A microcatheter for local coronary artery targeting

Abstract

The utility model discloses a kind of coronary artery local targeting drug delivery microcatheter, it is related to medical instrument technical field;Including luer joint, handle, reinforcement, marker ring, near section pipe, far section pipe, support guide wire, dosing hole, recess structure, guide wire outlet, developing ring and sharp port, the luer joint is connected in one end of handle, the near section pipe is connected in the other end of handle, the near section pipe is connected with far section pipe away from handle one end;It can be quickly withdrawn and advanced in coronary artery, can be quickly exchanged, retain the passage of guide wire, can quickly inject drug into coronary artery interior targeted, can be dosed and dosing range is more accurate and effective.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a microcatheter for local targeted drug delivery in the coronary artery. Background Technology

[0002] Data from the diagnosis and treatment of ischemic heart disease in China in 2024 shows that a total of 8.368 million cases of coronary heart disease were treated in my country in 2023, of which 1.9 million underwent percutaneous coronary intervention (PCI), accounting for 22.7% of the total number of hospitalized patients with coronary heart disease. Among them, 68.8% received coronary artery stenting, 13.1% received coronary artery drug-eluting balloon angioplasty, and 12.4% received both coronary artery stenting and coronary artery drug-eluting balloon angioplasty.

[0003] Intravascular coronary intervention (ICI) is a treatment method in which medication is directly injected into the specific diseased coronary artery (i.e., the "target vessel") during percutaneous coronary intervention (PCI). The advantages of ICI include: medication entering the coronary artery does not need to pass through systemic circulation, acting directly and precisely on the target vessel and lesion; significantly increasing the local drug concentration in the target vessel; rapid onset of action and flexible intraoperative control, enhancing treatment efficacy; avoiding drug effects on non-target vessels; and reducing systemic side effects. ICI has become an important adjunct to PCI, and the following issues often arise during PCI that necessitate the use of ICI:

[0004] 1. Patients with acute myocardial infarction have a heavy thrombus burden in the target vessel. Thrombolytic drugs are injected into the target vessel of the coronary artery to dissolve the thrombus. Thrombolytic agents (such as alteplase) or antiplatelet drugs (such as tirofiban) are injected into the target vessel to quickly dissolve the thrombus and reduce embolism in the distal target vessel.

[0005] 2. No-reflow phenomenon in the coronary arteries during PCI can lead to myocardial insufficiency or poor perfusion. Current evidence suggests that intracoronary injection of drugs such as tirofiban, sodium nitroprusside, verapamil, and nicorandil can effectively prevent and treat no-reflow phenomenon and improve patient prognosis.

[0006] 3. Coronary artery spasm during PCI can be relieved by intravascular application of drugs such as nitroglycerin.

[0007] Although intravascular coronary intervention (ICI) is an important adjunct to PCI, there are currently no dedicated and effective instruments available clinically. Operators typically use existing or self-made instruments, such as balloon puncture, aspiration catheters, or microcatheters. Balloon puncture has its limitations: it is very inconvenient and time-consuming to perform the procedure; administering medication through balloon puncture with a syringe is strenuous, and during withdrawal, the punctured balloon may snag on the stent beam, making withdrawal difficult; it is a non-standardized procedure. Aspiration catheters and microcatheters lack specific administration ports; aspiration catheters are space-consuming and expensive; and medication administration using aspiration catheters is a non-standardized procedure. Single-lumen microcatheters require the guidewire to be withdrawn before administration, increasing the risk of guidewire exchange and significantly prolonging the operation time. Utility Model Content

[0008] The purpose of this invention is to provide a microcatheter for local targeted drug delivery in the coronary artery, so as to at least solve some of the above-mentioned problems.

[0009] To achieve the above objectives, this utility model provides the following technical solution: a coronary artery local targeted drug delivery microcatheter, comprising a Luer connector, a handle, a reinforcing member, a marking ring, a proximal tube, a distal tube, a supporting guidewire, a drug delivery port, a groove structure, a guidewire outlet, a contrast ring, and a tip. The Luer connector is connected to one end of the handle, the proximal tube is connected to the other end of the handle, and the end of the proximal tube away from the handle is connected to the distal tube.

[0010] The reinforcing member is located at the connection between the handle and the proximal tube. The proximal tube is provided with a marking ring. One end of the support guide wire is connected to the distal end inside the proximal tube.

[0011] The distal tube includes a guidewire lumen, a drug delivery lumen, and a groove structure. The portion of the distal tube close to the proximal tube is the drug delivery lumen and is connected to the proximal tube. The portion of the distal tube away from the proximal tube is the guidewire lumen. The groove structure is located between the guidewire lumen and the drug delivery lumen.

[0012] Furthermore, the Luer connector can be connected to a three-way valve or directly to a syringe, and the three-way valve can be connected to two syringes respectively.

[0013] Furthermore, the distal tube is made of polyether block polyamide material, the outer side of the distal tube is coated with a hydrophilic coating, and the groove structure is a sealed cavity;

[0014] The guidewire cavity includes a guidewire outlet, a radiopaque ring, and a tip. The guidewire passes through the tip, radiopaque ring, and guidewire outlet in sequence. The distance between the guidewire outlet and the tip is 13 mm.

[0015] Furthermore, the drug delivery cavity is provided with staggered drug delivery holes, the number of which is 4-8;

[0016] The diameter of the administration port is 0.3-0.45 mm, and the distance between the administration port and the tip is 30-40 mm.

[0017] Furthermore, the support guide wire is welded to the distal end of the proximal tube, with a welding length of 5-10 mm and a diameter less than or equal to 0.30 mm. The other end of the support guide wire passes through the drug delivery chamber fixing groove structure or can be free within the drug delivery chamber.

[0018] Furthermore, the proximal tube is a thiocyanate tube made of metal alloy or stainless steel, and the outer wall of the proximal tube has a hydrophilic coating.

[0019] Furthermore, there are two marking rings, and the distances between the marking rings and the tip of the distal tube are 900mm and 1000mm, respectively.

[0020] Furthermore, the proximal tube has a length of 1100 mm, an outer diameter of 0.60-0.87 mm, and an inner diameter of 0.38-0.65 mm;

[0021] The distal segment is 340 mm long. The outer diameter of the drug delivery chamber in the distal segment is 0.64-0.91 mm, the inner diameter is 0.42-0.69 mm, the outer diameter of the guidewire chamber is 0.64-0.91 mm, and the inner diameter of the guidewire chamber is 0.41-0.86 mm.

[0022] Compared with the prior art, the beneficial effects of this utility model are:

[0023] This invention allows for rapid retraction and advancement within the coronary artery, enabling rapid exchange while preserving the guidewire pathway. It allows for targeted and rapid injection of drugs into the coronary artery, and allows for multiple administrations with more precise and effective drug delivery.

[0024] This invention utilizes a local targeted drug delivery microcatheter in the coronary artery to selectively angiographically visualize the blood flow in the distal segment of the coronary artery. This avoids the need for large amounts of contrast agent via a guiding catheter, which could exacerbate myocardial ischemia, thus ensuring surgical safety, improving surgical efficiency, and shortening surgical time. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the overall structure of the coronary artery local targeted drug delivery microcatheter according to an embodiment of the present invention;

[0026] Figure 2 This is a schematic diagram of the distal segment of the coronary artery local targeted drug delivery microcatheter according to an embodiment of the present invention;

[0027] Figure 3 This is a schematic diagram of the groove structure of the coronary artery local targeted drug delivery microcatheter according to an embodiment of the present invention;

[0028] Figure 4 This is a schematic diagram of the coronary artery local targeted drug delivery microcatheter connected to a three-way valve and a syringe according to an embodiment of this utility model;

[0029] In the figure, 1-Luer connector, 2-handle, 3-reinforcement, 4-marker ring, 5-proximal tube, 6-distal tube, 610-drug delivery chamber, 620-guidewire chamber, 7-guidewire support, 8-drug delivery port, 9-groove structure, 10-guidewire outlet, 11-contrast ring, 12-tip port, 13-guidewire, 14-β angle, 15-three-way valve, 16-first syringe, 17-second syringe. Detailed Implementation

[0030] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present utility model. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments.

[0031] The following is a detailed description of a coronary artery local targeted drug delivery microcatheter according to the present invention, with reference to the accompanying drawings. Figures 1-4 The present invention is a coaxial single-cavity structure, including a Luer connector 1, a handle 2, a reinforcing member 3, a proximal tube 4, a marking ring 5, a distal tube 6, a support guidewire 7, a drug delivery cavity 610, a drug delivery hole 8, a groove structure 9, a guidewire outlet 10, a guidewire cavity 620, and a tip port 12.

[0032] The proximal tube 5 is a thiocyanate tube made of metal alloy or stainless steel. The length of the proximal tube 5 is 1100mm. The surface of the proximal tube 5 has a hydrophilic coating to reduce the pushing resistance of the catheter. The outer diameter of the lumen is 0.60-0.87mm, the wall thickness of the thiocyanate tube is 0.11mm, and the inner diameter is 0.38-0.65mm. Two marking rings 4 are set on the proximal tube 5 at positions 900mm and 1000mm away from the tip port 12.

[0033] Marker ring 4 indicates the position of the microcatheter during delivery to the operator. The metal alloy or stainless steel hypo tube provides good pushability and flexural strength for delivering the microcatheter.

[0034] A metal support guide wire 7 is welded to the inner wall of the distal cavity (i.e., the cavity where the proximal tube is close to the distal tube) of the proximal tube 5. The diameter of the proximal section of the support guide wire 7 is less than or equal to 0.30 mm, and the welding length is 5 mm. The support guide wire 7 enters the drug delivery cavity 610 from the distal cavity of the proximal tube 5 and extends to the groove structure 9. The distal end of the support guide wire 7 is fixed in the groove structure 9, or it can be free in the drug delivery cavity 610. The diameter of the support guide wire 7 can gradually become thinner in the lumen of the drug delivery cavity 610. The support guide wire 7 is conducive to the transmission of the pushing force of the proximal tube 5 to the distal tube 6, thereby improving the support and bending resistance of the distal tube 6.

[0035] The distal tube 6 is made of polyether block polyamide material, and its outer surface is coated with a hydrophilic coating. The distal tube 6 includes a drug delivery chamber 610, a groove structure 9, and a guidewire lumen 620. The drug delivery chamber 610 is connected to the distal end of the proximal tube 5, and the groove structure 9 connects the drug delivery chamber 610 and the guidewire lumen 620. The length of the distal tube 6 is 340 mm. The outer diameter of the drug delivery chamber 610 in the distal tube 6 is 0.64-0.91 mm, and the inner diameter of the drug delivery chamber 610 is 0.42-0.69 mm.

[0036] The drug delivery holes 8 (number of which is 4-8) are staggered in the distal section of the drug delivery cavity 610 (i.e., near the guide wire cavity 620), with a diameter of 0.3-0.45 mm. The drug delivery holes 8 are staggered in the four directions of up, down, left, and right in the drug delivery cavity 610 and at different positions. The distance between the distal drug delivery hole 8 and the tip of the distal tube 6 is 30 mm. The drug delivery holes 8 can be distributed in the drug delivery cavity with an axial length of 30-40 mm.

[0037] The guidewire 13 enters from the tip 12, passes through the guidewire lumen 620, and exits from the guidewire outlet 10. The distal end of the groove structure 9 is located after the guidewire outlet 10. The proximal outer diameter of the guidewire lumen 620 is 0.64-0.91 mm, and the inner diameter is 0.41-0.86 mm, allowing passage of a standard 0.36 mm diameter coronary guidewire. The guidewire lumen 620 is thermoformed into a cone shape or a tapered tendency to reduce the "fish mouth effect" at the bend of the blood vessel where the microcatheter tip 12 passes.

[0038] A contrast ring 11 is provided between the tip port 12 and the guidewire outlet 10. The contrast ring 11 is closer to the guidewire outlet 10 and is 13 mm away from the tip port 12 of the microcatheter. The marking ring 4 can be used to identify the location of the microcatheter tip port 12 and the drug delivery port 8 in the coronary artery.

[0039] The groove structure 9 is formed by thermoforming the rear section of the guidewire outlet 10, ensuring that the guidewire lumen 620 and the drug delivery chamber 8 are coaxial but not connected. The groove structure is 10 mm long. After exiting the guidewire outlet 10, the direction of the guidewire 13 is not consistent with the long axis of the catheter, and the direction of the guidewire 13 after exiting the guidewire outlet 10 forms an angle β with the catheter wall of the guidewire outlet 10. The angle β causes the front and rear walls of the guidewire 13 and the guidewire outlet 10 to squeeze and cut each other, affecting the sliding of the microcatheter on the guidewire. The structure of the groove structure 9 makes the angle β smaller (less than 15 degrees), which can solve the problem of mutual squeezing and cutting between the front and rear walls of the guidewire 13 and the guidewire outlet 10, making it easier for the microcatheter to advance and retract on the guidewire 13. The groove structure 9 can seal the lumen between the guidewire lumen 620 and the drug delivery chamber 610, which is conducive to the injection of drugs into the coronary artery from the drug delivery port 8.

[0040] Handle 1 is connected to the proximal end of proximal tube 5 (i.e., the end connected to the handle). The intermediate reinforcing member 3 serves to fix the connection and prevent the connection from being bent. The distal section of proximal tube 5 is inserted into the proximal cavity of distal tube 6 and connected by welding. The connection overlaps by 5-10mm. Inserting the distal section of proximal tube 5 into the cavity of distal tube 6 helps to support the guide wire 7 to enter the distal tube 6.

[0041] Example 1

[0042] In acute myocardial infarction PCI, the target vessel has a heavy local thrombus burden, no-reflow within the target vessel, and coronary artery spasm, requiring immediate local targeted drug delivery via the coronary artery. First, the coronary guidewire 13 is inserted into the distal true lumen of the target coronary artery. The Luer connector 1 is connected to one port of the three-way valve 15, or an extension tube can be connected before connecting to the other port of the three-way valve 15. The other two ports of the three-way valve 15 can be connected to two syringes: the first syringe 16 can be a 5ml syringe, and the second syringe 17 can be a 10ml syringe. The first syringe 16 contains the drug, and the second syringe 17 contains saline. After connecting the external three-way valve 15 to the Luer connector 1 and the two syringes, the three-way valve 15 is manually operated via a knob to control the opening and closing of the tubing. The second syringe... The device 17 injects saline solution into the microcatheter to purge the gas inside the microcatheter. The guide wire 13 enters from the tip port 12, passes through the guide wire lumen 620, and exits from the guide wire outlet 10. The microcatheter enters the guiding catheter under the guidance of the guide wire 13. The distal tube 6 enters the target blood vessel through the pushing action of the proximal tube 5. The location of the drug delivery port in the coronary artery is confirmed by the imaging ring 11. The drug in the first syringe 16 is delivered to the drug delivery lumen 610 through the proximal tube 5. The drug is injected into the coronary artery through the drug delivery port 8. The microcatheter can be withdrawn and advanced in the coronary artery without losing the guide wire 13 pathway. It can continuously and repeatedly administer drugs in the coronary artery, with a wider drug delivery range. The microcatheter can be withdrawn at any time, allowing for flexible control, improving surgical efficiency, and shortening surgical time.

[0043] After the first syringe 16 has finished administering the medication, the second syringe 17 can inject saline solution into the microcatheter and inject the remaining medication in the microcatheter into the coronary artery.

[0044] Example 2

[0045] The Luer connector 1 can be directly connected to the first syringe 16, which contains the drug. The gas in the microcatheter is emptied externally. The guide wire 13 enters from the tip, passes through the guide wire lumen 620, and exits from the guide wire outlet 10. The microcatheter enters the guiding catheter through the guidance of the guide wire 13. The distal tube 6 enters the target blood vessel through the pushing action of the proximal tube 5. The location of the drug delivery port 8 in the coronary artery is identified by the imaging ring 11. The first syringe 16 delivers the drug through the proximal tube 5 to the drug delivery lumen 610 and injects the drug into the coronary artery through the drug delivery port 8.

[0046] Example 3

[0047] During percutaneous coronary intervention (PCI), the first syringe 16 contains contrast agent. The guidewire 13 enters from the tip port 12, passes through the guidewire lumen 620, and exits from the guidewire outlet 10. The microcatheter, guided by the guidewire 13, enters the guiding catheter. The proximal tube 5 pushes the distal end of the microcatheter into the target vessel. The contrast ring 11 clarifies the local location of the microcatheter's administration port 8 in the coronary artery. The first syringe 16, containing contrast agent, is delivered to the administration lumen 610 through the proximal tube 5. The contrast agent is injected into the coronary artery through the administration port 8 for selective angiography, observing the blood flow in the distal segment of the coronary artery. This avoids the use of large doses of contrast agent through the guiding catheter, which could lead to large-area myocardial ischemia and circulatory collapse in the patient, ensuring surgical safety, improving surgical efficiency, and shortening the operation time.

[0048] It will be apparent to those skilled in the art that this invention is not limited to the details of the exemplary embodiments described above, and that it can be implemented in other specific forms without departing from the spirit or essential characteristics of this invention. Therefore, the embodiments should be considered illustrative and non-limiting in all respects, and the scope of this invention is defined by the appended claims rather than the foregoing description. Thus, it is intended that all variations falling within the meaning and scope of equivalents of the claims be included within this invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

Claims

1. A coronary artery local targeted drug delivery microcatheter, characterized in that, It includes a Luer connector, a handle, a reinforcing member, a marking ring, a proximal tube, a distal tube, a support guidewire, a drug delivery port, a groove structure, a guidewire outlet, a contrast ring, and a pointed end. The Luer connector is connected to one end of the handle, the proximal tube is connected to the other end of the handle, and the end of the proximal tube away from the handle is connected to the distal tube. The reinforcing member is located at the connection between the handle and the proximal tube. The proximal tube is provided with a marking ring, and one end of the support guide wire is connected to the distal end of the proximal tube. The distal tube includes a guidewire lumen, a drug delivery lumen, and a groove structure. The portion of the distal tube close to the proximal tube is the drug delivery lumen and is connected to the proximal tube. The portion of the distal tube away from the proximal tube is the guidewire lumen. The groove structure is located between the guidewire lumen and the drug delivery lumen.

2. The coronary artery local targeted drug delivery microcatheter according to claim 1, characterized in that, The Luer connector can be connected to a three-way valve or directly to a syringe, and the three-way valve can be connected to two syringes respectively.

3. The coronary artery local targeted drug delivery microcatheter according to claim 1, characterized in that, The distal tube is made of polyether block polyamide material, and the outer side of the distal tube is coated with a hydrophilic coating. The groove structure is a sealed cavity. The guidewire cavity includes a guidewire outlet, a radiopaque ring, and a tip. The guidewire passes through the tip, radiopaque ring, and guidewire outlet in sequence. The distance between the guidewire outlet and the tip is 13 mm.

4. The coronary artery local targeted drug delivery microcatheter according to claim 3, characterized in that, The drug delivery cavity is provided with staggered drug delivery holes, and the number of drug delivery holes is 4-8. The diameter of the administration port is 0.3-0.45 mm, and the distance between the administration port and the tip is 30-40 mm.

5. The coronary artery local targeted drug delivery microcatheter according to claim 1, characterized in that, The support guide wire is welded inside the proximal tube. The welding length of the support guide wire is 5-10 mm, and the diameter of the support guide wire is less than or equal to 0.30 mm. The other end of the support guide wire passes through the drug delivery chamber fixing groove structure or can be free in the drug delivery chamber.

6. The coronary artery local targeted drug delivery microcatheter according to claim 1, characterized in that, The proximal tube is a hyaluronic acid tube, made of metal alloy or stainless steel, and has a hydrophilic coating on the outer wall of the proximal tube.

7. The coronary artery local targeted drug delivery microcatheter according to claim 6, characterized in that, The number of marking rings is two, and the distances between the marking rings and the tip of the distal tube are 900mm and 1000mm, respectively.

8. The coronary artery local targeted drug delivery microcatheter according to claim 1, characterized in that, The proximal section of the tube is 1100 mm long, with an outer diameter of 0.60-0.87 mm and an inner diameter of 0.38-0.65 mm. The distal segment is 340 mm long. The outer diameter of the drug delivery chamber in the distal segment is 0.64-0.91 mm, the inner diameter is 0.42-0.69 mm, the outer diameter of the guidewire chamber is 0.64-0.91 mm, and the inner diameter of the guidewire chamber is 0.41-0.86 mm.

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