Medical guiding wire and the manufacture method thereof with insulating coating
[technical field]
The present invention relates to a kind of medical instruments field, particularly relate to a kind of medical guiding wire and manufacture method thereof with insulating coating.
[background technology]
Medical guiding wire great majority are that single line structure is as Chinese patent (200620107266.7) at present, existing medical guiding wire is in operation technique, because hardness is large, elasticity is poor, easily cause and wear out some important tissues, as blood vessel, increase the risk of operation, and easily cause conduit easily to interlock and tie a knot or sell off or fracture when going deep into human body, affect normal operation technique; Also have in existing seal wire and do not there is insulating coating, in some operations, can not adopt conductive metallic material to import the person, so the scope of using is restricted.Seal wire metal itself, with some trace element, as nickel, has certain toxicity in addition, as direct contact tissue can be deposited in tissue, endangers personal health.
In order to overcome above-mentioned problem, I have developed a kind of medical guiding wire and manufacture method thereof with insulating coating.
[summary of the invention]
In order to overcome the deficiency of background technology, the object of this invention is to provide a kind of medical guiding wire and manufacture method thereof with insulating coating, make it have the performance of electric insulation, and when importing human body, there is good elasticity and lubricity, difficult staggered knotting or fracture, reduce the infringement to human body to operation process.
The present invention will solve the technical scheme that its technical problem adopts: a kind of medical guiding wire with insulating coating, and it comprises:
One core silk, it adopts metal material to make flexible linear body; Its head is bending, and the point diameter of head becomes greatly gradually along rear extreme direction, makes this head larger with respect to the middle part flexibility of core silk; Its afterbody is straight type/bending, and the end diameter of afterbody becomes greatly gradually along inferior extreme direction, makes this afterbody larger with respect to the middle part flexibility of core silk;
One elastomer, it adopts metal material to make coil spring shape, and described core silk is placed in described elastomer inner chamber and supports this elastomer, and described front end and end are fixed in elastomer two ends, so that elastomer changes with core filament shape; In the corresponding position of described header/trailer, form the flexible introduction segment of this medical guiding wire; And,
Insulating coating, it is formed at described elastomeric surface.
In the above-mentioned medical guiding wire with insulating coating, described core silk adopts rustless steel or Nitinol to make, and its header/trailer is prismatoid or cone-shaped.
In the above-mentioned medical guiding wire with insulating coating, described elastomer adopts rustless steel or Nitinol to make.
In the above-mentioned medical guiding wire with insulating coating, described insulating coating is PTFE coating or hydrophilic superslide degradable coating.
Due to the built-in core silk of elastomer, the head of core silk and afterbody are flexible large, and bending, under the effect of elastic force, elastomer is changed with core filament shape, and surface of elastomer is coated with insulating coating, in operation process, insulating coating possesses nonconducting performance, and smooth surface while importing human body resistance little, import more smooth and easy; The elasticity of elastomer own is large, is not easy to occur knotting or bending or fractures, and effectively reduces the injury of operation process to human body.
The present invention also provides this to have the manufacture method of the medical guiding wire of insulating coating, and it comprises the following steps:
A, heart yearn making step:
Step 1,
Get the raw materials ready, straightening is processed, shear: select 304,316 or MP35N metal steel wire or Nitinol, with accurate straightener/aligning machine by crooked material orthopedic be rectilinear solid wire rod, according to the difference requirement of seal wire, be cut into different length.
Step 2,
Grind: adopt grinding machine to grind and make it form flexible head and afterbody as the importing end of seal wire through the steel wire after the PROCESS FOR TREATMENT such as straightening above-mentioned.
Step 3,
Bend forming: head and/or afterbody by heart yearn after above-mentioned steps one and step 2 processing carry out " J " soft molding, make it form the soft head end of " J " type that is applicable to importing human body.
B, elastomer making step:
Step 1,
Get the raw materials ready: select satisfactory 304,316 or metal steel wire or the Nitinol line of MP35N;
Step 2,
Spring processed: by 304,316 or the metal steel wire of MP35N or Nitinol line through coiling machine stage clip technique, be made into helical spring body;
C, heart yearn and elastomer combination making step:
Step 1,
Threading: the heart yearn after processing through above-mentioned A heart yearn making step is penetrated to above-mentioned elastomer inner chamber;
Step 2,
Welding: adopt argon arc welding or laser weld or Plasma Welding or electron beam welding mode fixed-type at the front end of above-mentioned heart yearn and end and described elastomeric two ends, to form the coherent wire guides of integral body;
Step 3,
Bed material coating: above-mentioned wire guides is immersed in the bed material of PTFE coating or hydrophilic superslide degradable coating and carries out bed material coating; Make its surface coverage have PTFE coating or hydrophilic superslide degradable coating;
Step 4,
Bed material baking: have PTFE coating or hydrophilic superslide degradable coating bed material wire guides afterwards at the uniform velocity to toast in shift-in oven above-mentioned dip-coating, baking temperature constant temperature under the condition of 150-180 degree Celsius keeps 10-15 minute, then natural cooling;
Step 5,
Fabric coatings: above-mentioned wire guides after PTFE coating or hydrophilic superslide degradable coating baking is immersed in to PTFE coating or hydrophilic superslide degradable coating carries out fabric coatings;
Step 6,
Fabric baking: by above-mentioned wire guides through the fabric coatings of PTFE coating or hydrophilic superslide degradable coating after at the uniform velocity shift-in oven toast, baking temperature is constant temperature maintenance 20-30 minute, then natural cooling under the condition of 350-400 degree Celsius;
Step 7,
Clean, dry: the wire guides after step 6 is processed, be placed in ultrasonic washing unit and carry out 1-2 cleaning, remove seal wire surface oils and fats and dirt; Put in oven and dry again, so that the inside and outside volume drying of wire guides, after oven dry, must there is the finished product of the medical guiding wire of insulating coating.
In the manufacture method of the above-mentioned medical guiding wire with insulating coating, described heart yearn making step and elastomer making step are separate, can make simultaneously or separately make.
In the manufacture method of the above-mentioned medical guiding wire with insulating coating, the baking temperature of described step 7 be Celsius 50 degree to 90 degree, drying time is 30 to 60 minutes.
In the manufacture method of the above-mentioned medical guiding wire with insulating coating, the grinding in described heart yearn making step two, the grinding machine of employing is surface grinding machine, and head and/or afterbody are worn into prismatoid shape, and it is emery wheel that grinding machine adopts emery wheel, and process of lapping adds liquid coolant.The prismatoid of head can be divided into five sections particularly, first paragraph length 10mm, diameter is 0.4mm; Second segment length is 10mm, and diameter is 0.3mm; The 3rd segment length is 10mm, and diameter is 0.2mm; The 4th segment length is 20mm, diameter 0.12mm; The 5th segment length is 30mm, and diameter is 0.08mm; The prismatoid of its afterbody is divided into three sections, and first paragraph length is 20mm, and diameter is 0.3mm; The 3rd segment length is 20mm, and diameter is 0.2mm; Above-mentioned each ladder section gradation is ground piecemeal.
In the manufacture method of the above-mentioned medical guiding wire with insulating coating, grinding in described heart yearn making step two, the grinding machine adopting is centerless grinder, head and/or afterbody are worn into cone-shaped or cone and cylindrical combination, it is emery wheel that grinding machine adopts emery wheel, and process of lapping adds liquid coolant.
The present invention compares produced beneficial effect with background technology:
The present invention has adopted above-mentioned technical scheme, and advantage is:
1. this has absolutely its heart yearn two ends of medical guiding wire of coating and carries out gradual change ladder supple-settlement technique, by firmly to soft, from coarse to fine, transitions smooth is submissive, the risk that the importing end of this medical guiding wire is reduced when clinical puncture or avoid the staggered knotting of seal wire or fracture, thus reduce or avoid the injury to patient at operation process.
2. supple-settlement molding has all been done at this medical guiding wire two with insulating coating, two all can be used as puncture and imports end clinically, doctor can select " J " type end or " I " type end as importing end according to vessel size or the not equal clinical practice situation of point of puncture, realize the breakthrough of two kinds of functions of a product, greatly facilitate clinical demand, have more hommization.
3. the effective barrier metal seal wire of insulating coating that this medical guiding wire with insulating coating has directly contacts with tissue, effectively avoids some poisonous element depositions that metal material itself has in tissue.
4. this medical guiding wire manufacture method with insulating coating has that technique is simple, stable performance, and yield rate is high, and cost of manufacture is low.The present invention is simple to operate, and production method is easily grasped and controlled, and produces the utilization rate of raw materials use high, and the conforming product rate of production is significantly increased, and production efficiency is also significantly improved, energy savings and not polluting.
5. the coating with the medical guiding wire of insulating coating of the present invention is close to the surface formation one deck insulation superslide thin film that is wrapped in the close body spring body of spiral, described thin film links up into whole, make between helical spring seamless, effectively avoid clinically or reduce blood samples of patients by the gap between spiral elastic ring, being penetrated into the inner space of seal wire, thereby reduced the blood residual quantity of patient on seal wire, reduced patient's risk.
6. medical insulating coating seal wire of the present invention is to carry out absolutely paint coatings after first making helical spring body again, the paint film layer of guaranteeing to be sticky deposited on helical spring body is perfect, possibility without any machining damage, coating is evenly unified, and thickness of coating layer can be controlled by the number of times of coating, and coating result is better.
[accompanying drawing explanation]
Fig. 1 is the medical guiding wire structural representation with insulating coating of the first embodiment of the present invention;
Fig. 2 is the profile of flexible introduction segment bending structure in Fig. 1;
Fig. 3 of the present invention first executes the structural representation of the head of SMIS silk;
Fig. 4 of the present invention first executes the structural representation of the afterbody of SMIS silk;
Fig. 5 is the profile of the straight type structure of flexible introduction segment in Fig. 1;
Fig. 6 is the medical guiding wire structural representation with insulating coating of the second embodiment of the present invention;
Fig. 7 of the present invention second executes the structural representation of the head of SMIS silk;
Fig. 8 of the present invention second executes the structural representation of the afterbody of SMIS silk;
Fig. 9 is for inventing the process chart of the manufacture method of the medical guiding wire with insulating coating.
[specific embodiment]
In description, the length with the medical guiding wire of insulating coating is not done special restriction, can suitably regulate according to actual needs.
In description, all direction explanations, as forward and backward, head, tail, etc.; Only to narrate and help reader understanding the present invention for more convenient, rather than restriction the present invention, particularly can not be to position, the restriction of orientation to the present invention's application, because if narration conversely, position, orientation also will be contrary.
In description, the diameter of core silk can not done special restriction, but conventional scope is that employing diameter is that 0.2mm is between 1.2mm.
In description, PTFE coating is Teflon coating, i.e. teflon coating, and its thickness is not done special restriction, and actual needs increases/reduces the number of plies and the thickness of coating and realizes suitable adjustment.PTFE coating and hydrophilic superslide degradable coating, the process conditions/parameter/device therefor in manufacturing the above-mentioned medical guiding wire with insulating coating all can be identical.
In description, MP35N alloy is a kind of Ni, Co, Cr molybdenum alloy without magnetic, has unique superelevation tensile strength, good ductility and toughness and extraordinary corrosion resistance.In addition, this alloy has also represented the performance of outstanding anti-sulfuration, high-temperature oxydation and hydrogen embrittlement.
In description, 316 rustless steels, its chemical composition: C≤0.08, Si≤1.00, Mn≤2.00, P≤0.035, S≤0.03, Ni:10.0-14.0, Cr:16.0-18.5, Mo:2.0-3.0.316 stainless steel machinery character, tensile strength (Mpa) 620MIN, yield strength (Mpa) 310MIN, percentage elongation (%) 30MIN, area reduction (%) 40MIN.
Heart yearn in description or elastomer, select 304 or 316 or MP35N metal steel wire or Nitinol, and the process conditions/parameter/device therefor in manufacturing the above-mentioned medical guiding wire with insulating coating all can be identical.
Below in conjunction with accompanying drawing, by the specific embodiment of the present invention is further described, make technical scheme of the present invention and beneficial effect thereof clearer, clear and definite.
The first embodiment:
Refer to shown in Fig. 1, Fig. 2, Fig. 5, it is a kind of medical guiding wire with insulating coating that embodiment of the present invention provides, and this medical guiding wire 100 comprises: a core silk, and it adopts metal material to make flexible linear body; Its head 11 is bending, and along rear end, 112 directions become greatly front end 111 diameters of head 11 gradually, makes this head 11 larger with respect to middle part 12 flexibilities of core silk; Its afterbody 13 is straight type, and end 131 diameters of afterbody 13 become greatly gradually along inferior end 112 directions, makes this afterbody 13 larger with respect to middle part 12 flexibilities of core silk; One elastomer 2, it adopts metal material to make coil spring shape, and described core silk is placed in described elastomer 2 inner chambers and supports this elastomer 2, and described front end 111 and end 131 are fixed in elastomer 2 two ends, so that elastomer 2 changes with core filament shape; In the corresponding position of described head 11, form the flexible introduction segment 110 of this medical guiding wire 100; In this corresponding position of afterbody 13, form another flexible introduction segment 130 of this medical guiding wire 100; And insulating coating 3, it is formed at the surface of described elastomer 2.
Please continue to refer to Fig. 3, Fig. 4, core silk adopts rustless steel, and selecting the trade mark is 304 stainless steel wires, and it is a kind of stainless steel material of versatility, and rustless property and high temperature resistant aspect are also relatively good.Head 11 and the afterbody 13 of core silk can be made into stepped.Illustrate in the situation that the diameter of core silk is 0.5, when the length of core silk is 1000mm, disclose further head 11 and the concrete parameter of afterbody 13 of this core silk, the ladder section of head 11 is divided into five sections, first paragraph 11a length 10mm, and diameter is 0.4mm; Second segment 11b length is 10mm, and diameter is 0.3mm; The 3rd section of 11c length is 10mm, and diameter is 0.2mm; The 4th segment length 11d is 20mm, diameter 0.12mm; The 5th section of 11e length is 30mm, and diameter is 0.08mm;
The prismatoid of afterbody 13 is divided into three sections, and first paragraph length is 20mm, and diameter is 0.3mm; The 3rd segment length is 20mm, and diameter is 0.2mm.
In the present embodiment, it is 304 stainless steel wires that elastomer 2 is selected the trade mark, and diameter is selected 0.15mm.Please continue to refer to Fig. 9, it is the above-mentioned manufacturing flow chart with the medical guiding wire of insulating coating, and it comprises as follows:
First, the making A of core silk: first, get the raw materials ready, straightening is processed, shear: adopting the satisfactory trade mark is 304 stainless steel wires, due to what to purchase the steel wire of returning be rolling, thereby need to carry out orthopedic, crooked steel wire orthopedic be rectilinear solid wire rod, according to the difference of seal wire, require to be cut into different length.
The second, adopt grinding machine to grind and make it form flexible head and afterbody as the importing end of seal wire through the steel wire after the PROCESS FOR TREATMENT such as straightening above-mentioned; Adopt surface grinding machine, head and/or afterbody are worn into stepped, it is emery wheel that grinding machine adopts emery wheel, and process of lapping adds liquid coolant.Stepped as the above-mentioned design parameter of enumerating, each ladder section gradation is ground piecemeal.
The 3rd, bend forming: use particular jig in one end strap grinding by above-mentioned through ground steel wire head, the outside and downward pulling force of exercising, forms the applicable soft head end of " J " type that imports human body
Secondly, elastomeric making B: the first, get the raw materials ready: selecting the satisfactory trade mark of satisfactory 304 employing is 304 stainless steel wires.
The second, spring processed: 304 metal steel wires are made into helical spring body through coiling machine stage clip technique;
Again, heart yearn and elastomer combination making step:
The first, threading: the heart yearn after processing through above-mentioned A heart yearn making step is penetrated to above-mentioned elastomer inner chamber;
The second, welding: adopt argon arc welding or laser weld or Plasma Welding or electron beam welding mode fixed-type at the front end of above-mentioned heart yearn and end and described elastomeric two ends, to form the coherent wire guides of integral body;
The 3rd, bed material coating: above-mentioned wire guides is immersed in PTFE coating bed material and carries out bed material coating;
The 4th, bed material baking: have PTFE coating bed material wire guides afterwards at the uniform velocity to toast in shift-in oven above-mentioned dip-coating, baking temperature constant temperature under the condition of 150-180 degree Celsius keeps 10-15 minute, then natural cooling.
The 5th, fabric coatings: above-mentioned wire guides after PTFE bed material coating baking is immersed in to fabric coatings in PTFE coating fabric;
The 6th, fabric baking: by above-mentioned medical guiding wire through PTFE coating fabric coatings after at the uniform velocity shift-in oven toast, baking temperature is constant temperature maintenance 20-30 minute, then natural cooling under the condition of 350-400 degree Celsius.
The 7th, clean, dry: the medical guiding wire after step 6 is processed, be placed in ultrasonic washing unit and carry out 1-2 cleaning, remove seal wire surface oils and fats and dirt; Put in oven and dry again, dry temperature is 60-90 degree Celsius, and drying time is 35-60 minute, so that the inside and outside volume drying of wire guides, must have the finished product of the medical guiding wire of insulating coating after oven dry
The second embodiment:
Refer to Fig. 6, Fig. 7, Fig. 8, Fig. 9, a kind of medical guiding wire with insulating coating that it provides for embodiment of the present invention, this medical guiding wire 200, identical with the first example of its structure substantially and its manufacture method, identical part is no longer repeated in this description; Difference is, it is provided with two heads 210 and 220; Be bending.
On the basis that can absolutely prove in the first enforcement, in a second embodiment, it is 316 or the metal steel wire of MP35N or Nitinol etc. that core silk 202 and elastomeric making material can be transformed to the trade mark.Core silk 202 and elastomeric length and diameter also can regulate as required; Below for explanation can be adjusted flexibly, further thin explanation in detail, the core silk that core silk adopts is made A, the grinding machine adopting in heart yearn making step two is centerless grinder, and heart yearn 202 diameters are worn into cone-shaped and cylinder assembly at 0.5mm head 212, head are worn into cone-shaped, being specially first paragraph 212a length is 40mm, footpath becomes from 0.5mm-0.2mm, and second segment length 212b is 30mm, and diameter is 0.2mm; By afterbody 222 wear into one cone-shaped, length is 40mm, footpath becomes from 0.5mm-0.2mm.
On the basis absolutely proving in the first enforcement, manufacture method in the second embodiment, can the root Ju different situation of those skilled in the art is in the scope of above-mentioned description, to technological parameter; As temperature, time, coating material, size, equipment etc., adapt to adjusting.At this, be no longer described in detail.
Be noted that especially, the present invention is not restricted to above-mentioned embodiment, in the manufacture method of other embodiments, the making A of core silk and elastomeric making B are separate making, priority regardless of time, can make also simultaneously and can separate making, by actual needs, is adjusted, certainly, to make be recombinant after heart yearn and elastomer complete respectively to the combination of heart yearn and elastomer.Can be understood as simply, if can adopt ready-made heart yearn and elastomer also can save the making A of coremaking silk and the technique of elastomeric making B, directly adopt C to make.
By the description of above-mentioned structure and manufacture method; person of ordinary skill in the field is to be understood that; the present invention is not limited to the above-mentioned specific embodiment; on basis of the present invention, adopt the improvement of techniques well known and substitute and all drop on protection scope of the present invention, should be limited by each claim.