CN102872509A - Disposable sterile safe injection needle and machining method thereof - Google Patents
Disposable sterile safe injection needle and machining method thereof Download PDFInfo
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- CN102872509A CN102872509A CN2012103796574A CN201210379657A CN102872509A CN 102872509 A CN102872509 A CN 102872509A CN 2012103796574 A CN2012103796574 A CN 2012103796574A CN 201210379657 A CN201210379657 A CN 201210379657A CN 102872509 A CN102872509 A CN 102872509A
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Abstract
The invention discloses a disposable sterile safe injection needle which comprises a syringe needle thin tube, a first inclined surface forming a 15-degree angle with an axial surface of the thin tube and a second inclined surface forming at 18-degree angle with the axial surface of the thin tube, wherein the width between two arc top ends of a crescent-moon-shaped cross section of the first inclined surface formed on the tube wall portion is equal to the standard thickness of the tube wall, an inner blade, a left blade and a right blade of the cross section are round fillets, and no burrs exist on a plane of the cross section. The disposable sterile safe injection needle cannot pick up tissue of human bodies or bring out fractionation, cannot damage the strength of a syringe needle, is truly safe, and can be used for replacing various medical syringe needles used in various occasions.
Description
Technical field
The present invention relates to medical apparatus and instruments, particularly a kind of medical needle and processing method thereof, the especially a kind of safe medical syringe needle that in injection inserting needle process, can not win the various tissues of human body fully.
Background technology
As everyone knows, injection needle is widely used as the important medical device for the treatment of human body diseases.But because of the defective of its design and processing, human body key health has been caused very large threat.
The conventional medical syringe needle hides significant damage.A large amount of experimental studies have found that, traditional syringe needle of existing disposable various different models is when having an injection transfusion and blood transfusion, the overwhelming majority can form wound surface in the injection, skin histology under the wound surface, muscular tissue, fatty tissue and vessel lumen tissue etc., can hold in syringe needle and form graininess or linear tissue debris under the effect of cutting edge of a knife or a sword mouth, they are pushed into the vein blood vessel tube chamber in the lump together with pin water.Although the tissue debris intravasation of being taken does not produce rejection, owing to the function of blood vessel without the discharge tissue debris, so that tissue debris is grown up gradually with blood flow, it may be adsorbed in blood vessel wall formation obstruction and bring out thrombosis and varicosis.Also may direct relation be arranged with the optimum or malignant tumor that current sickness rate linearly rises.
The tradition injection needle normally processes with the rustless steel tubule, process first one in the termination of rustless steel tubule 1 ' and be first inclined-plane at 15 degree angles with axial plane, then the second inclined-plane that is 18 degree angles at the front end on the first inclined-plane through regrind one-tenth and axial plane, left and right sides chamfering forms needle point, shown in Figure 1A and Fig. 2 A.After this double inclined plane needle point grinding finishes, the tube wall of rustless steel tubule can form the cross section 2 ' of crescent shape in first inclined-plane at 15 degree angles, this cross section is formed by needle interior wall near the arc end (inner arc end) of needle point, be sharp inner edge (interior pin cutting edge of a knife or a sword) 21 ', away from needle point is the outer arc end, formed by the needle tubing outer wall, also claim outer pin cutting edge of a knife or a sword 22 '.Because the precision that tradition is ground is not in place, also inevitably can there be burr in the inner arc end, the inner edge that this is sharp and burr, when each inserting needle, inevitably shear tissue, or when the molten medicine of plug bottle, cutting bottle stopper, the microgranule under inner edge shearing and burr are hung enters people's cognition and brings in the recent period and late injury.
For above problem, the inventor once proposed improved safe medical syringe needle, in 200610112919.5, propose inner edge sharp in the first inclined-plane is polished into fillet, so really, the syringe needle before can not polishing reduces the sharpness of shearing, resistance strengthens in the inserting needle process yet simple sphering is processed, and therefore uses still imperfect.The inventor proposes another corrective measure in 200920153715.5, that the second inclined-plane is lengthened, and the pin cutting edge of a knife or a sword is established the little concave arc that extends back near the camber line apical position in the first inclined-plane, the mode of this syringe needle by the second inclined-plane is lengthened, be equivalent to prolong the length that outer pin cutting edge of a knife or a sword is cut tissue open during use, make inserting needle smooth and easy, the resistance on the first inclined-plane is alleviated simultaneously, and no longer tissue is cut off in cutting.Though the syringe needle of this kind form truly has effect aspect the tissue avoiding extracing, yet for the excessive syringe needle of extension amplitude, the rigidity of syringe needle own may be destroyed, rigidity might have not the risk of broken needle to exist and other potential safety hazard occur.Therefore, also need further research, seek better solution.
Aspect the removing of syringe needle burr, general enforcement blasting treatment, right existing blasting treatment is quick conveying-type, sandblasting machine is established 1 to being no more than 5 shower nozzles with the clear sword of the clear hair of vertical single angle, and adopting all the time glass ball sand is shower nozzle, and its matter is crisp frangible, is equivalent to throw an egg against a rock with the syringe needle metal bump, the result causes burr thoroughly not remove, and the inner edge that syringe needle is very sharp still exists.
Summary of the invention
Neither can win tissue when main purpose of the present invention is to provide a kind of the use, not destroy the aseptic safe injection needle of disposable use of syringe needle intensity.
The aseptic safe injection needle of a kind of disposable use of the present invention, comprise a syringe needle tubule, with the tubule axial plane be 15 the degree angles the first inclined-plane and be 18 the degree angles the second inclined-plane, the width of the first inclined-plane between its two arc top of cross section of the crescent shape of tube wall position formation equals the tube wall standard thickness, and the inner edge in this cross section and left and right sides sword are fillet, and sectional plane is without burr.
The axial length on described the first inclined-plane lengthens.
Another purpose of the present invention is to provide a kind of processing method of aseptic safe injection needle, particularly the disposable thorough grit-blasting treatment process of removing the hair sword.
The processing method of the aseptic safe injection needle of the disposable use of the present invention may further comprise the steps:
1) the syringe needle tubule is finish grinded, form the second inclined-plane that is 18 degree angles with the tubule axial plane;
2) this syringe needle tubule inclined-plane is finish grinded again, form the first inclined-plane that is 15 degree angles with the tubule axial plane;
3) polished at cross section inner edge and the left and right sides sword of the crescent shape of tube wall position formation in the first inclined-plane, grind off the part above pipe thickness, the burr of pair cross-section is polished simultaneously.
Described polishing is finished dealing with by sand spray machine sand spray.
Described sandblasting machine adopts the accurate gravity setting of conveying-type, compressed air 〉=6bar (kg/m
2),＜0.5～1 centimetre of workpiece and shower nozzle distance, the sand material adopts stainless steel shot (its diameter＜0.1mm), join 12～16 shower nozzles, 4 every group, nozzle diameter
The present invention removes cutting edge of a knife or a sword hair sword in the first inclined-plane by special blasting treatment mode, crescent shape cross section in the first inclined-plane is shortened, and realize absolutely not cutting, thereby inserting needle is more smooth and easy, the resistance on the first inclined-plane is alleviated simultaneously, and no longer tissue is cut off in cutting.
Distinguishing feature of the present invention has:
1, inserting needle is more smooth and easy.
2, tissue is not cut in shallow quiet puncture.
3, patient's pain alleviates during inserting needle.
4, inserting needle end amount of bleeding is few.
5, the inserting needle penetration Resistance is low.
6, during the molten medicine of plug bottle, do not cut bottle stopper, hanging fascia bits, be perfectly safe.
7, stopping plug comes off and causes the hard nut to crack of infusion reaction.
8, removed make up a prescription and puncture in operator's trouble and worry, make it needn't worry that microgranule is injected into the infusion reaction that human body may cause, and thoroughly realize making up a prescription and the following one's bent of shallow quiet puncture.
9, processing can adopt the conventional needles production procedure can finish through local special setting fast, is beneficial to industrialized implementation.
10, through expert testimony, the needle point structure of optimization is expected to become the standard index of medical needle.
Description of drawings
Figure 1A is existing structure needle head structure sketch map;
Figure 1B is the sketch map of needle head structure contrast Figure 1A of the present invention;
Fig. 1 C is the hair tooth shape shape sketch map that grinds off;
Fig. 2 A is sectional structure and the size sketch map of existing structure syringe needle;
Fig. 2 B is sectional structure and the size sketch map of syringe needle contrast Fig. 2 A of the present invention;
Fig. 3 is syringe needle process equipment sketch map of the present invention.
The specific embodiment
The present invention improves and the aseptic safe injection needle of a kind of disposable use of acquisition on the basis of existing syringe needle inserting needle structure.
The existing structure syringe needle, shown in Figure 1A and Fig. 2 A, comprise the first inclined-plane and the second inclined-plane that is 18 degree angles that are 15 degree angles with rustless steel tubule axial plane, wherein the first inclined-plane can form the cross section 2 ' of crescent shape at the tube wall position, its inner arc end is inner edge 21 ', and the outer arc end is outer pin cutting edge of a knife or a sword 22 '.The inventor further furthers investigate discovery, the syringe needle of this existing structure, width b ' between crescent section 2 ' its two arc top of 15 ° of angle grinding formation is all above tube wall standard thick (common needle tubing broadening value＞0.02～0.03 millimeter, thin-walled needle tubing broadening value＞0.03～0.04 millimeter).The wider explanation sword of its value of exceeding face is thinner, and is also namely sharper; On the other hand, inner edge 21 ' is won the burr on sharp inner edge, left and right sides sword and the grinding Formation cross-section plane that the arch-criminal of tissue is its rear end.
Inventor and then improved the syringe needle of existing structure and obtain breakthrough achievement.Improvement of the present invention is, at first reduces the area of crescent section, and inner edge, left and right sides sword and the plane burr of key ground, and obtains safe injection needle of the present invention.
Shown in Figure 1B and Fig. 2 B, the structure that has shown syringe needle of the present invention, and please with Figure 1A and Fig. 2 A relatively referring to, syringe needle of the present invention, comprise being first inclined-plane (the first inclined-plane axial length is S ') at 15 degree angles with rustless steel tubule axial plane and being 18 the second inclined-planes of spending angles that wherein the first inclined-plane can form the cross section 2 of crescent shape at the tube wall position; The inner arc end of existing structure syringe needle is inner edge 21 ', the outer arc end is outer pin cutting edge of a knife or a sword 22 ', the present invention keeps outer pin cutting edge of a knife or a sword 22 ' constant, reduce the area of crescent section, the polish inner edge 21 ' of existing structure syringe needle of the mode of adopt grinding, make inner edge 21 ' outside pin cutting edge of a knife or a sword 22 ' direction indentation in rounding, according to camber line radian inside and outside the cross section, grind off part hair sword 3(referring to Fig. 1 C from the inner edge direction), obtain syringe needle of the present invention cross section 2, the more initial backward indentation of inner edge 21 ' of syringe needle of the present invention cross section 2 inner arc ends 21, until the width b between crescent section 2 its two arc tops equals the tube wall standard thickness, so, the axial length S on the first inclined-plane is then greater than raw footage S ', and the axial length that is equivalent to the first inclined-plane lengthens.In grinding inner edge 21 ', inner edge, left and right sides sword are carried out synchronous sphering process and the plane burr is polished synchronously, and obtain safe injection needle of the present invention.
Among the present invention, remove hair sword 3 and sphering and can realize by blasting treatment the polishing of burr.The sandblasting machine that is used for the present invention adopts the accurate gravity setting of conveying-type, compressed air 〉=6bar (kg/m
2),＜0.5～1 centimetre of workpiece and shower nozzle distance, the sand material adopts stainless steel shot (its diameter＜0.1mm), (line is arranged and is divided three ~ four groups to join 12～16 shower nozzles, every group three are positioned respectively left and right, rear end and are used for grinding and sphering, the 4th sectional plane that is positioned crescent shape is used for removing burr), nozzle diameter φ 8mm; 300～500 syringe needles can disposablely be finished closely blasting treatment.
Syringe needle processing of the present invention adopts the clear sword High-speed Computer number control conveying-type high speed and precision gravity sandblasting machine (referring to Fig. 3) of clear hair to finish, and the complete machine manufacturing structure is the 316L rustless steel and meets the GMP requirement.Be that the employing compressed air is power, to form the high velocity jet bundle, to needing to process surface of the work, the mechanical performance of surface of the work changed the material spray high velocity jet, by abrasive material abrasive action is played in the impact of surface of the work.
Technical parameter:
1, long 3500 * wide by 800 * high by 1500 (mm) of complete machine size.2, long 1000 * wide by 800 * high by 1500 (mm) of work chamber size.3, the workpiece entrance high by 30 * wide by 100 (mm).4, work stage height: 800 (mm).5, spray gun number: 12-16 props up, and every spray gun all can be controlled separately independent adjust blood pressure.6, illumination: 4 60W explosion-proof lamps.7, adjustable employing frequency control in transporting velocity: the 0-5m/min.8, conveyer belt width dimensions: degree 30 * wide by 101 (mm).9, conveyer belt: the poroid level metal conveyor belt that places of stainless (steel) wire.10, exhaust air rate: 75m3/min～5300m3/min.11, carry motor: 380V 50Hz 750W.12, return the sand motor: 380V 50Hz 400W.13, dedusting motor: 380V 50HZ 3.7kw.14, compressed air: 6-7bar (kg/m
2).15, flow: 8-12m3/min.16, dust removing effects reaches national environmental standard.
Sandblasting machine of the present invention divides four groups by establishing 12～16 first lines arrangements of sandblast, every group of four location are to one jiao of i.e. left and right, rear end and crescent section plane, vertically without the dead angle sandblast, the first inclined-plane inner edge at needle point the 15th degree angle after guaranteeing to grind is fillet, smooth surface is sharp without burr, the lubricated needle point of needle tubing, and realize that inserting needle is more smooth and easy, and resistance is alleviated, and no longer tissue is cut off in cutting.
The upper introduction the invention provides following entry needle example according to this, referring to table 1:
Table 1: entry needle example of the present invention and relevant parameter
The present invention verifies by experiment, normal wall syringe needle, and the various different tissues of absolute cutting human body during clearance rate＜0.03mm cut the various different tissues of human body at＞0.03 o'clock anything but; The various different tissues of absolute cutting human body cut the various different tissues of human body anything but during thin-walled syringe needle clearance rate＜0.05mm during＞0.05mm.
1, the wound rate detects:
Get 3 at specification 1.2 syringe needles, be installed in respectively on the adaptive syringe, adopt artificial skin (silicone rubber piece) simulation human body skin, injection system extraction distilled water enters in the syringe routinely, air-out, then artificial skin is punctured, until directly puncturing, syringe needle pulls out immediately needle tubing after without hindrance to needle point, water for injection in three syringes is pushed same transparent and be equipped with in the glass of 5mL water for injection, behind 0.45 μ m membrane filtration, be transferred on the glass slide at the biology microscope Microscopic observation with a small amount of normal saline, investigate in the mirror lower area whether have particulate matter and particulate matter quantity and size, use the VDN-200M digit microscope in the experiment.More than operation repeats 10 times, gets statistical data and calculates the wound rate, and 1 particle diameter of appearance is greater than the particulate matter of particulate matter 0.2mm in for example detecting for 10 times, and then the wound rate is 10%.
Normal wall and Bao Bi Cheongju remove the rate testing result:
1), from testing result as seen, whether no matter with fillet, its pin water injection flow rate and traditional syringe needle relatively do not change in the first bevel range of medical needle.
2), when normal wall is sheared plate Cheongju except rate＞0.03mm, namely as seen can not occur under the mirror being won and cut off particulate material and enter needle tubing, do not won and cut off particulate material and enter needle tubing but as seen severe can appear during except rate＜0.03mm in Cheongju under the mirror,
3), cutting off did not appear in simulated skin (polyurethane film) when thin-walled was sheared plate Cheongju except rate＞0.05mm, but＜during 0.05mm under the mirror as seen, simulated skin (polyurethane film) the severe cut-out occurs and enters needle tubing.
2, rigidity detects: press table 2 regulation among the GB18457-2001, specification 1.2 syringe needle maximum defluxions are 0.45mm, and tested syringe needle amount of deflection surpasses this numerical value and is considered as not meeting the rigidity standard.
3, puncture force detects: according to GB15811-2001 table 4 regulation, it is qualified that specification 1.1,1.2 syringe needle maximums pierce through power≤1.15N.
Method is described:
A) with tested pin and simulated skin (polyurethane film, thickness 0.35mm ± 0.05mm, hardness: Shao Shi A85 ± 10) under 22 ℃ ± 2 ℃, place at least 24h, and under uniform temp, test;
B) simulated skin with appropriate size is clipped on the anchor clamps, must not have any obvious stretching or compression stress to be applied on the simulated skin;
C) tested syringe needle is contained in (the pressure transducer measuring range: on 0 ~ 50N) the transducing unit, its axis is perpendicular to the surface of simulated skin, and needle point points to circular puncture zone (after clamping with pressure measuring element
The center;
D) mobile transducing unit, translational speed is set as 100mm/min, and tested syringe needle is to the circle regional center implementation piercing process that punctures;
E) in the piercing process, record simultaneously peak-peak power or the record power/displacement diagram of puncture.
Test evaluation:
Peak-peak in the power/displacement diagram of gained (specification 1.2 pin puncture forces≤1.15N) relatively, when peak-peak during less than or equal to setting, then is judged to be this puncture force by chaining pin and meets the requirements with requiring the setting specification.Puncture force numerical value is less, illustrates that the inserting needle resistance is less, and inserting needle is more smooth and easy.
Send medical apparatus and instruments quality supervision and test center, State Food and Drug Administration Beijing to detect at the syringe needle of listed 1 specification 1.1 of table 1 and 1.2, simultaneously with the same specification syringe needle of commercially available world famous brand name in contrast, maximum pierces through force inspecting and the results are shown in Table 2.
Table 2: the maximum puncture force assay of different syringe needles
Claims (5)
1. aseptic safe injection needle of disposable use, comprise a syringe needle tubule, with the tubule axial plane be 15 the degree angles the first inclined-plane and be 18 the degree angles the second inclined-plane, it is characterized in that, the width of the first inclined-plane between its two arc top of cross section of the crescent shape of tube wall position formation equals the tube wall standard thickness, and the inner edge in this cross section and left and right sides sword are fillet, and sectional plane is without burr.
2. the aseptic safe injection needle of disposable use according to claim 1 is characterized in that, the axial length on described the first inclined-plane lengthens.
3. the processing method of the aseptic safe injection needle of disposable use may further comprise the steps:
1) the syringe needle tubule is finish grinded, form the second inclined-plane that is 18 degree angles with the tubule axial plane;
2) this syringe needle tubule inclined-plane is finish grinded again, form the first inclined-plane that is 15 degree angles with the tubule axial plane;
3) polished at cross section inner edge and the left and right sides sword of the crescent shape of tube wall position formation in the first inclined-plane, grind off the part above pipe thickness, the burr of pair cross-section is polished simultaneously.
4. processing method according to claim 3 is characterized in that, described polishing is finished dealing with by sand spray machine sand spray.
5. processing method according to claim 4 is characterized in that, described sandblasting machine adopts the accurate gravity setting of conveying-type, compressed air 〉=6bar (kg/m
2),＜0.5～1 centimetre of workpiece and shower nozzle distance, the sand material adopts stainless steel shot (its diameter＜0.1mm), join 12～16 shower nozzles, 4 every group, nozzle diameter φ 8mm.
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Cited By (4)
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| CN105196145A (en) * | 2015-10-09 | 2015-12-30 | 温州职业技术学院 | Forming system and forming technology for cutting edge |
| CN106512141A (en) * | 2016-11-21 | 2017-03-22 | 江苏康友医用器械有限公司 | Inner-wound-free slight soreness medical needle and machining method thereof |
| CN106730173A (en) * | 2016-11-21 | 2017-05-31 | 江苏康友医用器械有限公司 | It is a kind of to create hypodynia sense medical needle without interior |
| CN114470411A (en) * | 2022-02-21 | 2022-05-13 | 李开雄 | Scrap-free needle tube and machining method thereof |
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| CN102390041A (en) * | 2011-11-04 | 2012-03-28 | 无锡朗特机械设备有限公司 | Gravity blanking type sand blasting machine |
| CN202859798U (en) * | 2012-10-09 | 2013-04-10 | 杨昌燕 | Disposable asepsis safe injection needle |
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| CN101357246A (en) * | 2008-09-24 | 2009-02-04 | 杨昌燕 | Safe medical needle head and processing method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105196145A (en) * | 2015-10-09 | 2015-12-30 | 温州职业技术学院 | Forming system and forming technology for cutting edge |
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| CN106730173A (en) * | 2016-11-21 | 2017-05-31 | 江苏康友医用器械有限公司 | It is a kind of to create hypodynia sense medical needle without interior |
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| CN114470411A (en) * | 2022-02-21 | 2022-05-13 | 李开雄 | Scrap-free needle tube and machining method thereof |
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Application publication date: 20130116 |