CN104014067B - There is medical guiding wire and the manufacture method thereof of insulating coating - Google Patents
There is medical guiding wire and the manufacture method thereof of insulating coating Download PDFInfo
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Abstract
The invention discloses a kind of medical guiding wire and the manufacture method thereof with insulating coating, this medical guiding wire comprises core silk, be positioned at elastomeric inside with the surface insulation coating making elastomer be formed at described elastomer 2, the elastomer that this medical guiding wire with insulating coating has, and there is when importing human body excellent elasticity, not easily staggered knotting or fracture, reduce the infringement of operation process to human body; Can select flexibly in different operations, application is wide; The effective barrier metal seal wire of insulating coating directly contacts with tissue, and some toxic element effectively avoiding metal material itself to have are deposited in tissue.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, and manufacturing process is easily grasped and controlled, energy savings and not polluting.
Description
[technical field]
The present invention relates to a kind of medical instruments field, particularly relate to a kind of medical guiding wire and the manufacture method thereof with insulating coating.
[background technology]
Current medical guiding wire great majority are that single line structure is as Chinese patent (200620107266.7), 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 staggered knotting or sell off or fracture when going deep into human body, affect normal surgical and operate; Also have in existing seal wire and not there is insulating coating, conductive metallic material can not be adopted to import the person in some operations, so the scope used is restricted.Seal wire metal itself is with some trace element in addition, as nickel, has certain toxicity, can be deposited in tissue as directly contacted tissue, the health of the harm person.
In order to overcome above-mentioned problem, I have developed a kind of medical guiding wire and the 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 the manufacture method thereof with insulating coating, make it have the performance of electric insulation, and there is when importing human body excellent elasticity and lubricity, not easily staggered knotting or fracture, reduce the infringement of operation process to human body.
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 large gradually along rear extreme direction, makes this head larger relative to the middle part flexibility of core silk; Its afterbody is straight type/bending, and the end diameter of afterbody becomes large gradually along secondary extreme direction, makes this afterbody larger relative 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, changes with core filament shape to make elastomer; The flexible introduction segment of this medical guiding wire is formed in the corresponding position of described header/trailer; And,
Insulating coating, it is formed at described elastomeric surface.
Have in the medical guiding wire of insulating coating above-mentioned, described core silk adopts rustless steel or Nitinol to make, and its header/trailer is prismatoid or cone-shaped.
Have in the medical guiding wire of insulating coating above-mentioned, described elastomer adopts rustless steel or Nitinol to make.
Have in the medical guiding wire of insulating coating above-mentioned, 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 flexibility are greatly, 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 during smooth surface importing human body, resistance is little, imports more smooth and easy; The elasticity of elastomer own is large, is not easy occur knotting or bending or fracture, and effectively reduces operation process to the injury of human body.
Present invention also offers the manufacture method that this has the medical guiding wire of insulating coating, it comprises the following steps:
A, heart yearn making step:
Step one,
Get the raw materials ready, straightening process, shearing: select 304,316 or MP35N metal steel wire or Nitinol, with accurate straightener/aligning machine by orthopedic for bending material be rectilinear solid wire rod, the difference requirement according to seal wire is cut into different length.
Step 2,
Grinding: adopt grinding machine to make it form flexible head and the afterbody importing end as seal wire above-mentioned steel wire grinding after the PROCESS FOR TREATMENT such as straightening.
Step 3,
Bend forming: the head of heart yearn after above-mentioned steps one and step 2 process and/or afterbody are carried out " J " soft head molding, makes it be formed to be applicable to the soft head end of " J " type importing human body.
B, elastomer making step:
Step one,
Get the raw materials ready: select satisfactory 304,316 or the metal steel wire of MP35N or Nitinol line;
Step 2,
Spring processed: 304,316 or the metal steel wire of MP35N or Nitinol line are made into helical spring body through coiling machine stage clip technique;
C, heart yearn and elastomer combination making step:
Step one,
Threading: the heart yearn after the process of above-mentioned A heart yearn making step is penetrated above-mentioned elastomer inner chamber;
Step 2,
Welding: the front end of above-mentioned heart yearn and end and described elastomeric two ends are adopted argon arc welding or laser weld or Plasma Welding or electron beam welding mode fixed-type, to form the wire guides of overall coherence;
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; Its surface coverage is made to have PTFE coating or hydrophilic superslide degradable coating;
Step 4,
Bed material toasts: above-mentioned dip-coating had the wire guides after PTFE coating or hydrophilic superslide degradable coating bed material at the uniform velocity to toast in shift-in oven, and 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 through PTFE coating or hydrophilic superslide degradable coating and after baking is immersed in PTFE coating or hydrophilic superslide degradable coating carries out fabric coatings;
Step 6,
Fabric toasts: by above-mentioned wire guides after the fabric coatings of PTFE coating or hydrophilic superslide degradable coating at the uniform velocity shift-in oven toast, baking temperature constant temperature under the condition of 350-400 degree Celsius keeps 20-30 minute, then natural cooling;
Step 7,
Cleaning, oven dry: by the wire guides after step 6 process, be placed in ultrasonic washing unit and carry out 1-2 cleaning, removes seal wire surface oils and fats and dirt; Put into again in oven and dry, to make volume drying inside and outside wire guides, the finished product of the medical guiding wire of insulating coating after oven dry, must be had.
Have in the manufacture method of the medical guiding wire of insulating coating above-mentioned, described heart yearn making step and elastomer making step separate, can carry out making or separately making simultaneously.
Have in the manufacture method of the medical guiding wire of insulating coating above-mentioned, the baking temperature of described step 7 is 50 degree to 90 degree Celsius, and drying time is 30 to 60 minutes.
Have in the manufacture method of the medical guiding wire of insulating coating above-mentioned, 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 grinding machine adopts emery wheel to be 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; 3rd segment length is 10mm, and diameter is 0.2mm; 4th segment length is 20mm, diameter 0.12mm; 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; 3rd segment length is 20mm, and diameter is 0.2mm; The gradation of above-mentioned each ladder section is ground piecemeal.
Have in the manufacture method of the medical guiding wire of insulating coating above-mentioned, grinding in described heart yearn making step two, the grinding machine adopted is centerless grinder, head and/or afterbody are worn into cone-shaped or cone and cylindrical combination, grinding machine adopts emery wheel to be emery wheel, and process of lapping adds liquid coolant.
The present invention compares produced beneficial effect with background technology:
Present invention employs above-mentioned technical scheme, advantage is:
1. the steps supple-settlement technique of gradual change is carried out at these its heart yearn two ends of medical guiding wire with absolutely coating, by firmly to soft, from coarse to fine, transitions smooth is submissive, the importing end of this medical guiding wire reduced when clinical puncture or avoids seal wire to interlock knotting or the risk that fractures, thus reduce or avoid in the injury of operation process to patient.
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 a product two kinds of functions, 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, and some toxic element effectively avoiding metal material itself to have are deposited 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 produce the utilization rate of raw materials that uses high, 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 being wrapped in the close body spring body of spiral and is formed one deck insulation superslide thin film, described thin film is coherent integrally, make between helical spring seamless, effectively avoid clinically or reduce blood samples of patients penetrates into seal wire inner space by the gap between spiral elastic ring, thus reduce the blood residuals amount of patient on seal wire, reduce patient risk.
6. medical insulating coating seal wire of the present invention carries out absolutely paint coatings again after first making helical spring body, guarantee that the paint film layer be sticky deposited on helical spring body is perfect, without the possibility of any mechanical processing trauma, coating uniform is unified, and thickness of coating layer is controlled by the number of times of coating, 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 is the of the present invention first structural representation executing the head of SMIS silk;
Fig. 4 is the of the present invention first structural representation executing 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 is the of the present invention second structural representation executing the head of SMIS silk;
Fig. 8 is the of the present invention second structural representation executing the afterbody of SMIS silk;
Fig. 9 is the process chart that invention has the manufacture method of the medical guiding wire of insulating coating.
[detailed description of the invention]
In the description, the length with the medical guiding wire of insulating coating does not do special restriction, can suitably regulate according to actual needs.
In the description, all directions illustrate, as forward and backward, head, tail, etc.; Only in order to more convenient carrying out describes and help reader understanding the present invention, instead of restriction the present invention, the restriction particularly can not applied the present invention position, orientation, because if describe conversely, position, orientation also will be contrary.
In the description, the diameter of core silk can not do special restriction, but conventional scope adopts diameter to be between 0.2mm to 1.2mm.
In the description, PTFE coating is Teflon coating, i.e. teflon coating, and its thickness does not do special restriction, and actual needs carries out increasing/reduce the number of plies of coating and thickness to realize suitable adjustment.PTFE coating and hydrophilic superslide degradable coating, all can be identical at the above-mentioned process conditions/parameter/device therefor had in the medical guiding wire of insulating coating of manufacture.
In the 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 also presents the performance of outstanding sulfuration resistant, high-temperature oxydation and hydrogen embrittlement.
In the 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 the description or elastomer, select 304 or 316 or MP35N metal steel wire or Nitinol, all can be identical at the above-mentioned process conditions/parameter/device therefor had in the medical guiding wire of insulating coating of manufacture.
Below in conjunction with accompanying drawing, by being further described the specific embodiment of the present invention, make technical scheme of the present invention and beneficial effect thereof clearly, clearly.
First embodiment:
Refer to shown in Fig. 1, Fig. 2, Fig. 5, its a kind of medical guiding wire with insulating coating provided for embodiment of the present invention, this medical guiding wire 100 comprises: a core silk, and it adopts metal material to make flexible linear body; Its head 11 is in bending, and front end 111 diameter of head 11 becomes large gradually along direction, rear end 112, makes this head 11 larger relative to middle part 12 flexibility of core silk; Its afterbody 13 is in straight type, and end 131 diameter of afterbody 13 becomes large gradually along secondary end 112 direction, makes this afterbody 13 larger relative to middle part 12 flexibility of core silk; Integral flexible body 2, it adopts metal material to make coil spring shape, and described core silk is placed in described elastomer 2 inner chamber and supports this elastomer 2, and described front end 111 and end 131 are fixed in elastomer 2 two ends, changes with core filament shape to make elastomer 2; The flexible introduction segment 110 of this medical guiding wire 100 is formed in the corresponding position of described head 11; Another flexible introduction segment 130 of this medical guiding wire 100 is formed in the corresponding position of this afterbody 13; 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 adopt rustless steel, select the trade mark to be 304 stainless steel wires, it is a kind of stainless steel material of versatility, rustless property and high temperature resistant aspect also relatively good.Head 11 and the afterbody 13 of core silk can be made into stepped.When the diameter illustrating core silk is 0.5, when the length of core silk is 1000mm, disclose the head 11 of this core silk and the concrete parameter of afterbody 13 further, 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; 3rd section of 11c length is 10mm, and diameter is 0.2mm; 4th segment length 11d is 20mm, diameter 0.12mm; 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; 3rd segment length is 20mm, and diameter is 0.2mm.
In the present embodiment, elastomer 2 selects the trade mark to be 304 stainless steel wires, and diameter selects 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, making A: the first of core silk, get the raw materials ready, straightening process, shearing: adopt the satisfactory trade mark to be 304 stainless steel wires, be rolling owing to purchasing the steel wire of returning, thus need to carry out orthopedic, namely orthopedic for bending steel wire be rectilinear solid wire rod, the difference requirement according to seal wire is cut into different length.
The second, adopt grinding machine to make it form flexible head and the afterbody importing end as seal wire above-mentioned steel wire grinding after the PROCESS FOR TREATMENT such as straightening; Adopt surface grinding machine, head and/or afterbody are worn into stepped, grinding machine adopts emery wheel to be emery wheel, and process of lapping adds liquid coolant.Stepped as the above-mentioned design parameter enumerated, the gradation of each ladder section is ground piecemeal.
3rd, bend forming: by above-mentioned through ground steel wire head particular jig in one end strap of grinding, outwards and exercise pulling force downwards, form the soft head end of " J " type being applicable to importing human body
Secondly, elastomeric making B: the first, gets the raw materials ready: select satisfactory 304 to adopt the satisfactory trade mark to be 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 the process of above-mentioned A heart yearn making step is penetrated above-mentioned elastomer inner chamber;
The second, welding: the front end of above-mentioned heart yearn and end and described elastomeric two ends are adopted argon arc welding or laser weld or Plasma Welding or electron beam welding mode fixed-type, to form the wire guides of overall coherence;
3rd, bed material coating: above-mentioned wire guides is immersed in PTFE coating bed material and carries out bed material coating;
4th, bed material toasts: above-mentioned dip-coating had the wire guides after PTFE coating bed material at the uniform velocity to toast in shift-in oven, and baking temperature constant temperature under the condition of 150-180 degree Celsius keeps 10-15 minute, then natural cooling.
5th, fabric coatings: above-mentioned wire guides after PTFE bed material coating also baking is immersed in fabric coatings in PTFE coating fabric;
6th, fabric toast: by above-mentioned medical guiding wire after PTFE coating fabric coatings at the uniform velocity shift-in oven toast, baking temperature under the condition of 350-400 degree Celsius constant temperature keep 20-30 minute, then natural cooling.
7th, cleaning, oven dry: by the medical guiding wire after step 6 process, be placed in ultrasonic washing unit and carry out 1-2 cleaning, remove seal wire surface oils and fats and dirt; Put in oven again and dry, dry temperature is 60-90 degree Celsius, and drying time is 35-60 minute, to make volume drying inside and outside wire guides, must have the finished product of the medical guiding wire of insulating coating after oven dry
Second embodiment:
Refer to Fig. 6, Fig. 7, Fig. 8, Fig. 9, its a kind of medical guiding wire with insulating coating provided for embodiment of the present invention, this medical guiding wire 200, identical with the first example of its structure substantially and its manufacture method, the no longer repeated description of identical part; Difference is, it is provided with two heads 210 and 220; Be bending.
Implement on the basis that can absolutely prove first, in a second embodiment, core silk 202 and elastomeric making material can be transformed to the metal steel wire or Nitinol etc. that the trade mark is 316 or MP35N.Core silk 202 and elastomeric length and diameter also can regulate as required; Below for explanation can adjust flexibly, thin explanation in detail further, the core silk that core silk adopts makes A, the grinding machine adopted in heart yearn making step two is centerless grinder, and heart yearn 202 diameter wears into cone-shaped and cylinder assembly at 0.5mm head 212, head is 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; Afterbody 222 is worn into one cone-shaped, length is 40mm, footpath become from 0.5mm-0.2mm.
Implement on the basis that absolutely proves first, manufacture method in the second embodiment, those skilled in the art can the different situation of root Ju in the scope of above-mentioned description, to technological parameter; As temperature, time, coating material, size, equipment etc., carry out adaptation and regulate.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, making A and the elastomeric making B of core silk are separate making, priority regardless of time, can make simultaneously also can separate making, be adjusted by actual needs, certainly, heart yearn and elastomer combination making are recombinants after heart yearn and elastomer complete respectively.Ready-made heart yearn and elastomer can be understood as simply, if can be adopted also can to save the making A of coremaking silk and the technique of elastomeric making B and 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 above-mentioned detailed description of the invention; basis of the present invention adopts the improvement of techniques well known and substitutes and all drop on protection scope of the present invention, should be limited by each claim.
Claims (6)
1. there is a manufacture method for the medical guiding wire of insulating coating, it is characterized in that, comprise the following steps:
A, heart yearn making step:
Step one,
Get the raw materials ready, straightening process, shearing: select 304,316 or MP35N metal steel wire or Nitinol line, with accurate straightener/aligning machine by orthopedic for bending material be rectilinear solid wire rod, the difference requirement according to seal wire is cut into different length;
Step 2,
Grinding: adopt grinding machine using above-mentioned through straightening process, shear metal steel wire after PROCESS FOR TREATMENT or the grinding of Nitinol line and make it form flexible head and the afterbody importing end as seal wire;
Step 3,
Bend forming: the head of heart yearn after above-mentioned steps one and step 2 process and/or afterbody are carried out " J " soft head molding, makes it be formed to be applicable to the soft head end of " J " type importing human body;
B, elastomer making step:
Step one,
Get the raw materials ready: select satisfactory 304,316 or the metal steel wire of MP35N or Nitinol line;
Step 2,
Spring processed: 304,316 or the metal steel wire of MP35N or Nitinol line are made into helical spring body through coiling machine stage clip technique;
C, heart yearn and elastomer combination making step:
Step one,
Threading: the heart yearn after the process of above-mentioned A heart yearn making step is penetrated above-mentioned elastomer inner chamber;
Step 2,
Welding: the front end of above-mentioned heart yearn and end and described elastomeric two ends are adopted argon arc welding or laser weld or Plasma Welding or electron beam welding mode fixed-type, to form the wire guides of overall coherence;
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; Its surface coverage is made to have PTFE coating or hydrophilic superslide degradable coating;
Step 4,
Bed material toasts: above-mentioned dip-coating had the wire guides after PTFE coating or hydrophilic superslide degradable coating bed material at the uniform velocity to toast in shift-in oven, and 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 through PTFE coating or hydrophilic superslide degradable coating and after baking is immersed in PTFE coating or hydrophilic superslide degradable coating carries out fabric coatings;
Step 6,
Fabric toasts: by above-mentioned wire guides after the fabric coatings of PTFE coating or hydrophilic superslide degradable coating at the uniform velocity shift-in oven toast, baking temperature constant temperature under the condition of 350-400 degree Celsius keeps 20-30 minute, then natural cooling;
Step 7,
Cleaning, oven dry: by the wire guides after step 6 process, be placed in ultrasonic washing unit and carry out 1-2 cleaning, removes seal wire surface oils and fats and dirt; Put into again in oven and dry, to make volume drying inside and outside wire guides, the finished product of the medical guiding wire of insulating coating after oven dry, must be had.
2. the manufacture method with the medical guiding wire of insulating coating according to claim 1, it is levied spy and is: described heart yearn making step and elastomer making step separate, can carry out making or separately making simultaneously.
3. the manufacture method with the medical guiding wire of insulating coating according to claim 1, it is levied spy and is: the bake out temperature of described step 5 is 50 degree to 90 degree Celsius, and drying time is 30 to 60 minutes.
4. the manufacture method with the medical guiding wire of insulating coating according to claim 1, it is levied spy and is: the grinding in described heart yearn making step two, and the grinding machine of employing is surface grinding machine, and head and/or afterbody are worn into stepped, grinding machine adopts emery wheel to be emery wheel, and process of lapping adds liquid coolant.
5. the manufacture method with the medical guiding wire of insulating coating according to claim 1, it is levied spy and is: the grinding in described heart yearn making step two, and the grinding machine of employing is centerless grinder, and head and/or afterbody are worn into cone-shaped, grinding machine adopts emery wheel to be emery wheel, and process of lapping adds liquid coolant.
6. the manufacture method with the medical guiding wire of insulating coating according to claim 4, is characterized in that: described core line diameter is 0.5mm; The ladder section of its head is divided into five sections, first paragraph length 10mm, and diameter is 0.4mm; Second segment length is 10mm, and diameter is 0.3mm; 3rd segment length is 10mm, and diameter is 0.2mm; 4th segment length is 20mm, diameter 0.12mm; 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; 3rd segment length is 20mm, and diameter is 0.2mm; The gradation of above-mentioned each ladder section is ground piecemeal.
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| CN104014067A (en) | 2014-09-03 |
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