6F catheter looping assembly for treating vertebral artery through radial artery path and application of 6F catheter looping assembly

Abstract

The invention relates to a 6F catheter looping assembly for treating a vertebral artery through a radial artery path and application of the 6F catheter looping assembly, and provides an improved TRA blood vessel treatment technology: the 6F catheter looping assembly is looped in an ascending aorta through the same-side radial artery path, and is pulled into a lesion side subclavian artery in a looping form; therefore, the included angle between the head end of the catheter and the VA opening section is changed from an obtuse angle to an acute angle, so that the balloon and stent implantation operation is easier, and the related risk of the operation is reduced. Compared with a TRA traditional mode of reverse angle operation, the LVAST technology can obtain the experience similar to forward operation through a femoral artery path, and meanwhile related complications caused by femoral artery puncture can be avoided.

Description

Technical Field

[0001] The present disclosure relates to the technical field of medical devices, and in particular to a 6F catheter looping assembly for treating vertebral arteries via radial artery pathway and application thereof. Background Art

[0002] The transradial approach (TRA) is increasingly used in the treatment of severe stenosis at the origin of the vertebral artery (VA). However, when the angle between the origin of the VA and the long axis of the distal subclavian artery is less than 90°, it is relatively difficult to enter the VA with a microguidewire during VA stent placement via TRA. In addition, due to the angle between the stent tip and the VA, the plaque at the origin of the VA is cut during the stent placement process, which increases the risk of plaque detachment.

[0003] VAST technology requires the use of a looped intermediate catheter, and the traditional sim2 access catheter is currently used. The Simmons catheter was first used clinically by American radiologist Simmons in 1973. Its special plastic structure can be naturally formed in the wider ascending aorta. In order to adapt to different aortic widths and elongated lengths, Simmons catheters with different rules are designed, such as the attached Figure 1 As shown, initially they are mainly divided into SIM-1, SIM-2 and SIM-3 types.

[0004] However, the original intention of the SIM tube design was to be used in complex and difficult cerebral angiography, so the design was mainly to ensure compliance. If it is used to provide support for treatment, its function is stretched. Figure 2 As shown, its main disadvantages are:

[0005] As attached Figure 2 As shown in Figure A, the red circle is located at the proximal elbow (also called the catheter seat), which is the most important part of the catheter to provide support. Therefore, it requires a material with good support. Currently, the proximal elbow is mostly made of vinyl acetate and nylon 12 materials, which are relatively soft and cannot provide good support.

[0006] As attached Figure 2 As shown in the middle figure B, the blue arrow indicates the current width of the tube: 20 mm at the proximal end and 30 mm at the distal end. This will make it difficult for the catheter to return to the subclavian region and put too much tension on the blood vessels, thereby increasing the risk of damaging the blood vessels and easily causing complications such as dissection.

[0007] As attached Figure 2 As shown in the middle figure C, the red angled part shows that the angle is too straight, which is not conducive to pointing to the vertebral artery opening and makes subsequent microguidewire operation difficult. Summary of the invention

[0008] In order to solve the above problems, the present application proposes a 6F catheter looping assembly for treating vertebral artery via radial artery approach and its application.

[0009] On the one hand, the present application provides a 6F catheter looping assembly for treating vertebral arteries via radial artery pathway, the 6F catheter looping assembly comprising a first brachiocephalic trunk 1, a proximal support curved tube portion 2, a second brachiocephalic trunk 3 and a catheter tip 4, the distance L1 between the proximal ends of the first brachiocephalic trunk 1 and the second brachiocephalic trunk 3 is 7-13 mm, and the distance L2 between the distal ends is 2-18 mm;

[0010] The distance L3 between the top of the proximal support elbow 2 and the bottom of the catheter head 4 is 8-12 cm;

[0011] The distance L4 between the top of the proximal support elbow portion 2 and the distal end of the second head arm trunk 3 is 4-8 mm;

[0012] The tube opening of the catheter tip 4 is directed toward the opening of the vertebral artery and is formed into a loop structure, and is pulled into the subclavian artery on the lesion side in the form of a loop.

[0013] Furthermore, the proximal supporting curved tube portion 2 is made of nylon 66.

[0014] Furthermore, the material of the proximal support elbow portion 2 is SS2312 die steel.

[0015] Furthermore, the proximal supporting curved tube portion 2 is made of polycarbonate PC.

[0016] Furthermore, the proximal supporting curved tube portion 2 is made of nylon alloy PA alloy.

[0017] Furthermore, the proximal supporting curved tube portion 2 is made of polycarbonate alloy PC alloy.

[0018] Furthermore, an angle α between the direction pointed by the tube opening of the catheter head end 4 and the direction pointed by the second head arm trunk 3 is 80-135°.

[0019] Furthermore, an angle α between the direction pointed by the tube opening of the catheter head end 4 and the direction pointed by the second head arm trunk 3 is a right angle.

[0020] On the other hand, the present application proposes a 6F catheter loop assembly for treating vertebral artery via radial artery approach and its application in treating VA.

[0021] Technical effects of the present invention:

[0022] This application proposes an improved TRA vascular treatment technology: the 6F catheter looping assembly is looped in the ascending aorta through the ipsilateral radial artery, and is pulled into the subclavian artery on the lesion side in the form of a loop, thereby changing the angle between the catheter tip and the VA opening segment from an obtuse angle to an acute angle, making the subsequent balloon and stent placement surgery easier and reducing surgery-related risks. Compared with the traditional TRA reverse angle operation, the LVAST technology can obtain a similar forward operation experience as the femoral artery route, while avoiding complications related to femoral artery puncture.

[0023] Further features and aspects of the present disclosure will become apparent from the following detailed description of exemplary embodiments with reference to the attached drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate exemplary embodiments, features, and aspects of the disclosure and, together with the description, serve to explain the principles of the disclosure.

[0025] Figure 1 Shown are schematic diagrams of the structures of three existing types of Simmons catheters;

[0026] Figure 2 A schematic diagram showing application disadvantages of the existing Simmons catheter is shown;

[0027] Figure 3 It is a schematic diagram showing the application structure of the 6F catheter loop forming assembly of the present invention;

[0028] Figure 4 The figure shows a schematic diagram of application dimensions of a 6F catheter loop forming assembly of the present invention. DETAILED DESCRIPTION

[0029] Various exemplary embodiments, features and aspects of the present disclosure will be described in detail below with reference to the accompanying drawings. The same reference numerals in the accompanying drawings represent elements with the same or similar functions. Although various aspects of the embodiments are shown in the accompanying drawings, the drawings are not necessarily drawn to scale unless otherwise specified.

[0030] The word “exemplary” is used exclusively herein to mean “serving as an example, example, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments.

[0031] In addition, in order to better illustrate the present disclosure, numerous specific details are given in the following specific embodiments. It should be understood by those skilled in the art that the present disclosure can also be implemented without certain specific details. In some examples, means, components and circuits well known to those skilled in the art are not described in detail in order to highlight the main purpose of the present disclosure.

[0032] Example 1

[0033] like Figure 3 and Figure 4 As shown, in one aspect, the present application provides a 6F catheter looping assembly for treating vertebral arteries via radial artery pathway, wherein the 6F catheter looping assembly comprises a first brachiocephalic trunk 1, a proximal support curved tube portion 2, a second brachiocephalic trunk 3 and a catheter tip 4, wherein the distance L1 between the proximal ends of the first brachiocephalic trunk 1 and the second brachiocephalic trunk 3 is 7-13 mm, and the distance L2 between the distal ends is 2-18 mm;

[0034] The distance L3 between the top of the proximal support elbow 2 and the bottom of the catheter head 4 is 8-12 cm;

[0035] The distance L4 between the top of the proximal support elbow portion 2 and the distal end of the second head arm trunk 3 is 4-8 mm;

[0036] The tube opening of the catheter tip 4 is directed toward the opening of the vertebral artery and is formed into a loop structure, and is pulled into the subclavian artery on the lesion side in the form of a loop.

[0037] Combination Figure 3 and Figure 4 As shown, in view of the defects of the conventional technology, the present invention improves the catheter in the following three aspects.

[0038] 1. Support. The proximal curved tube part is the most important place for the catheter to provide support. Through the application of special materials in this part, the support and bending resistance are greatly improved, so as to provide sufficient support for the treatment process such as delivering balloons and stents. The present invention adopts non-traditional materials such as vinyl acetate and nylon 12 to prepare the proximal supporting curved tube part 2, and adopts materials with higher strength, rigidity and toughness than vinyl acetate and nylon 12 materials, so as to improve its supporting force. The specific material used for the proximal supporting curved tube part 2 can be: nylon 66, SS2312 mold steel, polycarbonate PC, nylon alloy PA alloy or polycarbonate alloy PC alloy.

[0039] As a pre-hardened large plastic mold steel, SS2312 mold steel has excellent support and machining properties and is an ideal choice to replace vinyl acetate or nylon 12 as the material of the SIM2 catheter seat. This recommendation is based on the characteristics and application range of SS2312 mold steel, aiming to improve the overall performance and service life of the SIM2 catheter.

[0040] PC is a high-performance plastic with high hardness, high stiffness and excellent toughness. It also has good impact resistance, heat resistance and chemical resistance. Polycarbonate / nylon alloy (PC / PA alloy): This alloy combines the advantages of PC and nylon, with excellent hardness, stiffness and toughness. At the same time, it also has good processing performance and chemical resistance.

[0041] The specific process and connection are not limited in this embodiment.

[0042] 2. Stability. The width of the traditional catheter makes it difficult to return the catheter to the subclavian area, and the tension on the blood vessels is too great, which increases the risk of damaging the blood vessels and easily causes complications such as dissection. The present invention improves this aspect, with the width set to 10mm at the proximal end and 15mm at the distal end. In addition, the overall length of the curved section is lengthened from 7.5cm of the SIM3 to 10cm, and the head end length is about 4cm. This increases the stability and safety of the system.

[0043] 3. Directionality. The traditional catheter tip is too straight, which is not conducive to pointing to the vertebral artery opening, and makes subsequent micro-guidewire operation difficult. However, the present invention pre-shapes the angle to about 90 degrees, which is more conducive to the tube opening pointing to the vertebral artery opening (pointing the catheter tip to the VA opening segment to form a loop), improving the operability of the operation, shortening the operation time, and increasing the safety of the operation.

[0044] Furthermore, the angle α between the direction pointed by the tube mouth of the catheter tip 4 and the direction pointed by the second head arm trunk 3 is 80-135°. The present invention preferably sets the angle α between the direction pointed by the tube mouth of the catheter tip 4 and the direction pointed by the second head arm trunk 3 to a right angle.

[0045] Example 2

[0046] Based on the implementation principle of Example 1, on the other hand, the present application proposes the use of a 6F catheter looping assembly for treating vertebral artery via radial artery approach in the treatment of VA.

[0047] This will be understood specifically in conjunction with the above-mentioned Embodiment 1 and Embodiment 2.

[0048] The embodiments of the present disclosure have been described above, and the above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and changes will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The selection of terms used herein is intended to best explain the principles of the embodiments, practical applications, or technical improvements in the market, or to enable other persons of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

1. A 6F catheter looping assembly for treating vertebral arteries via the radial artery route, the 6F catheter looping assembly comprising a first brachiocephalic trunk (1), a proximal support elbow (2), a second brachiocephalic trunk (3) and a catheter tip (4), characterized in that: The distance L1 between the proximal ends of the first brachiocephalic trunk (1) and the second brachiocephalic trunk (3) is 7-13 mm, and the distance L2 between the distal ends is 2-18 mm; The distance L3 between the top of the proximal support curved tube portion (2) and the bottom of the catheter head end (4) is 8-12 cm; The distance L4 between the top of the proximal support curved tube portion (2) and the distal end of the second brachiocephalic trunk (3) is 4-8 mm; The tube opening of the catheter head end (4) points to the opening of the vertebral artery and is formed into a loop structure, and is pulled into the subclavian artery on the lesion side in the form of a loop.

2. The 6F catheter loop assembly for treating vertebral artery via radial artery approach according to claim 1, characterized in that: The proximal supporting curved tube portion (2) is made of nylon 66.

3. The 6F catheter loop assembly for treating vertebral artery via radial artery approach according to claim 1, characterized in that: The proximal supporting curved pipe portion (2) is made of SS2312 die steel.

4. The 6F catheter looping assembly for treating vertebral artery via radial artery approach according to claim 1, characterized in that: The material of the proximal supporting curved tube portion (2) is polycarbonate (PC).

5. The 6F catheter looping assembly for treating vertebral artery via radial artery approach according to claim 1, characterized in that: The material of the proximal supporting curved tube portion (2) is nylon alloy (PA alloy).

6. The 6F catheter looping assembly for treating vertebral artery via radial artery approach according to claim 1, characterized in that: The material of the proximal supporting curved tube portion (2) is polycarbonate alloy (PC alloy).

7. The 6F catheter loop assembly for treating vertebral artery via radial artery approach according to claim 1, characterized in that: The angle α between the direction pointed by the tube opening of the catheter head end (4) and the direction pointed by the second head arm trunk (3) is 80-135°.

8. The 6F catheter looping assembly for treating vertebral artery via radial artery approach according to claim 1, characterized in that: The angle α between the direction pointed by the tube opening of the catheter head end (4) and the direction pointed by the second head arm trunk (3) is a right angle.

9. Use of the 6F catheter looping assembly for treating vertebral artery via radial artery approach according to any one of claims 1 to 8 in treating VA.

Images