Guide wire and extracorporeal circulation puncture sleeve bag
By using reinforcement agents and nickel-titanium alloy materials in the guidewire, combined with sheath and hydrophilic coating, the problem of insufficient guidewire strength is solved, achieving efficient operation and safety in vascular intervention.
Patent Information
- Application Number
- CN202411326012.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-09-23
- Publication Date
- 2024-12-27
AI Technical Summary
The existing guidewire is insufficient, which leads to inconvenient use in vascular intervention and makes it difficult to effectively treat vascular diseases.
Using a wire and core wire design including reinforcement, combined with sheath, hydrophilic coating and marking points, Ni-titanium alloy and nanoparticle reinforcement are added to the core wire and wire winding material of the guide wire, and through the dilator and introduction The device assists in handling, and the guide wire design improves mechanical strength and flexibility.
It improves the mechanical strength and flexibility of the guidewire, enhances patency and operation stability in complex blood vessels, and improves the success rate and safety of interventional surgery.
Smart Images
Figure CN119185751A_ABST
Abstract
Description
Technical Field
[0001] The present application relates to the field of medical technology, and in particular to a guide wire and an extracorporeal circulation puncture kit. Background Art
[0002] With the improvement of living standards, the incidence of vascular diseases has gradually increased. In order to treat vascular diseases, minimally invasive intervention has become an important clinical treatment method. Guidewires are commonly used materials in minimally invasive interventions. They are used to guide other devices into blood vessels, establish percutaneous access pathways that help intravascular devices, or perform intravascular positioning, or establish intravascular pathways. However, the guidewires in existing designs are not strong enough, which brings inconvenience in use.
[0003] Improvements in guidewires are urgently needed to more effectively treat patients. Summary of the invention
[0004] The present application mainly provides a guide wire, which has the advantage of good strength.
[0005] In order to solve the above technical problems, the technical solution adopted in the present application is: to provide a guide wire, which includes a winding wire and a core wire, both ends of the winding wire are connected to the core wire, and the core wire connected at one end of the winding wire constitutes the proximal end of the guide wire, and the core wire connected at the other end constitutes the distal end of the guide wire; wherein the material of at least one of the core wire and the winding wire includes a reinforcing agent.
[0006] Wherein, the reinforcing agent includes a nano-particle reinforcing agent; the material of the core wire further includes a metal, and the material of the core wire further includes a nickel-titanium alloy.
[0007] The guide wire further includes a sheath, a hydrophilic coating and a marking point, wherein the sheath surrounds the core wire and the winding wire; the material of the sheath includes at least one of polyurethane (PU) and tungsten; the hydrophilic coating is formed on the outer surface of the sheath; the material of the hydrophilic coating includes polyvinyl pyrrolidone (PVP); the marking point is formed on the winding wire, and the material of the marking point includes ink.
[0008] There are two marking points, and the two marking points are arranged at intervals along the extension direction of the winding wire; and / or the core wire constituting the distal end of the guide wire is hook-shaped.
[0009] In order to solve the above technical problems, the present application also provides an extracorporeal circulation puncture kit, which includes the guide wire described in the above embodiment. The extracorporeal circulation puncture kit also includes a dilator, and the dilator includes a pipe and a tube seat. The pipe and the tube seat are connected by a Luer method.
[0010] The extracorporeal circulation puncture kit also includes a guidewire introducer, which is connected to the guidewire and is used to assist in the manipulation of the guidewire during interventional surgery.
[0011] The extracorporeal circulation puncture kit further comprises a puncture needle, which comprises a puncture needle tube and a puncture needle tube seat connected to each other and a kit, wherein the kit is sleeved on the outside of the puncture needle tube.
[0012] Among them, the extracorporeal circulation puncture kit also includes a cutting knife, which includes a blade and a handle connected to each other and a protective cover, and the protective cover is used to cover the blade; the material of the blade includes at least one of carbon tool steel or alloy tool steel, the material of the handle includes polystyrene (PS); the material of the protective cover includes high-density polyethylene (HDPE).
[0013] Among them, the extracorporeal circulation puncture kit also includes a flusher; the flusher includes sensors and microelectronic devices, wherein the sensors are used to monitor blood flow status and pressure changes; the microelectronic devices are used to perform data analysis and algorithm optimization based on the information measured by the sensors, and automatically adjust the pump speed and flow rate of the flusher.
[0014] Wherein, the outer surface of at least one of the puncture needle, the guide wire or the guide wire introducer further includes a passivation layer, and the passivation layer is obtained through the plasma treatment technology.
[0015] Wherein, the outer surface of at least one of the puncture needle, the guide wire or the guide wire introducer further includes an anticoagulant coating, and the anticoagulant coating is prepared by coating with an anticoagulant active substance.
[0016] Wherein, the material of the dilator, the incision knife or the puncture needle includes polymer material.
[0017] The beneficial effects of the present application are as follows: in the present application, the elastic member is arranged around the stent body, and a plurality of elastic members are arranged in the axial direction of the stent body, so that the stent body has elasticity; the stent body is a hollow structure, which is convenient for blood flow. When the blood flow pressure in the stent body is relatively large, the elastic member will be squeezed to expand outward, thereby increasing the inner diameter of the guide wire and the extracorporeal circulation puncture kit, so that more blood can pass through. The guide wire and the extracorporeal circulation puncture kit in the present application can flexibly adjust the inner diameter according to the blood flow pressure, and the adjustment method is simple and easy to implement. At the same time, the stent has a good use effect, the patency rate of branch blood vessels is improved, and the rate of device re-intervention is low. BRIEF DESCRIPTION OF THE DRAWINGS
[0018] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for the description of the embodiments. 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 creative work. Among them:
[0019] Figure 1 This is a schematic structural diagram of an implementation method of a guide wire in this application;
[0020] Figure 2 for Figure 1 A schematic cross-sectional structure diagram of an implementation method of a middle guide wire;
[0021] Figure 3 This is a schematic structural diagram of an embodiment of an extracorporeal circulation puncture kit in the present application;
[0022] Figure 4 for Figure 3 A schematic structural diagram of another embodiment of a dilator in an extracorporeal circulation puncture kit;
[0023] Figure 5 for Figure 3 A schematic structural diagram of an embodiment of a guide wire and a puncture needle in an extracorporeal circulation puncture kit;
[0024] Figure 6 for Figure 3 A schematic structural diagram of an implementation scheme of a central guide wire and a central incision knife in an extracorporeal circulation puncture kit.
[0025] Explanation of reference numerals: 100 guide wire and extracorporeal circulation puncture kit; 10 guide wire; 11 core wire; 12 wire wrap; 13 proximal end; 14 distal end; 15 sheath; 16 marking point; 17 hydrophilic coating; 20 dilator; 21 pipeline; 22 tube seat; 30 guide wire introducer; 40 puncture needle; 41 puncture needle tube; 42 puncture needle tube seat; 43 kit; 50 incision knife; 51 blade; 52 knife handle; 53 protective cover; 60 irrigator; D diameter. DETAILED DESCRIPTION
[0026] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.
[0027] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by technicians in the technical field to which this application belongs; the terms used herein are only for the purpose of describing specific embodiments and are not intended to limit this application; the terms "including" and "having" in the specification and claims of this application and the above-mentioned figure descriptions and any variations thereof are intended to cover non-exclusive inclusions.
[0028] In the description of the embodiments of the present application, the technical terms "first", "second", etc. are only used to distinguish different objects, and cannot be understood as indicating or implying relative importance or implicitly indicating the number, specific order or primary and secondary relationship of the indicated technical features. In the description of the embodiments of the present application, the meaning of "multiple" is more than two, unless otherwise clearly and specifically defined.
[0029] Reference to "embodiments" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.
[0030] In the description of the embodiments of the present application, unless otherwise clearly specified and limited, technical terms such as "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, and it can be the internal connection of two elements or the interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the embodiments of the present application can be understood according to the specific circumstances.
[0031] See also Figure 1 and Figure 2 The present application provides a guide wire 10, which includes a winding wire 12 and a core wire 11, wherein both ends of the winding wire 12 are connected to the core wire 11, and the core wire 11 connected at one end of the winding wire 12 constitutes the proximal end 13 of the guide wire 10, and the core wire 11 connected at the other end constitutes the distal end 14 of the guide wire 10; wherein the material of at least one of the core wire 11 and the winding wire 12 includes an enhancer.
[0032] Specifically, the core wire 11 located at both ends of the winding wire 12 constitutes the proximal end 13 and the distal end 14 of the guide wire 10, respectively. The distal end 14 is the end away from the operator, and the proximal end 13 is the end close to the operator. By rotating the guide wire 10 at the proximal end 13, the rotation of the distal end 14 of the guide wire 10 can be driven. For example, for every 90° rotation of the proximal end 13 of the guide wire 10, the rotation angle of the distal end 14 is not less than 60°; for every 360° rotation of the proximal end 13, the rotation angle of the distal end 14 is not less than 300°. In the present application, by using an enhancer in the core wire 11 or the winding wire 12 of the guide wire 10, or using an enhancer in both the core wire 11 and the winding wire 12, the mechanical strength of the guide wire 10 can be improved to meet the use requirements. When the guide wire 10 containing an enhancer is used during surgery, it is also conducive to the stable operation and improved safety.
[0033] Further, the reinforcing agent includes a nanoparticle reinforcing agent. By adding the nanoparticle reinforcing agent to the guide wire 10, the mechanical strength and mechanical properties of the guide wire 10 can be effectively improved, and the durability of the guide wire 10 can also be improved. During use, the stability of the use of the guide wire 10 is enhanced to ensure stable performance during long-term surgery. Among them, the particle size of the nanoparticle reinforcing agent is between 1 and 100 nanometers. Specifically, the particle size of the nanoparticle reinforcing agent can be 1, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 nanometers.
[0034] In one embodiment, the nanoparticle reinforcing agent includes at least one of nano-alumina, nano-zero-valent iron, and nano-titanium dioxide. Specifically, the nanoparticle reinforcing agent of the guide wire 10 in the present application includes one or a combination of nano-alumina, nano-zero-valent iron, or nano-titanium dioxide. Of course, the nanoparticle reinforcing agent of the guide wire 10 in the present application may include all of nano-alumina, nano-zero-valent iron, or nano-titanium dioxide.
[0035] In one embodiment, the material of the core wire 11 further includes metal, and the material of the core wire 11 further includes nickel-titanium alloy. The metal material has good rigidity, which meets the use requirements of the core wire 11. Nickel-titanium alloy is a shape memory alloy, which is a special alloy that can automatically restore its own plastic deformation to its original shape at a certain temperature. It has good plasticity and meets the use requirements of the core wire 11. The use of nickel-titanium alloy makes the guide wire 10 have better elasticity, flexibility and scalability, is not easy to deform when used in complex vascular lesions, has good durability, and has excellent compliance and support. In another embodiment, the material of the core wire 11 includes a new type of stainless steel, and the use of the new type of stainless steel material makes the guide wire 10 have better maneuverability and tracking.
[0036] In one embodiment, the diameter D of the guide wire 10 is 0.5-0.65 mm. Specifically, the diameter D of the guide wire 10 can be 0.5, 0.55, 0.6 or 0.65 mm.
[0037] Please continue reading Figure 2 The guidewire 10 also includes a sheath 15, which surrounds the core wire 11 and the winding wire 12; the material of the sheath 15 includes at least one of polyurethane (PU) and tungsten. The design of the sheath 15 surrounding the core wire 11 and the winding wire 12 can protect the core wire 11 and the winding wire 12, while preventing the core wire 11 and the winding wire 12 from directly contacting the outside world. The use of the sheath 15 can also facilitate the application of the guidewire 10. In one embodiment, the material of the sheath 15 is selected from polyurethane or tungsten, or a combination of polyurethane and tungsten, which has a wear-resistant effect, and can extend the service life of the sheath 15, while making the surface of the guidewire 10 smooth, reducing the passing resistance of the guidewire 10.
[0038] In one embodiment, the guidewire 10 also includes a hydrophilic coating 17 formed on the outer surface of the sheath 15; the material of the hydrophilic coating 17 includes polyvinyl pyrrolidone (PVP). Specifically, the design of the hydrophilic coating 17 can reduce the friction during the use of the guidewire 10, and the hydrophilic coating 17 attracts water molecules to form a "gel-like" surface on the surface of the guidewire 10. Reduce the friction during the use of the guidewire 10. PVP is a non-ionic polymer compound with excellent stability during use. Of course, in another embodiment, a hydrophobic coating can be used instead of the hydrophilic coating 17. The hydrophobic coating resists water molecules to form a "wax-like" surface on the surface of the guidewire 10, reduce friction, and increase the traceability of the guidewire 10. In another embodiment, the guidewire 10 in the present application can also adopt a design combining a hydrophilic coating 17 and a hydrophobic coating.
[0039] Please continue reading Figure 2 The guide wire 10 further includes a marking point 16 formed on the winding wire 12, and the material of the marking point 16 includes ink. Specifically, the design of the marking point 16 facilitates the determination of the position of the guide wire 10 and facilitates its use. The marking point 16 is made of ink, which has good visibility under X-ray and other examinations, and the marking point 16 can help doctors accurately find and operate the guide wire 10 during complex surgical procedures.
[0040] Please continue reading Figure 2, the number of marking points 16 is two, and the two marking points 16 are arranged at intervals along the extension direction of the winding wire 12. The marking points 16 are arranged at intervals to facilitate the operator to measure the length of the lesion area. In one embodiment, more marking points 16, such as 3, 4, 5 or more marking points 16, can be set, and the multiple marking points 16 are arranged at equal intervals, and the interval between adjacent marking points 16 can be 5mm, 8mm or 10mm, so that the operator can accurately obtain the length information of the lesion area.
[0041] In one embodiment, the core wire 11 constituting the distal end 14 of the guide wire 10 is hook-shaped. The hook-shaped design can better adapt to the curvature of the blood vessel, can more easily pass through the complex vascular lesions, is suitable for complex interventional surgery, and can improve the success rate of the surgery. Of course, in another embodiment, the core wire 11 constituting the distal end 14 of the guide wire 10 is straight, that is, a straight-tip guide wire, which is convenient for passing through narrow blood vessels, is suitable for relatively simple interventional surgery, and is relatively simple to operate.
[0042] See also Figure 3 and Figure 4 The present application also provides an extracorporeal circulation puncture kit 100, which includes the guide wire 10 described in the above embodiment. The extracorporeal circulation puncture kit 100 also includes a dilator 20, and the dilator 20 includes a pipe 21 and a tube seat 22, and the pipe 21 and the tube seat 22 are connected by a Luer method. The dilator 20 is used in percutaneous puncture surgery to expand, establish and maintain a percutaneous puncture channel. Specifically, the dilator 20 seat is a locking 6% Luer internal cone connector, and the minimum peak tension at the connection between the dilator 20 pipe 21 and the tube seat 22 is 15N. The dilator 20 in the present application adopts percutaneous puncture technology (Seldinger technique) to establish a percutaneous access pathway that helps intravascular devices, and does not have the function of intravascular positioning or establishing an intravascular pathway. Therefore, the Seldinger technique mostly refers to the vascular puncture technique in digital subtraction angiography.
[0043] Please continue reading Figure 3 The extracorporeal circulation puncture kit 100 also includes a guidewire introducer 30, which is connected to the guidewire 10 and is used to assist in the manipulation of the guidewire 10 during the interventional surgery. The guidewire introducer 30 is made of polypropylene (PP) and acrylonitrile-butadiene-styrene copolymer (ABS). The guidewire introducer 30 is provided to facilitate the use of the guidewire 10. At the same time, PP and ABS materials are easy to obtain, which is conducive to the preparation of the guidewire introducer 30.
[0044] Please continue reading Figure 3 and Figure 5The extracorporeal circulation puncture kit 100 also includes a puncture needle 40, which includes a puncture needle tube 41 and a puncture needle tube seat 42 connected to each other and a set 43, which is sleeved on the outside of the puncture needle tube 41. Among them, the puncture needle tube 41 is used for puncture operations, the puncture tube seat 22 is convenient for users to take, and the set 43 is used to protect the puncture needle tube 41. The puncture needle 40 is used to puncture the human body, and its use is used to establish a percutaneous access path that helps intravascular devices.
[0045] Please continue reading Figure 3 and Figure 6 The extracorporeal circulation puncture kit 100 further includes a scalpel 50, which includes a blade 51, a handle 52 and a protective cover 53 connected to each other. The protective cover 53 is used to cover the blade 51. Specifically, the blade 51 is used to cut the skin, the handle 52 is convenient for the operator to hold, and the protective cover 53 is covered on the blade 51 to protect the blade 51. The scalpel 50 can be used once during surgery.
[0046] In one embodiment, the material of the blade 51 includes at least one of carbon tool steel or alloy tool steel. The use of carbon tool steel or alloy tool steel can ensure the use effect of the blade 51.
[0047] In one embodiment, the material of the knife handle 52 includes polystyrene (PS). Polystyrene is easy to obtain, so the knife handle 52 is easy to prepare.
[0048] In one embodiment, the material of the protective cover 53 includes high-density polyethylene (HDPE). Polyethylene can effectively protect the blade 51 and is easy to obtain, which is beneficial to the preparation of the protective cover 53.
[0049] In one embodiment, the extracorporeal circulation puncture kit 100 further includes a flusher 60; the flusher 60 includes sensors and microelectronic devices, wherein the sensors are used to monitor blood flow status and pressure changes; the microelectronic devices are used to perform data analysis and algorithm optimization based on the information measured by the sensors, and automatically adjust the pump speed and flow rate of the flusher 60. Specifically, the flusher 60 is used to flush the surgical site to facilitate further surgery by the surgeon. Advanced manufacturing processes such as laser cutting and 3D printing are used for the flusher 60 to ensure that the various parts are tightly connected, and delamination and damage are not likely to occur, thereby ensuring the use effect.
[0050] In one embodiment, the outer surface of at least one of the puncture needle 40, the guide wire 10 or the guide wire introducer 30 further includes a passivation layer, which is obtained by plasma treatment technology. The blood contact surface of the puncture needle 40, the guide wire 10 or the guide wire introducer 30 is physically modified by plasma treatment technology to increase the surface energy, thereby increasing the anti-coagulation function.
[0051] In one embodiment, the outer surface of at least one of the puncture needle 40, the guide wire 10 or the guide wire introducer 30 further includes an anticoagulant coating, which is prepared by coating with an anticoagulant active substance. By coating the surface of the puncture needle 40, the guide wire 10 or the guide wire introducer 30 that contacts the blood with an anticoagulant coating containing an anticoagulant active substance, it helps to reduce the risk of thrombosis and prolong the service life of the extracorporeal circulation puncture kit 100.
[0052] In addition, the materials of the dilator 20, the incision knife 50 or the puncture needle 40 in the present application include polymer materials. Specifically, the polymer materials include polypropylene (PP) and acrylonitrile-butadiene-styrene copolymer (ABS). Polymer materials have excellent biocompatibility and can significantly reduce immune response and inflammatory response. At the same time, the components of the extracorporeal circulation puncture kit 100 in the present application can be prepared using microfluidic technology to accurately control the size and shape of each component of the dilator 20, the guide wire 10, the incision knife 50, the puncture needle 40, the irrigator 60 and the guide wire introducer 30, thereby improving the consistency and reliability of the product.
[0053] The above description is only an implementation method of the present application, and does not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made using the contents of the present application specification and drawings, or directly or indirectly used in other related technical fields, are also included in the patent protection scope of the present application.
Claims
1. A guide wire, characterized in that: include: Wire winding; A core wire, both ends of the winding wire are connected with a core wire, and the core wire connected to one end of the winding wire constitutes the proximal end of the guide wire, and the core wire connected to the other end constitutes the distal end of the guide wire; Wherein, the material of at least one of the core wire and the winding wire includes a reinforcing agent.
2. The guide wire according to claim 1, characterized in that The reinforcing agent includes a nanoparticle reinforcing agent; The material of the core wire further includes metal, and the material of the core wire further includes nickel-titanium alloy.
3. The guide wire according to claim 2, characterized in that Also includes: A sheath, surrounding the core wire and the winding wire; the material of the sheath comprises at least one of polyurethane (PU) and tungsten; A hydrophilic coating formed on the outer surface of the sheath; The material of the hydrophilic coating includes polyvinyl pyrrolidone (PVP); Marking points are formed on the winding wire, and the material of the marking points includes ink.
4. The guide wire according to claim 3, characterized in that The number of the marking points is two, and the two marking points are arranged at intervals along the extension direction of the winding wire; And / or, the core wire constituting the distal end of the guide wire is hook-shaped.
5. An extracorporeal circulation puncture kit, comprising the guide wire according to any one of claims 1 to 4, characterized in that: The extracorporeal circulation puncture kit also includes: The expander comprises a pipe and a pipe seat, wherein the pipe and the pipe seat are connected by Luer connection.
6. The extracorporeal circulation puncture kit according to claim 5, characterized in that: Also includes: A guidewire introducer is connected to the guidewire and is used to assist in the manipulation of the guidewire during interventional surgery.
7. The extracorporeal circulation puncture kit according to claim 5, characterized in that: Also includes: A puncture needle, comprising: A puncture needle tube and a puncture needle tube seat connected to each other; The kit is sleeved on the outer side of the puncture needle tube.
8. The extracorporeal circulation puncture kit according to claim 5, characterized in that: Also includes: A cutting knife, comprising: interconnected blade and handle; A protective cover, used for covering the blade; The material of the blade includes at least one of carbon tool steel or alloy tool steel. The material of the knife handle includes polystyrene (PS); The material of the protective sleeve includes high-density polyethylene (HDPE).
9. The extracorporeal circulation puncture kit according to claim 5, characterized in that: Also includes: Flushing device; The flusher includes: a sensor for monitoring blood flow status and pressure changes; A microelectronic device is used to perform data analysis and algorithm optimization based on the information measured by the sensor, and automatically adjust the pump speed and flow rate of the flusher.
10. The extracorporeal circulation puncture kit according to claim 6 or 7, characterized in that: The outer surface of at least one of the puncture needle, the guide wire or the guide wire introducer further comprises: The passivation layer is obtained by plasma treatment technology.
11. The extracorporeal circulation puncture kit according to claim 6 or 7, characterized in that: The outer surface of at least one of the puncture needle, the guide wire or the guide wire introducer further comprises: The anticoagulant coating is prepared by coating with an anticoagulant active substance.
12. The extracorporeal circulation puncture kit according to any one of claims 5 to 8, characterized in that: The material of the dilator, the incision knife or the puncture needle includes a polymer material.