Welding method for quick exchange port of balloon catheter

Abstract

The balloon catheter comprises an inner tube and an outer tube, a notch is formed in the outer tube, the far end of the inner tube is arranged in the far end of the outer tube in a penetrating mode, and the near end of the inner tube extends out of the notch of the outer tube to form the rapid exchange opening. The inner pipe and the outer pipe are fixed through laser welding, and the method comprises the steps that S1, preparation is conducted, specifically, the two ends of the guide pipe are fixed to a chuck of a laser welding machine; s2, welding an incision area, wherein the guide pipe is subjected to swing welding according to the periodical constant-speed reciprocating rotation of-90-90 degrees; s3, welding a transition section at the near end of the incision: welding by adopting swing welding; s4, the laser welding head is moved to the far-end area of the notch; s5, welding a transition area at the far end of the notch, wherein circumferential welding is adopted; and S6, after welding is finished, the guide pipe is taken down, the mandrel is taken out, and the heat-shrinkable sleeve is torn down. The welding efficiency is high, the near-end transition section and the far-end transition area of the quick exchange port are subjected to reinforced welding, it is guaranteed that the whole quick exchange port is welded in place, the sealing performance is better, and the quality is more stable.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a welding method for a quick exchange port of a balloon catheter. Background Art

[0002] Balloon catheter is an interventional medical device, mainly used to dilate narrowed blood vessels or relieve organ compression. It is delivered to the target location through a delivery system and then inflated. The gas pressure is used to expand the balloon, thereby temporarily compressing the surrounding tissues to achieve the purpose of treatment. Balloon catheters play an important role in the cardiovascular field, such as interventional treatment of coronary artery and peripheral vascular diseases.

[0003] The balloon catheter usually includes an inner tube, an outer tube and a balloon. The outer tube is provided with an incision for the inner tube to pass through, and the inner tube and the outer tube are welded at the incision. The welding process of the balloon catheter rapid exchange port (RX port) is that the inner tube passes through the outer tube and then passes through the incision, and then the inner tube and the outer tube are welded together using a hot air welding machine. For example, Chinese invention patent CN 115253032 B (authorization announcement date 2024.05.28) discloses a method for making a metal RX port balloon catheter. The welding of the RX port includes placing the RX port in the wind slot of the air outlet of the welding machine, the RX port is directly opposite to the air outlet, and the RX port is formed after welding for 13s-15s. The method of welding using a hot air welding machine is relatively simple to operate and has low equipment cost. However, manual operation will cause the strength and speed of the welding point to be difficult to control during the rotation process, causing it to be heated unevenly, thereby affecting the welding effect, and welding takes a certain amount of time and has low efficiency. Summary of the invention

[0004] In order to solve the above-mentioned deficiencies in the prior art, the present invention provides a welding method for a rapid exchange port of a balloon catheter with high welding efficiency and good quality.

[0005] In order to achieve the above technical purpose, the technical solution adopted by the present invention is:

[0006] A method for welding a rapid exchange port of a balloon catheter, the balloon catheter comprises an inner tube and an outer tube, the outer tube is provided with an incision, the distal end of the inner tube is inserted into the distal end of the outer tube, and the proximal end of the inner tube extends from the incision of the outer tube to form a rapid exchange port; the characteristic is that: the inner tube and the outer tube are fixed by laser welding, and the welding method is:

[0007] S1. Preparation: insert the distal end of the inner tube into the distal end of the outer tube, extend the proximal end of the inner tube from the incision of the outer tube, insert the mandrel from the proximal end of the outer tube, press the distal inclined surface of the mandrel against the outer wall of the inner tube away from the incision, and cover the heat shrink sleeve to the incision area; fix the two ends of the catheter on the chuck of the laser welding machine respectively;

[0008] S2, welding incision area: the laser welding head of the laser welding machine moves from the distal end of the incision on the outer tube along the outer tube axis to the proximal end of the incision for welding. During the welding process, the catheter reciprocates at a constant speed at -90 to 90 degrees periodically;

[0009] S3, welding incision proximal transition section: the laser welding head continues to move 2 to 3 mm from the proximal end of the incision toward the proximal end of the outer tube for welding; during the welding process, the catheter reciprocates at a constant speed at -90 to 90 degrees periodically;

[0010] S4, moving the laser welding head to the distal end of the incision: moving the laser welding head from the end of step S3 to the distal end of the outer tube, without welding, across the incision area of ​​the outer tube and stopping within 1 to 3 mm from the distal end of the incision;

[0011] S5, welding the transition zone at the distal end of the incision: the laser welding head is fixed at the end of step S4, circumferential welding is adopted, the position of the welding head is fixed, and the catheter is rotated 360° at a constant speed;

[0012] S6. After welding, remove the catheter, take out the mandrel, and tear off the heat shrink tubing.

[0013] Preferably, in step S2, the welding power of the welding cut area is 800-900 mW.

[0014] Preferably, in step S3, the welding power of the transition section proximal to the welding incision is 600-700 mW.

[0015] Preferably, in step S5, the welding power of the transition zone at the far end of the welding incision is 500-700 mW.

[0016] The beneficial effects of the present invention are:

[0017] The welding method of the balloon catheter rapid exchange port of the present invention adopts laser welding, which has higher welding efficiency, better sealing performance of the rapid exchange port, and more stable quality. The present invention ensures that the entire rapid exchange port is welded in place by performing enhanced welding on the proximal transition section and the distal transition zone of the rapid exchange port. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0019] Figure 1 It is a schematic diagram of a rapid exchange port of a balloon catheter of the present invention;

[0020] Figure 2This is a diagram of the quick exchange port before welding is completed.

[0021] Figure numerals: 1 - inner tube, 2 - outer tube, 3 - incision, 4 - core shaft, 11 - distal end of inner tube, 12 - proximal end of inner tube, 21 - distal end of outer tube, 22 - proximal end of outer tube, 31 - distal end of incision, 32 - proximal end of incision. DETAILED DESCRIPTION

[0022] To make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. The components of the embodiments of the present application generally described and shown in the drawings here can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the application claimed for protection, but merely represents the selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians of the art without making creative work are within the scope of protection of the present application.

[0023] A welding method for a rapid exchange port of a balloon catheter, such as Figure 1 , Figure 2 As shown, the balloon catheter comprises an inner tube 1 and an outer tube 2, an incision 3 is provided on the outer tube 2, the inner tube distal end 11 is inserted into the outer tube distal end 21, and the inner tube proximal end 12 extends from the outer tube incision 3 to form a quick exchange port; the inner tube 1 and the outer tube 2 are fixed by laser welding, and the welding method is:

[0024] S1. Preparation: insert the inner tube distal end 11 into the outer tube distal end 21, extend the inner tube proximal end 12 from the outer tube incision 3, insert the mandrel 4 from the outer tube proximal end 22, press the distal end slope of the mandrel 4 against the outer wall of the inner tube away from the incision, and cover the heat shrink sleeve to the incision area; fix the two ends of the catheter on the chuck of the laser welding machine respectively, with the incision facing the laser welding head;

[0025] S2, welding incision area: the welding head of the laser welding machine moves from the distal end 31 of the incision on the outer tube to the proximal end 32 of the incision along the outer tube axial direction for welding, and the welding power is 800-900mW; during the welding process, the catheter reciprocates at a constant speed at -90-90° periodically;

[0026] S3, welding the transition section at the proximal end of the incision: the laser welding head moves 2 to 3 mm from the proximal end 32 of the incision to the proximal end 22 of the outer tube for welding, and the welding power is 600 to 700 mW; during the welding process, the catheter is periodically reciprocated at a constant speed of -90 to 90 degrees; the swing welding is used to fuse the gap between the proximal extension section of the inner tube and the outer tube to enhance the stability of the rapid exchange port;

[0027] S4, moving the laser welding head to the distal end of the incision: moving the laser welding head from the end of step S3 to the distal end 21 of the outer tube, with the power being 0 and no welding, crossing the incision 3 area of ​​the outer tube and stopping within a range of 1 to 3 mm from the distal end of the incision;

[0028] S5, welding the transition zone at the distal end of the incision: the laser welding head is fixed at the end of step S4, circumferential welding is adopted, the position of the welding head is fixed, the catheter rotates 360° at a constant speed, and the welding power is 500-700mW; the distal end of the incision is the starting position of welding, and this area is not easy to seal. Adding circumferential welding in this step can increase the welding area, further ensuring the stability and sealing of the rapid exchange port;

[0029] S6. After welding, remove the catheter, take out the mandrel, and tear off the heat shrink tubing.

[0030] Of course, the present invention may have many other embodiments. Without departing from the spirit and essence of the present invention, technicians familiar with the field may make various corresponding changes and deformations based on the present invention, but these corresponding changes and deformations should all fall within the scope of protection of the claims attached to the present invention.

Claims

1. A method for welding a rapid exchange port of a balloon catheter, wherein the balloon catheter comprises an inner tube and an outer tube, wherein a notch is provided on the outer tube, wherein the distal end of the inner tube is inserted into the distal end of the outer tube, and the proximal end of the inner tube extends from the notch of the outer tube to form a rapid exchange port; wherein the method comprises: The inner tube and the outer tube are fixed by laser welding, and the welding method is: S1. Preparation: insert the distal end of the inner tube into the distal end of the outer tube, extend the proximal end of the inner tube from the incision of the outer tube, insert the mandrel from the proximal end of the outer tube, press the distal inclined surface of the mandrel against the outer wall of the inner tube away from the incision, and cover the heat shrink sleeve to the incision area; fix the two ends of the catheter on the chuck of the laser welding machine respectively; S2, welding incision area: the laser welding head of the laser welding machine moves from the distal end of the incision on the outer tube along the outer tube axis to the proximal end of the incision for welding. During the welding process, the catheter reciprocates at a constant speed at -90 to 90 degrees periodically; S3, welding incision proximal transition section: the laser welding head continues to move 2 to 3 mm from the proximal end of the incision toward the proximal end of the outer tube for welding; during the welding process, the catheter reciprocates at a constant speed at -90 to 90 degrees periodically; S4, moving the laser welding head to the distal end of the incision: moving the laser welding head from the end of step S3 to the distal end of the outer tube, without welding, across the incision area of ​​the outer tube and stopping within 1 to 3 mm from the distal end of the incision; S5, welding the transition zone at the distal end of the incision: the laser welding head is fixed at the end of step S4, circumferential welding is adopted, the position of the welding head is fixed, and the catheter is rotated 360° at a constant speed; S6. After welding, remove the catheter, take out the mandrel, and tear off the heat shrink tubing.

2. The welding method of the balloon catheter rapid exchange port according to claim 1, characterized in that: In step S2, the welding power is 800-900 mW.

3. The welding method of the balloon catheter rapid exchange port according to claim 1, characterized in that: In step S3, the welding power is 600-700 mW.

4. The welding method of the rapid exchange port of a balloon catheter according to claim 1, characterized in that: In step S4, the welding power is 500-700 mW.

Images