Interventional guide wire and interventional guide wire catheter system

Abstract

The utility model discloses an interventional guide wire and an interventional guide wire catheter system, the front end of the interventional guide wire is provided with a soft part with the length H of 3-10cm, the head end of the interventional guide wire is provided with a Fibonacci spiral part, the number of spiral turns of the Fibonacci spiral part is two, the interventional guide wire catheter system comprises the interventional guide wire and a catheter, the interventional guide wire penetrates through the catheter, a balloon is arranged at the position, close to the head end, of the catheter, and a water injection connector is arranged at the position, close to the tail end, of the catheter. The novel interventional guide wire with the Fibonacci spiral part at the head end is adopted, and damage to the heart structure caused by misoperation or poor ultrasonic development can be effectively avoided; and the size of the balloon is selected according to the size of the left atrium prompted by a cardiac ultrasound result of a patient, and after the catheter reaches the left atrium, the balloon which is 2cm away from the front end of the catheter is expanded through a lateral pipeline in a water injection manner and the like, so that the development is clearer, and the effect of fixing a guide wire catheter in the left atrium can be achieved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to an interventional guidewire and an interventional guidewire catheter system. Background Art

[0002] The current conventional ultrasound-guided percutaneous atrial septal defect closure procedure involves: After femoral vein puncture, a catheter (MP2 catheter) is placed through the puncture sheath over a guidewire (super-smooth guidewire) under transesophageal or transthoracic ultrasound guidance. The catheter is then advanced through the atrial septal defect to the left atrium and left superior pulmonary vein. The Amplatz guidewire (a stiffened guidewire that supports the occluder delivery sheath) is exchanged for the super-smooth guidewire, the MP2 catheter is withdrawn, and the occluder delivery system is advanced over the Amplatz guidewire into the left atrium. The occluder umbrella is then delivered to the desired location and released.

[0003] Currently, during percutaneous atrial septal defect closure, the occluder system is delivered to the atrial septal defect over a stiffened guidewire for device release. The commonly used Amplatz stiffened guidewire is internally supported by metal, with a 7-cm, unsupported, flexible tip that bends 180°. During percutaneous atrial septal defect closure under ultrasound guidance alone, the two-dimensional nature of cardiac ultrasound imaging hinders visualization of the guidewire and catheter tip, making it difficult to confirm that the guidewire and catheter have reached their intended position. Under ultrasound guidance, catheter manipulation in the right atrium is relatively simple and controllable. However, smooth manipulation of the guidewire and catheter within the left atrium is challenging under ultrasound guidance. In particular, catheters are difficult to reach the left superior pulmonary vein under ultrasound guidance. Sometimes, the tip of a conventional catheter cannot be accurately positioned, making it prone to dislodging from the left atrium. Furthermore, the stiffened Amplatz guidewire can cause structural damage to the heart, such as valve damage or atrial rupture, if improperly manipulated. Under ultrasound guidance alone, it is difficult to determine the positional relationship between the guidewire catheter tip and the left atrium and left superior pulmonary vein, which may cause damage to the cardiac structure. Utility Model Content

[0004] The purpose of this section is to summarize some aspects of the embodiments of the present invention and briefly introduce some preferred embodiments. Some simplifications or omissions may be made in this section and in the abstract and title of the utility model to avoid obscuring the purpose of this section, the abstract and the title of the utility model, and such simplifications or omissions shall not be used to limit the scope of the present invention.

[0005] Therefore, the purpose of the present invention is to provide an interventional guidewire and an interventional guidewire catheter system to change the imaging image of the guidewire tip and catheter in cardiac ultrasound, making the imaging clearer, thereby improving the safety of percutaneous atrial septal defect occlusion under simple ultrasound guidance and reducing the difficulty of the operation.

[0006] In order to solve the above technical problems, according to one aspect of the present invention, the present invention provides the following technical solutions:

[0007] An interventional guidewire, wherein the front end of the interventional guidewire has a soft portion with a length H of 3-10 cm, and the tip of the interventional guidewire has a Fibonacci spiral portion;

[0008] The number of spiral turns of the Fibonacci spiral portion is two.

[0009] As a preferred embodiment of the interventional guidewire described in the present invention, the interventional guidewire is internally supported by metal, and the metal surface is coated with a polytetrafluoroethylene coating.

[0010] As a preferred solution of the interventional guidewire described in the present invention, the metal is 304 stainless steel.

[0011] As a preferred embodiment of the interventional guidewire described in the present invention, the diameter of the Fibonacci spiral portion is 13 mm, which can be adjusted according to the size of the left atrium of different patients.

[0012] An interventional guidewire catheter system, comprising:

[0013] an interventional guidewire;

[0014] a catheter through which the interventional guidewire passes;

[0015] A balloon is provided near the head end of the catheter, a water injection joint is provided near the tail end of the catheter, and a channel is provided on the side of the catheter to connect the balloon and the water injection joint.

[0016] As a preferred solution of the interventional guidewire catheter system described in the present invention, the balloon is arranged at a position 2 cm away from the front end of the catheter.

[0017] As a preferred solution of the interventional guidewire catheter system described in the present invention, the catheter is provided with three layers and is sterilized by ethylene oxide, wherein the outer layer is a polyamide layer and the middle layer is a stainless steel layer.

[0018] As a preferred solution of the interventional guidewire catheter system described in the present invention, the balloon is made of thermoplastic polyamide elastomer material.

[0019] Compared with the existing technology, the utility model has the following beneficial effects: the utility model adopts a new type of interventional guidewire with a Fibonacci spiral portion at the head end, which can effectively avoid damage to the heart structure caused by improper operation or poor imaging under ultrasound, and selects the balloon size and guidewire size according to the size of the left atrium indicated by the patient's echocardiogram results. When the catheter reaches the left atrium, the balloon 2 cm away from the front end of the catheter is expanded through the lateral channel by means of water injection, etc., so that the imaging is clearer and fixed left and right, thereby improving the safety of percutaneous atrial septal defect closure under simple ultrasound guidance and reducing the difficulty of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the present invention will be described in detail below in conjunction with the accompanying drawings and detailed embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without inventive labor. Among them:

[0021] Figure 1 This is a structural diagram of an interventional guidewire of the present invention;

[0022] Figure 2 This is a structural diagram of an interventional guidewire catheter system of the present invention;

[0023] Figure 3 This is a schematic diagram comparing the bending of the conventional guide wire provided by the present invention and the interventional guide wire provided by the present invention, wherein Figure 3 (a) is a schematic diagram of the bending of a conventional guide wire. Figure 3 (b) Schematic diagram of the bending of the interventional guide wire;

[0024] Figure 4 This is a schematic diagram comparing the imaging of the conventional guide wire provided by the present invention and the interventional guide wire provided by the present invention under ultrasound, wherein Figure 4 (a) is a schematic diagram of conventional guidewire development under ultrasound. Figure 4 (b) Schematic diagram of the development of the interventional guidewire under ultrasound. DETAILED DESCRIPTION

[0025] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0026] Next, the present invention is described in detail with reference to schematic diagrams. For ease of illustration, cross-sectional views of device structures may be partially enlarged and not to scale when describing the embodiments of the present invention. Furthermore, the schematic diagrams are merely illustrative and should not limit the scope of protection of the present invention. Furthermore, in actual production, three-dimensional dimensions, including length, width, and depth, should be included.

[0027] In order to make the purpose, technical solutions and advantages of the present invention more clear, the embodiments of the present invention will be described in further detail below with reference to the accompanying drawings.

[0028] The utility model provides an interventional guidewire and an interventional guidewire catheter system, which change the imaging image of the guidewire head and catheter in cardiac ultrasound, make the imaging clearer, and improve the safety of percutaneous atrial septal defect occlusion under simple ultrasound guidance and reduce the difficulty of the operation.

[0029] Example 1

[0030] Figure 1 The figure shows a schematic diagram of the structure of an interventional guide wire according to the present invention. Figure 1 An interventional guidewire according to this embodiment uses metal as an internal support (specifically, 304 stainless steel can be used), the metal surface is coated with a polytetrafluoroethylene coating, and has a soft portion with a length H of 3-10 cm, more preferably 5-6 cm, and a Fibonacci spiral portion 110 at the tip end. The diameter of the Fibonacci spiral portion 110 is 13 mm, wherein the Fibonacci spiral portion 110 is formed by drawing a square with each number in the Fibonacci sequence as the side length, and connecting the squares with smooth curves drawn along the diagonal of each square. The Fibonacci sequence is: A1=A2=X, A3=A1+A2, A4=A2+A3..., An=An-2+An-1. The normal Fibonacci sequence is A1=A2=1. Since the size of the atria of patients of different ages is different, the size of the Fibonacci spiral portion 110 can be changed by changing the size of A1.

[0031] The size of a normal person's atrium under transesophageal ultrasound is 40 mm. The size of the Fibonacci spiral portion 110 at the tip of the interventional guidewire 100 should be one-third of the size of the atrium. The number of spiral turns of the Fibonacci spiral portion 110 should be two. Too many spiral turns will produce strong artifacts and cause an enhancement effect, while too few turns will lead to poor display of the guidewire position.

[0032] After using the new interventional guidewire 100, the Fibonacci spiral portion 110 at the guidewire tip is a spiral structure, which reflects more ultrasound waves than conventional guidewires, making imaging clearer. The soft part at the front end of conventional hardened guidewires is 7 cm, while the soft part at the front end of the new interventional guidewire 100 is 5-6 cm, which can effectively avoid damage to the heart structure caused by improper operation or poor ultrasound imaging. In addition, Figure 3 As shown in (a), the conventional guidewire will bend into a "V" shape after reaching the left atrial wall or sitting on the pulmonary vein. It is also not well displayed on ultrasound and can easily lead to misjudgment, causing the operator to continue to push the guidewire and cause damage to the heart structure. Figure 3As shown in (b), if the new interventional guidewire 100 continues to be pushed after reaching the target, the spiral will increase, generating a stronger reflection, effectively avoiding damage to the heart structure. In addition, due to the "hook" shape at the front end of the conventional guidewire, it may hook into the heart structure, such as the valve and papillary muscle, when withdrawing the guidewire, which also leads to surgical risks. The new guidewire has a spiral tip, and the "hook" shape is wrapped in the spiral. This greatly reduces the risk of heart damage caused by traction on the guidewire tip during withdrawal.

[0033] Example 2

[0034] like Figure 2 As shown, the present invention provides an interventional guidewire catheter system, comprising an interventional guidewire 100 and a catheter 200, wherein the interventional guidewire 100 passes through the catheter 200;

[0035] Among them, a balloon 210 is provided near the head end of the catheter 200, and a water injection joint 220 is provided near the tail end of the catheter 200. The side of the catheter 200 has a channel connecting the balloon 210 and the water injection joint 220. The balloon 210 is arranged at a position 2 cm away from the front end of the catheter 200. The balloon 210 is made of thermoplastic polyamide elastomer material. The catheter 200 is provided with three layers and is sterilized by ethylene oxide, wherein the outer layer is a polyamide layer and the middle layer is a stainless steel layer.

[0036] Conventional catheters often do not show up well under ultrasound. If the position of the catheter cannot be clearly determined, on the one hand, a catheter with a certain hardness may damage the cardiac structure. On the other hand, if the catheter falls off, it will need to be re-operated and inserted, which prolongs the operation time. Therefore, the present invention adopts a new type of interventional guidewire catheter system. The size of the balloon 210 is selected according to the size of the patient's left atrium indicated by the echocardiogram results. When the catheter 200 reaches the left atrium, the balloon 210 2 cm away from the front end of the catheter 200 can be expanded through the side channel by injecting water or other methods, so as to make the imaging clearer. And as Figure 4 As shown in (a), the conventional guidewire passes through the atrial septal defect as a vertical line. Figure 4 As shown in (b), the new guidewire appears as a shadowy mass when passing through the atrial septal defect. After the catheter 200 reaches the left atrium along the guidewire 100, it is easily secured in the left atrium by the dilation balloon 210, allowing for clearer imaging. In summary, the present invention, with its guidewire tip shaped into a Fibonacci spiral portion 110, accurately displays the position of the guidewire 100 and catheter 200 under ultrasound, improving the safety of pure ultrasound-guided percutaneous atrial septal defect closure and preventing complications related to the catheter 200 and the guidewire. The clearer visualization of the guidewire tip reduces the difficulty of ultrasound-guided percutaneous atrial septal defect closure.

[0037] While the present invention has been described above with reference to specific embodiments, various modifications may be made and equivalent components may be substituted without departing from the scope of the present invention. In particular, as long as no structural conflicts exist, the various features of the embodiments disclosed herein may be combined with one another in any manner, and the omission of an exhaustive description of these combinations in this specification is solely for the sake of space and resource conservation. Therefore, the present invention is not limited to the specific embodiments disclosed herein, but encompasses all technical solutions within the scope of the claims.

Claims

1. An interventional guidewire (100), characterized in that: The front end of the interventional guide wire (100) has a soft portion with a length H of 3-10 cm, and the head end of the interventional guide wire (100) has a Fibonacci spiral portion (110); The number of spiral turns of the Fibonacci spiral portion (110) is two.

2. The interventional guidewire (100) according to claim 1, characterized in that: The interventional guide wire (100) is supported internally by metal, and the metal surface is coated with a polytetrafluoroethylene coating.

3. The interventional guidewire (100) according to claim 2, characterized in that: The metal is 304 stainless steel.

4. The interventional guidewire (100) according to claim 1, characterized in that: The diameter of the Fibonacci spiral portion (110) is 13 mm.

5. An interventional guidewire catheter system, characterized in that: include: An interventional guidewire (100) according to any one of claims 1 to 4; a catheter (200) through which the interventional guide wire (100) passes; The catheter (200) is provided with a balloon (210) near the head end, and a water injection joint (220) is provided near the tail end. The side of the catheter (200) has a channel connecting the balloon (210) and the water injection joint (220).

6. The interventional guidewire catheter system according to claim 5, characterized in that: The balloon (210) is arranged at a position 2 cm away from the front end of the catheter (200).

7. The interventional guidewire catheter system according to claim 5, characterized in that: The catheter (200) is provided with three layers and is sterilized by ethylene oxide, wherein the outer layer is a polyamide layer and the middle layer is a stainless steel layer.

8. The interventional guidewire catheter system according to claim 5, characterized in that: The balloon (210) is made of thermoplastic polyamide elastomer material.

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