Guide catheter

Abstract

The utility model relates to the technical field of medical instruments, in particular to a guiding catheter. A guiding catheter comprises a catheter body, a bending part is formed at the far end of the catheter body, the bending angle of the bending part is 30-80 degrees, and the length of the bending part is 2.5-200 mm; and the balloon is arranged close to the bending part and is communicated with the inner cavity of the tube body. The utility model provides a guide catheter which can easily pass through a C2 tortuous section of an internal carotid artery to reach a C2 horizontal section, and ensures the thrombus removal effect.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a guide tube. Background Technology

[0002] The balloon of the long-sheath balloon guiding catheter (BGC) is positioned at the distal end of the catheter, with a standard straight tip, typically 0.4-1.0 mm in length. Due to the design of the short, straight distal tip and the catheter's own structure, the distal tip can only reach the C2 vertical segment or C1 segment of the internal carotid artery, unable to pass through the tortuous vessel at the junction of the C2 vertical and horizontal segments. Thus, when the entire catheter is withdrawn after thrombectomy, because the short, straight tip in the C2 vertical segment is coaxial with the C2 vertical segment, the withdrawn mechanical thrombectomy system or aspiration catheter system, when re-entering the short, straight tip after passing the tortuous junction of the C2 vertical and horizontal segments, may form a contact angle with the short, straight tip, preventing complete and smooth entry into the BGC lumen. Furthermore, some small thrombus fragments may detach and remain in the gap between the distal end of the BGC balloon occlusion site, the short, straight tip, and the vessel wall, affecting complete thrombus removal. Utility Model Content

[0003] Therefore, the technical problem to be solved by this utility model is to overcome the defects of the prior art where the balloon guiding catheter cannot pass through the tortuous segment of C2 to reach the C2 level segment of the internal carotid artery, and the angle formed when the thrombectomy system is retrieved causes thrombus fragments to be retained, affecting the clearance effect. Thus, a guiding catheter that can easily pass through the tortuous segment of C2 of the internal carotid artery to reach the C2 level segment and ensure the thrombus clearance effect is provided.

[0004] To solve the above-mentioned technical problems, this utility model provides a guide tube, comprising:

[0005] The tube body has a bent portion formed at its distal end, the bending angle of which is 20-80° and the length is 2.5-200mm;

[0006] The balloon is positioned near the bend and communicates with the inner cavity of the tube.

[0007] Optionally, the bending angle of the bent portion is 30-70°, and the length of the bent portion is 3-100mm.

[0008] Optionally, the bending angle of the bent portion is 45-65°, and the length of the bent portion is 5-50mm.

[0009] Optionally, the bending angle of the bent portion is 50-60°, and the length is 10-15mm.

[0010] Optionally, the distal end of the bent portion is provided with a flexible end, the length of which is 0.4-1.5mm.

[0011] Optionally, the flexible head end consists of an inner liner and at least one polymer layer arranged radially from the inside to the outside.

[0012] Optionally, the inner liner is a polytetrafluoroethylene layer, and the polymer layer includes at least two layers, which are polyurethane layers or polyetheramide elastomers.

[0013] Optionally, the thickness of the first polymer layer is 0.002-0.01 inches, and the thickness of the remaining polymer layers is 0.001-0.007 inches.

[0014] Optionally, the bent portion of the tube body is further provided with a visible structure.

[0015] Optionally, the developing layer includes a first visible structure disposed at the distal end of the bend and a second visible structure disposed at the proximal end of the bend.

[0016] The technical solution of this utility model has the following advantages:

[0017] 1. The guiding catheter provided by this utility model has a distal bend that allows for adjustment of the bend's direction via control at the proximal end of the catheter. This facilitates the distal end of the guiding catheter passing through the C2 level segment of the internal carotid artery. Specifically, the distal end of the BGC is positioned at the C2 level segment, while the balloon occlusion site remains proximal to the C1 or C2 vertical segment of the internal carotid artery. This configuration ensures that when the intermediate catheter, microcatheter, thrombectomy stent, and thrombus in the BGC device lumen are withdrawn into the BGC, the distal long tip of the BGC remains at the C2 level segment. This allows for coaxial retrieval with the withdrawn intermediate catheter and thrombectomy stent, preventing a step effect and ensuring effective thrombus removal.

[0018] 2. The guide tube provided by this utility model has a flexible head end at the far end of the bent part, which can play a better guiding role.

[0019] 3. The guide tube provided by this utility model has two visible structures at the bend of the tube body, which makes the outline and length of the entire distal head clearly visible under DSA image, facilitating subsequent operations. Attached Figure Description

[0020] To more clearly illustrate the specific embodiments of this utility model or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0021] Figure 1 A schematic diagram of the guide tube provided by this utility model;

[0022] Figure 2 This is a schematic diagram of the guide tube provided by this utility model in use.

[0023] Explanation of reference numerals in the attached figures:

[0024] 1. Pipe body; 2. Bend; 3. Balloon; 4. Three-way valve seat; 5. Flexible head end; 6. Visible structure; 7. Stress tube; 8. C2 horizontal section; 9. C2 vertical section. Detailed Implementation

[0025] The technical solution of this utility model will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this utility model. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model.

[0026] Furthermore, the technical features involved in the different embodiments of this utility model described below can be combined with each other as long as they do not conflict with each other.

[0027] like Figures 1 to 2 One specific embodiment of the guide tube shown includes a tube body 1, a bend 2 and a balloon 3 disposed near the distal end of the tube body 1, and a three-way valve seat 4 disposed near the proximal end of the tube body 1, wherein the end of the guide tube closer to the operator during use is the proximal end, and the end farther from the operator is the distal end.

[0028] like Figure 1 As shown, the distal end of the tube body 1 is formed with a bent portion 2, the bending angle α of the bent portion 2 being 20-80° and the length b being 2.5-200mm. Further, the bending angle α of the bent portion 2 is 30-70°, and the length b of the bent portion 2 is 3-100mm. Still further, the bending angle α of the bent portion 2 is 45-65°, and the length b of the bent portion 2 is 5-50mm. Preferably, the bending angle α of the bent portion 2 is 50-60°, and the length b is 10-15mm.

[0029] The distal end of the bent portion 2 is provided with a flexible end 5, the length of which is 0.4-1.5 mm. The flexible end 5 consists of an inner liner layer and at least two polymer layers arranged radially from the inside out. The inner liner layer is a polytetrafluoroethylene layer, and the polymer layers include at least two layers, which are polyurethane layers or polyetheramide elastomer layers. The thickness of the first polymer layer is 0.002-0.01 inches, preferably 0.003-0.006 inches, and the thickness of the remaining polymer layers is 0.001-0.007 inches, preferably 0.002-0.005 inches.

[0030] The precision manufacturing process of the bent part 2 is described below:

[0031] The first step is to use a special mold to heat the material uniformly for 300 to 600 seconds in a strictly controlled ambient temperature range of 100 to 160°C using infrared radiation-assisted heating to achieve initial shape shaping.

[0032] Subsequently, to further optimize its shape and durability, a shaped metal mandrel with a specific angle design is used. This mandrel is made of stainless steel or copper and coated with PTFE or Pyrene to ensure smooth operation and non-stick properties. Rapid heating and shaping is performed at a high temperature of 150 to 200°C, using fluorinated FEP heat shrink tubing and hot air as an auxiliary heat source, for 30 to 120 seconds. After this precision operation, the heat shrink tubing is gently removed to maintain and fix the resulting bend.

[0033] Finally, an innovative, integrated, non-invasive design was employed for the distal end of the bend, the flexible tip. Specifically, the PTFE liner of the balloon sheath, along with the adjacent first and second polymer layers, extends to the extreme point of this tip. Subsequently, through a single, precise laser processing technique, aided by the heat shrinking of the heat shrink tubing, a perfectly integrated, rounded, and non-invasive tip is created in one piece, seamlessly blending with the main body of the tube. This meticulously designed non-invasive tip is carefully controlled in length between 0.4 mm and 1.5 mm to ensure optimal performance and safety.

[0034] The bent portion 2 of the tube body 1 is further provided with a visible structure 6. Specifically, the visible structure 6 includes a first visible structure located at the distal end of the bent portion 2 and a second visible structure located at the proximal end of the bent portion 2. The visible structure 6 can be formed by combining one or more of the following methods:

[0035] 1) Utilizing the natural radiopaque properties of tungsten wire or platinum-tungsten alloy wire, the overall outline structure of the distal head can be directly and clearly delineated under DSA imaging technology without the need for additional markings.

[0036] 2) A carefully designed polymer outer tube layer, consisting of two or three layers of overlapping film, contains a specific proportion of tungsten powder, titanium dioxide, or a mixture of barium sulfate and titanium dioxide. These components give the outer tube layer high visibility under DSA images. Therefore, the distal part of the tube, including its pre-shaping angle, can be clearly displayed in DSA images.

[0037] 3) To further enhance the visualization effect under DSA, we used a stainless steel braided layer as the base and superimposed a spring layer of tungsten wire or platinum-tungsten alloy wire on it. Subsequently, by superimposing a double-layer polymer outer tube, a head end structure that is both robust and easily identifiable in DSA was formed, and its pre-shaping angle was also clearly visible.

[0038] 4) In addition, we explored a more complex structural design, namely, combining a three-layer laminated polymer outer tube with a double-wire spring or diamond-shaped braided layer (made of tungsten wire or platinum-tungsten alloy wire). This design not only enhances the strength and flexibility of the head end, but also ensures its full-range visualization under DSA imaging, including the pre-shaping angle of the head end, achieving a clear display from the tapered head end to the overall outline.

[0039] The innovative visualization design of the distal flexible tip 5 completely eliminates the limitations of traditional technology that relies on a single imaging ring for local visualization, solving the problem of abrupt changes in outer diameter caused by this. Instead, it achieves seamless, continuous, and clear display of the entire tube contour under DSA imaging, enabling surgeons to make more accurate judgments and operations, thus improving the safety and success rate of the surgery.

[0040] The balloon 3 is positioned near the bend 2 and communicates with the inner cavity of the tube 1. The balloon 3 communicates with the inner cavity of the tube 1 through an opening in the tube 1. The injection fluid enters the balloon 3 from the proximal three-way valve seat 4 through the inner cavity of the tube 1, and the volume of the balloon 3 increases with the volume of the injection fluid. To release stress, a stress tube 7 is also provided between the three-way valve seat 4 and the tube 1. The inner diameter of the end of the stress tube 7 connected to the three-way valve seat 4 is larger than the inner diameter of the other end connected to the tube 1.

[0041] The guide tube provided in this embodiment has a pre-shaped angled bend 2 at its distal end, such as... Figure 2 As shown, the direction of the bend 2 can be adjusted by the torsion control of the proximal three-way valve seat 4, easily passing through the internal carotid artery C2 to reach the horizontal segment 8 of C2, thereby placing the distal end of the catheter in the horizontal segment 8 of the internal carotid artery C2, realizing the coaxial retrieval of the thrombectomy system, while the balloon is still placed in the vertical segment 9 of C2 for occlusion, so that the thrombectomy system and the thrombus can be smoothly retrieved into the catheter lumen, ensuring the thrombus removal effect.

[0042] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the protection scope of this invention.

Claims

1. A guiding tube, characterized in that, include: The tube body (1) has a bent portion (2) formed at its distal end. The bending angle of the bent portion (2) is 20-80° and the length is 2.5-200mm. The balloon (3) is disposed near the bend (2) and communicates with the inner cavity of the tube (1).

2. The guiding tube according to claim 1, characterized in that, The bending angle of the bending part (2) is 30-70°, and the length of the bending part (2) is 3-100mm.

3. The guide tube according to claim 2, characterized in that, The bending angle of the bending part (2) is 45-65°, and the length of the bending part (2) is 5-50mm.

4. The guiding tube according to claim 3, characterized in that, The bending angle of the bent part (2) is 50-60° and the length is 10-15mm.

5. The guiding tube according to claim 1, characterized in that, The distal end of the bent portion (2) is provided with a flexible head end (5), the length of which is 0.4-1.5mm.

6. The guide tube according to claim 5, characterized in that, The flexible head end (5) consists of an inner liner and at least one polymer layer in the radial direction from the inside to the outside.

7. The guide tube according to claim 6, characterized in that, The inner lining is a polytetrafluoroethylene layer, and the polymer layer includes at least two layers, which are polyurethane layers or polyetheramide elastomers.

8. The guide tube according to claim 7, characterized in that, The thickness of the first polymer layer is 0.002-0.01 inches, and the thickness of the remaining polymer layers is 0.001-0.007 inches.

9. The guiding tube according to any one of claims 1-8, characterized in that, The tube body (1) is also provided with a visible structure (6) on the bent part (2).

10. The guide tube according to claim 9, characterized in that, The visible structure (6) includes a first visible structure located at the far end of the bent portion (2) and a second visible structure located at the near end of the bent portion (2).

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