Coronary bifurcation lesion protection catheter

Abstract

This invention provides a coronary artery bifurcation lesion protection catheter, comprising a tube body, a push rod, and a handle connected in sequence. The tube body has an axially extending through-hole for guidewire passage. The push rod is made of solid steel wire, with one end connected to the rear end of the tube body and the other end connected to the handle. This invention uses a 1.0F solid push rod, effectively reducing the diameter while ensuring support and pushing force, allowing for easy simultaneous placement of one stent catheter and two branch protection catheters within a 6F guiding catheter.

Description

Technical Field

[0001] This invention relates to a branch protection catheter for coronary artery bifurcation lesions, used in the interventional treatment of coronary artery bifurcation lesions. Background Technology

[0002] Coronary artery bifurcation lesions refer to severe stenosis in the main branch and branches of the coronary arteries, either separately or simultaneously. They account for 15%-20% of all percutaneous coronary interventions (PCI) and represent a challenging aspect of coronary interventional treatment.

[0003] For the treatment of bifurcation lesions, two approaches are currently recognized: dual-stent implantation, provisional stent implantation, and single-stent implantation. The latter, or Cross-Over procedure, refers to implanting a stent in the main branch with or without protection at the branch ostium. Randomized clinical trials and registry studies suggest that single-stent implantation appears to be better in the long term; therefore, current PCI guidelines and expert consensus tend to favor the simple single-stent treatment strategy.

[0004] However, after a stent is implanted in the main branch during a single-stent procedure, the branch vessel openings often experience severe stenosis due to the "snowplow effect" or ridge displacement, or even acute branch occlusion, posing a high risk, especially in cases where the branch opening stenosis is severe, the branch angle is small, and the branch vessel has significant functional value. Therefore, branch protection is crucial.

[0005] The most common branch protection measures in clinical practice are guidewire protection and balloon protection. Guidewires, however, can only serve as markers and cannot effectively protect branches, so they are rarely used nowadays. Balloon protection, also known as jailed balloon technique (JBT), is currently the most widely used branch protection technique.

[0006] The procedure for the confinement balloon technique involves first implanting a balloon at the branch ostium. After the main branch stent is released with low pressure, the side branch balloon is pre-dilated with low pressure. This dilation alters the shape of the atherosclerotic plaque, protecting the branch vessel. The branch balloon is then withdrawn into the guiding catheter, and the main branch stent is dilated with high pressure to ensure good stent apposition and reduce the risk of branch vessel occlusion. However, the confinement balloon technique and its modifications have drawbacks. The balloon body is relatively thin, resulting in weak protection for the branch. Furthermore, active dilation of the branch balloon may cause dissection, even severe spiral dissection or intramural hematoma, leading to branch loss and negating its protective function.

[0007] Therefore, the applicant in this case proposed a new balloon restraint technique, namely, a deep-embedded, non-inflatable balloon restraint technique. Its key technical points mainly include: deep-embedded protective balloon, non-inflatable balloon, and simultaneous withdrawal of the guidewire and balloon. The specific procedure includes: (A) guidewires are inserted into the main branch and branch vessels respectively; (B) after pre-dilation of the main branch with a balloon, a stent is inserted into the main branch; (C) a small balloon is inserted into the branch vessel, reaching the distal segment; (D) the main branch stent is released with appropriate pressure; (E) a non-compliant balloon is fully inflated to ensure stent apposition to the vessel wall; (F) the branch balloon is not inflated, and the branch balloon and guidewire are withdrawn (simultaneously), with no significant involvement of the branch ostium; the procedure is complete.

[0008] The safety and effectiveness of the above method have been confirmed through more than 300 clinical applications. However, certain problems still exist with this method.

[0009] First, the balloon pusher is relatively thick, meaning a single guiding catheter can only accommodate one balloon catheter and one stent catheter, making it impossible to simultaneously protect two branch vessels. Furthermore, due to the thicker balloon stem, when performing balloon protection, the stent catheter must be inserted first, followed by the balloon catheter; otherwise, successful insertion is impossible. Finally, while the balloon was initially designed for lesion dilation, our clinical practice and data have confirmed that its dilation function is unnecessary for branch protection. In fact, balloon branch protection positioning requires lowering the balloon to the branch opening, necessitating repeated injections of contrast agent for localization, increasing radiation exposure and contrast agent usage. Summary of the Invention

[0010] The purpose of this invention is to provide a coronary artery bifurcation lesion protection catheter to solve the above-mentioned technical problems existing in the prior art.

[0011] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0012] A coronary artery bifurcation lesion protection catheter, characterized in that it comprises a tube body, a push rod, and a handle connected in sequence, wherein:

[0013] The tube body has a through hole along the axial direction, which allows the guide wire to pass through;

[0014] The push rod is made of solid steel wire, with one end connected to the rear end of the tube and the other end connected to the handle.

[0015] The aforementioned coronary artery bifurcation lesion protection catheter, wherein the catheter body is made of polyamide material.

[0016] The aforementioned coronary artery bifurcation lesion protection catheter, wherein the tip of the catheter body is tapered.

[0017] The aforementioned coronary artery bifurcation lesion protection catheter, wherein: a mark is provided near the tip of the catheter body.

[0018] The aforementioned coronary artery bifurcation lesion protection catheter, wherein the section where the push rod connects to the rear end of the catheter body gradually tapers.

[0019] The aforementioned coronary artery bifurcation lesion protection catheter, wherein the handle has a hexagonal cross-sectional shape.

[0020] The aforementioned coronary artery bifurcation lesion protection catheter has the following characteristics: the tube body is 3cm long, the inner diameter is 0.04cm, the outer diameter is 0.07cm, the outer diameter of the tube tip is 0.06cm, and the tapered length is 1mm.

[0021] The aforementioned coronary artery bifurcation lesion protection catheter, wherein: a mark is provided in the tube body near the tip, the mark being arranged 2mm from the tip and having a length of 1mm.

[0022] The aforementioned coronary artery bifurcation lesion protection catheter, wherein the diameter of the push rod is 0.05 cm.

[0023] The main advantages of this invention are: (1) It has a thinner push rod, which leaves enough space inside the guiding catheter to facilitate pushing the instrument or performing multi-branch protection operations. (2) It adopts a tubular design with a shorter tip, which makes the operation simpler and provides good protection. (3) There are currently no similar products in clinical practice, and balloon catheters are used for branch protection. Attached Figure Description

[0024] Figure 1 This is a cross-sectional view of the overall structure of the coronary artery bifurcation lesion protection catheter provided by the present invention.

[0025] Figure 2 This is a schematic diagram showing the working combination of the guidewire and the coronary artery bifurcation lesion protection catheter.

[0026] Figures 3A-3F This is a schematic diagram illustrating the usage steps of the present invention.

[0027] Explanation of reference numerals in the attached diagram: Branch protection catheter A; Tube body 1; Push rod 2; Handle 3; Guide wire 5; Support 6. Detailed Implementation

[0028] like Figure 1 As shown, this invention provides a coronary artery bifurcation lesion protection catheter, which consists of a tube body 1, a push rod 2, and a handle 3 connected in sequence, wherein:

[0029] The tube body 1 is made of polyamide (nylon) material, and its tip is tapered to facilitate passage through narrow lesion areas. A marker 11 is provided radially inside the tube body 1 near the tip, which can be visualized under X-rays to help determine the position of the tube body 1. A through hole 12 is provided axially inside the tube body 1 to allow the guide wire 5 (see Figure 3) to pass through.

[0030] The push rod 2 is made of solid steel wire, which can minimize the diameter while ensuring support, so that one stent catheter and two branch protection catheters can be accommodated in the same guiding catheter at the same time. One end of the push rod 2 gradually tapers (called the transition section) and wraps around the rear end of the tube body 1. The transition section adopts a gradually tapering structure, which not only ensures the pushing ability of the tube body 1, but also improves the tracking ability of the tube body 1, making it easier to pass through branch vessels with large angles or tortuous vessels. Furthermore, it can make the push rod 2 and the tube body 1 form a firm connection, preventing the tube body 1 from breaking or falling off when the branch protection catheter is withdrawn.

[0031] The handle 3 preferably has a hexagonal cross-sectional shape, which makes the branch protection catheter highly identifiable outside the body, making it easy to quickly find the branch protection catheter among many instruments. At the same time, this design makes it easy for the operator to hold and effectively apply force during the withdrawal of the branch protection catheter, so as to control the smooth withdrawal of the branch protection catheter.

[0032] In the above embodiment, the tube body 1 has a length of 3cm, an inner diameter of 1.2F (0.04cm), an outer diameter of 2.1F (0.07cm), an outer diameter of 1.8F (0.06cm) at the tip of the tube body 1, a tapered length of 1mm, and a marker 11 is placed 2mm from the tip with a length of 1mm.

[0033] In the above embodiment, the push rod 2 is a solid circular 316L stainless steel push rod 2 with a length of 140cm and a diameter of 1.5F (0.05cm). While ensuring the pushing force, the outer diameter of the pushing part is reduced as much as possible.

[0034] This invention provides a branch protection catheter A for coronary artery bifurcation lesions. When both the main branch and the branch opening are stenotic, the branch vessels are crucial for myocardial blood supply, and the branch opening stenosis is severe, increasing the likelihood of branch occlusion after stent deployment, balloon protection is necessary. The steps of this invention include: (A) inserting guidewires 5 into the main branch and branch vessels respectively; (B) using the branch guidewire 5 as a guide rail, inserting the branch protection catheter A to the distal segment of the vessel. Depending on the number of branches to be protected, two branch protection catheters can be inserted. (A) Protect both branch vessels simultaneously; (C) After pre-dilation of the main branch with a balloon, insert the stent 6 into the main branch; (D) Release the main branch stent 6 with appropriate pressure; (E) Use a non-compliant balloon for full post-dilation to ensure stent adherence to the vessel wall; (F) Insert the branch guidewire 5 into the through-hole 12 of the tube body 1, pull the handle 3 at the rear end of the branch protection catheter A outward, and withdraw it together with the guidewire 5 to avoid removing the branch protection catheter A first and then the guidewire 5, which could damage the stent surface coating; (F) If the branch opening is not significantly affected, the procedure is complete.

[0035] This invention provides a branch protection catheter A for coronary artery bifurcation lesions, which has the following advantages: First, it uses a 1.0F solid push rod 2, which effectively reduces the diameter while ensuring support and pushing force, allowing it to easily accommodate one stent catheter and two branch protection catheters A simultaneously within a 6F guiding catheter. Second, the distal outer diameter of the tube body 1 is 2.1F, which effectively supports the branch ridge, avoids plaque displacement compression, and protects the branch opening. The tube body 1 is made of nylon material, improving the passage and smoothness of retraction of the branch protection catheter A. Finally, a 1mm marker 11 is set at 2mm of the tip of the tube body 1, which can be clearly identified under X-ray. During operation, it only needs to be pushed into the branch through the marker 11, without repeated positioning, making the operation very simple, and the pushing depth does not exceed 30mm.

[0036] The above description is illustrative only and not restrictive of the present invention. Those skilled in the art will understand that many modifications, variations or equivalents can be made without departing from the spirit and scope defined by the claims, and all such modifications, variations or equivalents will fall within the protection scope of the present invention.

Claims

1. A coronary artery bifurcation lesion protection catheter, used in a deep-implanted non-dilatational balloon restraint method, the method comprising: (A) Guidewires are inserted into the main branch and branch vessels respectively; (B) After pre-dilation of the main branch with a balloon, a stent is inserted into the main branch. (C) Using the coronary bifurcation lesion protection catheter, a branch balloon is inserted into the branch vessel to the distal segment of the branch vessel; (D) The main branch stent is released; (E) The non-compliant balloon is fully inflated to ensure the main branch stent adheres to the vessel wall; (F) The branch balloon is not inflated, and the branch balloon and guidewire within the branch vessel are withdrawn; The catheter is characterized in that it consists of a tube body, a push rod, and a handle connected in sequence, wherein: The tube is tubular in shape and 3cm in length. A through hole is provided axially inside the tube so that the guide wire can pass through. The diameter of the push rod is 0.05cm; the push rod is made of solid steel wire, one end of which is connected to the rear end of the tube body, and the other end is connected to the handle.

2. The coronary artery bifurcation lesion protection catheter according to claim 1, characterized in that: The tube body is made of polyamide.

3. The coronary artery bifurcation lesion protection catheter according to claim 1, characterized in that: The head end of the tube is tapered.

4. The coronary artery bifurcation lesion protection catheter according to claim 1, characterized in that: A mark is provided inside the tube near the head end.

5. The coronary artery bifurcation lesion protection catheter according to claim 1, characterized in that: The section where the push rod connects to the rear end of the tube gradually tapers.

6. The coronary artery bifurcation lesion protection catheter according to claim 1, characterized in that: The handle has a hexagonal cross-sectional shape.

7. The coronary artery bifurcation lesion protection catheter according to claim 1, characterized in that: The tube has an inner diameter of 0.04 cm, an outer diameter of 0.07 cm, an outer diameter of 0.06 cm at the tip, and a tapered length of 1 mm.

8. The coronary artery bifurcation lesion protection catheter according to claim 7, characterized in that: A mark is provided inside the tube near the tip, the mark being located 2 mm from the tip and having a length of 1 mm.

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