阅读说明：本技术 一种显影元件的设置方法及介入式医疗器械 (Method for setting developing element and interventional medical instrument ) 是由 朱清 赵明杰 张云生 朱永锋 屠春霖 于 2020-06-10 设计创作，主要内容包括：本发明涉及一种显影元件的设置方法及介入式医疗器械,所述显影元件的设置方法包括提供基体和显影元件,所述显影元件的熔点高于所述基体的熔点；将所述显影元件套设在所述基体的外部,所述基体和所述显影元件过盈配合；加热所述基体上设置有所述显影元件的部位至该部位达到熔融状态,以使所述显影元件嵌入所述基体；停止加热,使所述基体和所述显影元件冷却。本发明具有操作简单、价格低廉、连接可靠的优点。(The invention relates to a method for arranging a developing element and an interventional medical instrument, wherein the method for arranging the developing element comprises the steps of providing a substrate and the developing element, wherein the melting point of the developing element is higher than that of the substrate; sleeving the developing element outside the base body, wherein the base body and the developing element are in interference fit; heating a part of the substrate, on which the developing element is disposed, until the part reaches a molten state, so that the developing element is embedded in the substrate; stopping heating and allowing the substrate and the developing element to cool. The invention has the advantages of simple operation, low price and reliable connection.)

1. A method of disposing a developing member, comprising:

providing a substrate and a developing element, wherein the melting point of the developing element is higher than that of the substrate;

sleeving the developing element outside the matrix, wherein the developing element is in interference fit with the matrix;

heating a part of the substrate, on which the developing element is disposed, until the part reaches a molten state, so that the developing element is embedded in the substrate; and the number of the first and second groups,

stopping heating and allowing the substrate and the developing element to cool.

2. The method of claim 1, further comprising, after the step of fitting the developing member to the outside of the base body and before the step of heating a portion of the base body where the developing member is provided: sleeving a heat shrinkable tube outside the developing element to coat the developing element;

and after the substrate and the developing element are cooled, further comprising: and removing the heat shrinkable tube.

3. The method of disposing a developing element according to claim 1 or 2, wherein a portion of the base body on which the developing element is disposed is uniformly heated.

4. The method of claim 1, wherein the developing element is a developing wire, and the developing wire has a spiral structure.

5. The method of claim 1, wherein the developing member is a tubular structure.

6. The method of claim 1, wherein the developing member is of an annular configuration.

7. The method of claim 1, wherein the substrate is made of a polymeric material.

8. The method of claim 1, wherein the substrate is a hollow conduit or a solid rod.

9. The method of claim 1, wherein an inner diameter of the developing member is smaller than an inner diameter of the base in a natural state.

10. An interventional medical device comprising a substrate and a visualization element, the visualization element being provided on the substrate by means of the method of providing a visualization element according to any of claims 1-9.

Technical Field

The invention relates to the technical field of medical instruments, in particular to a method for setting a developing element and an interventional medical instrument.

Background

In the medical device industry, many interventional medical devices, such as catheters, are required to have a visualization function to facilitate positioning or gauging of the medical device within a patient. The medical device may be provided with a developing function by providing a developing member on the medical device, the developing member being generally made of a noble metal such as platinum-iridium alloy, tantalum, tungsten, or the like. Common development elements are development rings, development wires, development strips, etc., wherein the development wires or strips may be embedded in the wall of the catheter and the development rings may be fixed to the outer surface of the catheter by forging.

Fixing the developing ring on the catheter by forging can cause the inner cavity of the catheter to be compressed, which affects the performance of the catheter, and needs to be equipped with a high-price crimping machine, which increases the manufacturing cost of the catheter. When the developing wire or the developing strip is arranged on the guide pipe, the developing wire or the developing strip is embedded while the guide pipe is extruded, so that the developing wire or the developing strip longitudinally penetrates through the whole guide pipe, and a large amount of developing material is wasted for the guide pipe which only needs to be positioned locally.

Disclosure of Invention

The invention aims to provide a method for arranging a developing element and an interventional medical device, which can arrange the developing element on a preset position of a substrate, and have simple operation and low cost.

To achieve the above object, the present invention provides a method of setting a developing element, comprising:

providing a substrate and a developing element, wherein the melting point of the developing element is higher than that of the substrate;

sleeving the developing element outside the matrix, wherein the developing element is in interference fit with the matrix;

heating a part of the substrate, on which the developing element is disposed, until the part reaches a molten state, so that the developing element is embedded in the substrate; and the number of the first and second groups,

stopping heating and allowing the substrate and the developing element to cool.

Optionally, after the developing element is sleeved outside the base body and before the portion of the base body on which the developing element is disposed is heated, the method further includes: sleeving a heat shrinkable tube outside the developing element to coat the developing element;

and after the substrate and the developing element are cooled, further comprising: and removing the heat shrinkable tube.

Alternatively, a portion of the base on which the developing element is provided is uniformly heated.

Optionally, the developing element is a developing wire, and the developing wire is of a spiral structure.

Optionally, the developing element is a tubular structure.

Optionally, the developing element is an annular structure.

Optionally, the matrix is made of a polymer material.

Optionally, the substrate is a hollow conduit or a solid rod.

Alternatively, in a natural state, the inner diameter of the developing member is smaller than the inner diameter of the base body.

In order to achieve the above object, the present invention also provides an interventional medical device comprising a base body and a development element, the development element being provided on the base body by means of the method of providing a development element as described in any of the preceding claims.

Compared with the prior art, the setting method of the developing element and the interventional medical instrument have the following advantages:

the setting method of the developing element comprises the following steps: providing a substrate and a developing element, wherein the melting point of the developing element is higher than that of the substrate; sleeving the developing element outside the matrix, wherein the developing element is in interference fit with the matrix; heating a part of the substrate, on which the developing element is disposed, until the part reaches a molten state, so that the developing element is embedded in the substrate; and stopping heating to cool the substrate and the developing element. When the development component cover is established when on the base member, the development component extrusion the surface of base member, thereby when the surface of base member is heated the melting and is softened, the base member with the surface that development component contacted forms the depressed part under the effect of compressive force, development component just is embedded in the depressed part, treat after the base member cools off, the depressed part can prevent development component from following deviate from on the base member in order to realize development component with the effective connection of base member. The method does not need expensive equipment, and can also arrange the developing element at a proper position of the substrate according to the requirement, thereby avoiding the waste of developing materials.

Drawings

Fig. 1 is a flowchart of a method of setting a developing element according to an embodiment of the present invention.

Detailed Description

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.

As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the plural forms "a plurality" includes more than two referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. Either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations. The same or similar reference numbers in the drawings identify the same or similar elements.

It is an object of embodiments of the present invention to provide a method for positioning a visualization element, wherein the substrate can be either a hollow catheter, such as various medical sheaths, or a solid rod, such as a guidewire for delivering medical stents or embolic coils.

As shown in fig. 1, the setting method of the developing member includes the steps of:

step S1: providing a substrate and a developing element, wherein the melting point of the developing element is higher than that of the substrate.

Step S2: and sleeving the developing element outside the base body, wherein the base body is in interference fit with the developing element.

Step S3: and heating the part of the substrate, which is provided with the developing element, until the part reaches a molten state, so that the developing element is embedded into the substrate. And the number of the first and second groups,

step S4: stopping heating and allowing the substrate and the developing element to cool.

Wherein, the substrate can be a hollow conduit or a solid rod body. The cross-section is generally circular when the substrate is a hollow conduit and circular when the substrate is a solid rod. The cross section of the developing element is matched with the base body, namely the cross section of the developing element is circular, and the inner diameter of the developing element is smaller than the outer diameter of the base body in a natural state (namely when the base body is separated from the developing element). In this way, when the developing element is mounted on the base body, the developing element and the base body are in interference fit, that is, the developing element applies a pressing force (i.e., a radial pressing force) directed toward the axis of the base body to the surface of the base body. When the surface of the base body is heated to be melted and softened, the surface of the base body is depressed towards the axis of the base body under the action of the pressing force to form a depressed part, and the developing element can be embedded into the depressed part. When the surface of the base body is cooled, the concave part can be used as a limiting structure to restrain the developing element on the surface of the base body, so that the developing element is prevented from being separated from the base body, and the developing element is effectively connected with the base body. On one hand, the method does not need high-price pressing and holding equipment and does not need to increase production investment. On the other hand, the developing element can be arranged at the preset position of the basal body according to the actual requirement, so that the waste of the developing material is avoided. On the other hand, for the hollow catheter, the inner cavity of the catheter cannot be affected adversely, and the quality of the catheter is guaranteed.

The present embodiment is not strictly limited to the specific structure of the developing member. In some embodiments, the developing element may be a ring-shaped structure formed from a developing material. In other embodiments, the developing element may be a tubular structure made of a material having developability, such as a tubular mesh structure woven from developing wires. In still other embodiments, the developing element may also be a developable wire that is helically coiled about an axis to form a helical structure. When the developing element is sleeved on the substrate, a radial pressing force is formed on the surface of the substrate.

Furthermore, it should be noted that the cross-section of the base body may also be non-circular, such as oval, oval or other shapes. However, the outer contour of the cross-section of the base body should be formed by a smooth transition of arcs, in order to avoid damage to the patient's tissue when the base body is introduced into the patient. The cross section of the developing element is matched with that of the substrate.

In some embodiments, the substrate may be made of a polymer material with good biocompatibility, such as polyurethane, silicone rubber, polyvinyl chloride, polyamide, polycarbonate, and the like. The developing element may be made of any metal having developing properties, such as tantalum, platinum-iridium alloy, tungsten, or the like, or may be made of a polymer material mixed with a developer such as barium sulfate, bismuth carbonate, or the like. Still alternatively, the developing member is made of a non-developing material coated with a developer on a surface thereof. In other embodiments, the base may be made of a biocompatible metallic material, such as stainless steel, and the developer element may be made of tungsten having a relatively high melting point to avoid softening of the developer element when the base is heated.

During the heating process of the substrate, care should be taken to ensure that the part of the substrate provided with the developing element is heated uniformly, for example, the same heating parameters are adopted to synchronously heat the whole circumferential direction of the part of the substrate provided with the developing element. The heating parameters comprise heating temperature, heating time, heating mode and the like. In actual operation, parameters such as heating temperature, heating time and the like are controlled according to the material of the substrate. Generally, the heating temperature is slightly higher than the melting point of the matrix during the heating process, so that the matrix is melted and softened but not flowed, thereby avoiding the surface roughness of the matrix caused by the irregular diffusion of the material of the matrix after melting. And after stopping heating the substrate, naturally cooling the substrate to room temperature.

Further, as shown in fig. 1, in the embodiment of the present invention, after the step S2 and before the step S3, the method further includes: step S21, sleeving a heat shrinkable tube outside the developing element to cover the developing element. Further, after step S4, the method further includes: and step S5, removing the heat shrinkable tube.

When the base body is heated, the heat shrinkage pipe is heated to generate radial shrinkage, namely, the heat shrinkage pipe applies radial extrusion force to the developing element, the developing element transmits the extrusion force to the surface of the base body, and the surface of the base body is further promoted to form a concave part so that the developing element is embedded into the base body. Meanwhile, after the heat shrinkable tube is arranged, if the surface of the base body is heated more and the material on the surface of the base body is melted and flows, the heat shrinkable tube can restrict the irregular flow of the base body material so as to reduce the surface roughness of the base body.

In particular, in the case of a developing element having a spiral structure, when the developing element is mounted on the base body, the base body supports the developing element so that the developing element radially expands and stores a radially-retracting force that acts on the base body to form a radial pressing force of the developing element against the base body. If the developing wire used to form the developing element is thin, the force of radial retraction stored by the developing element is small, and the force of radial retraction is insufficient to form a depression in the substrate when the substrate is softened. In this case, by providing the heat shrinkable tube, the radial shrinkage of the heat shrinkable tube is utilized to apply the radial pressing force to the developing element, and the pressing force is transmitted to the surface of the base body by the developing element, so that the pressing force applied to the surface of the base body is increased, which is advantageous for forming the recessed portion on the surface of the base body.

Further, the embodiment of the present invention further provides an interventional medical device, which includes a substrate and a developing element, and the substrate and the developing element are connected by using the method for disposing the developing element.

In this embodiment, the substrate includes, but is not limited to, various types of interventional catheters and guidewires. The structure of the development element includes, but is not limited to, a ring structure, a tubular structure, or a helical structure.

In the method for setting the developing element and the interventional medical instrument provided by the embodiment of the invention, firstly, the developing element is sleeved on the substrate, the melting point of the developing element is higher than that of the substrate, and the developing element is in interference fit with the substrate so as to enable the developing element to apply radial extrusion force to the substrate. And then, heating the part of the matrix, which is provided with the developing element, so that the surface of the matrix is softened, and further, under the action of the extrusion force, a concave part is formed on the surface of the matrix, and the developing element is embedded into the concave part. When the substrate is cooled, the recessed portion forms a limiting structure to limit the developing element on the substrate. The method does not need to be provided with expensive equipment, does not cause the waste of developing materials, and has the advantages of simple and convenient operation and low cost.

Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.