An insulated septal puncture guide wire

Abstract

This invention discloses an insulated atrial septum puncture guidewire, comprising a core wire, which includes a middle section, a tip, and a tail. The advantages are as follows: When the guidewire of this invention passes through the atrial septum, compared to traditional mechanical puncture with a needle, the mechanical force required for puncture is much lower. The J-shaped coil at the tip of the guidewire is softer and less sharp, significantly reducing the risk of cardiac perforation and making the procedure safer. Simultaneously, after the guidewire passes through the atrial septum, the sheath and dilator can pass through the septum along with the guidewire. Using the guidewire for atrial septum puncture, compared to the existing technology using mechanical puncture needles, eliminates the need to remove the guidewire from the sheath and insert a needle during the puncture process. The guidewire can simultaneously serve as a guide and puncture point, greatly reducing the number of puncture steps in the atrial septum, lowering the possibility of cardiac damage during atrial septum puncture, and thus reducing the risk of surgical complications.

Description

Technical Field

[0001] This utility model relates to the field of vascular interventional diagnosis and treatment technology, specifically to an insulated septal puncture guidewire. Background Technology

[0002] With the development of interventional cardiovascular diagnosis and treatment, there are increasingly more techniques for performing various interventional procedures in the left atrium. Atrial septal puncture is an essential route for entering the left ventricular system from outside the right heart during cardiac interventional procedures, and it is the first step for a successful operation. Therefore, atrial septal puncture has become a crucial step in completing these interventional procedures.

[0003] Traditional atrial septal puncture needles share common drawbacks in clinical use: 1. After the needle punctures the fossa ovalis and enters the left atrium, contrast agent or pressure monitoring is required for verification. Clinical application has shown that the contrast agent dose injected through the needle is often very small, resulting in unclear imaging and a risk of misinterpretation. 2. The puncture tip of the atrial septal puncture needle is relatively thick, requiring significant puncture force. After breaking through the atrial septum, the needle may accidentally puncture the left endocardium or left atrial appendage due to inertia and loss of resistance. 3. In many elderly patients, post-surgical patients, or patients who have undergone atrial septal repair / closure, after successful atrial septal puncture, the sheath is often unable to pass through the atrial septum using the traditional J-wire exchange method due to insufficient guidewire support. If the J-wire is not exchanged and the needle is advanced directly along with the puncture needle, the needle or dilator may puncture the left atrial wall or left atrial appendage due to inertia after the sheath breaks through the atrial septum, causing serious complications. This increases the operation time and poses risks to the patient. Utility Model Content

[0004] (a) Technical problems to be solved

[0005] The technical problem to be solved by this utility model is to provide an insulated atrial septum puncture guidewire that can reduce the risk of cardiac perforation and is safer to operate, in light of the current state of the technology.

[0006] (II) Technical Solution

[0007] This utility model is achieved through the following technical solution: This utility model proposes an insulated interatrial septum puncture guide wire, including a core wire, the core wire including a middle section, a head end and a tail end, the tail end being located at one end of the middle section and the other end of the middle section, the head end having a J-shaped structure and the bending angle of the head end being greater than 270°, a polymer protective sleeve being installed on the outside of the middle section, the polymer protective sleeve having a hydrophilic coating on the outside, and a spiral structure winding wire being installed on the head end.

[0008] Furthermore, the core wire extends through the polymer protective sleeve, and the hydrophilic coating is applied to the outside of the polymer protective sleeve.

[0009] By adopting the above technical solution, the core wire is made by grinding, wherein the head end is ground into a conical, parabolic, streamlined or any other structure, which can provide good flexibility and pushing performance for the guide wire.

[0010] Furthermore, the tail end is the exposed end of the core wire.

[0011] By adopting the above technical solution, the tail end allows the guidewire to deliver energy to the core wire using an electrosurgical unit or other instruments, so as to form a high voltage current at the head end, thereby allowing the guidewire to locally heat the puncture site and ensure that the guidewire can pass through the interatrial septum from the heated site.

[0012] Furthermore, the core wire is made of a material with good resistance to deformation and suitable for use as a guide wire, including nickel-titanium alloy, Fe-Ni alloy or Ti-Ni-X alloy, 304 stainless steel, 316 stainless steel, cobalt-based alloy, Fe-Mn alloy, and Cu-Zn alloy.

[0013] By adopting the above technical solution, the core wire is mainly used to conduct electrical energy so as to heat the intercompartment with the head end, so as to facilitate the passage of the core wire.

[0014] Furthermore, the circular diameter of the head end is 1-8mm, and the length of the circular portion is 3-24mm.

[0015] By adopting the above technical solution, the head end shape is completed by a shaping process, which is heat treatment shaping and / or cold shaping. Heat treatment shaping is used at a temperature of 200℃-600℃ and a time of 1min-30min. Cold shaping is used by preparing specialized equipment and using external force to bend the head end into the required shape.

[0016] Furthermore, the winding wire is wound around the head end, and the winding wire wraps around the head end.

[0017] By adopting the above technical solution, the reliable installation of the winding wire at the head end can be achieved.

[0018] Furthermore, the winding is composed of one or two of the following: platinum-tungsten springs, platinum-nickel springs, platinum-iridium springs, gold springs, and stainless steel springs.

[0019] By adopting the above technical solution, the developing spring has good developing performance, enhances the visibility of the guide wire under X-ray, and the winding wire is made by a spring winding machine.

[0020] Furthermore, the polymer protective sleeve is made of one or more of polyurethane, polylactic acid, nylon elastomer, and polyetheretherketone, and the hydrophilic coating is made of one of polyvinylpyrrolidone coating, polyethylene oxide coating, transparent ester acrylic coating, or polymethyl vinyl ether-maleic anhydride coating.

[0021] By adopting the above technical solution, the polymer protective sleeve is fixed to the core wire by overheating and melting. The polymer protective sleeve is installed in the middle section of the core wire, and the tail end is exposed, so that the guide wire has the characteristics of being conductive at both ends and insulating in the middle. The hydrophilic coating can be applied by spraying, dipping, or brushing. The coating is cured and formed by a certain method, making it not easy to fall off. After the hydrophilic coating is applied, the appearance of the coating on the guide wire surface is observed for any abnormalities. The hydrophilic coating can make the guide wire surface have very good lubricity, thereby reducing the flow resistance of the guide wire in the blood vessel, making the guide wire easy to push. At the same time, the circular part of the guide wire is smooth, soft, and non-invasive, the guide wire surface is smooth, and the tip is soft and safe. In addition, the preparation method is simple, easy to implement, and low in cost.

[0022] (III) Beneficial Effects

[0023] Compared with the prior art, this utility model has the following advantages:

[0024] 1. To address the problem that traditional atrial septal puncture needles require significant puncture force during clinical use, and that the needle may accidentally puncture the left endocardium or left atrial appendage due to inertia after breaking through the atrial septum and losing resistance instantly, the guidewire described in this invention requires much less mechanical force when passing through the atrial septum compared to traditional mechanical puncture needles. The J-shaped coil at the tip of the guidewire is also softer and less sharp, which greatly reduces the risk of cardiac perforation and makes the operation safer.

[0025] 2. To address the problem that traditional atrial septal puncture needles require withdrawal and J-wire exchange after successful puncture, which can lead to insufficient guidewire support and prevent the sheath from passing through the atrial septum, and if the needle is advanced directly without exchanging the J-wire, the needle or dilator may puncture the left atrial wall or left atrial appendage due to inertia after the sheath breaks through the atrial septum, causing serious complications, increasing surgical time, and posing risks to the patient, the present invention allows the sheath and dilator to pass through the atrial septum along with the guidewire. Compared to existing mechanical puncture techniques, this method eliminates the need to remove the guidewire from the sheath and reinsert the needle during atrial septal puncture. The guidewire serves both guiding and puncture functions, significantly reducing the number of steps involved in atrial septal puncture, lowering the possibility of cardiac damage, and thus reducing the risk of surgical complications. Attached Figure Description

[0026] Figure 1 This is a front sectional view of an insulated interatrial septum puncture guide wire according to the present invention;

[0027] Figure 2 This is a front view of an insulated interventricular septum puncture guide wire described in this utility model.

[0028] The annotations in the attached figures are explained as follows:

[0029] 1. Winding wire; 2. Hydrophilic coating; 3. Polymer protective sleeve; 4. Core wire; 401. Head end; 402. Middle section; 403. Tail end. Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of this utility model clearer, the present utility model will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present utility model and are not intended to limit the present utility model.

[0031] like Figures 1-2 As shown, an insulated atrial septum puncture guidewire in this embodiment includes a core wire 4, which comprises a middle section 402, a head end 401, and a tail end 403. The tail end 403 is located at one end of the middle section 402 and the other end of the middle section 402. The head end 401 has a J-shaped structure and a bending angle greater than 270°. A polymer protective sleeve 3 is installed on the outside of the middle section 402, and a hydrophilic coating 2 is provided on the outside of the polymer protective sleeve 3. A spiral-shaped winding wire 1 is also installed on the head end 401. By using this guidewire to puncture the atrial septum, compared with the mechanical puncture technique used in the prior art, this method provides a more efficient and effective method. Atrial septal puncture eliminates the need to remove the guidewire from the sheath and insert the puncture needle during the procedure. The guidewire serves both guiding and puncture functions, significantly reducing the number of puncture steps and minimizing the possibility of cardiac damage during atrial septal puncture, thus reducing the risk of surgical complications. Furthermore, using an electrocautery puncture with a guidewire requires much less mechanical force compared to traditional mechanical puncture with a needle, resulting in higher precision and less damage to surrounding tissues. The 401 J-shaped coil at the tip is also soft and non-sharp, all of which greatly reduce the risk of cardiac perforation, making the procedure safer.

[0032] like Figures 1-2 As shown, in this embodiment, the core wire 4 penetrates the polymer protective sleeve 3, the hydrophilic coating 2 is coated on the outside of the polymer protective sleeve 3, and the core wire 4 is made by grinding process, wherein the head end 401 is ground into a conical, parabolic, streamlined or any other structure, which can provide good flexibility and pushing performance for the guide wire.

[0033] like Figures 1-2 As shown, in this embodiment, the tail end 403 is the exposed end of the core wire 4. The tail end 403 allows the guide wire to deliver energy to the core wire 4 using other instruments such as an electrosurgical unit, so as to form a high voltage current at the head end 401, thereby allowing the guide wire to locally heat the puncture site and ensure that the guide wire can pass through the interatrial septum from the heated site.

[0034] like Figures 1-2 As shown, in this embodiment, the core wire 4 is made of a material with good deformation resistance and suitable for use as a guide wire, including nickel-titanium alloy, Fe-Ni alloy or Ti-Ni-X alloy, 304 stainless steel, 316 stainless steel, cobalt-based alloy, Fe-Mn alloy, and Cu-Zn alloy. The core wire 4 is mainly used to conduct electrical energy so that the compartment can be heated by the head end 401, so that the core wire 4 can pass through. The circular diameter of the head end 401 is 1-8mm, and the length of the circular part is 3-24mm. The shape of the head end 401 is completed by a shaping process, which is heat treatment shaping and / or cold shaping. Heat treatment shaping is used at a temperature of 200℃-600℃ for a time of 1min-30min. Cold shaping is used by preparing specialized equipment and using external force to bend the head end 401 into the required bending shape.

[0035] like Figures 1-2 As shown, in this embodiment, the winding wire 1 is wound around the head end 401, and the winding wire 1 wraps around the head end 401, which can realize the reliable installation of the winding wire 1 on the head end 401. The winding wire 1 is composed of one or two of platinum tungsten springs, platinum nickel springs, platinum iridium springs, gold springs, and stainless steel springs. The developing spring has good developing performance and enhances the visibility of the guide wire under X-ray. The winding wire 1 is made by winding the spring machine.

[0036] like Figures 1-2 As shown, in this embodiment, the polymer protective sleeve 3 is made of one or more of polyurethane, polylactic acid, nylon elastomer, and polyetheretherketone. The hydrophilic coating 2 is made of one of polyvinylpyrrolidone coating, polyethylene oxide coating, transparent ester acrylic coating, or polymethyl vinyl ether-maleic anhydride coating. The polymer protective sleeve 3 is fixed to the core wire 4 by a heat-melting process. The polymer protective sleeve 3 is installed in the middle section 402 of the core wire 4, and the tail end 403 is exposed, so that the guide wire has the characteristics of being conductive at the head and tail and insulating in the middle. The hydrophilic coating 2 can be applied by spraying, dipping, or brushing. The coating is cured and formed by a certain method, making it not easy to fall off. After the hydrophilic coating 2 is applied, the appearance of the coating on the guide wire surface is observed for any abnormalities. The hydrophilic coating 2 can make the guide wire surface very lubricated, thereby reducing the resistance of the guide wire in the blood vessel, making the guide wire easy to push. At the same time, the circular part of the guide wire is smooth, soft, and non-invasive. The guide wire surface is smooth, and the head end 401 is soft and safe. In addition, the preparation method is simple, easy to implement, and low in cost.

[0037] The specific implementation process of this embodiment is as follows: When puncturing the atrial septum of a patient, firstly, the tail end 403 is energized with an electrocautery knife. Then, simply place the tip end 401 against the atrial septum inside the patient's heart to heat the atrial septum, allowing the guidewire to pass through the heated area. Because of this type of guidewire, the tip end 401 is pre-shaped into a J-bend during use. Since the tip end 401 is arc-shaped, soft, and non-sharp, the risk of cardiac perforation is greatly reduced. Furthermore, the pre-shaped and non-pre-shaped portions of the guidewire are on the same plane, giving the guidewire strong maneuverability. The middle section 402 is rheoformed with a polymer protective sheath 3, exposing the tail end 403 of the core wire 4. The guidewire has the characteristics of being conductive at both ends and insulated in the middle, ensuring that energy can be delivered to the core wire 4 by other instruments such as an electrosurgical unit. The tip 401 of the core wire 4 generates a high-voltage current, and the guidewire locally heats the puncture site, allowing the guidewire to pass through the interatrial septum through the heated site. The tip 401 has an arc-shaped J-bend of >270°, which is soft and non-sharp. Even if the guidewire breaks through the interatrial septum, it will not damage the left endocardium or left atrial appendage due to the instantaneous loss of resistance and the forward push under inertia. At the same time, the core wire 4 is made of metal alloy and has strong support. After the tip 401 passes through the interatrial septum, the sheath and dilator can pass through the interatrial septum along the guidewire without the need for other exchanges, thus saving time.

[0038] The above description of the disclosed embodiments enables those skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. An insulatable atrial septal puncture guide wire, characterized by: The device includes a core wire (4), which includes a middle section (402), a head end (401), and a tail end (403). The tail end (403) is located at one end of the middle section (402) and at the other end of the middle section (402). The head end (401) has a J-shaped structure and the bending angle of the head end (401) is greater than 270°. A polymer protective sleeve (3) is installed on the outside of the middle section (402). A hydrophilic coating (2) is provided on the outside of the polymer protective sleeve (3). The head end (401) is also equipped with a spiral winding wire (1).

2. The insulatable atrial transseptal puncture guide wire of claim 1, wherein: The core wire (4) penetrates the polymer protective sleeve (3), and the hydrophilic coating (2) is applied to the outside of the polymer protective sleeve (3).

3. The insulatable atrial-puncturing guide wire according to claim 1, wherein: The tail end (403) is the exposed end of the core wire (4).

4. The insulatable atrial-puncturing guide wire according to claim 1, wherein: The core wire (4) is made of a material with good resistance to deformation and suitable for use as a guide wire, including nickel-titanium alloy, Fe-Ni alloy or Ti-Ni-X alloy, 304 stainless steel, 316 stainless steel, cobalt-based alloy, Fe-Mn alloy, and Cu-Zn alloy.

5. The insulatable atrial-puncturing guide wire according to claim 1, wherein: The diameter of the circular part (401) is 1-8mm, and the length of the circular part is 3-24mm.

6. The insulatable atrial-puncturing guide wire according to claim 1, wherein: The winding wire (1) is wound around the head end (401), and the winding wire (1) wraps around the head end (401).

7. The insulatable atrial-puncturing guide wire according to claim 6, wherein: The winding (1) is composed of one or two of platinum-tungsten springs, platinum-nickel springs, platinum-iridium springs, gold springs, and stainless steel springs.

8. The insulatable atrial-puncturing guide wire according to claim 1, wherein: The polymer protective sleeve (3) is made of one or more of polyurethane, polylactic acid, nylon elastomer, and polyetheretherketone, and the hydrophilic coating (2) is made of one of polyvinylpyrrolidone coating, polyethylene oxide coating, transparent ester acrylic coating, or polymethyl vinyl ether-maleic anhydride coating.

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