Background technology
As everyone knows, injection needle is widely used as the important medical device of treatment human body diseases.But, human body key health has been caused very big threat because of the defective of its design and processing.
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, because blood vessel does not have the function of discharging tissue debris, make tissue debris grow 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, the termination of rustless steel tubule has first inclined-plane, front end on first inclined-plane forms second inclined-plane by secondary cutting then, and referring to shown in Figure 1, wherein the first chamfer length L1 is greater than the second chamfer length L2.Earlier cut human skin tissue open during inserting needle by second inclined-plane, lunge skin by first inclined-plane more thereupon, because the first inclined-plane inserting needle area is greater than second inclined-plane, the skin histology that second inclined-plane is cut open produces resistance through first inclined-plane time, be pushed into vein thereby downcut groups of people soma by pin peak in first inclined-plane under the effect of inserting needle thrust together with pin water.In zoopery, find through microscope is considerable, inserting needle all will cut down somatic cell, hair follicle, skin, muscle, fat, venous blood tube wall and by tissues (referring to Fig. 3) such as the chrotoplast of thorn landing and genes each time.Above-mentioned situation inevitably occurs in therapeutic processes such as intramuscular injection, blood transfusion, transfusion and puncture, and brings very big harm to human body.
Therefore, be badly in need of the structure of existing medical needle is improved, to stop the healthy hidden danger that the disposable needle head brings to people from the source.
Summary of the invention
Can not win tissue and keep inserting needle safe medical needle head smoothly when the purpose of this utility model is to provide a kind of design science and changes existing syringe needle processing technique, use hardly.
The safe medical needle head that this utility model provides comprises a syringe needle tubule, and syringe needle tubule front end is established second inclined-plane and first inclined-plane, wherein, needs lengthening second inclined-plane among the present invention, and the length L 1 that makes first inclined-plane is less than the second chamfer length L2.
In the prioritization scheme, the length L 1 on first inclined-plane accounts for 25~35% of two inclined-plane length overall L, and promptly the second chamfer length L2 accounts for 65~75% of two inclined-plane total length L.
Prioritization scheme more, the second chamfer length L2 accounts for 70% of two inclined-plane total length L.
Prioritization scheme also, 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 first inclined-plane.
The length that described little concave arc extends back is 0.2mm, and arc length is the semicircle girth.
This utility model is equivalent to during use prolong the length that outer pin cutting edge of a knife or a sword is cut tissue open by the mode with second inclined-plane lengthening, makes inserting needle smooth and easy, and the resistance on first inclined-plane is alleviated simultaneously, and no longer tissue is cut off in cutting.Distinguishing feature of the present utility model has:
1, inserting needle does not cut the cut-out tissue.
2, patient's pain alleviates during inserting needle.
Lack than traditional inserting needle amount of bleeding when 3, inserting needle finishes.To cut off the tissue amount of bleeding many because of pin cutting edge of a knife or a sword cutting in traditional inserting needle.
4, inserting needle is smooth and easy.
5, the inserting needle penetration Resistance reduces.
6, extract pin water puncture rubber bottle cap and do not advance granule obstruction needle tubing.
7, processing is easy, can adopt the conventional needles production procedure to finish, and need not special process equipment, is beneficial to industrialized implementation.
8, except that optimizing needle point structure, all other service indexs all meet national regulation.
The specific embodiment
This utility model is to improve and a kind of safe medical needle head of acquisition on the basis of existing syringe needle inserting needle structure.
The existing structure syringe needle, referring to shown in Figure 1, second inclined-plane 2 ' of first inclined-plane 1 ' of close syringe rear end and close needle point constitutes the fluid part of syringe needle jointly, and wherein the axial length on first inclined-plane 1 ' is L1 ', the axial length on second inclined-plane 2 ' is L2 ', L1 ' 〉=L2 '.
The inventor recognizes under study for action: the existing structure syringe needle in use, second inclined-plane 2 ' is used for puncture, can the connection tissue not enter needle tubing, and the inserting needle area on first inclined-plane 1 ' (being formed by the encirclement of steel pipe internal and external pin cutting edge of a knife or a sword) is greater than second inclined-plane, 2 ' inserting needle area, make that first inclined-plane 1 ' can produce bigger inserting needle resistance in the inserting needle process, and first inclined-plane 1 ' has sharp interior pin cutting edge of a knife or a sword, then can win tissue when meeting the inserting needle resistance, wound in tissue is produced.Reason is that second inclined-plane 2 ' can be cut open and organizes inserting needle, because it only accounts for 1/2nd of whole needle tubing diameter, and 1/2nd can not the cutting tissue open and allow the smooth and easy puncture of its needle tubing of first inclined-plane 1 ', just promote skin to pass through fatty muscle and arrive the vein tube chamber, tissues such as human body skin, fat, muscle and blood vessel are flexibles, but toughness is to have ultimately, oversteps the extreme limit and must rupture.Key is that the needle tubing of cutting tissue open only accounts for 50% of diameter, the toughness of tissue is also held greatly the extruding of other 50% needle tubing of cutting function of organization open of daring not accept again, its very sharp interior pin cutting edge of a knife or a sword is then brought the cut-off parts tissue into needle tubing, thereby caused each inserting needle especially as a punch press, the shallow meat mat of inserting needle dashes thinly, inserting needle deeply then meat mat dashes thickly, the patient felt special pain when special intramuscular injection inserting needle was dark, the degree of depth with entry needle advances patient's skin this moment, fat, muscle is filled whole injection needle already and is pushed into human muscle's plate depths again with liquid medicine.
Inventor and then improved the syringe needle of existing structure and obtain breakthrough achievement.Improvement of the present utility model is, reduces the inserting needle area on first inclined-plane 1 ' by the mode that shortens first chamfer length (L1 '), thus wound in the nothing when improving the inserting needle state and realizing that syringe needle uses.
Referring to shown in Figure 2, be the structural representation of this utility model syringe needle, and please with Fig. 1 relatively referring to, can clearly understanding be arranged to this utility model.Syringe needle of the present utility model comprises near first inclined-plane 1 of syringe rear end with near second inclined-plane 2 of needle point and forming jointly that wherein the axial length on first inclined-plane 1 is L1, and the axial length on second inclined-plane 2 is L2, and, L1<L2.Here, keep the inclined-plane total length L of existing syringe needle constant (, guaranteeing the injection volume and the matches criteria of pin water), by second inclined-plane 2 is made L1<L2 to the mode that first inclined-plane 1 prolongs to satisfy the medical apparatus and instruments existing standard.
In optimization experiment, find that second inclined-plane 2 extended to first inclined-plane 1 at 30%~50% o'clock, being equivalent to L2 is 65~75% of L, can obviously reduce the inserting needle resistance, and through simulation puncture experimental check, can not win artificial skin at the syringe needle of this range.
The design that this utility model is more optimized is on the basis of above-mentioned second inclined-plane, 2 prolongations 30%~50%, the interior pin cutting edge of a knife or a sword on first inclined-plane 1 is improved.
Referring to shown in Figure 3, the interior pin cutting edge of a knife or a sword on syringe needle first inclined-plane 1 is an axial symmetric camber line, extreme direction is camber line summit P1 behind the syringe needle, this utility model is should be moved to the P2 position backward by interior pin cutting edge of a knife or a sword camber line summit P1 by fluid sandblast mode, thereby form one section little concave arc 3 on interior pin cutting edge of a knife or a sword camber line top, these little concave arc 3 axial distances (distance of P1 to P2) S is 0.2 millimeter, and the arc length of little concave arc 3 is the girth of semicircle.
The detection of this utility model medical needle:
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, directly puncture to needle point until syringe needle and to pull out needle tubing immediately after without hindrance, 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 and under biological microscope, observe 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%.
2, piercing through power detects:
Method of testing:
A) with tested pin and simulated skin (polyurethane film, thickness 0.35mm ± 0.05mm, hardness: Shao Shi A85 ± 10) under 22 ℃ ± 2 ℃, place 24h at least, and under uniform temp, test;
B) simulated skin with appropriate size is clipped on the anchor clamps, must not have any tangible stretching or compression stress to be applied on the simulated skin;
C) tested syringe needle is contained in has pressure measuring element (the pressure transducer measuring range: on 0~50N) the transducing unit, its axis normal is in the surface of simulated skin, and needle point points to circular puncture zone (behind the clamping
Center 10mm);
D) mobile transducing unit, translational speed is set at 100mm/min, and tested syringe needle is implemented piercing process to circle puncture regional center;
E) in the piercing process, record the peak-peak power or the record power/displacement diagram of puncture simultaneously.
Test evaluation:
Peak-peak in the power/displacement diagram of gained (1.2 pin puncture forces≤1.15N) relatively, when peak-peak during smaller or equal to setting, then is judged to be this power that pierces through by chaining pin and meets the requirements with requiring the setting specification.Puncture force numerical value is more little, illustrates that the inserting needle resistance is more little, and inserting needle is smooth and easy more.
Tested syringe needle has: No. 12 conventional medical syringe needles (code name 0); Same model this utility model syringe needle: L2 lengthening 10% (code name 10), L2 lengthening 20% (code name 20) L2 lengthening 30% (code name 30), L2 40% (code name 40) that extend, L2 50% (code name 50) that extend, L2 60% (code name 60) that extend; L2 lengthening 30% is with little concave arc (code name 30B), and L2 lengthening 40% is with little concave arc (code name 40B), and L2 lengthening 50% is with little concave arc (code name 50B).
The testing result ginseng is shown in Table 1.From testing result as seen, second chamfer length of medical needle is in first inclined-plane has extended 30~50% scopes, no matter whether have little concave arc, pin water injection flow and traditional syringe needle relatively do not have significant change, but the particulate material won can not appear under the mirror, point out this syringe needle can not win tissue in use, belong to ultra-safe syringe needle; The granule won in a large number then can appear in traditional syringe needle (code name 0), points out it to have insecurity; The syringe needle of other processing (code name 10,20), more traditional syringe needle has bigger improvement, but still can win the part granule, still has potential safety hazard during use; And for the excessive syringe needle of extension amplitude (as code name 60), the rigidity of syringe needle own may be destroyed, and rigidity causes broken needle also to have other potential safety hazard inadequately.For the medical supplies that directly relate to personal life security; for respecting for life, exist the product of 1% potential safety hazard to use, therefore; the product that this utility model selection has being perfectly safe property, promptly the syringe needle of the second chamfer length elongation in 30~50% scopes is as the protection content.Someone may avoid this scope of application, as is chosen in 28% or 51% elongation and produces similar products, it should be understood that thisly to remain infringement of the present utility model for escaping the selection that infringement deliberately makes.
Table 1: different syringe needle result of use testing results
The syringe needle code name |
Inserting needle pierces through power |
Pin discharge |
Mirror is observed 0.1mm~0.2mm particulate matter down |
The wound rate |
0 |
≤1.15N |
Normally |
Particulate matter is arranged, particulate matter>0.2mm |
98~99% |
10 |
1.05N |
Normally |
Particulate matter is arranged, particulate matter 0.1mm~0.2mm, a small amount of>0.2mm |
40~45% |
20 |
1.00N |
Normally |
Substantially there is not particulate matter, particulate matter 0.1mm~0.2mm |
22~25% |
30 |
0.95N |
Normally |
No particulate matter |
0% |
30B |
0.88 |
Normally |
No particulate matter |
0% |
40 |
0.94N |
Normally |
No particulate matter |
0% |
40B |
0.86 |
Normally |
No particulate matter |
0% |
50 |
0.90N |
Normally |
No particulate matter |
0% |
50B |
0.85 |
Normally |
No particulate matter |
0% |
60 |
≤1.15N |
Normally |
No particulate matter |
0% |
On the other hand, more than experiment has also been verified, the prolongation of the second chamfer length L2 reduces the power that the pierces through numerical value of inserting needle, illustrates that the inserting needle resistance reduces, and inserting needle is more smooth and easy.The inserting needle resistance directly influences inserting needle amount of bleeding and patient's pain.The product that this utility model is selected owing to reduced the inserting needle resistance, causes the minimizing of inserting needle amount of bleeding and patient's pain to alleviate.And its biggest advantage of syringe needle that has little concave arc is more to alleviate the inserting needle resistance, reduces the inserting needle pain, alleviates the amount of bleeding after inserting needle finishes, thereby makes inserting needle more smooth and easy, and the resistance on first inclined-plane is thoroughly alleviated, and no longer tissue is cut off in cutting.
In sum as can be seen, this utility model the second chamfer length L2 is prolonged and in first inclined-plane pin cutting edge of a knife or a sword establish little concave arc, make syringe needle in piercing process, can not cause winning disconnected tissue, and the reduction of inserting needle puncture force, resistance are reduced, inserting needle is more smooth and easy, inserting needle amount of bleeding, pain alleviate, and therefore syringe needle of the present utility model is a safe medical needle head.