A kind of manufacturing method of the reinforced segmental epidural catheter of flexibilityTechnical field
The present invention relates to the field of medical instrument technology, reinforce more particularly to a kind of for the flexible of anesthetic liquid medicine infusionType segmental epidural catheter and its manufacturing method.
Background technique
Flexible reinforced segmental epidural catheter is the new product that just new release lists in the market in recent years, is substantiallyIt is normal in clinic to solve common segmental epidural catheter currently used in the market for a kind of important breakthrough of manufacturing process technologyPhenomena such as conduit often occurred is easy to puncture endorchis, is strayed into cavum subarachnoidale, gives a discount causes operation patients body spinal analgesia occur, cutThe security hidden troubles such as paralysis, extradural hemorrhage, because due to approved and favored by vast clinical expert.
Currently, since the manufacturing technology of flexible reinforced segmental epidural catheter is extremely complex and to precision requirement poleHeight, careless slightly or method is inappropriate to will cause defect in product quality, and then when causing during product clinical useOften occur conduit rupture, internal support spring steel wire and outer conduit fusion it is insecure occur the draw, de- pipe and can not go and buy Chinese medicineSecurity risk.
In view of this, the prior art could be improved and improve.
Summary of the invention
Place in view of above-mentioned deficiencies of the prior art, the purpose of the present invention is to provide a kind of reinforced epidural anesthesias of flexibilityLiquor-saturated conduit and its manufacturing method ensure that it in the reinforced segmental epidural catheter tool of property manufactured using the manufacturing methodThere is super soft tip, avoids puncturing endorchis in clinical manipulation or damaging blood vessel etc. causing the clinics such as extradural hemorrhage or hemotoncusComplication, simultaneously, it is ensured that conduit outer wall plastic layer and " molten " the unification body of pipe inner wall steel wire floor de- pipe, the draw do not occur or lead" discounting " phenomenon is managed, is guaranteed unblocked when clinical infusion anesthetic liquid medicine.Meanwhile catheter surface is super smooth, reduces doctor and setsThe resistance of pipe ejector sleeve and secondary damage to vascular tissue.
In order to achieve the above object, this invention takes following technical schemes:
A kind of reinforced segmental epidural catheter of flexibility, wherein the reinforced segmental epidural catheter of flexibility includes usingIt is communicated in the feeding opening of the tube body of water conservancy diversion anesthetic liquid medicine, the tube body with medicine outlet, the intracavitary support being further provided with of tube bodySpring body；One of the tube body is equipped with flexible tip section, and the pliability of the flexible tip section is better than the main body of the tube bodyThe pliability of section.
Preferably, the reinforced segmental epidural catheter of flexibility, wherein the circular in cross-section of the tube body is ellipseCircle, and it is transparent or translucent.
Preferably, the reinforced segmental epidural catheter of flexibility, wherein the support spring body is by stainless steel materialOr nickel-titanium alloy material is made one, support spring body is helical arrangement, and support spring body line footpath is 0.03 mm-0.18mm；The pitch of loose section of adjacent coil springs circle of the tube body is 0.2 mm-1.0mm, and loose section of length is10mm-100mm.
Preferably, the reinforced segmental epidural catheter of flexibility, wherein the tube body is set at the rear portion of flexible tipThere is side opening medicine outlet, the tube body front is equipped with scale mark, described convenient for the depth of doctor's accurate perception conduit implantation human bodyTube body leading portion, middle part, rear portion are equipped with loose section and are used as watch window, and whether observe liquid infusion convenient for doctor normal and haveBlood back.
Preferably, the reinforced segmental epidural catheter of flexibility, wherein the number of the side opening medicine outlet is 1 to 3A, side opening medicine outlet diameter is 0.10mm to 0.80mm.
A kind of manufacturing method of the above-mentioned reinforced segmental epidural catheter of flexibility, wherein the method includes following stepsIt is rapid:
S1, the tube body for making TPU material；It further comprises stock, baking material and extruding pipe material；
S2, production support spring body；
S3, tube body and support spring are mentioned and combined.
Preferably, the manufacturing method of the reinforced segmental epidural catheter of flexibility, wherein the step S1 is specifically wrappedIt includes:
S11, thermoplastic polyurethane material is selected, thermoplastic polyurethane material's pellet is dried using drying machine or materal drierIt is dry, remove pellet moisture；Between 80 to 100 degree, drying time is to be advisable 4 to 6 hours for drying temperature control；
S12, required tube body is squeezed out by predefined parameter using plastic cement tube extruding machine, outer tube diameter is set as 0.60 millimeter of -1.90 milliRice, interior to be set as 0.30 millimeter -0.90 millimeter, tube length is cut into 1300-1500 millimeters on demand.
Preferably, the manufacturing method of the reinforced segmental epidural catheter of flexibility, wherein the step S2 is specifically wrappedIt includes:
S21, the metal steel wire or Nitinol line for selecting satisfactory 304,316 or MP35N；
S22, the metal steel wire of 304,316 or MP35N or Nitinol line are fabricated to by coiling machine pressure spring technique it is softProperty helical spring body；The line footpath of spring body is set as 0.03 millimeter -0.18 millimeter, and spring body outer diameter is set as 0.30 millimeter of -0.95 milliRice, the length of spring body can be cut according to actual needs；
S23, the flexible pellet spring body made is cleaned into its surface and oil contaminant using supersonic wave cleaning machine, cleaning temperature is taken the photograph for 50- 80 degrees Celsius of family name's degree, scavenging period minute 5-8 minutes；
S24, the spring body after above-mentioned ultrasonic cleaning is placed on dryer and is toasted -3 hours 2 hours, baking temperature is setIt is 150 degrees Celsius -250 degrees Celsius.
Preferably, the manufacturing method of the reinforced segmental epidural catheter of flexibility, wherein the step S2 is also into oneStep includes:
S25, press preset requirement, three sections of windows before, during and after flexible pellet spring body being issued using at the uniform velocity pulling force molding machineMouthful, so that doctor observes anesthetic liquid medicine water conservancy diversion or blood backflow situation in real time；It is soft to conduit implantation human body one end according to clinicThe different of degree require, and preceding see-through window length are set as 30 millimeters -100 millimeters, middle window, rear window length are set as 10 millis- 30 millimeters of rice.Pitch between window adjacent coil springs circle is uniformly set as 0.2 millimeter -1.0 millimeters.
Preferably, the manufacturing method of the reinforced segmental epidural catheter of flexibility, wherein the step S3 is specifically wrappedIt includes:
S31, the outer solid stainless steel wire through being less than spring intracoelomic cavity is pierced into and is placed in spring intracoelomic cavity to support wholeThe hardness of spring body；
S32, it the flexible pellet spring body of window before, during and after above-mentioned issue is pierced into is placed in tube cavity, extraction supportSolid stainless steel wire；
S33, the tube body for having set spring body is stretched round about using specific at the uniform velocity puller system, both ends are fixed on Y typeOn bracket, so that the even tube wall of tube body is close to together with the complete outer wall of spring body；
S34, the above-mentioned tube body fixed being placed in specific thermostatic oven baking, baking temperature is set as 100 degree of -190 degree,Baking time is -25 minutes 15 minutes, and baking number is set as 1 time -2 according to the actual conditions of tube body and the fusion of spring body outer wallIt is secondary, so that the tube wall of tube body is fused completely with spring body and is integrated and fixed-type；
S35, the good conduit of above-mentioned hot melt molding is subjected to scale mark printing with professional pad printer；Wherein, print requestAs follows: scale marks for every 1 centimetre one backward from implantation human body one end, and printing length is 25 centimetres in total, and scale wants 360 degree of circlesIt is whole full, clearly, there cannot be unfilled corner, alcohol screen test cannot fall paint, and surface cannot be uneven, and end graduation mark covers bullet justSpring end；
S36, the above-mentioned conduit for printing scale mark is placed on customization baking box and is toasted, 80 degrees Celsius of baking temperature-Between 150 degrees Celsius, baking time -30 minutes 15 minutes；Conduit is taken out, natural airing takes cotton swab to dip in wet 75% medicinal alcohol and existsScraped on scale mark 10 times or more it is no paint-shedding；
S37, one end of above-mentioned conduit implantation human body is subjected to the supple-settlement of tip cambered surface, so that catheter proximal end forms taper,Resistance when setting pipe is reduced, while conduit leading portion softness is moderate, does not damage epidural vessel and its soft tissue when being placed in human body, reallyProtect clinical use safety；The molding at tip is divided to two kinds, and one is directly the processing of tip cambered surface is carried out in catheter tip, another kind isTip, which is carried out, using the thermoplastic polyurethane material with developer and existing tube body welds fuse process；
S38, side opening is opened up as medicine outlet using above-mentioned conduit using professional puncher, side opening can open 1 according to actual needsTo 3 side openings, each aperture is 0.30-0.80 millimeters, and distance is 0.40-0.60 millimeters between side opening.The side opening of distalmost end fromEnd is about 5-8 millimeters；
S39, above-mentioned conduit is placed on professional automated fluid coating apparatus or is soaked in hydrophilic superslide coating solutionOr the processing of catheter surface superslide or anti-infective processing are carried out in the container slot of anti-infective solution, make catheter surface with a layer thicknessAbout 0.02-0.10 millimeters of specific function outer layer；
S310, it above-mentioned surface treated conduit is placed in professional thermostatic oven carries out Temperature Treatment, solidification is ledThe specific function outer layer of pipe surface, heating temperature are set as between 80 to 150 degrees Celsius, and by above-mentioned conduit be placed in ultrasonic wave intoRow cleaning 1 to 2 time, removes catheter surface stain；Clean gas is connected with Highpressure Tee plate again to be followed by above-mentioned conduit emptying leadingPipe internal residual moisture, while observing whether ventilatory conditions have plugging.
Compared with prior art, the reinforced segmental epidural catheter of flexibility of the invention and its manufacturing method advantage are:
1, this method rational technology, strong operability, securely and reliably
2, simple process is easily mastered, and production cost is low, high-efficient, reliable in quality.
3, tube body one is equipped with the flexible soft tip of taper cambered surface, propelling resistance is reduced when setting pipe, while front end is soft, noEasy damaged human body soft tissue efficiently reduces injury of the surgical procedure to human body, prevents possible medical-risk.
4, this method use is expanded with heat and contract with cold forming principle, and conduit is fused completely with flexible pellet spring body and is integrated, fusion jailGu Resisting fractre, anti-pull, avoid occurring the hair that " conduit and spring are detached from " causes potential medical-risk in conduit use processIt is raw.
Detailed description of the invention
Fig. 1 is the stream of the tube body of production TPU material in the manufacturing method of the flexible reinforced segmental epidural catheter of the present inventionCheng Tu.
Fig. 2 is the tube body of production support spring body in the manufacturing method of the flexible reinforced segmental epidural catheter of the present inventionFlow chart.
Specific embodiment
The reinforced segmental epidural catheter of flexibility provided by the invention and its manufacturing method.To make the purpose of the present invention, skillArt scheme and effect are clearer, clear, and the present invention is described in more detail as follows in conjunction with drawings and embodiments.It should manageSolution, described herein specific examples are only used to explain the present invention, is not intended to limit the present invention.
The present invention provides a kind of reinforced segmental epidural catheters of flexibility, wherein the reinforced epidural anesthesia of flexibilityLiquor-saturated conduit includes the tube body for water conservancy diversion anesthetic liquid medicine, and the feeding opening of the tube body is communicated with medicine outlet, and tube body is intracavitary furtherThe support spring body being provided with；One of the tube body is equipped with flexible tip section, and the pliability of the flexible tip section is better than instituteState the pliability of the main paragraph of tube body.In the present embodiment, the circular in cross-section or ellipse of the tube body, and it is transparent orIt is translucent.The support spring body is made one by stainless steel material or nickel-titanium alloy material, and support spring body is spiral shellShape arrangement is revolved, support spring body line footpath is 0.03 mm-0.18mm；The section of loose section of adjacent coil springs circle of the tube bodyAway from for 0.2 mm-1.0mm, loose section of length is 10mm-100mm.The tube body is equipped with side opening at the rear portion of flexible tipMedicine outlet, the tube body front are equipped with scale mark, convenient for the depth of doctor's accurate perception conduit implantation human body, before the tube bodySection, middle part, rear portion are equipped with loose section and are used as watch window, and whether observe liquid infusion convenient for doctor normal and whether have blood back.The number of the side opening medicine outlet is 1 to 3, and side opening medicine outlet diameter is 0.10mm to 0.80mm.Flexible reinforcement of the inventionType segmental epidural catheter has super soft tip, avoids puncturing endorchis in clinical manipulation or damaging blood vessel etc. causing dura materThe clinical complications such as external hemorrhage or hemotoncus, meanwhile, conduit outer wall plastic layer and " molten " the unification body of pipe inner wall steel wire floor do not occurDe- pipe, the draw or conduit " discounting " phenomenon guarantee unblocked when clinical infusion anesthetic liquid medicine.Meanwhile the super light of catheter surfaceIt is sliding, it reduces doctor and sets the resistance of pipe ejector sleeve and the secondary damage to vascular tissue.
The production method for highlighting down the above-mentioned reinforced segmental epidural catheter of flexibility below, mainly includes threeStep:
S1, the tube body for making TPU material；It further comprises stock, baking material and extruding pipe material；
S2, production support spring body；
S3, tube body and support spring are mentioned and combined.
Referring to Fig. 1, the step S1 is specifically wrapped in the manufacturing method of the reinforced segmental epidural catheter of flexibilityIt includes:
S11, thermoplastic polyurethane material (TPU) is selected, using drying machine or materal drier thermoplastic polyurethane material's grainMaterial drying, removes pellet moisture；Between 80 to 100 degree, drying time is to be advisable 4 to 6 hours for drying temperature control；
S12, required tube body is squeezed out by predefined parameter using plastic cement tube extruding machine, outer tube diameter is set as 0.60 millimeter of -1.90 milliRice, interior to be set as 0.30 millimeter -0.90 millimeter, tube length is cut into 1300-1500 millimeters on demand.
Further, the manufacturing method of the reinforced segmental epidural catheter of flexibility, as shown in Fig. 2, the stepS2 is specifically included:
S21, the metal steel wire or Nitinol line for selecting 304,316 or MP35N；
S22, the metal steel wire of 304,316 or MP35N or Nitinol line are fabricated to by coiling machine pressure spring technique it is softProperty helical spring body；The line footpath of spring body is set as 0.03 millimeter -0.18 millimeter, and spring body outer diameter is set as 0.30 millimeter of -0.95 milliRice, the length of spring body can be cut according to actual needs；
S23, the flexible pellet spring body made is cleaned into its surface and oil contaminant using supersonic wave cleaning machine, cleaning temperature is taken the photograph for 50- 80 degrees Celsius of family name's degree, scavenging period minute 5-8 minutes；
S24, the spring body after above-mentioned ultrasonic cleaning is placed on dryer and is toasted -3 hours 2 hours, baking temperature is setIt is 150 degrees Celsius -250 degrees Celsius.
Preferably, in the manufacturing method of the reinforced segmental epidural catheter of flexibility, the step S2 is also furtherInclude:
S25, press preset requirement, three sections of windows before, during and after flexible pellet spring body being issued using at the uniform velocity pulling force molding machineMouthful, so that doctor observes anesthetic liquid medicine water conservancy diversion or blood backflow situation in real time；It is soft to conduit implantation human body one end according to clinicThe different of degree require, and preceding see-through window length are set as 30 millimeters -100 millimeters, middle window, rear window length are set as 10 millis- 30 millimeters of rice.Pitch between window adjacent coil springs circle is uniformly set as 0.2 millimeter -1.0 millimeters.
Further, the manufacturing method of the reinforced segmental epidural catheter of flexibility, the step S3 are specifically included:
S31, the outer solid stainless steel wire through being less than spring intracoelomic cavity is pierced into and is placed in spring intracoelomic cavity to support wholeThe hardness of spring body；
S32, it the flexible pellet spring body of window before, during and after above-mentioned issue is pierced into is placed in tube cavity, extraction supportSolid stainless steel wire；
S33, the tube body for having set spring body is stretched round about using specific at the uniform velocity puller system, both ends are fixed on Y typeOn bracket, so that the even tube wall of tube body is close to together with the complete outer wall of spring body；
S34, the above-mentioned tube body fixed being placed in specific thermostatic oven baking, baking temperature is set as 100 degree of -190 degree,Baking time is -25 minutes 15 minutes, and baking number is set as 1 time -2 according to the actual conditions of tube body and the fusion of spring body outer wallIt is secondary, so that the tube wall of tube body is fused completely with spring body and is integrated and fixed-type；
S35, the good conduit of above-mentioned hot melt molding is subjected to scale mark printing with professional pad printer；Wherein, print requestAs follows: scale marks for every 1 centimetre one backward from implantation human body one end, and printing length is 25 centimetres in total, and scale wants 360 degree of circlesIt is whole full, clearly, there cannot be unfilled corner, alcohol screen test cannot fall paint, and surface cannot be uneven, and end graduation mark covers bullet justSpring end；
S36, the above-mentioned conduit for printing scale mark is placed on customization baking box and is toasted, 80 degrees Celsius of baking temperature-Between 150 degrees Celsius, baking time -30 minutes 15 minutes；Conduit is taken out, natural airing takes cotton swab to dip in wet 75% medicinal alcohol and existsScraped on scale mark 10 times or more it is no paint-shedding；
S37, one end of above-mentioned conduit implantation human body is subjected to the supple-settlement of tip cambered surface, so that catheter proximal end forms taper,Resistance when setting pipe is reduced, while conduit leading portion softness is moderate, does not damage epidural vessel and its soft tissue when being placed in human body, reallyProtect clinical use safety；The molding at tip is divided to two kinds, and one is directly the processing of tip cambered surface is carried out in catheter tip, another kind isTip, which is carried out, using the thermoplastic polyurethane material with developer and existing tube body welds fuse process；
S38, side opening is opened up as medicine outlet using above-mentioned conduit using professional puncher, side opening can open 1 according to actual needsTo 3 side openings, each aperture is 0.30-0.80 millimeters, and distance is 0.40-0.60 millimeters between side opening.The side opening of distalmost end fromEnd is about 5-8 millimeters；
S39, above-mentioned conduit is placed on professional automated fluid coating apparatus or is soaked in hydrophilic superslide coating solutionOr the processing of catheter surface superslide or anti-infective processing are carried out in the container slot of anti-infective solution, make catheter surface with a layer thicknessAbout 0.02-0.10 millimeters of specific function outer layer；
S310, it above-mentioned surface treated conduit is placed in professional thermostatic oven carries out Temperature Treatment, solidification is ledThe specific function outer layer of pipe surface, heating temperature are set as between 80 to 150 degrees Celsius, and by above-mentioned conduit be placed in ultrasonic wave intoRow cleaning 1 to 2 time, removes catheter surface stain；Clean gas is connected with Highpressure Tee plate again to be followed by above-mentioned conduit emptying leadingPipe internal residual moisture, while observing whether ventilatory conditions have plugging.
Finally, above-mentioned conduit is placed in professional drying box heating so that volume drying inside and outside conduit, according to practical needIt asks and conduit is packed.
In conclusion the reinforced segmental epidural catheter of flexibility provided by the invention and its manufacturing method, wherein described softThe reinforced segmental epidural catheter of property includes the tube body for water conservancy diversion anesthetic liquid medicine, feeding opening and the medicine outlet phase of the tube bodyIt is logical, the intracavitary support spring body being further provided with of tube body；One of the tube body is equipped with flexible tip section, the flexible tipPliability of the pliability of section better than the main paragraph of the tube body.The manufacturing method of the reinforced segmental epidural catheter of flexibilityIt is rational technology, strong operability, safe and reliable；It with simple process, is easily mastered, production cost is low, high-efficient, reliable in qualityThe advantages that.
It, can according to the technique and scheme of the present invention and its hair it is understood that for those of ordinary skillsBright design is subject to equivalent substitution or change, and all these changes or replacement all should belong to the guarantor of appended claims of the inventionProtect range.