Shaping guide wire with adjustable supporting force

Abstract

The invention provides a shaping guide wire with adjustable supporting force, and relates to the technical field of neurointervention medical instruments. The shaping guide wire with the adjustable supporting force comprises an outer layer protection tube which is a section of continuous cutting tube with compression resistance and torsion control conduction performance; the middle-layer winding spring is tightly sleeved on the inner wall of the outer-layer protective tube; the inner-layer core wire is arranged in the middle-layer winding spring and the outer-layer protection tube in a penetrating manner; wherein the inner-layer core wire is movably or fixedly arranged relative to the middle-layer winding spring and is used for adjusting the length of the inner-layer core wire inserted into the outer-layer protection tube so as to adjust the supporting performance of the guide wire. The technical problems that most of existing nerve intervention guide wires are of an integrated structure, supporting force is fixed, and the requirements for flexibility needed by entering a complex bent blood vessel and supporting performance needed by pushing an instrument to pass through a lesion area in an operation are difficult to meet at the same time are solved.

Description

Technical Field

[0001] This invention relates to the technical field of neurointerventional medical devices, and more particularly to a shaping guidewire with adjustable support force. Background Technology

[0002] Most existing neurointerventional guidewires are one-piece structures with fixed support. During the procedure, the surgeon needs the guidewire to be both flexible enough to enter complex and tortuous small blood vessels, and also provides sufficient support at specific moments to push instruments such as microcatheters through the lesion area.

[0003] Existing guidewire products can usually only preset the softness or support force during the design phase, making it difficult to dynamically adjust their performance. This limits the flexibility of surgery, especially when entering distal blood vessels or complex vascular structures, where the "rigid-flexible" properties of the guidewire are difficult to balance simultaneously.

[0004] Therefore, there is an urgent need for a guidewire with dynamically adjustable support properties to better meet the needs of clinical procedures. Summary of the Invention

[0005] The purpose of this invention is to provide a shaping guidewire with adjustable support force, which solves the technical problem that most existing neurointerventional guidewires are one-piece structures with fixed support force, making it difficult to simultaneously meet the flexibility required to enter complex and tortuous blood vessels during surgery and the support required to propel instruments through the lesion area.

[0006] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows: This invention provides a shaped guidewire with adjustable support force, comprising: an outer sheath, which is a continuous cut tube with compressive strength and torsional conduction properties; a middle coiled spring, tightly fitted inside the outer sheath; and an inner core wire, which passes through the middle coiled spring and the outer sheath; wherein the inner core wire is movably or fixedly disposed relative to the middle coiled spring, and is used to adjust its length inserted into the outer sheath to adjust the support of the guidewire.

[0007] Furthermore, the outer protective tube is made of hyaluronic acid tube, and its tube wall has spiral or mesh cuts to maintain a certain degree of flexibility and provide pressure resistance and torsion control performance.

[0008] Furthermore, the middle layer spring adopts an integral or segmented structure. When a segmented structure is adopted, its distal segment is fitted onto the distal end of the inner core wire to achieve development.

[0009] Furthermore, the inner core wire is made of stainless steel and has been precision ground to have gradient rigidity.

[0010] Furthermore, it also includes a connecting tube, the distal end of which is tightly fitted into the proximal end of the middle layer spring; The inner core wire is also threaded through the connecting tube and is movable or fixed relative to the connecting tube.

[0011] Furthermore, the portion of the connecting tube extending proximally is exposed outside the outer protective tube.

[0012] Furthermore, the connecting tube is a sheath.

[0013] Furthermore, it also includes a tensioning element disposed on the exposed portion of the connecting tube, used to release or fix the inner core wire by loosening or tightening the connecting tube.

[0014] Furthermore, the tightening element is a Y-valve.

[0015] Furthermore, the distal end of the outer sheath is covered with a tubular shaping material layer to give the distal portion of the guidewire plasticity.

[0016] Furthermore, the distal end of the shaping material layer protrudes and covers the end face of the outer protective tube, and is rounded to serve as the contact end of the guide wire.

[0017] Compared with the prior art, the present invention has at least the following beneficial effects: This invention utilizes a multi-layered structural design consisting of an inner movable stainless steel ground core wire, a middle coiled spring, and an outer hypotube to dynamically adjust the guidewire support force. When accessing curved or distal microvessels, adjusting the insertion length of the inner core wire or withdrawing it enhances guidewire flexibility and reduces the risk of vessel wall damage. When pushing microcatheters or passing through stenotic lesions, inserting the inner core wire improves guidewire rigidity and support force, effectively solving the problem of existing guidewires being unable to balance rigidity and flexibility. Attached Figure Description

[0018] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0019] Figure 1 This is a partial structural diagram of the adjustable support force shaping guide wire provided in this embodiment, wherein the middle layer spring adopts an integral structure; Figure 2 This is a partial structural diagram of the adjustable support force shaping guide wire provided in this embodiment, wherein the middle layer spring adopts a segmented structure; Figure 3This is a partial structural diagram of the adjustable support force shaping guidewire provided in this embodiment.

[0020] Figure label: 1-Outer protective tube; 2-Middle layer spring; 3-Inner core wire; 4-Shaping material layer; 5-Connecting pipe; 6-Y valve mounting area. Detailed Implementation

[0021] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0022] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0023] The following detailed description of some embodiments of the present invention is provided in conjunction with the accompanying drawings. Unless otherwise specified, the following embodiments and features can be combined with each other.

[0024] This embodiment provides a shaping guidewire with adjustable support force. Please refer to [reference needed]. Figure 1-3 As shown, it includes: an outer sheath 1, which is a continuous cut tube with pressure resistance and torsion control conduction performance; a middle coiled spring 2, which is tightly fitted inside the outer sheath 1; and an inner core wire 3, which passes through the middle coiled spring 2 and the outer sheath 1; wherein, the inner core wire 3 is movably or fixedly arranged relative to the middle coiled spring 2, and is used to adjust its length inserted into the outer sheath 1 to adjust the support of the guide wire.

[0025] Specifically, the guidewire comprises three layers from the outside in: an outer sheath 1 (a cutting tube providing pressure resistance and torsional conduction), a middle coiled spring 2, and an inner core wire 3 inserted between the two. The inner core wire 3 can be movable or fixed relative to the middle coiled spring 2, and the overall support of the guidewire can be dynamically adjusted by changing the length of the inner core wire 3 inserted into the outer sheath 1. This solution solves the core problem of the fixed and unadjustable support force of existing guidewires, enabling the guidewire to adjust its support during the procedure by moving the inner core wire 3 to adjust its insertion length into the outer sheath 1 according to the interventional needs (including flexibly switching between flexibility (complete withdrawal, i.e., zero insertion length) and support (insertion to a certain length)). This greatly improves the adaptability and safety of the procedure. In addition, the outer surface of the outer sheath 1 is coated with a hydrophilic coating, providing low-friction properties and enhancing the guidewire's advancement and tracking within the blood vessel. Furthermore, this hydrophilic coating can be distributed along the entire length or in segments to adapt to different operational requirements.

[0026] In this embodiment, the outer protective tube 1 is made of hyaluronic acid tube, and its tube wall has spiral or mesh cuts to maintain a certain degree of flexibility and provide pressure resistance and torsion control performance.

[0027] Specifically: The outer sheath 1 is made of hyaluronic acid tube, which is a metal microtube made by laser cutting and other processes. Its tube wall has spiral or mesh-like cuts. This cut design can give it good flexibility while maintaining the tubular structure and provide excellent pressure resistance and torsional conduction performance. The outer diameter D5 and inner diameter D6 of the hyaluronic acid tube can be set according to the actual situation and the size of each component. For example, its inner diameter D6 can be matched with the outer diameter of the tubular shaping material layer 4, or after the two are combined, the inner diameter D4 of the shaping material layer 4 is greater than the diameter D1 of the inner core wire 3 (or meets the diameter difference requirement).

[0028] In this embodiment, please refer to Figure 1-2 As shown, the middle layer spring 2 adopts an integral or segmented structure. When the segmented structure is adopted, its distal segment is fitted onto the distal end of the inner core wire 3 to achieve development.

[0029] Specifically, when the middle layer spring 2 is segmented, a platinum-tungsten alloy segment spring with a length of about 9cm can be used to achieve imaging in areas with smaller distal diameters, while a stainless steel segment spring can be used in areas with larger proximal diameters. The two segments of spring work together to provide certain structural support and also have good X-ray imaging performance.

[0030] In this embodiment, the inner core wire 3 is made of stainless steel ground core wire, which has gradient rigidity after precision grinding.

[0031] Specifically: The inner core wire 3 is made of stainless steel core wire that has been precision ground and has gradient rigidity. For example, the diameter D1 at the head end is a smaller diameter, the diameter D2 in the middle part is a gradually changing diameter, the size transitions from the smaller diameter of D1 to the larger diameter of D3, and the diameter D3 at the rear end is a larger diameter. Each part has a certain length in axial extension. Among them, the head end of the stainless steel core wire becomes thinner, which can move more easily in the inner cavity of the guide wire.

[0032] In this embodiment, a connecting tube 5 is further included, the distal end of which is tightly fitted into the proximal end of the middle layer spring 2; the inner core wire 3 is also inserted through the connecting tube 5 and is movable or fixed relative to the connecting tube 5. The portion of the connecting tube 5 extending proximal to the proximal end is exposed outside the outer protective tube 1. The connecting tube 5 is a sheath.

[0033] Specifically: The distal end of the connecting tube 5 (i.e., the end furthest from the operator) is tightly fitted into the proximal end of the middle layer spring 2, and the inner core wire 3 also passes through the connecting tube 5 and can move or be fixed relative to it; the connecting tube 5 can be a sheath, which is a non-metallic hollow tube that can accommodate the guide wire to enter and exit, and its tip / distal end can be inserted into the middle layer spring 2; in actual use, the sheath is inserted into the guide wire 3-5cm, and the remaining sheath can be exposed outside the guide wire; the sheath can ensure that the stainless steel core wire is not easily bent, and the exposed part is convenient for installing the tensioning device. By adjusting the tensioning device, the doctor can quickly switch between the "adjustment mode" (the inner core wire 3 can move) and the "locking mode" (the inner core wire 3 is fixed and the guide wire support is stable), which greatly improves the convenience and efficiency of the surgical operation.

[0034] In this embodiment, a tensioning element is also included. The tensioning element is disposed on the exposed portion of the connecting tube 5 and is used to release or fix the inner core wire 3 by loosening or tightening the connecting tube 5. The tensioning element is a Y-valve.

[0035] Preferably, the tightening element is a Y-valve, installed in the Y-valve installation area 6 shown in the figure. The Y-valve is an instrument accessory in the field of neurointervention (its structure, installation and principle can be referred to the existing technology, and will not be described in detail here). The Y-valve has a rotating thread for tightening and loosening. When it is necessary for the stainless steel core wire to move in the guidewire, the Y-valve can be loosened to allow the inner core wire 3 to move freely in the sheath and guidewire. When it is necessary for the stainless steel core wire to be fixed to the guidewire, the Y-valve can be tightened. The Y-valve can retract and lock the sheath to fix the guidewire and core wire.

[0036] In this embodiment, the distal end of the outer sheath 1 is covered with a tubular shaping material layer 4 to give the distal portion of the guidewire shapeability. The distal end of the shaping material layer 4 protrudes and covers the end face of the outer sheath 1, and is rounded to serve as the contact end of the guidewire.

[0037] Specifically, the tubular shaping material layer 4 (with a certain length L1, made of TPU material, which has steam-forming properties) gives the distal end of the guidewire plasticity. During shaping, the shaping needle is bent at a certain angle and inserted into the tip of the guidewire. The tip of the guidewire will bend at a certain angle under the action of the shaping needle. After that, the guidewire is heated on steam for a certain period of time, and the shaping needle is removed. The tip of the guidewire will maintain a certain angle of bending. The TPU extends a certain length L2 beyond the tip of the hypotube, and the tip is rounded using a laser welding machine to prevent scratching blood vessels.

[0038] Working principle: The adjustable support guidewire of this application consists of an outer sheath 1 (hypo tube), a middle coiled spring 2, and a connecting tube 5 (sheath) forming a relatively fixed frame. The inner stainless steel ground core wire can be inserted into this frame. The support force is adjusted by adjusting the length of the inner core wire 3 inserted into the outer sheath 1 (including withdrawing the core wire to enhance the guidewire's flexibility to adapt to curved / distal vessels, and pushing / inserting the core wire to improve the guidewire's support to move the device). The inner core wire 3 is indirectly released or fixed by the Y valve located on the exposed part of the connecting tube 5 through the action of the connecting tube 5 (including the inner core wire 3 being released by the connecting tube 5 when the Y valve is loosened, allowing it to move freely to adjust the support force; and the Y valve tightening the connecting tube 5 when the Y valve is tightened, thereby fixing the inner core wire 3 to maintain stable support force). At the same time, the tubular TPU shaping material layer 4 covering the distal end of the outer sheath 1 can be shaped to form a specific angle to adapt to tortuous vessels, and the distal end of this material layer is rounded to avoid scratching the vessels.

[0039] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A shapeable guidewire with adjustable support force, characterized in that, The utility model relates to a kind of medical devices, including: Outer sheath (1), is a continuous and has the cutting pipe of pressure and torsion control transmission performance; Middle layer coil spring (2), tightly packed in the outer sheath (1); Inner layer core wire (3), is arranged in the middle layer coil spring (2) and the outer sheath (1); Wherein, the inner layer core wire (3) is movably or fixedly arranged relative to the middle layer coil spring (2), for adjusting its length inserted into the outer sheath (1) to adjust the support of the guide wire.

2. The support force adjustable, contouring guidewire of claim 1, wherein, The outer sheath (1) adopts hypotube, and the tube wall has spiral or mesh incision, for keeping certain flexibility and providing pressure resistance and torsion control transmission performance.

3. The support force adjustable, contouring guidewire of claim 1, wherein, The middle layer coil spring (2) adopts integrated or segmented structure, when adopting segmented structure, its distal end segment is packed in the distal end of the inner layer core wire (3), for realizing development.

4. The support force adjustable, contouring guidewire of claim 1, wherein, The inner layer core wire (3) adopts stainless steel grinding core wire, which has gradient rigidity after precision grinding treatment.

5. The support force adjustable, contouring guidewire of claim 1, wherein, It further includes connecting tube (5), and its distal end is tightly packed in the proximal end of the middle layer coil spring (2); The inner layer core wire (3) is also arranged in the connecting tube (5), and it is movably or fixedly arranged relative to the connecting tube (5).

6. The support force adjustable, contouring guidewire of claim 5, wherein, The connecting tube (5) is extended to the proximal end, and the part is exposed outside the outer sheath (1).

7. The support force adjustable, contouring guidewire of claim 5, wherein, The connecting tube (5) adopts sheath tube.

8. The support force adjustable, contouring guidewire of claim 6, wherein, It further includes elastic member, and the elastic member is arranged on the exposed part of the connecting tube (5), for releasing or fixing the inner layer core wire (3) by loosening or tightening the connecting tube (5).

9. The support force adjustable, contouring guidewire of claim 1, wherein, The distal end of the outer sheath (1) is covered with tubular plastic material layer (4), for making the distal end part of the guide wire have plasticity.

10. The support force adjustable, contouring guidewire of claim 9, wherein, The distal end of the plastic material layer (4) protrudes and covers the end face of the outer sheath (1), and is rounded, as the contact head end of the guide wire.

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