CN100464719C - Two-stage flexible tip dilator and method of making the same - Google Patents

Abstract

A double-step flexible tip expander and a manufacturing method thereof relate to an expander applied to minimally invasive interventional medicine and a manufacturing method thereof. In the structure of the invention, materials with different rigidities are layered to form a tube body and a tip of a slender coreless tube, and the tube body and the tip which are layered by the materials with different rigidities are of an integrally formed integral structure; the rigidity gradient from the inner layer to the outer layer is enhanced; the tip is formed by mechanically grinding the tube body without a core, and the tip comprises a gradient arrangement structure with flexible materials and rigid materials from the head to the back. The manufacturing method comprises three steps of forming a tube, namely a tube body, for the expander by two layers of extrusion, forming a tip by coreless grinding and smoothing the tip. The invention has the remarkable progress that: can effectively ensure the requirements of the flexibility and the rigidity of the dilator in clinic; the head of the tip is high in flexibility, so that damage to an inner membrane of a tube cavity is reduced, the rear part of the tip is high in rigidity, and sufficient pushing force is guaranteed; the tip and the tube body are integrated, so that the tip and the tube body cannot fall off in the clinical process, and the safety of the product is ensured.

Description

Two-stage flexible tip dilator and method of making the same

technical field

The invention relates to the technical field of medical devices, in particular to a two-stage flexible tip dilator used in minimally invasive interventional medicine and a manufacturing method thereof.

Background technique

Minimally invasive medical interventional therapy is to introduce specific surgical instruments through small skin incisions or direct puncture methods to treat the lesion accordingly. It has the characteristics of small wound, high efficiency, safety, less complications, short recovery period, strong repeatability, and no damage to the original anatomical structure.

The dilator involved in the present invention is a device used in minimally invasive interventional therapy, and is a flexible tubular device used to expand small percutaneous incisions or percutaneous puncture channels that enter blood vessels or human body lumens. The method of use is as follows: in minimally invasive interventional therapy, a specific device such as a catheter sheath is usually placed on the outside, and the dilator is closely matched with the specific device on the outside, and enters the blood vessel or the lumen of the human body, and the dilator is pulled out to form a specific The passage for instruments to enter and exit the human body lumen.

According to the domestic industry standard YY0450-1-2003 and the international standard ISO11070:1998, the dilator material and design guidelines require that the dilator should have a certain degree of flexibility and be rigid enough to dilate the percutaneous puncture channel into the blood vessel. The cutting-edge design should minimize the phenomenon of retraction when it enters the human tissue.

In order to meet various clinical requirements for dilators, the clinically used dilators have the following characteristics:

1. The end shape is slender, easy to enter small incisions or puncture holes;

2. The tip is smooth and round, less damage to the tissue;

3. The smooth transition of the tip lip improves the safety of the product.

Therefore, basically meet the requirements of international standards or industry standards. However, in terms of rigidity and flexibility, there is still a certain distance to clinical application. Some products are made of flexible materials, which have the characteristics of less damage to the intima of the lumen, but clinicians think that they are not rigid enough to push them; some products are made of hard synthetic materials to ensure the rigidity of the products, but the tip is not soft enough, and some It may cause damage to the intima and increase the mental stress of clinicians. In this construction, the body and the tip are made of the same material with the same rigidity. Some products also weld or glue flexible tips on rigid materials to meet the requirements for product flexibility and rigidity, but the flexible tips are in danger of falling off, which reduces the safety of the product. In this structure, the tube body and the tip are made of different rigid materials, and the rigid material and the flexible material are connected in segments.

Contents of the invention

On the basis of summarizing the prior art, aiming at the deficiencies of the prior art, the present invention starts from the material and the combination of the material, and aims to introduce a dilator with a new structure and a manufacturing method.

In order to achieve the above object and complete the above task, the technical scheme of the two-stage flexible tip dilator and its manufacturing method of the present invention is as follows.

The structure of the double-stage flexible tip dilator of the present invention includes a tube body and a tip, and different rigid materials are layered to form the tube body and the tip of a slender coreless tube, and the different rigid materials in the prior art are segmented into sections. For layered construction, this innovation fundamentally solves the problem of existing products welding or bonding flexible tips on rigid materials, which may cause the flexible tips to fall off and cause clinical safety accidents. The tube body and the tip formed by layers of materials with different rigidities are an integrated structure formed integrally.

In the double-stage flexible tip dilator of the present invention, the materials with different rigidities are layered and thermally fused.

In the double-stage flexible tip dilator of the present invention, the rigidity gradient from the inner layer to the outer layer is enhanced when the different rigid materials are layered and thermally fused, the rigidity of the inner layer material is smaller than that of the outer layer material, and the inner layer is a flexible layer. The outer layer is a rigid layer, thereby ensuring the flexible and rigid requirements of the dilator of the present invention on the tube body and the tip.

In the double-stage flexible tip dilator of the present invention, the thicknesses of the above-mentioned layers of different rigid materials thermally fused can be different, and the thickness of the flexible layer and the rigid layer can be adjusted to meet various clinical requirements for flexibility and rigidity.

The tip of the double-stage flexible tip dilator of the present invention is formed by mechanical coreless grinding of the tube body. From the head to the back, the tip includes a gradient arrangement structure with flexible materials and rigid materials. On the longitudinal section, it presents a tapered shape. The tip of the flexible layer and the tapered rigid layer. It not only ensures the flexibility of the tip head, but also ensures the rigidity of the tip rear, so as to realize the organic unity of flexible materials and rigid materials at the tip.

The manufacturing method of the double-stage flexible tip dilator of the present invention includes three steps of extruding two layers to form a dilator tube, coreless grinding to form a tip, and smoothing the tip.

Compared with the prior art, the double-stage flexible tip dilator and the manufacturing method of the present invention have significant progress. First, the two-stage flexible tip dilator of the present invention, the tube body is formed of different rigid materials, and the rigidity is arranged in a gradient from the inside to the outside, and the thickness of different hardness layers can be adjusted during the production process, which can effectively ensure the clinical flexibility. and rigid requirements; second, the tip is formed by mechanical coreless grinding of the tube body, and as the taper unfolds backwards, different materials are exposed, thus forming a flexible stacking arrangement from the beginning to the back, Thus, the flexible superposition is formed, which makes the tip head flexible and reduces the damage to the inner membrane of the lumen, and the rigidity of the rear part of the tip is strong, ensuring sufficient pushing force. Third, since the tip is integrated with the tube body, it will not fall off during the clinical process, which ensures the safety of the product.

Description of drawings

Fig. 1 is the structural representation of the double-stage flexible tip dilator of the present invention;

Fig. 2 is a schematic diagram of a two-layer extruded tube for forming a dilator in the manufacturing method of the two-stage flexible tip dilator of the present invention;

Fig. 3 is a schematic view of the tip formed by coreless grinding in the manufacturing method of the two-stage flexible tip dilator of the present invention;

Fig. 4 is a schematic diagram of the tip smoothing process of the manufacturing method of the two-stage flexible tip dilator of the present invention.

In the figure: 1. Tube body, 2. Tip, 3. Flexible material layer (flexible layer), 4. Rigid material layer (rigid layer), 5. Extruder, 6. Multi-layer co-extrusion head, 7. Grinding Machine, 8, electric heating furnace, 9, engine oil heat transfer pool, 10, silicone oil pool.

Detailed ways

Hereinafter, specific embodiments of the present invention will be described in conjunction with the accompanying drawings.

The structure of the double-stage flexible tip dilator of the present invention includes a tube body (1) and a tip (2), and different rigid materials are layered to form the tube body (1) and tip (2) of a slender coreless tube. The segmental connection of different rigid materials in the prior art is changed to a layered connection. This innovation fundamentally solves the problem of welding or bonding flexible tips on rigid materials in existing products, which may cause the flexible tips to fall off and cause The problem of clinical safety incidents. The tube body (1) and the tip (2) formed by layers of materials with different rigidities are integrally formed integral structures.

In the double-stage flexible tip dilator of the present invention, the materials with different rigidities are layered and thermally fused.

In the double-stage flexible tip dilator of the present invention, the rigidity gradient from the inner layer to the outer layer is enhanced when the different rigid materials are layered and thermally fused, the rigidity of the inner layer material is smaller than that of the outer layer material, and the inner layer is a flexible layer ( 3), the outer layer is a rigid layer (4), thereby ensuring the flexibility and rigidity requirements of the dilator of the present invention on the tube body (1) and the tip (2).

In the double-stage flexible tip dilator of the present invention, the thicknesses of the above-mentioned layered heat-fused different rigid materials can be different, and the thicknesses of the flexible layer (3) and the rigid layer (4) can be adjusted to meet various clinical requirements for flexibility and rigidity. Require.

In the double-stage flexible tip dilator of the present invention, the tip (2) is formed by mechanical coreless grinding of the tube body (1), and the tip (2) includes a gradient arrangement of flexible materials and rigid materials from the head to the back. The structure, in longitudinal section, presents the tip (2) of the conical flexible layer (3) and the conical rigid layer (4). Both the flexibility of the head of the tip (2) and the rigidity of the rear of the tip (2) are guaranteed.

In the double-stage flexible tip dilator of the present invention, the flexible layer (3) and the rigid layer (4) are made of thermoplastic synthetic materials, but their rigidity is different.

The double-stage flexible tip dilator of the present invention can have multiple options for its length and tube diameter.

The manufacturing method of the double-stage flexible tip dilator of the present invention comprises three steps of extruding two layers to form a dilator tube (1), coreless grinding to form a tip (2), and smoothing the tip (2).

In the step of forming the expander tube (1) by two-layer extrusion, two extruders (5) and one multi-layer co-extrusion head (6) are used for processing, and materials with different rigidities are respectively obtained from two The extruder (5) enters, and the tube of the expander is the tube body (1) extruded from the multilayer co-extrusion head (6).

In the step of coreless grinding to form the tip (2), a grinder (7) is used to grind one end of the dilator tube, that is, the tube body (1), into a circular tip (2).

In the smoothing treatment step of the tip (2), heat treatment is adopted to heat the engine oil heat transfer pool (9) with an electric furnace (8), and the silicone oil in the silicone oil pool (10) placed in the engine oil heat transfer pool (9) is heated, The tip (2) of the present invention is rubbed in silicone oil for smoothing.

The above is only a preferred embodiment of the two-stage flexible tip dilator and its manufacturing method of the present invention, and is not intended to limit the technical scope of the present invention. Any subtleties made to the above embodiments based on the technical essence of the present invention Modifications, equivalent changes and modifications all still fall within the scope of the technical solutions of the present invention.

Claims (7)

1, two rank flexible point dilator, comprise pipe shaft (1) and most advanced and sophisticated (2), the layers of material of different rigidity constitutes the pipe shaft (1) and most advanced and sophisticated (2) of elongated centreless pipe, it is characterized in that: the pipe shaft (1) that the layers of material of described different rigidity constitutes is the integrative-structure of global formation with most advanced and sophisticated (2); The material that constitutes the described different rigidity of pipe shaft (1) and most advanced and sophisticated (2) fuses for layering heat; Strengthen to outer rigidity gradient from internal layer when described different rigidity layers of material heat fuses, the rigidity of inner layer material is littler than the rigidity of cladding material, and internal layer is flexible layer (3), and skin is rigid layer (4); Most advanced and sophisticated (2) comprise the arrangement of gradients structure with flexible material and rigid material backward from the head, on the vertical section, present the tip (2) of flexible layer (3) with the rigid layer (4) of taper of taper.

2, according to claim 1 pair of rank flexible point dilator is characterized in that: the flexible layer (3) that above-mentioned layering heat fuses can be adjusted with the thickness of rigid layer (4).

3, according to claim 1 pair of rank flexible point dilator is characterized in that: flexible layer (3) selects for use thermoplastic synthetic material to make with rigid layer (4).

4, the manufacture method of described pair of rank flexible point dilator of claim 1 is characterized in that: comprise that the two-layer formation dilator of extruding is that pipe shaft (1), centreless grinding taper off to a point (2), three steps of most advanced and sophisticated (2) smooth treatment with pipe.

5, according to claim 4 pair of rank flexible point dilator manufacture method, it is characterized in that: two-layerly extrude that to form dilator be in the step of pipe shaft (1) with pipe, process with two extruding machines (5) and a multi-layer co-extruded head (6), the material of different rigidity enters from two extruding machines (5) respectively, and dilator is that pipe shaft (1) is from multi-layer co-extruded head (6) extrusion molding with pipe.

6, according to claim 4 pair of rank flexible point dilator manufacture method is characterized in that: centreless grinding tapers off to a point in (2) step, is that an end of pipe shaft (1) grind conglobate described tip (2) with dilator with pipe with grinder (7).

7, according to claim 4 pair of rank flexible point dilator manufacture method, it is characterized in that: in most advanced and sophisticated (2) smooth treatment step, adopt heating treatment method, with electric furnace (8) heating machine oil heat transfer pond (9), place the interior silicone oil in silicone oil pond (10) in machine oil heat transfer pond (9) to be heated, most advanced and sophisticated (2) Nu Zhong silicone oil is moving, to carry out smooth treatment.

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