CN101122557B - Blood vessel implant conveyer air bubble removing method and device therefor - Google Patents
Blood vessel implant conveyer air bubble removing method and device therefor Download PDFInfo
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- CN101122557B CN101122557B CN200610030011XA CN200610030011A CN101122557B CN 101122557 B CN101122557 B CN 101122557B CN 200610030011X A CN200610030011X A CN 200610030011XA CN 200610030011 A CN200610030011 A CN 200610030011A CN 101122557 B CN101122557 B CN 101122557B
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- conveyer
- fluid injection
- closed container
- blood vessel
- implant
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Abstract
The invention relates to a method of eliminating bubbles in an implant conveyor in vascular and a device used for implementing the method, belonging to a medical instrument intervention in the vascular field, in particular to an implant in the vascular field. The method includes steps mentioned below. Firstly, a conveyor preassembled with an implant in vascular is arranged in an enclosed vessel. Secondly, a vacuum pumping processing is implemented on the enclosed vessel. Thirdly, medical liquid is injected in implant conveyor in vascular under the vacuum status. The used devices include the enclosed vessel, the conveyor preassembled with the implant in vascular and arranged in the enclosed vessel, an air pumping pipe for connecting the enclosed vessel and the vacuum pump and a filling device which is communicated with a filling port or an insert end of the implant conveyor in vascular. With the improvement of the packaging process and the packaging device for the implant in vascular and the conveyor, the device solves a retention problem of bubbles in the conveyor, which can bring great damage to a human body. And the preoperative preparation operation process of clinical doctors can be simplified.
Description
Technical field
The present invention relates to a kind ofly get rid of the method for blood vessel implant conveyer air bubble and implement the used device of this method, belong in the blood vessel especially blood vessel implant technical field of interventional medical device.
Background technology
Along with the continuous maturation of interventional technique in being rooted in the hearts of the people of treatment technology and the blood vessel is hindered by Wicresoft, the blood vessel implant iatrotechnics is used as the first-selected methods of treatment of the especially arterial vascular pathology of treatment vascular lesion just more and more.Most blood vessel implant all has supporting with it dedicated transport device and is contained in the conveyer in advance before dispatching from the factory.Before the blood vessel that conveyer is inserted as transfer passage, but must as liquaemin physiological saline the air in the conveyer be discharged with the medical use liquid of venoclysis with anticoagulation, so as not to when implant discharge the air intravasation, cause air embolism.The method of discharging air generally is to inject aforesaid medical use liquid by the liquid injection port of conveyer in conveyer, and allow conveyer keep the low attitude of the high tail end of insertion end, marginal not is gone into the liquid limit and is knocked conveyer gently and make attached to the bubble disengagement on conveyer inwall, push rod or the blood vessel implant, allows air discharge from insertion end.Problem is that the gap between push rod and the conveyer is generally very little, and liquid is difficult to very pass through swimmingly conveyer; And some blood vessel implant, as be in also to exist in the film-coated vascular support slit of folded state and be difficult to the air driven away in a large number.If in these gases even fraction enters entocranial artery or coronary artery in the support dispose procedure, promptly might lead to grave consequences, as paralysis, the forfeiture of some nervous functions, miocardial infarction, even life danger.
Summary of the invention
The invention discloses and a kind ofly get rid of the method for blood vessel implant conveyer air bubble and implement the used device of this method, by this method and use the used device of this method that blood vessel implant and conveyer are carried out special processing and can thoroughly remove the danger that retains the air embolism that causes because of air in the conveyer.
This method may further comprise the steps:
A. the conveyer that will pre-install blood vessel implant places in the closed container,
B. closed container is vacuumized processing,
C. under vacuum state, medical use liquid is injected blood vessel implant conveyer.
May further comprise the steps after the further improving of this method:
A. the conveyer that will pre-install blood vessel implant places in the closed container,
B. closed container is vacuumized processing,
C. in closed container, inject soluble gas,
D. again closed container is vacuumized processing,
E. under vacuum state, medical use liquid is injected blood vessel implant conveyer.
Described medical use liquid refers to directly to inject the liquid of blood vessel, as physiological saline, glucose injection, uses the liquaemin physiological saline with anticoagulation usually.Described blood vessel implant is meant can be with the medicine equipment that does not contain air bag or closed cavity structure in the blood vessel interventional method implant into body, mainly comprise intravascular stent, overlay film frame in the blood vessel, vascular filter, blood vessel blocking device, hemangioma filling turn and door vena systemica shunting support, wherein most importantly overlay film frame and blood vessel blocking device in the blood vessel.The implant that contains air bag or closed cavity structure may suffer damage because of external pressure lowers described vacuumizing in the processing procedure, so inapplicable this method.Described soluble gas is meant the gas that dissolves in medical use liquid or blood and human body is not damaged after processing, as carbon dioxide, water vapor, ammonia or hydrogen chloride gas.Consider convenience and clinical use experience preferably carbon dioxide gas, carbon dioxide gas can be as the intravascular contrast media at position except that cardiovascular and cerebrovascular, and ammonia and hydrogen chloride gas need with corresponding acidity or alkaline buffer solution flushing after liquid injects, neutralizing just is unlikely to human body is damaged; Though water vapor is harmless, inflation the time can make closed container, blood vessel implant and conveyer be heated, and water has a breeding that is beneficial to microorganism, is unfavorable for the maintenance of blood vessel implant and conveyer germ-free condition when transportation and storage.Back three's advantage is that the effect of eliminating bubble is more reliable.
Method after the improvement can implementation step C, D once, also can repeat to implement once more than, this depends on and vacuumizes the level of vacuum that can reach at every turn, accessible vacuum tightness is high more, required multiplicity is few more.
Implementing the used device of this method comprises: closed container, the conveyer of blood vessel implant that placed prepackage in the closed container connects the exhaust tube of closed container and vacuum pump, the priming device that is connected with blood vessel implant conveyer liquid injection port or insertion end.Described closed container can be the sealed tube of hard, also can be soft sealing bag.
Further improvement to this device comprises: on the basis of aforementioned means, increase the draft tube that is used to connect closed container and soluble gas input media, this draft tube can directly be connected with closed container, also can be connected, and be connected with space in the closed container by priming device and blood vessel implant conveyer with priming device.Described priming device is to inject medical use liquid by this device, can not destroy the structure of closing the container vacuum state in accumulating and fluid injection process again simultaneously; Described blood vessel implant conveyer insertion end is meant that it inserts an endovascular end when using, and the other end is a tail end.
This device is under the situation that does not change blood vessel implant and conveyer construction, by improvement to conveyer packaging process and packing device, solved and to have caused the conveyer air bubble of great harm to retain problem to human body, and, can also simplify clinician's the preceding beamhouse operation process of art, therefore have a good application prospect.
Description of drawings
Fig. 1 has pre-installed the conveyer synoptic diagram of support
Fig. 2 has pre-installed local amplification of conveyer insertion end of support
Fig. 3 comprises the bubble remover synoptic diagram of negative pressure box and filling head
Fig. 4 filling head sectional view
Fig. 5 conveyer joint sleeve and conveyer insertion end synoptic diagram
Fig. 6 conveyer joint sleeve and conveyer insertion end part sectioned view
Fig. 7 comprises the bubble remover synoptic diagram of negative pressure box and fluid injection capsule
Fig. 8 comprises the bubble remover synoptic diagram of stay pipe and fluid injection capsule
Fig. 9 comprises the bubble remover synoptic diagram of filling head and gas-filled tube
Figure 10 comprises the bubble remover synoptic diagram of fluid injection capsule and gas-filled tube
Figure 11 comprises the bubble remover fluid injection process synoptic diagram of negative pressure box and fluid injection capsule
Figure 12 comprises the bubble remover fluid injection process synoptic diagram of stay pipe and fluid injection capsule
Figure 13 comprises the bubble remover synoptic diagram of multiple self-locking seal bar opening
The multiple self-locking seal bar of Figure 14 sectional view
Figure 15 comprises the bubble remover synoptic diagram of clips opening
Figure 16 clips side view
Figure 17 clips sectional view
Embodiment
The present invention is further elaborated below in conjunction with embodiment, and described blood vessel implant is example with the intravascular stent.
Embodiment 1
With reference to figure 1-6, this device comprises: sealing bag 11, the conveyer 2 of having pre-installed intravascular stent 21 places in the sealing bag 11, negative pressure box 12, described negative pressure box 12 is communicated with conveyer insertion end 22 by a conveyer joint sleeve 9, there are 3, one filling heads 42 of an exhaust tube that can be communicated with to be communicated with conveyer liquid injection port 24 on the negative pressure box 12 through fluid injection connecting pipe 41 with vacuum pump; Conveyer tail end 23 and insertion end 22 all have slit 25 or the passage that communicates with space, conveyer inner support place.Described negative pressure box 12 is a closed container that can resist atmospheric pressure, its role is to hold remaining gas and make the vacuum state that keeps higher level in the sealing bag when injecting liquid in conveyer.Described conveyer joint sleeve 9 is made up of a horn-like hard tube 91 and the soft ring 92 of liner resilient material, and its effect is airtightly to be connected and don't to damage conveyer with conveyer insertion end 22 realizes conveniently freeing.Described filling head 42 is the device of a similar infusion bottle bottleneck structure, and hard shell 421 1 ends and 41 airtight connections of fluid injection connecting pipe, the other end are 422 sealings of resilient material cork, puncture cork 422 when conveyer injects liquid.
Using method may further comprise the steps:
Dispatch from the factory pre-treatment and accumulating
1. connect vacuum pump and sealing bag 11 vacuumized processing,
2. seal exhaust tube 3, releasing is connected with vacuum pump,
3. store and transportation,
Clinical use
1. conveyer 2 is placed the low state of the high tail end of insertion end,
2. with large syringe puncture filling head cork 422, in filling head, inject medical use liquid 45,
3. when sufficient liquid to be had enters the negative pressure box 12, set level conveyer 2,
4. break exhaust tube 3, the negative pressure state of depressurization bag 11,
5. take out conveyer 2, close liquid injection port 24,
6. can use.
With reference to figure 7,11, embodiment 1 described filling head 42 is replaced with fluid injection capsule 43, and the fluid injection switch 44 of a clamped-in style is set on the fluid injection connecting pipe, improved purpose is to cause air accident to enter conveyer because of misoperation, syringe needle in conjunction with gas leakage between imprecision or syringe pintle and the sleeve with syringe puncture filling head and the process of injecting liquid in order to prevent.Described fluid injection capsule 43 is one and the similar soft bag of common transfusion bags, with 41 airtight connections of fluid injection connecting pipe.
Using method may further comprise the steps:
Dispatch from the factory pre-treatment and accumulating
1. fluid injection is opened 44 passes and places opening,
2. connect vacuum pump and sealing bag 11 vacuumized processing,
3. seal exhaust tube 3, releasing is connected with vacuum pump,
4. fluid injection switch 44 is placed closed condition,
5. store and transportation,
Clinical use
6. puncture fluid injection capsule 43 injects the capacity medical use liquid in the capsule bag,
7. conveyer 2 is placed the low state of the high tail end of insertion end,
8. open fluid injection switch 44, liquid enters conveyer automatically,
9. sufficient liquid to be had enters negative pressure box 12 and in the fluid injection capsule 43 still during retain liquid, sets level conveyer,
10. break exhaust tube 3, the negative pressure state of depressurization bag 11,
11. the taking-up conveyer cuts out liquid injection port 24,
12. can use.
With reference to figure 8,12, this device comprises that one one end inserts the sealing bag 11 of one section stay pipe 13, the conveyer 2 that one cover has been pre-installed intravascular stent places in the sealing bag, conveyer tail end 23 and liquid injection port 24 place in the stay pipe 13, being positioned at the outer fluid injection capsule 43 of sealing bag is communicated with conveyer insertion end 22 through the fluid injection connecting pipe 41 and the conveyer joint sleeve 9 of band fluid injection switch 44, conveyer 22 insertion ends leave slit or the passage that communicates with space, conveyer inner support place, and conveyer liquid injection port 24 places the release position; A connection vacuum pump exhaust tube 3 is arranged on the sealing bag.Described stay pipe 13 can be the hard tube of one section suitable dimension, and its effect is similar to aforesaid negative pressure 12 boxes, and the stay pipe two ends are made duckbill and removed corner angle, can reduce the possibility of vacuum state lower seal bag 11 breakages; Described exhaust tube 3 is from stretching into the through conveyer tail ends of sealing bag 11 near the conveyer insertion end, and in its part that is positioned at sealing bag a plurality of side openings 31 is set, and helps thoroughly extracting out the gas in the sealing bag.The inboard of one side at least at sealing bag is provided with one deck fabric, can increase the fastness of sealing bag, and helps getting rid of the bubble that may be closed in the part.
Using method may further comprise the steps:
Dispatch from the factory pre-treatment and accumulating
1. fluid injection switch 44 is placed opening,
2. connect vacuum pump and sealed tube 11 vacuumized processing,
3. seal exhaust tube 3, releasing is connected with vacuum pump,
4. fluid injection switch 44 is placed closed condition.
5. store and transportation,
Clinical use
6. puncture fluid injection capsule 43 injects capacity medical use liquid 45 in the capsule bag,
7. conveyer is placed the high state of the low tail end of insertion end 22 23,
8. open switch 44, liquid enters conveyer automatically,
9. treated that sufficient liquid 45 flows out and in the fluid injection capsule 43 still during retain liquid, sets level conveyer from conveyer liquid injection port 24,
10. the negative pressure state of depressurization bag 11
11. the taking-up conveyer cuts out liquid injection port 24,
12. can use.
Embodiment 4
With reference to figure 8,9,10, on the basis of the used bubble remover of embodiment 1,2,3, increase the gas-filled tube 5 that can be communicated with priming device and soluble gas injection device, the soluble gas that present embodiment uses is carbon dioxide, and the soluble gas injection device is the carbon dioxide gas-holder.Gas-filled tube and priming device are connected with and are beneficial to the air of replacing more up hill and dale in the priming device.
Using method may further comprise the steps:
Dispatch from the factory pre-treatment and accumulating
1. the fluid injection switch is put 44 in opening,
2. with vacuum pump sealing bag is vacuumized processing,
3. injecting carbon dioxide,
4. once more sealing bag is vacuumized processing,
5. repeating step 2,3,
6. sealing exhaust tube 3 and gas-filled tube 5, and being connected of releasing and vacuum pump and carbon dioxide gas-holder,
7. fluid injection switch 44 is placed closed condition,
8. store and transportation,
Clinical use
Identical with corresponding embodiment 1,2,3.
With reference to Figure 13,14,15,16,17, the described device of embodiment 1-4, implement in manufacturer because of handling early stage, so it is applied and depends on manufacturer and adopt this technology, present embodiment is provided with a self-enclosed opening 14 on the used sealing bag of embodiment 3, and vacuum pump at the scene, and then whole implementation process all can be finished at operative site, this means that this device can be in clinical use rig-site utilization in existing commercial intravascular stent conveyor system.Described self-enclosed opening 14 refers to can not implement to seal by other special implements the hatch frame of processing, can use multiple self-locking seal bar 141 or clips 142 structures, the former is usually used in the food preservation bag these two kinds of hermetically-sealed constructions, the latter is usually used in the vacuum storing bag of under negative pressure state stores clothes or cotton-wadded quilt, and market is on sale.Multiple self-locking seal bar 141 is formed by being positioned at many cylindric raised lines 1411 that seal sack 14 1 sides and being positioned at the corresponding groove 1412 of sealing sack 14 opposite sides.Clips 142 is made up of two jig arm 1421, folder axle 1422 and snap close 1423, article two, be provided with concavo-convex relative resilient material cushion 14211 on the jig arm respectively, clamping sealing sack 14 with arm 1421 during use can seal it, by snap close 1423 retaining clip tightening seal states.
Using method may further comprise the steps:
With stand-by prepackage the conveyer of intravascular stent put into sealing bag by self-enclosed opening 14, the conveyer liquid injection port places the release position,
And the conveyer insertion end is connected with the conveyer joint sleeve appropriate,
3. close encapsulation bag opening 14,
4. the fluid injection switch is placed opening,
5. connect vacuum pump and sealing bag vacuumized processing,
6. sealing exhaust tube is removed and being connected of vacuum pump,
7. the fluid injection switch is placed closed condition.
8. puncture fluid injection capsule injects the capacity medical use liquid in the capsule bag,
9. bracket conveyer is placed insertion end to hang down the high state of tail end,
10. open the fluid injection switch, liquid enters conveyer automatically,
Flow out and in the fluid injection capsule still during retain liquid, set level conveyer from the conveyer liquid injection port 11. treated sufficient liquid,
12. the negative pressure state of depressurization bag,
13. the taking-up conveyer cuts out liquid injection port,
14. can use.
Embodiment 6
If support and conveyer can be preserved in the following long period of state of injecting medical use liquid, then use the whole exhaust fluid injection process of this patent method to finish at production site.Perhaps, inject the liquid such as the distilled water that can allow a small amount of intravasation again with the induction system long preservation at production site, using the scene with suitable liquid such as liquaemin physiological saline are injected conveyer from liquid injection port, the liquid that displacement conveyer preservation state uses down also can reach the purpose of avoiding air embolism to take place.Based on the strictness operation of production site, can save described disposable use filling head or fluid injection bag in the device of use, liquid injection pipe directly is connected with liquid-injection equipment such as automatic injector, still can reach the effect of avoiding air to enter conveyer.Can further save cost like this and simplify clinician's operation steps.
What need additional disclosure is, because of support and conveyer thereof should be in germ-free condition in use, as sterilize and use the method that contacts with sterile medium, stifling as epoxy acetate gas, should before packing, finish sterilization process, packaging process should carry out in gnotobasis, uses sterilizable material and carries out sterile working; As sterilize and use non-medium contact sterilization method, as the radioactive ray irradiation sterilization, then require wrappage can tolerate this sterilization process and be not destroyed.
Claims (13)
1. bubble remover of getting rid of blood vessel implant conveyer air bubble, it is characterized in that this device comprises: closed container, the conveyer of blood vessel implant that placed prepackage in the closed container, the exhaust tube that is communicated with closed container and vacuum pump, the priming device that is connected with blood vessel implant conveyer liquid injection port or insertion end.
2. bubble remover as claimed in claim 1, it is characterized in that this device also comprises the gas-filled tube that is used to be communicated with closed container and soluble gas input media, this gas-filled tube directly is connected with closed container, or be connected, and be connected with space in the closed container by priming device and blood vessel implant conveyer with described priming device.
3. bubble remover as claimed in claim 1 or 2 is characterized in that described blood vessel implant is an intravascular stent.
4. bubble remover as claimed in claim 3 is characterized in that described closed container is made up of sealing bag, negative pressure box and conveyer joint sleeve, and exhaust tube is communicated with the negative pressure box; The negative pressure box is communicated with the conveyer insertion end by the conveyer joint sleeve, and conveyer insertion end and tail end leave slit or the passage that communicates with space, conveyer inner support place; Described priming device comprises filling head and fluid injection connecting pipe, and filling head is connected with the blood vessel implant conveyer liquid injection port by the fluid injection connecting pipe.
5. bubble remover as claimed in claim 3 is characterized in that described priming device comprises fluid injection capsule, fluid injection connecting pipe and fluid injection switch, and the fluid injection capsule is communicated with the conveyer liquid injection port by the fluid injection connecting pipe, and the fluid injection switch is positioned on the fluid injection connecting pipe.
6. bubble remover as claimed in claim 3 is characterized in that described closed container is a sealing bag of inserting one section stay pipe, and the conveyer tail end comprises that liquid injection port places stay pipe; Described priming device comprises fluid injection capsule, fluid injection connecting pipe, conveyer joint sleeve and fluid injection switch, and the fluid injection capsule is communicated with the conveyer insertion end through fluid injection connecting pipe and conveyer joint sleeve, and the fluid injection switch is positioned on the fluid injection connecting pipe; The conveyer insertion end leaves slit or the passage that communicates with space, conveyer inner support place, and the conveyer liquid injection port places open state.
7. bubble remover as claimed in claim 1 is characterized in that a self-enclosed opening is arranged on the described closed container.
8. bubble remover as claimed in claim 1 is characterized in that described self-enclosed opening is the sack structure with multiple self-locking seal bar or clips.
9. the using method of bubble remover as claimed in claim 1 is characterized in that may further comprise the steps:
A. the conveyer that will adorn blood vessel implant pre-places in the closed container,
B. closed container is vacuumized processing,
C. under vacuum state, medical use liquid is injected blood vessel implant conveyer.
10. the using method of bubble remover as claimed in claim 2 is characterized in that may further comprise the steps
A. the conveyer that will adorn blood vessel implant pre-places in the closed container,
B. closed container is vacuumized processing,
C. in closed container, inject soluble gas,
D. once more closed container is vacuumized processing,
E. repeating step C and D are n time,
F. under vacuum state, medical use liquid is injected blood vessel implant conveyer,
Wherein n is the integer more than or equal to 0.
11. using method as claimed in claim 10 is characterized in that described soluble gas is carbon dioxide gas, hydrogen chloride gas, ammonia or water vapor.
12. using method as claimed in claim 11 is characterized in that described soluble gas is a carbon dioxide gas.
13., it is characterized in that described operation steps all finishes at production site as claim 9 or 10 described using method.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200610030011XA CN101122557B (en) | 2006-08-11 | 2006-08-11 | Blood vessel implant conveyer air bubble removing method and device therefor |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200610030011XA CN101122557B (en) | 2006-08-11 | 2006-08-11 | Blood vessel implant conveyer air bubble removing method and device therefor |
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| Publication Number | Publication Date |
|---|---|
| CN101122557A CN101122557A (en) | 2008-02-13 |
| CN101122557B true CN101122557B (en) | 2011-06-15 |
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| CN200610030011XA Expired - Fee Related CN101122557B (en) | 2006-08-11 | 2006-08-11 | Blood vessel implant conveyer air bubble removing method and device therefor |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US10729880B2 (en) | 2017-02-01 | 2020-08-04 | Cook Medical Technologies Llc | Packaged intravascular medical device with variable viscosity intravenous liquid solution |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101472530A (en) * | 2006-05-12 | 2009-07-01 | 华沙整形外科股份有限公司 | Instruments and methods for delivering multiple implants |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101472530A (en) * | 2006-05-12 | 2009-07-01 | 华沙整形外科股份有限公司 | Instruments and methods for delivering multiple implants |
Non-Patent Citations (1)
| Title |
|---|
| JP特开平5-56984A 1993.03.09 |
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Granted publication date: 20110615 Termination date: 20130811 |