CN114559627A

CN114559627A - Guide wire, ultra-smooth guide wire forming method, single core wire coating extrusion system and application

Info

Publication number: CN114559627A
Application number: CN202210175821.3A
Authority: CN
Inventors: 余木火; 李兆敏; 董现明; 邓智华; 李书同
Original assignee: Chuangmai Medical Technology Shanghai Co ltd; Maitong Medical Technology Jiaxing Co ltd
Current assignee: Chuangmai Medical Technology Shanghai Co ltd; Maitong Medical Technology Jiaxing Co ltd
Priority date: 2022-02-24
Filing date: 2022-02-24
Publication date: 2022-05-31
Anticipated expiration: 2042-02-24

Abstract

The invention relates to a guide wire forming method, which can be used for preparing an ultra-smooth guide wire by adopting a single core wire coating extrusion system provided by the invention. This single core silk cladding extrusion system is including getting silk filling unit, cladding extrusion unit, drawing cooling unit and dry collection unit, and the single in-process that waits the cladding core silk to move in the extrusion tooling of cladding extrusion unit is wrapped by macromolecular material's fuse-element, and this system is equipped with core silk external diameter detection device, and the accessible detects the core silk external diameter and then controls the input speed of core silk moving speed and polymer fuse-element. The method and the device of the invention continuously form the guide wires one by one, and have the functions of automatically taking out and filling the core wires, automatically drawing and coating, and automatically taking out and drying; the whole method has high automation degree and less personnel intervention, effectively improves the outer diameter uniformity and quality stability of the guide wire coating forming, and reduces the waste of raw materials.

Description

Guide wire, ultra-smooth guide wire forming method, single core wire coating extrusion system and application

Technical Field

The invention relates to the technical field of guide wire manufacturing, in particular to a guide wire forming method, an ultra-smooth guide wire forming method, a single core wire coating extrusion system and application.

Background

The ultra-smooth guide wire is a guide wire for special interventional therapy, is used as a forerunner in interventional therapy, and has an indispensable guiding function in minimally invasive surgery and intravascular therapy. It is easy to pass in blood vessels/non-blood vessels, has small stimulation to channel walls, and is applied to the fields including coronary vessels, peripheral vessels, urology and the like.

The manufacturing process of the ultra-smooth guide wire mainly comprises the steps of core wire treatment, polymer layer coating, surface ultra-smooth layer coating and the like. The core wire of the ultra-smooth guide wire is mainly made of nickel-titanium wires or other metal wires by grinding, has variable diameters in structure and is divided into a thick section, a gradual change section and a thin section. The thick section is rigid and beneficial to pushing and torque transmission, the thin section is soft and beneficial to trafficability and reducing damage to the cavity, and the gradual change section is positioned between the thick section and the thin section and gradually changes from the aspects of diameter and flexibility. From the shape of the core wire, a straight guide wire and a head end bending guide wire are mainly used. The guide wire with the bent head end is beneficial to passing through bifurcate and excessively bent cavity channels and improves the passing performance of complex cavity channels, and the bent part is usually positioned on a thin soft section of the core wire. Wherein the metal core wire with the bent head end is obtained by bending and heat setting by means of heat treatment equipment.

The macromolecule layer coating is the core step of guide wire manufacturing, and the uneven coating of the macromolecule layer or the infirm bonding of the macromolecule layer and the metal core wire can influence the performance of the guide wire and is directly related to the trafficability characteristic and the safety of the guide wire. The conventional polymer coating technology mainly comprises: (1) sleeving a high-molecular pipe on a core wire for hot melting molding; (2) continuous extrusion coating molding similar to wire and cable is adopted. For hot melt molding, the outer diameter of the core wire varies greatly from end to end, so that a polymer pipe with an accurate variable inner diameter cannot be prepared, the outer diameter of the guide wire formed by hot melt molding is not uniform on a long shaft, so that the coating defects of polymers on the surface of the core wire are more, and the coating force is weak. In addition, the operation of the process personnel is complex and the forming efficiency is low.

For continuous extrusion coating molding of similar wire and cable, the method has the limitation of using the method although the efficiency is improved by comparison with hot melting molding. For example, there has been reported a method of continuously coating and extruding a variable diameter core wire, in which each core wire is sequentially connected end to form an integrated core wire, and the integrated core wire includes a plurality of core wires required for a guide wire; the integrated core wire is extruded and coated and then is cut into a plurality of core wires in sections. The method has the following defects: firstly, the continuous integral diameter-variable core wire is very difficult to process, and the core wire needs to rotate at a high speed during grinding, so that the technology limits the maximum length of several meters of the conventional processing technology, and the conventional grinding technology is mainly limited to single grinding; secondly, in the coating and extruding process, the outer diameter of the core wire has high change frequency and large fluctuation, so the outer diameter is difficult to control; moreover, the coated guide wire needs to be cut in a segmented manner, and the coated guide wire is difficult to determine the cutting position, so that the guide wire is poor in consistency; in addition, for the guide wire with the bent head end, the thin end of the core wire needs to be bent and heat-set before extrusion coating, and the continuous core wire is inconvenient to heat-set, inaccurate in setting position control and low in efficiency.

As another example, another extrusion coating apparatus and method has been reported, which employs continuous extrusion for single coating extrusion. The drawing device of the continuous extrusion equipment is fixed and arranged behind the cooling groove, two ends of the core wire are lengthened for drawing to be used as a drawn lead wire and a drawn tail wire, and the lead wire and the tail wire are partially cut after being coated. First, this approach wastes long leads and tails; secondly, after one wire is coated and extruded in the method, a second wire needs to be re-threaded, coated and extruded, so that the limitation of the traditional wire and cable extruding method is not completely overcome, the personnel intervention is more, and the production efficiency is low.

Therefore, it is necessary to develop a method for forming a single ultra-smooth guide wire with less intervention of personnel, stable forming quality and high production efficiency.

Disclosure of Invention

Based on the above, the invention aims to provide a guide wire forming method, which adopts full-automatic equipment with automatic feeding and automatic discharging, can continuously coat and form a plurality of single core wires and has the functions of automatically taking out and filling the core wires, automatically drawing and coating, and automatically taking out and drying; and (3) the single coated core wire is obtained through coating molding, and the single independent core wire is separated without complicated sectional cutting. The whole method has high automation degree and less personnel intervention, effectively improves the outer diameter uniformity and quality stability of the guide wire coating forming, and reduces the waste of raw materials.

The above object of the present invention can be achieved by the following means.

In a first aspect of the present invention, a single core filament coating extrusion system is provided, the single core filament coating extrusion system comprises a filament taking and filling unit, a coating extrusion unit and a traction cooling unit, which are arranged along an extending direction of a core filament, and the coating extrusion unit is located between the filament taking and filling unit and the traction cooling unit;

the core wire drawing and filling unit comprises a core wire drawing and filling unit, the cladding and extruding unit comprises a core wire drawing mechanism, a cladding and extruding unit and a drawing and cooling unit, wherein the core wire drawing and filling unit comprises a core wire drawing mechanism and a cladding and extruding unit; the cooling groove is positioned below the clamping traction mechanism;

the single core wire coating extrusion system further comprises a drying and collecting unit, and the drying and collecting unit is adjacent to the cooling groove.

In some embodiments, the core wire removing and filling unit further comprises a core wire removing mechanism and a core wire rack; the core wire taking-out mechanism is positioned above the core wire frame; the filling mechanism is positioned between the core wire frame and the extrusion die, and the filling mechanism and the extrusion die can be adjusted to the same horizontal height along the extension direction of the core wire.

In some embodiments, the cladding extrusion unit further comprises a melt pump and an extruder, the melt pump being located between the extruder and the extrusion die.

In some embodiments, the extruder, the melt pump, and the extrusion die are each independently provided with a temperature control device.

In some embodiments, the sheathing extrusion unit further comprises a core wire outer diameter detection device between the filling mechanism and the extrusion die, and a guide wire outer diameter detection device between the extrusion die and the traction cooling unit; the filling mechanism, the core wire outer diameter detection device, the extrusion die and the guide wire outer diameter detection device can be adjusted to the substantially same horizontal height in the core wire extending direction.

In some embodiments, a detection signal transmission channel is arranged between the core wire outer diameter detection device and the clamping and pulling structure; and/or the presence of a catalyst in the reaction mixture,

a detection signal transmission channel is arranged between the core wire outer diameter detection device and the melt pump; and/or the presence of a catalyst in the reaction mixture,

the core wire outer diameter detection device is used for non-contact outer diameter test; and/or the presence of a catalyst in the reaction mixture,

the guide wire outer diameter detection device is used for non-contact outer diameter test.

In some embodiments, the extrusion die is a T-die comprising a first cavity through which the core filament passes and a first channel into which the polymer melt flows, the first channel being in communication with the first cavity and being angled.

In some embodiments, the dry collection unit comprises a guidewire retrieval mechanism located above the cooling bath.

In some embodiments, the drying and collecting unit further comprises a drying device and/or a guide wire collecting chamber for drying and/or collecting the guide wire taken out by the guide wire taking-out mechanism.

In some embodiments, the guidewire retrieval mechanism is provided with a conveyor belt or a robotic arm; and/or the drying device is provided with a conveyor belt.

In some embodiments, one or more of the following features are also included:

a melt pressure sensor is also arranged on the extrusion die;

the clamping traction mechanism is provided with a clamping hand and a moving guide rail;

the clamping points of the filling mechanism, the extrusion die and the clamping and traction mechanism are basically located on the same straight line.

In some embodiments, the single core filament over-extrusion system is used for continuous guidewire shaping.

In a second aspect of the present invention, there is provided a guidewire shaping method comprising the steps of:

penetrating one end of a single core wire to be coated into an extrusion die and then penetrating out;

moving the single core wire in the extrusion die by clamping and pulling the penetrating end;

coating the polymer melt on the surface of the core wire to form a coated core wire in the process that the single core wire moves in the extrusion die;

correspondingly regulating and controlling the traction speed of the single core wire and the input speed of the polymer melt to the extrusion die according to the position and the size of the core wire which is being coated, so that the radial sizes of the coated core wires are basically the same;

after the whole covered core wire penetrates out of the extrusion die, putting the whole covered core wire into a cooling medium for cooling and shaping; and

and taking out the cooled and shaped guide wire, drying and collecting.

In some embodiments, the single core filament sheath extrusion system of the first aspect of the present invention is used for forming a guide wire, and the guide wire forming method comprises the following steps:

loading the single core wire to be coated into the coating extrusion unit through the loading mechanism, and enabling one end of the single core wire to be coated to penetrate through the extrusion die and then penetrate out;

the penetrating end is clamped and pulled by the clamping and pulling mechanism, so that the single core wire moves in the extrusion die and penetrates out of the extrusion die;

in the process that the single core wire moves in the extrusion die, the coating extrusion unit provides a high polymer melt and coats the surface of the core wire to form the coated core wire;

detecting the size of the core wire at the position where the core wire is extruded out of the extrusion die, determining the position and the size of the core wire which is being coated, and correspondingly regulating and controlling the traction speed of the single core wire and the input speed of the polymer melt to the extrusion die to ensure that the radial sizes of the coated core wires are basically the same;

after the whole coated core wire penetrates out of the extrusion die, releasing the clamping of the penetrating end, and placing the whole coated core wire in a cooling medium of the cooling tank for cooling and shaping; and

and taking out the cooled and shaped guide wire from the cooling tank by using the drying and collecting unit, drying and collecting.

In some embodiments, the polymer melt is input into the extrusion die from a melt pump of the cladding extrusion unit, the output flow direction of the polymer melt from the melt pump forms an angle with the moving direction of the single core wire in the extrusion die, and the flow direction of the polymer melt after entering the extrusion die is changed to be substantially consistent with the drawing direction of the core wire.

In some embodiments, the clamping and pulling structure regulates and controls the pulling speed of the coated core wire and the output speed of the melt pump according to the real-time detection result of the core wire outer diameter detection device on the core wire outer diameter.

In some embodiments, the clamping and pulling structure regulates the pulling speed of the single core wire and the output speed of the melt pump according to the following formula (I):

D²＝d²+4 XQ/pi/v formula (I);

wherein Q represents the output speed of the melt pump; d represents a guide wire target cladding outer diameter; d represents the core wire outer diameter at the coating position; v represents the pull rate for the single core wire; and pi represents the circumferential ratio.

In some embodiments, a core wire outer diameter detection device is used to detect whether a core wire is loaded into the loading mechanism, and a guide wire outer diameter detection device is used to detect whether the core wire has reached a target position; when the core wire outer diameter detection device detects that a core wire is loaded into the loading mechanism, the loading mechanism is started, and one end of the core wire penetrates into the extrusion die and then penetrates out; when the guide wire outer diameter detection device detects that the core wire reaches the target position, the filling mechanism stops filling, the clamping and traction mechanism is started, clamps the penetrating end of the core wire, and pulls the core wire to move.

In some embodiments, the guidewire shaping method is an automated continuous shaping method.

In some embodiments, the single core wire to be covered is made by a grinding process; and/or the presence of a catalyst in the reaction mixture,

the single core wire to be coated consists of a core wire thin section, a core wire transition section and a core wire thick section, the diameters of which are sequentially increased, and the single core wire to be coated is a straight core wire or a core wire with a bent thin section; wherein the thick core wire section is used as a front section passing through the extrusion die; and/or the presence of a catalyst in the reaction mixture,

the polymer melt is selected from thermoplastic polyurethane, block polyether amide elastomer, nylon, composite materials of the materials and modified materials of any one of the materials.

In a third aspect of the present invention, a method for forming a super-smooth guide wire is provided, which includes the following steps:

preparing a guide wire with a high polymer material coating layer by adopting the method of the second aspect of the invention;

cutting off the redundant sections of the guide wire and sealing the end to obtain a super-smooth guide wire matrix; the end sealing method is hot melt molding or dip molding;

and adhering a lubricating coating on the surface of the ultra-smooth guide wire parent body to obtain the ultra-smooth guide wire.

In some embodiments, the lubricious coating is a hydrophilic coating selected from any one of a polyvinylpyrrolidone coating, a hydrophilic coating of a polyvinylpyrrolidone derivative, a polyethylene glycol coating, a hydrophilic coating of a polyethylene glycol derivative, an acrylic resin coating, and a hydrophilic coating of an acrylic resin derivative.

In a fourth aspect of the present invention, there is provided the use of a single core filament covered extrusion system according to the first aspect of the present invention in the preparation of an ultra-smooth guidewire.

In a fifth aspect of the present invention, there is provided a use of the guide wire prepared by the method of the second or third aspect of the present invention in an interventional medical device.

The invention also provides the guide wire prepared by the guide wire forming method of the second aspect.

The invention also provides the ultra-smooth guide wire prepared by the ultra-smooth guide wire forming method of the third aspect.

The single-core-wire coating extrusion system provided by the first aspect of the invention comprises a coating extrusion system, wherein the coating extrusion system comprises a wire taking and filling unit, a coating extrusion unit, a traction cooling unit and a drying and collecting unit, and continuous molding of a single guide wire can be realized by using the system. Taking out the core wire to be coated by the wire taking and filling unit, penetrating one end of the core wire into the extrusion die and then penetrating out, clamping the penetrating end by adopting a clamping and traction structure of a traction cooling unit to move, enabling the core wire to move in the extrusion die of the coating extrusion unit to penetrate out completely, coating the high polymer material on the surface of the core wire in the process of moving the core wire in the extrusion die to form a coated core wire (the core wire with a high polymer material coating layer), and cooling and drying after coating to obtain the cooled and shaped guide wire; the system is an automatic device for continuously forming a single guide wire, takes a single core wire as an object to be coated, and has the functions of automatically taking out and filling the core wire, automatically drawing and coating, and automatically taking out and drying; further, the system is also provided with a core wire outer diameter detection device for detecting the outer diameter of the core wire at the inlet of the extrusion die, so that the position (the current cladding position) of the core wire which is being clad and the outer diameter of the core wire at the position are determined, detection signals can be respectively transmitted to the clamping traction structure of the traction cooling unit and the melt pump of the cladding extrusion unit, the traction speed of the clamping traction structure to a single core wire is regulated and controlled in real time, the speed of the melt pump for outputting a polymer melt to the extrusion die is increased, uniform cladding of the single core wire is realized, and a single guide wire with uniform outer diameter can be obtained. Further, the obtained single guide wire is attached with the lubricating coating one by one, and the single ultra-smooth guide wire with uniform radial dimension can be obtained.

The guide wire forming method provided by the second aspect of the invention can be used for coating a single core wire, solves the technical problem of coating and extruding the single core wire, can realize highly automatic continuous forming and accurate control of the size of the single core wire at the same time compared with a mode of preparing a long guide wire and then cutting the long guide wire in sections, has high yield, and can avoid unqualified core wire size caused by improper cutting; the method can be used for continuously forming the guide wires one by the single-core wire coating extrusion system of the first aspect of the invention, and the method comprises the steps of automatically taking out and filling the core wires, automatically drawing and coating, and automatically taking out and drying; the whole method has high automation degree and less personnel intervention, effectively improves the outer diameter uniformity and quality stability of the guide wire coating forming, and reduces the waste of raw materials.

The guide wire forming method and the ultra-smooth guide wire forming method provided by the invention have the advantages of less personnel intervention, stable forming quality and high production efficiency, and can form not only straight guide wires but also guide wires with bent head ends.

The single core wire coating extrusion system provided by the invention can realize continuous coating one by one, the feeding, coating and collecting processes are full-automatic, and the production efficiency is high; the guide wire forming machine can be used for forming a straight guide wire and a guide wire with a bent head end; the formed guide wire has uniform outer diameter and good coating effect; less intervention of operators; the guide wire has stable quality and high consistency.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application and to more fully understand the present application and the advantages thereof, the drawings used in the description of the embodiments will be briefly introduced below. It is obvious that the drawings in the following description are only some embodiments of the application, and that other drawings can be derived from these drawings by a person skilled in the art without inventive effort. It is also to be noted that the drawings are drawn in simplified form and are provided solely for the purpose of facilitating and distinctly facilitating the description of the invention. The various dimensions of each component shown in the figures are arbitrarily illustrated, may be precision or may not be drawn to scale. For example, the dimensions of the elements in the figures may be exaggerated where appropriate to improve clarity. The various features of the drawings are not drawn to scale unless specifically indicated. The present invention is not limited to each size of each component.

Wherein like reference numerals refer to like parts in the following description.

FIG. 1 is a schematic view of a single core filament sheath extrusion system in accordance with an embodiment of the present invention;

FIG. 2 is a schematic structural view of a single core filament to be coated in an embodiment of the present invention;

FIG. 3 is a schematic structural diagram of a straight single super-lubricious guidewire precursor in one embodiment of the invention;

FIG. 4 is a schematic structural view of a single ultra-smooth guidewire precursor with a bent core wire segment according to an embodiment of the present invention;

description of reference numerals: 1-a filament taking and filling unit; 2-coating an extrusion unit; 3-a traction cooling unit; 4-a dry collection unit; 11-a core wire take-out mechanism; 12-a core wire frame; 13-a filling mechanism; 21-an extruder; 22-a melt pump; 23-an extrusion die; 24-core wire outer diameter detection device; 25-a guide wire outer diameter detection device; 31-a clamping traction mechanism; 32-a cooling tank; 41-a guide wire withdrawing mechanism; 42-a drying device; 43-a guidewire collection chamber; 101-core yarn to be coated (or marked as core yarn without polymer material coating); 1011-thick core wire section; 1012-core wire transition section; 1013-core filament thin section; 102-a covered core wire; 103-the cooled and shaped guide wire; 104-a polymer material coating layer; 106-ultra-smooth guidewire precursor.

Detailed Description

The present invention will be described in further detail with reference to the drawings, embodiments and examples. It should be understood that these embodiments and examples are given solely for the purpose of illustrating the invention and are not to be construed as limiting the scope of the invention, which is provided for the purpose of providing a more thorough understanding of the present disclosure. It is also understood that the present invention may be embodied in many different forms and is not limited to the embodiments and examples described herein, and that various changes and modifications may be effected therein by one of ordinary skill in the art without departing from the spirit and scope of the invention and the resulting equivalents are within the scope and range of equivalents of the present application. Furthermore, in the following description, numerous specific details are set forth in order to provide a more thorough understanding of the present invention, and it is to be understood that the present invention may be practiced without one or more of these details.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments and examples only and is not intended to be limiting of the invention.

Term(s) for

Unless otherwise stated or contradicted, terms or phrases used herein have the following meanings:

the term "and/or", "and/or" as used herein is intended to be inclusive of any one of the two or more items listed in association, and also to include any and all combinations of the items listed in association, including any two or more of the items listed in association, any more of the items listed in association, or all combinations of the items listed in association. It should be noted that when at least three items are connected by at least two conjunctive combinations selected from "and/or", "or/and", "and/or", it should be understood that, in the present application, the technical solutions definitely include the technical solutions all connected by "logic and", and also the technical solutions all connected by "logic or". For example, "A and/or B" includes A, B and A + B. For example, the embodiments of "a, and/or, B, and/or, C, and/or, D" include any of A, B, C, D (i.e., all embodiments using a "logical or" connection), any and all combinations of A, B, C, D, i.e., any two or any three of A, B, C, D, and four combinations of A, B, C, D (i.e., all embodiments using a "logical and" connection).

The present invention relates to "plural", etc., and unless otherwise specified, means 2 or more in number or 2. For example, "one or more" means one or two or more.

As used herein, "a combination thereof," "any combination thereof," and the like, includes all suitable combinations of any two or more of the listed items.

In the present specification, the term "suitable" in "a suitable combination, a suitable manner," any suitable manner "and the like shall be construed to mean that the technical solution of the present invention can be implemented, the technical problem of the present invention can be solved, and the technical effect of the present invention can be achieved.

The terms "preferably", "better" and "suitable" are used herein only to describe preferred embodiments or examples, and it should be understood that the scope of the present invention is not limited by these terms. If multiple "preferences" appear in one embodiment, each "preference" is independent if no special description is provided, and there are no contradictions or mutual constraints.

In the present invention, "further", "still further", "specifically" and the like are used for descriptive purposes to indicate differences in content, but should not be construed as limiting the scope of the present invention.

In the present invention, "optionally", "optional" and "optional" refer to the presence or absence, i.e., to any one of two juxtapositions selected from "present" and "absent". If multiple optional parts appear in one technical scheme, if no special description exists, and no contradiction or mutual constraint relation exists, each optional part is independent.

In the present invention, the terms "first", "second", "third", "fourth", etc. in the terms of "first aspect", "second aspect", "third aspect", "fourth aspect", etc. are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or quantity, nor as implying that importance or quantity indicating the technical feature being indicated. Also, "first," "second," "third," "fourth," etc. are used for non-exhaustive enumeration of description purposes only and should not be construed as a closed limitation to the number.

In the present invention, the technical features described in the open type include a closed technical solution composed of the listed features, and also include an open technical solution including the listed features.

All documents referred to herein are incorporated by reference into this application as if each were individually incorporated by reference. The citation referred to herein is incorporated by reference in its entirety for all purposes unless otherwise in conflict with the present disclosure's objectives and/or technical solutions. Where a citation is referred to herein, the definition of a reference in the document, including features, terms, nouns, phrases, etc., that is relevant, is also incorporated by reference. In the present invention, when the citation is referred to, the cited examples and preferred embodiments of the related art features are also incorporated by reference into the present application, but the present invention is not limited to the embodiments. It should be understood that where the citation conflicts with the description herein, the application will control or be adapted in accordance with the description herein.

In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the invention.

In the present invention, unless otherwise expressly specified or limited, the terms "mounted," "connected," "secured," "attached," and the like are to be construed broadly and can, for example, be fixedly connected or detachably connected or integrated; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the present invention, unless otherwise expressly stated or limited, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through an intermediate. In the present invention, unless otherwise explicitly specified and limited, the first feature "on" or "under" the second feature may indicate a mutual positional relationship of the horizontal heights, or may indicate only that there is an adhesion relationship without limiting the mutual positional relationship of the horizontal heights. Also, a first feature "on," "over," and "above" a second feature may be directly or diagonally above the second feature, or may simply indicate that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature may be directly under or obliquely under the first feature, or may simply mean that the first feature is at a lesser elevation than the second feature.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

As used herein, "core filament" is to be understood broadly to include core filaments of any of the forms of any of the embodiments of the aspects of the present invention, including but not limited to core filaments to be coated 101, core filaments being coated with a polymer melt, coated core filaments 102. The core wire moves in the extrusion die comprises two processes, namely a process of enabling the end to be clamped of the core wire to penetrate into the extrusion die and then penetrate out to reach a preset position (at the moment, the cladding is not started, and the core wire exists in the form of the core wire to be clad), and a moving process after the cladding is started (at the moment, the core wire exists in the form of the core wire being clad or the core wire which is completely clad and penetrates out).

In the present invention, "coated core yarn" means a core yarn having a partially or completely coated polymer material layer, which is formed by partially or completely coating a core yarn to be coated with a polymer material in an axial direction. The form of the 'coating core yarn' mainly exists in the coating process and the cooling and shaping process of the polymer melt.

In the present invention, the "guide wire" is a core wire coated with a polymer material, and includes a coated core wire, a guide wire obtained after cooling and shaping, and further processing forms thereof, which exist in a stage after a polymer melt starts to be coated, including but not limited to a polymer melt coating process, a cooling and shaping process, a surplus section cutting and end capping process, and a lubricating coating adhesion process. For example, the guidewire is further cut away from the excess section and capped, and the guidewire is further coated with a lubricious coating. In the invention, the ultra-smooth guide wire matrix refers to a guide wire to be attached with a lubricating coating, which is obtained by cutting an excess section and sealing an end, and the ultra-smooth guide wire can be obtained by attaching the lubricating coating. In the present invention, the "ultra-smooth guide wire" refers to a guide wire obtained by attaching a lubricating coating. The ultra-smooth guide wire is one form of the guide wire.

Guide wire forming method

In one aspect of the invention, the guide wire forming method adopts full-automatic equipment with automatic feeding and automatic discharging, can continuously clad and form guide wires one by one, and has the functions of automatically taking out and filling core wires, automatically drawing and cladding, and automatically taking out and drying; after the coating is finished, the independent single guide wire is obtained without carrying out sectional cutting on the long guide wire, and the single guide wire to be attached with the lubricating coating is obtained only by carrying out micro-modification on the end part. Therefore, in the guide wire forming method of the invention, the core wire is cut into the required length in advance, and one of the differences from the traditional technology is that the equipment and the steps of unwinding and winding are not needed in the method. The whole method has high automation degree and less personnel intervention, effectively improves the outer diameter uniformity and quality stability of the guide wire coating forming, and reduces the waste of raw materials. According to the method, the traction speed of a single core wire and the input speed of the polymer melt to the extrusion die can be correspondingly regulated and controlled in real time according to the position and the size of the core wire which is being coated, so that the radial sizes of the coated core wires are basically the same, the coated core wires with uniform outer diameters are obtained, and the guide wires (including but not limited to ultra-smooth guide wires) with uniform outer diameters are further obtained.

In the present invention, "substantially the same size" includes the complete equivalence of the sizes and the existence of a certain deviation, such as ± 30%, ± 28%, ± 25%, ± 23%, ± 20%, ± 18%, ± 15%, ± 12%, ± 10%, ± 8%, ± 6%, ± 5%, ± 4%, ± 3%, ± 2%, ± 1%, etc.

In some embodiments, the guidewire shaping method comprises the steps of:

moving the single core wire in the extrusion die by clamping and pulling the through-out end (it should be understood that the entire through-out can also be made);

coating the surface of the core wire with a polymer melt in the process of moving the single core wire in the extrusion die to form a coated core wire;

correspondingly regulating and controlling the traction speed of the single core wire and the input speed of the polymer melt to the extrusion die according to the position and the size of the core wire which is coated, so that the radial size of the coated core wire is basically the same (the coated core wire, namely the coated core wire has the uniform and better outer diameter);

and taking out the cooled and shaped guide wire, drying and collecting.

In some embodiments, a guide wire forming method is provided, wherein the guide wire forming is performed by using the single core wire coating extrusion system provided by the invention, and the guide wire forming method comprises the following steps:

loading the single core wire 101 to be coated into the coating extrusion unit 2 through the loading mechanism 13, and enabling one end of the single core wire to be coated to penetrate through the extrusion die 23 and then penetrate out;

the clamping and traction mechanism 31 clamps and draws the penetrating end to enable the single core wire to move in the extrusion die 23 and penetrate out of the whole core wire;

in the process that a single core wire moves in the extrusion die 23, the cladding extrusion unit 2 provides a high polymer melt and the high polymer melt is clad on the surface of the core wire to form a clad core wire 102;

detecting the size of the core wire at the inlet position of the extrusion die 23, determining the position and the size of the core wire which is being coated, and correspondingly regulating and controlling the traction speed of a single core wire and the input speed of the polymer melt to the extrusion die 23 to ensure that the radial sizes of the coated core wires are basically the same;

after the whole coated core wire 102 passes through the extrusion die 23, the clamping of the passing end is released, and the whole coated core wire 102 is placed in the cooling medium of the cooling groove 32 for cooling and shaping; and

the cooled and shaped guide wire is taken out from the cooling tank 32 in the drying and collecting unit 4, dried and collected.

In some embodiments, the guide wire obtained by cooling and setting the coated core wire 102 (the guide wire that has been cooled and set) is taken out from the cooling bath 32 by the guide wire take-out mechanism 41 of the drying and collecting unit 4.

Preferably, the guide wire forming method is an automatic continuous forming method, that is, the guide wire forming is continuously performed on a plurality of single core wires, and the method comprises the steps that the plurality of single core wires continuously penetrate into an extrusion die and then are completely penetrated out, and the coating process of the high polymer material is continuously completed in the extrusion die. In some embodiments, a plurality of individual core filaments can be continuously loaded into a loading mechanism, threaded into an extrusion die, threaded out, coated with a polymeric material while moving in the extrusion die, cooled to shape after threaded out, dried, and collected.

In some embodiments, the polymer melt is fed into the extrusion die 23 from the melt pump 22 of the cladding extrusion unit 2, the output flow direction of the polymer melt from the melt pump 22 forms an angle (greater than 0 ° and less than 180 °, such as 90 °, 80 °, 70 °, 60 °, 50 °, 45 °, 30 °, 20 °, 15 °, 10 °, and the like) with the moving direction of a single core filament in the extrusion die 23 (consistent with the drawing direction of the core filament), and the flow direction of the polymer melt after entering the extrusion die 23 is changed to be substantially consistent with the drawing direction of the core filament.

In some embodiments, a guide wire forming method is provided, wherein a single core wire cladding extrusion system provided by the invention is used for guide wire forming, and the single core wire cladding extrusion system comprises a wire taking and filling unit 1, a cladding extrusion unit 2, a traction cooling unit 3 and a drying and collecting unit 4; wherein, the silk taking and filling unit 1 comprises a filling mechanism 13; the cladding extrusion unit 2 includes an extrusion die 23; the traction cooling unit 3 comprises a clamping traction mechanism 31 and a cooling groove 32, wherein the clamping traction mechanism 31 is positioned above the cooling groove 32 and can pull the core wire to move, so that the core wire passes through the extrusion die 23 (the core wire moves in the extrusion die 23 and passes through the whole core wire); the drying and collecting unit 4 includes a guide wire taking-out mechanism 41, and the guide wire taking-out mechanism 41 is used for taking out the guide wire 103 which is cooled and shaped in the cooling medium of the cooling tank 32; the core wire can be loaded from the loading mechanism 13 into the extrusion die 23 and the end to be clamped is passed out into the clampable area of the clamping and pulling mechanism 31, so that the core wire is moved while being clamped by the clamping and pulling mechanism 31 with the through end. With regard to the "clamping and pulling means 31 being located above the cooling bath 32", it is to be understood that this is also the case with "the clamping and pulling means 31 being located above the cooling bath 32" with respect to the above of the cooling bath bottom, such as the positional relationship shown in fig. 1.

In some embodiments, a core wire outer diameter detection device 24 (located between the extrusion die 23 and the wire taking and filling unit 1) is used to detect whether a core wire is filled into the filling mechanism 13, and a guide wire outer diameter detection device 25 (located between the extrusion die 23 and the traction cooling unit 3) is used to detect whether the core wire has reached a target position; when the core wire outer diameter detection device 24 detects that the core wire is loaded into the loading mechanism 13, the loading mechanism 13 is started, and one end of the core wire penetrates into the extrusion die 23 and then penetrates out; when the guide wire outer diameter detection device 25 detects that the end to be clamped of the core wire reaches the target position, the filling mechanism 24 stops filling, then the clamping and pulling mechanism 31 is started, clamps the penetrating end of the core wire, and pulls the core wire to move. When the core wire outer diameter detection device 24 or/and the guide wire outer diameter detection device 25 detects that the core wire reaches the target position, the coating is started, and the melt of the high polymer material is input into the extrusion die.

In some embodiments, the clamping and pulling mechanism 31 is activated when the guide wire outer diameter detection device 25 detects that the core wire has reached the target position, clamps the through end of the core wire, pulls the core wire to move, and moves in the extrusion die 23 under the pulling action, and the core wire is coated at different positions with the melt of the polymer material as the core wire moves in the extrusion die 23.

In some embodiments, a guidewire shaping method comprises the steps of: loading a single core wire 101 to be coated into the coating extrusion unit 2 through the loading mechanism 13 of the wire taking and loading unit 1, enabling one end of the core wire to penetrate through the extrusion die 23, clamping the penetrating end of the core wire by using the clamping and traction mechanism 31 of the traction and cooling unit 3, enabling the core wire to move in the extrusion die 23 at a certain traction speed, coating the molten high polymer material on the surface of the core wire in the process of moving the core wire in the extrusion die 23 to form a coated core wire 102, realizing uniform coating in the extrusion die 23, and releasing clamping until the whole coated core wire penetrates out of the extrusion die 23 (at the moment, coating of the single core wire is finished). The drawing speed of the core wire by the clamping and drawing mechanism 31 can be regulated and controlled according to the position of the core wire being coated and the outer diameter of the core wire at the position, and is matched with the melt input speed of the high polymer material, so that the core wire is uniformly coated, and the coated core wire 102 with uniform outer diameter size is obtained. In the case where the curve of the outer diameter of the core wire 101 to be coated with the axial position is known, the position of the core wire being coated and the outer diameter of the core wire at the position can be estimated from the result of detection of the outer diameter of the core wire at the entrance of the extrusion die by the core wire outer diameter detection device 24 of the traction cooling unit 3. The input speed of the melt of the polymer material can be controlled by controlling the output speed of the melt pump 22 of the cladding extrusion unit 2, and the output speed of the melt pump 22 can be adjusted in response according to the detection result of the outer diameter of the cladding core wire, and at least comprises the detection result of the core wire outer diameter detection device 24, and the detection result of the guide wire outer diameter detection device 25 can be combined to detect whether the outer diameter of the cladding core wire part penetrating out of the extrusion die conforms to the preset size.

In some embodiments, the clamping and pulling mechanism 31 controls the pulling speed of the coated core wire and the output speed of the melt pump 22 according to the real-time detection result of the core wire outer diameter detection device 25 on the outer diameter of the core wire.

It should be understood that the extrusion die 23 has a tubular cavity through which the core wire passes, which may be referred to as a first cavity. The process of the core filament passing through the extrusion die 23, i.e. the process of the core filament passing through the first cavity, is performed by the high polymer material coating the core filament in the first cavity. It should also be understood that the first chamber has an inlet for the polymer melt, through which the first chamber communicates with a melt outlet channel of the melt pump.

In one embodiment, as shown in fig. 1, the holding and pulling mechanism 31 holds the core wire leading end to move the covered core wire 102 in the cooling medium of the cooling bath 32, so that the covered core wire 102 is pulled out and simultaneously the cooling setting is completed in the cooling bath 32. In another embodiment, the clamping and pulling mechanism 31 clamps the core wire leading end to move the coated core wire 102 over the cooling medium in the cooling tank 32, and after the coated core wire 102 passes through the extrusion die 23, the clamping is released, and the coated core wire 102 is put into the cooling medium in the cooling tank 32 for cooling and shaping.

In one embodiment, after the entire covered core wire 102 is cooled and set in the cooling tank 32, the cooled and set guide wire 103 is taken out from the cooling tank 32 by the guide wire take-out mechanism 41 of the drying and collecting unit 4, dried, and collected.

In some embodiments, the yarn taking and filling unit 1, the coating extrusion unit 2 and the traction cooling unit 3 are controlled by an automatic system to cooperate with each other, so that the core yarns can be continuously and periodically coated and formed one by one, and the drying and collecting unit 4 can continuously dry and collect the guide yarns one by one. The collected guide wire is cut into redundant segments and is subjected to end sealing treatment (to avoid the bare core wire), and the ultra-smooth guide wire matrix 106 can be obtained. And adhering a lubricating coating on the surface of the ultra-smooth guide wire parent body 106 to obtain the ultra-smooth guide wire. The definition of "redundant segments" is as follows.

In some embodiments, the core wire 101 to be coated used is a single core wire. Compared with a plurality of core wires, the uniformity of the outer diameter of the coated core wire is easier to improve.

In some embodiments, the individual core wires 101 to be covered are made by a grinding process.

In some embodiments, a single core wire 101 to be covered is composed of a core wire fine section 1013, a core wire transition section 1012, and a core wire thick section 1011, which are sequentially increased in diameter.

In some embodiments, the single core filament to be covered comprises a straight core filament and a core filament with a segment of a bend. The core wire with the bent thin section can be obtained by shaping one end of the straight core wire after heat treatment, and a corresponding shaping mould can be adopted according to the shape requirement.

In some embodiments, the thick core filament section serves as a front section of the extrusion die, i.e., the thick core filament section, the transition core filament section, and the thin core filament section are sequentially coated with the polymer material.

In some embodiments, the thread take-up loading unit 1 includes a core thread take-up mechanism 11 and a core thread holder 12 in addition to the loading mechanism 13. At this time, the core wire taking and loading unit 1 includes a core wire taking mechanism 11, a core wire rack 12 and a loading mechanism 13, the core wire taking mechanism 11 is located above the core wire rack 12, the core wire rack 12 and the loading mechanism 13 are located at substantially the same level (so that the core wire taking mechanism 11 can more easily load the core wire 101 to be coated into the loading mechanism 13 after grabbing the single core wire), and the loading mechanism 13 is located between the core wire rack 12 and the extrusion die 23. Wherein, the core wire frame 12 can be used for horizontally placing the core wire 101 to be coated; the core wire take-out mechanism 11 is located above the core wire holder 12, and is capable of gripping the core wires 101 to be coated one by one from the core wire holder 12 and then loading the core wires into the loading mechanism 13. Further, in some embodiments, the step of loading the core filament into the cladding extrusion unit 2 via the loading mechanism 13 comprises: the core wire taking-out mechanism 11 is adopted to grab a core wire from the core wire rack 12 each time, one end of the core wire is loaded into the loading mechanism 13, the core wire is fed into the extrusion die 23 by the loading mechanism 13, the front end of the core wire penetrates out of the extrusion die 23 (the end of the core wire which firstly penetrates out of the extrusion die 23 is marked as a penetrating end), the penetrating end is clamped by the clamping and traction mechanism 31 of the traction cooling unit 3, the core wire moves in the extrusion die 23 under the traction action of the traction cooling unit 3, and after the coating is finished, the coated core wire penetrates out completely under the traction action.

In the present invention, "substantially the same horizontal height" includes the exact same horizontal height and the presence of an angular deviation, for example, ± 5 °, ± 4 °, ± 3 °, ± 2 °, ± 1 °, etc.

In some embodiments, the thread take-up and loading unit 1 is composed of a core thread take-up mechanism 11, a core thread holder 12, and a loading mechanism 13.

In some embodiments, the loading mechanism 13 includes tracks, rollers, and a robot.

In some embodiments, the cladding extrusion unit 2 includes a melt pump 22 and an extruder 21 in addition to an extrusion die 23. At this time, the sheathing extrusion unit 2 includes an extrusion die 23, a melt pump 22, and an extruder 21, and the melt pump 22 is connected to the extruder 21 and the extrusion die 23, respectively. Wherein, the extruder 21 is used for heating, plasticizing and conveying the high polymer material into the melt pump 22; the melt pump 22 is used to control the flow of the polymer melt and to feed the polymer melt into the extrusion die 23. The melt pump 22 can precisely control the output speed of the polymer melt, and thus the flow rate and velocity of the polymer melt entering the extrusion die 23. The extrusion die 23 provides a first cavity for coating the core filament, so that the melted polymer material is uniformly coated on the surface of the core filament by the die.

In some embodiments of the present invention, the material of the core filament (which is not coated with the polymer material) is not particularly limited, as long as it is acceptable in the art. In some embodiments, the core wire (not coated with polymeric material) may be selected from nitinol wire, stainless steel wire, other metal or alloy wire.

In some embodiments, the kind of the polymer material is not particularly limited as long as it is a polymer material acceptable in the art that can be used for the core filament coating. In some embodiments, useful polymeric materials include, but are not limited to, Thermoplastic Polyurethane (TPU), block polyether amide elastomer (PEBAX), nylon (PA), composites of the foregoing materials (e.g., TPU/PA composites), and modifications of any of the foregoing materials. The modified material used in the invention is a new material which can still basically exert the functions of the material before modification and has new functions after modification, and the invention is limited to a modification mode which introduces new functions to modify without influencing the basic functions (basically unchanged or better) of the raw materials. The molecular weight of the polymer material is not particularly limited as long as it can be used for covering the core yarn in the application. It will be appreciated that the polymeric material is capable of coating the core filament in the molten state. Examples of the "modifying material" include materials doped with a developing component, such as materials containing a developing component such as tungsten, barium sulfate, and the like, and specific examples thereof include tungsten-containing polyurethane and barium sulfate-containing polyurethane. When the guide wire modified by the developing component is clinically used, the guide wire can be visually observed in a corresponding developing mode, so that clinical use is more convenient and accurate. The content of the visualization component is preferably an amount required for clinical use.

In some embodiments, the cladding extrusion unit 2 further includes a core wire outer diameter detection device 24 located between the loading mechanism 13 and the extrusion die 23 for detecting the outer diameter of the core wire and detecting whether the core wire is loaded into the loading mechanism 13. In some embodiments, core wire outer diameter detection device 24 is a non-contact outer diameter test, preferably a laser outer diameter test device.

In some embodiments, the sheath extrusion unit 2 further comprises a guide wire outer diameter detection device 25 located between the extrusion die 23 and the traction cooling unit 3, for detecting the outer diameter of the core wire (sheath core wire 102) coated with the polymer material and detecting whether the core wire is loaded into and passes through the extrusion die 23 to reach a target position, which includes but is not limited to a position where the core wire passes out of the extrusion die 23 and extends out by a certain length so as to be drawn and clamped. In some embodiments, the guidewire outer diameter detection device 25 is a non-contact outer diameter test, preferably a laser outer diameter test device. The filling mechanism 13, the core wire outer diameter detection device 24, the extrusion die 23, and the guide wire outer diameter detection device 25 are all at the same level. Whether the entire covered core wire 102 passes through the extrusion die 23 or not can be detected by the guide wire outer diameter detection device 25, so as to control the clamping loosening time.

In some embodiments, the cladding extrusion unit 2 includes an extruder 21, a melt pump 22, an extrusion die 23, a core wire outer diameter detection device 24, and a guide wire outer diameter detection device 25. The extrusion die 23 is positioned between the guide wire outer diameter detection device 25 and the core wire outer diameter detection device 24, is at the same horizontal height in a working state, and is communicated through a first cavity; meanwhile, the melt pump 22 is respectively connected with the extruder 21 and the extrusion die 23 and is communicated through a first channel; the first cavity and the first channel intersect or are perpendicular.

In some embodiments, extrusion die 23 is a T-die, and includes a first cavity through which the core filament passes and a first channel for the macromolecule melt to enter the first cavity, the first channel communicating with the first cavity at an intermediate location of the first cavity to form a "T" shape. It should be understood that the first channel forms an angle with the axis of the first cavity, and the angle of the angle is not particularly limited as long as the melt is allowed to pass through the first channel into the first cavity. The included angle formed between the first channel and the axis of the first cavity is, for example, 15 °, 20 °, 25 °, 30 °, 35 °, 40 °, 45 °, 50 °, 55 °, 60 °, 65 °, 66 °, 70 °, 75 °, 80 °, 85 °, 86 °, 87 °, 88 °, 89 °, 90 °, and the like. It should also be understood that the shape of the first cavity and the first channel, independently of each other, may be straight or may have curved sections. In addition, the position of the first cavity communicating with the first channel may be designed according to the target input position of the melt, and may be at a middle position, a front section (a section between the core wire inlet and the middle position), and a rear section (a section between the core wire outlet and the middle position) of the axis of the first cavity. Preferably, the first cavity is in communication with the first passage at a location forward of the first cavity.

In some preferred embodiments, the extrusion die 23 is a T-shaped die, and the output flow direction of the polymer melt from the melt pump 22 is substantially perpendicular to the moving direction of the core filament in the extrusion die 23 (which is the same as the drawing direction of the core filament), the flow direction of the polymer melt after entering the extrusion die 23 is changed to be substantially the same as the drawing direction of the core filament, and then the polymer melt is coated on the surface of the core filament.

In the present invention, "substantially perpendicular" allows 90 ° or some deviation from 90 ° (e.g., ± 10 °, ± 8 °, ± 5 °, ± 4 °, ± 3 °, ± 2 °, ± 1 °, etc.) as long as the functioning between two members in a defined relative positional relationship is not affected. In the present invention, "the directions are substantially the same" allows some deviation (e.g., + -10 °, + -8 °, + -5 °, + -4 °, + -3 °, + -2 °, + -1 °, etc.) as long as the function between two members which should not be defined as a positional relationship is exerted.

In some embodiments, when the core wire outer diameter detection device 24 detects that a core wire is loaded into the loading mechanism 13, the loading mechanism 13 is activated to insert one end of the core wire into the extrusion die 23 and then eject the core wire, and when the guide wire outer diameter detection device 25 detects that the core wire has reached the target position (i.e., detects the inserted end of the core wire), the loading mechanism 13 stops loading.

In some embodiments, the cladding extrusion unit 2 is comprised of an extruder 21, a melt pump 22, an extrusion die 23, a core wire outer diameter detection device 24, and a guide wire outer diameter detection device 25.

In some embodiments, a melt pressure sensor is also provided on the extrusion die 23 for monitoring the melt pressure in the die to adjust the input of the melt in real time.

In some embodiments, the extruder 21, the melt pump 22, and the extrusion die 23 are each independently provided with a temperature control device, and the heating temperature can be controlled separately. Further, the extrusion die 23 is provided with a melt pressure sensor.

In some embodiments, the traction cooling unit 3 is composed of a clamping traction mechanism 31 and a cooling tank 32.

In some embodiments, the clamp pulling mechanism 31 is provided with a clamping hand and a motion guide. In some embodiments, when the guide wire outer diameter detection device 25 detects that the core wire has reached the target position, the gripper starts and grips one end of the core wire (the core wire feed end), pulls the core wire to move, so that different positions of the core wire are covered by the polymer melt in the extrusion die 23 to form covered core wires 102 with different covering lengths, and releases the grip after the covered core wires 102 completely pass through the extrusion die 23 (at this time, the covering of the core wire is completed). When the coated core wire moves under the traction action, the movement and the coating are simultaneously carried out. In practicing the method of forming the guide wire of the present invention, the cooling tank 32 should be filled with a cooling medium (such as cooling water, further such as circulating cooling water, etc.) for cooling and shaping the covered core wire 102 that passes through the extrusion die 23.

The core wire part which penetrates out of the extrusion die can be firstly drawn into the cooling medium of the cooling groove for cooling, or can not enter the cooling medium temporarily, and after the whole core wire penetrates out of the extrusion die, the whole core wire is cooled and shaped.

One end of the core wire penetrates through the extrusion die 23 and then penetrates out, and the penetrating end is clamped by the clamping and traction mechanism 31, so that the core wire can be pulled to move along a preset track. In some embodiments, the exit end is drawn into the cooling bath 32, and during continued drawing, the portion of the core wire entering the cooling bath 32 may be immersed in a cooling medium to be cooled while the portion of the core wire still in the extrusion die 23 is coated, with cooling and coating occurring simultaneously. In some specific embodiments, when the guide wire outer diameter detection device 25 detects that the core wire has reached the target position, the gripper starts and grips one end (core wire leading end) of the covered core wire 102, on one hand, to pull the covered core wire 102 to move in the cooling medium of the cooling tank 32, and on the other hand, to achieve covering of the polymer material still in the core wire portion of the extrusion die 23. After the covered core wire 102 has fully entered the cooling bath 32, the clamping is released and the entire covered core wire 102 is immersed in the cooling medium.

In some embodiments, the coated core wire that exits the extrusion die 23 is not immersed in the cooling medium in the cooling tank 32, but the entire coated core wire is immersed in the cooling medium after the entire coated core wire exits the extrusion die 23.

The time for immersing the coated core wire, which passes out of the extrusion die 23, into the cooling medium can be flexibly selected by adjusting the height of the core wire passing end.

In some embodiments, the drying and collecting unit 4 includes a guide wire withdrawing mechanism 41, and further, the guide wire withdrawing mechanism 41 is located above the cooling tank 32 so as to withdraw the guide wire 103 with cooling and shaping from the cooling tank 32, and the withdrawing timing can be controlled by the time length of cooling and shaping.

In some embodiments, the drying and collecting unit 4 further includes a drying device 42 and a guide wire collecting chamber 43 in addition to the guide wire take-out mechanism 41; the guide wire taking-out mechanism 41 is used for taking out the guide wire 103 which is cooled and shaped in the cooling groove 32, the drying device 42 is used for drying the taken-out guide wire which is cooled and shaped (preferably, removing surface moisture to achieve the effect of surface drying), and the guide wire collecting bin 43 is used for collecting the dried guide wire.

In some embodiments, the drying and collecting unit 4 is composed of a guide wire take-out mechanism 41, a drying device 42, and a guide wire collecting magazine 43.

In some embodiments, the drying device 42 uses a conveyor belt to continuously convey the dried guide wires into the guide wire collecting bin 43 one by one, and the dried guide wires are conveyed to be dried, wherein the dried guide wires are arranged in a direction substantially perpendicular to the conveying direction of the conveyor belt. Drying means include, but are not limited to, by blowing or heating. Those skilled in the art will appreciate that the drying by blowing air is preferably performed by blowing high-pressure gas.

In some embodiments, the removal mechanism 41 includes a conveyor and a robot that transports the removed guidewire to the drying device 42.

In some embodiments, the clamping pulling mechanism 31 is controllable and adjustable to both the pulling speed of the coated core wire 102 and the output speed of the melt pump 22. Because the outer diameters of the core wires at different positions are different, the single core wire coating extrusion system can change the traction speed and the output speed of the melt pump in real time according to the outer diameter of the core wire (the outer diameter of the core wire of the section to be coated before entering the extrusion die) detected by the core wire outer diameter detection device 24, and can obtain the coated core wire with controllable outer diameter from head to tail, including but not limited to obtaining the coated core wire with uniform outer diameter from head to tail.

In some embodiments, the drawing speed of the holding and drawing structure 31 for the coated core wire 102 and the output speed of the melt pump 22 are respectively adjusted according to the real-time detection result of the core wire outer diameter detection device 24 for the core wire outer diameter.

In some embodiments, the clamping points of the charging mechanism 13, the extrusion die 23, and the clamping and pulling mechanism 31 are substantially collinear. "substantially in the same line" allows some deviation from a straight line as long as the pulling of the core wire is not affected.

In some embodiments, the extrusion coating process of the present invention preferably comprises the sequence of coating the core filament thick segment 1011 followed by the core filament transition segment 1022 and the core filament thin segment 1013.

In order to obtain the ultra-smooth guide wire with controllable outer diameter, in particular the ultra-smooth guide wire with uniform outer diameter, the control of the coating process is key and can be realized by the cooperative control of the speeds of all links, particularly comprising the speed of inputting the polymer melt into the extrusion die (which can be adjusted by controlling the output speed of the melt pump) and the moving speed of the core wire (which can be adjusted by controlling the traction cooling unit 3 to the traction speed of the core wire). Other means in the art for controlling speed in real time may also be used to implement the present invention.

The single core wire coating and extruding system has an automatic control function, so that signals among the wire taking and filling unit 1, the coating and extruding unit 2, the traction cooling unit 3 and the drying and collecting unit 4 can be interacted. For example, the melt pump 22, the loading mechanism 13, the clamping and pulling mechanism 31, and the like may be made to respond to the size detection signals of the core wire outer diameter detection device 24 and the guide wire outer diameter detection device 25 independently or in coordination with each other. For example, a detection signal transmission channel may be provided between the core wire outer diameter detection device 24 and the clamping and pulling structure 31; for another example, a detection signal transmission path may be provided between the core wire outer diameter detection device 24 and the melt pump 22.

For the cladding of the core filament strand, the melt extrusion rate (i.e. the output speed or flow rate of the melt pump) of the extrusion die 23 is denoted Q₁Accordingly, the drawing speed (also called drawing speed) of the core wire by the clamping and drawing mechanism 31 at this time is recorded as v₁(ii) a For the core filament transition zone, the melt extrusion rate of the extrusion die 23 is noted as Q₂Accordingly, the drawing speed v of the core wire by the clamping and drawing mechanism 31 at this time is recorded₂(ii) a For the core filament thick strand, the melt extrusion rate of the extrusion die 23 is noted as Q₃Correspondingly, the drawing speed v of the core wire by the clamping and drawing mechanism 31 at the moment is recorded₃。

The drawing speed of the clamping drawing mechanism 31 to the core wire and the output speed of the melt pump 22 to the melt are controllable and adjustable. For a certain core wire, the diameter of the core wire at the current coating position can be calculated according to the diameter of the core wire measured by the core wire outer diameter detection device 24. For example, a curve of the core wire diameter at different positions with respect to the position change may be predetermined, so that the current coating position may be determined according to the detection result of the core wire outer diameter detection device 24, and the core wire diameter at the current coating position may be determined.

Because the outer diameters of the core wires at different positions are different, the system changes the traction speed and the output speed of the melt pump in real time according to the outer diameters of the core wires at different positions detected by the core wire outer diameter detection device 24. The output speed of the melt pump, the target cladding outer diameter of the guide wire, the outer diameter of the core wire at the cladding position and the traction speed meet the following calculation formula: d²＝d²+4 XQ/pi/v, formula (I). Wherein Q represents the output speed of the melt pump; d represents a guide wire target cladding outer diameter; d represents the core wire outer diameter at the coating position; v represents the traction speed; piThe circumferential ratio is expressed. For the fine segment, Q/pi/v is Q₁/π/v₁(ii) a For the transition section, Q/π/v is Q₂/π/v₂(ii) a For the coarse section, Q/π/v is Q₃/π/v₃。

By way of example, the operator can achieve precise control of the clad outer diameter in three ways:

(1) the output speed Q of the melt pump is fixed and the traction speed v is adjusted to control the coating outer diameter D. Taking the case that the outer diameter of a thick section of a certain core wire is 0.5mm, the outer diameter of a thin section of the core wire is 0.15mm, the outer diameters of transition sections of the core wires are uniformly transited, and the target cladding outer diameter of the guide wire is 0.85mm, the output speed of a fixed melt pump can be 40mm³The system can automatically calculate the required traction speed in real time according to the detection signal and the calculation formula, for example, the traction speed of a thick section is 108mm/s, the traction speed of a thin section is 73mm/s, and the transition section is adjusted in real time according to the outer diameter of the coating position;

(2) the fixed traction speed v is unchanged, and the output speed Q of the melt pump is adjusted to control the coating outer diameter D. Taking the example that the outer diameter of a thick section of a certain core wire is 0.5mm, the outer diameter of a thin section of the core wire is 0.15mm, the outer diameter of a transition section of the core wire is in uniform transition, and the outer diameter of a target cladding of the guide wire is 0.85mm, the fixed traction speed can be 100mm/s, and the system can automatically calculate the flow rate of the required melt pump in real time according to the detection signal and the calculation formula, for example, the flow rate of the thick section melt pump is 37mm³S, flow rate of the melt pump in the fine section of 55mm³The output speed of the melt pump is adjusted in real time by the transition section according to the outer diameter of the cladding position;

(3) the outer diameter D of the cladding is controlled by adjusting the pulling speed v and the output flow rate Q of the melt pump. Taking the outer diameter of a thick section of a certain core wire as 0.5mm, the outer diameter of a thin section of the core wire as 0.15mm, the outer diameter of a transition section of the core wire as uniform transition and the outer diameter of a guide wire target coating as 0.85mm as an example, according to the output speed change function phi (Q) of the melt pump, the system can automatically calculate the change function F (v) of the required traction speed in real time according to the calculation formula, so that the traction speed v is matched with the output flow rate Q of the melt pump in real time in the coating process. And the system can automatically calculate the required output speed change function phi (Q) of the melt pump in real time according to a calculation formula according to the change function F (v) of the traction speed, so that the output flow rate Q of the melt pump is matched with the traction speed v in real time in the coating process.

In some embodiments, the guidewire shaping methods of the present invention further comprise the steps of: and cutting off and sealing the redundant sections of the dried guide wire to obtain the ultra-smooth guide wire matrix. Further, end-capping methods include, but are not limited to, hot melt molding and dip molding, preferably with the aid of a molding die, to achieve a more desirable end profile. And further, a lubricating coating is attached to the ultra-smooth guide wire. In the capping process, capping after vertical cutting is preferred.

The "redundant segment" refers to the excess part of the cooled and shaped guide wire relative to the ultra-smooth guide wire parent body with preset size. In the process of preparing a single guide wire, the length of the core wire 101 to be coated is slightly longer than the length of the core wire segment to be coated (also referred to as a target core wire segment) in the target ultra-smooth guide wire. This is because: to achieve core wire draw, prior to the initial coating position (the direction of core wire travel for draw is referred to as "front", the opposite direction is referred to as "back", as opposed to "front end" and "back end", respectively), the core wire 101 to be coated should be of sufficient length to provide a feed-through end that can be gripped; after the clamping is finished, the transition from starting traction to traction speed to the matching preset program can generate a certain transition section at the front end (head end) of the coated core wire 102; after the target core wire segment is coated, a transition segment is generated at the rear end (tail end) of the guide wire due to factors such as tail dragging until the whole coated core wire 102 is drawn out of the extrusion die. The above factors cause that certain redundant sections exist at the head end and the tail end of the coated core wire and the guide wire obtained by cooling and shaping, and the redundant sections at the two ends need to be cut off before the lubricating coating is coated.

In order to obtain an ultra-smooth guidewire matrix that conforms to the pre-set dimensions, portions, i.e., "excess segments," are cut from the cooled and shaped guidewire.

Those skilled in the art will appreciate that the resection is similar to shaping the guide wire end-to-end, and is fundamentally different from the conventional technique of cutting a long guide wire into multiple guide wires.

In another aspect of the present invention, a method for forming an ultra-smooth guide wire is provided, which includes the following steps:

preparing a guide wire with a high polymer material coating layer (preferably the guide wire which is cooled and shaped) by adopting the guide wire forming method;

cutting off the redundant sections of the guide wire and sealing the end to obtain a super-smooth guide wire matrix;

and (3) attaching a lubricating coating on the surface of the ultra-smooth guide wire matrix to obtain the ultra-smooth guide wire.

Further, methods of end-capping include, but are not limited to, hot melt molding and dip molding, preferably with the aid of a molding die, to achieve a more desirable end profile.

Further, in some embodiments, the ultra-smooth guidewire shaping method further comprises the steps of: and (3) attaching a lubricating coating to the surface of the ultra-smooth guide wire matrix to obtain the ultra-smooth guide wire. Further, ways to attach the lubricious coating include, but are not limited to, dip coating and spray coating.

In some embodiments, the lubricious coating is a hydrophilic coating. In some preferred embodiments, the lubricious coating may be selected from: including but not limited to polyvinylpyrrolidone coatings (PVP coatings), hydrophilic coatings of polyvinylpyrrolidone derivatives, polyethylene glycol coatings (PEG coatings), hydrophilic coatings of polyethylene glycol derivatives, acrylic coatings, hydrophilic coatings of acrylic derivatives, and the like.

In some embodiments, the lubricating layer has a thickness of 0.5 to 50 micrometers, further can be 1 to 50 micrometers, further can be 2 to 40 micrometers. The thickness of the lubricating layer can be, for example, 0.5 to 40 micrometers, 0.5 to 30 micrometers, 0.5 to 20 micrometers, 1 to 40 micrometers, 1 to 30 micrometers, 1 to 20 micrometers, 1.5 to 40 micrometers, 1.5 to 30 micrometers, 1.5 to 20 micrometers, 2 to 40 micrometers, 2 to 30 micrometers, 2 to 20 micrometers, and the like. Examples of the thickness of the lubricating layer may also include, but are not limited to: 0.5 microns, 1 micron, 1.5 microns, 2 microns, 2.5 microns, 3 microns, 3.5 microns, 4 microns, 4.5 microns, 5 microns, 5.5 microns, 6 microns, 6.5 microns, 7 microns, 7.5 microns, 8 microns, 8.5 microns, 9 microns, 9.5 microns, 10 microns, 11 microns, 12 microns, 13 microns, 14 microns, 15 microns, 18 microns, 20 microns, 25 microns, 30 microns, 35 microns, 40 microns, 45 microns, 50 microns, and the like.

The guide wire forming method (including the ultra-smooth guide wire forming method) provided by the invention can be used for coating a single core wire, and solves the technical problem of coating and extruding the single core wire; the method can be used for continuously forming the guide wires one by one in the single core wire coating extrusion system, and has the functions of automatically taking out and filling the core wires, automatically drawing and coating, and automatically taking out and drying; the whole method has high automation degree and less personnel intervention, effectively improves the outer diameter uniformity and quality stability of the guide wire coating forming, and reduces the waste of raw materials.

The guide wire forming method provided by the invention has the advantages of less personnel intervention, stable forming quality and high production efficiency, and can form not only straight guide wires but also guide wires with bent head ends.

In another aspect of the invention, the guide wire prepared by the guide wire forming method is also provided.

In another aspect of the invention, the ultra-smooth guide wire prepared by the ultra-smooth guide wire forming method is also provided.

Single core wire cladding extrusion system

In another aspect of the present invention, a single core filament sheath extrusion system is provided, which can be used to perform the method for forming a guidewire as described above, thereby producing an ultra-smooth guidewire. This single core silk cladding extrusion system is including getting silk filling unit, cladding extrusion unit, drawing cooling unit and dry collection unit, and the single in-process that moves in the extrusion tooling who treats cladding core silk and cladding extrusion unit is wrapped by macromolecular material's fuse-element, and this system is equipped with core silk external diameter detection device, and the accessible detects the core silk external diameter and then controls the input speed of core silk moving speed and macromolecular fuse-element. The single-core-wire coating extrusion system provided by the invention can be used for continuous guide wire forming, can realize continuous coating one by one, has full-automatic feeding, coating and collecting processes and high production efficiency; the guide wire forming machine can be used for forming a straight guide wire and a guide wire with a bent head end; the formed guide wire has uniform outer diameter and good coating effect; less intervention of operators; the guide wire has stable quality and high consistency.

By the present invention, an "individual core filament sheath extrusion system" is meant, although not limited to, the preparation of individual core filaments in the manner exemplified by the present invention, to enable sheath extrusion of individual core filaments. For example, multiple (≧ 2) core wires are allowed to enter the extrusion die in parallel, allowing simultaneous drawing of multiple core wires. Likewise, it is also allowed that the sheath extrusion unit comprises a plurality (≧ 2) of first cavities for the core filaments to pass through, thereby enabling the system to process a plurality of individual core filaments simultaneously.

The single core filament sheath extrusion system also includes, but is not limited to, any of the single core filament sheath extrusion systems previously described.

In some embodiments of the present invention, the single core filament coating extrusion system comprises a filament taking and filling unit 1, a coating extrusion unit 2 and a traction cooling unit 3, which are arranged along the extending direction of the core filament, wherein the coating extrusion unit 2 is located between the filament taking and filling unit 1 and the traction cooling unit 3;

the filament taking and filling unit 1 comprises a filling mechanism 13, the coating and extruding unit 2 comprises an extruding die 23, the traction cooling unit 3 comprises a clamping and traction mechanism 31 and a cooling tank 32, and the filling mechanism 13, the extruding die 23 and the clamping and traction mechanism 31 are sequentially arranged along the extension direction of the core filament; the filling mechanism 13 can penetrate one end of a single core wire 101 to be coated into the extrusion die 23 one by one and then penetrate out, and the clamping and traction mechanism 31 can clamp the penetrating end of the core wire to move and control the moving direction and the moving speed of the core wire; the cooling tank 32 is positioned below the clamping and pulling mechanism 31, and after the clamping and pulling mechanism 31 releases the clamping of the core wire, the core wire can be entirely placed in the cooling medium in the cooling tank 32;

the single core filament covering extrusion system further comprises a drying and collecting unit 4, and the drying and collecting unit 4 is adjacent to the cooling tank 32. The position of the drying and collecting unit 4 with respect to the cooling bath 32 is not particularly limited as long as the drying and collecting unit 4 can take out the cooled and shaped guide wire from the cooling bath 32, and dry and collect it.

In some embodiments, the drying collection unit 4 is located below or to the side of the traction cooling unit 3. In some embodiments, the drying collection unit 4 is located below or to the side of the cooling tank 32. In some embodiments, the drying and collecting unit 4 includes a guide wire take-out mechanism 41, and the guide wire take-out mechanism 41 can take out the guide wire from the cooling bath 32. In some embodiments, the guidewire extraction mechanism 41 is located to the side or above the grip traction mechanism 31. In some embodiments, the guidewire extraction mechanism 41 is located above the cooling bath 32.

In some embodiments, the core wire taking and filling unit 1 further includes a core wire taking mechanism 11 and a core wire holder 12; the core wire frame 12 can horizontally receive the core wire 101 to be coated; the core wire taking-out mechanism 11 is positioned above the core wire frame 12, and can grab the core wires 101 to be coated one by one from the core wire frame 12 and then put into the filling mechanism 13; the loading mechanism 13 is located between the core filament frame 12 and the extrusion die 23, and the loading mechanism 13 and the extrusion die 23 can be adjusted to the same horizontal height along the extending direction of the core filament, so that the single core filament 101 to be coated is conveniently aligned to the core filament inlet (inlet of the first cavity) of the extrusion die, and one end of the core filament 101 to be coated is clamped by the clamping and pulling mechanism 31 after penetrating through the extrusion die 23. In the present invention, there is some deviation from the "same level" as long as the loading of the cored wire into the extrusion die is not affected.

In some embodiments, the cladding extrusion unit 2 further comprises a melt pump 22 and an extruder 21, the melt pump 22 being located between the extruder 21 and the extrusion die 23. The extruder 21 is used for conveying the melt of the high polymer material into the melt pump 22; the melt pump 22 is used for controlling the output speed of the melt of the high polymer material and inputting the melt of the high polymer material into the extrusion die 23; the extrusion die 23 is capable of passing the core filament in and out of the whole filament, and provides a first cavity for the melt of the polymer material to coat the core filament to prepare the coated core filament 102.

In some embodiments, extruder 21, melt pump 22, and extrusion die 23 are each independently provided with a temperature control device.

In some embodiments of the invention, the cladding extrusion unit 2 further comprises a core wire outer diameter detection device 24 and a guide wire outer diameter detection device 25. Reference may be made to the single core filament sheath extrusion system shown in fig. 1.

The core wire outer diameter detection device 24 is located between the loading mechanism 13 and the extrusion die 23, and is used for detecting the outer diameter of the core wire 101 to be coated and detecting whether the core wire is loaded into the loading mechanism 13. In some embodiments, the core wire outer diameter detection device 24 has a detection frequency of 8000 to 12000Hz, such as 8000Hz, 9000Hz, 10000Hz, 11000Hz, 12000Hz, and the like.

In some embodiments of the present invention, a detection signal transmission channel is provided between the core wire outer diameter detection device 24 and the clamping and pulling structure 31, so that the pulling speed can be adjusted in real time according to the core wire outer diameter.

In some embodiments of the present invention, a detection signal transmission channel is provided between the core wire outer diameter detection device 24 and the melt pump 22, so that the output speed of the melt pump can be adjusted in real time according to the outer diameter of the core wire.

In some embodiments of the present invention, a detection signal transmission channel is provided between the guide wire outer diameter detection device 25 and the clamping and pulling structure 31, so that the pulling speed can be adjusted in real time according to the outer diameter verification result of the coated core wire.

In some embodiments of the present invention, a detection signal transmission channel is provided between the guide wire outer diameter detection device 25 and the melt pump 22, so that the output speed of the melt pump can be adjusted in real time according to the outer diameter verification result of the coated core wire.

In some embodiments of the present invention, the core wire outer diameter detection device 24 and the guide wire outer diameter detection device 25 are each independently a non-contact outer diameter test, and are each independently preferably a laser outer diameter test device.

In some embodiments of the present invention, a guide wire outer diameter detection device 25 is located between the extrusion die 23 and the traction cooling unit 3, and is configured to detect the outer diameter of the core wire (coated core wire 102) coated with the polymer material, and detect whether the core wire is loaded into and passes through the extrusion die 23 to reach a target position; the "target position" includes a position where the core wire passes through the extrusion die 23 and protrudes by a certain length so as to be drawn and clamped, and the guide wire outer diameter detection device 25 can also detect whether the covered core wire reaches a position where clamping is released. In some embodiments, the guide wire outer diameter detection device 25 detects the outer diameter of the guide wire at 8000 to 12000Hz, such as 8000Hz, 9000Hz, 10000Hz, 11000Hz, 12000Hz, and the like.

In some embodiments of the present invention, the guidewire outer diameter detection device 25 is a non-contact outer diameter test, preferably a laser outer diameter test device.

In some embodiments, the cladding extrusion unit 2 further comprises a core wire outer diameter detection device 24 located between the filling mechanism 13 and the extrusion die 23, and a guide wire outer diameter detection device 25 located between the extrusion die 24 and the traction cooling unit 3; the loading mechanism 13, the core wire outer diameter detection device 24, the extrusion die 23, and the guide wire outer diameter detection device 25 can be adjusted to substantially the same level in the core wire extending direction.

The single core wire coating extrusion system can only arrange a traction device on one side of the extrusion die 23, and can only carry out single-side traction on the core wire in the coating process (double-side traction in the traditional technology). In some preferred embodiments, a single pulling device is provided on the exit side of the extrusion die 23. Further, the single pulling device is integrated in the holding pulling means 31.

In some embodiments, the drying and collecting unit 4 further comprises a drying device 42 and/or a guide wire collecting chamber 43 for drying and/or collecting the guide wire taken out by the guide wire taking-out mechanism.

The single core wire coating extrusion system is loaded with a speed control program so as to control the speed of the whole process of guide wire forming and realize automatic continuous operation. The speed control program may be integrated with the corresponding device/means/mechanism or may be provided as a separate speed control means. The speed between some devices/apparatuses/mechanisms may also be controlled in a correlated manner, such as by the melt pump 22 and the pinch pull mechanism 31 via equation (I) above.

In some embodiments of the present invention, reference is made to the single core filament covering extrusion system shown in fig. 1, comprising a filament taking and filling unit 1, a covering and extrusion unit 2, a traction cooling unit 3 and a drying and collecting unit 4; the core wire taking and filling unit 1 comprises a core wire taking mechanism 11, a core wire frame 12 and a filling mechanism 13; the cladding extrusion unit 2 comprises an extruder 21, a melt pump 22 and an extrusion die 23; the traction cooling unit 3 comprises a clamping traction mechanism 31 and a cooling groove 32; the drying and collecting unit 4 includes a guide wire take-out mechanism 41, a drying device 42, and a guide wire collecting chamber 43.

The core wire frame 12 is used for placing the core wires 101 to be coated (preferably horizontally placed so as to be taken out by the core wire taking-out mechanism 11 individually), the core wire taking-out mechanism 11 can grab a single core wire from the core wire frame 12 at a time, and the filling mechanism 13 is used for feeding the core wires into the extrusion die 23.

The extruder 21 is used for conveying the melt of the high polymer material into the melt pump 22; the melt pump 22 is used for controlling the output speed of the melt of the high polymer material and inputting the melt of the high polymer material into the extrusion die 23; the extrusion die 23 is capable of passing the core filament in and out entirely and is used for coating the core filament with a melt of a polymer material to prepare a coated core filament 102.

In some embodiments, extrusion die 23 is a T-die, and includes a first channel for passing the core filament therethrough and a first cavity for allowing the polymer melt to flow into, the first channel being in communication with the first cavity and being angled. "T-form" is defined as described above. The "angled arrangement" can be used to control the angle between the output flow of the polymer melt from melt pump 22 and the direction of movement of the single core filament in extrusion die 23. The angle of the "angled arrangement" is not particularly limited, and may be greater than 0 ° and less than 180 °, such as 90 °, 80 °, 70 °, 60 °, 50 °, 45 °, 30 °, 20 °, 15 °, 10 °, and the like, as long as the input control of the polymer melt can be achieved. The clamping and pulling mechanism 31 can clamp the core wire penetrating end from the extrusion die 23 and pull the core wire to move, so that the core wire penetrates through the extrusion die 23 (after penetrating into the extrusion die 23, the core wire moves in the extrusion die and penetrates out of the whole core wire); in addition, the portion that has passed out of the extrusion die 23 may be drawn to move inside or over the cavity of the cooling slot 32.

The guide wire taking-out mechanism 41 is used for taking out the guide wire 103 which is cooled and shaped in the cooling groove 32; the drying device 42 is used for drying the taken out cooled and shaped guide wire 103, and the guide wire collecting bin 43 is used for collecting the dried guide wire.

In some embodiments, a detection signal transmission channel is provided between the core wire outer diameter detection device 24 and the clamping and pulling structure 31; and a detection signal transmission channel is arranged between the core wire outer diameter detection device 24 and the melt pump 22.

The definition of the individual core filaments covering the components of the extrusion system is also described above in the present invention.

FIG. 1 is a schematic diagram of a single core filament sheath extrusion system in accordance with an embodiment of the present invention. The single core wire coating extrusion system comprises a wire taking and filling unit 1, a coating extrusion unit 2, a traction cooling unit 3 and a drying and collecting unit 4; the core wire taking and filling unit 1 comprises a core wire taking mechanism 11, a core wire frame 12 and a filling mechanism 13; the cladding extrusion unit 2 comprises an extruder 21, a melt pump 22, an extrusion die 23, a core wire outer diameter detection device 24 and a guide wire outer diameter detection device 25; the traction cooling unit 3 comprises a clamping traction mechanism 31 and a cooling groove 32; the drying and collecting unit 4 comprises a guide wire taking-out mechanism 41, a drying device 42 and a guide wire collecting bin 43; the connection relationship between the components is the same as described above. And will not be described in detail herein. In fig. 1, a core wire 101 to be coated is horizontally placed on a core wire rack 12, when a production line is started, a core wire taking-out mechanism 11 picks up a single core wire from the core wire rack 12 each time and transfers the core wire to a loading mechanism 13, when a core wire outer diameter detection device 24 detects that a core wire is loaded into the loading mechanism 13, the loading mechanism 13 is started, the core wire is fed into an extrusion die 23 by the loading mechanism 13, and one end of the core wire penetrates into the extrusion die 23 (the end which firstly penetrates out of the extrusion die 23 is marked as a penetrating end) and then penetrates out. The guide wire outer diameter detection device 25 is also used to detect whether the core wire is loaded and passes through the extrusion die 23 to reach the target position, and when the guide wire outer diameter detection device 25 detects that the core wire has reached the target position, the loading is stopped. Before being fed into the extrusion die, the core wire outer diameter detection device 24 may be used to detect whether or not the core wire is properly loaded into the loading mechanism 13. When the through end reaches the clampable area of the traction cooling unit 3, the clamping and traction mechanism 31 is adopted to clamp the core wire through end and draw the core wire to move so as to lead the core wire to pass through the extrusion die 23. After the clamping is completed, in the process that the core filament moves in the extrusion die 23, the extruder 21 heats and plasticizes the high polymer material, and conveys the formed melt of the high polymer material into the melt pump 22, the melt pump 22 controls the output speed of the melt of the high polymer material and conveys the melt of the high polymer material into the extrusion die 23, so as to realize the coating of the core filament passing through the extrusion die 23, and obtain the coated core filament 102. The timing for starting the coating can be determined by the detection result of the core wire outer diameter detection device 24 or/and the guide wire outer diameter detection device 25. The coated core wire 102 is drawn to move (the penetrated part moves in the cavity of the cooling tank 32 or moves above the cavity of the cooling tank 32; the non-penetrated part moves in the extrusion die) by the clamping and drawing of the core wire penetrating end of the clamping and drawing mechanism 31, and the part of the coated core wire entering the cooling tank 32 in the moving process can be not immersed in the cooling medium of the cooling tank 32 or can be completely immersed in the cooling medium. The type of the cooling medium can be flexibly selected as long as the coated core wire that has passed out of the extrusion die 23 can be cooled as required. In a preferred embodiment, the cooling medium is circulating cooling water. After the whole core wire passes through the extrusion die 23, the clamping of the coated core wire is released, the whole coated core wire is placed in a cooling medium (such as cooling circulating water) of the cooling tank 32 for cooling and shaping, after the cooling and shaping are finished, the guide wire 103 which is cooled and shaped is taken out from the cooling tank 32 by using the guide wire taking-out mechanism 41, drying is carried out by using the drying device 42, and the dried guide wire is collected by using the guide wire collecting bin 43.

Fig. 2 is a schematic structural diagram of a single core filament to be coated according to an embodiment of the present invention. The single core filament 101 to be covered is composed of a core filament thick section 1011, a core filament transition section 1012 and a core filament thin section 1013.

Fig. 3 is a schematic structural diagram of a straight single super-lubricity guidewire matrix in an embodiment of the invention. The ultra-smooth guide wire matrix 106 is composed of a core wire 101 to be coated and a high polymer material coating layer 104. According to the single core wire coating extrusion system, the traction speed and the output speed of the melt pump are changed in real time according to the outer diameters of different positions of the core wire detected by the core wire outer diameter detection device 24, and the coated core wire with uniform outer diameter from top to bottom as shown in fig. 3 can be realized.

Fig. 4 is a schematic structural diagram of a single ultra-smooth guidewire precursor with a bent core wire segment according to an embodiment of the invention. The ultra-smooth guide wire parent body 106 is also composed of a core wire 101 to be coated (thin section bending) and a high polymer material coating layer 104. Likewise, a super-lubricious guidewire precursor of uniform outside diameter from end to end as shown in fig. 4 can be achieved.

In some embodiments of the present invention, the cooling tank 32 contains a cooling medium (e.g., circulating cooling water) for cooling and shaping the coated core wire.

In some embodiments of the present invention, a melt pressure sensor is also provided on the extrusion die 23 for monitoring the melt pressure within the die.

In some embodiments of the present invention, the clamping and pulling mechanism 31 is provided with a clamping hand and a moving guide rail, wherein the clamping hand is used for clamping the penetrating end of the coated core wire from the extrusion die 23, and the moving guide rail is used for controlling the pulling track of the coated core wire; and/or the presence of a catalyst in the reaction mixture,

in some embodiments of the invention, the extruder 21, melt pump 22, and extrusion die 23 are each independently provided with a temperature control device.

In some embodiments of the invention, the nip points of the loading mechanism 13, extrusion die 23, and nip traction mechanism 31 are substantially collinear.

In some embodiments of the invention, the guidewire retrieval mechanism 41 is provided with a conveyor belt or a robotic arm.

In some embodiments of the invention, the drying device 42 is provided with a conveyor belt.

Applications of

In another aspect of the present invention, there is provided a use of the single core filament covered extrusion system of the present invention in the preparation of an ultra-smooth guidewire. The prepared ultra-smooth guide wire has more uniform outer diameter and more stable size.

In another aspect of the present invention, a guide wire obtained by the guide wire forming method of the present invention or an application of the ultra-smooth guide wire obtained by the ultra-smooth guide wire forming method of the present invention is provided, including but not limited to an application in an interventional medical device.

In some embodiments, interventional medical devices include, but are not limited to, coronary vascular devices, peripheral vascular devices, urological devices, and the like.

Some specific examples are as follows.

Embodiments of the present invention will be described in detail with reference to examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. The experimental procedures for the conditions not specified in the following examples, preferably with reference to the guidelines given in the present invention, may also be performed according to the experimental manual or the conventional conditions in the art, may also be performed according to the conditions suggested by the manufacturer, or may be performed according to the experimental procedures known in the art.

In the following specific examples, the measurement parameters relating to the components of the raw materials, if not specified otherwise, may be subject to slight deviations within the accuracy of the weighing. Temperature and time parameters are involved to allow for acceptable deviation due to instrument test accuracy or operational accuracy.

The raw materials and reagents used in the following examples are all commercially available unless otherwise specified. The polyurethanes used in the examples below were either tungsten-containing polyurethanes or conventional polyurethanes containing no tungsten. It will be understood by those skilled in the art that the polymer material in the following examples can be replaced by a polymer material containing other developing components or other modifying components, and all of them can be used to implement the single core filament covering, the guide wire forming method, and the ultra-smooth guide wire forming method of the present invention, and it can be expected that the following examples can achieve substantially the same technical effects.

PVP photocureable coating: jAqua, manufactured by Jiemet coating technology (Xiamen) Co., Ltd^TMA hydrophilic ultra-slip coating. PVP refers to polyvinylpyrrolidone.

Example 1.

The core wire is made of nickel-titanium alloy, the diameter of the thick section is 0.5mm, the length of the thick section is 1400mm, the diameter of the thin section is 0.15mm, the length of the thin section is 200mm, the length of the transition section is 100mm, the transition section is uniform, the length of a single core wire is 1700mm, and the outer diameter of the coated core wire with the length of the thick section is set to be 0.85 mm. The coated high polymer material is made of polyurethane, the coating mode is concentric coating, and the thickness of single-side coating is 0.175-0.35 mm.

The single core wire coating extrusion system shown in fig. 1 is adopted to coat, cool, shape, dry and collect the single core wire to be coated, then the excessive sections are cut off to prepare the ultra-smooth guide wire matrix, and the ultra-smooth guide wire is prepared after a lubricating coating is added. The single core wire coating extrusion system used in the embodiment comprises a wire taking and filling unit 1, a coating extrusion unit 2, a traction cooling unit 3 and a drying and collecting unit 4; the core wire taking and filling unit 1 comprises a core wire taking mechanism 11, a core wire frame 12 and a filling mechanism 13; the cladding extrusion unit 2 comprises an extruder 21, a melt pump 22 and an extrusion die 23; the traction cooling unit 3 comprises a clamping traction mechanism 31 and a cooling groove 32; the drying and collecting unit 4 includes a guide wire take-out mechanism 41, a drying device 42, and a guide wire collecting chamber 43. Wherein the extruder 21, the melt pump 22 and the extrusion die 23 are respectively provided with a temperature control device; the filling mechanism 13, the melt pump 22 and the clamping traction mechanism 31 are respectively provided with a speed control device; a detection signal transmission channel (connecting element) is arranged between the core wire outer diameter detection device 24 and the clamping traction structure 31; a detection signal transmission channel (connecting element) is also arranged between the core wire outer diameter detection device 24 and the melt pump 22; the extrusion die 23 is also provided with a melt pressure sensor; the clamping traction mechanism 31 is provided with a clamping hand and a moving guide rail; the guide wire take-out mechanism 41 is provided with a manipulator; the drying device 42 is provided with a conveyor belt. The positional relationship between the above components is as described in the foregoing description of fig. 1, and will not be described in detail here. The holding and pulling mechanism 31 is only located on the exit side of the extrusion die, and realizes single-side pulling of the core wire. The speed control of the melt pump 22 and the clamp pull 31 are controlled by the system program in accordance with equation (I). The extrusion die 23 is a T-shaped die, and has a tubular cavity (first cavity) parallel to the drawing direction of the core wire and a tubular passage (first passage) perpendicular to the drawing direction of the core wire, the first cavity and the first passage intersect and communicate with the axial middle position of the first cavity, and the first passage communicates with the outlet of the melt pump to form a supply passage of the polymer melt. The core wire outer diameter detection device 24 is a non-contact outer diameter test.

Preparation parameters are as follows: extruder temperature 175 ℃, melt pump temperature 175 ℃, extrusion dieWith a temperature of 175 ℃. The core wire penetration speed was 100 mm/s. Fixed melt pump output speed 40mm³S; the core wire outer diameter detection device is adopted to detect the size of the core wire in real time, the detection frequency is 10000Hz, the proper traction speed is calculated in real time according to a system program and is adjusted, the traction speed of a thick section is 108mm/s, the traction speed of a thin section is 73mm/s, and for a transition section, the system program is adjusted in real time according to the outer diameter of a coating position and a proper calculation formula. Wherein, the calculation formula adopts the formula (I): d²＝d²+4 XQ/π/v; wherein Q represents the output speed of the melt pump; d represents a guide wire target cladding outer diameter; d represents the core wire outer diameter at the coating position; v represents the traction speed; and pi represents the circumferential ratio.

After the clamping and traction mechanism loosens the guide wire, the stay time of the guide wire in the cooling groove is more than 10 s.

The drying is carried out by hot air at 80 deg.C for 1 min.

The length of 100mm is cut off from both ends respectively, and the ultra-smooth guide wire parent body with the length of 1500mm is prepared after the end sealing is carried out by adopting a hot melting mode.

The lubricating coating is PVP photocureable coating, and the thickness of the coating is 5 microns.

And (3) testing the outer diameter: the outer diameter is very uniform. 100 sampling positions are uniformly selected, the diameter is 0.85 +/-0.01 mm, and the uniformity degree of the outer diameter is very high.

Comparative example 1 continuous coating (lengthening end to end) comparative example

The core wire coating extrusion system in the comparative example adopts a traditional technical mode, and comprises a core wire frame 12, an extruder 21, a melt pump 22, an extrusion die 23, a guide wire outer diameter detection device 25 and a cooling groove 32, wherein a cooling medium is water, and the structure and position relation of each part are consistent with those in fig. 1. And traction devices are arranged on the inlet side and the outlet side of the extrusion die. And the wire releasing mechanism and the wire winding mechanism are respectively used for releasing the core wire to be coated and winding the coated and cooled core wire. And the compressed air drying mechanism is arranged behind the cooling tank and in front of the wire collecting mechanism and is used for continuously drying the coated guide wire.

The core yarn covering and extruding system in this comparative example is not provided with the yarn taking and filling unit 1, the core yarn outer diameter detecting device 24, the clamping and pulling mechanism 31, the drying and collecting unit 4, and the like.

The core wire is made of nickel-titanium alloy, the diameter of the thick section is 0.5mm, the length of the thick section is 3400mm, the diameter of the thin section is 0.15mm, the length of the thin section is 2200mm, the length of the transition section is 100mm, the transition section is uniform, the length of a single core wire is 5700mm, and the outer diameter of the coated core wire with the length of the thick section is set to be 0.85 mm. The coated high polymer material is polyurethane, and the coating mode is concentric coating.

Preparation parameters are as follows: extruder temperature 175 ℃ and extrusion die temperature 175 ℃.

And (4) carrying out bilateral traction on the core wire by utilizing traction devices on the two sides of the extrusion die. Manually penetrating one end of the core wire into the extrusion die and then penetrating out, fixing the head and tail ends of the core wire on the head and tail traction devices respectively and straightening, starting traction, and synchronizing the head and the tail in the traction process.

The cladding extrusion process adopts a fixed melt pump with the flow rate of 40mm³And/s, the traction speed is adjusted in real time by using the system, the traction speed of the thick section is 108mm/s, the traction speed of the thin section is 73mm/s, and the system is adjusted in real time according to the outer diameter of the coating position and a proper calculation formula about the transition section. The same calculation formula (I) as in example 1 was used: d²＝d²+4×Q/π/v。

And after the coating is finished, performing water cooling, taking out the coated guide wire, and drying. The drying was carried out in the same manner as in example 1.

The length of 2100mm is cut at both ends, and the ultra-smooth guide wire parent body with the length of 1500mm is prepared after the end sealing is carried out by adopting a hot melting mode.

And (3) testing the outer diameter: 0.85 + -0.05 mm (100 sampling locations are chosen uniformly). It can be seen that the outer diameter control of the guidewire is not as uniform as the molding process of the present application shown in example 1.

Comparative example 2. continuous coating (end-to-end) comparative example:

the same core filament sheath extrusion apparatus as in comparative example 1 was used.

The core wire is made of nickel-titanium alloy, the diameter of the thick section is 0.5mm, the length of the thick section is 2400mm, the diameter of the thin section is 0.15mm, the length of the thin section is 1200mm, the length of the transition section is 100mm, the transition section is uniform, and the length of a single section is 3700 mm.

The core wires of each guide wire of the core wires are connected into a whole end to end, the connection is realized in a welding mode, and the welding point is polished after butt welding to ensure that the outer diameter is not more than 0.5mm so as to prevent the die from being clamped.

The coated high polymer material is polyurethane, and the coating mode is concentric coating.

Extruder temperature 175 ℃ and extrusion die temperature 175 ℃.

And (4) carrying out bilateral traction on the core wire by utilizing traction devices on the two sides of the extrusion die. Manually penetrating one end of the core wire into the extrusion die and then penetrating out, respectively fixing the head and tail ends of the core wire on the head traction device and straightening, starting traction, and synchronizing the head and tail ends in the traction process.

The cladding extrusion process adopts a fixed melt pump with the flow rate of 40mm³And/s, the traction speed is 108 mm/s.

And locally cutting the cladding layer to find a welding position, and determining a target length cutting position of the guide wire by taking the welding point as an original point. The length of 1100mm is cut at both ends respectively, and the length of the ultra-smooth guide wire parent body is 1500mm after hot melting and end sealing, wherein the thick section is 1300mm, the thin end is 100mm, and the transition section is 100 mm.

And (3) testing the outer diameter: the outer diameter is not uniform, the fluctuation is large, wherein the thick section is 0.85 plus or minus 0.05mm, and the thin section is 0.70 plus or minus 0.10 mm.

The features of the above embodiments and examples may be combined in any suitable manner, and for the sake of brevity, all possible combinations of features in the above embodiments and examples are not described in detail, but should be construed to fall within the scope of the present disclosure unless there is any conflict between such combinations of features.

The above examples only show some embodiments of the present invention, so as to facilitate the detailed and detailed understanding of the technical solutions of the present invention, but not to be construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Furthermore, it should be understood that after reading the above teachings of the present invention, various changes or modifications may be made to the invention by those skilled in the art, and equivalents may be obtained and still fall within the scope of the present application. It should also be understood that the technical solutions provided by the present invention, which are obtained by logical analysis, reasoning or limited experiments, are within the scope of the present invention as set forth in the appended claims. Therefore, the protection scope of the present patent shall be subject to the content of the appended claims, and the description and drawings can be used to explain the content of the claims.

Claims

1. The single core wire coating extrusion system is characterized by comprising a wire taking and filling unit, a coating extrusion unit and a traction cooling unit, wherein the wire taking and filling unit, the coating extrusion unit and the traction cooling unit are arranged along the extension direction of a core wire;

2. The single core filament covering extrusion system of claim 1, wherein the filament removing and filling unit further comprises a core filament removing mechanism and a core filament rack; the core wire taking-out mechanism is positioned above the core wire frame; the filling mechanism is positioned between the core wire frame and the extrusion die, and the filling mechanism and the extrusion die can be adjusted to the same horizontal height along the extension direction of the core wire.

3. The single core filament covering extrusion system of claim 1, wherein the covering extrusion unit further comprises a melt pump and an extruder, the melt pump being located between the extruder and the extrusion die.

4. The single core filament covered extrusion system of claim 3, wherein said extruder, said melt pump and said extrusion die are each independently provided with temperature control means.

5. The single core filament covering extrusion system of claim 3, wherein the covering extrusion unit further comprises a core filament outer diameter detection device between the filling mechanism and the extrusion die, and a guide wire outer diameter detection device between the extrusion die and the traction cooling unit; the filling mechanism, the core wire outer diameter detection device, the extrusion die and the guide wire outer diameter detection device can be adjusted to the substantially same horizontal height in the core wire extending direction.

6. The single core wire cladding extrusion system of claim 5, wherein a detection signal transmission channel is provided between said core wire outer diameter detection device and said clamping traction structure; and/or the presence of a catalyst in the reaction mixture,

7. The single core filament covering extrusion system of claim 1, wherein the extrusion die is a T-die comprising a first cavity for the core filament to pass through and a first channel for the macromolecule melt to flow into, the first channel being in communication with the first cavity and being angled.

8. The single core filament covering extrusion system of claim 1, wherein the dry collection unit comprises a guide wire take-off mechanism positioned above the cooling tank.

9. The single core wire over-extrusion system of claim 8, wherein the drying and collecting unit further comprises a drying device and/or a guide wire collecting bin for drying and/or collecting the guide wire removed by the guide wire removing mechanism.

10. A single core filament sheath extrusion system as in claim 9, wherein the filament take-off mechanism is provided with a conveyor belt or a robot; and/or the drying device is provided with a conveyor belt.

11. The single core filament sheath extrusion system of claim 1, further comprising one or more of the following features:

a melt pressure sensor is also arranged on the extrusion die;

12. A single core filament covering extrusion system as in any of claims 1 to 11, wherein the system is used for continuous filament forming.

13. A guide wire forming method is characterized by comprising the following steps:

moving the single core wire in the extrusion die by clamping and drawing the penetrating end;

and taking out the cooled and shaped guide wire, drying and collecting.

14. The method for forming a guidewire as in claim 13, wherein the method for forming a guidewire using the single core wire over extrusion system as in any one of claims 1-12 comprises the steps of:

detecting the size of the core wire at the inlet position of the extrusion die, determining the position and the size of the core wire which is being coated, and correspondingly regulating and controlling the traction speed of the single core wire and the input speed of the polymer melt to the extrusion die to ensure that the radial sizes of the coated core wires are basically the same;

15. The guide wire molding method according to claim 14, wherein the polymer melt is input into the extrusion die from a melt pump of the cladding extrusion unit, the output flow direction of the polymer melt from the melt pump forms an angle with the moving direction of the single core wire in the extrusion die, and the flow direction of the polymer melt after entering the extrusion die is changed to be substantially consistent with the drawing direction of the core wire.

16. The guidewire molding method according to claim 15, wherein the drawing speed of the cladding core wire and the output speed of the melt pump by the clamping and drawing structure are respectively regulated and controlled according to the real-time detection result of the core wire outer diameter detection device on the core wire outer diameter.

17. The guidewire shaping method of claim 15, wherein the gripping and pulling structure regulates a pulling speed of the single core wire and an output speed of the melt pump according to the following formula (I):

D²＝d²+4 XQ/pi/v formula (I);

18. The guidewire shaping method of claim 15,

detecting whether a core wire is loaded into the loading mechanism by adopting a core wire outer diameter detection device, and detecting whether the core wire reaches a target position by adopting a guide wire outer diameter detection device; when the core wire outer diameter detection device detects that a core wire is loaded into the loading mechanism, the loading mechanism is started, and one end of the core wire penetrates into the extrusion die and then penetrates out;

when the guide wire outer diameter detection device detects that the core wire reaches the target position, the filling mechanism stops filling, the clamping and traction mechanism is started, clamps the penetrating end of the core wire, and pulls the core wire to move.

19. The method of claim 13, wherein the method of guidewire shaping is an automated continuous shaping method.

20. The guidewire shaping method of claim 13,

the single core wire to be coated is prepared by a grinding method; and/or the presence of a catalyst in the reaction mixture,

21. A method for forming an ultra-smooth guide wire is characterized by comprising the following steps:

preparing a guide wire with a high polymer material coating layer by adopting the method of any one of claims 13-20;

22. The method for forming an ultra-smooth guidewire according to claim 21, wherein the lubricant coating is a hydrophilic coating selected from the group consisting of a polyvinylpyrrolidone coating, a polyvinylpyrrolidone derivative hydrophilic coating, a polyethylene glycol derivative hydrophilic coating, an acrylic resin coating, and an acrylic resin derivative hydrophilic coating.

23. Use of a guide wire prepared according to any one of claims 13 to 22 in interventional medical devices.