Kink-resistant high-strength PTCA guide wire and use method thereof

Abstract

The invention relates to the technical field of medical instruments, and discloses an anti-kink high-strength PTCA guide wire and a use method.The anti-kink high-strength PTCA guide wire comprises a near-end pushing rod, a coaxial composite core assembly is arranged on the outer side of the near-end pushing rod, and a protection assembly is arranged on the outer side of the coaxial composite core assembly; the end, away from the coaxial composite core assembly, of the protection assembly is fixedly connected with an end head, a connecting assembly is arranged between the end head and the coaxial composite core assembly, the coaxial composite core assembly comprises a core shaft, the core shaft is arranged in the middle of the near-end pushing rod, an inner core is arranged on the periphery of the core shaft, and the inner core is arranged in the middle of the near-end pushing rod. And the periphery of the inner core is fixedly connected with a shell pipe. The periphery of the inner core is coated with the outer shell tube made of the nickel-titanium alloy, and when the guide wire is bent along with a blood vessel path, the elastic restoring force of the outer shell tube can offset part of bending stress, so that the inner core and the mandrel in the guide wire are protected against plastic deformation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an anti-kink high-strength PTCA guidewire and its usage method. Background Technology

[0002] Percutaneous transluminal coronary angioplasty (PTCA) is currently the main minimally invasive procedure for treating coronary artery stenosis or occlusion. The guidewire is primarily used to guide the balloon catheter or stent accurately to the lesion site. The guidewire's passageway, maneuverability, and structural stability within the blood vessel directly affect the success rate and efficiency of the procedure.

[0003] In existing technologies, to ensure sufficient pushing force on the guidewire, its mandrel is typically made of a single metal material with high rigidity. However, when this type of mandrel passes through vascular lesions with high tortuosity or severe calcification, it is prone to plastic deformation due to stress exceeding the material's yield limit. This causes the guidewire tip to fail to return to its original straight shape, thereby losing subsequent directional selection ability and control precision.

[0004] Existing guidewires often have a sheath made of a single polymer tubing, lacking an effective radial support structure. When the guidewire travels through sharp bends in a blood vessel, the sheath is prone to flattening or even sharp-angle creases under bending stress. This not only increases the frictional resistance of the guidewire within the blood vessel but may also damage the inner wall of the vessel.

[0005] The transition of the guidewire from a highly rigid pusher to a flexible tip typically requires an extremely reliable connection structure. Traditional connection methods often employ simple butt welding or adhesive bonding, resulting in abrupt stiffness transitions at the interface and limited contact area. During surgical procedures involving rotation or penetration of hard plaques, the connection point often becomes a weak point of stress concentration, prone to breakage or detachment due to fatigue or overload, posing serious safety risks to the procedure.

[0006] Therefore, this invention proposes an anti-kink high-strength PTCA guidewire and its usage method to overcome the shortcomings of the prior art. Summary of the Invention

[0007] To address the shortcomings of existing technologies, this invention provides a high-strength, kink-resistant PTCA guidewire and its usage method. This solves the problems in existing technologies, such as the guidewire mandrel easily undergoing plastic deformation and losing its shape recovery ability in tortuous or calcified blood vessels, the sheath layer being easily flattened and bent due to lack of radial support, leading to corrosion of internal components, and the guidewire tip connection transition being prone to breakage or detachment due to stress concentration.

[0008] To achieve the above objectives, the present invention provides a high-strength PTCA guidewire with anti-kink, including a proximal push rod, a coaxial composite core assembly disposed on the outer side of the proximal push rod, a protective assembly disposed on the outer side of the coaxial composite core assembly, an end cap fixedly connected to the end of the protective assembly away from the coaxial composite core assembly, and a connecting assembly disposed between the end cap and the coaxial composite core assembly.

[0009] The coaxial composite core assembly includes a mandrel, which is located in the middle of the proximal push rod. An inner core is provided on the outer periphery of the mandrel, and an outer shell tube is fixedly connected to the outer periphery of the inner core. A tip is fixedly connected to the end of the mandrel away from the proximal push rod.

[0010] Preferably, the protective component includes a sheath disposed between the outer shell tube and the end, the outer periphery of the sheath being provided with a polymer fiber woven mesh, and both the polymer fiber woven mesh and the outer periphery of the outer shell tube being covered with a polymer outer jacket, the outer side of the polymer outer jacket being coated with a hydrophilic coating.

[0011] Preferably, a fixing block is fixedly connected to the outer periphery of the tip, and the connecting component is disposed between the fixing block and the tip.

[0012] Preferably, the connecting assembly includes a first connecting end and a second connecting end. The first connecting end is fixedly connected to the middle of the fixing block, and the second connecting end is fixedly connected to the middle of the end. A second connecting rod is provided at the end of the first connecting end and the second connecting end that are close to each other. A first connecting rod is provided at the other end of the plurality of second connecting rods. The first connecting rod and the second connecting rod are interleaved. The first connecting end, the second connecting rod, the first connecting rod and the second connecting end are connected by a nickel-titanium sodium thiosulfate tube.

[0013] Preferably, a first high-strength adhesive is provided between the fixing block and the first connecting end, and a second high-strength adhesive is provided between the end and the second connecting end.

[0014] Preferably, the nickel-titanium sodium thiosulfate tube has multiple welding holes in its middle section, which are used to improve the connection stability between the first connecting end, the second connecting rod, and the first connecting rod and the second connecting end by increasing the number of welding points.

[0015] Preferably, the inner core, the first connecting end, the second connecting end, and the first connecting rod are all made of high-strength stainless steel, while the outer shell tube and the second connecting rod are both made of nickel-titanium alloy.

[0016] A second aspect of the present invention provides a method for using an anti-kink high-strength PTCA guidewire, comprising:

[0017] S1. Preoperative preparation: Use saline to soak the protective component, activate the hydrophilic coating on the outside of the polymer jacket to reduce the surface friction coefficient, and check the connection status between the proximal push rod and the end.

[0018] S2, Interventional Push: The guidewire is inserted into the blood vessel by operating the proximal push rod. The coaxial composite core assembly is used to transmit axial thrust. At this time, the inner core and the outer shell bend synchronously with the blood vessel path, and the outer shell provides elastic support to protect the internal structure from plastic deformation.

[0019] S3. Crossing the lesion: When the guidewire travels to the tortuous or stenotic lesion, the first and second connecting rods in the connecting assembly work together with the nickel-titanium thiosulfate tube to achieve multi-directional adaptive bending of the tip. At the same time, the polymer fiber braided mesh in the protective assembly resists the radial pressure of the blood vessel wall and maintains the circular cross section of the sheath to prevent kinking.

[0020] S4. Retraction and Withdrawal: After the surgical procedure is completed, the guidewire is retracted. The elastic restoring force of the outer shell and mandrel is used to eliminate bending stress, so that the guidewire returns to a straight shape and is withdrawn from the body.

[0021] This invention provides a high-strength, anti-kink PTCA guidewire and its application method. It offers the following advantages:

[0022] 1. This invention enhances the guidewire's resistance to deformation through a coaxial composite core assembly. A nickel-titanium alloy outer shell surrounds the inner core; when the guidewire bends along the blood vessel path, the elastic restoring force of the outer shell offsets some of the bending stress, thus protecting the inner core and mandrel from plastic deformation. This ensures the guidewire returns to its original straight shape after passing through tortuous blood vessels, maintaining the guidewire's control precision.

[0023] 2. This invention utilizes protective components to enhance the guidewire's anti-kink performance and corrosion resistance. The polymer fiber woven mesh provides radial support, allowing the guidewire to maintain the circular cross-section of the sheath even when bent, preventing creases or dead kinks caused by local flattening. At the same time, the polymer jacket, combined with a hydrophilic coating, constructs a water-blocking barrier, which reduces the surface friction coefficient to improve blood vessel permeability while effectively preventing blood or body fluids from seeping into the guidewire, thus avoiding the failure of internal metal components due to liquid corrosion.

[0024] 3. This invention optimizes the stress distribution and connection strength of the guidewire tip through the connecting components. The staggered first and second connecting rods are used in conjunction with the nickel-titanium sodium thiosulfate tube for fixation, allowing the guidewire tip to adapt to bending requirements in multiple directions. By filling the connection end with high-strength adhesive between the connection end and the fixing block and the end, and by laser welding the connection nodes, the concentrated stress generated during bending can be evenly distributed to different nodes, avoiding the risk of breakage due to excessive local stress, thereby improving the safety of surgical procedures. Attached Figure Description

[0025] Figure 1 This is a perspective view of the present invention;

[0026] Figure 2 This is a schematic diagram of the polymer fiber woven mesh of the present invention;

[0027] Figure 3 This is a schematic diagram of the sheath of the present invention;

[0028] Figure 4 This is a schematic diagram of the coaxial composite core assembly of the present invention;

[0029] Figure 5 This is a schematic diagram of the connection component of the present invention;

[0030] Figure 6 This is a schematic cross-sectional view of the end of the present invention;

[0031] Figure 7 This is a schematic diagram of a nickel-titanium hypotube of the present invention.

[0032] Legend

[0033] 1. Proximal push rod; 2. Coaxial composite core assembly; 21. Outer shell tube; 22. Tip; 23. Inner core; 24. Mandrel; 3. Protective assembly; 31. Polymer fiber woven mesh; 32. Sheath; 33. Polymer outer jacket; 34. Hydrophilic coating; 4. Connecting assembly; 41. Nickel-titanium sodium thiosulfate tube; 42. First connecting end; 43. Second connecting end; 44. First connecting rod; 45. Second connecting rod; 5. Fixing block; 6. End; 7. First high-strength adhesive; 8. Second high-strength adhesive; 9. Welding hole. Detailed Implementation

[0034] The technical solutions in 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, and 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.

[0035] Please see the appendix Figure 1 - Appendix Figure 5 The present invention provides a high-strength PTCA guidewire with anti-kink, including a proximal push rod 1, a coaxial composite core assembly 2 disposed on the outside of the proximal push rod 1, a protective assembly 3 disposed on the outside of the coaxial composite core assembly 2, an end 6 fixedly connected to the end of the protective assembly 3 away from the coaxial composite core assembly 2, and a connecting assembly 4 disposed between the end 6 and the coaxial composite core assembly 2.

[0036] In one specific embodiment, the proximal pusher 1 constitutes the operating handle and main propulsion component of the guidewire, responsible for receiving the operator's mechanical input and for delivering the guidewire distally during interventional surgery. The coaxial composite core assembly 2, as an extension carrier of the proximal pusher 1, serves to bear and transmit mechanical energy. The proximal pusher 1 and the coaxial composite core assembly 2 are structurally closely fitted, providing axial support stiffness for the guidewire as it travels within the blood vessel. The protective assembly 3 covers the periphery of the coaxial composite core assembly 2 and the connecting parts, forming the interface layer where the guidewire directly contacts the vessel wall, providing crucial radial support and preventing the guidewire from flattening or bending during sharp bending, thereby maintaining good device shape. The connecting assembly 4, as a flexible hub for force transmission, precisely transmits the torsional force from the coaxial composite core assembly 2 to the tip 6. This structure ensures efficient force transmission while providing multiple degrees of freedom for bending. Combined with the internal high-strength adhesive layer to buffer stress, it effectively prevents the guidewire from breaking or falling off due to local stress concentration when rotating through tortuous lesions.

[0037] Please see the appendix Figure 3 and attached Figure 4 The coaxial composite core assembly 2 includes a core shaft 24, which is located in the middle of the proximal push rod 1. An inner core 23 is provided on the outer periphery of the core shaft 24, and an outer shell tube 21 is fixedly connected to the outer periphery of the inner core 23. A tip 22 is fixedly connected to the end of the core shaft 24 away from the proximal push rod 1.

[0038] In one specific embodiment, the inner core 23 covers the outer periphery of the mandrel 24 to enhance the structural strength of the central portion. The outer shell 21 is made of a highly elastic nickel-titanium alloy and fits tightly against the outside of the inner core 23. When the guidewire bends along the vascular path, the outer shell 21 and the inner core 23 deform synchronously. The elastic restoring force of the outer shell 21 can offset part of the bending stress, protecting the inner core 23 and mandrel 24 from plastic deformation, thereby maintaining the original straight shape memory of the guidewire and ensuring that it can return to its original shape after the external force is removed, thus ensuring the effectiveness of the guidewire in the blood vessel.

[0039] Please see the appendix Figure 1 - Appendix Figure 3 The protective component 3 includes a sheath 32, which is disposed between the outer shell tube 21 and the end 6. A polymer fiber woven mesh 31 is provided on the outer periphery of the sheath 32. Both the polymer fiber woven mesh 31 and the outer periphery of the outer shell tube 21 are covered with a polymer outer jacket 33. The outer side of the polymer outer jacket 33 is coated with a hydrophilic coating 34.

[0040] In one specific embodiment, the polymer fiber braided mesh 31 enhances the radial support of the sheath 32 through its physical braided structure. When the guidewire passes through a tortuous blood vessel, causing the core to bend, the braided layer can resist radial pressure, maintain the circular cross-sectional shape of the sheath 32, and prevent sharp-angle creases caused by local flattening. The polymer jacket 33 encapsulates the braided mesh and the outer shell tube 21, forming a continuous and smooth outer surface. The hydrophilic coating 34 reduces the surface friction coefficient upon contact with water, improving the guidewire's passage within the blood vessel. At the same time, this coating layer, together with the polymer jacket 33, forms a water-blocking barrier, preventing blood or body fluids from seeping into the guidewire and corroding the metal components.

[0041] Please see the appendix Figure 5 and attached Figure 6 A fixing block 5 is fixedly connected to the outer periphery of the tip 22, and the connecting component 4 is disposed between the fixing block 5 and the end 6.

[0042] In one specific embodiment, the fixing block 5 ensures a clear force transmission path, enabling the operator's control over the tip 22 to be effectively transmitted to the farthest end 6. At the same time, the presence of the fixing block 5 increases the contact area of ​​the connection interface, improving the reliability of the connection.

[0043] Please see the appendix Figure 5 - Appendix Figure 7 The connecting component 4 includes a first connecting end 42 and a second connecting end 43. The first connecting end 42 is fixedly connected to the middle of the fixing block 5, and the second connecting end 43 is fixedly connected to the middle of the end head 6. A second connecting rod 45 is provided at one end of the first connecting end 42 and the second connecting end 43. A first connecting rod 44 is provided at the other end of the plurality of second connecting rods 45. The first connecting rod 44 and the second connecting rod 45 are intersected. The first connecting end 42, the second connecting rod 45, the first connecting rod 44 and the second connecting end 43 are connected by a nickel-titanium sodium thiosulfate tube 41.

[0044] In one specific embodiment, the connecting component 4 adopts a multi-segmented, staggered rod structure. The rods extending from the first connecting end 42 and the second connecting end 43 are spatially staggered and secured by an external nickel-titanium thiosulfate tube 41 and laser-welded. The arrangement of multiple second connecting rods 45 enables the guidewire tip to bend in multiple directions and with multiple curvatures, adapting to complex vascular anatomy. The nickel-titanium thiosulfate tube 41, while fixing the positions of each component, limits excessive radial displacement of the connecting rods, ensuring structural integrity during bending.

[0045] Please see the appendix Figure 6 A first high-strength adhesive 7 is provided between the fixing block 5 and the first connecting end 42, and a second high-strength adhesive 8 is provided between the end 6 and the second connecting end 43.

[0046] In one specific embodiment, a first high-strength adhesive 7 is applied to the joint between the first connecting end 42 and the fixing block 5, and a second high-strength adhesive 8 is applied to the joint between the second connecting end 43 and the end cap 6. After curing, these adhesives form a stress-relief layer, which, in addition to its bonding and fixing function, also evenly distributes the stress concentrated at the connection point to the surrounding structure when the guidewire is bent. This stress dispersion mechanism reduces the risk of metal fatigue or fracture due to localized stress concentration, thus improving the safety of the guidewire under extreme bending conditions.

[0047] Please see the appendix Figure 7 The nickel-titanium sodium thiosulfate tube 41 has multiple welding holes 9 in the middle, which are used to improve the connection stability between the first connecting end 42, the second connecting rod 45, the first connecting rod 44 and the second connecting end 43 by increasing the welding points.

[0048] In one specific embodiment, welding holes 9 are distributed along the axial direction of the nickel-titanium sodium thiosulfate tube 41. During manufacturing, a laser beam passes through the welding holes 9 and acts directly on the first connecting rod 44 and the second connecting rod 45 inside, forming molten weld points. The presence of welding holes 9 increases the penetration depth and bonding area of ​​the solder, enabling the internal rods to form a strong metallurgical bond with the external sodium thiosulfate tube, preventing relative sliding or detachment of the components when subjected to axial tensile or torsional forces.

[0049] The inner core 23, the first connecting end 42, the second connecting end 43 and the first connecting rod 44 are all made of high-strength stainless steel, while the outer shell tube 21 and the second connecting rod 45 are both made of nickel-titanium alloy.

[0050] In one specific embodiment, the mechanical properties of different metallic materials are utilized to optimize guidewire performance. Specifically, the inner core 23, the first connecting end 42, the second connecting end 43, and the first connecting rod 44 are made of high-strength stainless steel, leveraging its high rigidity and excellent pushability to ensure the guidewire can effectively transmit operating forces. The outer shell tube 21 and the second connecting rod 45 are made of nickel-titanium alloy, utilizing the superelasticity and shape memory effect of nickel-titanium alloy to give the guidewire excellent flexibility and flexural strength, allowing it to conform to the curvature of the blood vessel without permanent deformation.

[0051] A second aspect of the present invention provides a method for using an anti-kink high-strength PTCA guidewire, comprising:

[0052] S1. Preoperative preparation: Use saline to wet the protective component 3, activate the hydrophilic coating 34 on the outside of the polymer jacket 33 to reduce the surface friction coefficient, and at the same time check the connection status between the proximal push rod 1 and the end 6.

[0053] S2, Interventional Push: The guidewire is inserted into the blood vessel by operating the proximal push rod 1. The coaxial composite core assembly 2 is used to transmit axial thrust. At this time, the inner core 23 and the outer shell tube 21 bend synchronously with the blood vessel path, and the outer shell tube 21 provides elastic support to protect the internal structure from plastic deformation.

[0054] S3. Crossing the lesion: When the guidewire travels to the tortuous or stenotic lesion, the first connecting rod 44 and the second connecting rod 45, which are staggered in the connecting component 4, work together with the nickel-titanium thiosulfate tube 41 to achieve multi-directional adaptive bending of the end 6. At the same time, the polymer fiber braided mesh 31 in the protective component 3 is used to resist the radial pressure of the blood vessel wall and maintain the circular cross section of the sheath 32 to prevent kinking.

[0055] S4. Retraction and withdrawal: After the surgical procedure is completed, the guidewire is retracted. The elastic restoring force of the outer shell tube 21 and the mandrel 24 is used to eliminate the bending stress, so that the guidewire returns to a straight shape and is withdrawn from the body.

Claims

1. A high-strength, kink-resistant PTCA guidewire, comprising a proximal pusher (1), characterized in that, A coaxial composite core assembly (2) is provided on the outside of the proximal push rod (1), and a protective assembly (3) is provided on the outside of the coaxial composite core assembly (2). An end (6) is fixedly connected to the end of the protective assembly (3) away from the coaxial composite core assembly (2), and a connecting assembly (4) is provided between the end (6) and the coaxial composite core assembly (2). The coaxial composite core assembly (2) includes a core shaft (24), which is located in the middle of the proximal push rod (1). An inner core (23) is provided on the outer periphery of the core shaft (24), and an outer shell tube (21) is fixedly connected to the outer periphery of the inner core (23). A tip (22) is fixedly connected to the end of the core shaft (24) away from the proximal push rod (1).

2. The anti-kink high-strength PTCA guidewire according to claim 1, characterized in that, The protective component (3) includes a sheath (32), which is disposed between the outer shell tube (21) and the end (6). A polymer fiber woven mesh (31) is provided on the outer periphery of the sheath (32). Both the polymer fiber woven mesh (31) and the outer periphery of the outer shell tube (21) are covered with a polymer outer jacket (33). The outer side of the polymer outer jacket (33) is coated with a hydrophilic coating (34).

3. The anti-kink high-strength PTCA guidewire according to claim 1, characterized in that, A fixing block (5) is fixedly connected to the outer periphery of the tip (22), and the connecting component (4) is disposed between the fixing block (5) and the end (6).

4. The anti-kink high-strength PTCA guidewire according to claim 3, characterized in that, The connecting component (4) includes a first connecting end (42) and a second connecting end (43). The first connecting end (42) is fixedly connected to the middle of the fixing block (5), and the second connecting end (43) is fixedly connected to the middle of the end (6). A second connecting rod (45) is provided at the end of the first connecting end (42) and the second connecting end (43) that are close to each other. A first connecting rod (44) is provided at the other end of the plurality of second connecting rods (45). The first connecting rod (44) and the second connecting rod (45) are intersected. The first connecting end (42), the second connecting rod (45), the first connecting rod (44) and the second connecting end (43) are connected by a nickel-titanium sodium thiosulfate tube (41).

5. The anti-kink high-strength PTCA guidewire according to claim 4, characterized in that, A first high-strength adhesive (7) is provided between the fixing block (5) and the first connecting end (42), and a second high-strength adhesive (8) is provided between the end (6) and the second connecting end (43).

6. The anti-kink high-strength PTCA guidewire according to claim 4, characterized in that, The nickel-titanium sodium thiosulfate tube (41) has multiple welding holes (9) in the middle, which are used to improve the connection stability between the first connecting end (42), the second connecting rod (45), the first connecting rod (44), and the second connecting end (43) by increasing the welding points.

7. The anti-kink high-strength PTCA guidewire according to claim 4, characterized in that, The inner core (23), the first connecting end (42), the second connecting end (43) and the first connecting rod (44) are all made of high-strength stainless steel, while the outer shell tube (21) and the second connecting rod (45) are both made of nickel-titanium alloy.

8. A method for using a high-strength, anti-kink PTCA guidewire, characterized in that, The high-strength, anti-kink PTCA guidewire described in claims 1-7 comprises: S1. Preoperative preparation: Use saline to soak the protective component (3), activate the hydrophilic coating (34) on the outside of the polymer jacket (33) to reduce the surface friction coefficient, and check the connection status between the proximal push rod (1) and the end (6). S2, interventional push: The guidewire is inserted into the blood vessel by operating the proximal push rod (1). The axial thrust is transmitted by the coaxial composite core assembly (2). At this time, the inner core (23) and the outer shell tube (21) bend synchronously with the blood vessel path, and the outer shell tube (21) provides elastic support to protect the internal structure from plastic deformation. S3, Crossing the lesion: When the guidewire travels to the tortuous or stenotic lesion, the first connecting rod (44) and the second connecting rod (45) in the connecting component (4) work together with the nickel-titanium hyaluronic acid tube (41) to achieve multi-directional adaptive bending of the end (6). At the same time, the polymer fiber braided mesh (31) in the protective component (3) resists the radial pressure of the blood vessel wall and maintains the circular cross section of the sheath (32) to prevent kinking. S4. Retraction and withdrawal: After the surgical procedure is completed, the guidewire is retracted. The elastic restoring force of the outer shell tube (21) and the mandrel (24) is used to eliminate the bending stress, so that the guidewire returns to a straight shape and is withdrawn from the body.

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