Electrocoagulation guide wire and preparation method thereof
By welding a ball head to the distal end of the core wire and the coiled spring of the electrocoagulation guidewire, and then attaching an insulating sheath and a hydrophilic coating, the problems of unstable current transmission and thrombus formation in the electrocoagulation guidewire are solved, thus achieving safe and efficient electrocoagulation therapy.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- CONLIFE MEDICAL SCI (SHENZHEN) CO LTD
- Filing Date
- 2026-02-06
- Publication Date
- 2026-04-17
AI Technical Summary
Existing electrocoagulation guidewires cannot effectively achieve distal electrocoagulation when transmitting current, and there is a risk of electrocoagulation of surrounding blood and thrombosis by the guidewire body, which affects the safety of surgical procedures.
By welding the distal end of the core wire and the coiled spring to form a distal ball head, and then fitting an insulating sheath and a hydrophilic coating, effective insulation of the electrocoagulation zone and stable current conduction are ensured, reducing thrombus formation.
This achieves stable current conduction through the electrocoagulation guidewire, reduces intraoperative risks, improves the safety and efficiency of surgical procedures, and ensures the precise formation and uniformity of the electrocoagulation zone.
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Figure CN121867929A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, and in particular to an electrocoagulation guidewire and its preparation method. Background Technology
[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.
[0003] Intracranial aneurysms are cerebral aneurysm-like protrusions caused by abnormal dilation of local blood vessels. Rupture of intracranial aneurysms is the leading cause of subarachnoid hemorrhage, with high mortality and disability rates. With the development of neurointerventional devices and techniques, neurointerventional therapy has gradually become the first-line treatment for intracranial aneurysms. Current interventional treatment methods for intracranial aneurysms mainly involve embolizing the aneurysm cavity with coils or other embolic materials. However, for aneurysms located in areas inaccessible to microcatheters, coil embolization is not feasible, and electrocoagulation guidewires can be used in these cases.
[0004] In existing electrocoagulation guidewire treatment techniques, if a standard guidewire is electrocoagulated, the following problems may arise: 1. Because the process in the distal region of the guidewire does not consider the electrocoagulation effect, current cannot be transmitted, thus the electrocoagulation effect cannot be achieved; 2. The guidewire body did not take insulation into account, which caused the guidewire body to have an electrocoagulation effect on the surrounding blood during the energization process. If the guidewire is inside the catheter, a thrombus will form inside the catheter, which will increase the friction between the electrocoagulation guidewire and the catheter and affect the surgical operation. In addition, if the thrombus in the catheter breaks off and moves to the blood vessel, it will increase the risk of cerebral infarction. If the guidewire is not inside the catheter, a thrombus will form directly in the artery, which may also lead to the risk of cerebral infarction. Summary of the Invention
[0005] The purpose of this invention is to overcome the shortcomings of the prior art and provide an electrocoagulation guidewire and its preparation method that can effectively transmit current to achieve electrocoagulation at the distal end and effectively insulate other areas outside the distal end to reduce electrocoagulation thrombus formation, thereby reducing intraoperative risks and minimizing the impact of surgical procedures.
[0006] The objective of this invention is achieved through the following technical solution: A method for preparing an electrocoagulation guidewire includes the following steps: Obtain a core wire and a coiled spring; wherein the coiled spring is sleeved on the core wire; The core wire and the coiled spring are subjected to a distal fusion welding operation so that the distal ends of the coiled spring and the distal ends of the core wire are welded together to form a distal ball head; The core wire is insulated so that the spring and the core wire are together covered with an insulating sheath; The core wire after the insulation treatment is subjected to hydrophilic treatment to form a hydrophilic coating on the outside of the insulating sheath; The hydrophilically treated core wire is subjected to end ablation treatment so that the distal ball head, the distal end of the core wire, and the distal end of the coiled spring are exposed to the insulating sheath and the hydrophilic coating to form an electrocoagulation zone.
[0007] In one embodiment, a distal welding operation is performed on the core wire and the coiled spring, specifically as follows: The core wire and the coiled spring are loaded such that the distal end of the core wire protrudes beyond the distal end of the coiled spring. The core wire and the coiled spring are fused together so that the portion of the core wire protruding beyond the far end of the coiled spring is heat-fused to form a core wire ball head, and the core wire ball head is accommodated in the far end of the coiled spring and fused around the far end of the coiled spring to form a far end ball head.
[0008] In one embodiment, a laser welding machine is used to weld the core wire and the spring.
[0009] In one embodiment, a plasma welding machine is used to perform fusion welding on the core wire and the coiled spring.
[0010] In one embodiment, the insulation treatment of the core wire includes the following steps: The coiled spring is subjected to TPU impregnation treatment so that the distal ball head and the coiled spring are together fitted with a TPU impregnation layer; The core filament after TPU impregnation is treated with a tear-away FEP heat shrink tubing so that a tear-away FEP heat shrink tubing is heat-shrinked onto the TPU impregnation layer, with a heat shrinking temperature ≥200℃. The core filament after TPU impregnation is heat-shrinked so that the PET heat-shrink tubing is fitted onto the proximal end of the core filament and connected to the proximal end of the TPU impregnation layer, and the proximal end of the core filament is at least partially exposed to the PET heat-shrink tubing.
[0011] In one embodiment, a laser device is used to ablate the tip of the hydrophilically treated core wire.
[0012] In one embodiment, after the step of performing distal welding on the core wire and the coiled spring, and before the step of insulating the core wire, the method for preparing the electrocoagulating conductor wire further includes the following steps: The spring is subjected to proximal end welding so that the proximal end of the spring is welded to the core wire, and / or so that the center position of the spring along its length is fixed to the core wire by soldering.
[0013] In one embodiment, the core wire and the spring are obtained, and the specific operation steps are as follows: The core wire, the developing spring, and the supporting spring are obtained, wherein the developing spring is sleeved on the distal end of the core wire, and the supporting spring is sleeved on both the core wire and the developing spring. The winding density at the distal end of the supporting spring is less than the winding density at the proximal end of the supporting spring; and... The distal end welding operation of the core wire and the spring is performed as follows: The distal end welding operation of the core wire, the developing spring, and the supporting spring is performed so that the distal ends of the core wire, the developing spring, and the supporting spring are welded together to form a distal ball head; and, The core wire is insulated, and the specific steps are as follows: the core wire is insulated so that an insulating sheath is fitted over both the developing spring and the supporting spring; and, The hydrophilically treated core wire is subjected to end ablation treatment. The specific operation steps are as follows: The hydrophilically treated core wire is subjected to end ablation treatment so that the distal ball head, the distal end of the core wire, the distal end of the developing spring and the distal end of the supporting spring are exposed to the insulating sheath and the hydrophilic coating to form an electrocoagulation zone. The proximal end of the electrocoagulation zone is flush with the proximal end of the developing spring.
[0014] In one embodiment, the distal welding operation of the core wire, the developing spring, and the supporting spring includes the following steps: The core wire, the developing spring, and the supporting spring are assembled such that the distal end of the core wire protrudes beyond the distal end of the developing spring and the distal end of the supporting spring. The core wire, the developing spring, and the supporting spring are subjected to distal end welding, so that the distal end of the core wire protruding beyond the distal end of the supporting spring is thermally melted to form a core wire ball head, and the core wire ball head is accommodated in the supporting spring and melted together with the distal end of the developing spring to form a distal ball head.
[0015] In one embodiment, the core wire, the developing spring, and the supporting spring are subjected to distal welding, including the following steps: The core wire is subjected to spot melting treatment so that the portion of the core wire protruding from the distal end face of the developing spring is heat-melted to form a distal ball head, and the distal ball head is accommodated in the distal ends of the developing spring and the supporting spring. The core wire and the developing spring after the spot melting treatment are melted together so that the distal ball head is melted together with the distal end of the developing spring and together they are melted and wrapped inside the distal end of the supporting spring to form a ball head structure.
[0016] An electrocoagulation wire is prepared by the method described in any of the above embodiments. The electrocoagulation wire includes a core wire, a coiled spring, an insulating sheath, and a hydrophilic coating. The coiled spring is sleeved on the core wire, and the distal end of the core wire and the distal end of the coiled spring are welded to form a distal ball head. The insulating sheath is sleeved on the distal ball head, the coiled spring, and the core wire. The hydrophilic coating is sleeved on the insulating sheath, and the distal end of the hydrophilic coating and the distal end of the insulating sheath are ablated together, so that the distal ball head, the distal end of the core wire, and the distal end of the coiled spring are exposed to the insulating sheath and the hydrophilic coating to form an electrocoagulation zone.
[0017] In one embodiment, the insulating sheath includes a spring sheath and a connecting sheath, the proximal end of the spring sheath being connected to the distal end of the connecting sheath, the spring sheath being fitted onto the distal end of the spring, the distal end of the spring sheath and the hydrophilic coating being dissolved together, so that the distal ball head, the distal end of the core wire and the distal end of the spring are exposed together to form an electrocoagulation zone on the spring sheath and the hydrophilic coating, the connecting sheath being fitted onto the proximal end of the core wire, and the proximal end of the core wire being at least partially exposed on the connecting sheath.
[0018] In one embodiment, the spring sheath is a TPU impregnation layer.
[0019] In one embodiment, the connecting sleeve is a PET heat shrink tubing.
[0020] In one embodiment, the thickness of the coiled spring sheath is 0.02 mm to 0.04 mm.
[0021] In one embodiment, the outer diameter of the connecting sleeve is the same as the outer diameter of the coiled spring sleeve.
[0022] In one embodiment, the core wire includes a distal core wire and a proximal core wire, the proximal end of the distal core wire being connected to the distal end of the proximal core wire, and the proximal end of the insulating sheath extending to the junction of the distal core wire and the proximal core wire.
[0023] In one embodiment, the outer diameter of the distal core wire is smaller than the outer diameter of the proximal core wire.
[0024] In one embodiment, the outer diameter of the distal core wire gradually increases in the direction from the distal end to the proximal end.
[0025] In one embodiment, the outer diameter of the distal core wire is 0.08 mm to 0.36 mm.
[0026] In one embodiment, the distal core wire is a nickel-titanium alloy core wire.
[0027] In one embodiment, the proximal core wire is a stainless steel core wire.
[0028] In one embodiment, at the junction of the proximal core wire and the distal core wire, the outer diameter of the proximal core wire is the same as that of the distal core wire.
[0029] In one embodiment, the electrocoating wire further includes a hydrophobic coating attached to the proximal end of the core wire, and an insulating sheath extending to the distal end of the hydrophobic coating.
[0030] In one embodiment, the spring includes a developing spring and a supporting spring. The developing spring is sleeved on the distal end of the core wire, and the supporting spring is sleeved on both the developing spring and the core wire. The distal ends of the developing spring, the supporting spring, and the core wire are welded together to form a distal ball head. The distal ball head, the distal end of the core wire, the developing spring, and the supporting spring are exposed to the insulating sheath and the hydrophilic coating to form an electrocoating region. The proximal end of the developing spring is flush with the proximal end of the electrocoating region.
[0031] In one embodiment, the developing spring is a platinum-tungsten spring or a gold spring.
[0032] In one embodiment, the wire diameter of the developing spring is 0.02mm to 0.05mm.
[0033] In one embodiment, the outer diameter of the developing spring is 0.1 mm to 0.2 mm.
[0034] In one embodiment, the winding pitch at the distal end of the support spring is 1.5 to 3 times the wire diameter of the support spring.
[0035] In one embodiment, the support spring is a stainless steel spring.
[0036] In one embodiment, the supporting spring includes a developing portion and a supporting portion. The proximal end of the developing portion is connected to the distal end of the supporting portion. The developing portion is sleeved on the distal end of the core wire. The proximal end of the developing portion protrudes from the proximal end of the electrocoagulation zone. The winding density of the developing portion is less than that of the supporting portion. The distal ends of the developing spring, the distal ends of the developing portion, and the distal ends of the core wire are welded together to form a distal ball head.
[0037] Compared with the prior art, the present invention has at least the following advantages: The aforementioned method for preparing the electrocoagulation guidewire involves welding the distal ends of the coiled spring and the core wire together to form a distal ball head. Then, an insulating sheath is fitted over both the coiled spring and the core wire, followed by the formation of a hydrophilic coating on the insulating sheath. This achieves effective insulation of the entire electrocoagulation guidewire, reducing electrocoagulation thrombus formation, thereby minimizing intraoperative risks and the impact of surgical procedures. The insulating sheath and hydrophilic coating are then ablated to form the electrocoagulation zone, ensuring precise formation of the electrocoagulation zone. The core wire is used to transmit high-frequency current to the distal end to act on the tissue, and the distal end of the core wire is welded to the distal end of the coiled spring to form the distal end. The ball-shaped head effectively reduces the contact resistance between the core wire and the coiled spring. The coiled spring is equivalent to multiple parallel conductive units, which can evenly distribute the current conducted by the core wire to the entire electrocoagulation zone. This ensures that the current in the electrocoagulation wire is conducted stably and with minimal loss to the entire electrocoagulation zone, thus avoiding the phenomenon of current concentration. In addition, the coiled spring increases the surface area of the electrocoagulation zone, and together with the arc surface of the distal ball-shaped head, it can make the current release more concentrated, so that the current forms a high-density energy field in the electrocoagulation zone. This not only improves the uniformity of electrocoagulation but also prevents local overheating and melting, achieving rapid coagulation of bleeding points or lesions and improving treatment efficiency. Attached Figure Description
[0038] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.
[0039] Figure 1 This is a flowchart illustrating a method for preparing an electrocoagulation guidewire according to an embodiment of the present invention. Figure 2 This is a schematic diagram of the structure of an electrocoagulation guide wire according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of an electrocoagulation guide wire according to another embodiment of the present invention; Figure 4 for Figure 3 A partial view of the electrocoagulation guidewire shown; Figure 5 for Figure 3 Another partial view of the electrocautery guidewire shown; Figure 6 This is a schematic diagram of the structure of an electrocoagulation guide wire according to another embodiment of the present invention; Figure 7 for Figure 6 A partial view of the electrocoagulation guide wire shown. Detailed Implementation
[0040] The present application will be further described in detail below with reference to the embodiments and examples. It should be understood that these embodiments and examples are for illustrative purposes only and are not intended to limit the scope of the present application. The purpose of providing these embodiments and examples is to enable a more thorough and comprehensive understanding of the disclosure of the present application. It should also be understood that the present application can be implemented in many different forms and is not limited to the embodiments and examples described herein. Those skilled in the art can make various modifications or alterations without departing from the spirit of the present application, and the equivalent forms obtained also fall within the protection scope of the present application. Furthermore, numerous specific details are set forth in the following description to provide a fuller understanding of the present application. It should be understood that the present application can be implemented without one or more of these details.
[0041] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.
[0042] In this invention, the technical features described in an open-ended manner include both closed-ended technical solutions composed of the listed features and open-ended technical solutions that include the listed features.
[0043] In this invention, numerical intervals (i.e., numerical ranges) are involved. Unless otherwise specified, the selected numerical distributions within the aforementioned numerical intervals are considered continuous, and include the two endpoints (i.e., the minimum and maximum values) of the numerical range, as well as every value between these two endpoints. Unless otherwise specified, when a numerical interval refers only to integers within that interval, it includes the two endpoint integers of the numerical range, as well as every integer between the two endpoints. In this document, this is equivalent to directly listing every integer. For example, if t is an integer selected from 1 to 10, it means that t is any integer selected from the group of integers consisting of 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10. Furthermore, when multiple ranges are provided to describe features or characteristics, these ranges can be merged. In other words, unless otherwise specified, the ranges disclosed herein should be understood to include any and all subranges to which they are included.
[0044] Unless otherwise specified, the temperature parameters in this invention can be either constant temperature treatment or vary within a certain temperature range. It should be understood that constant temperature treatment allows temperature fluctuations within the precision range controlled by the instrument. Fluctuations are permitted within ranges such as ±5℃, ±4℃, ±3℃, ±2℃, and ±1℃.
[0045] It should be noted that in this application, the end closer to the operator during use is called the "proximal end", and the end farther from the operator is called the "distal end". Based on this principle, the "proximal end" and "distal end" of any component of the electrocoagulation guidewire are defined.
[0046] This application provides a method for preparing an electrocoagulation wire. The method includes the following steps: obtaining a core wire and a coiled spring; wherein the coiled spring is sleeved on the core wire; performing a distal end welding operation on the core wire and the coiled spring to weld the distal ends of the coiled spring and the core wire together to form a distal ball head; performing insulation treatment on the core wire to cover the coiled spring and the core wire together with an insulating sheath; performing hydrophilic treatment on the insulated core wire to form a hydrophilic coating on the outside of the insulating sheath; and performing end ablation treatment on the hydrophilic treated core wire to expose the distal ball head, the distal end of the core wire, and the distal end of the coiled spring together to form an electrocoagulation zone by exposing the insulating sheath and the hydrophilic coating.
[0047] To better understand the preparation method of the electrocoagulation wire of this application, the preparation method of the electrocoagulation wire of this application will be further explained below: Please refer to the following: Figures 1 to 2 The preparation method of the electrocoagulation guide wire 10 according to one embodiment includes the following steps: S100, Obtain the core wire 100 and the coiled spring 200; wherein, the coiled spring 200 is sleeved on the core wire 100. It can be understood that the core wire 100 is prone to breakage at stress concentration points after repeated bending. The helical structure of the coiled spring 200 can evenly distribute the bending stress to multiple spring coils, significantly reducing the local stress peak of the core wire 100 and effectively improving the fatigue fracture resistance of the guide wire.
[0048] S300, perform a distal welding operation on the core wire 100 and the coiled spring 200 so that the distal ends of the coiled spring 200 and the distal ends of the core wire 100 are welded together to form a distal ball head 100a. It is understandable that the core wire 100 is used to transmit high-frequency current to the distal end to act on the tissue, causing the distal end of the core wire 100 to be welded to the distal end of the coiled spring 200 to form a distal ball head 100a. This effectively reduces the contact resistance between the core wire 100 and the coiled spring 200. Furthermore, the coiled spring 200 is equivalent to multiple parallel conductive units of spring coils, which can evenly distribute the current conducted by the core wire 100 to the entire electrocoagulation area. This ensures that the current in the electrocoagulation guide wire 10 is conducted to the entire electrocoagulation area stably and with minimal loss, thus avoiding the phenomenon of current concentration. In addition, the coiled spring 200 increases the surface area of the electrocoagulation area, and together with the arc surface of the distal ball head 100a, it can make the current release more concentrated, so that the current forms a high-density energy field in the electrocoagulation area. This not only improves the uniformity of electrocoagulation but also prevents local overheating and melting, achieving rapid coagulation of bleeding points or lesions and improving treatment efficiency.
[0049] S500, the core wire 100 is insulated so that the coiled spring 200 and the core wire 100 are together covered with an insulating sheath 300. It can be understood that having the coiled spring 200 and the core wire 100 together covered with an insulating sheath 300 strictly limits the release of current from areas outside the electrocoagulation zone, effectively insulating areas outside the electrocoagulation zone of the electrocoagulation guidewire 10 to reduce electrocoagulation thrombus formation, thereby reducing intraoperative risks and minimizing the impact of surgical procedures.
[0050] S700: The insulated core wire 100 is hydrophilically treated to form a hydrophilic coating 400 on the outside of the insulating sheath 300. It is understood that the hydrophilic coating 400 can effectively reduce the adhesion of blood components such as platelets and fibrin, reducing the risk of thrombosis and thus mitigating embolic complications caused by thrombus detachment from the guidewire surface. Furthermore, it reduces the friction coefficient between the guidewire and the blood vessel wall, allowing the electrocoagulation guidewire 10 to be pushed relatively easily in tortuous and narrow blood vessels, significantly improving surgical efficiency.
[0051] S900, the hydrophilically treated core wire 100 undergoes tip ablation treatment, so that the distal end of the ball head 100a, the distal end of the core wire 100, and the distal end of the coiled spring 200 are exposed to the insulating sheath 300 and the hydrophilic coating 400 to form the electrocoagulation zone 200a. It can be understood that promoting the ablation of the insulating sheath 300 and the hydrophilic coating 400 to form the electrocoagulation zone 200a better ensures the precise formation of the electrocoagulation zone 200a, thereby strictly limiting the current release range and ensuring the specificity of the electrocoagulation thrombus formation location.
[0052] The above-described method for preparing the electrocoagulation guidewire 10 involves welding the distal ends of the coiled spring 200 and the core wire 100 together to form a distal ball head 100a. Then, an insulating sheath 300 is fitted over both the coiled spring 200 and the core wire 100. A hydrophilic coating 400 is then formed on the outer surface of the insulating sheath 300, achieving effective insulation of the entire electrocoagulation guidewire 10 to reduce electrocoagulation thrombus formation, thereby reducing intraoperative risks and minimizing the impact of surgical procedures. The insulating sheath 300 and the hydrophilic coating 400 are then ablated to form the electrocoagulation zone 200a, ensuring precise formation of the electrocoagulation zone 200a. The core wire 100 is used to transmit high-frequency current to the distal end to act on the tissue, and the distal end of the core wire 100 is connected to the distal end of the coiled spring 200. The welding forms the distal ball head 100a, which effectively reduces the contact resistance between the core wire 100 and the coiled spring 200. The coiled spring 200 is equivalent to multiple parallel conductive units of spring coils, which can evenly distribute the current conducted by the core wire 100 to the entire electrocoagulation zone 200a. This ensures that the current in the electrocoagulation guide wire 10 is conducted to the entire electrocoagulation zone 200a stably and with minimal loss, thus avoiding the phenomenon of current concentration. In addition, the coiled spring 200 increases the surface area of the electrocoagulation zone 200a. Combined with the arc surface of the distal ball head 100a, it can make the current release more concentrated, so that the current forms a high-density energy field in the electrocoagulation zone 200a. This not only improves the uniformity of electrocoagulation but also prevents local overheating and melting, achieving rapid coagulation of bleeding points or lesions and improving treatment efficiency.
[0053] Please refer to the following: Figures 1 to 2 In one embodiment, a remote welding operation is performed on the core wire 100 and the coiled spring 200, specifically as follows: The core wire 100 and the coiled spring 200 are loaded such that the distal end of the core wire 100 protrudes beyond the distal end of the coiled spring 200. It is understandable that if the core wire 100 does not protrude from the coiled spring 200, but melts together with the coiled spring 200 after melting, the distal end of the coiled spring 200 and the distal end of the core wire 100 will be fused and doped. Consequently, during electrocoagulation, the distal ends of the coiled spring 200 and the distal ends of the core wire 100 are prone to electrochemical corrosion, which affects the connection stability between the core wire 100 and the coiled spring 200, affects the guidance and support of the core wire 100, and may even cause the coiled spring 200 to fall off the core wire 100, thereby increasing the surgical risk. Therefore, the core wire 100 is designed to protrude from the coiled spring 200 so that after the core wire 100 melts into a ball, it further melts with the coiled spring 200 and covers the coiled spring 200 to form a distal ball head 100a. This effectively reduces the electrochemical corrosion of the distal ball head 100a, thereby improving the connection stability between the distal end of the core wire 100 and the distal end of the coiled spring 200.
[0054] Furthermore, the core wire 100 and the coiled spring 200 are fused together so that the portion of the distal end of the core wire 100 protruding from the distal end of the coiled spring 200 is thermally fused to form a ball head of the core wire 100. The ball head of the core wire 100 is accommodated within the distal end of the coiled spring 200 and fused around it to form a distal ball head 100a. It can be understood that the distal end of the core wire 100 is gradually thermally fused and formed into a ball head under surface tension. Then, the ball head of the core wire 100 is further fused together with the inner wall of the coiled spring 200. At this point, the coiled spring 200, under stress, covers the ball head of the core wire 100 to form the distal ball head 100a, effectively reducing the electrochemical corrosion of the distal ball head 100a, thereby improving the connection stability between the distal end of the core wire 100 and the distal end of the coiled spring 200.
[0055] Please refer to the following: Figures 1 to 2 In one embodiment, a laser welding machine is used to perform fusion welding on the core wire 100 and the coiled spring 200. Further, in other embodiments, a plasma welding machine is used to perform fusion welding on the core wire 100 and the coiled spring 200.
[0056] Please refer to the following: Figures 1 to 2 In one embodiment, after the step of performing distal welding on the core wire 100 and the coiled spring 200, and before the step of insulating the core wire 100, the method for preparing the electrocoagulating conductor 10 further includes the following step: performing proximal welding on the coiled spring 200 so that the proximal end of the coiled spring 200 is welded to the core wire 100. Further, the proximal welding of the coiled spring 200 specifically involves the following steps: performing proximal welding on the supporting coiled spring 220 so that the proximal end of the supporting coiled spring 220 is welded to the core wire 100. Further, the proximal end of the coiled spring 200 and the core wire 100 are soldered. Since the proximal end of the coiled spring 200 is insulated, the proximal end of the coiled spring 200 will not be immersed in the electrolyte solution and cause corrosion; therefore, soldering can be used, as it is low-cost and easy to operate. Further, the coiled spring 200 is soldered to the core wire 100 at its central position along its length. Furthermore, multiple fixing points are formed between the center position of the coiled spring 200 and the core wire 100 through soldering, so that the coiled spring 200 and the core wire 100 are more stably connected to form a whole, which improves the performance of the electrocoagulation wire 10 in transmitting torque from the proximal end to the distal end.
[0057] Please refer to the following: Figure 1 , Figures 3 to 5 In one embodiment, the core wire 100 is insulated, including the following steps: The coiled spring 200 undergoes a TPU impregnation treatment so that the distal ball head 100a and the coiled spring 200 are both fitted with a TPU impregnation layer 310. It is understood that the thickness of the TPU impregnation layer 310 is 0.02mm~0.04mm. The TPU impregnation layer 310 is relatively soft and has good insulation properties, achieving flexibility at the distal end of the electrocoated guide wire 10. The specific formation process is as follows: First, TPU is dissolved into a liquid state, and then impregnated onto the surface of the guide wire spring section to form an insulating sheath 300, resulting in a uniform insulating sheath 300. Further, the coiled spring is subjected to a TPU impregnation treatment under vacuum conditions. It is understood that this process promotes… Furthermore, the core filament 100 after TPU impregnation is treated with a tear-away FEP heat-shrink tubing, so that a tear-away FEP heat-shrink tubing is heat-shrinkably attached to the TPU impregnation layer 310, with a heat-shrinking temperature ≥200℃. Furthermore, the heat-shrinking temperature is lower than the degradation temperature of the tear-away FEP heat-shrink tubing and the degradation temperature of the TPU impregnation. Furthermore, a heat radiation laminating machine is used to treat the core filament 100 after TPU impregnation with tear-away FEP heat-shrink tubing. Furthermore, the tear-away FEP heat-shrink tubing is also attached to the distal ball head 100a and the coiled spring 200, so that the tear-away FEP heat-shrink tubing presents a test tube shape with one end closed and the other end open, thereby reducing the overflow of the TPU impregnation layer. It is understandable that the uniformity of the thickness of the TPU extraction layer 310 of the electrocoagulation guidewire has a significant impact on the electrocoagulation effect, specifically as follows: 1. The electrocoagulation guidewire requires the TPU extraction layer to provide reliable insulation performance. If the local TPU extraction is too thin, the TPU extraction layer is easily broken down under the action of high-frequency electrocoagulation current, and the current will leak into the surrounding normal tissue, causing burns in non-target areas and the formation of electrocoagulation thrombi in non-target areas; 2. Uneven thickness of the TPU extraction layer will lead to differences in dielectric constant in different areas, resulting in uneven current distribution during electrocoagulation and affecting the electrocoagulation effect; 3. Uneven thickness of the TPU extraction layer will cause stress to concentrate in the thinner areas of the TPU extraction layer during advancement, making the electrocoagulation guidewire prone to breakage at these areas when repeatedly bent, causing medical accidents. Therefore, in this application, heating at a temperature ≥200℃ causes the tearable FEP heat shrink tubing to wrap around the surface of the TPU extraction layer 310, and At this point, the TPU extraction layer 310 is in a molten and flowable state. Based on the fact that the tear-off FEP heat shrink tubing shrinks uniformly during heat shrinkage, by selecting a tear-off FEP heat shrink tubing with an appropriate heat shrink ratio, the molten and flowable TPU extraction layer 310 is shaped to a certain thickness. This means that the TPU extraction layer 310 in thicker areas flows to thinner areas under the action of the tear-off FEP heat shrink tubing. In other words, the outer diameter of the TPU extraction layer 310 is controlled by the inner diameter of the tear-off FEP heat shrink tubing, which effectively improves the thickness uniformity of the TPU extraction layer 310. Then, the tear-off FEP heat shrink tubing is removed, so that the electrocoagulation guide wire 10 avoids the problem of the TPU extraction layer 310 being too thin or even not covered in some areas on the coiled spring 200 without increasing the thickness of other layers. This effectively improves the thickness uniformity of the TPU extraction layer 310.
[0058] Furthermore, the TPU-extracted core filament 100 is subjected to heat-shrink tubing treatment, so that a PET heat-shrinkable tube 320 is fitted onto the proximal end of the core filament 100 and connected to the proximal end of the TPU-extracted layer 310, with at least a partial exposure of the proximal end of the core filament 100 to the PET heat-shrinkable tube 320. Furthermore, the heat-shrinking temperature of the PET heat-shrinkable tube 320 is 160℃~240℃. It is understandable that, considering that the insulation is difficult to guarantee when the thickness of the TPU-coated insulating sheath 300 is small, and the outer diameter of the near end of the core wire 100 is large, the near end of the core wire 100 is made to form an insulating sheath 300 through a PET heat-shrink tubing 320. The PET heat-shrink tubing 320 has very good insulation when the thickness is small, with a heat-shrinking temperature between 160-240℃. At the same time, both ends of the PET heat-shrink tubing 320 need to cover the near end of the TPU-coated sheath and the far end of the hydrophobic coating near the near end of the core wire 10, so as to ensure that the entire surface of the electrocoating conductor 10 is covered by the insulating sheath 300.
[0059] It is understandable that after achieving a stable connection between the coiled spring 200 and the core wire 100, it is necessary to consider the coating on the overall outer surface of the core wire 100 and the coiled spring 200. The coating needs to serve two purposes: first, to improve surface smoothness, requiring the outermost layer to have a hydrophilic coating 400; second, to provide insulation to the guide wire surface, preventing the transmission of current to the arterial blood vessels through the middle part of the guide wire body, thus preventing thrombosis and blockage of the blood vessels. Therefore, it is necessary to first apply an insulating sheath 300, and then apply a hydrophilic coating 400. This process ensures an effective insulation layer for the core wire 100 and the coiled spring 200, except for the electrocoagulation zone 200a, while also ensuring that the connection of the hydrophilic coating 400 is firm and not easily detached.
[0060] It is also understandable that TPU extract layers are prone to micropores and thickness fluctuations after solvent drying and removal, especially the TPU extract layers between spring coils, which may even sink inward, thus exacerbating the uneven distribution of the TPU extract layer thickness on the electrocoagulation guidewire. Adding additives to the TPU solution formed by the TPU extract layer or modifying the TPU is difficult to effectively improve the thickness uniformity of the TPU extract layer. Similarly, eliminating air bubbles through hot pressing is also difficult to effectively improve the thickness uniformity of the TPU extract layer. However, by attaching a tear-off FEP heat-shrink tubing to the TPU extract layer, the heat shrinking of the tear-off FEP heat-shrink tubing applies uniform radial pressure to the TPU extract layer, causing the TPU to melt and forcibly fill the sinks and micropores, thereby reshaping the thickness of the TPU extract layer and effectively improving the thickness uniformity of the TPU extract layer, thus ensuring a better electrocoagulation effect.
[0061] In one embodiment, the coiled spring 200 is subjected to TPU impregnation treatment to increase the thickness of the TPU impregnation layer 310 that is sleeved on the distal ball head 100a and the coiled spring 200 to 0.002mm~0.005mm, so as to ensure that the thickness of the TPU impregnation layer 310 after the step of treating the core wire 100 with a tear-away FEP heat shrink tubing after TPU impregnation treatment can reach 0.02mm~0.04mm.
[0062] Please refer to the following: Figure 1 , Figures 3 to 5 In one embodiment, the insulating core filament 100 is subjected to hydrophilic treatment. The specific operation steps are as follows: a hydrophilic coating 400 is formed on the surface of the TPU impregnation layer 310, and the hydrophilic coating 400 extends to the distal end covering the PET heat shrink tubing 320.
[0063] Please refer to the following: Figure 1 , Figures 3 to 5 In one embodiment, a laser device is used to ablate the tip of the hydrophilically treated core wire 100. It is understood that because an insulating sheath 300 and a hydrophilic coating 400 are formed in the electrocoagulation region 200a of the core wire 100, the electrocoagulation region 200a of the electrocoagulation guide wire 10 cannot transmit current to the aneurysm to produce an electrocoagulation effect. Therefore, the insulating sheath 300 and hydrophilic coating 400 at the electrocoagulation region 200a of the core wire 100 are removed. Specifically, according to a preset length of the electrocoagulation region 200a of the electrocoagulation guide wire 10, a laser device is used to ablate the insulating sheath 300 and hydrophilic coating 400 formed on the electrocoagulation region 200a. Without damaging the core wire 100 and the coiled spring 200, the length of the exposed electrocoagulation area 200a after ablation can be kept consistent with the length of the electrocoagulation area 200a preset in the electrocoagulation guide wire 10, which better meets the needs of clinical use of the electrocoagulation guide wire 10. The appropriate electrocoagulation length can be selected according to the size of the aneurysm. That is, the previous forming process of the electrocoagulation guide wire 10 of any size and electrocoagulation length can be kept consistent. Then, by controlling the preset length of laser ablation, the electrocoagulation guide wire 10 of the appropriate electrocoagulation length selected for each aneurysm size can be obtained.
[0064] Please refer to the following: Figure 1 , Figures 3 to 5 In one embodiment, obtaining the core wire 100 includes the following steps: Obtain the distal core filament 110 and the proximal core filament 120. It can be understood that the core filament 100 is formed by combining two parts to allow the distal core filament 110 to use a more flexible material, while the proximal core filament 120 uses a more supportive material.
[0065] Furthermore, the proximal core filament 120 is subjected to hydrophobic treatment, so that the surface of the proximal core filament 120 is covered with a hydrophobic coating 500, and the hydrophobic coating 500 does not extend to the proximal end of the proximal core filament 120, that is, the proximal end of the proximal core filament 120 is at least partially exposed to the hydrophobic coating 500.
[0066] Furthermore, the distal core wire 110 is ground so that the outer diameter of the distal core wire 110 gradually increases in the direction from the distal end to the proximal end, thereby further improving the flexibility of the distal core wire 110.
[0067] Furthermore, the distal core wire 110 and the proximal core wire 120 are welded together to ensure the connection strength of the distal core wire 110 and the proximal core wire 120.
[0068] Please refer to the following: Figure 1 , Figures 3 to 5It is understandable that in existing technologies, the tip of the electrocoagulation guidewire 10 used in treatment is designed with a contrast-enhancing coiled spring 200, such as a platinum-tungsten coiled spring 200. However, because the length of the electrocoagulation zone 200a cannot be actually observed during electrocoagulation, it may lead to misoperation or electrocoagulation in non-target areas, causing vascular occlusion and increasing surgical risks. Traditionally, the length of the platinum-tungsten coiled spring 200 is the same as the length of the electrocoagulation zone 200a, which is generally 1mm to 5mm long. The welding point between the platinum-tungsten coiled spring 200 and the stainless steel coiled spring 200 is too close to the tip of the electrocoagulation guidewire 10, resulting in a stiffer tip. Furthermore, it is not easy to shape, which reduces the guiding performance of the guidewire or causes greater damage to blood vessels. Therefore, in this application, in order to ensure the guiding performance of the electrocoagulation guidewire 10 and minimize the damage to blood vessels caused by the electrocoagulation guidewire 10, in one embodiment, a core wire 100 and a coiled spring 200 are obtained. The specific operation steps are as follows: the core wire 100, the imaging coiled spring 210 and the support coiled spring 220 are obtained. The imaging coiled spring 210 is sleeved on the distal end of the core wire 100, and the support coiled spring 220 is sleeved on the core wire 100 and the imaging coiled spring 210 together. The coiling density at the distal end of the support coiled spring 220 is less than the coiling density at the proximal end of the support coiled spring 220. It can be understood that the contrast-enhancing spring 210 is sleeved at the distal end of the core wire 100, and the proximal end of the contrast-enhancing spring 210 is flush with the proximal end of the electrocoagulation zone 200a. The support spring 220 is sleeved on the contrast-enhancing spring 210 and the core wire 100 together, with the distal end of the core wire 100 protruding beyond the distal ends of the contrast-enhancing spring 210 and the support spring 220. This ensures that the position of the contrast-enhancing spring 210 under DSA is the position of the electrocoagulation zone 200a, guaranteeing that the operator can determine the location of the electrocoagulation zone 200a under DSA during the procedure, thus preventing the formation of electrocoagulation thrombi outside the required electrocoagulation area. It can also be understood that the winding density at the distal end of the support spring 220 is less than that at the proximal end, better ensuring the effective penetration and adhesion of the TPU extraction layer at the contrast-enhancing spring. It is also understandable that, since the support spring is sleeved on the developing spring, the TPU impregnation layer at the support spring and the developing spring is more likely to form an indentation between the spring coils, which in turn has a greater impact on the electrocoagulation effect. Therefore, it is necessary to treat the core wire 100 after TPU impregnation with a tear-away FEP heat shrink tubing to effectively improve the uniformity of the TPU impregnation layer thickness.
[0069] Further, a remote welding operation is performed on the core wire 100 and the spring 200. The specific operation steps are as follows: a remote welding operation is performed on the core wire 100, the developing spring 210 and the supporting spring 220 so that the remote ends of the core wire 100, the developing spring 210 and the supporting spring 220 are welded together to form a remote ball head 100a. It is understandable that the electrocoagulation zone 200a of the core wire 100 can generate a stable current to stably electrocoagulate and form a thrombus sufficient to achieve a blocking effect. Furthermore, the head and tail regions of the imaging spring 210 under DSA imaging are the head and tail regions of the electrocoagulation zone 200a, ensuring stable and clear imaging of the electrocoagulation zone 200a. This also ensures the bluntness of the distal ends of the core wire 100, the imaging spring 210, and the support spring 220 to reduce damage to the vessel wall. In addition, the imaging spring is a platinum-tungsten spring 200 or a gold spring 200, which has good electrochemical corrosion resistance. This further enhances the electrochemical corrosion resistance of the core wire 100 after it melts through the imaging spring, and it further melts with and encapsulates within the support spring 220, effectively improving the electrochemical corrosion resistance of the distal ball head 100a. In other words, it further effectively improves the connection stability of the core wire 100, the imaging spring 210, and the support spring 220.
[0070] Furthermore, the core wire 100 is insulated. The specific operation steps are as follows: The core wire 100 is insulated so that the developing spring 210 and the supporting spring 220 are together covered with an insulating sheath 300.
[0071] Furthermore, the hydrophilic-treated core wire 100 undergoes a head-end ablation treatment. The specific operation steps are as follows: The hydrophilic-treated core wire 100 undergoes head-end ablation treatment so that the distal ball head 100a, the distal end of the core wire 100, the distal ends of the developing coil spring 210 and the supporting coil spring 220 are exposed together to form an electrocoagulation zone 200a in the insulating sheath 300 and the hydrophilic coating 400. The proximal end of the electrocoagulation zone 200a is flush with the proximal end of the developing coil spring 210.
[0072] It is understandable that the imaging spring 210 is positioned at the electrocoagulation zone 200a, and the proximal end of the imaging spring 210 is flush with the proximal end of the electrocoagulation zone 200a. This means that the position of the imaging spring 210 under DSA imaging is the position of the electrocoagulation zone 200a. The support spring 220 is sleeved on the imaging spring 210 and the core wire 100. The winding density at the distal end of the support spring 220 is less than that at the proximal end of the support spring 220. The distal ends of the imaging spring 210, the support spring 220, and the core wire 100 are welded together to form the distal ball head 100a. This results in good flexibility of the support spring 220 at the distal end of the core wire 100 and good support strength of the support spring 220 at the proximal end of the core wire 100. This effectively ensures the guiding performance of the electrocoagulation guidewire 10 and minimizes damage to blood vessels caused by the electrocoagulation guidewire 10.
[0073] Please refer to the following: Figure 1 , Figures 3 to 5 In one embodiment, a remote welding operation is performed on the core wire 100, the developing spring 210, and the supporting spring 220, including the following steps: The core wire 100, the developing spring 210, and the supporting spring 220 are assembled so that the distal end of the core wire 100 protrudes beyond the distal end of the developing spring 210 and the distal end of the supporting spring 220. Furthermore, the core wire 100, the developing spring 210, and the supporting spring 220 are subjected to distal end welding treatment, so that the distal end of the core wire 100 protruding beyond the distal end of the supporting spring 220 is thermally melted to form a ball head of the core wire 100, and the ball head of the core wire 100 is contained within the supporting spring 220 and melted together with the distal end of the developing spring 210 to form a distal ball head 100a.
[0074] Please refer to the following: Figure 1 , Figures 3 to 5 In one embodiment, the core wire 100, the developing spring 210, and the supporting spring 220 are subjected to remote welding, including the following steps: The core wire 100 is hot-melted to form a distal ball head 100a by heat-melting the portion of the core wire 100 protruding beyond the distal end face of the developing spring 210. The distal ball head 100a is housed within the distal ends of the developing spring 210 and the supporting spring 220. Further, before hot-melting the core wire 100, the core wire 100, the developing spring 210, and the supporting spring 220 are fixed in place by a clamp. Further, the distal portion of the supporting spring 220 protrudes beyond the clamp. Further, a portion of the developing spring 210 protrudes beyond the supporting spring 220. Further, a portion of the core wire 100 protrudes beyond the supporting spring 220. Furthermore, in one embodiment, the core wire 100 undergoes a spot-melting process. Specifically, a pulsed laser beam is coaxially aligned with the distal end face of the core wire 100 for spot melting, causing the portion of the core wire 100 protruding from the developing spring 210 to melt and form a distal ball head 100a. The ball head gradually approaches the developing spring 210 and the supporting spring 220, and is accommodated within the distal ends of the developing spring 210 and the supporting spring 220. It is understood that the specific parameters of laser welding can be tested based on the purpose of spot melting of the distal end of the core wire 100; therefore, the specific parameters of laser welding will not be elaborated further. Alternatively, in other embodiments, the core wire 100 is subjected to spot melting treatment. Specifically, the plasma welding needle is coaxially aligned with the distal end face of the core wire 100 and spot melted, causing the portion of the core wire 100 protruding from the developing spring 210 to melt and form a distal ball head 100a. The ball head gradually approaches the developing spring 210 and the supporting spring 220 and is accommodated within the distal ends of the developing spring 210 and the supporting spring 220. It is understood that the specific parameters of plasma welding can be tested based on the purpose of spot melting of the distal end of the core wire 100; therefore, the specific parameters of plasma welding will not be described in detail.
[0075] Further, the core wire 100 and the developing spring 210, after point melting treatment, are melted together so that the distal ball head 100a is fused with the distal end of the developing spring 210 and together they are fused and wrapped within the distal end of the supporting spring 220 to form a ball head structure. Further, the pitch of the supporting spring 220 protruding from the fixture is the wire diameter of the supporting spring 220. Further, in one embodiment, the pulsed laser beam is further directed towards the inner wall of the supporting spring 220, causing the metal on the inner side of the supporting spring 220 to melt. Under stress, the supporting spring 220 will adhere to the ball head of the core wire 100, causing the ball head of the core wire 100 to fuse with the inner wall of the supporting spring 220, and the ball head of the core wire 100 will be wrapped within the supporting spring 220. It is understood that the specific parameters of laser welding can be tested based on the purpose of melting the inner wall of the supporting spring 220; therefore, the specific parameters of laser welding will not be elaborated further. Alternatively, in other embodiments, the core wire 100 is subjected to spot melting treatment, specifically by aligning the plasma welding needle with the inner wall of the support spring 220, causing the metal on the inner side of the support spring 220 to melt. It is understood that the specific parameters of the plasma welding can be obtained by testing based on the melting of the inner wall of the support spring 220; therefore, the specific parameters of the plasma welding will not be elaborated further.
[0076] Please refer to the following: Figure 1 , Figures 3 to 5 In one embodiment, the distal end of the core wire 100 protrudes from the distal end face of the supporting spring 220 / developing spring 210 by a length of 3mm to 6mm. Further, the diameter of the portion of the core wire 100 protruding from the supporting spring 220 is 0.08mm to 0.1mm.
[0077] It is understandable that the core-shell structure of the ball head effectively reduces the electrochemical corrosion of the ball head structure during the electrocoagulation process. Even if the outer layer of the ball head structure at the distal end of the electrocoagulation guidewire 10 is not a molten mixture of dissimilar alloys, but only a single alloy shell covering the supporting spring 220, it plays a role in protecting the ball head structure during the electrocoagulation process. This effectively reduces the risk of the ball head structure breaking during the electrocoagulation process and causing part of the structure to fall into the blood vessel, thus reducing the surgical risk.
[0078] Please refer to the following: Figure 1 , Figures 6 to 7 In one embodiment, obtaining the support spring 220 includes the following steps: Obtain the imaging portion 221 and the support portion 222. It can be understood that the support coil spring 220 is formed by combining two parts to allow the imaging portion 221 of the support coil spring 220 to be formed with imaging material to be located at the position of the longer distal portion of the imaging core wire 100 during the operation, while the support portion 222 is formed with a material with better support strength to provide better support propulsion force.
[0079] Furthermore, laser welding is performed on the developing section 221 and the support section 222 to weld the proximal end of the developing section 221 to the distal end of the support section 222, thereby ensuring the connection strength between the developing section 221 and the support section 222.
[0080] Please refer to the following: Figures 1 to 2 In one embodiment, after the step of insulating the core wire 100 and before the step of hydrophilic treatment of the insulating core wire 100, the method for preparing the electrocoagulating wire 10 further includes the following step: performing a final cleaning treatment on the core wire 100. Further, an ultrasonic cleaning device is used to perform the final cleaning treatment on the core wire 100. It can be understood that this pre-cleaning, which promotes the formation of the hydrophilic coating 400 on the electrocoagulating wire 10, is necessary to ensure effective adhesion of the hydrophilic coating 400 to the insulating sheath 300 and the core wire 100. This needs to be completed in a cleanroom, specifically by using an ultrasonic cleaning device to clean the core wire 100, and then drying the core wire 100 in a cleanroom oven after cleaning.
[0081] This application also provides an electrocoagulation wire, which is prepared by the preparation method of the electrocoagulation wire in any of the above embodiments. The electrocoagulation wire includes a core wire, a coiled spring, an insulating sheath, and a hydrophilic coating. The coiled spring is sleeved on the core wire, and the distal end of the core wire and the distal end of the coiled spring are welded to form a distal ball head. The insulating sheath is sleeved on the distal ball head, the coiled spring, and the core wire together. The hydrophilic coating is sleeved on the insulating sheath and the core wire together. The distal end of the hydrophilic coating and the distal end of the insulating sheath are dissolved together, so that the distal ball head, the distal end of the core wire, and the distal end of the coiled spring are exposed to the insulating sheath and the hydrophilic coating to form an electrocoagulation zone.
[0082] To better understand the electrocoagulation wire of this application, the following further explanation is provided: Please see Figure 2 In one embodiment, the electrocoagulation wire 10 includes a core wire 100, a coiled spring 200, an insulating sheath 300, and a hydrophilic coating 400. The coiled spring 200 is sleeved on the core wire 100, and the distal end of the core wire 100 and the distal end of the coiled spring 200 are welded to form a distal ball head 100a. The insulating sheath 300 is sleeved on the distal ball head 100a, the coiled spring 200, and the core wire 100. The hydrophilic coating 400 is sleeved on the insulating sheath 300, and the distal end of the hydrophilic coating 400 and the distal end of the insulating sheath 300 are ablated together, so that the distal ball head 100a, the distal end of the core wire 100, and the distal end of the coiled spring 200 are exposed to the insulating sheath 300 and the hydrophilic coating 400 to form an electrocoagulation zone 200a.
[0083] The aforementioned electrocoagulation guidewire 10 allows the insulating sheath 300 to be fitted onto the distal ball head 100a, the coiled spring 200, and the core wire 100, with the hydrophilic coating 400 fitted onto the insulating sheath 300. This achieves effective insulation of the entire electrocoagulation guidewire 10, reducing electrocoagulation thrombus formation, thereby reducing intraoperative risks and minimizing the impact of surgical procedures. The insulating sheath 300 and hydrophilic coating 400 are then ablated, exposing the distal ball head 100a, the distal end of the core wire 100, and the distal end of the coiled spring 200 to the insulating sheath 300 and hydrophilic coating 400, forming the electrocoagulation zone 200a. This ensures the precise formation of the electrocoagulation zone 200a. The core wire 100 transmits high-frequency current to the distal end to act on the tissue, causing the distal end of the core wire 100 to interact with the coiled spring 200. The distal welding of the core wire 100 forms a distal ball head 100a, which effectively reduces the contact resistance between the core wire 100 and the coiled spring 200. The coiled spring 200 is equivalent to multiple parallel conductive units of spring coils, which can evenly distribute the current conducted by the core wire 100 to the entire electrocoagulation zone 200a. This ensures that the current in the electrocoagulation guide wire 10 is conducted to the entire electrocoagulation zone 200a stably and with minimal loss, thus avoiding the phenomenon of current concentration. In addition, the coiled spring 200 increases the surface area of the electrocoagulation zone 200a. Combined with the arc surface of the distal ball head 100a, it can make the current release more concentrated, so that the current forms a high-density energy field in the electrocoagulation zone 200a. This not only improves the uniformity of electrocoagulation but also prevents local overheating and melting, achieving rapid coagulation of bleeding points or lesions and improving treatment efficiency.
[0084] Please refer to the following: Figures 6 to 7In one embodiment, the insulating sheath 300 includes a spring sheath 310 and a connecting sheath 320. The proximal end of the spring sheath 310 is connected to the distal end of the connecting sheath 320. The spring sheath 310 is sleeved on the distal end of the spring 200. The distal end of the spring sheath 310 and the hydrophilic coating 400 are dissolved together, so that the distal ball head 100a, the distal end of the core wire 100, and the distal end of the spring 200 are exposed together in the spring sheath 310 and the hydrophilic coating 400 to form an electrocoating region 200a. The connecting sheath 320 is sleeved on the proximal end of the core wire 100, and the proximal end of the core wire 100 is at least partially exposed in the connecting sheath 320. Further, the spring sheath 310 is a TPU impregnation layer 310. Further, the thickness of the spring sheath 310 is 0.02mm~0.04mm. Furthermore, the connecting sleeve 320 is a PET heat shrink tubing 320. Furthermore, the outer diameter of the connecting sleeve 320 is the same as the outer diameter of the spring-loaded sleeve 310. Furthermore, the connecting sleeve 320 is fitted onto the connection point of the proximal core wire 120 and the distal core wire 110, effectively ensuring the insulation of the core wire 100 and the spring 200 under the coverage of the insulating sleeve 300. This reduces the risk of thrombus dislodgement due to electrocoagulation of the electrocoagulation guidewire 10 in areas where electrocoagulation is not required, and also mitigates the impact on the smooth movement of the electrocoagulation guidewire 10 within the catheter. It is also understandable that the TPU impregnation layer 310 has high flexibility and conformability, which ensures the flexibility of the distal end of the electrocoagulation conductor 10. However, the insulation effect is difficult to guarantee in the case of ultra-thinness. Therefore, PET heat shrink tubing 320 is used for insulation treatment at the part with a larger outer diameter at the proximal end of the core wire 100, that is, at the connection between the distal core wire 110 and the proximal core wire 120. While ensuring flexibility, it still provides good insulation protection for the core wire 100 and the coiled spring 200 even when the thickness is reduced by using PET heat shrink tubing 320.
[0085] Please refer to the following: Figures 3 to 5In one embodiment, the core wire 100 includes a distal core wire 110 and a proximal core wire 120, with the proximal end of the distal core wire 110 connected to the distal end of the proximal core wire 120. The proximal end of the insulating sheath 300 extends to the connection point of the distal core wire 110 and the proximal core wire 120. Further, a connecting sheath 320 is sleeved on the connection point of the distal core wire 110 and the proximal core wire 120. Further, the outer diameter of the distal core wire 110 is smaller than the outer diameter of the proximal core wire 120. Further, the outer diameter of the distal core wire 110 gradually increases in the direction from the distal end to the proximal end. Further, the outer diameter of the distal core wire 110 is 0.08 mm to 0.36 mm. Further, the distal core wire 110 is a nickel-titanium alloy core wire 100. Further, the proximal core wire 120 is a stainless steel core wire 100. Furthermore, at the connection between the proximal core wire 120 and the distal core wire 110, the outer diameter of the proximal core wire 120 is the same as that of the distal core wire 110, which better ensures the flexibility of the distal end and the support strength of the proximal end of the core wire 100.
[0086] Please refer to the following: Figures 3 to 5 In one embodiment, the electrocoagulation wire further includes a hydrophobic coating 500, which is attached to the proximal end of the core wire 100, and the insulating sheath 300 extends to the distal end of the hydrophobic coating 500, ensuring the hydrophobicity of the proximal end of the electrocoagulation wire 10.
[0087] Please refer to the following: Figures 3 to 5In one embodiment, the spring 200 includes a developing spring 210 and a supporting spring 220. The developing spring 210 is sleeved on the distal end of the core wire 100, and the supporting spring 220 is sleeved on both the developing spring 210 and the core wire 100. The distal ends of the developing spring 210, the supporting spring 220, and the core wire 100 are welded together to form a distal ball head 100a. The distal ball head 100a, the distal end of the core wire 100, the developing spring 210, and the supporting spring 220 are exposed to the insulating sheath 300 and the hydrophilic coating 400 to form an electrocoating region 200a. The proximal end of the developing spring 210 is flush with the proximal end of the electrocoating region 200a. Further, the developing spring 210 is a platinum-tungsten spring or a gold spring. Further, the wire diameter of the developing spring 210 is 0.02mm~0.05mm. Furthermore, the outer diameter of the developing spring 210 is 0.1mm~0.2mm. Furthermore, the winding pitch at the distal end of the supporting spring 220 is 1.5 to 3 times the wire diameter of the supporting spring 220, which better ensures the flexibility of the supporting spring 220, and thus, together with the core wire 100 and the developing spring 210, better ensures the guiding performance of the distal end of the electrocoagulation guide wire 10. It is understandable that the imaging spring 210 is sleeved at the distal end of the electrode core, and the proximal end of the imaging spring 210 is flush with the proximal end of the electrocoagulation zone 200a. This means that the position of the imaging spring 210 under DSA is the position of the electrocoagulation zone 200a. The support spring 220 is sleeved on the imaging spring 210 and the core wire 100. The winding density at the distal end of the support spring 220 is less than that at the proximal end. The distal ends of the imaging spring 210, the support spring 220, and the core wire 100 are welded together to form the distal ball head 100a. This makes the support spring 220 more flexible at the distal end of the core wire 100 and provides better support strength at the proximal end of the core wire 100. This ensures the guiding performance of the electrocoagulation guidewire 10 and minimizes damage to blood vessels.
[0088] Please refer to the following: Figures 3 to 5 In one embodiment, the support spring 220 is a stainless steel spring, which better ensures the support effect. Furthermore, the lower wire density at the distal end of the support spring 220 better ensures the guiding performance. Please refer to [further details omitted]. Figures 6 to 7In one embodiment, the support spring 220 includes a developing section 221 and a support section 222. The proximal end of the developing section 221 is connected to the distal end of the support section 222. The developing section 221 is sleeved on the distal end of the core wire 100. The proximal end of the developing section 221 protrudes beyond the proximal end of the electrocoagulation zone 200a. The winding density of the developing section 221 is less than that of the support section 222. The distal ends of the developing spring 210, the distal ends of the developing section 221, and the distal ends of the core wire 100 are welded together to form a distal ball head 100a. Further, the developing section 221 is a platinum-tungsten spring. Further, the support section 222 is a stainless steel spring. It can be understood that even if the developing section 221 in the support spring 220 is developed under DSA, the entire distal end of the electrocoagulation guide wire 10 is effectively developed. The position of the enhanced development formed by the developing spring 210 is the position of the electrocoagulation zone 200a.
[0089] Compared with the prior art, the present invention has at least the following advantages: The above-described method for preparing the electrocoagulation guidewire 10 involves welding the distal ends of the coiled spring 200 and the core wire 100 together to form a distal ball head 100a. Then, an insulating sheath 300 is fitted over both the coiled spring 200 and the core wire 100. A hydrophilic coating 400 is then formed on the outer surface of the insulating sheath 300, achieving effective insulation of the entire electrocoagulation guidewire 10 to reduce electrocoagulation thrombus formation, thereby reducing intraoperative risks and minimizing the impact of surgical procedures. The insulating sheath 300 and the hydrophilic coating 400 are then ablated to form the electrocoagulation zone 200a, ensuring precise formation of the electrocoagulation zone 200a. The core wire 100 is used to transmit high-frequency current to the distal end to act on the tissue, and the distal end of the core wire 100 is connected to the distal end of the coiled spring 200. The welding forms the distal ball head 100a, which effectively reduces the contact resistance between the core wire 100 and the coiled spring 200. The coiled spring 200 is equivalent to multiple parallel conductive units of spring coils, which can evenly distribute the current conducted by the core wire 100 to the entire electrocoagulation zone 200a. This ensures that the current in the electrocoagulation guide wire 10 is conducted to the entire electrocoagulation zone 200a stably and with minimal loss, thus avoiding the phenomenon of current concentration. In addition, the coiled spring 200 increases the surface area of the electrocoagulation zone 200a. Combined with the arc surface of the distal ball head 100a, it can make the current release more concentrated, so that the current forms a high-density energy field in the electrocoagulation zone 200a. This not only improves the uniformity of electrocoagulation but also prevents local overheating and melting, achieving rapid coagulation of bleeding points or lesions and improving treatment efficiency.
[0090] The above embodiments merely illustrate several implementation methods of this application to facilitate a detailed understanding of the technical solutions of this application, but should not be construed as limiting the scope of protection of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the scope of protection of this application. Furthermore, it should be understood that after reading the above teachings, those skilled in the art can make various alterations or modifications to this application, and the equivalent forms obtained also fall within the scope of protection of this application. It should also be understood that technical solutions obtained by those skilled in the art based on the technical solutions provided in this application through logical analysis, reasoning, or limited experimentation are all within the scope of protection of the appended claims. Therefore, the scope of protection of this patent application should be determined by the content of the appended claims, and the specification and drawings can be used to interpret the content of the claims.
Claims
1. A method for preparing an electrocoagulation wire, characterized in that, Includes the following steps: Obtain a core wire and a coiled spring; wherein the coiled spring is sleeved on the core wire; The core wire and the coiled spring are subjected to a distal fusion welding operation so that the distal ends of the coiled spring and the distal ends of the core wire are welded together to form a distal ball head; The core wire is insulated so that the spring and the core wire are together covered with an insulating sheath; The core wire after the insulation treatment is subjected to hydrophilic treatment to form a hydrophilic coating on the outside of the insulating sheath; The hydrophilically treated core wire is subjected to end ablation treatment so that the distal ball head, the distal end of the core wire, and the distal end of the coiled spring are exposed to the insulating sheath and the hydrophilic coating to form an electrocoagulation zone.
2. The method for preparing the electrocoagulation guide wire according to claim 1, characterized in that, The core wire and the coiled spring are subjected to remote welding, and the specific operation is as follows: The core wire and the coiled spring are loaded such that the distal end of the core wire protrudes beyond the distal end of the coiled spring. The core wire and the coiled spring are fused together so that the portion of the core wire protruding beyond the far end of the coiled spring is heat-fused to form a core wire ball head, and the core wire ball head is accommodated in the far end of the coiled spring and fused around the far end of the coiled spring to form a far end ball head.
3. The method for preparing the electrocoagulation guide wire according to claim 2, characterized in that, The core wire and the coiled spring are fused together using a laser welding machine; or, The core wire and the coiled spring are fused together using a plasma welding machine.
4. The method for preparing the electrocoagulation wire according to claim 1, characterized in that, The insulation treatment of the core wire includes the following steps: The coiled spring is subjected to TPU impregnation treatment so that the distal ball head and the coiled spring are together fitted with a TPU impregnation layer; The core filament after TPU impregnation is treated with a tear-away FEP heat shrink tubing so that a tear-away FEP heat shrink tubing is heat-shrinked onto the TPU impregnation layer, with a heat shrinking temperature ≥200℃. The core filament after TPU impregnation is heat-shrinked so that the PET heat-shrink tubing is fitted onto the proximal end of the core filament and connected to the proximal end of the TPU impregnation layer, and the proximal end of the core filament is at least partially exposed to the PET heat-shrink tubing.
5. The method for preparing the electrocoagulation guide wire according to claim 1, characterized in that, The hydrophilically treated core wire is subjected to ablation treatment at its tip using laser equipment.
6. The method for preparing the electrocoagulation guide wire according to claim 1, characterized in that, After the step of performing distal welding on the core wire and the coiled spring, and before the step of insulating the core wire, the method for preparing the electrocoagulating conductor wire further includes the following steps: The spring is subjected to proximal end welding so that the proximal end of the spring is welded to the core wire, and / or so that the center position of the spring along its length is fixed to the core wire by soldering.
7. The method for preparing the electrocoagulation guide wire according to claim 1, characterized in that, The specific steps for obtaining the core wire and the winding spring are as follows: Obtain the core wire, the developing winding spring, and the supporting winding spring. The developing winding spring is sleeved on the distal end of the core wire, and the supporting winding spring is sleeved on both the core wire and the developing winding spring. The winding density at the distal end of the supporting winding spring is less than the winding density at the proximal end of the supporting winding spring; and... The distal end welding operation of the core wire and the spring is performed as follows: The distal end welding operation of the core wire, the developing spring, and the supporting spring is performed so that the distal ends of the core wire, the developing spring, and the supporting spring are welded together to form a distal ball head; and, The core wire is insulated, and the specific steps are as follows: the core wire is insulated so that an insulating sheath is fitted over both the developing spring and the supporting spring; and, The hydrophilically treated core wire is subjected to end ablation treatment. The specific operation steps are as follows: The hydrophilically treated core wire is subjected to end ablation treatment so that the distal ball head, the distal end of the core wire, the distal end of the developing spring and the distal end of the supporting spring are exposed to the insulating sheath and the hydrophilic coating to form an electrocoagulation zone. The proximal end of the electrocoagulation zone is flush with the proximal end of the developing spring.
8. The method for preparing the electrocoagulation wire according to claim 7, characterized in that, The remote welding operation of the core wire, the developing spring, and the supporting spring includes the following steps: The core wire, the developing spring, and the supporting spring are assembled such that the distal end of the core wire protrudes beyond the distal end of the developing spring and the distal end of the supporting spring. The core wire, the developing spring, and the supporting spring are subjected to distal end welding, so that the distal end of the core wire protruding beyond the distal end of the supporting spring is thermally melted to form a core wire ball head, and the core wire ball head is accommodated in the supporting spring and melted together with the distal end of the developing spring to form a distal ball head.
9. The method for preparing the electrocoagulation guide wire according to claim 8, characterized in that, The distal welding process for the core wire, the developing spring, and the supporting spring includes the following steps: The core wire is subjected to spot melting treatment so that the portion of the core wire protruding from the distal end face of the developing spring is heat-melted to form a distal ball head, and the distal ball head is accommodated in the distal ends of the developing spring and the supporting spring. The core wire and the developing spring after the spot melting treatment are melted together so that the distal ball head is melted together with the distal end of the developing spring and together they are melted and wrapped inside the distal end of the supporting spring to form a ball head structure.
10. An electrocoagulation wire, characterized in that, The electrocoagulation wire is prepared by the method described in any one of claims 1 to 9. The electrocoagulation wire includes a core wire, a coiled spring, an insulating sheath, and a hydrophilic coating. The coiled spring is sleeved on the core wire, and the distal end of the core wire and the distal end of the coiled spring are welded to form a distal ball head. The insulating sheath is sleeved on the distal ball head, the coiled spring, and the core wire. The hydrophilic coating is sleeved on the insulating sheath, and the distal end of the hydrophilic coating and the distal end of the insulating sheath are dissolved together, so that the distal ball head, the distal end of the core wire, and the distal end of the coiled spring are exposed to the insulating sheath and the hydrophilic coating to form an electrocoagulation zone.
11. The electrocoagulation wire according to claim 10, characterized in that, The insulating sheath includes a spring sheath and a connecting sheath. The proximal end of the spring sheath is connected to the distal end of the connecting sheath. The spring sheath is fitted onto the distal end of the spring. The distal end of the spring sheath and the hydrophilic coating are dissolved together, so that the distal ball head, the distal end of the core wire, and the distal end of the spring are exposed together in the spring sheath and the hydrophilic coating to form an electrocoagulation zone. The connecting sheath is fitted onto the proximal end of the core wire, and the proximal end of the core wire is at least partially exposed in the connecting sheath.
12. The electrocoagulation wire according to claim 11, characterized in that, The spring sheath is a TPU impregnation layer; and / or... The connecting sleeve is a PET heat shrink tubing; and / or... The thickness of the coiled spring sheath is 0.02mm~0.04mm; and / or, The outer diameter of the connecting sleeve is the same as the outer diameter of the coiled spring sleeve.
13. The electrocoagulation wire according to claim 12, characterized in that, The core wire includes a distal core wire and a proximal core wire, the proximal end of the distal core wire is connected to the distal end of the proximal core wire, and the proximal end of the insulating sheath extends to the connection point of the distal core wire and the proximal core wire.
14. The electrocoagulation wire according to claim 13, characterized in that, The outer diameter of the distal core wire is smaller than the outer diameter of the proximal core wire; and / or In the direction from the distal end of the distal core wire toward the proximal end, the outer diameter of the distal core wire gradually increases; and / or, The outer diameter of the distal core wire is 0.08mm~0.36mm; and / or, The distal core wire is a nickel-titanium alloy core wire; and / or The proximal core wire is a stainless steel core wire; and / or... At the junction of the proximal core wire and the distal core wire, the outer diameter of the proximal core wire is the same as that of the distal core wire.
15. The electrocoagulation wire according to claim 10, characterized in that, The electrocoagulation conductor also includes a hydrophobic coating, which is attached to the proximal end of the core wire, and the insulating sheath extends to the distal end of the hydrophobic coating.
16. The electrocoagulation wire according to claim 10, characterized in that, The spring includes a developing spring and a supporting spring. The developing spring is sleeved on the distal end of the core wire. The supporting spring is sleeved on both the developing spring and the core wire. The distal ends of the developing spring, the supporting spring, and the core wire are welded together to form a distal ball head. The distal ball head, the distal end of the core wire, the developing spring, and the supporting spring are exposed on the insulating sheath and the hydrophilic coating to form an electrocoating zone. The proximal end of the developing spring is flush with the proximal end of the electrocoating zone.
17. The electrocoagulation wire according to claim 16, characterized in that, The developing spring is a platinum-tungsten spring or a gold spring; and / or... The wire diameter of the developing coil is 0.02mm~0.05mm; and / or, The outer diameter of the developing coil is 0.1mm~0.2mm; and / or, The pitch of the winding at the distal end of the supporting spring is 1.5 to 3 times the wire diameter of the supporting spring.
18. The electrocoagulation wire according to claim 16, characterized in that, The supporting spring is a stainless steel spring; or, The supporting coil spring includes a developing section and a supporting section. The proximal end of the developing section is connected to the distal end of the supporting section. The developing section is sleeved on the distal end of the core wire. The proximal end of the developing section protrudes from the proximal end of the electrocoagulation zone. The winding density of the developing section is less than that of the supporting section. The distal ends of the developing coil spring, the distal ends of the developing section, and the distal ends of the core wire are welded together to form a distal ball head.