CN201135683Y - A tapered balloon dilatation catheter - Google Patents

Abstract

The utility model relates to a vertebral balloon expansion catheter used for percutaneous puncture coronary angioplasty in interventional treatment technology. It includes a balloon, a catheter, and a Luer connector. The balloon is located at the front of the catheter. The catheter is connected to the Luer connector or connected to the Luer connector through a protective tube. An inner tube is arranged in the catheter. The end is a tapered section structure at both ends, and the middle section of the balloon is a transitional tapered structure; since the main body of the balloon adopts a tapered structure, it is ergonomic, so that the balloon or the stent that relies on the balloon expansion conforms to the inner diameter of the human blood vessel The natural change that gradually becomes thinner from near to far, so this kind of balloon can reduce the damage to the distal blood vessel caused by the over-expansion of the traditional balloon when expanding the stent, make the stent adhere to the wall better, and reduce postoperative thrombus or The possibility of restenosis; the tapered structure design can improve the performance of the balloon catheter passing through blood vessels or lesions.

Description

A tapered balloon dilatation catheter

technical field

The utility model belongs to the field of medical equipment, and relates to a balloon dilation catheter used in percutaneous puncture angioplasty, in particular to a vertebral balloon dilation catheter used in percutaneous coronary angioplasty of interventional treatment technology.

Background technique

Interventional therapy technology was developed in the late 1970s. Under the guidance of imaging medicine, including X-ray, ultrasound, CT, and magnetic resonance imaging (MRI), special catheters or instruments are inserted into the lesion through percutaneous puncture. for diagnosis or treatment. Percutaneous coronary angioplasty is the use of percutaneous puncture technology to insert a balloon catheter into the stenosis of the coronary artery, and under the guidance and monitoring of medical imaging equipment, the balloon is expanded to expand the coronary artery stenosis , increase myocardial blood flow, improve myocardial blood circulation.

As shown in Figure 1, since the diameter of the distal end of the human coronary artery is generally smaller than the diameter of the proximal end, the middle section of the balloon dilation catheter currently used is a straight structure, which is unreasonable in design and does not conform to the inner diameter of the human blood vessel. The natural changes of the stent can easily cause transitional damage or malapposition to the distal end of the coronary artery, causing restenosis of the distal end of the stent.

Contents of the invention

The purpose of this utility model is to provide a conical balloon expansion catheter with reasonable structure and good wall-attachment effect, which can improve the transitional damage to the distal end of the blood vessel when expanding the stent or directly using the balloon to expand, and reduce postoperative thrombosis or likelihood of restenosis.

The technical solution adopted by the utility model: a tapered balloon dilatation catheter, including a balloon, a catheter, and a Luer connector. An inner tube is arranged inside, the balloon distal end and the balloon proximal end are tapered at both ends, and the middle section of the balloon is a transitional tapered structure.

The taper diameter at one end of the middle section matches the taper diameter at the distal end of the balloon, and the taper diameter at the other end matches the taper diameter at the proximal end of the balloon.

The taper diameter of the balloon distal end of the balloon is smaller than the taper diameter of the proximal end of the balloon; the taper diameter of the middle section of the balloon from the proximal end of the balloon is greater than the taper diameter of the distal end of the balloon; the distal end of the balloon and the taper diameter of the balloon The taper angles of the tapered sections at both ends of the proximal end are larger than the taper angles of the middle section.

The wall thickness of the tapered section at both ends of the distal end of the balloon and the proximal end of the balloon is 1-30% thicker than that of the transitional tapered section of the middle section.

The inner tube is embedded or sleeved with at least one imaging mark, which is arranged at the junction of the vertebral segment and the middle segment at the distal end of the balloon and the proximal end of the balloon. The effective length of the latter is equivalent.

The front tube body of the catheter is provided with a guide wire side opening, and a gradient or tapered flexible transition element is arranged in the front tube body, and the flexible transition element is connected with the rear tube body.

The tail end of the inner tube is connected to the side port of the catheter, the front part of the inner tube enters the balloon through the front body of the catheter, the outer edge of the tip of the inner tube is connected and sealed with the top end of the balloon, and the balloon of the balloon The proximal end is connected with the outer edge of the front tube of the catheter.

The front end of the rear tube body of the catheter is in the shape of a gradient groove, which is inserted into the front tube body, or a gradient groove is welded on the front end of the rear tube body made of metal tube material, and inserted into the front tube body, or inserted into the front tube body made of stainless steel tube material. The front end of the rear pipe body is provided with a stainless steel wire ring and inserted into the front pipe body.

The inner tube is made of polymer composite material, that is, the outer wall is nylon and the inner wall is polyethylene, or the outer wall is modified nylon (PEBAX) and the inner wall is polyethylene, or the inner wall of the inner tube is coated with polyethylene coating.

The material of the front tube body of the catheter is modified nylon (PEBAX), and the back tube body is a metal tube wrapped with a polymer material, or a stainless steel tube, or a polymer plastic tube or coated with a polymer plastic tube outside the back tube body. Tetrafluoroethylene (PTFE) coating.

The positive beneficial effect that the utility model has:

1. Both ends of the balloon body have a tapered structure, and the taper diameter at the distal end of the balloon is smaller than that at the proximal end of the balloon, which conforms to the natural change of the inner diameter of the human blood vessel gradually narrowing from near to far, and reduces the excessive pressure caused by traditional balloons. The damage caused by expansion to the distal blood vessels makes the stent adhere better and reduces the possibility of postoperative thrombosis or restenosis;

2. The middle part of the balloon is a tapered structure, which is in line with the structure of human blood vessels, especially in line with the characteristics of the coronary artery gradually becoming thinner from the aorta downward, which greatly improves the damage to the blood vessel caused by expanding the stent or directly expanding the balloon;

3. The wall thickness of the balloon is different, and the wall thickness of the cone section at both ends is greater than the wall thickness of the cone section in the middle working section, which improves the expansion effect of the balloon;

4. The taper angle of the tapered sections at both ends of the balloon is greater than that of the middle working section, which can improve the performance of the balloon catheter passing through blood vessels or lesions.

Description of drawings

Figure 1 is a schematic diagram of the existing flat balloon structure;

Fig. 2 is a structural representation of the utility model;

Fig. 3 is a schematic diagram of the structure of the tapered balloon of the present invention.

Detailed ways

Referring to Fig. 2, a tapered balloon dilatation catheter mainly includes components such as a balloon 1, an inner tube 2, a catheter 3, a protective tube 4, and a Luer connector 5; The expansion element is located at the front of the catheter 3, the two ends of the balloon 1 are tapered, and the middle part is a transitional tapered shape, including the distal end 101 of the balloon, the proximal end 102 of the balloon, the middle section 103, and the top end of the balloon 104, integrally formed Integral or heat-sealed connection; the catheter 3 is a single-lumen tube, including a relatively hard front tube body 301 that is closer to the proximal end 102 of the balloon and a relatively soft rear tube body 302 that is farther from the proximal end 102 of the balloon, The material of the front tube body 301 is modified nylon (PEBAX), and the rear tube body 302 is a metal tube wrapped with a polymer material, which can also be made of stainless steel tube, or it can be set outside the rear tube body 302 A polymer plastic tube or coated with a layer of polytetrafluoroethylene (PTFE) coating, to reduce the frictional resistance to the human body during use; the appropriate part of the front tube body 301 is provided with a guide wire side port 303, the front tube body 301 is provided with a flexible transition element, such as a gradient or tapered metal wire 304 for support, and the tail end of the metal wire 304 is connected with the rear pipe body 302; It is in the shape of a gradient groove, which is inserted into the front body 301, or welded with a gradient groove on the front end of the rear body 302 made of metal pipe, and inserted into the front body 301, or at the front end of the rear body 302 made of stainless steel A stainless steel wire ring is set to be inserted into the front body 301, and the length of the tapered metal wire 304 and the gradient bevel or the stainless steel wire ring is 50-300mm; the tail end of the rear pipe body 302 is directly connected to the Luer connector 5, or The tail end of the rear tube body 302 is connected to the protective tube 4, through which the protective tube 4 is connected to the Luer connector 5; It constitutes the filling and discharging channel of the balloon 1.

The catheter 3 is provided with an inner tube 2, and the inner tube 2 is a polymer composite material, that is, nylon material is used as the outer wall and polyethylene material is used as the inner wall, or modified nylon (PEBAX) material is used as the outer wall and polyethylene material is used as the inner wall , or the inner wall of the inner tube 2 is coated with a layer of polyethylene coating, which can greatly reduce the friction between the inner wall of the catheter channel and the guide wire; the tail end of the inner tube 2 is connected to the side port of the catheter 3 by heat sealing 303, a guide wire channel is formed, and the front part of the inner tube 2 enters the balloon 1 through the front tube body 301 of the catheter 3, and the outer edge of the tip of the inner tube 2 matches the top end 104 of the balloon, and is connected by heat sealing to form a seal The proximal end 102 of the balloon is matched with the outer edge of the front tube body 301 of the catheter 3 and connected by heat sealing; for visualization during the operation, at least one gold or platinum ring development mark 201 is embedded or sleeved on the inner tube 2, and its setting position At the junction of the vertebral segments at both ends of the balloon distal end 101 and the proximal end 102 of the balloon 1 and the conical middle segment 103, and the length between the two visible marks 201 is equal to the effective length of the expanded balloon 1 quite.

Referring to Figure 3, the balloon 1 is made of semi-compliant material, such as nylon or modified nylon (PEBAX), or the middle cone section is made of semi-compliant material, and the cone sections at both ends are made of non-compliant material. The distal end 101 of the balloon and the proximal end 102 of the balloon in 1 have a tapered structure at both ends with a large angle. Smaller than the taper diameter of the proximal end 102 of the balloon, the above-mentioned taper refers to the angle between the centerline of the cone section and the taper surface, the taper diameter refers to the diameter of the expanded balloon 1, and the middle section 103 of the balloon 1 is a transition cone structure, the tapered transition length is 5-100 mm, the taper is 0-30 degrees, and the taper diameter at one end of the middle section 103 is matched with the taper diameter at the distal end 101 of the balloon, and the taper diameter at the other end is close to the balloon. The taper diameter of the end 102 is matched and connected. After the balloon 1 is expanded, the taper diameter of the middle section 103 is 1-10 mm, and the taper diameter of the proximal end 102 of the balloon is greater than the taper diameter of the distal end 101 of the balloon. End 101 and the taper angle of the tapered sections at both ends of the proximal end 102 of the balloon are greater than the tapered angle of the middle section 103; the wall thickness of the balloon 1 is different, and the wall thickness of the tapered sections at both ends is greater than that of the middle section 103 transition cone Shaped wall thickness 1 to 30%.

The working process of the utility model: the guide wire is penetrated from the top lumen of the balloon 1 and passed out from the side port 303 of the guide wire; when the balloon 1 needs to be pressurized, the pressurized liquid can be directly passed through the lumen Er joint 5 is sent into the inner chamber of the rear tube body 302 and the cavity between the front tube body 301 and the inner tube 2 to reach the balloon 1, and the expansion process for the balloon 1 is completed. After the balloon 1 is expanded by eight atmospheres With a diameter of 1-10 mm, the bursting pressure of such a balloon can exceed 20 atmospheres.

Claims (10)

1. A tapered balloon dilatation catheter, comprising a balloon, a catheter, and a Luer connector, the balloon is positioned at the catheter front, the catheter is connected to the Luer connector or connected to the Luer connector through a protective tube, and an inner tube is arranged in the catheter, The balloon distal end and the balloon proximal end are tapered sections at both ends, and the feature is that the middle section (103) of the balloon (1) is a transitional tapered structure. 2. A tapered balloon dilatation catheter according to claim 1, characterized in that the taper diameter at one end of the middle section (103) matches the taper diameter at the distal end (101) of the balloon, and the taper diameter at the other end The taper diameter matches the taper diameter of the proximal end (102) of the balloon. 3. A tapered balloon dilatation catheter according to claim 1, characterized in that the tapered diameter of the balloon distal end (101) of the balloon is smaller than the tapered diameter of the balloon proximal end (102): the balloon ( 1) The taper diameter of the middle section (103) from the balloon proximal end (102) is greater than the taper diameter from the balloon distal end (101); the balloon distal end (101) and the balloon proximal end (102) are tapered The taper angle of the segment is greater than the taper angle of the middle segment (103). 4. A tapered balloon dilatation catheter according to claim 1, characterized in that the distal end (101) of the balloon (1) and the tapered sections at both ends of the proximal end (102) of the balloon (1) are The wall thickness is 1-30% greater than the wall thickness of the transition cone of the middle section (103). 5. A tapered balloon dilatation catheter according to claim 1, characterized in that at least one visible marker (201) is embedded or sleeved on the inner tube (2), and is arranged at the distal end of the balloon (101 ) and the junction of the vertebral segments at both ends of the proximal end of the balloon (102) and the middle segment (103), the length between the two visible marks (210) is equivalent to the effective length of the expanded balloon (1). 6. A tapered balloon dilatation catheter according to claim 1, characterized in that a guide wire side opening (303) is provided on the front tube body (301) of the catheter (3), and the front tube body (301) 301) is provided with a gradient or tapered flexible transition element, and the flexible transition element is connected with the rear pipe body (302). 7. A tapered balloon dilatation catheter according to claim 1 or 6, characterized in that the tail end of the inner tube (2) is connected to the side port (303) of the catheter (3), and the inner tube ( 2) The front part enters the balloon (1) through the front body (301) of the catheter (3), the outer edge of the tip of the inner tube (2) is connected and sealed with the balloon tip (104) of the balloon (1), and the balloon The balloon proximal end (102) of the balloon (1) is connected with the outer edge of the front tube body (301) of the catheter (3). 8. A tapered balloon dilatation catheter according to claim 1, characterized in that the front end of the rear tube body (302) of the catheter (3) is in the shape of a gradient bevel, and is inserted into the front tube body (301). Connect, or weld a gradient groove on the front end of the rear pipe body (302) made of metal pipe material and insert it with the front pipe body (301), or set a stainless steel wire ring on the front end of the rear pipe body (302) made of stainless steel pipe material and connect it to the front end The pipe body (301) is plugged. 9. A tapered balloon dilatation catheter according to claim 1, characterized in that the inner tube (2) is a polymer composite material, that is, the outer wall is nylon and the inner wall is polyethylene, or the outer wall is modified Nylon and the inner wall are polyethylene, or the inner wall of the inner pipe (2) is coated with polyethylene coating. 10. A tapered balloon dilatation catheter according to claim 1, characterized in that the material of the front body (301) of the catheter (3) is modified nylon, and the rear body (302) is wrapped A metal pipe of polymer material is arranged, or a stainless steel pipe, or a polymer plastic pipe or coated polytetrafluoroethylene coating outside the rear pipe body (302).

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