LU600484B1 - Balloon dilatation catheter with drug injection interface for arteriovenous fistula - Google Patents

Abstract

The invention discloses an arteriovenous fistula balloon dilation catheter with a drug injection interface, and relates to the field of medical auxiliary equipment. Comprises a main body, a main catheter, a balloon, a catheter head end, a channel integration device, a drug injection tube, a drug injection channel, a drug injection port, a guiding wire tube, a guiding wire channel, a guiding wire, a balloon tube, a balloon channel and a balloon water injection port. In the invention, the device realizes balloon expansion and drug injection at the same time through integrated design, and improves treatment efficiency and patient safety. There are three independent channels in the catheter body, which are used for balloon water injection, guiding wire guidance and drug injection respectively. The drug injection port adopts automatic sealing design to ensure accurate delivery and safe operation. The invention simplifies the operation flow, reduces the operation time and medical cost, and improves the treatment effect at the same time, and is suitable for thrombus treatment in arteriovenous fistula surgery.

Description

Balloon dilatation catheter with drug injection interface for arteriovenous 1000606 fistula

Technical Field

The invention relates to the field of medical auxiliary equipment, and in particular to an arteriovenous fistula balloon dilation catheter with a drug injection interface.

Background Technology

In the current treatment of arteriovenous fistula, balloon dilatation catheter 1s used to solve the problem of thrombus blockage. This treatment method is widely used in dialysis patients, and the patency of arteriovenous fistula is affected by thrombus in vascular lumen. Traditional treatment relies on balloon dilatation of arteriovenous fistula to restore blood flow. However, this technology faces some key technical challenges.

When performing balloon dilatation, if there is a stubborn thrombus or incomplete thrombus expansion, doctors usually need to stop balloon dilatation, first withdraw the catheter and re-inject thrombolytic drugs to dissolve the thrombus.

After the drug is injected, the catheter must be inserted again for balloon dilatation to deal with thrombosis. This process needs repeated operations, which leads to low treatment efficiency and complicated operation process, which increases the risk of patients and the operation time. Therefore, there is an urgent need for a balloon dilatation catheter with drug injection interface to solve this problem.

Contents of Invention

The main purpose of the invention is to provide an arteriovenous fistula balloon dilation catheter with a drug injection interface, which can effectively solve the problems in the background technology. 10000666

In order to achieve the above purpose, the technical scheme adopted by the invention is as follows: an arteriovenous fistula balloon dilation catheter with a drug injection interface, wherein one end of the main body is connected with a channel integration device; the other end of the channel integration device is connected with the main tube; the other end of the main tube 1s connected with a balloon; the top of the balloon 1s connected with the catheter head end; the channel integration device has a tee structure; the channel integration device 1s respectively connected with a channel injection channel, a guiding wire channel and a balloon channel; the other end of the drug injection channel is connected with a drug injection tube; the other end of the guiding wire channel is connected with a guiding wire tube; the other end of the balloon channel 1s connected with a balloon tube; the front end of the drug injection channel 1s connected with a drug injection port; a guiding wire is arranged in the guiding wire channel; the front end of the balloon channel is provided with a balloon water injection port.

Further, the drug injection tube has a multi-layer tube structure, the inner layer is a drug delivery layer, and the outer layer 1s a protective layer; the inn layer and that out layer of the drug injection tube are fixedly connected through an adhesive.

Further, the balloon channel is connected with a balloon water injection port through a connecting hole on the inner wall of the catheter; the aperture of the connecting hole is between 0.5 mm and 2 mm, preferably 0.8 mm.

Further, the diameter of the guiding wire channel is 1 mm; the guiding wire is guided through a guiding wire channel and connected with the main body (1) through a connecting hole with an aperture of 0.9 mm.

Further, the drug injection channel is a channel connected with the drug injection port; the drug injection port has a design of automatic sealing when contacting with the blood vessel wall.

Compared with the prior art, the invention has the following beneficial effects.

Doctors can complete drug injection and balloon dilation in one operation, and the drug injection port and drug injection tube accurately control the release amount and timing of drugs through the drug flow controller, which enhances the thrombolytic effect, can solve the thrombus problem in real time, and ensures the maximum effectiveness of drugs in the treatment process. By reducing the number of operations in the treatment process, doctors no longer need to change the catheter frequently or interrupt the operation, which saves the operation time and reduces the medical cost and unnecessary consumption caused by multiple operations.

Explanation on Drawings

Fig. 1 is a schematic diagram of the overall structure of the present invention;

Fig. 2 is a detailed view of part A of the present invention;

Fig. 3 is a detailed view of part B of the present invention;

Fig. 4 is a detailed view of part C of the present invention;

Fig. 5 is a catheter path diagram in balloon dilatation of arteriovenous fistula of the present invention.

In the figures:

I, main body; 2. main tube; 3. balloon; 4, catheter head end; 5. channel integration device; 6. drug injection tube; 7. drug injection channel; 701, drug injection port; 8. guiding wire tube; 9. guiding wire channel; 901, guiding wire; 10. balloon tube; 11. balloon channel; 1101, balloon water injection port; a, arms; b, arteriovenous fistula; c. veins; d. arteries.

Specific Implementation Method

In order to make the technical means, creative features, goals and effects of the rt invention easy to understand, the invention will be further elaborated with specific embodiments.

In the description of the present invention, it should be noted that the azimuth or positional relationship indicated by the terms "upper", "lower", "inner", "outer", "front end", "both ends", "one end" and "the other end" are based on the azimuth or positional relationship shown in the attached drawings, and are only for the convenience of describing the present invention and simplifying the description, and are not indicated or implied. In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise specified and limited, the terms "installed", "provided with" and "connected" should be broadly understood, such as "connected", which can be a fixed connection, a detachable connection or an integrated connection; it can be a mechanical connection or an electrical connection; it can be directly connected, can also be indirectly connected through an intermediate medium, and can be connected inside two elements. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood in specific situations.

Example

Referring to Figs. 1-5, the present invention provides a technical scheme:

A arteriovenous fistula balloon dilation catheter with a drug injection interface, wherein one end of the main body 1 is connected with a channel integration device 5; the other end of the channel integration device 5 is connected with the main tube 2; the other end of the main tube 2 is connected with a balloon 3; the top of the balloon 3 is connected with the catheter head end 4; the channel integration device 5 has a tee structure; the channel integration device 5 is respectively connected with a channel injection channel, a guiding wire channel 9 and a balloon channel 11; the other end of the drug injection channel 7 is connected with a drug injection tube 6; 5 the other end of the guiding wire channel 9 is connected with the guiding wire tube 8; the other end of the balloon channel 11 is connected with a balloon tube 10; the front end of the drug injection channel 7 is connected with the drug injection port 701, and a guiding wire 901 is arranged in the guiding wire channel 9; the front end of the balloon channel 11 is provided with a balloon water injection port 1101.

Further, the drug injection tube 6 is a multi-layer tube structure, the inner layer 1s a drug delivery layer and the outer layer is a protective layer; the inner and outer layers of the drug injection tube 6 are fixedly connected by adhesive.

Further, the balloon channel 11 is connected with the balloon water injection port 1101 through a connecting hole on the inner wall of the catheter; the aperture of the connecting hole is between 0.5 mm and 2 mm, preferably 0.8 mm.

Further, the diameter of the guiding wire channel 9 is 1 mm; the guiding wire 901 1s guided through the guiding wire channel 9 and connected with the catheter through a connecting hole with an aperture of 0.9 mm.

Further, the drug injection channel 7 is a channel connected with the drug injection port 701; the drug injection port 701 has a design of automatic sealing when contacting with the blood vessel wall.

In the utility model, the balloon dilatation catheter for arteriovenous fistula adopts a medical-grade polyurethane main body, and its proximal end integrates three independent channels through a channel integration device. The channel integration device has a tee structure and is respectively connected with:

Drug injection channel: the proximal end is connected with a double-layer drag injection tube, the inner layer is made of PTFE material, and the outer layer is a

PEBAX protective layer, which is bonded and fixed by medical epoxy resin. The distal end extends to the drug injection port, which is designed with a silica gel sealing ring, and elastically deforms to form a sealing interface when contacting the blood vessel wall.

Guiding wire channel: the inner diameter is 1.0mm, and a nickel-titanium alloy guiding wire 1s built in. The gap between the guiding wire and the inner wall of the channel 1s 0.05 mm, and it is fixed at the 0.9 mm connection hole of the catheter body by laser welding.

Balloon channel: it 1s communicated with the balloon water injection port through the 0.8 mm connecting hole on the inner wall of the catheter. The channel has an inner diameter of 1.2 mm and 1s formed by multi-layer co-extrusion process, including anti-leakage shielding layer.

The distal end of the catheter body is connected with a balloon, which is made of flexible polymer material and connected with the channel integration device through the main conduit. The head end of the catheter is designed with a tapered angle of 15°, which is convenient for intravascular advancement.

Operation process:

The patient was supine, with the upper limb abduction of 80° at the operation side, and vascular sheath was inserted through radial artery puncture to establish catheter access. Inject heparin saline to prevent thrombosis, and connect all channel interfaces of the catheter synchronously to complete the calibration of the pressure

Sensor.

The guiding wire of NiTi alloy was sent through the guide tube and accurately pushed to the distal end of arteriovenous fistula under the guidance of ultrasound or bus

DSA. Confirm the position through the platinum-iridium developing ring at the head end of the catheter, and ensure that the distance between the catheter body and the blood vessel wall is < 1 mm.

Connect the high-pressure injection pump, inject the contrast agent at the rate of 3 mL/s to inflate the balloon to the working pressure, and keep expanding the stenosis for 30 seconds. Monitor the changes of blood vessel diameter in real time and evaluate the residual thrombus simultaneously.

If there 1s intractable thrombus, the rt-PA solution is injected accurately at 0.5 mL/min through the drug injection tube. The balloon maintains 4 atm pressure to promote drug penetration, and with the pulse pressure increase to the working pressure every 60 seconds, the thrombolytic efficiency is enhanced.

Step up the balloon pressure to the target pressure. Monitor the diameter of blood vessels in real time, and confirm that the contrast medium returns evenly without truncation, thus completing the vascular morphological remodeling.

After actively pumping the balloon to -0.5 atm, close the drug injection channel and fix the guiding wire in turn, and withdraw the catheter body at a speed of < 2 cm/s. Finally, the guiding wire and vascular sheath were withdrawn, and the puncture point was compressed for 10 minutes to stop bleeding.

The pressure gradient equation established by dynamic coupling of pressure and drug 1s as follows

AP = EE a + 0055) n: blood viscosity, L: lesion length, Q: drug flow, d: catheter diameter and blood vessel diameter.

Fatigue test: after 5000 insertion and removal cycles, the inner diameter bus deformation of the guiding wire channel is less than 0.05 mm.

Those skilled in the art can adopt the following alternatives:

The connection hole of the balloon channel can be adjusted between 0.5 and 2 mm. Experiments show that when the aperture is 1.2 mm, the balloon inflation time 1s shortened to 3 seconds, but a higher pressure pump is needed.

Double-layer pipe can be fixed by adding anti-leakage shielding layer and changing it into three-layer structure, or by co-extrusion molding process instead of adhesive.

The basic principle, main features and advantages of the present invention have been shown and described above. It should be understood by those skilled in the art that the present invention 1s not limited by the above-mentioned embodiments, and what is described in the above-mentioned embodiments and descriptions only illustrates the principles of the present invention. Without departing from the spirit and scope of the present invention, there will be various changes and improvements in the present invention, which fall within the scope of the claimed invention. The scope of the present invention is define by the appended claim and their equivalents.

Claims (5)

1. Claims LU600484

   I. An arteriovenous fistula balloon dilation catheter with a drug injection interface, comprising a main body (1), a drug injection tube (6), a drug injection channel (7) and a drug injection port (701), wherein one end of the main body (1) 1s connected with a channel integration device (5); the other end of the channel integration device (5) is connected with the main tube (2); the other end of the main tube (2) is connected with a balloon (3); the top of the balloon (3) is connected with the catheter head end (4); the channel integration device (5) has a tee structure; the channel integration device (5) is respectively connected with a channel injection channel, a guiding wire channel (9) and a balloon channel (11); the other end of the drug injection channel (7) is connected with a drug injection tube (6); the other end of the guiding wire channel (9) is connected with a guiding wire tube (8); the other end of the balloon channel (11) 1s connected with a balloon tube (10); the front end of the drug injection channel (7) is connected with a drug injection port (701); a guiding wire (901) 1s arranged in the guiding wire channel (9); the front end of the balloon channel (11) is provided with a balloon water injection port (1101).
2. 2. The arteriovenous fistula balloon dilation catheter with a drug injection interface according to claim 1, characterized in that the drug injection tube (6) has a multi-layer tube structure, the inner layer is a drug delivery layer, and the outer layer 1s a protective layer; the inn layer and that out layer of the drug injection tube (6) are fixedly connected through an adhesive.
3. 3. The arteriovenous fistula balloon dilation catheter with a drug injection interface according to claim 1, characterized in that the balloon channel (11) is connected with a balloon water injection port (1101) through a connecting hole on the inner wall of the catheter; the aperture of the connecting hole 1s between 0.5 mm and 2 mm, preferably 0.8 mm. 1000606
4. 4. The arteriovenous fistula balloon dilation catheter with a drug injection interface according to claim 1, characterized in that the diameter of the guiding wire channel (9) is 1 mm; the guiding wire (901) is guided through a guiding wire channel (9) and connected with the main body (1) through a connecting hole with an aperture of 0.9 mm.
5. 5. The arteriovenous fistula balloon dilation catheter with a drug injection interface according to claim 1, characterized in that the drug injection channel (7) is a channel connected with the drug injection port (701); the drug injection port (701) has a design of automatic sealing when contacting with the blood vessel wall.