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Far-end passage catheter and manufacturing method thereof

A manufacturing method and catheter technology, applied in the direction of catheters, coatings, etc., can solve the problems of thin-walled tubing, such as easy deformation, poor vascular transport, and poor concentricity, and achieve reduced processing surface defects and internal voids, good vascular compliance and Passability, stable and controllable process

Pending Publication Date: 2021-12-21
成都百瑞恒通医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At this stage, the processing process of the distal access catheter is mostly welded, and the tolerance of the inner and outer diameters is relatively large. The outer layer of the multi-layer structure is formed by welding or extrusion, and the dimensional accuracy is poor. Oval or special-shaped catheters are often produced. Extremely poor concentricity
In addition, in order to ensure the mechanical properties of the catheter, it is often designed as a multi-layer composite structure. Although the comprehensive mechanical properties of the structure increase after the multi-layer composite, its hardness is difficult to control, and it is impossible to have a soft distal tip, resulting in If the end is hard, it cannot have a good instrument passability, and it will be discounted during the bending process, and the intravascular delivery will be poor, and even damage the blood vessel, making the operation difficult, affecting the operation process and even failing the operation
[0004] The Chinese patent with the application number CN201911210077.0 discloses a highly flexible distal access catheter and its preparation method. In this technical solution, the outer surface is coated with a composite outer layer with different hardness, and injected by an injection machine, It is molded after foaming. However, under this process condition, the low hardness material is too soft due to its low molding temperature, and it is often easy to deform and stick to each other after being made into thin-walled pipes, which will make the tolerance of the prepared catheter The accuracy is poor, and elliptical or special-shaped catheters are often produced, with extremely poor concentricity

Method used

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Examples

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Embodiment 1

[0040] A method of making a distal access catheter, comprising the following steps:

[0041] S1. Coating the inner layer: First, coat the PTFE coating on the upper surface of the metal tube mandrel, the coating thickness is 20 μm, and then process the spring layer on the surface of the PTFE coating, the thickness of the spring layer is 25 μm, and secondly, in the spring The surface of the layer is cross-woven with metal flat wires, and the thickness of the cross-braid is 50 μm to obtain the first semi-finished product;

[0042] S2. Coating the outer layer: Then use an online extruder with a mandrel to extrude the first plastic layer on the surface of the first semi-finished product, the first plastic layer is TPU; use the rollers to extrude the surface at the rear end of the extrusion die Extruding, the molten first plastic layer is wrapped on the surface of the braided layer during online extrusion, the thickness of the first plastic layer is 75 μm, and the second semi-finish...

Embodiment 2

[0046] A method of making a distal access catheter, comprising the following steps:

[0047] S1. Coating the inner layer: First, coat the PTFE coating on the upper surface of the metal tube mandrel, the coating thickness is 10 μm, and then process the spring layer on the surface of the PTFE coating, the thickness of the spring layer is 30 μm, and secondly, the The surface of the layer is cross-braided with metal flat wires, and the thickness of the cross-braid is 60 μm to obtain the first semi-finished product;

[0048] S2. Coating the outer layer: Then use an online extruder with a mandrel to extrude the first plastic layer on the surface of the first semi-finished product. The first plastic layer is made of nylon material; The surface is extruded, and the molten first plastic layer is wrapped on the surface of the braided layer during online extrusion. The thickness of the first plastic layer is 80 μm, and the second semi-finished product is obtained; The outer layer of pla...

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Abstract

The invention provides a far-end passage catheter. According to the far-end passage catheter, a catheter Luer taper and a catheter are sequentially arranged from the near end to the far end, the catheter is of a four-layer structure and sequentially comprises a PTFE coating, a spring layer, a braid layer and a plastic layer from inside to outside, the spring layer and the braid layer are partially crossed with each other, and the crossing thickness is 30-60 microns; a manufacturing method comprises the following steps that the surface of a metal pipe core rod is coated with the PTFE coating, the spring layer is processed, the braid layer and a first plastic layer, and a second semi-finished product is obtained; the head end of the second semi-finished product is treated, the first plastic layer and part of the braid layer on the surface of the head end are removed, then a low-hardness plastic layer is coated, and finally a Luer taper and a catheter sheath are installed to obtain the far-end passage catheter. The catheter is high in comprehensive mechanical property, the near end has high supporting performance and pushing performance, the far end has high flexibility, the catheter conforms to blood vessels, over-bent blood vessels are not bent, and the catheter does not deform during suction.

Description

technical field [0001] The invention relates to the technical field of medical devices, in particular to a distal access catheter and a manufacturing method thereof. Background technique [0002] In my country, the number of cardiovascular diseases is extremely high, among which more than 13 million are strokes and more than 11 million are coronary heart diseases. In 2019, the number of stroke patients in China ranked first in the world. The incidence of stroke is high and it is the main cause of death. Neurointerventional technology, as the name implies, treats neurological diseases. With the support of the digital subtraction angiography (DSA) system, it uses intravascular catheter operation technology to treat lesions involving the human neurovascular system through specific methods such as selective angiography, embolization, dilatation, mechanical removal, and drug delivery. for diagnosis and treatment. It is an emerging minimally invasive clinical technology, which ...

Claims

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Application Information

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IPC IPC(8): A61M25/00
CPCA61M25/0009A61M25/0012A61M25/0045A61M25/005
Inventor 高飞徐兰馨
Owner 成都百瑞恒通医疗科技有限公司
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