Background technique
Use various types of medical fluid infusion devices that the liquid of controlled quatity and/or gaseous matter are transfused to disease
People, a typical field is Image Diagnosis, especially digital subtraction angiography (Digital Subtraction
Angiography, DSA).Implement DSA be related to for carbon dioxide gas or other contrast agent being infused into the vascular system of patient with
Patient blood is replaced, the X-ray image shot before and after contrast agent will be injected and be digitized input picture computer, by subtracting shadow, increasing
The processes such as strong and reimaging obtain the better blood vessel image of effect.DSA is mainly used for observing vascular lesion, and hemadostewnosis is determined
Position measurement, and true stereo-picture is provided for interventional therapy, it is the necessary condition of various interventional therapy.Suitable for heart and brain blood
Pipe, peripheral blood vessel, the inspection of tumour and interventional minimally-invasive treatment etc..
Existing experience shows that carbon dioxide is a kind of good fluid, can be used to replace blood in blood vessel so as to
Gap is created in blood vessel, and is visualized by DSA.But due to carbon dioxide gas be it is colorless and transparent and sightless,
Therefore it is easy for normal air to be mixed into the vascular system of patient when being transfused carbon dioxide gas, and air once enters patient
Vascular system, may result in angiemphraxis, even result in cerebral embolism, apoplexy or death.
It is meaningful using sealing system safe infusion carbon dioxide due to this serious safety problem.Traditional
Method is that syringe is connected to high-pressure carbon dioxide gas tank, the filling arbon dioxide into syringe, then by syringe from gas
Tank disconnects and is connected to the conduit connecting with patient or pipe group, to be transfused the carbon dioxide of controlled amounts to patient.If necessary
Syringe and conduit or pipe group are then disconnected, repeat the above process by more carbon dioxide.However, due to by syringe needle
Head connect the amount of carbon dioxide that may cause syringe suction with high-pressure carbon dioxide gas tank greater than actual demand amount, and will injection
Device and conduit or pipe group disconnect the process reconnected and are easy to cause the vascular system for introducing air into patient.
It once attempted the three port plug valves by one with syringe and is connected to high-pressure carbon dioxide gas tank and patient's conduit
Between, a port of plug valve connects syringe, and another two port is connected respectively to patient's conduit and high-pressure carbon dioxide gas
Tank, but due to the pressure of carbon dioxide gas tank be much higher than blood pressure, if plug valve turns in the wrong direction, make high-pressure carbon dioxide gas source with
Patient's conduit is directly connected, and will lead to gas tank and is in a very short period of time infused into patient body great amount of carbon dioxide and causes thing
Therefore.
A kind of closed infusion system of the U.S. Patent Publication of Patent No. 6315762, is up to 2000ml's for capacity
Contrast agent sack is first coupled to high-pressure carbon dioxide gas tank, after obtaining the gas that pressure is sustained, then passes through a rotation again
Plug valve and the threeway with syringe and two check valves are connected to patient's conduit, are pushed away by the drawing of syringe by carbon dioxide gas
It is infused into patient.The system is disadvantageous in that, on the one hand, even across repeatedly repeatedly fill carbon dioxide gas side by side
Sky, sack is retained there are still inside the potential risk for not draining air.On the other hand, it is isolated when although being normally transfused gas
High pressure gas holder, but sack capacity is larger, sack is accidentally squeezed in the case that plug valve is in and opens, since air pressure rises suddenly
Height, two check valves in threeway can still be connected cause to have by one it is dangerous and may be fatal amount carbon dioxide gas outburst
Property it is infused to the risk of the vascular system of patient.
The Chinese patent of Patent No. 103596619 discloses a kind of closed infusion system, by utilizing multistage valve,
Such as one the changeover valve of T-shaped structure of K shape valve module or two interconnections constitute multistage extrusion infusing pipeline and realize fluid source and enter people
The isolation of the conduit of body, there is no the risks for being transfused excess fluid to patient suddenly, therefore have the characteristics that safe fool proof (exists
High-pressure fluid source connect in systems, and be unaware that or not according in normal operating requirement opening system it is each manually it is operable
In the case where valve, it will not lead to be transfused excess fluid explosively to patient).The system is due to during providing medical fluid
Need not system component be disconnected and be reconnected, also greatly reduce probability of the air intrusion into system and the fluid of supply.
But the system is transfused carbon dioxide using at least two syringes, every to complete primary infusion movement and need to two syringes
Piston carries out drawing push operation respectively, therefore using relative complex cumbersome.In addition, when connecting high-pressure fluid source, from high-pressure fluid
The nearest syringe in source is easy to happen the accident impacted and fallen off by high-pressure fluid.
Summary of the invention
Therefore, the purpose of the present invention is to provide the components that the fluid of controlled doses is safely and reliably transfused to patient by one kind
And system, it almost can be safely and effectively used cooperatively with any carbon dioxide source or other medical fluid sources, regardless of fluid
Which type of it is maintained under pressure or environment.Further, medical fluid infusion component of the invention and system can be particularly effectively
Carbon dioxide or other contrast fluids are infused to the vascular system of patient in a controlled manner and obtains quality and more preferably puts
Penetrate image.Further, medical fluid infusion component of the invention and system can be effectively prevented the air of potential danger amount into
Enter fluid and is supplied to patient.In a preferred embodiment, medical fluid infusion component of the invention and system can provide foot
Enough fault secures and Anti-stiff operation only allow medical fluid being supplied to patient with reliable and accurate controlled dosage.It is special
Not advantageously, medical fluid infusion component of the invention and system can use relatively little of component to constitute infusion system, and grasp
Make simple.
On the one hand, the present invention relates to a kind of medical fluid infusion component, for by medical fluid from fluid source controlled delivery
To patient, comprising: input valve module, output valve module and the utricule being connected between input valve module and output valve module.By
The fluid in medical fluid source can be sustained in utricule, therefore the infusion assembly can be directly connected to high-pressure fluid source and make
With, and reduce impact of the high-pressure fluid to output valve module.
Preferably, the utricule has fluid inlet port and fluid export port, and the fluid inlet port is connected to
The input valve module, the fluid export port are connected to the output valve module.
Preferably, the output valve module includes the valve body of input port, output port and Centronics port, the input terminal
Mouth can be fluidly connected to the fluid export port, and the output port can be fluidly connected to output duct, the centre
Port is connected to syringe.
Preferably, the output valve module further includes syringe, and the syringe is connected to the Centronics port.
Preferably, the output valve module includes being rotatably mounted in the intracorporal plug valve of the valve, for selectively
Any the two being connected in the input port, the Centronics port and the output port.It is particularly preferred that the plug valve
For that can and can only select between the two positions, that is, the position for being connected to the input port and the Centronics port is selected, and
Selection is connected to the position of the Centronics port and the output port.
Preferably, check valve is provided in the input port and the output port.
Preferably, the input valve module includes the first port for being connected to the medical fluid source, for connecting
To the second port of the fluid inlet port of the utricule, and it is set between the first port and the second port
, the slow release valve for being input to the utricule for manipulating fluid.
Preferably, the slow release valve is plug valve.
Preferably, check valve is provided in the first port.
Preferably, the first port connects the medical fluid source with female Luer by the medical tube of coiling.More
Preferably, wherein being provided with check valve in the female Luer.
Preferably, the infusion assembly further includes a box body, and the utricule is set in the box body.
Preferably, the input valve module and the utricule are all set in the box body.It is particularly preferred that described at this time
The slow release valve for inputting valve module is hanging plug valve.
Preferably, further comprise the downstream valve for being connected to the output valve module, for it is following at least one: it is clear
Except the fluid in the medical fluid infusion component, other streams of conveying in addition to the fluid into the conduit for entering patient
Body.
Preferably, the upstream of utricule is provided with filter, to filter out bacterium and the particle in fluid.
Preferably, the downstream of utricule is provided with fluid test paper, to indicate whether fluid reaches utricule downstream.
On the other hand, the invention further relates to a kind of fluid infusion systems, including fluid source, such as above-mentioned various medical fluids
Infusion assembly, and enter patient's conduit in patient body.
According to the description below to attached drawing and preferred embodiment, other targets of the invention, feature and advantage be will become apparent from out
Come.
Specific embodiment
Fig. 1, which is schematically depicted, is controllably infused into the stream of patient for medical fluid, such as contrast agent carbon dioxide gas
Body infusion system 1.System 1 includes fluid source 11, is, for example, high-pressure carbon dioxide gas tank, infusion assembly 10, for that will come from
The fluid controllable of fluid source 11 is infused into patient 12.Pass through medical catheter 8,9 between fluid source 11, infusion assembly 10 and patient 12
Connection.
Fig. 2 show the defeated of the medical fluid for being transfused controlled dose for being transfused contrast agent carbon dioxide gas
Infuse component 10.Infusion assembly 10 includes input valve module 15, output valve module 16 and is connected to input valve module 15 and delivery valve
Between component 16, the utricule 30 with fluid inlet port 45 and fluid export port 46.Input valve module 15 is for that can be connected to
Ground is connected to medical high-pressure fluid source such as high-pressure carbon dioxide gas tank, and by the fluid inlet port 45 of utricule 30 to utricule 30
Input carbon dioxide gas.Utricule 30 is for playing reduction to the carbon dioxide gas especially high-pressure carbon dioxide gas of input
The buffer function of pressure and flow velocity.Output valve module 16 is for that can be fluidly connected to patient, and the fluid for passing through utricule 30 is defeated
The carbon dioxide gas buffered to be infused into the vascular system of patient by exit port 46.
Utricule 30 is made of soft elastomer, pore-free material, has the ability for accommodating certain capacity fluid.It is so-called herein
Capacity refers to when utricule 30 fills the body that fluid makes its internal pressure equal to the accommodated fluid of utricule in the case where ambient atmosphere pressure
Product.The capacity of utricule 30 can according to different demands make various specifications capacity, such as 50ml, 70ml, 100ml, 150ml,
200ml, 500ml, 1000ml, 2000ml etc..But preferably due to can be directly connected to fluid source can be with using, utricule
Suitably select relatively small capacity, e.g., less than or equal to 50ml, 70ml, 100ml, 150ml, 200ml etc..Fig. 2 is typically
The utricule 30 that capacity is 50ml is shown, the appearance of utricule 30 can be labelled on 30 outer surface of utricule with scale 31 or word tag 32
Amount.
Input valve module 15 includes the slow release valve 41 for manipulating high-pressure fluid input, for being connected to the port of fluid source
47, and the port 48 of the fluid inlet port 45 for being connected to utricule 30.Port 47 and fluid source such as high-pressure carbon dioxide
Medical input pipe 28 between gas tank generally by coiling connects.
Slow release valve 41 shown in Figure 2 is plug valve, and the direction for changing valve rod 42 can open, close slow release valve 41 and adjust
The fluid flow of the slow release valve that throttled 41.Preferably, slow release valve 41 can be the hanging plug valve for pressing formula as described later.
In order to filter out bacterium and the impurity in fluid, it is such as mixed into the molecule in gas, utricule can be inputted in fluid
Filter (not shown) is arranged in preceding pipeline to be filtered fluid, for example, being arranged filter in port 47 or port 48
It is interior.Preferably, filter is positioned close in the port 48 of utricule 30 to filter out the fluid impurity into utricule 30 as far as possible.It crosses
Filter is preferably micro-strainer, is generally made of the miillpore filter of single-layer or multi-layer, such as filter membrane is continuously folded to constitute
Micro-strainer.The material of miillpore filter can be from polytetrafluoroethylene (PTFE) (PTFE), polyether sulfone (PES), poly- third according to the difference of fluid
Alkene (PP), cellulose acetate (CA), nitrocellulose (NC), mixed cellulose ester (MCE), Kynoar (PVD), nylon
(Nylon) etc. it is selected.
Exporting valve module 16 includes the valve body 33 for being on the whole usually T-type, and there are three fluid delivery ports 34,35,36 for tool.
Generally but it will limit ground, two of them port such as port 34 and port 36 are located along the same line, and respectively become input port
And output port, and the pipeline axis in such as port 35 of another port becomes Centronics port perpendicular to the straight line.Such as Fig. 2
Shown, middle port 34 is connect with the fluid export port 46 of utricule 30, and for connecting with syringe 80, port 36 is used for port 35
Yu Yuyi output duct such as medical catheter 60 connects.
Exporting valve module 16 further comprises a plug valve 51, and plug valve 51 is rotatably installed in valve body 33.One valve
Bar 56 is mounted on valve body 33, for being selectively rotated one of position selected in 51 to three positions of plug valve,
It is connected to port 34 with port 35, or is connected to port 35 with port 36, or be connected to port 34 with port 36.However, one
In a preferred embodiment, valve rod 56 can only selectively rotate plug valve 51 to selected wherein one in two positions
A position even if also port 34 is connected to port 35, or is connected to port 35 with port 36, but cannot select to make port 34 and end
Mouth 36 is connected to.As shown in Figure 2, when arrow 57 indicates that valve rod 56 is directed toward 35 direction of port, port 34 is connected to port 35, works as valve
When bar 56 turns to direction 36 direction of port, port 35 is connected to port 36, and valve rod can only rotate between the two positions.By
It will not be connected in port 34 with port 36, fluid source is isolated with medical catheter 60 and the aftermentioned conduit entered in patient body,
Therefore, even if the fluid source of access is high-pressure fluid source, it will not be directly connected to patient's conduit, with safe fool proof
Effect.
Infusion assembly 10 further comprises syringe 80.Syringe 80 is used for and note for being connected in output valve module 16
On the port such as port 35 of emitter connection.Syringe 80 is typically plug-type syringe, has push-pull rod 81, push-pull rod 81
Syringe piston can be pushed and pulled to draw fluid into syringe or the fluid in syringe is discharged.Syringe 80 and port 35
Connection is met medical seal and is connected with the connector of firm requirement by various.Medical tubing jointing such as Shandong typically and preferably
That connector.Female Luer concrete details is well known for a person skilled in the art.Syringe 80 is shown in Fig. 2
Female Luer 82 and match therewith, female Luer 55 on port 35.The general root of piston cylinder capacity of syringe 80
According to the Fluid Volume determination for wanting a secondary infusion.For example, the piston cylinder capacity of syringe 80 can for contrast agent carbon dioxide gas
Think 20ml or 25ml.
Fluid inversely flows to fluid source in order to prevent, check valve can be arranged in port 47 or port 48, show in Fig. 2
Check valve 49 is provided at port 47.To prevent fluid from inversely flowing to utricule 30 and valve body 16, can be set in port 34 and port 36
Check valve is set, as shown in Fig. 2, being provided with check valve 52 at port 34, check valve 53 is provided at port 36.
Preferably, the input valve module 15 of infusion assembly 10, output valve module 16 and utricule 30 are permanently connected, pipe therein
Each component such as road, valve, utricule can be born from environmental pressure up to nearly ten the even fluid of more than ten a standard atmospheric pressures,
Such as 10 standard atmospheric pressures even fluid of about 15 standard atmospheric pressures can be born, so that the component can be straight with high-pressure injector
Use is connect in succession.
Preferably, the medical input pipe 28 for connecting with fluid source can be a part of input valve module 15, and
One end can for good and all connect with the port 47 of input valve module 15 and the other end with (not scheming with fluid source output pipe connector
Show) connection female Luer 20, as shown in Figure 3.Certainly, medical input pipe 28 and port 47 can also by a female Luer into
Row is detachably connected.Further, medical input pipe 28 is provided with check valve 24,20 structure of female Luer near female Luer 20
At a port connector of check valve 24, and the another port of check valve 24 is connected by female Luer 26 and medical input pipe 28
It connects, so as to prevent fluid from inversely flowing to fluid source.Medical input pipe 28 is typical generally with the length of 10cm to 100cm
Ground is for example about 30cm to 60cm, is preferably for example about 40cm to 50cm.In order to protect medical input pipe 28 preceding not in use
It is contaminated, there are common reagent seals 22 at female Luer 20.Certainly, one end of medical input pipe 28 can also pass through example
If female Luer and the port 47 of input valve module 15 are detachably connected, and the other end is directly connected to fluid source or is connected to
Check valve 24 with female Luer 20.
Referring to fig. 2, the medical tube 60 of coiling can be a part of output valve module 16, one end and output valve module 16
Port 36 can be permanently connected.Certainly, medical tube 60 can also removably be connected with port 36 by a female Luer
It connects.With further reference to Fig. 4, generally, medical tube 60 need to be connected to patient's conduit 18 by a downstream valve 64.There are various both ends
Mouth or three port plug valves can be used in downstream valve 64.In a specific embodiment shown in Fig. 4, downstream valve 64 is that have
The plug valve 70 of three ports, middle port 62 are connected to medical tube 60, and by rotatably operating valve lever 73 come selective
Ground is discharged from whole system by Single port 72 or removes fluid, such as emptying the air in utricule 30, or has selection
Whole system is connected to property by patient's conduit 18 by port 74.Downstream valve 64 includes a check valve 66, to limit fluid only
It can be along the flowing from medical tube 60 by direction shown in valve 64 to arrow 68.In order to guarantee that downstream valve 64 is not got dirty using preceding
It contaminates, is provided with common reagent seals at port 72.Common reagent seals have good Fluid Sealing effect, but its
Material again be particularly suitable for such as the syringe needle of syringe, female Luer tapered front end puncture component penetrate, to lead to when needed
It crosses syringe or other conduits and is transfused other contrast agent or medicament from port 72 to patient's conduit 18.Patent No. 103596619
Chinese patent disclose the downstream valve module and its usage mode of multiple structural forms, as space is limited, the present invention is herein by it
It is fully incorporated using as reference.
Each component of infusion assembly can be separately formed, and permanently connected place is being needed to connect using the airtight combination of the techniques such as welding
It connects.Preferably, valve body 33 is made of polymer, metal and/or the metal alloy of various medical grades.In general, valve body 33 wraps
Include the integral structure of molding process manufactures that an injection molding technique manufactures or other.Preferably, utricule 30 is using various soft
The good high resiliency medical polymer material of soft and air-tightness, such as latex, nylon (Nylon) use such as dip molding, injection
The manufacture of the techniques such as molding.Various medical catheters are preferably manufactured using the polymer extrusion molding process of various medical grades.It is defeated
Note each component of component integrally formed can also make, and preferably be manufactured at this time using the polymer material of various medical grades,
If needing that multicomponent injection molding process can be used using the manufacture of different polymer materials for utricule, valve body and conduit
Whole manufacture.
Fig. 5 shows another specific embodiment of infusion assembly 10 of the present invention.In this embodiment, utricule 30 is arranged
In an at least partly transparent box body 200, and preferably it is arranged in box body 200 in permanently connected mode.Box body 200 is at least
It is partially transparent refer to the utricule 30 being provided with can be at least visually viewed through box body 200, in this way, operate fluid is defeated
It is visual when entering in utricule 30, to be also convenient for controlling, when being especially manually operated.Box body 200 has an enclosure body
201, it is preferable that input valve module 15 is arranged in enclosure body 201, and exports valve module 16 and be preferably provided in box body 200
It (since the details of output valve module 16 has been described in detail above, is substituted here with framework without showing it outside
Details).As previously described, in a preferred embodiment, input valve module 15 includes a hanging plug valve 93.Such as Fig. 5
Shown, the spool of plug valve 93 has fluid channel 95, but fluid channel 95 and is arranged in shell sheet in the state of not exerting a force
45 phase of fluid inlet port of utricule 30 in body 201 blocks, such as the channel axis of fluid channel 95 and fluid inlet port 45
Line deviates and the two is caused to be blocked.Apply active force to plug valve 93, such as the force button 94 of plug valve 93 is applied downwards
Plus-pressure, the spring 96 of spool lower part, which is pressurized, to be compressed, and fluid channel 95 and the passage axis of fluid inlet port 45 will gradually become
The channel of fluid channel 95 and fluid inlet port 45 is set to be in partly or completely fully conducting state to close to even identifying,
Thus fluid passes through plug valve 93.The good sealing property of conventional stopcock valve valve and more specific structure are to those skilled in the art
It is well known for member, therefore its working principle is only sketched with typical case herein.
Preferably, in fluid inlet port 45, the upstream of close plug valve 93 or downstream are provided with filter 92.More
Preferably, filter 92 is removably sealingly disposed in enclosure body 201 in order to replace.The material and form of filter with
The material and homomorphosis of filter in aforementioned embodiments.
It in the embodiment illustrated in figure 5, can be to avoid accidentally squeezing due to being arranged utricule 30 in box body 200
The unexpected infusion pressing utricule 30 and may cause.In addition, in a further preferred embodiment shown in Fig. 5, output
It in 16 3 ports of valve module, be connected to port 34 will not with port 36, output valve module 16 can only be in port 34 and port 35
Between or port 35 and port 36 between selected in two connected states, in this way, having in box body 200 to utricule 30
In the case where anti-unexpected extruding, the ability of safe fool proof can be further provided for.
In above each embodiment, if the fluid of infusion is colourless gas, such as carbon dioxide gas, it is preferable that
Gas test paper such as carbon dioxide test paper can be set in the downstream of infusion assembly 10, to show whether gas reaches downstream
Mouthful, for example, fluid detection test paper can be arranged at the port 36 in Fig. 2, or set at the port 62 or port 74 in Fig. 4
Set test paper.It is, of course, also possible to which fluid detection test paper is arranged in the suitable position in the upstream end of infusion assembly 10 simultaneously, such as in Shandong
At that connector 20 or female Luer 26, infusion assembly 10 is entered to indicate to have in operating process fluid to pass through high-pressure fluid source
In.
In above each embodiment, before 10 use of infusion assembly, the fluid in utricule 30 has been excluded, and
The entire pipe-line system of infusion assembly 10 is thoroughly cleaned with fluid, in addition, the common reagent pipe that use-case is as shown in Figure 3
Sealing element 22 and the common reagent seals 72 shown in Fig. 4 etc. seal component or pipe-line system, therefore do not have to face
The problem of to the air in utricule 30 is emptied repeatedly.Since utricule 30, syringe 80 etc. do not need to insert in infusion flow liquid process
Pull-off is from therefore will not generating the interference of air.
In the respective embodiments described above, due to can directly be connected with high-pressure fluid source and carry out fluid infusion, it is not necessary to make
High-pressure fluid source is plugged repeatedly with syringe, or utricule is connected into high-pressure fluid source repeatedly to empty air, therefore keep away
Exempt from the uncontrolled infusion of possible dosage and air interference, even if needing more fluid, the capacity of utricule also without requiring very big,
Therefore it reduces component cost and improves safety in utilization.
In the respective embodiments described above, defeated due to only needing to carry out the fluid for carrying out fluid source using a syringe
Note, and be transfused in the case where being directly directly connected to the various fluid sources such as high pressure, large capacity, therefore be transfused operation
Simply facilitate compared with prior art.
It is replaced it should be evident that the present invention does not repel the K-type valve as disclosed in the Chinese patent of Patent No. 103596619
Output valve module therein is changed, therefore this is also a kind of optional embodiment of the invention.
In above-mentioned various embodiments, high-pressure fluid is sustained due to using utricule 30, it can be big
It avoids greatly making the syringe close to utricule be detached from valve body because of excessive impact force caused by access high-pressure fluid source, and thus leads
The air interference and the pollution of possible component of cause, thus improve the safety of infusion process.
In addition, the respective embodiments described above are preferably manually to operate the infusion of fluid.But it is clear that various operations
It carries out operating by programmable control system also possible.It will be appreciated that the programmable control system will include that control is each
Opening, closing or the gating of kind valve, and control program and electrical connection to drawing, the push operation of syringe etc..Preferably, it is flowing
Body be input to utricule 30 before pipeline in be provided with flowmeter, be provided in utricule 30 Fluid pressure detection pressure sensing
Device is more preferably controlled with realizing.
Although specific features of the invention are shown in other attached drawings in certain attached drawings, this is used for the purpose of facilitating
See, because each feature can be combined with according to the present invention any and whole other features.
Although falling into the scope of the present invention in addition, specific embodiment gives particularly preferred embodiment of the present invention
Within many other modifications and variations of structure of the invention will be that those skilled in the art are readily apparent that.Thus, it will be appreciated that
These specific descriptions are only explanation of the principles of the present invention rather than are limited.