A transradial access cerebral vessel intervention cannula assembly

Abstract

This invention relates to a cannula assembly for cerebrovascular intervention via the radial artery approach, comprising an outer cannula, an intermediate access catheter, and a guidewire. The outer cannula has a first curved section, a first straight section, a second curved section, a second straight section, a third curved section, a linear section, and an outer cannula connector. The second curved section bends distally, with the curvature of the distal section being greater than that of the proximal section. The second straight section is longer and has a greater inclination than the first straight section. The intermediate access catheter has a cephalic section, a cervical section, a linear section, and an intermediate access catheter connector. The outer cannula is more rigid than the intermediate access catheter. This invention improves the convenience and success rate of transradial cerebral vascular superselection, avoids vascular injury, and is applicable to either the left or right radial artery approach. It can be used for both cerebral angiography and interventional treatment of cerebrovascular diseases.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a transradial approach cerebral vascular interventional cannula assembly. Background Technology

[0002] The radial artery approach to cerebral angiography or treatment offers significant advantages over the femoral artery approach. From the patient's perspective, the radial artery approach provides benefits such as privacy protection, fewer puncture site complications, less prolonged bed rest, faster postoperative recovery, and consequently, shorter hospital stays and lower costs. From the operator's perspective, the frequency and complexity of complications are significantly reduced, as is the nursing workload. However, the radial artery approach involves a more tortuous path to the brain's blood supply arteries, especially on the aortic arch where the approach reverses direction from the foot to the head. Selective cannulation is more complex, catheter manipulation and achieving satisfactory support are more difficult, the success rate of selective cannulation on secondary vessels above the aortic arch is lower, and the X-ray exposure is significantly greater for most interventional physicians.

[0003] The inventor disclosed a cerebral angiography cannula and a cerebral angiography tube in patent CN202427021U filed in 2012. The cerebral angiography cannula has a first bend, a second bend, and a straight tail end. The first bend is 4.5-7 cm long, larger than the average diameter of the aortic arch, and has an angle of 85-95 degrees. The length and curvature of the second bend are consistent with the subclavian artery. The outer diameter of the cerebral angiography cannula is 1.67 mm, and the inner diameter is 1.6 mm. The cerebral angiography tube includes the aforementioned cerebral angiography cannula and also includes an inner tube, which is a single-bend angiography tube with a bend of 130-140 degrees. The shape design of the cannula in this patent is to facilitate the provision of support on the aortic arch, solving the problem that when the aortic arch, the blood supply artery to the brain, runs upwards in the opposite direction during radial artery angiography, support cannot be provided on the arch. However, in practice, this type of cannula cannot provide adequate support for the aortic arch and is difficult to insert into the brachiocephalic trunk, common carotid artery, and vertebral artery, resulting in a low success rate.

[0004] In addition, patent document CN204619123U, published in 2015, provides a catheter for cerebral angiography via the right radial artery, used for superselective cannulation of the bilateral common carotid arteries and vertebral arteries during cerebral angiography via the radial artery. The catheter for cerebral angiography via the right radial artery comprises five parts: a catheter tip, a distal section, a folded section, a catheter body, and a tail connector. The catheter tip has a tapered structure, bends inward at an angle, and is relatively short, with a bending angle of 150°; the distal section is a straight section, approximately 5-10 cm in length; the folded section is a 360° reverse arc with a small diameter, and this section has micro-steel wires embedded in its wall; the distal section of the catheter body has an approximately 120° arc bend; the tail connector is compatible with a universal tee connector; the catheter is made of medical-grade polymer material, with an outermost layer treated with a super-slippery coating. The catheter for cerebral angiography via the right radial artery is designed based on the anatomical characteristics of cerebral angiography via the right radial artery. The surgical sequence is as follows: First, the catheter is superselectively inserted into the right vertebral artery via the right subclavian artery to complete angiography. Then, a guidewire is used to push the catheter into the aortic arch. After the guidewire is removed, the folded portion returns to its original shape. At this point, the loop is located in the ascending aorta, and the catheter tip is located in the aortic arch. The catheter is then pushed into the left subclavian artery, and the catheter tip is then inserted into the left vertebral artery. After angiography is completed, the catheter is withdrawn, allowing the catheter tip to bounce into the left common carotid artery. After angiography is completed, the catheter tip is bounced into the brachiocephalic trunk. At this point, the catheter is pulled back to complete the angiography of the right common carotid artery. The condition of the cerebral blood vessels is observed through bilateral common carotid and vertebral artery angiography. After the operation is completed, a guidewire is inserted, and the catheter is pushed back until the folded portion naturally straightens. The catheter and guidewire are removed from the body together from the right radial artery, completing the operation. However, this catheter is only suitable for cerebral angiography via the right radial artery, and it is difficult to achieve selective angiography of secondary branches above the aortic arch.

[0005] Furthermore, patent document CN105031801A, published in 2015, provides a guiding catheter, catheter assembly, and angiography method for angiography. The catheter assembly includes a guiding catheter and an angiography catheter. The guiding catheter includes a tubular body with a guiding tip at its front end. A lateral opening communicating with the inner bore of the tubular body is provided on the rear side of the guiding tip. The catheter assembly also includes a guidewire for inserting the angiography catheter into the inner bore of the tubular body and allowing the tip of the angiography catheter to exit through the lateral opening. In use, the guiding catheter is first inserted into the aortic arch, aligning the lateral opening with the corresponding branch vessel. The angiography catheter is coaxially introduced into the guiding catheter with the help of the guidewire. Then, by rotating the guidewire, the angiography catheter extends from the lateral opening of the guiding catheter into the right subclavian artery or aortic arch. The guidewire is withdrawn, and the location of the branch vessel is determined by manual angiography. The angiography catheter, in conjunction with the guidewire, is selectively inserted into the branch vessel for further cerebral angiography. However, in practice, to extend the angiography catheter from the opening on the side wall of the guiding catheter, the tip of the angiography catheter basically needs to be bent at 90 degrees. Moreover, the diameter of the side hole is limited, making the operation quite difficult. Furthermore, since the angiography catheter and the guiding catheter are basically at a 90-degree angle after the angiography catheter extends from the opening on the side wall of the guiding catheter, it is still quite difficult to push the angiography catheter further toward the common carotid artery, even with guidewire guidance. It is basically impossible to achieve superselection of the internal carotid artery, external carotid artery, and vertebral artery.

[0006] In addition, there are other reports on catheters for cerebral angiography via the radial artery approach, but all of them have certain limitations. Currently, there is a lack of catheters that excel in terms of vascular selection convenience, success rate, and avoidance of vascular injury, and are applicable to either the left or right radial artery approach, suitable for both cerebral angiography and interventional cerebral vascular treatment. Summary of the Invention

[0007] The purpose of this invention is to address the shortcomings of existing technologies by providing a catheter that excels in terms of vascular superselectivity, success rate, and avoidance of vascular damage, and is applicable to either the left or right radial artery approach, and can be used for both cerebral angiography and cerebral vascular interventional therapy.

[0008] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0009] A transradial artery approach cerebrovascular interventional cannula assembly includes an outer cannula, an intermediate access catheter, and a guidewire. The outer cannula, from distal to proximal, consists of a first curved section, a first straight section, a second curved section, a second straight section, a third curved section, a linear section, and an outer cannula connector. In its natural state, the first curved section is arc-shaped with an arc length of 20-40 mm and a central angle θ1 between 60-88 degrees. The second curved section is curved, curving distally, with the distal section exhibiting a greater curvature than the proximal section. The second straight section is longer and has a greater inclination than the first straight section. The intermediate access catheter, from distal to proximal, consists of a cephalic section, a cervical section, a linear section, and an intermediate access catheter connector. The outer cannula is more rigid than the intermediate access catheter.

[0010] As a preferred embodiment of the present invention, the first straight section is straight with a length of 30-50 mm and an angle θ2 of 102-115 degrees with the radius of the near end point of the first curved section.

[0011] As another preferred embodiment of the present invention, the length of the second bending section is 50-80 mm.

[0012] As another preferred embodiment of the present invention, the second straight section is straight with a length of 40-55mm, and the angle θ3 between it and the line connecting the two endpoints of the second curved section is 65-75 degrees.

[0013] As another preferred embodiment of the present invention, the third curved section is an arc with an arc length of 30-40mm and a central angle θ4 of 25-30 degrees.

[0014] As another preferred embodiment of the present invention, the angle θ5 between the radii at the far end of the second straight section and the third curved section is 85-95 degrees.

[0015] As another preferred embodiment of the present invention, the tip and neck segments of the intermediate access catheter of the transradial artery cerebrovascular interventional cannula assembly are pre-shaped as follows: the tip segment is straight with a length of 5-8 mm; the neck segment is arc-shaped with an arc length of 7-7.5 mm and a central angle θ6 of 50-55 degrees; the angle θ7 between the radii at the distal endpoints of the tip and neck segments is 90-100 degrees.

[0016] As another preferred embodiment of the present invention, the distal end of the intermediate access catheter tip section of the transradial artery approach cerebrovascular interventional cannula assembly is made of a material that is softer than its main body.

[0017] As another preferred embodiment of the present invention, the intermediate passage catheter connector is adapted to a universal tee connector.

[0018] As another preferred embodiment of the present invention, the intermediate access catheter is made of medical polymer material, and the inner wall and outer layer are treated with a super-slippery coating.

[0019] The advantages of this invention are:

[0020] 1. The radial artery approach cerebral vascular interventional cannula assembly of the present invention has a rigid outer cannula and a softer intermediate access catheter. The shape and size of each segment of the outer cannula are reasonably designed so that it can be well supported in the position of the aortic arch, providing a smooth curved access path for the intermediate access catheter. The softer intermediate access catheter can be easily advanced and selected for branch vessels under the guidance of the guide wire, thereby completing whole cerebral angiography with a high success rate, reduced difficulty in vessel selection, and significant saving of operation time.

[0021] 2. Due to the reasonable shape design of the outer cannula, the access to each blood vessel is smoother, thus reducing damage to the blood vessel. In addition, the selection of branch blood vessels is achieved by a softer intermediate access catheter, and the distal end of the intermediate access catheter is made of a softer material, thus minimizing damage to the blood vessel.

[0022] 3. The cerebral vascular interventional cannula assembly via the radial artery of the present invention is applicable to either the left or right radial artery approach.

[0023] 4. The transradial artery approach cerebral vascular interventional cannula assembly of the present invention, when its overall diameter is enlarged, can not only be used for angiography, but also for interventional treatment of intracerebral blood vessels, such as cerebral aneurysm embolization or cerebral thrombosis removal. Attached Figure Description

[0024] Appendix Figure 1 This is a schematic diagram of the structure of the transradial artery approach cerebrovascular interventional cannula assembly of the present invention.

[0025] Figure 2 This is a schematic diagram of the parameters for each section of the outer jacket.

[0026] Figure 3 This is a schematic diagram of the parameters of each section of the intermediate access catheter.

[0027] Figure 4-7 This is a schematic diagram of the radial artery approach cerebrovascular interventional cannula assembly of the present invention in use. Detailed Implementation

[0028] The specific embodiments provided by the present invention will be described in detail below with reference to the accompanying drawings.

[0029] The reference numerals and components involved in the accompanying drawings are shown below:

[0030] 1. Outer tube 11. First bending section

[0031] 12. First straight section 13. Second curved section

[0032] 14. Second straight section 15. Third curved section

[0033] 16. Linear section of outer casing 17. Outer casing joint

[0034] 2. Intermediate access catheter 21. Tip segment

[0035] 22. Neck segment 23. Linear segment of intermediate access catheter

[0036] 24. Intermediate access catheter connector 3. Guide wire

[0037] 4. Aortic arch 5. Left common carotid artery

[0038] 6. Brachiocephalic trunk 7. Right common carotid artery

[0039] 8. Ascending aorta 9. Right vertebral artery

[0040] 10. Left vertebral artery

[0041] Example 1

[0042] Please see Figure 1 , Figure 1 This is a schematic diagram of the structure of the transradial artery approach cerebrovascular interventional cannula assembly of the present invention. The transradial artery approach cerebrovascular interventional cannula assembly includes an outer cannula 1, an intermediate access catheter 2, and a guide wire 3.

[0043] The outer sheath 1, from distal to proximal, consists of a first curved section 11, a first straight section 12, a second curved section 13, a second straight section 14, a third curved section 15, a linear section 16, and an outer sheath connector 17. The first curved section 11, the first straight section 12, the second curved section 13, the second straight section 14, the third curved section 15, and the linear section 16 are integrally formed, forming a hollow circular tube structure with an outer diameter of 2-2.4 mm, an inner diameter of 1.9-2.3 mm, and an overall length of 90-110 cm. The intermediate conduit 2, from distal to proximal, consists of a head section 21, a neck section 22, a linear section 23, and an intermediate conduit connector 24. The head section 21, neck section 22, and intermediate access catheter linear section 23 are integrally formed, forming a hollow circular tube structure with an outer diameter of 1.8-2.2 mm, an inner diameter of 1.7-2.1 mm, and an overall length of 115-130 cm. In use, the guide wire 3 passes through the interior of the intermediate access catheter 2.

[0044] Please see Figure 2 , Figure 2This is a schematic diagram of the parameters of each section of the outer sheath. The first curved section 11, the first straight section 12, the second curved section 13, the second straight section 14, and the third curved section 15 are pre-molded into the following shapes: The first curved section 11 is an arc shape with an arc length of 20-40mm and a central angle θ1 between 60-88 degrees. The first straight section 12 is a straight line with a length of 30-50mm and an angle θ2 between it and the radius r1 of the near end of the first curved section 11 with a radius of 102-115 degrees. The second curved section 13 is curved, bending towards the distal end, with a length of 50-80mm. The line connecting the two ends of the second curved section 13 is L1, and the perpendicular line at the midpoint of L1 is L2. L1 and L2 divide the second curved section 13 into two intervals. The point on the second curved section 13 farthest from L1 is located in the interval closer to the distal end, and the distance from L1 is 12-16mm. The second straight section 14 is straight, with a length of 40-55mm, and the angle θ3 between it and the line L1 connecting the two endpoints of the second curved section 13 is 65-75 degrees. The third curved section 15 is arc-shaped, with an arc length of 30-40mm, and the central angle θ4 subtended by it is 25-30 degrees. The angle θ5 between the radius r2 at the far endpoints of the second straight section 14 and the third curved section 15 is 85-95 degrees. The outer sleeve linear section 16 is linear.

[0045] Please see Figure 3 , Figure 3 This is a schematic diagram of the parameters of each section of the intermediate access catheter. The tip section 21 and the neck section 22 are pre-shaped as follows: the tip section 21 is straight, with a length of 5-8 mm, and its distal 2-4 mm is made of a softer material than its main body; the neck section 22 is arc-shaped, with an arc length of 7-7.5 mm and a central angle θ6 of 50-55 degrees. The angle θ7 between the radius r3 at the distal end of the tip section 21 and the neck section 22 is 90-100 degrees. The linear section 23 of the intermediate access catheter is linear, and the angle θ8 between it and the radius r4 at the proximal end of the neck section 22 is 85-95 degrees.

[0046] Please see Figure 4-7 , Figure 4-7This is a schematic diagram illustrating the usage of the transradial artery approach cerebrovascular interventional cannula assembly of the present invention. The usage method and principle of the transradial artery approach cerebrovascular interventional cannula assembly of the present invention are as follows: Taking left radial artery approach cerebral angiography as an example, after successful left radial artery puncture, the intermediate access catheter 2 is folded inside the outer cannula 1. The guide wire 3 is guided inside the intermediate access catheter 2, passing through the radial artery, brachial artery, axillary artery, and left subclavian artery to reach the aortic arch 4, and further advanced into the descending aorta. After the second curved section 13 of the outer cannula 1 reaches the aortic arch 4, the guide wire 3 and intermediate access catheter 2 are slowly withdrawn. After reaching the proximal end of the second curved section 13 of the outer cannula 1, the entire outer cannula 1 is pushed forward, allowing it to return to its pre-shaped state within the aortic arch 4. The second curved section 13 returns to its curved shape. Through rotation, pushing, and withdrawal actions, the distal end of the first curved section 11 of the outer cannula can be aligned and entered into the entrance of the left common carotid artery 5. Then, the entire outer cannula 1, guide wire 3, and... The intermediate access catheter 2, under the straightening action of the first straight section 12 and the second straight section 14, combined with the size and curvature design of each section, allows the second curved section 13 to press against the lower wall of the aortic arch 4, forming strong support. Guided by the guide wire 3, the intermediate access catheter 2 is pushed to the distal outer side of the outer cannula 1. Contrast agent is injected through the intermediate access catheter connector 24 to confirm the course of the distal vessel. Then, the guide wire 3 is advanced to assist the intermediate access catheter 2 in further pushing forward. Because the intermediate access catheter 2 is made of a softer material, it will not damage the vessel wall. At the same time, because the second curved section 13 of the outer cannula 1 forms stable support at the aortic arch 4, a smooth transition passage is formed here, making it easy to push the intermediate access catheter 2 upward to the target site of the internal or external carotid artery. After the intermediate access catheter 2 is in place, the guide wire 3 is withdrawn, and contrast agent is injected through the intermediate access catheter connector 24 to complete the angiography. Withdraw the intermediate access catheter 2 to the proximal end of the second curved section 13 of the outer cannula 1, apply a slight rotational force, and push the outer cannula 1 forward as a whole. The outer cannula 1 will generally advance towards the aortic arch 4 and the ascending aorta 8, exiting from the left common carotid artery 5. When the first curved section 11 is aligned with the brachiocephalic trunk 6, withdraw the outer cannula 1 as a whole. The first curved section 11 and the first straight section 12 enter the entrance of the brachiocephalic trunk 6. Advance the intermediate access catheter 2 to complete the injection of contrast agent into the brachiocephalic trunk. Then, using the guide wire 3, advance the outer cannula 1 slightly forward. At this time, the first curved section 11 of the outer cannula 1 is completely inserted into the right common carotid artery 7. Its second curved section 13, under the action of the first straight section 12 and the second straight section 14, is stably supported at the junction of the aortic arch 4 and the ascending aorta 8, forming a stable support here. The guide wire 3 guides the intermediate access catheter to further enter the target position of the right internal and external carotid arteries. Withdraw the guide wire 3 and inject the contrast agent to complete the angiography.The intermediate access catheter 2 is withdrawn to the proximal end of the second curved section 13 of the outer cannula 1. A slight rotational force is applied, and the outer cannula 1 is pushed forward as a whole. With the rotational operation and, if necessary, the guide wire 3, the first curved section 11 of the tip of the outer cannula 1 can enter the right subclavian artery. Further, the intermediate access catheter 2, guided by the guide wire 3, can enter the right vertebral artery 9. The second curved section 13 of the outer cannula 1 is stably supported at the junction of the aortic arch 4 and the ascending aorta 8, forming a smooth access route. Finally, angiography is completed within the right vertebral artery 9 through the access catheter 2. The outer cannula 1 and intermediate access catheter 2 are then withdrawn as a whole. Just before reaching the opening of the left vertebral artery 10, the intermediate access catheter 2 and guide wire 3 are slightly withdrawn. The distal end of the first curved section 11 of the outer cannula 1 returns to its pre-shaped form and curves upward, entering the left vertebral artery 10. The intermediate access catheter 2 is further pushed forward, and contrast agent is injected to complete the angiography. After the angiography is completed, all catheters are withdrawn as a whole. When performing cerebral angiography via the right radial artery approach, the procedure can be as follows: first, perform angiography of the right vertebral artery, then the right common carotid artery and the right internal and external carotid arteries, then the left common carotid artery and the left internal and external carotid arteries, and finally the left vertebral artery. Throughout the angiography process, the outer cannula 2 provides stable support at the aortic arch, facilitating the advancement of the intermediate access catheter 1 and enabling successful entry into the branch vessels to complete the angiography.

[0047] Regarding this application, it should be noted that the present invention improves the shape and size of the first curved section 11, the second curved section 13, and the third curved section 15 of the outer cannula 1, as well as the shape and size of the first straight section 12 and the second straight section 14 of the outer cannula 1. This allows the third curved section 15 to be stably supported by the left or right subclavian artery. The highest point of the second curved section 13 is more inclined towards the first straight section 12, that is, the curvature of the distal section of the second curved section 13 is greater than that of the proximal section. In addition, the second straight section 14 is longer and has a greater inclination than the first straight section 12. Therefore, the second curved section 13 is stably supported at the aortic arch position under the action of the first straight section 12 and the second straight section 14. Furthermore, the outer cannula 1 is designed with a relatively rigid material, providing strong support. Thus, a smooth, curved access channel is formed for the intermediate access catheter 2. The intermediate access catheter 2 is made of a softer material, making it easier to insert. Its distal end is also made of a softer material, allowing it to be easily advanced under the guidance of the guide wire 3 and into the next-level branch vessels, successfully completing superselective angiography of all cerebral vessels. According to our clinical statistics, using the transradial artery approach cerebral vascular interventional cannula assembly of this invention for left or right radial artery cerebral angiography, a total of 132 cases were performed, all with success, a success rate of 100%. Furthermore, the difficulty of vascular access is significantly reduced, saving the time required for the entire angiography process. In addition, the transradial artery approach cerebral vascular interventional cannula assembly of this invention, with its overall increased inner and outer diameters, can complete interventional treatment of cerebrovascular diseases. Regarding the intermediate access catheter 2, its intermediate access catheter connector 24 is adapted to a universal three-way connector. The intermediate access catheter 2 is made of medical-grade polymer material, with an ultra-slippery coating on the inner and outer walls to facilitate instrument advancement.

[0048] The above description is only a preferred embodiment of the present invention. It should be noted that those skilled in the art can make several improvements and additions without departing from the method of the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention.

Claims

1. A transradial approach cerebrovascular interventional cannula assembly, characterized in that, It includes an outer tube (1), an intermediate access catheter (2), and a guide wire (3); the outer tube (1) consists of a first curved section (11), a first straight section (12), a second curved section (13), a second straight section (14), a third curved section (15), a linear section (16), and an outer tube connector (17) from distal to proximal; in its natural state, the first curved section (11) is arc-shaped with an arc length of 20-40 mm and a central angle between 60-88 degrees; the second curved section (13) is curved, curving towards the distal end, and the curvature of the distal section of the second curved section (13) is greater than that of the proximal section; the first straight section (12) 12) is straight, with a length of 30-50mm, and the angle between it and the radius of the proximal end of the first curved section (11) is 102-115 degrees; the second straight section (14) is straight, with a length of 40-55mm, and the angle between it and the line connecting the two ends of the second curved section (13) is 65-75 degrees; the second straight section (14) is longer and has a greater inclination than the first straight section (12); the intermediate access catheter (2) consists of a head section (21), a neck section (22), an intermediate access catheter linear section (23), and an intermediate access catheter connector (24) from distal to proximal; the outer sheath (1) has a greater hardness than the intermediate access catheter (2).

2. The transradial artery approach cerebrovascular interventional cannula assembly according to claim 1, characterized in that, The length of the second bending section (13) is 50-80 mm.

3. The transradial cerebrovascular interventional cannula assembly according to claim 1, characterized in that, The third curved section (15) is arc-shaped with an arc length of 30-40mm and a central angle of 25-30 degrees.

4. The transradial artery approach cerebrovascular interventional cannula assembly according to claim 1, characterized in that, The angle between the radius at the far end of the second straight section (14) and the third curved section (15) is 85-95 degrees.

5. The transradial artery approach cerebrovascular interventional cannula assembly according to claim 1, characterized in that, The head section (21) and neck section (22) are pre-shaped as follows: the head section (21) is straight with a length of 5-8 mm; the neck section (22) is arc-shaped with an arc length of 7-7.5 mm and a central angle of 50-55 degrees; the angle between the radii at the distal ends of the head section (21) and the neck section (22) is 90-100 degrees.

6. The transradial cerebrovascular interventional cannula assembly according to claim 1, characterized in that, The distal end of the head section (21) is made of a material that is softer than its body.

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