CN1927419A - Medical guiding wire and method for manufacturing same - Google Patents

Abstract

The invention relates to a medical guide wire. Wherein, it is a line made from metal materila, whose front end is smaller than back end, outer surface is smooth, and two ends are in semi ball shapes. The inventive production comprises that a, selecting materials and stiffing; b, memory treatment; c, surface electrolytic furnish; d, grinding and treating end; e, washing and drying. The inventive product has less transmission resistance and less hurt on the patient.

Description

Medical guiding wire and preparation method thereof

Technical field

The present invention relates to a kind of medical guiding wire and preparation method thereof; Belong to technical field of medical instruments.

Background technology

Obstruction of naso lacrimal duct is an ophthalmology common disease, not only blocks the tear that overflows, and easily develops into anxious, slow dacryocystisis.It can be divided into congenital and posteriority two big classes; Anel had introduced probing of lacrimal passages flush operation treatment obstruction of naso lacrimal duct first in 1713, and Bowman in 1851 has initiated again and increased thick serial probe gradually, is used to expand lacrimal point, lacrimal ductule and stenosis of naso lacrimal duct.It is simple that logical flushing is visited in the road, but the lasting curative effect of early stage this method treatment is relatively poor, and cause easily that mucosa injury, lacrimal point split, the lacrimal ductule damage and via.The treatment obstruction of naso lacrimal duct more and more adopts operation and Drug therapy, and operative treatment is complicated operation not only, and the patient suffering is many, and the postoperative face leaves cut channel, the influence beauty treatment; The Drug therapy untoward reaction is more, and effect is relatively poor.The someone applied for Chinese patent (02214902.3) " nasolacrimal duct dredge " afterwards, it is made up of tube core, body and handle, tube core moves back and forth in body, and tube core head projection is circular arc, the edge is the ring sword, body is a hollow pipe, and mouth of pipe end has round clasp for the ring sword near head, with tube core head ring sword ring cutting, there is shell fragment can make things convenient for opening and closing in the handle.Though have said structure as can be seen this nasolacrimal duct dredge can excise the obstruction of naso lacrimal duct thing, it is longer by the inevitable time that be detained in nasolacrimal duct of excision obstruction of naso lacrimal duct thing, can produce bigger damage to the tissue of intranasal pipe like this.

Summary of the invention

Purpose of the present invention is exactly to propose a kind of medical guiding wire and preparation method thereof in order to overcome above-mentioned technical problem, use this product can reduce when carrying resistance and to injury of human.

Above-mentioned purpose of the present invention is achieved by the following technical programs: a kind of medical guiding wire, body is a thread like body that metal material is made, its two ends are respectivelyfront end 2 and rear end, it is characterized in that,front end 2 diameters of this seal wire are less than its rear end diameter, the outer surface of seal wire is smooth transition, and sealwire front end 2 is hemispherical.

In above-mentioned medical guiding wire, the diameter of describedfront end 2 is 0.08mm～0.20mm, and the diameter of rear end is 0.30mm～0.35mm.

In above-mentioned medical guiding wire, the guidewire sections that describedfront end 2 length are 1 5～25mm is equal diameter, later on along the overstriking formation taper gradually of back extreme direction.

In above-mentioned medical guiding wire, described rear end is hemispherical.

Because sharp-pointed termination can produce damaging action to the tissue of nasolacrimal duct, so the present invention makes hemispherical with the termination of the rear and front end of nasolacrimal duct seal wire, reduced the damage to the nasolacrimal duct tissue like this; In addition seal wire of the present invention is made pyramidal structure, resistance is less when carrying like this, carries comparatively smooth and easy; The rear end diameter of seal wire of the present invention is slightly less than the diameter of nasolacrimal duct, the too for a short time purpose that does not have mediation of diameter; Diameter causes the cracking of nasolacrimal duct too greatly easily.

The present invention also provides the manufacture method of this medical guiding wire, and this method comprises following step down:

A, selection, tetanic processing: select satisfactory wire guide for use, and it is carried out tetanic processing;

B, memory are handled: the seal wire blank after the tetanic processing of above-mentioned process is remembered processing, and being about to the seal wire blank, to be placed on temperature be that constant temperature kept 5～10 minutes under 485～510 ℃ the condition, naturally cools to room temperature then; Surface color is for differentiating when determining that temperature and heat time heating time come out of the stove according to seal wire, and qualified medical guiding wire is the blue effect of the method for deep sky blue; When color jaundice color be temperature cross low or constant temperature time too short; When color is navy blue or black-and-bluely will shows that temperature is set too high or warm-up time is long;

C, surperficial electrobrightening: the above-mentioned seal wire blank of handling through memory is carried out surperficial electrobrightening;

Handle d, plunge grinding, termination: become to increase thick cone-shaped metal thread like body gradually with grinding machine through the shape of the seal wire blank after the surface finish according to seal wire with above-mentioned, and be ground to the termination of rear and front end hemispherical;

E, cleaning, oven dry: seal wire blank that will be above-mentioned immerses in the carbon tetrachloride and soaked 3～10 minutes, after the reuse dehydrated alcohol wiping 1～3 time, use pure water rinsing 1～3 time at last after, promptly get the medical guiding wire finished product after the oven dry.

In the manufacture method of above-mentioned medical guiding wire, be grouped into by the one-tenth of following percetage by weight basically at the wire guide described in the step a:

Nickel: 45%～55%, oxygen: 0～0.30% (not comprising 0);

Carbon: 0～0.30% (not comprising 0), all the other are titanium.

As preferably, the composition of the preferred weight percent of described shape is

Nickel: 50.7%, oxygen: 0～0.10% (not comprising 0);

Carbon: 0～0.10% (not comprising 0), all the other are titanium.

Used in the present invention wire guide is the NiTi alloy, wherein contains 50% Ni, but in human body being had the toxic metal of latent property, the toxicity of nickel is only second to silver, if nickel is implanted separately in the master object, the nickel element of stripping will produce very maxicell toxicity.After nickel entered body, major sedimentary was in skin, central nervous system, kidney and liver.These factors will cause those skilled in the art that it is used in misgivings in the medical apparatus and instruments, but this element is better as the Memorability metal effect, therefore the inventor is by producing Memorability with itself and titanium as the preparation medical guiding wire, and shape of the present invention is handled by memory, the surface chemistry polishing, plunge grinding, handle the termination, second polishing, clean, the oven dry back forms equally distributed oxide-film on the medical guiding wire surface, the seal wire smooth surface does not have the defective that scratches impression, this oxide-film is at the surperficial even compact of seal wire, thereby improved the corrosion resistance of seal wire and under physiological environment, kept relative inertness, prevented disengaging of nickel element; And the seal wire of making by above-mentioned manufacture method produces Memorability, and characterizing this Memorability form is that super-elasticity promptly keeps guidewire shaft to rectilinearity.This seal wire can be surveyed by X ray such as Digital Subtraction machines when the mediation nasolacrimal duct; The stressed bending of this seal wire or when coiling into diameter 100mm, the medical guiding wire that knee is removed back made of the present invention in the external force shape that resiles immediately.

In the manufacture method of above-mentioned medical guiding wire, detailed process in the tetanic processing described in the step a is: wire guide is made parcel, then with damping draught line on it, is to make seal wire be in spasticity under 300～400 ℃ in temperature, constant temperature kept 3～10 minutes, naturally cooled to room temperature.

In the manufacture method of above-mentioned medical guiding wire, in the detailed process of the surperficial electrobrightening described in the step c be: dop is done at seal wire blank two ends, it is immersed in electrolyte as anode, diamond locating piece and stone grinder wheel are as negative electrode; Under the effect of the pulse power, it was carried out surperficial electrobrightening 1～5 minute, wherein electrolyte be mass fraction 10%～20% contain Na saline solution or KOH solution; Used power pulse dc source in the electrobrightening, voltage is 0～100V, and pulse width is 10～50 μ s, and waveform is a square wave.Since memorial alloy after memory is handled again through general machining because heat production or additional stress reduce memory performance, and adopt surperficial electrobrightening, and electrolyte is taken away fully and is produced heat and make seal wire maintenance superperformance because additional stress is very little.

In the manufacture method of above-mentioned medical guiding wire, be centerless grinder at the grinding machine described in the steps d, the emery wheel of grinding machine is a diamond, adds cooling medium when grinding; Described cooling medium is the NaCl deionized water solution of mass fraction 1～2%.

In the manufacture method of above-mentioned medical guiding wire, after steps d, also comprise the seal wire blank sent into and carry out second polishing in the grinding tool; Described grinding tool is hard cloth wheel.

In the manufacture method of above-mentioned medical guiding wire, bake out temperature is 40～80 ℃ in step e, and drying time is 1 5～60 minutes.

Therefore the present invention has the following advantages:

1, medical guiding wire of the present invention can not produce damaging action to tissue, and transporting resistance is little in mediation nasolacrimal duct obstruction process, to patient cause painful less.

2, the medical guiding wire of making by manufacture method of the present invention has been eliminated the toxic action of poisonous metal nickel to human body, meets the physiological condition of body.

3, the medical guiding wire of making by manufacture method of the present invention has good Memorability under the temperature conditions of human body, can dredge along with the distribution of nasolacrimal duct, can not cause nasolacrimal duct via and cracking phenomena.

Description of drawings:

Fig. 1 is the structural representation after medical guiding wire of the present invention is coiled;

Fig. 2 is the structural representation that medical guiding wire expansion of the present invention is stretched;

Fig. 3 is a medical guiding wire front end of the present invention termination enlarged diagram;

Fig. 4 is termination, a medical guiding wire of the present invention rear end enlarged diagram;

Fig. 5 is the process chart of manufacture method of the present invention.

Among the figure, 1, body; 2, front end; 21, front end termination; 3, rear end; 31, termination, rear end.

The specific embodiment:

Below make specific embodiments of the invention, and in conjunction with the accompanying drawings technical scheme of the present invention is further described, but the present invention is not limited to these embodiment.

Embodiment 1

As depicted in figs. 1 and 2, medical guiding wire, length is 80cm, is to increase thick wire-like body gradually; As shown in Figure 3 and Figure 4,front end termination 21 and termination,rear end 31 are hemispherical, the 25mm offront end 2 is that diameter is the cylinder of 0.20mm, after the 25mm to 80cm offront end 2 seal wire body 1 gradually overstriking form cone-shaped, wherein the diameter of termination,rear end 31 is 0.35mm.

The manufacture method of above-mentioned medical guiding wire: select satisfactory wire guide for use, the composition of described wire guide is as shown in table 1, wire guide is carried out tetanic processing to be about to wire guide and to make parcel, then with damping draught line on it, be to make seal wire be in spasticity under 300 ℃ the condition in temperature, constant temperature keeps naturally cooling to room temperature after 10 minutes; Seal wire blank after the tetanic processing of above-mentioned process remembered handle to be about to the seal wire blank to be placed on temperature be that constant temperature kept 10 minutes under 485 ℃ the condition, naturally cool to room temperature then; Dop is done at seal wire blank two ends, it is immersed in electrolyte as anode, diamond locating piece and stone grinder wheel carry out surperficial electrobrightening 5 minute to it as negative electrode under the effect of the pulse power; Wherein electrolyte is the NaCl solution of mass percent 10%, and used power supply is a pulse dc power in the electrobrightening, and voltage is 0～100V, and pulse width is 30 μ s, and waveform is a square wave; Seal wire blank behind the surperficial electrobrightening of above-mentioned process is ground to centerless grinder according to the shape of seal wire increases thick cone-shaped metal thread like body gradually, wherein the 25mm offront end 2 is that diameter is the cylinder of 0.20mm, after the 25mm to 80cm offront end 2 seal wire gradually overstriking form bullet, wherein the diameter of termination,rear end 31 is 0.35mm; And be ground to into the termination of rear and front end hemispherical; Wherein the emery wheel of grinding machine is a diamond, adds mass percent during grinding and is 1～2% NaCl deionized water solution and cool off as cooling medium; Above-mentioned it being sent into through the seal wire blank after plunge grinding, the termination processing carried out second polishing in the grinding tool, wherein said grinding tool is a pair of homodromal hard cloth wheel that contacts, and the soap lye water of employing 10% in the second polishing process cools off; Seal wire blank after will be above-mentioned handling through second polishing immerses in the carbon tetrachloride and soaked 10 minutes, after the reuse dehydrated alcohol wiping 1～3 time, use pure water rinsing 1～3 time at last after, under 40 ℃ condition, dry and promptly get the medical guiding wire finished product after 60 minutes.The manufacture method process chart of this seal wire as shown in Figure 5.

Embodiment 2

As depicted in figs. 1 and 2, medical guiding wire, length is 70cm, is to increase thick wire-like body gradually; As shown in Figure 3 and Figure 4,front end termination 21 and termination,rear end 31 are hemispherical, the 20mm offront end 2 is that diameter is the cylinder of 0.15mm, after the 20mm to 70cm offront end 2 seal wire body 1 gradually overstriking form bullet, wherein the diameter of termination,rear end 31 is 0.32mm.

The manufacture method of above-mentioned medical guiding wire: select satisfactory wire guide for use, the composition of described wire guide is as shown in table 1, wire guide is carried out tetanic processing to be about to wire guide and to make parcel, then with damping draught line on it, be to make seal wire be in spasticity under 350 ℃ the condition in temperature, constant temperature keeps naturally cooling to room temperature after 5 minutes; Seal wire blank after the tetanic processing of above-mentioned process remembered handle to be about to the seal wire blank to be placed on temperature be that constant temperature kept 8 minutes under 500 ℃ the condition, naturally cool to room temperature then; Dop is done at seal wire blank two ends, it is immersed in electrolyte as anode, diamond locating piece and stone grinder wheel carry out surperficial electrobrightening 3 minute to it as negative electrode under the effect of the pulse power; Wherein electrolyte is the NaCl solution of mass percent 15%, and used power supply is a pulse dc power in the electrobrightening, and voltage is 0～100V, and pulse width is 50 μ s, and waveform is a square wave; Seal wire blank behind the surperficial electrobrightening of above-mentioned process is ground to centerless grinder according to the shape of seal wire increases thick cone-shaped metal thread like body gradually, wherein the 20mm offront end 2 is that diameter is the cylinder of 0.15mm, after the 20mm to 70cm offront end 2 seal wire gradually overstrikingform bullet 3 wherein the diameter of termination,rear end 31 be 0.32mm, and be ground to into the termination of rear and front end hemispherical; Wherein the emery wheel of grinding machine is a diamond, adds mass percent during grinding and is 1～2% NaCl deionized water solution and cool off as cooling medium; Above-mentioned it being sent into through the seal wire blank after plunge grinding, the termination processing carried out second polishing in the grinding tool; Wherein said grinding tool is a pair of homodromal hard cloth wheel that contacts; The soap lye water of employing 10% cools off in the second polishing process; Seal wire blank after will be above-mentioned handling through second polishing immerses to soak in the carbon tetrachloride and kept 6 minutes, after the reuse dehydrated alcohol wiping 1～3 time, use pure water rinsing 1～3 time at last after, under 60 ℃ condition, dry and promptly get the medical guiding wire finished product after 30 minutes.The manufacture method process chart of this seal wire as shown in Figure 5.

Embodiment 3

As depicted in figs. 1 and 2, medical guiding wire, length is 60cm, is to increase thick wire-like body gradually; As shown in Figure 3 and Figure 4,front end termination 21 and termination,rear end 31 are hemispherical, the 15mm offront end 2 is that diameter is the cylinder of 0.12mm, after the 15mm to 60cm offront end 2 seal wire body 1 gradually overstriking form bullet, wherein the diameter of termination,rear end 31 is 0.30mm.

The manufacture method of above-mentioned medical guiding wire: select satisfactory wire guide for use, the composition of described wire guide is as shown in table 1, wire guide is carried out tetanic processing to be about to wire guide and to make parcel, then with damping draught line on it, being 400 ℃ in temperature makes seal wire be in spasticity,constant temperature 3 minutes naturally cools to room temperature; Seal wire blank after the tetanic processing of above-mentioned process remembered handle to be about to the seal wire blank to be placed on temperature be constant temperature 5 minutes under 510 ℃ the condition, naturally cool to room temperature then; Dop is done at seal wire blank two ends, it is immersed in electrolyte as anode, diamond locating piece and stone grinder wheel are as negative electrode; Under the effect of the pulse power it was carried out surperficial electrobrightening 1 minute, wherein electrolyte is the KOH solution of mass fraction 20%; Used power supply is a pulse dc power in the electrobrightening, and voltage is 0～100V, and pulse width is 10 μ s, and waveform is a square wave; Seal wire blank behind the surperficial electrobrightening of above-mentioned process is ground to centerless grinder according to the shape of seal wire increases thick cone-shaped metal thread like body gradually, wherein the 15mm offront end 2 is that diameter is the cylinder of 0.12mm, after the 15mm to 60cm offront end 2 seal wire gradually overstriking form bullet wherein the diameter of termination,rear end 31 be 0.30mm; And be ground to into the termination of rear and front end hemispherical; Wherein the emery wheel of grinding machine is a diamond, and the adding mass fraction is that 1～2% NaCl deionized water solution is the cooling medium cooling during grinding; Above-mentioned it being sent into through the seal wire blank after plunge grinding, the termination processing carried out second polishing in the grinding tool; Wherein said grinding tool is a pair of contacting with the hard cloth wheel that turns to rotation; The soap lye water of employing 10% cools off in polishing process; Seal wire blank after will be above-mentioned handling through second polishing immerses in the carbon tetrachloride and soaked 3 minutes, after the reuse dehydrated alcohol wiping 1～3 time; After using pure water rinsing 1～3 time at last, under 80 ℃ condition, dry and promptly get the medical guiding wire finished product after 15 minutes.The manufacture method process chart of this seal wire as shown in Figure 5.

Table 1: the composition of the shape of the embodiment of the invention 1～3

Medical guiding wire to the foregoing description 1～3 preparation carries out the Memorability detection

1 visual inspection: should keep original shape at said temperature scope inner guide wire, promptly total length does not have obvious bending, and has elasticity.Can return to original shape after its distortion, method becomes internal diameter 100mm plate-like with draw-off godet, and keeps its this shape 8 hours, after seal wire is released, and the seal wire shape that can resile immediately, its total length does not have obvious bending.

2 super-elasticity monitoring: in constant temperature 30-35 ℃ environment, operate, parked earlier 15 minutes, seal wire is fixed on the monitoring table top,front end 2 is exposed, form cantilever beam,front end 2 is demarcated distance hang miniweights, seal wire will produce the winding degree distortion this moment, and silk should return initial point after counterweight is withdrawn.

The memory of 3 high low temperature detects: will examine product fully and be put in below 0 ℃ in the environment, seal wire will follow the string, and can't keep its original rectilinearity, simultaneously flexible one-tenth arbitrary shape and can't independently keeping; The product of should examining are put back in the 30-35 ℃ of environment, and seal wire will recover elasticity gradually, the shape that will resile simultaneously (keeping the total length rectilinearity).

Biocompatibility to medical guiding wire of the present invention detects: the method people's of employing epithelial tissue cell carries out co-cultivation with the used shape of making seal wire of the present invention, pure titanium, pure nickel and rustless steel, the result shows: the used shape smooth surface of seal wire of the present invention does not have corrosion, can be accepted by epithelial cell well.

In sum: medical guiding wire of the present invention can not produce damaging action to tissue, and transporting resistance is little in mediation nasolacrimal duct obstruction process, to patient cause painful less; The medical guiding wire that manufacture method of the present invention is made has been eliminated the toxic action of poisonous metal nickel to human body, meets the physiological condition of body; The medical guiding wire that manufacture method of the present invention is made has good Memorability under the temperature conditions of human body, can dredge along with the distribution of nasolacrimal duct, can not cause nasolacrimal duct via and cracking phenomena.

Specific embodiment described in the present invention only is that the present invention's spirit is illustrated.The technical staff of the technical field of the invention can make various modifications or replenishes or adopt similar mode to substitute described specific embodiment, but can't depart from spirit of the present invention or surmount the defined scope of appended claims.

Although the present invention has been made detailed explanation and has quoted some instantiations as proof, to those skilled in the art, only otherwise leave that the spirit and scope of the present invention can be done various variations or correction is obvious.

Claims (10)

1, a kind of medical guiding wire, body (1) is a thread like body that metal material is made, its two ends are respectively front end (2) and rear end (3), it is characterized in that, the front end of this seal wire (2) diameter is less than its rear end (3) diameter, the outer surface of seal wire is smooth transition, and seal wire front end termination (21) is hemispherical.

2, medical guiding wire according to claim 1 is characterized in that, the diameter of described front end (2) is 0.08mm～0.20mm, and the diameter of rear end (3) is 0.30mm～0.35mm.

3, medical guiding wire according to claim 1 and 2 is characterized in that, described front end (2) length is that the guidewire sections of 15～25mm is equal diameter, (3) direction overstriking formation taper gradually along the rear end later on.

4, a kind of manufacture method of medical guiding wire, this method comprise following step down:

A, selection, tetanic processing: select satisfactory wire guide for use, and it is carried out tetanic processing;

B, memory are handled: the seal wire blank after the tetanic processing of above-mentioned process is remembered processing, and being about to the seal wire blank, to be placed on temperature be that constant temperature kept 5～10 minutes under 485～510 ℃ the condition, naturally cools to room temperature then; Surface color is for differentiating when determining that temperature and heat time heating time come out of the stove according to seal wire, and qualified medical guiding wire is the blue effect of the method for deep sky blue; When color jaundice color be temperature cross low or constant temperature time too short; When color is navy blue or black-and-bluely will shows that temperature is set too high or warm-up time is long;

C, surperficial electrobrightening: the above-mentioned seal wire blank of handling through memory is carried out surperficial electrobrightening;

Handle d, plunge grinding, termination: become to increase thick cone-shaped metal thread like body gradually with grinding machine through the shape of the seal wire blank after the surface finish according to seal wire with above-mentioned, and be ground to the termination of rear and front end hemispherical;

E, cleaning, oven dry: seal wire blank that will be above-mentioned immerses in the carbon tetrachloride and soaked 3～10 minutes, after the reuse dehydrated alcohol wiping 1～3 time, use pure water rinsing 1～3 time at last after, promptly get the medical guiding wire finished product after the oven dry.

5, the manufacture method of medical guiding wire according to claim 4 is characterized in that, is grouped into by the one-tenth of following percetage by weight basically at the wire guide described in the step a:

Nickel: 45%～55%, oxygen: 0～0.30% (not comprising 0);

Carbon: 0～0.30% (not comprising 0), all the other are titanium.

As preferably, the composition of the preferred weight percent of described shape is

Nickel: 50.7%, oxygen: 0～0.10% (not comprising 0);

Carbon: 0～0.10% (not comprising 0), all the other are titanium.

6, the manufacture method of medical guiding wire according to claim 4, it is characterized in that, detailed process in the tetanic processing described in the step a is: wire guide is made parcel, then with damping draught line on it, in temperature is to make seal wire be in spasticity under 300～400 ℃, constant temperature kept 3～10 minutes, naturally cooled to room temperature.

7, the manufacture method of medical guiding wire according to claim 4, it is characterized in that, detailed process at the surperficial electrobrightening described in the step c is: dop is done at seal wire blank two ends, it is immersed in electrolyte as anode, diamond locating piece and stone grinder wheel are as negative electrode; Under the effect of the pulse power, it was carried out surperficial electrobrightening 1～5 minute, wherein electrolyte be mass fraction 10%～20% contain Na saline solution or KOH solution; Used power pulse dc source in the electrobrightening, voltage is 0～100V, and pulse width is 10～50 μ s, and waveform is a square wave.

8, the manufacture method of medical guiding wire according to claim 4 is characterized in that, is centerless grinder at the grinding machine described in the steps d, and the emery wheel of grinding machine is a diamond, adds cooling medium when grinding; Described cooling medium is the NaCl deionized water solution of mass fraction 1～2%.

9, the manufacture method of medical guiding wire according to claim 4 is characterized in that, also comprises the seal wire blank sent into after steps d carrying out second polishing in the grinding tool; Described grinding tool is hard cloth wheel.

10, the manufacture method of medical guiding wire according to claim 4 is characterized in that, is 40～80 ℃ at the bake out temperature described in the step e, and drying time is 15～60 minutes.

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