CN116650755A - A micro-injection pump management and control system and method - Google Patents
A micro-injection pump management and control system and method Download PDFInfo
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- CN116650755A CN116650755A CN202310525112.8A CN202310525112A CN116650755A CN 116650755 A CN116650755 A CN 116650755A CN 202310525112 A CN202310525112 A CN 202310525112A CN 116650755 A CN116650755 A CN 116650755A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/1407—Infusion of two or more substances
- A61M5/1408—Infusion of two or more substances in parallel, e.g. manifolds, sequencing valves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/16804—Flow controllers
- A61M5/16827—Flow controllers controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3306—Optical measuring means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3334—Measuring or controlling the flow rate
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- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Control Of Non-Positive-Displacement Pumps (AREA)
Abstract
本发明涉及一种微量注射泵管控系统及方法。系统还包括:处理单元,用于控制第一泵单元和第二泵单元推动流体的体积流量;混合部,用于至少两种流体的混合述混合部以设置收缩流动部分的方式减小由第一泵单元和第二泵单元推动的至少两种流体的扩散,并且在处理单元对第一泵单元和第二泵单元的控制下调节混合部中混合流体的浓度。对于本发明来说,能够采用多个泵单元进行混合流体供应的方式将该需要人工完成的操作作为微量注射泵的自动化流程,并且设置的各结构减小了多个泵单元组合使用导致的流体扩散、浓度不均匀、混合时间较少等问题。
The invention relates to a control system and method for a micro-injection pump. The system also includes: a processing unit for controlling the volumetric flow rate of fluid pushed by the first pump unit and the second pump unit; a mixing part for mixing at least two fluids. The diffusion of at least two fluids driven by the first pump unit and the second pump unit, and the concentration of the mixed fluid in the mixing part is adjusted under the control of the first pump unit and the second pump unit by the processing unit. For the present invention, multiple pump units can be used for mixed fluid supply, and the manual operation can be used as an automated process for micro-injection pumps, and the various structures provided reduce the fluid consumption caused by the combined use of multiple pump units. Diffusion, uneven concentration, less mixing time, etc.
Description
技术领域technical field
本发明涉及医疗器械技术领域,尤其涉及一种微量注射泵管控系统及方法。The invention relates to the technical field of medical devices, in particular to a control system and method for a micro-injection pump.
背景技术Background technique
微量输液泵(简称微量泵)是一种新型泵力仪器,将少量药液精确、微量、均匀、持续地泵入体内,操作便捷、定时、定量,根据病情需要可随时调整药物浓度、速度,使药物在体内能保持有效血药浓度。一直以来,医疗现场都使用可以高精度地对患者注射药液的微量注射泵。微量注射泵构成为可以保持不同尺寸、不同种类的注射器,可以通过驱动用于按压注射器活塞的活塞按压部,从而按下活塞,将注射器内的药液准确地送出。Micro-infusion pump (micro-pump for short) is a new type of pumping instrument, which can pump a small amount of liquid medicine into the body accurately, micro-quantity, uniformly and continuously. So that the drug can maintain effective blood drug concentration in the body. Microsyringe pumps, which can inject medical solutions to patients with high precision, have been used in the medical field for a long time. The micro-injection pump is configured to hold syringes of different sizes and types, and can accurately deliver the drug solution in the syringe by driving the piston pressing part for pressing the plunger of the syringe to press the plunger.
现有技术中的微量泵之所以不采用多个注射器的混合注入的工作方式,是因为多个注射器混合注入容易造成流体浓度的波动。而引起该波动的主要原因在于:多个注射器进行混合注入时,混合处流体的扩散导致混合流体浓度不均;泵送组件的各泵送精度由于活塞或其余结构的粘附导致流体部分残留而影响微量成分的混合。The reason why the micropumps in the prior art do not adopt the working mode of mixed injection of multiple syringes is that the mixed injection of multiple syringes is likely to cause fluctuations in fluid concentration. The main reasons for this fluctuation are: when multiple syringes are mixed and injected, the diffusion of the fluid at the mixing place will lead to uneven concentration of the mixed fluid; Affects the mixing of minor ingredients.
中国专利CN110772684B公开了一种自动换药微量注射泵及工作方法,包括输液管、多个液-液转换器、活塞型压水器、步进电机、第一和第二换药自保持电磁铁、毛细管和微控制器,微控制器控制第一和第二换药自保持电磁铁动作,首先打开第一支路,断开第二支路,利用第一液-液隔离器输液,当微控制器检测到第一和第二压力传感检测毛细管两端的压力相等时,第一液-液转换器输液完毕,微控制器控制第一和第二换药自保持电磁铁动作,断开第一支路,打开第二支路,利用第二液-液转换器进行输液;该专利能够准确的检测输液管中的药液流量,同时在一种药液输完后自动输送另一种药物,实现了换药的自动控制,极大的减轻了医护人员的工作量,保证了输液的连续性。但是该专利的缺陷在于:对于混合流体的注入仍然需要医务人员进行人工操作,增加了医务人员的工作量。注射的流体不能随着患者病情的改变进行调节,导致其使用性较差。该专利虽能进行药液的更换,但是对于需要进行即时混合的药液来说,其依然不能解决医务人员工作量较大的问题。Chinese patent CN110772684B discloses a micro-injection pump for automatic dressing change and its working method, including infusion tube, multiple liquid-liquid converters, piston type water press, stepper motor, first and second dressing self-holding electromagnets , capillary and microcontroller, the microcontroller controls the action of the first and second dressing self-maintaining electromagnets, first opens the first branch, disconnects the second branch, uses the first liquid-liquid isolator to infuse, when the micro When the controller detects that the pressures at both ends of the first and second pressure sensing detection capillaries are equal, the infusion of the first liquid-liquid converter is completed. One branch, open the second branch, and use the second liquid-liquid converter for infusion; this patent can accurately detect the flow of liquid medicine in the infusion tube, and at the same time automatically deliver another medicine after one kind of medicine is infused , Realized the automatic control of dressing change, greatly reduced the workload of medical staff and ensured the continuity of infusion. But the defect of this patent is: still need medical personnel to carry out manual operation for the injection of mixed fluid, increased the workload of medical personnel. The injected fluid cannot be adjusted as the patient's condition changes, resulting in poor usability. Though this patent can carry out the replacement of medicinal liquid, for the medicinal liquid that needs to mix immediately, it still can't solve the problem that the workload of medical personnel is bigger.
中国专利CN103955236B公开了一种医学检测设备的流体控制系统,包括数个用于吸取液体的小型泵,和配套用于控制流量的微量控制阀,以及用于输送液体并连接所述小型泵和微量控制阀的加液管,小型泵通过所述加液管分别连接装有加样液的液体瓶和微量控制阀,通过微量控制阀的加液管末端管口处设置有用于集合并且固定加液管的加样针板。该系统结构精巧,安装维护简易,有效提高其在医学检测设备中的工作效率,更有针对性地进行高精度液体加样工序,并且能够高度配合医学检测设备其它部件进行灵活的整合应用。但是该专利不能够用于微量注射泵中,仅用于液体的加样配置,虽具有高精度的检测功能,但是对于患者微量注射而言,不能带来工作效率的提升,不能用于微量注射泵液体分配和浓度控制。Chinese patent CN103955236B discloses a fluid control system for medical testing equipment, which includes several small pumps for sucking liquid, and matching micro-control valves for controlling flow, and for transporting liquid and connecting the small pumps and micro-pumps The liquid feeding pipe of the control valve, through which the small pump is respectively connected to the liquid bottle containing the sample liquid and the micro control valve, is provided at the end nozzle of the liquid feeding pipe through the micro control valve for collecting and fixing the liquid feeding Tube pin plate. The system is compact in structure, easy to install and maintain, effectively improves its work efficiency in medical testing equipment, performs more targeted high-precision liquid sampling procedures, and can highly cooperate with other components of medical testing equipment for flexible integration and application. However, this patent cannot be used in micro-injection pumps, and is only used for liquid sample addition configuration. Although it has a high-precision detection function, it cannot improve work efficiency for micro-injection of patients, and cannot be used for micro-injection. Pump liquid distribution and concentration control.
此外,一方面由于对本领域技术人员的理解存在差异;另一方面由于申请人做出本发明时研究了大量文献和专利,但篇幅所限并未详细罗列所有的细节与内容,然而这绝非本发明不具备这些现有技术的特征,相反本发明已经具备现有技术的所有特征,而且申请人保留在背景技术中增加相关现有技术之权利。In addition, on the one hand, due to differences in the understanding of those skilled in the art; The present invention does not possess the characteristics of these prior art, on the contrary, the present invention already possesses all the characteristics of the prior art, and the applicant reserves the right to add relevant prior art to the background technology.
发明内容Contents of the invention
针对现有技术之不足,本发明提供了一种微量注射泵管控系统,至少包括第一泵单元和第二泵单元。所述第一泵单元和第二泵单元用于推动至少两种流体以进行混合注射。所述系统还包括:处理单元,用于控制第一泵单元和第二泵单元推动流体的体积流量;混合部,用于至少两种流体的混合。所述混合部以设置收缩流动部分的方式减小由所述第一泵单元和第二泵单元推动的至少两种流体的扩散,并且在所述处理单元对所述第一泵单元和第二泵单元的控制下调节所述混合部中混合流体的浓度。对于本发明来说,能够采用多个泵单元进行混合流体供应的方式将该需要人工完成的操作作为微量注射泵的自动化流程,并且设置的各结构减小了多个泵单元组合使用导致的流体扩散、浓度不均匀、混合时间较少等问题。上述设置还能够减小流体对于管路的粘滞,避免部分流体残留于管路中。通过连续的泵入克服管路对流体的粘附,防止粘附对流体中浓度的影响。本发明通过减小流体对管路壁的吸附来减少吸附对浓度的干扰。Aiming at the deficiencies of the prior art, the present invention provides a micro-injection pump management and control system, which at least includes a first pump unit and a second pump unit. The first pump unit and the second pump unit are used to push at least two fluids for mixed injection. The system further includes: a processing unit for controlling the volumetric flow rate of fluid pushed by the first pump unit and the second pump unit; and a mixing unit for mixing at least two fluids. The mixing portion reduces diffusion of at least two fluids pushed by the first pump unit and the second pump unit in such a manner as to set a constricted flow portion, and in the processing unit to the first pump unit and the second pump unit The concentration of the mixed fluid in the mixing section is adjusted under the control of the pump unit. For the present invention, multiple pump units can be used for mixed fluid supply, and the operation that needs to be done manually can be used as an automated process for micro-injection pumps, and the various structures set reduce the fluid consumption caused by the combined use of multiple pump units. Diffusion, uneven concentration, less mixing time, etc. The above arrangement can also reduce the viscosity of the fluid to the pipeline, and avoid part of the fluid remaining in the pipeline. Overcome the adhesion of the pipeline to the fluid by continuous pumping, and prevent the influence of adhesion on the concentration of the fluid. The invention reduces the interference of the adsorption on the concentration by reducing the adsorption of the fluid to the pipeline wall.
根据一种优选的实施方式,所述第一泵单元中的高流速流量的流体和所述第二泵单元中的微量流体在所述混合部中混合,所述第一泵单元和第二泵单元产生流体流速以在所述混合部处通过所述处理单元控制下产生连续的可变浓度流体。本发明设立的混合部,通过汇流管和检测区域的设置,能够实现建立流体的浓度梯度,无需进行二次配药,直接对患者所需的浓度进行持续调节。According to a preferred embodiment, the high-velocity fluid in the first pump unit and the trace fluid in the second pump unit are mixed in the mixing part, and the first pump unit and the second pump A unit generates a fluid flow rate to produce a continuously variable concentration fluid at the mixing section under control by the processing unit. The mixing part set up in the present invention can realize the establishment of the concentration gradient of the fluid through the setting of the confluence pipe and the detection area, without the need for secondary dispensing, and can directly continuously adjust the concentration required by the patient.
根据一种优选的实施方式,所述处理单元被配置为:在第一时间段内控制第一流体流入所述混合部以及在第二时间段内定量输送第二流体;所述第一泵单元中的所述第一流体在所述第一时间段进行泵送,所述第二泵单元在所述第二时间段产生与所述第一流体相对的具有镜像流速的第二流体,以实现对所述第一流体和第二流体组合的所述混合流体的流速控制。为了获取良好的治疗效果,精确控制混合流体的浓度梯度非常重要。流体的意外或不受控制的运动会改变由此产生的浓度梯度。由于微量泵中的流体的流速非常慢,即使是非常小的流体运动对于较大的注射系统来说也是微不足道的。According to a preferred embodiment, the processing unit is configured to: control the flow of the first fluid into the mixing part within a first period of time and quantitatively deliver the second fluid within a second period of time; the first pump unit The first fluid in the pump unit is pumped during the first time period, and the second pump unit produces a second fluid having a mirrored flow rate opposite to the first fluid during the second time period to achieve A flow rate control of the mixed fluid of the combination of the first fluid and the second fluid. In order to obtain a good therapeutic effect, it is very important to precisely control the concentration gradient of the mixed fluid. Unexpected or uncontrolled movement of fluids can alter the resulting concentration gradient. Due to the very slow flow rate of the fluid in the micropump, even very small fluid movements are insignificant against larger injection systems.
根据一种优选的实施方式,所述收缩流动部分的流道能够设置于所述第一泵单元和第二泵单元的第一管路和第二管路的交汇处,或者所述收缩流动部分的流道能够设置于所述第一管路和第二管路上。所述收缩流动部分的流道横截面积随着所述第一管路和第二管路向所述混合部的延伸而减小。减小第一管路和第二管路连接处的横截面积以减小流体扩散,从而提高所得的混合流体的浓度的精确度。According to a preferred embodiment, the flow channel of the constricted flow part can be arranged at the intersection of the first pipeline and the second pipeline of the first pump unit and the second pump unit, or the constricted flow part The flow channels can be arranged on the first pipeline and the second pipeline. The flow path cross-sectional area of the constricted flow portion decreases as the first and second conduits extend toward the mixing section. The cross-sectional area of the junction of the first pipeline and the second pipeline is reduced to reduce fluid diffusion, thereby improving the concentration accuracy of the obtained mixed fluid.
根据一种优选的实施方式,所述第一泵单元和第二泵单元以独立推动不同成分的流体的方式将所述第一流体和第二流体送入所述混合部以进行所述混合流体的注射,其中,由所述第一泵单元和第二泵单元注射入的混合流体的总体积流量保持恒定或基于处理单元对患者用药需求的判断而被调节。According to a preferred embodiment, the first pump unit and the second pump unit send the first fluid and the second fluid into the mixing part in a manner of independently pushing fluids of different components to perform the mixed fluid Injection, wherein the total volume flow rate of the mixed fluid injected by the first pump unit and the second pump unit is kept constant or adjusted based on the judgment of the processing unit on the patient's need for medication.
根据一种优选的实施方式,所述第一管路和第二管路的连接处设有还设有汇流管,所述汇流管具有第一汇流形态和第二汇流形态。在所述汇流管中汇集的所述混合流体对所述混合部的限流件的压力达到阈值时,所述限流件导通而使得所述混合流体进入患者体内,或所述处理单元基于至少两种流体所需的混合条件而控制所述限流件的导通状态和闭锁状态的转变。According to a preferred embodiment, a junction of the first pipeline and the second pipeline is further provided with a confluence pipe, and the confluence pipe has a first confluence form and a second confluence form. When the pressure of the mixed fluid collected in the manifold to the restrictor of the mixing part reaches a threshold value, the restrictor is turned on so that the mixed fluid enters the patient, or the processing unit based on The required mixing conditions of at least two fluids control the transition of the flow restrictor between the conducting state and the blocking state.
根据一种优选的实施方式,所述限流件限制所述混合流体朝向患者的输送,使得在至少两个注射器将待混合流体推送至所述汇流管时,所述待混合流体于所述汇流管堆积。至少两个注射器分别从所述第一管路和第二管路将待混合流体推至所述汇流管中,推入所述汇流管的待混合流体使得所述汇流管从所述第一汇流形态转变为所述第二汇流形态。注射器活塞的阻力容易造成活塞爬行或进行非滑动摩擦,导致流体流动出现短暂暂停。此时,汇流管的伸缩作用使其具有从第二汇流形态转变为第一汇流形态的趋势,从而使得汇流管补充暂停的流体,实现流体的连续注射。According to a preferred embodiment, the restrictor restricts the delivery of the mixed fluid towards the patient, so that when at least two syringes push the fluid to be mixed to the manifold, the fluid to be mixed is at the manifold tube stacking. At least two injectors respectively push the fluid to be mixed into the manifold from the first pipeline and the second pipeline, and the fluid to be mixed pushed into the manifold causes the manifold to flow from the first manifold The morphology transitions to the second confluent morphology. The resistance of the syringe plunger can easily cause the plunger to crawl or engage in non-sliding friction, causing brief pauses in fluid flow. At this time, the expansion and contraction of the confluence pipe makes it have a tendency to change from the second confluence form to the first confluence form, so that the confluence pipe replenishes the suspended fluid and realizes continuous injection of fluid.
根据一种优选的实施方式,所述混合流体在所述第一泵单元和第二泵单元推动下以预定的流体流速进入所述汇流管和限流件之间的检测区域,以在所述检测区域达成所需的混合流体浓度,其中,所述处理单元通过改变所述第一泵单元和第二泵单元的流体流速的方式建立流体浓度梯度。According to a preferred embodiment, the mixed fluid is pushed by the first pump unit and the second pump unit into the detection area between the manifold and the restrictor at a predetermined fluid flow rate, so that The detection area achieves the desired mixed fluid concentration, wherein the processing unit establishes a fluid concentration gradient by changing the fluid flow rates of the first pump unit and the second pump unit.
本发明还涉及一种微量注射泵管控方法,所述方法包括,推动至少两种流体以进行混合注射;控制第一泵单元和第二泵单元推动流体的体积流量;以设置收缩流动部分的方式减小由所述第一泵单元和第二泵单元推动的至少两种流体的扩散,并且在处理单元对所述第一泵单元和第二泵单元的控制下调节所述混合部中混合流体的浓度。The present invention also relates to a method for controlling a micro-injection pump, the method comprising: pushing at least two fluids for mixed injection; controlling the volume flow of the fluid pushed by the first pump unit and the second pump unit; reducing the diffusion of at least two fluids pushed by the first pump unit and the second pump unit, and adjusting the mixed fluid in the mixing part under the control of the first pump unit and the second pump unit by the processing unit concentration.
根据一种优选的实施方式,所述方法还包括:所述第一泵单元中的高流速流量的流体和所述第二泵单元中的微量流体在所述混合部中混合,所述第一泵单元和第二泵单元产生流体流速以在所述混合部处通过所述处理单元控制下产生连续的可变浓度流体。According to a preferred embodiment, the method further includes: mixing the high-velocity fluid in the first pump unit and the trace fluid in the second pump unit in the mixing part, the first A pump unit and a second pump unit generate fluid flow rates to produce a continuously variable concentration fluid at the mixing section under control by the processing unit.
附图说明Description of drawings
图1是本发明提供的一种优选实施方式的微量注射泵管控系统的简化模块连接关系示意图;Figure 1 is a schematic diagram of the simplified module connection relationship of a micro-injection pump management and control system according to a preferred embodiment of the present invention;
图2是本发明提供的一种优选实施方式的混合部的简化结构示意图;Fig. 2 is a simplified structural schematic diagram of a mixing section of a preferred embodiment provided by the present invention;
图3是本发明提供的一种优选实施方式的收缩流动部分的简化结构示意图。Fig. 3 is a simplified structural schematic diagram of a constricted flow part of a preferred embodiment provided by the present invention.
附图标记列表List of reference signs
1:处理单元;2:第一泵单元;3:第二泵单元;4:混合部;5:汇流管;6:第一管路;7:第二管路;8:限流件;9:检测区域;10:收缩流动部分。1: processing unit; 2: first pump unit; 3: second pump unit; 4: mixing part; 5: manifold; 6: first pipeline; 7: second pipeline; 8: restrictor; 9 : detection area; 10: contraction flow part.
具体实施方式Detailed ways
下面结合附图进行详细说明。A detailed description will be given below in conjunction with the accompanying drawings.
本发明的描述中,需要说明的是,术语“竖直”、“上”、“下”、“水平”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "vertical", "upper", "lower" and "horizontal" are based on the orientation or positional relationship shown in the drawings, and are only for It is convenient to describe the present invention and simplify the description, but does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and thus should not be construed as limiting the present invention.
在本发明的描述中,还需要说明的是,除非另有明确的规定和限定,术语“设置”、“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,还可以是两个元件内部的连通。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。In the description of the present invention, it should also be noted that, unless otherwise clearly specified and limited, the terms "installation", "installation", "connection" and "connection" should be understood in a broad sense, for example, it may be a fixed connection, It can also be a detachable connection, or an integral connection; it can be a mechanical connection, or it can be an electrical connection; it can be a direct connection, or an indirect connection through an intermediary, or an internal communication between two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.
术语“流体”通常是指任何可流动介质或组合物,例如液体、气体、蒸汽、超临界流体、它们的组合,或本领域技术人员所理解的普通含义。The term "fluid" generally refers to any flowable medium or composition, such as liquids, gases, vapors, supercritical fluids, combinations thereof, or ordinary meanings understood by those skilled in the art.
实施例1Example 1
本发明涉及一种微量注射泵管控系统及方法,以解决现有技术中微量泵所存在的技术问题。系统可以包括微量注射泵主体,其至少具有第一泵单元2和第二泵单元3。第一泵单元2和第二泵单元3用于推动至少两种流体以进行混合注射。在本实施例中,第一泵单元2和第二泵单元3能够连接有驱动电机以推动第一泵单元2和第二泵单元3上的注射器进行精准的微量注射。系统还包括用于控制第一泵单元2和第二泵单元3推动流体的体积流量的处理单元1。The invention relates to a control system and method for a micro-injection pump to solve the technical problems existing in the micro-pump in the prior art. The system may comprise a microsyringe pump body having at least a first pump unit 2 and a second pump unit 3 . The first pump unit 2 and the second pump unit 3 are used to push at least two fluids for mixed injection. In this embodiment, the first pump unit 2 and the second pump unit 3 can be connected with driving motors to push the syringes on the first pump unit 2 and the second pump unit 3 for precise microinjection. The system also comprises a processing unit 1 for controlling the volumetric flow of fluid propelled by the first pump unit 2 and the second pump unit 3 .
优选地,处理单元1可以是通用计算机,包括用于存储控制第一泵单元2和第二泵单元3的程序指令的存储器。优选地,处理单元1可以包括磁盘驱动器、光盘驱动器或其它合适的组件,用于读取包含在处理单元1可读介质上的指令以控制第一泵单元2和第二泵单元3。优选地,处理单元1还用于接收、分析和显示从各检测单元传递的信息。优选地,处理单元1还可以外接各自输入设备,包括显示器、鼠标、键盘或者本领域技术人员已知的其它合适的部件,用于接收和显示医务人员的操作。优选地,处理单元1控制第一泵单元2和第二泵单元3以稳定的方式输出平稳、连续的流体。如本领域技术人员所知,第一泵单元2和第二泵单元3可以产生低至一纳升/每分钟的体积流量。优选地,第一泵单元2和第二泵单元3被控制以在注射管的混合端产生混合流体。混合流体在混合端具有随时间连续变化的比例,以产生连续的浓度梯度。Preferably, the processing unit 1 may be a general purpose computer comprising a memory for storing program instructions for controlling the first pump unit 2 and the second pump unit 3 . Preferably, the processing unit 1 may comprise a magnetic disk drive, an optical disk drive or other suitable components for reading instructions contained on a medium readable by the processing unit 1 to control the first pump unit 2 and the second pump unit 3 . Preferably, the processing unit 1 is also used for receiving, analyzing and displaying information transmitted from each detection unit. Preferably, the processing unit 1 can also be externally connected with respective input devices, including a display, a mouse, a keyboard or other suitable components known to those skilled in the art, for receiving and displaying operations of medical personnel. Preferably, the processing unit 1 controls the first pump unit 2 and the second pump unit 3 to output smooth and continuous fluid in a stable manner. As is known to those skilled in the art, the first pump unit 2 and the second pump unit 3 can generate a volume flow down to one nanoliter per minute. Preferably, the first pump unit 2 and the second pump unit 3 are controlled to generate a mixed fluid at the mixing end of the syringe. The mixed fluid has a ratio that changes continuously over time at the mixing end to create a continuous concentration gradient.
根据一种优选的实施方式,微量注射泵主体还包括显示单元和控制面板。控制面板能够为非触屏的按键结构,以减少出现故障及触屏失灵无法使用的情况。显示单元用于显示处理单元1的各所需显示的信息。微量注射泵主体还包括异常检测单元。异常检测单元用于检测第一泵单元2和/或第二泵单元3的异常情况。上述异常情况例如是第一泵单元2和/或第二泵单元3上设置的注射器安装出现偏差的情况。本发明能够通过异常检测单元检测注射器与第一泵单元2和/或第二泵单元3的安装状态。仅在异常检测单元检测状态为正常时,处理单元1控制第一泵单元2和/或第二泵单元3进行微量注射。优选地,第一泵单元2和第二泵单元3对注射器进行推注的动力源上还设置有传感器。该传感器能够是压力传感器或是对动力源的输出功率进行检测的传感器,从而获取动力源对注射器的压力或动力源的输出功率。当压力传感器检测到动力源对注射器的压力过大时,或当动力源的输出功率过大时,判断注射器至患者体内的管路出现堵塞,导致流体流动受限。优选地,第一泵单元2和第二泵单元3设置有减压组件,以在处理单元1判断管路流体流动受限时进行减压处理。减压组件能够是例如与注射器内部连接或放置的有膜的阀或孔,但不限于此。优选地,各组件和/或传感器能够通信连接。需要说明的是,微量输液泵各组件能够由外部电源进行电流供应,并且内置有未图示的蓄电组件,也能通过蓄电组件进行电流供应。上述异常检测单元能够是光电传感器,通过检测注射器的位置或第一泵单元2和/或第二泵单元3的位置或注射器是否与第一泵单元2和/或第二泵单元3啮合以判断注射器的安装状态。优选地,上述异常检测单元还能够采用微动开关直接检测第一泵单元2和/或第二泵单元3的位置。异常检测单元还能够采用多种传感器进行检测,例如尺寸检测传感器等,在此不作赘述。According to a preferred embodiment, the main body of the micro-injection pump further includes a display unit and a control panel. The control panel can be a non-touch screen button structure, so as to reduce failures and unusable situations of touch screen failure. The display unit is used for displaying information required to be displayed by the processing unit 1 . The micro syringe pump main body also includes an abnormality detection unit. The abnormality detection unit is used to detect the abnormality of the first pump unit 2 and/or the second pump unit 3 . The above-mentioned abnormal situation is, for example, a situation in which the installation of the syringe provided on the first pump unit 2 and/or the second pump unit 3 deviates. The present invention can detect the installation state of the syringe and the first pump unit 2 and/or the second pump unit 3 through the abnormality detection unit. Only when the detection state of the abnormality detection unit is normal, the processing unit 1 controls the first pump unit 2 and/or the second pump unit 3 to perform micro-injection. Preferably, the power source for injecting the syringe by the first pump unit 2 and the second pump unit 3 is also provided with a sensor. The sensor can be a pressure sensor or a sensor for detecting the output power of the power source, so as to obtain the pressure of the power source on the syringe or the output power of the power source. When the pressure sensor detects that the pressure of the power source on the syringe is too large, or when the output power of the power source is too large, it is determined that the pipeline from the syringe to the patient is blocked, resulting in restricted fluid flow. Preferably, the first pump unit 2 and the second pump unit 3 are provided with a decompression component, so as to perform decompression treatment when the processing unit 1 judges that the fluid flow in the pipeline is restricted. The pressure relief component can be, for example, a valve or orifice with a membrane attached to or placed inside the syringe, but is not limited thereto. Preferably, the various components and/or sensors are communicatively connectable. It should be noted that each component of the microinfusion pump can be supplied with current by an external power supply, and has a built-in power storage component (not shown), and can also supply current through the power storage component. The above-mentioned abnormality detection unit can be a photoelectric sensor, by detecting the position of the syringe or the position of the first pump unit 2 and/or the second pump unit 3 or whether the syringe is engaged with the first pump unit 2 and/or the second pump unit 3 to judge The installed state of the syringe. Preferably, the above abnormality detection unit can also directly detect the position of the first pump unit 2 and/or the second pump unit 3 by using a micro switch. The abnormality detection unit can also use a variety of sensors for detection, such as size detection sensors, etc., which will not be described in detail here.
在通过微量泵对患者进行微量流体注射时,由于需要在较长时间段向患者连续输送流体,在所输送的流体浓度较小或所需连续输送的时间较长时,会引发注射流体的各自问题。例如,在输送浓度较小的流体时,由于混合流体为一次性配置,患者在注射流体的开始,往往需要浓度较低的流体,而在注射入一定量流体后,需要加大其浓度以达到最优的治疗效果。此时需要医务人员更换注射器并且重新配置混合流体,导致浪费了大量的时间,甚至注射的暂停使得医用流体治疗的效果大打折扣。再例如,医用流体在长时间保持混合状态,可能出现药效的改变。即,部分医用流体需要进行即时混合注射,导致医务人员需要在定点的时间周期进行相应流体的混合与注射工作。When microfluid injection is performed on a patient through a micropump, due to the need to continuously deliver the fluid to the patient for a long period of time, when the delivered fluid concentration is small or the time required for continuous delivery is long, the respective injection fluids will be triggered. question. For example, when delivering a fluid with a low concentration, since the mixed fluid is a one-time configuration, the patient often needs a fluid with a low concentration at the beginning of the fluid injection, and after a certain amount of fluid is injected, the concentration needs to be increased to achieve optimal therapeutic effect. At this time, medical personnel need to replace the syringe and reconfigure the mixed fluid, resulting in wasting a lot of time, and even the suspension of the injection greatly reduces the effect of the medical fluid treatment. For another example, if the medical fluid remains in a mixed state for a long time, the drug effect may change. That is, some medical fluids need to be mixed and injected immediately, so that medical personnel need to mix and inject corresponding fluids in a fixed time period.
在通过微量注射泵对患者进行流体注射时,由于该流体注射过程需要进行较长时间,在所注射的流体的容量量级较小(如纳升的流体)或所需注射的持续时间较长时,会导致流体注射的临床问题。例如,在某一种流体的注射过程中,由于所需流体的流量较小并且远小于输液管的内部容量,就会导致该微量流体残留在输液管中,即可能附着在输液管的内壁上,从而造成注入患者体内的流体剂量发生不可预测的改变。再例如,当患者需注射入混合流体时,部分特殊性质的流体需要进行及时混合注射,否则会影响其治疗效果,而微量注射泵需要长时间的工作,该混合后流体可能因为长时间未注入人体而发生性质的改变。基于上述缺陷,本发明提出能够实时混合的微量注射泵管控系统。When a patient is injected with a microinjection pump, since the fluid injection process takes a long time, the volume of the injected fluid is small (such as nanoliter fluid) or the duration of the required injection is long , can lead to clinical problems with fluid injection. For example, during the injection of a certain fluid, since the required fluid flow rate is small and much smaller than the internal volume of the infusion tube, the tiny amount of fluid will remain in the infusion tube, that is, it may adhere to the inner wall of the infusion tube , resulting in unpredictable changes in the dose of fluid injected into the patient. For another example, when a patient needs to inject a mixed fluid, some fluids with special properties need to be mixed and injected in time, otherwise the therapeutic effect will be affected, and the micro-injection pump needs to work for a long time, and the mixed fluid may not be injected for a long time. changes in the nature of the human body. Based on the above defects, the present invention proposes a micro-injection pump management and control system capable of real-time mixing.
根据一种优选的实施方式,第一泵单元2和第二泵单元3的混合端设置有用于混合流体的混合部4。需要说明的是,本发明列举出通过混合部4和管路连接的第一泵单元2和第二泵单元3,但是并不代表不能在此基础上,设置第三泵单元或第四泵单元。优选地,第一泵单元2和第二泵单元3向患者微量泵送需要的流体。优选地,第一泵单元2和第二泵单元3上的至少两个注射器通过管路连接至混合部4。优选地,至少两个注射器通过独立的管路进行流体输送,并且汇流入同一管路。优选地,混合部4能够通过鲁尔连接器而可拆卸连接至注射器。According to a preferred embodiment, the mixing ends of the first pump unit 2 and the second pump unit 3 are provided with a mixing part 4 for mixing fluids. It should be noted that the present invention lists the first pump unit 2 and the second pump unit 3 connected through the mixing part 4 and the pipeline, but it does not mean that the third pump unit or the fourth pump unit cannot be set on this basis . Preferably, the first pump unit 2 and the second pump unit 3 micro-pump the required fluid to the patient. Preferably, at least two syringes on the first pump unit 2 and the second pump unit 3 are connected to the mixing section 4 by tubing. Preferably, at least two syringes are fluidly delivered through separate lines and merge into the same line. Preferably, the mixing part 4 is detachably connectable to the syringe via a Luer connector.
根据一种优选的实施方式,混合部4包括分别连接至不同注射器的第一管路6和第二管路7。第一管路6和第二管路7的连接处设有汇流管5。第一管路6、第二管路7和汇流管5构成“Y”型结构。汇流管5具有第一汇流形态和第二汇流形态。优选地,汇流管5起始处于第一汇流形态而在注射入流体后,逐渐转化为第二汇流形态。第一汇流形态为收紧状态,此时汇流管5的容积较小。第二汇流形态为放松状态,此时汇流管5的容积较大。汇流管5作为混合腔室,能够短暂将一种或多种流体于其中进行混合。优选地,汇流管5的下游设置于限流件8。限流件8例如是压力阀或压力膜,在汇流管5中汇集的混合流体对该限流件8的压力达到阈值时,限流件8导通而使得混合流体进入患者体内。例如,在开启压力为0.17MPa~0.21MPa之间的情况下,使得流体从汇流管5中流出。优选地,限流件8还能采用自动在导通状态和闭锁状态转化的阀门组件。在限流件8处于导通状态时,允许混合流体从汇流管5流入患者体内。在限流件8处于闭锁状态时,限制混合流体从汇流管5流出。优选地,处理单元1基于至少两种流体所需的混合条件而控制限流件8的导通状态和闭锁状态的转变。上述混合条件是指不同流体所需的浓度以及容量。According to a preferred embodiment, the mixing part 4 comprises a first pipeline 6 and a second pipeline 7 respectively connected to different syringes. A confluence pipe 5 is provided at the junction of the first pipeline 6 and the second pipeline 7 . The first pipeline 6, the second pipeline 7 and the manifold 5 form a "Y"-shaped structure. The confluence pipe 5 has a first confluence form and a second confluence form. Preferably, the confluence tube 5 is initially in the first confluence configuration and gradually transforms into the second confluence configuration after the fluid is injected. The first confluence form is a tightened state, and at this time the volume of the confluence pipe 5 is relatively small. The second confluence state is a relaxed state, and at this time the volume of the confluence pipe 5 is relatively large. The manifold 5 serves as a mixing chamber in which one or more fluids can be briefly mixed. Preferably, the flow restrictor 8 is arranged downstream of the manifold 5 . The restrictor 8 is, for example, a pressure valve or a pressure membrane. When the pressure of the mixed fluid collected in the manifold 5 reaches a threshold value, the restrictor 8 conducts to allow the mixed fluid to enter the patient's body. For example, when the opening pressure is between 0.17 MPa and 0.21 MPa, the fluid is allowed to flow out from the manifold 5 . Preferably, the restrictor 8 can also use a valve assembly that automatically switches between the conducting state and the blocking state. When the restrictor 8 is in the conduction state, the mixed fluid is allowed to flow from the manifold 5 into the body of the patient. When the restrictor 8 is in a closed state, it restricts the mixed fluid from flowing out of the manifold 5 . Preferably, the processing unit 1 controls the transition of the flow restrictor 8 between the conducting state and the blocking state based on the required mixing conditions of at least two fluids. The mixing conditions mentioned above refer to the required concentrations and volumes of the different fluids.
根据一种优选的实施方式,在将混合流体注射入患者体内之前,限流件8处于闭锁状态。至少两个注射器中预存有一定浓度的待混合流体。优选地,限流件8限制混合流体朝向患者的输送管路,使得在至少两个注射器将待混合流体推送至汇流管5时,待混合流体于汇流管5堆积。此时汇流管5处于第一汇流形态。优选地,至少两个注射器分别从第一管路6和第二管路7将待混合流体推至汇流管5中。推入汇流管5的待混合流体使得汇流管5从第一汇流形态转变为第二汇流形态。在上述情况下,汇流管5容纳从至少两个注射器推送的一定量的流体,而逐渐伸展为第二汇流形态。第二汇流形态为汇流管5的最大容积。优选地,汇流管5保持第二汇流形态并且不具有返回第一汇流形态的趋势。汇流管5使得至少两个微量流体在其中进行混合。在处理单元1控制下,或在至少两个注射器的持续加压注射下,限流件8转变为导通状态而不再限制混合流体进入患者体内。因此在微量注射泵的持续泵送过程中,该混合流体被注入患者体内。本发明通过第一泵单元2和第二泵单元3将传统的先混合再注射的工作流程转变为先推动再混合,最后注入。由此节省医务人员进行多次药物浓度的配比工作,混合比例能够自动调节。设置的汇流管5同时作为混合腔室能够在注射过程中,对至少两种流体进行实时混合。本发明的汇流管5还用于流体流速的稳定性补充,在微量泵进行低速给药时,容易出现针头回血和凝血堵塞。汇流管5具有一定的伸缩性,从而在针管活塞爬行和流速波动时,通过一定的形变力对流速进行补充,使得注射的混合流体具有连续性。例如,在需要以10ml/h的注射速度对患者进行混合流体注射时,注射器活塞的阻力容易造成活塞爬行或进行非滑动摩擦,导致流体流动出现短暂暂停。此时,汇流管5的伸缩作用使其具有从第二汇流形态转变为第一汇流形态的趋势,从而使得汇流管5补充暂停的流体,实现流体的连续注射。According to a preferred embodiment, before the mixed fluid is injected into the patient, the restrictor 8 is in a closed state. At least two syringes are prestored with fluids to be mixed at a certain concentration. Preferably, the restrictor 8 restricts the delivery line of the mixed fluid towards the patient so that the fluid to be mixed accumulates in the manifold 5 when at least two syringes push the fluid to be mixed to the manifold 5 . At this time, the confluence pipe 5 is in the first confluence configuration. Preferably, at least two injectors push the fluid to be mixed into the manifold 5 from the first line 6 and the second line 7 respectively. The fluid to be mixed pushed into the manifold 5 causes the manifold 5 to change from the first manifold configuration to the second manifold configuration. In the above case, the manifold 5 accommodates a certain amount of fluid pushed from at least two syringes, and gradually expands into a second manifold configuration. The second confluence form is the maximum volume of the confluence pipe 5 . Preferably, the manifold 5 maintains the second manifold configuration and has no tendency to return to the first manifold configuration. The manifold 5 allows at least two microfluidics to mix therein. Under the control of the processing unit 1, or under the continuous pressurized injection of at least two syringes, the restrictor 8 turns into a conduction state and no longer restricts the mixed fluid from entering the patient's body. The mixed fluid is thus injected into the patient during the continuous pumping of the microsyringe pump. The present invention transforms the traditional working process of mixing first and then injecting into pushing first, then mixing, and finally injecting through the first pump unit 2 and the second pump unit 3 . This saves medical personnel from performing multiple rationing of drug concentrations, and the mixing ratio can be automatically adjusted. The provided manifold 5 serves as a mixing chamber at the same time, so that at least two fluids can be mixed in real time during the injection process. The confluence tube 5 of the present invention is also used to supplement the stability of the fluid flow rate. When the micropump performs low-speed drug administration, it is easy to cause needle tip bleeding and coagulation blockage. The manifold 5 has a certain degree of flexibility, so that when the needle piston crawls and the flow rate fluctuates, the flow rate is supplemented by a certain deformation force, so that the injected mixed fluid has continuity. For example, when a patient needs to inject mixed fluids at an injection rate of 10ml/h, the resistance of the syringe plunger can easily cause the plunger to crawl or engage in non-sliding friction, resulting in a short pause in fluid flow. At this time, the expansion and contraction of the confluence pipe 5 makes it have a tendency to change from the second confluence form to the first confluence form, so that the confluence pipe 5 replenishes the suspended fluid and realizes the continuous injection of the fluid.
根据一种优选的实施方式,汇流管5和限流件8之间还设置有检测区域9。检测区域9能够由检测单元进行分析。至少两个注射器推动的流体于汇流管5内进行被动混合和流体组分的充分相互作用。优选地,检测单元可以包括通过某一数据采集技术获取混合流体的测量值(例如浓度)。检测单元可操作地连接至处理单元1,用于接收和存储从检测区域9获得的测量结果。处理单元1能够对测量结果进行分析并以可读的形式将结果呈现给医务人员。上述检测区域9例如是具有微流体芯片的微尺度通道和/或流体混合区域。具体地,微流控芯片使用微加工领域中常见的固体基板制造,例如二氧化硅基板、玻璃、石英、硅或多晶硅以及其他已知的基底。至少两个基底组成了检测区域9以用于流体参数的监控。优选地,在流体经过该检测区域9时,处理单元1进行特定分析。混合流体在微量注射泵推动下以预定的流体流速适当地进入检测区域9,以在检测区域9达成所需的流体浓度。优选地,处理单元1通过改变流体流速的方式建立流体浓度梯度。优选地,流体浓度梯度随时间变化。优选地,流体浓度梯度是时间中流体浓度沿时间中的一定时间段的变化。例如,当患者由于消化道出血所需的初次泵入的垂体后叶素的浓度为0.2U/分,若患者症状未出血缓解,则需要进行浓度梯度的持续加量,直至0.4U/分。对于常规医疗手段来说,需要先配置一定时间段(例如一小时)所需的O.2U/分的垂体后叶素,并且泵入患者体内,再观测患者身体状态。若注射无明显效果,再配置更高浓度的垂体后叶素并且进行注射。由此,浪费了医务人员大量的时间,还容易出现操作失误的多种临床情况。本发明设立的混合部4,通过汇流管5和检测区域9的设置,能够实现建立流体的浓度梯度,无需进行二次配药,直接对患者所需的浓度进行持续调节。优选地,流体浓度梯度也可以认为是流体流过一个空间点时随容量变化的浓度变化。例如再注入一定量的混合流体后,改变其浓度再进行注射。为了获取良好的治疗效果,精确控制混合流体的浓度梯度非常重要。流体的意外或不受控制的运动会改变由此产生的浓度梯度。由于微量泵中的流体的流速非常慢,即使是非常小的流体运动对于较大的注射系统来说也是微不足道的。同样,溶解化学物质在流体中的扩散可以改变混合流体的浓度,而与流体流动无关。这种扩散传输在微量泵中可能非常重要,因为微量泵的空间小且流速非常慢。According to a preferred embodiment, a detection area 9 is also provided between the manifold 5 and the restrictor 8 . The detection area 9 can be analyzed by a detection unit. The fluid driven by at least two syringes in the manifold 5 undergoes passive mixing and sufficient interaction of the fluid components. Preferably, the detection unit may include acquiring measurements (eg concentration) of the mixed fluid by some data acquisition technique. The detection unit is operatively connected to the processing unit 1 for receiving and storing measurements obtained from the detection area 9 . The processing unit 1 is able to analyze the measurement results and present the results in a readable form to medical personnel. The above-mentioned detection area 9 is, for example, a micro-scale channel and/or a fluid mixing area with a microfluidic chip. Specifically, microfluidic chips are fabricated using solid substrates common in the field of micromachining, such as silicon dioxide substrates, glass, quartz, silicon or polysilicon, and other known substrates. At least two substrates constitute the detection zone 9 for monitoring of fluid parameters. Preferably, the processing unit 1 performs a specific analysis when the fluid passes through the detection zone 9 . The mixed fluid properly enters the detection area 9 at a predetermined fluid flow rate under the push of the micro-injection pump, so as to achieve the required fluid concentration in the detection area 9 . Preferably, the processing unit 1 establishes a fluid concentration gradient by changing the fluid flow rate. Preferably, the fluid concentration gradient varies with time. Preferably, the fluid concentration gradient is the change in fluid concentration in time along a certain period of time in time. For example, when the initial pumped pituitary hormone concentration required by a patient due to gastrointestinal bleeding is 0.2 U/min, if the patient’s symptoms are not relieved from bleeding, the concentration gradient needs to be continuously increased until 0.4 U/min. For conventional medical methods, it is necessary to configure 0.2U/min of pituitary hormone required for a certain period of time (for example, one hour), and pump it into the patient's body, and then observe the patient's physical state. If the injection has no obvious effect, a higher concentration of vasopressin is prepared and injected. As a result, a large amount of time of medical personnel is wasted, and various clinical situations of operational errors are prone to occur. The mixing unit 4 set up in the present invention, through the arrangement of the manifold 5 and the detection area 9, can realize the establishment of the concentration gradient of the fluid, without the need for secondary dispensing, and directly continuously adjust the concentration required by the patient. Preferably, the fluid concentration gradient can also be regarded as the concentration change with the volume change when the fluid flows through a space point. For example, after injecting a certain amount of mixed fluid, change its concentration before injecting. In order to obtain a good therapeutic effect, it is very important to precisely control the concentration gradient of the mixed fluid. Unexpected or uncontrolled movement of fluids can alter the resulting concentration gradient. Due to the very slow flow rate of the fluid in the micropump, even very small fluid movements are insignificant against larger injection systems. Likewise, the diffusion of dissolved chemicals in a fluid can change the concentration of a mixed fluid independent of fluid flow. This diffusive transport can be very important in micropumps, which have small spaces and very slow flow rates.
根据一种优选的实施方式,检测单元能够通过荧光监测混合流体的方式在检测区域9检测混合流体浓度。混合流体中所含有的化学物质浓度与荧光强度成正比。对于上述荧光检测,可以使用本领域技术人员已知的任何类型的光路。激发光源可以是任何合适的光源LS,例如绿色氦氖激光器、红色二极管激光器等。检测单元可以包括光检测器,用于检测来自和/或通过发生反应的检测区域9的荧光。检测单元也可以使用光电倍增管。检测单元还可以使用其他光学配置,例如将光从激发源传输到检测区域9以及从检测区域9中的流体到光电探测器的光纤传输。上述检测单元的检测方式还能包括磷光、荧光变体(例如偏振荧光、荧光发射光谱等)以及使用放置在流体流动中的传感器的其他非光学技术(例如pH或其他离子选择性电极等)。According to a preferred embodiment, the detection unit can detect the concentration of the mixed fluid in the detection area 9 by means of fluorescence monitoring of the mixed fluid. The concentration of the chemical contained in the mixed fluid is directly proportional to the intensity of the fluorescence. For the fluorescence detection described above, any type of light path known to those skilled in the art can be used. The excitation light source can be any suitable light source LS, such as a green He-Ne laser, a red diode laser, and the like. The detection unit may comprise a light detector for detecting fluorescence from and/or through the detection zone 9 where the reaction takes place. The detection unit may also use a photomultiplier tube. The detection unit can also use other optical configurations, such as fiber optics to transmit light from the excitation source to the detection region 9 and from the fluid in the detection region 9 to the photodetectors. The detection means of the above detection unit can also include phosphorescence, fluorescence variants (eg polarized fluorescence, fluorescence emission spectroscopy, etc.) and other non-optical techniques using sensors placed in the fluid flow (eg pH or other ion selective electrodes, etc.).
汇流管5和检测区域9布局如图所示。第一管路6和第二管路7输入两种流体。第一泵单元2和第二泵单元3分别通过第一管路6和第二管路7推进并且在流体混合交汇点处进行混合。优选地,系统还可以包括两个以上的泵单元和管路,用于在混合部4混合两个以上的分离的不同成分的流体。优选地,混合部4能够通过扩散的方式进行混合或通过产生涡流的特殊结构的流体管路结构来进行混合,优选为Y型结。优选地,检测区域9能够为回型管路结构,以留足检测所需时间。The layout of the manifold 5 and the detection area 9 is shown in the figure. The first pipeline 6 and the second pipeline 7 input two fluids. The first pump unit 2 and the second pump unit 3 are propelled through the first line 6 and the second line 7 respectively and mix at the fluid mixing junction. Preferably, the system may also include more than two pump units and pipelines for mixing more than two separated fluids of different components in the mixing part 4 . Preferably, the mixing part 4 can mix by means of diffusion or by a fluid pipeline structure with a special structure that generates eddy currents, preferably a Y-shaped junction. Preferably, the detection area 9 can be a return-type pipeline structure to allow enough time for detection.
根据一种优选的实施方式,第一泵单元2和第二泵单元3以独立的、不同流体进入混合部4以进行混合流体的注射。优选地,由第一泵单元2和第二泵单元3注射入的总体积流量在运行期间保持恒定或基于患者用药需求而改变。优选地,独立的泵单元输送的流体的流量比能够随时间变化而进行控制,从而使得混合物的浓度梯度随时间变化而变化。优选地,当混合流体通过检测区域9时,检测单元以预定间隔对流过的混合流体进行检测。对通过检测区域9的混合流体进行的测量可以绘制为混合流体的时间和浓度相关的曲线。According to a preferred embodiment, the first pump unit 2 and the second pump unit 3 enter the mixing part 4 with independent and different fluids for injection of the mixed fluid. Preferably, the total volume flow injected by the first pump unit 2 and the second pump unit 3 is kept constant during operation or varied based on the patient's medication requirements. Preferably, the flow ratios of the fluids delivered by the individual pump units can be controlled over time so that the concentration gradient of the mixture varies over time. Preferably, when the mixed fluid passes through the detection area 9, the detection unit detects the flowing mixed fluid at predetermined intervals. Measurements of the mixed fluid passing through the detection zone 9 can be plotted as a time and concentration dependent curve of the mixed fluid.
现有技术中的微量泵之所以不采用多个注射器的混合注入的工作方式,是因为多个注射器混合注入容易造成流体浓度的波动。而引起该波动的主要原因在于:多个注射器进行混合注入时,混合处流体的扩散导致混合流体浓度不均;泵送组件的各泵送精度由于活塞或其余结构的粘附导致流体部分残留而影响微量成分的混合。例如,当输入的第一管路6中流体的流速以及流量大于第二管路7中流体的流速以及流量时,低流速流量会导致高流速流量的第一管路6中的流体流入第二管路7,导致部分流体堆积于第二管路7或第一管路6与第二管路7的连接处,使得流体浓度降低。具体地,Y型结包括具有不同流体的第一管路6和第二管路7。两种流体流动相邻。此时第一管路6中的高流速流量的流体扩散到第二管路7中。当第二管路7中低流速流量的流体被推进到混合部4时,扩散来的流体首先被推入混合部4,使得混合部4中的流体混合是非线性的并且所推注的流体存在微量误差。The reason why the micropumps in the prior art do not adopt the working mode of mixed injection of multiple syringes is that the mixed injection of multiple syringes is likely to cause fluctuations in fluid concentration. The main reasons for this fluctuation are: when multiple syringes are mixed and injected, the diffusion of the fluid at the mixing place will lead to uneven concentration of the mixed fluid; Affects the mixing of minor ingredients. For example, when the flow rate and the flow rate of the fluid in the input first pipeline 6 are greater than the flow rate and flow rate of the fluid in the second pipeline 7, the low flow rate flow will cause the fluid in the first pipeline 6 with high flow rate flow to flow into the second pipeline. The pipeline 7 causes part of the fluid to accumulate in the second pipeline 7 or the connection between the first pipeline 6 and the second pipeline 7, so that the fluid concentration is reduced. Specifically, the Y-junction comprises a first conduit 6 and a second conduit 7 with different fluids. The two fluids flow adjacently. At this time, the high-velocity fluid in the first pipeline 6 diffuses into the second pipeline 7 . When the fluid with a low flow rate in the second pipeline 7 is pushed into the mixing part 4, the diffused fluid is first pushed into the mixing part 4, so that the fluid mixing in the mixing part 4 is nonlinear and the injected fluid exists Minor error.
如上所述,当流体从一个管路扩散至混合连接处的另一个管路时,可能会造成混合流体浓度的突变。此时,流体扩散能够用菲克定律描述:As mentioned above, when the fluid diffuses from one line to another line at the mixing junction, sudden changes in the concentration of the mixed fluid may be caused. At this point, fluid diffusion can be described by Fick's law:
其中,F为流体流量(摩尔/秒),Dc为扩散系数(厘米的平方/秒),ΔC为第一管路6和第二管路7的浓度差,Δx为第一管路6和第二管路7的距离。由上式可得,减小第一管路6和第二管路7的距离,即能够减小扩散的发生。优选地,减小第一管路6和第二管路7连接处的横截面积以减小流体扩散。优选地,第一管路6和第二管路7的横截面积小于混合部4的横截面积。优选地,第一管路6和第二管路7连接处的横截面积逐渐减小以形成流体收缩流动。Wherein, F is the fluid flow rate (mole/second), Dc is the diffusion coefficient (centimeter square/second), ΔC is the concentration difference between the first pipeline 6 and the second pipeline 7, and Δx is the first pipeline 6 and The distance of the second pipeline 7. It can be obtained from the above formula that reducing the distance between the first pipeline 6 and the second pipeline 7 can reduce the occurrence of diffusion. Preferably, the cross-sectional area of the junction of the first pipeline 6 and the second pipeline 7 is reduced to reduce fluid diffusion. Preferably, the cross-sectional area of the first pipeline 6 and the second pipeline 7 is smaller than that of the mixing part 4 . Preferably, the cross-sectional area of the junction of the first pipeline 6 and the second pipeline 7 gradually decreases to form a constricted fluid flow.
根据一种优选的实施方式,第一管路6和第二管路7包括具有收缩流动部分10的流道,用以减小流体扩散。第一管路6和第二管路7中的流体通过混合部4混合。优选地,第一管路6和第二管路7中流体的流速是变化的,以在混合部4实现对患者流体浓度梯度的调整。在本实施例中,收缩流动部分10的流道能够沿第一管路6和第二管路7设置于交汇处,或者收缩流动部分10的流道可以设置于第一管路6和第二管路7的任一部位。收缩流动部分10的流道离混合部4越远,收缩流动部分10的流道对减少流体扩散效应的有效性就越低。优选地,收缩流动部分10的流道横截面积随着第一管路6和第二管路7向混合部4的延伸而减小。混合部4内的管路同样能够设置为较窄的横截面积。优选地,还能够通过增大第一管路6和/或第二管路7中流体阻力的方式来减小扩散效应。According to a preferred embodiment, the first line 6 and the second line 7 comprise a flow channel with a constricted flow portion 10 to reduce fluid dispersion. The fluids in the first pipeline 6 and the second pipeline 7 are mixed by the mixing part 4 . Preferably, the flow rate of the fluid in the first pipeline 6 and the second pipeline 7 is varied, so as to adjust the concentration gradient of the patient's fluid at the mixing part 4 . In this embodiment, the flow channel of the constricted flow part 10 can be arranged at the intersection along the first pipeline 6 and the second pipeline 7, or the flow channel of the constricted flow part 10 can be provided at the first pipeline 6 and the second pipeline. Any part of the pipeline 7. The farther the flow path of the constricted flow portion 10 is from the mixing portion 4, the less effective the flow path of the constricted flow portion 10 is in reducing the diffusion effect of the fluid. Preferably, the flow channel cross-sectional area of the constricted flow portion 10 decreases as the first conduit 6 and the second conduit 7 extend toward the mixing portion 4 . The lines in the mixing section 4 can likewise be provided with a narrower cross-sectional area. Preferably, the diffusion effect can also be reduced by increasing the fluid resistance in the first pipeline 6 and/or the second pipeline 7 .
根据一种优选的实施方式,如上所述,当第一管路6和/或第二管路7中的流体在混合部4处保持静止时,来自第二管路7和/或第一管路6的流体可以扩散或流入静止流体中。上述静止流体例如是需要调整混合流体的浓度而暂时停止某一泵单元的流体推送。静止流体保持静止的时间越长,扩散流体的量就越大,因此,浓度的精度就越小。因此,可以通过减小静止流体保持静止的时间来减少扩散流体的量。优选地,处理单元1被配置为:在第一时间段内控制第一流体流入混合部4以及在第二时间段内定量输送第二流体。优选地,第一时间段能够与第二时间段部分重合。优选地,处理单元1控制不同流体在不同时间段下进行定量混合。优选地,系统包括在第一时间段内提供高流速流量的第一泵单元2和在第二时间段内提供微量流体的第二泵单元3。优选地,第一泵单元2中的高流速流量的流体和第二泵单元3中的微量流体在混合部4中混合。优选地,第二时间段能够与第一时间段同步开启。上述定量供给的具体数值取决于需要配置的混合流体的化学参数。第一泵单元2和第二泵单元3用于产生流体流速以便在混合部4处实现连续的可变浓度流体。第一泵单元2和第二泵单元3可以连续产生保持恒定的总体积流量的流体。第一泵单元2中的第一流体在第一时间段进行泵送,而第二泵单元3在第二时间段产生镜像流速,以实现对第一流体和第二流体组合流速的控制。由于第一泵单元2和第二泵单元3的流量在任一时间内的相对流速不为零,所以当第一管路6或第二管路7中的任一一个流体保持静止时,存在最小时间段,使得流体扩散效应减小。在实现上述效果的同时,同步实现随时间推移的混合流体浓度梯度的控制。上述镜像流速是指:第一流体的流速与第二流体的流速处于镜像互补状态,即第一流体和第二流体流速和大于零。如此设置的技术效果在于:将需要高流速流量的流体在第一时间段内输送至混合部4内,并且在第二时间段内输送微量流体。传统的微量药液配制是通过定量加入流体的组分并且通过将两种或多种连续的流体混合而形成混合流体,并且用以注射。医务人员需要预先配置一定量的混合流体后,再通过微量输液泵进行混合流体的注射。对于本发明来说,能够采用多个泵单元进行混合流体供应的方式将该需要人工完成的操作作为微量注射泵的自动化流程,并且设置的各结构减小了多个泵单元组合使用导致的流体扩散、浓度不均匀、混合时间较少等问题。上述设置还能够减小流体对于管路的粘滞,避免部分流体残留于管路中。通过连续的泵入克服管路对流体的粘附,防止粘附对流体中浓度的影响。本发明通过减小流体对管路壁的吸附来减少吸附对浓度的干扰。对于多个种类的流体的混合注射来说,若所需混合的多种类流体中的一种或多种需要进行微量的混合注射,而另一种或多种流体需要相较于其余种类流体更高的容量的混合,则在若干种流体混合的开始阶段,常规微量注射泵难以维持该不同注射器内推送来的不同种类的流体流。即,在所需的一种或多种流体所需的流量过大,而另一种或多种流体所需的流量过小时,会导致该微量注射泵形成的混合流体难以进行连续的混合工作。本发明设置的第一时间段和第二时间段将高容量流体与微量流体分别进行供应混合。与传统的进行若干个流体的定量混合相比,本发明能够减小医务人员的工作量,通过自动化流程实现流体的混合,并且解决了由于机械混合会产生的流速不可控问题。例如在其中的一种或多种流体属于微量需要时,进行连续混合的流体会极大减小其出射流速,即高容量流体需要配合微量流体的注射而减小其混合流体的整体注射,由此导致混合流体注射精度低等多种问题。本发明将各不同容量需要的流体按照各自的时间段进行定量混合,通过多个泵单元、限流件和收缩流动部分1O的配合,提供连续的可控流速且具有高精度的混合流体。According to a preferred embodiment, as mentioned above, when the fluid in the first pipeline 6 and/or the second pipeline 7 remains stationary at the mixing part 4, the fluid from the second pipeline 7 and/or the first pipeline The fluid in path 6 can diffuse or flow into a stationary fluid. The static fluid mentioned above, for example, needs to adjust the concentration of the mixed fluid to temporarily stop the fluid delivery of a certain pump unit. The longer a stationary fluid remains stationary, the greater the amount of diffusing fluid and, therefore, the less precise the concentration. Thus, the amount of diffusing fluid can be reduced by reducing the time that the stationary fluid remains stationary. Preferably, the processing unit 1 is configured to: control the flow of the first fluid into the mixing part 4 during the first time period and quantitatively deliver the second fluid during the second time period. Preferably, the first time period can partially coincide with the second time period. Preferably, the processing unit 1 controls the quantitative mixing of different fluids in different time periods. Preferably, the system comprises a first pump unit 2 providing a high flow rate during a first period of time and a second pump unit 3 providing a trace amount of fluid during a second period of time. Preferably, the high flow rate fluid in the first pump unit 2 and the microfluid in the second pump unit 3 are mixed in the mixing part 4 . Preferably, the second time period can be started synchronously with the first time period. The specific numerical value of the quantitative supply depends on the chemical parameters of the mixed fluid to be configured. The first pump unit 2 and the second pump unit 3 are used to generate a fluid flow rate to achieve a continuously variable concentration fluid at the mixing section 4 . The first pump unit 2 and the second pump unit 3 can continuously generate fluid with a constant total volume flow. The first fluid in the first pump unit 2 is pumped during the first time period, and the second pump unit 3 produces a mirrored flow rate during the second time period, so as to control the combined flow rate of the first fluid and the second fluid. Since the relative flow velocity of the flow of the first pump unit 2 and the second pump unit 3 is not zero at any time, when any one of the fluid in the first pipeline 6 or the second pipeline 7 remains static, there is The minimum time period, such that fluid diffusion effects are reduced. While achieving the above effects, the control of the concentration gradient of the mixed fluid over time is simultaneously realized. The aforementioned mirror image flow rate means that: the flow rate of the first fluid and the flow rate of the second fluid are in a mirror image complementary state, that is, the sum of the flow rates of the first fluid and the second fluid is greater than zero. The technical effect of such an arrangement is that the fluid requiring a high flow rate is delivered to the mixing part 4 within the first time period, and a small amount of fluid is delivered within the second time period. Traditional micro-dose preparation is by dosing the components of the fluid and by mixing two or more successive fluids to form a mixed fluid for injection. Medical personnel need to configure a certain amount of mixed fluid in advance, and then inject the mixed fluid through a micro-infusion pump. For the present invention, multiple pump units can be used for mixed fluid supply, and the operation that needs to be done manually can be used as an automated process for micro-injection pumps, and the various structures set reduce the fluid consumption caused by the combined use of multiple pump units. Diffusion, uneven concentration, less mixing time, etc. The above arrangement can also reduce the viscosity of the fluid to the pipeline, and avoid part of the fluid remaining in the pipeline. Overcome the adhesion of the pipeline to the fluid by continuous pumping, and prevent the influence of adhesion on the concentration of the fluid. The invention reduces the interference of the adsorption on the concentration by reducing the adsorption of the fluid to the pipeline wall. For the mixed injection of multiple types of fluids, if one or more of the multiple types of fluids to be mixed needs to be mixed with a small amount of injection, and the other or more fluids need to be more For high-capacity mixing, it is difficult for conventional microsyringe pumps to maintain the flow of different kinds of fluids pushed from different syringes at the beginning of mixing of several kinds of fluids. That is, when the required flow rate of one or more fluids is too large, while the required flow rate of another or more fluids is too small, it will cause the mixed fluid formed by the micro-injection pump to be difficult to perform continuous mixing work. . The first time period and the second time period set by the present invention supply and mix the high-capacity fluid and the microfluid respectively. Compared with the traditional quantitative mixing of several fluids, the invention can reduce the workload of medical personnel, realize the mixing of fluids through an automated process, and solve the problem of uncontrollable flow rate caused by mechanical mixing. For example, when one or more of the fluids is required in a small amount, the continuous mixed fluid will greatly reduce its exit flow rate, that is, the high-capacity fluid needs to cooperate with the injection of a small amount of fluid to reduce the overall injection of the mixed fluid. This leads to various problems such as low injection accuracy of the mixed fluid. The present invention quantitatively mixes the fluids required by different volumes according to their respective time periods, and provides continuous controllable flow rate and high-precision mixed fluids through the cooperation of multiple pump units, restrictors and constricted flow parts 10.
具体地,在需要改变注射入患者体内的流体的浓度的情况下,能够通过对第一泵单元2和第二泵单元3的调节实现流体浓度的调节。限流件8能够处于闭锁状态以在汇流管5中混合流体浓度达到相应需求后,再泵入患者体内,或基于流体的浓度梯度持续改变流体浓度,直至达到患者所需的阈值。例如,硝酸甘油和氯化钠溶液的混合注入是为了缓解患者的心绞痛。其初次注入的混合速率为10μg/min,随后每5分钟~10分钟增加5~10μg,最大量为200μg/min。对此,本发明混合注入通过调整硝酸甘油的注入量即能实现对浓度和流速的调节。再例如,在对患者注入利多卡因时,作为初次注射需要以25mg/分钟的速率进行注射,并且注射2~3分钟后暂停,必要时在以每五分钟注射50mg的速率进行注射,一小时总量在300mg以内。最后以1mg~4mg/分钟的速率维持注射。该注射方式对于传统医务人员进行配置注射过程来说,需要进行反复的操作,以完成微量泵入。但是对于本发明来说,仅需要进行混合、注射、暂停等自动化操作以后,即能完成上述的间断性操作。本发明能够实现对混合流体的持续性浓度调整以及泵入速率、时间的调整。Specifically, in the case that the concentration of the fluid injected into the patient needs to be changed, the adjustment of the fluid concentration can be realized by adjusting the first pump unit 2 and the second pump unit 3 . The restrictor 8 can be in a closed state to pump the mixed fluid into the patient after the concentration of the mixed fluid in the manifold 5 reaches the corresponding requirement, or continuously change the fluid concentration based on the concentration gradient of the fluid until the threshold required by the patient is reached. For example, a mixture of nitroglycerin and sodium chloride solution is infused to relieve angina in patients. The mixing rate of the initial injection was 10 μg/min, and then increased by 5–10 μg every 5 to 10 minutes, with a maximum of 200 μg/min. In this regard, the mixed injection of the present invention can realize the adjustment of concentration and flow rate by adjusting the injection amount of nitroglycerin. For another example, when injecting lidocaine into a patient, it needs to be injected at a rate of 25 mg/min as the initial injection, and the injection is suspended after 2 to 3 minutes, and if necessary, it is injected at a rate of 50 mg every five minutes for one hour. The total amount is within 300mg. Finally, the injection was maintained at a rate of 1 mg to 4 mg/min. For this injection method, repeated operations are required for the traditional medical personnel to perform the configuration injection process to complete micro-pumping. However, for the present invention, the above-mentioned discontinuous operations can be completed only after automatic operations such as mixing, injection, and pause are performed. The invention can realize continuous concentration adjustment of mixed fluid and adjustment of pumping rate and time.
在全文中,“优选地”所引导的特征仅为一种可选方式,不应理解为必须设置,故此申请人保留随时放弃或删除相关优选特征之权利。需要注意的是,上述具体实施例是示例性的,本领域技术人员可以在本发明公开内容的启发下想出各种解决方案,而这些解决方案也都属于本发明的公开范围并落入本发明的保护范围之内。本领域技术人员应该明白,本发明说明书及其附图均为说明性而并非构成对权利要求的限制。本发明的保护范围由权利要求及其等同物限定。本发明说明书包含多项发明构思,诸如“优选地”、“根据一个优选实施方式”或“可选地”均表示相应段落公开了一个独立的构思,申请人保留根据每项发明构思提出分案申请的权利。Throughout the text, the features introduced by "preferably" are only optional, and should not be interpreted as having to be set. Therefore, the applicant reserves the right to waive or delete relevant preferred features at any time. It should be noted that the above-mentioned specific embodiments are exemplary, and those skilled in the art can come up with various solutions inspired by the disclosure of the present invention, and these solutions also belong to the scope of the disclosure of the present invention and fall within the scope of this disclosure. within the scope of protection of the invention. Those skilled in the art should understand that the description and drawings of the present invention are illustrative rather than limiting to the claims. The protection scope of the present invention is defined by the claims and their equivalents. The description of the present invention contains a number of inventive concepts, such as "preferably", "according to a preferred embodiment" or "optionally" all indicate that the corresponding paragraph discloses an independent concept, and the applicant reserves the right to propose a division based on each inventive concept right to apply.
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| US20090268548A1 (en) * | 2005-08-11 | 2009-10-29 | Eksigent Technologies, Llc | Microfluidic systems, devices and methods for reducing diffusion and compliance effects at a fluid mixing region |
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