A new atrial septum puncture guide wire and a puncture system composed of the guide wire
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- 艾科脉医疗器械(绍兴)有限公司
- Filing Date
- 2024-12-19
- Publication Date
- 2026-07-07
AI Technical Summary
Existing atrial septal puncture instruments require multiple angle adjustments during the puncture process, increasing the risk of intravascular and extravascular exchange, and the long exposure time to radiation may lead to vascular and cardiac damage.
A novel guidewire for atrial septal puncture has been designed, comprising a guidewire body, a tip electrode, a spring, and an insulating layer. The guidewire body has variable diameters at both ends, the tip electrode is a metal cavity, the spring is sleeved on the outside of the guidewire, and the insulating layer covers the outer surface of the guidewire. The tip of the guidewire can be bent into a 'J' shape and a 'pigtail' shape, reducing the number of instrument exchanges and radiation exposure time.
By securing the catheter with a stable anchor point, the number of instrument exchanges is reduced, the risk of vascular injury is lowered, the operation time is shortened, radiation exposure is reduced, clear imaging guidance is provided, and the burden on patients and doctors is reduced.
Smart Images
Figure CN224462106U_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical devices, specifically to a transseptal puncture guidewire and a puncture system composed of the guidewire. Background Technology
[0002] The human heart consists of the right atrium, right ventricle, left atrium, and left ventricle. The right atrium shares blood flow with the superior and inferior vena cava, and is separated from the left atrium by the interatrial septum. Currently, all electrophysiological surgeries for atrial fibrillation require access to the left atrium, and the treatment instruments must be inserted through the inferior vena cava and interatrial septum into the left atrium. The commonly used instrument for atrial septal puncture in China is a mechanical puncture needle, made of stainless steel. Because the tip is made of stainless steel and cannot be bent, multiple adjustments to the tip angle may be necessary during the procedure. After the puncture, the needle must be withdrawn and a guidewire replaced for subsequent procedures. This instrument exchange involves the exchange of blood between the internal and external vascular systems, easily exposing the patient to risks such as vascular injury and the introduction of air into the circulatory system, potentially causing very serious damage to the heart.
[0003] After the routine puncture is completed, the puncture needle is withdrawn and the guidewire is replaced with a guiding device. It is necessary to observe under X-ray that the tip of the guidewire is placed on the left upper pulmonary vein as a marker. This process will increase the X-ray exposure time. Utility Model Content
[0004] To achieve the above objectives, this application provides a novel atrial septal puncture guidewire, characterized in that it comprises: a guidewire body, a tip electrode, a spring, and an insulating layer; the tip electrode is a metal cavity with a through hole at one end for the guidewire body to pass through and a closed spherical surface at the other end; the guidewire body has variable diameters at both ends, and each end of the guidewire body passes through the through hole and is welded and fixed to one of the tip electrodes inside the spherical surface; one end of the guidewire body is bent into a "J" shape, and multiple coils or multiple wraps are generated as the J-shaped end extends to the other end; the spring is sleeved on the outside of the guidewire body, and the two ends of the spring are welded and fixed to the guidewire body; the insulating layer wraps around and covers the outer surface of the novel atrial septal puncture guidewire except for the tip electrode.
[0005] In one specific embodiment of this application, a hydrophilic coating is applied to the head electrode.
[0006] In one specific embodiment of this application, the diameter of the guidewire body is 0.81 mm or 0.89 mm.
[0007] In one specific embodiment of this application, the insulating layer is a polymer material.
[0008] In one specific embodiment of this application, the polymer material is selected from polyimide, polyether-front polyamide, polytetrafluoroethylene, polyether ether ketone, thermoplastic polyurethane rubber, polyethylene, and polyamide fiber.
[0009] This application provides a novel atrial septal puncture system, characterized in that it consists of a sheath, a radio frequency transmitter, and the aforementioned novel atrial septal puncture guidewire.
[0010] The beneficial effects of this application are as follows:
[0011] Compared with existing technologies, the novel atrial septal puncture guidewire and puncture system provided in this application utilizes a pig tail end for puncture. After puncture, the tip electrode of the pig tail end can be restored to a pig tail shape in the left atrium for fixation, providing a stable anchor point for catheter advancement. At the same time, clear images can be obtained under ICE, reducing the radiation exposure time of puncture and reducing the burden on doctors and patients. In addition, the "J"-shaped end is used as a monopolar mapping electrode in the atrium, reducing the number of instruments used during the operation. Attached Figure Description
[0012] The accompanying drawings are provided to better understand this application and do not constitute an undue limitation thereof. Wherein:
[0013] Figure 1 A schematic diagram of the novel transseptal puncture guidewire provided in this application;
[0014] Figure 2 A schematic diagram of the head electrode provided in this application, wherein A is a schematic diagram of the head electrode provided in this application; and B is a cross-sectional view of the head electrode provided in this application.
[0015] Figure 3 This is a schematic diagram of the guidewire tip provided in this application;
[0016] Figure 4 This is a schematic diagram of the guidewire tip provided in this application;
[0017] Figure 5 A schematic diagram of the puncture process of the novel transseptal puncture system provided in this application;
[0018] Figure 6 A schematic diagram showing the completed puncture state of the novel interatrial septal puncture system provided in this application.
[0019] Explanation of reference numerals in the attached figures
[0020] 1-Guidewire body, 2-Head electrode, 3-Spring, 11-“J”-shaped end, 12-Pig tail end, 21-Head electrode head end, 22-Head electrode through hole. Detailed Implementation
[0021] Specific embodiments of the present application will now be described in more detail with reference to the accompanying drawings. While specific embodiments of the present application are shown in the drawings, it should be understood that the present application can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the present application and to fully convey the scope of the present application to those skilled in the art.
[0022] It should be noted that certain terms are used in the specification and claims to refer to specific components. Those skilled in the art will understand that different terms may be used to refer to the same component. This specification and claims do not distinguish components based on differences in terminology, but rather on differences in function. The terms "comprising" or "including" used throughout the specification and claims are open-ended and should be interpreted as "comprising but not limited to." The following descriptions in the specification are preferred embodiments for carrying out this application; however, these descriptions are for the purpose of understanding the general principles of the specification and are not intended to limit the scope of this application. The scope of protection of this application shall be determined by the appended claims.
[0023] In the description of this application, it should be noted that the terms "upper", "lower", "inner", "outer", "front", "rear", "left", "right", etc., indicate the orientation or positional relationship based on the orientation or positional relationship in the working state of this application. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.
[0024] In this application, "pig tail shape" is a figurative description, referring to the shape of the surface guidewire body, in which multiple coils or loops are generated around a certain point as one end extends to the other.
[0025] This application provides a novel atrial septal puncture guidewire, characterized in that it comprises a guidewire body, a tip electrode, a spring, and an insulating layer; one end of the tip electrode has a through hole for the guidewire body to pass through and insert, and the other end is a closed smooth spherical surface; both ends of the guidewire body are variable in diameter, with the diameter gradually decreasing at both ends, and both ends of the guidewire body pass through the through hole and are welded and fixed to one of the tip electrodes inside the smooth spherical surface; the spring is sleeved on the outside of the guidewire body, and both ends of the spring are welded and fixed to the guidewire body; the insulating layer wraps around and covers the outer surface of the novel atrial septal puncture guidewire except for the tip electrode.
[0026] In one specific embodiment of this application, a hydrophilic coating is applied to the head electrode.
[0027] In one specific embodiment of this application, the hydrophilic coating is any coating material used in conventional catheters, such as polyvinylpyrrolidone, polytetrafluoroethylene, or silicone.
[0028] In one specific embodiment of this application, the head electrode is a metal cavity, which can be made of a compatible material such as stainless steel, platinum-iridium alloy, or titanium-based alloy.
[0029] In one specific embodiment of this application, the diameter of the guidewire body is 0.81-0.889 mm, for example, it can be 0.815 mm, 0.82 mm, 0.825 mm, 0.83 mm, 0.835 mm, 0.84 mm, 0.845 mm, 0.85 mm, 0.855 mm, 0.86 mm, 0.865 mm, 0.87 mm, 0.875 mm, 0.88 mm, 0.885 mm, or 0.889 mm.
[0030] In one specific embodiment of this application, the guide wire body is made of stainless steel.
[0031] In one specific embodiment of this application, the guide wire body is a nickel-titanium alloy.
[0032] In one specific embodiment of this application, the guide wire body is made of a combination of stainless steel and nickel-titanium alloy.
[0033] In one specific embodiment of this application, the guidewire body is made of any metal material that conforms to clinical medical regulations.
[0034] In one specific embodiment of this application, the insulating layer is a polymer material.
[0035] In one specific embodiment of this application, the polymer material is selected from one or more of polyimide, polyether-front polyamide, polytetrafluoroethylene, polyether ether ketone, thermoplastic polyurethane rubber, polyethylene, and polyamide fiber.
[0036] In one specific embodiment of this application, both ends of the guidewire body are designed with different shapes, one of which is a "J" shape.
[0037] In one specific embodiment of this application, both ends of the guidewire body are designed with different shapes, one of which is a pig tail shape.
[0038] In one specific embodiment of this application, one end of the guidewire body is bent into a "J" shape, and multiple turns of curling or winding are generated as the J-shaped end extends to the other end.
[0039] In one specific embodiment of this application, the spring is a guide wire body formed by winding round or flat wires on a spring suspension bed.
[0040] In one specific embodiment of this application, the spring is made of stainless steel.
[0041] In one specific embodiment of this application, the spring is made of any metal material that meets mechanical requirements and clinical medical regulations.
[0042] In one specific embodiment of this application, the spring can be wound only around a portion of the area near the tip electrode, or it can cover the entire area of the guidewire body.
[0043] This application also provides a novel atrial septal puncture system, which consists of a sheath, a radio frequency transmitter, and the novel atrial septal puncture guidewire provided in this application.
[0044] Example 1
[0045] like Figures 1-3 The illustration shows a novel guidewire for atrial septal puncture, characterized by comprising: a guidewire body 1, a tip electrode 2, a spring 3, a waterproof coating, and an insulating layer; the guidewire body 1 is made of stainless steel, with a main diameter of 0.85 mm, gradually decreasing in diameter to 0.815 mm at both ends; one end of the guidewire body 1 is a "J"-shaped end 11 bent into a "J" shape, and the other end is a pigtail-shaped end 12 formed by multiple bends. The tip electrode 2 is also made of stainless steel. Figure 2 As shown in Figure A, the head electrode 2 can be considered as a combination of two segments of varying diameter cylinders and a hemisphere. The curved surface of the hemisphere forms the head end 21 of the head electrode. This curved surface is smooth and connects to the larger diameter cylinder with the same diameter. The two cylinders have different diameters and are stacked concentrically, forming a small step-like structure on the outer surface of the head electrode 2. Figure 2Figure B shows the other end of the tip electrode 2, which is a cylinder with a smaller diameter and has a tip electrode through hole 22. The head section 2 of the "J"-shaped end 11 is inserted into the tip electrode 2 through the tip electrode through hole 22 and welded to the tip electrode 2; the head section 2 of the pig tail end 12 is inserted into the tip electrode 2 through the tip electrode through hole 22 and welded to the tip electrode 2. The two ends of the guidewire body 1 are welded to the ends of the spring 3 and polished smooth. The spring 3 is made of round stainless steel wire wound on a spring suspension bed. The surface of the guidewire body 1, on which the spring 3 is wound, is also wrapped with an insulating layer made of an insulating material. This insulating layer wraps around and covers the outer surface of the novel interatrial septal puncture guidewire except for the tip electrode. The insulating material is a high-molecular-weight polyimide. The tip electrode 2 is also coated with a hydrophilic coating made of polytetrafluoroethylene.
[0046] Example 2
[0047] This embodiment provides a novel atrial septal puncture system, which consists of a sheath, a radio frequency transmitter, and the novel atrial septal puncture guidewire provided in Embodiment 1.
[0048] This atrial septal puncture system can perform atrial septal puncture and establish a passage between the left and right atria using a single system. It eliminates the need to change guides and puncture instruments, reducing intraoperative instrument exchanges, surgical time, and the clinical risks associated with changing instruments during the procedure.
[0049] The puncture was performed using the novel atrial septal puncture system provided in Example 2, such as... Figure 5 The diagram shows the use of the pig tail end 12 of the guidewire to puncture the interatrial septum. At this point, the pig tail end 12 is not maintained in a pig tail shape for ease of puncture. After the guidewire passes through the interatrial septum and enters the left atrium, as shown... Figure 6 As shown in the diagram, the pig tail end 12 will return to its pig tail shape and be fixed in the left atrium, providing a stable anchor point for the push of the catheter.
[0050] Using the novel atrial septal puncture guidewire and puncture system provided in this application embodiment, puncture is performed using a pig tail end. After puncture, the tip electrode of the pig tail end can be restored to a pig tail shape in the left atrium for fixation, providing a stable anchor point for catheter advancement. At the same time, clear images can be obtained under ICE, reducing the radiation exposure time of puncture and reducing the burden on doctors and patients. Meanwhile, the "J"-shaped end is used as a monopolar mapping electrode in the atrium, reducing the number of instruments used during the operation.
[0051] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of this 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 protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.
Claims
1. A novel guidewire for atrial septal puncture, characterized in that, include: Guidewire body; Head end electrode; spring; as well as, Insulating layer; The head electrode is a metal cavity, with a through hole at one end for the guide wire body to be inserted through, and a closed smooth spherical surface at the other end. The guidewire body has variable diameters at both ends, and each end of the guidewire body passes through the through hole and is welded and fixed to the inside of the smooth spherical surface by one of the head electrodes; One end of the guidewire body is bent into a "J" shape, and multiple turns of curling or winding are generated as the J-shaped end extends to the other end; The spring is sleeved on the outside of the guide wire body, and both ends of the spring are welded and fixed to the guide wire body; The insulating layer wraps around and covers the outer surface of the novel interatrial septal puncture guidewire, except for the tip electrode.
2. The guidewire according to claim 1, characterized in that, A hydrophilic coating is applied to the head electrode.
3. The guidewire according to claim 1, characterized in that, The diameter of the guidewire body is 0.81 mm or 0.89 mm.
4. The guidewire according to claim 1, characterized in that, The material of the head electrode is selected from stainless steel, platinum-iridium alloy, or titanium-based alloy.
5. The guidewire according to claim 1, characterized in that, The insulating layer is a polymer material.
6. The guidewire according to claim 5, characterized in that, The polymer material is selected from one of polyimide, polyether-front polyamide, polytetrafluoroethylene, polyether ether ketone, thermoplastic polyurethane rubber, polyethylene, and polyamide fiber.
7. A novel atrial septal puncture system, characterized in that, It consists of a sheath, a radio frequency transmitter, and the novel interatrial septal puncture guidewire as described in any one of claims 1-6.