mesh, the sheath body is coated on the circumference of the flexible section, the proximal end of the terminal is connected to the distal end of the sheath body, and the terminal is an X-ray visible terminal; and

[0011] A developing ring is arranged in the sheath and surrounds the circumference of the flexible section.

[0012] As a preferred solution, the developing ring is spring-shaped and has elasticity.

[0013] As a preferred embodiment, the flexible segment includes a first bend and a second bend, the first bend is located at the nearest end of the flexible segment, and the central angle α of the first bend is in the range of 20°~40°; the second bend is located at the farthest end of the flexible segment, and the central angle β of the second bend is in the range of 50°~70°.

[0014] As a preferred solution, the flexible section further includes a first tapered portion and a second tapered portion, the first tapered portion connects the first curved portion and the second curved portion, and the second tapered portion connects the first curved portion and the rigid section.

[0015] As a preferred solution, in the YOZ projection plane where the first bend is located, the horizontal distance L3 between the proximal end of the first bend and the distal end of the second bend is in the range of 4 mm to 8 mm, and the vertical distance L4 between the proximal end of the first bend and the distal end of the second bend is in the range of 2 mm to 4.5 mm.

[0016] As a preferred embodiment, a horizontal length L1 from the distal end of the second bend to the proximal end of the second bend ranges from 2 mm to 3 mm, and a vertical length L2 from the distal end of the second bend to the proximal end of the second bend ranges from 3 mm to 5 mm.

[0017] As a preferred solution, there are multiple developing rings and the number is consistent with the number of the bending parts, and each developing ring is located on the circumference of the corresponding bending part.

[0018] As a preferred solution, the softness of the guide wire body gradually increases from the proximal end to the distal end.

[0019] As a preferred solution, the outer surface of the sheath is coated with a super-slip coating.

[0020] Compared with the prior art, the above one or more technical solutions in a pre-shaped guidewire provided by the present application have at least one of the following technical effects:

[0021] By setting up an X-ray visible end and a developing ring, the movement trajectory of the guide wire body can be effectively tracked when the guide wire enters the blood vessel, and the controllability is better. By setting a groove on the curved part, the flexibility of the guide wire is enhanced, making the curved part more flexible. By setting the sheath body to an elastic mesh, the passability of the sheath in passing through the blood vessel is effectively improved, effectively improving the controllability while reducing the damage to the inner wall of the blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0023] Figure 1 This is a schematic diagram of the sheath structure of the pre-shaped guide wire in this application.

[0024] Figure 2 This is a schematic diagram of the guidewire body structure of the pre-shaped guidewire in this application.

[0025] Figure 3 This is another structural schematic diagram of the guidewire body of the pre-shaped guidewire in this application.

[0026] Figure 4 This is a schematic diagram of the curved portion structure of the pre-shaped guide wire in this application.

[0027] Figure 5 It is a schematic diagram of the structure of the guide wire body of the pre-shaped guide wire in the present application projected on the YOZ plane.

[0028] Figure 6 It is a structural schematic diagram of the guidewire body of the pre-shaped guidewire in the present application projected on the XOY plane.

[0029] Figure 7 This is a schematic diagram of the structure of the guidewire body of the pre-shaped guidewire in the present application passing through a curved blood vessel.

[0030] Figure 8 yes Figure 7 A magnified schematic diagram of center A.

[0031] Fig. 9 This is a schematic diagram of the structure of a guidewire body (without grooves) of a pre-shaped guidewire in the prior art passing through a curved blood vessel.

[0032] Description of reference numerals:

[0033] 100-guide wire body; 110-rigid section; 120-flexible section; 121-bend; 122-groove; 123-first bend; 124-second bend; 125-first tapered section; 126-second tapered section; 200-sheath; 210-sleeve body; 220-end; 300-developing ring. DETAILED DESCRIPTION

[0034] The embodiments of the present invention are described in detail below, and examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are intended to be used to explain the embodiments of the present invention, and should not be construed as limiting the present invention.

[0035] In the description of the embodiments of the present invention, 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 accompanying drawings, and are only for the convenience of describing the embodiments of the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0036] 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. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the embodiments of the present utility model, the meaning of "multiple" is two or more, unless otherwise clearly and specifically defined.

[0037] In the embodiments of the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the embodiments of the present invention can be understood according to specific circumstances.

[0038] In one embodiment of the present application, Figure 1-Figure 3As shown, a pre-shaped guide wire is provided, comprising a guide wire body 100 , a sheath 200 and a developing ring 300 . The sheath 200 is arranged outside the guide wire body 100 , and the developing ring 300 is arranged inside the sheath 200 .

[0039] The guidewire body 100 includes a rigid section 110 and a flexible section 120, wherein the proximal end of the flexible section 120 is connected to the distal end of the rigid section 110. The flexible section 120 includes a plurality of curved portions 121, wherein the curved portions 121 are curved in an arc shape, and at least two of the curved portions 121 are not in the same plane. In this embodiment, by providing at least two curved curved portions 121, when the guidewire is placed in a blood vessel, the curved portions 121 can be adapted to the branch blood vessel, and the doctor does not need to manually shape the guidewire.

[0040] The curved portion 121 is provided with a plurality of grooves 122, and the positions of the grooves 122 are consistent with the bending direction of the curved portion 121. Since the cross-sectional area of ​​the grooves 122 is small, the material thickness of the guide wire is reduced at the grooves 122, thereby increasing the flexibility of the guide wire and making the curved portion 121 more flexible.

[0041] Specifically, the flexible section 120 includes a first curved portion 123 and a second curved portion 124, wherein the first curved portion 123 is located at the most proximal end of the flexible section 120, and the center angle α of the first curved portion 123 is in the range of 20° to 40°; the second curved portion 123 is located at the most distal end of the flexible section 120, and the center angle β of the second curved portion 123 is in the range of 50° to 70°. Accordingly, the groove 122 is provided on the first curved portion 123 and the second curved portion 124, and the width of the groove 122 on the second curved portion 124 is smaller than the width of the groove 122 on the first curved portion 123.

[0042] Please refer to Fig. 9 Since the flexible segment 120 of the prior art includes a first curved portion 123 and a second curved portion 124, the first curved portion 123 and the second curved portion 124 are curved in an arc shape, and the first curved portion 123 and the second curved portion 124 are not in the same plane. When the flexible segment 120 passes through a curved blood vessel, the first curved portion 123 is in the same direction as the curved blood vessel, but the second curved portion 124 is not in the same direction as the curved blood vessel, so that the distal end of the guide wire abuts against the blood vessel wall, increasing the resistance to the guide wire being pushed forward, and even damaging the blood vessel if excessive force is applied.

[0043] In order to avoid the above situation in the prior art, the flexible segment 120 described in the embodiment of the present application is provided with a plurality of grooves 122 on the bending portion 121, and the positions of the grooves 122 are consistent with the bending direction of the bending portion 121. Figure 7 and Figure 8 Since the second curved portion 124 is provided with a plurality of the grooves 122, when the distal end of the guide wire abuts against the blood vessel wall, the blood vessel wall has a reaction force on the second curved portion 124, causing the second curved portion 124 to temporarily deform in the direction of the blood vessel bending, thereby preventing the guide wire from moving toward the blood vessel wall during the forward pushing process, thereby enabling the guide wire of this embodiment to pass through the curved blood vessel smoothly.

[0044] In this embodiment, the bending portion 121 has strong toughness and can maintain a certain shape after being shaped. Figure 5 and Figure 6 Taking the direction relative to the observer as an example, the first curved portion 123 is located in the YOZ plane, the second curved portion 124 is located in the XOY plane, the first curved portion 123 extends to the upper right relative to the rigid segment 110, and the second curved portion 124 extends to the upper left or lower right relative to the first curved portion 123.

[0045] Further, in the YOZ projection plane where the first curved portion 123 is located, the horizontal distance L3 between the proximal end of the first curved portion 123 and the distal end of the second curved portion 124 is in the range of 4 mm to 8 mm, and the vertical distance L4 between the proximal end of the first curved portion 123 and the distal end of the second curved portion 124 is in the range of 2 mm to 4.5 mm. The horizontal length L1 from the distal end of the second curved portion 124 to the proximal end of the second curved portion 124 is in the range of 2 mm to 3 mm, and the vertical length L2 from the distal end of the second curved portion 124 to the proximal end of the second curved portion 124 is in the range of 3 mm to 5 mm.

[0046] Furthermore, the flexible section 120 further includes a first tapered portion 125 and a second tapered portion 126, wherein the first tapered portion 125 connects the first curved portion 123 and the second curved portion 124, and the second tapered portion 126 connects the first curved portion 123 and the rigid section 110. In this embodiment, the first tapered portion 125 and the second tapered portion 126 make the first curved portion 123 and the second curved portion 124 more autonomous and flexible in movement.

[0047] In this embodiment, the guide wire body 100 is made of a variety of materials including nickel-titanium alloy, stainless steel, cobalt-based alloy, manganese-iron alloy, zinc-copper alloy, and nickel-iron alloy, and the softness of the guide wire body 100 gradually increases from the proximal end to the distal end, effectively ensuring the operability and easy-to-bend guide shape of the guide wire. Specifically, the softness of the first curved portion 123 is greater than the softness of the rigid segment 110, and the softness of the second curved portion 124 is greater than the softness of the first curved portion 123.

[0048] The sheath 200 is coated with a super-slip coating to reduce surface friction, improve the tracking and passability of the guidewire, and thus improve the efficiency of interventional treatment. The super-slip coating can be a coating made of polyurethane, fluoroplastics, thermoplastic elastomers, polylactic acid, polyetheretherketone, nylon elastomer or PTFE (polytetrafluoroethylene). Specifically, the super-slip coating is preferably a PTFE coating, which has the advantages of low water absorption, surface non-stickiness, corrosion resistance, high temperature resistance, excellent electrical insulation, high strength, light weight, good flexibility, and long life.

[0049] The sheath 200 includes a sheath 210 and a terminal 220. The sheath 210 is an elastic mesh, and the sheath 210 is coated on the circumference of the flexible segment 120. The elastic sheath 210 can reduce the damage to the inner wall of the blood vessel when the guidewire enters the blood vessel, and the mesh sheath 210 can provide support and retention force for the guidewire body 100, and is not easy to deform. In addition to ensuring the stiffness of the guidewire, the sheath 210 can also improve the bending resistance of the guidewire so that the flexible segment 120 in the middle is not easy to bend. Furthermore, after the sheath 210 is coated with an ultra-slip coating, its outer wall is smooth and treated with an ultra-slip coating, with a small friction coefficient, which can meet the needs of various interventional treatments.

[0050] The proximal end of the terminal 220 is connected to the distal end of the sleeve 210, and the terminal 220 is connected to the distal end of the second curved portion 124, which improves the penetration and passability of the guide wire when encountering resistance, and improves the tactile feedback of the guide wire, helping the operator to better perceive the movement of the guide wire. In addition, the terminal 220 is an X-ray visible terminal, which is visible under X-ray irradiation, and is convenient for observing the intervention position during interventional treatment.

[0051] The developing ring 300 is disposed in the sheath 200 and surrounds the circumference of the flexible section 120. The developing ring 300 is spring-shaped and has elasticity, so as to avoid affecting the bending angle of the bending portion 121.

[0052] Furthermore, there are a plurality of developing rings 300 and the number of the developing rings 300 is the same as the number of the bending portions 121 , and each developing ring 300 is located on a circumferential side of the corresponding bending portion 121 .

[0053] The utility model provides the X-ray visible end 220 and the developing ring 300 to effectively track the movement trajectory of the guide wire body 100 when the guide wire enters the blood vessel, and the controllability is better. The groove 122 is provided on the curved portion 121 to enhance the flexibility of the guide wire, making the curved portion 121 more flexible. The sleeve body 210 is provided in an elastic mesh shape to effectively improve the passability of the sheath 200 when passing through the blood vessel, effectively improve the controllability and reduce the damage to the inner wall of the blood vessel.

[0054] The above description is only a specific implementation mode of the present application, but the protection scope of the present application is not limited thereto. Any technician familiar with the technical field can easily think of various equivalent modifications or substitutions within the technical scope disclosed in the present application, and these modifications or substitutions should be included in the protection scope of the present application.

Claims

1. A pre-shaped guide wire, characterized in that: include: A guidewire body, the guidewire body comprising a rigid section and a flexible section, the proximal end of the flexible section being connected to the distal end of the rigid section, the flexible section comprising a plurality of curved portions, and at least two of the curved portions are not in the same plane, the curved portions are provided with a plurality of grooves, and the positions of the grooves are consistent with the bending directions of the curved portions; A sheath, the sheath comprising a sheath body and a terminal, the sheath body is in the shape of an elastic mesh, the sheath body is coated on the circumference of the flexible section, the proximal end of the terminal is connected to the distal end of the sheath body, and the terminal is an X-ray visible terminal; and A developing ring is arranged in the sheath and surrounds the circumference of the flexible section.

2. A pre-shaped guide wire according to claim 1, characterized in that: The developing ring is spring-shaped and has elasticity.

3. A pre-shaped guide wire according to any one of claims 1-2, characterized in that: The flexible segment includes a first curved portion and a second curved portion, wherein the first curved portion is located at the nearest end of the flexible segment, and a central angle α of the first curved portion ranges from 20° to 40°; the second curved portion is located at the farthest end of the flexible segment, and a central angle β of the second curved portion ranges from 50° to 70°.

4. A pre-shaped guide wire according to claim 3, characterized in that: The flexible section further includes a first tapered portion and a second tapered portion, the first tapered portion connecting the first curved portion and the second curved portion, and the second tapered portion connecting the first curved portion and the rigid section.

5. A pre-shaped guide wire according to claim 3, characterized in that: In the YOZ projection plane where the first bend is located, the horizontal distance L3 between the proximal end of the first bend and the distal end of the second bend ranges from 4mm to 8mm, and the vertical distance L4 between the proximal end of the first bend and the distal end of the second bend ranges from 2mm to 4.5mm.

6. A pre-shaped guide wire according to claim 3, characterized in that: A horizontal length L1 from the distal end of the second curved portion to the proximal end of the second curved portion ranges from 2 mm to 3 mm, and a vertical length L2 from the distal end of the second curved portion to the proximal end of the second curved portion ranges from 3 mm to 5 mm.

7. A pre-shaped guide wire according to any one of claims 1-2, characterized in that: There are a plurality of developing rings, and the number of the developing rings is consistent with the number of the bending parts, and each developing ring is located at a peripheral side of the corresponding bending part.

8. A pre-shaped guide wire according to any one of claims 1-2, characterized in that: The softness of the guide wire body gradually increases from the proximal end to the distal end.

9. A pre-shaped guide wire according to any one of claims 1-2, characterized in that: The outer surface of the sheath is coated with a super-slip coating.

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