CN110575573B - A disposable pipeline installation system for continuous purification treatment of artificial cerebrospinal fluid - Google Patents

Abstract

The invention relates to the field of lumbar spine purification equipment, in particular to a disposable pipeline installation system for continuous purification and treatment of artificial cerebrospinal fluid. The present invention includes a storage device, an infusion volume-determining device, a liquid output volume-determining device, a waste liquid bag and a double-lumen catheter; the storage device includes a storage bag for storing artificial cerebrospinal fluid, and a liquid storage device connected to a liquid outlet of the storage bag A connecting pipe and a filter arranged on the liquid storage connecting pipe and used for filtering artificial cerebrospinal fluid in the liquid storage connecting pipe; Between the valve and the liquid outlet of the first syringe pump, the artificial cerebrospinal fluid flows from the first syringe pump to the double lumen catheter. The invention can cooperate with the existing special artificial cerebrospinal fluid continuous purification equipment, and is applied to the external purification treatment of the cerebrospinal fluid of the central nervous system diseases which cause the changes of the artificial cerebrospinal fluid composition, properties and circulation dynamics.

Description

A disposable pipeline installation system for continuous purification treatment of artificial cerebrospinal fluid

technical field

The invention relates to the field of lumbar spine purification equipment, in particular to a disposable pipeline installation system for continuous purification and treatment of artificial cerebrospinal fluid.

Background technique

As neurosurgery techniques have improved, the chance of death from primary causes has declined, while death and severe neurological deficits from secondary brain damage have remained high. Drug therapy for chronic degenerative neurological diseases and neuro-autoimmune diseases has limited efficacy; effective drug delivery methods in the central nervous system are still under investigation; control management of intracranial hypertension, cerebral edema, brain injury, rapid decontamination of the cerebrospinal fluid environment, and Problems such as the smooth implementation of local mild hypothermia treatment have become the bottleneck restricting the development of neurology, and need to be solved urgently.

Brain trauma, cerebrovascular accident, intracranial infection, acute Guillain-Barre syndrome and other acute intracranial lesions all cause changes in the chemical composition of cerebrospinal fluid and its circulation dynamics, resulting in a series of pathophysiological reactions, resulting in early brain damage and delayed onset Brain damage occurs, even life-threatening. The pathophysiological mechanism of brain injury is very complex, and it is still not clear, and there is no effective clinical measure to improve the prognosis.

The solute transport of cerebrospinal fluid is an important way to remove toxic molecules and metabolites in the brain and transport nutrients to brain cells, and plays an important role in the pathophysiological process of the central nervous system. The cerebrospinal fluid and the interstitial fluid of the brain communicate with each other, which directly affects the living environment of the central nervous cells. Correction and management of cerebrospinal fluid homeostasis may be a therapeutic direction to improve secondary brain damage.

For nearly half a century, many medical scientists have tried to design various devices to purify human cerebrospinal fluid in vitro, which can be roughly divided into three design directions:

1. Cerebrospinal fluid discharge: From the earliest cerebrospinal fluid discharge through lumbar puncture, to the currently widely used intraspinal single lumen drainage (LD) or transventricular drainage (EVD), and the IRRAS- The flow system (patent number: US8398581B2) is a purification management method for cerebrospinal fluid mainly used to discharge cerebrospinal fluid. Although it has clinically shown benefits such as shortened CSF purification time (average 5-10 days), relief of high intracranial pressure and headache symptoms, and shortened ICU stay, there is no conclusive evidence for the effectiveness of this method. Randomized controlled studies have shown that Cerebrospinal fluid drainage had no effect on 6-month outcomes. Due to the limitation of the daily production volume of cerebrospinal fluid, intracranial pressure, and lumbar drainage tube, the efficiency of cerebrospinal fluid purification by this method is low, especially for intracranial cerebrospinal fluid. Therefore, the goal of complete purification of cerebrospinal fluid cannot be achieved in the early stage, and a series of complications are brought about.

2. Cerebrospinal fluid filtration treatment: Since the 1980s, German medical scientists have invented the cerebrospinal fluid filtration treatment (CSFF) system, which has been used for clinical treatment of patients with Guillain-Barre syndrome, which has opened a precedent for cerebrospinal fluid purification treatment. However, due to the backward material engineering technology at that time, frequent pipeline blockage incidents, and low filter efficiency, the clinical effect was not significant and was once neglected.

In 2001, the team of domestic scholar Professor Wang Yongjun designed and invented a WLCSFPS-777 cerebrospinal fluid purification system (patent number 200520110390.4). Referring to the principle of blood purification equipment, improvements were made in the design of pipelines and filters, but it still belongs to the single-lumen lumbar spine. Tube drainage and filtration treatment, the incidence of tube blockage is high; and the filter design can only be used to remove cells and macromolecular substances in cerebrospinal fluid, but cannot remove inflammatory mediators, blood lysates, excitatory amino acids and neurotransmitters that really cause neuropathic damage. and small molecular pathological components such as electrolyte acid-base disorder, so it has not been clinically promoted.

In 2009, Americans designed an in vitro biofilter (patent number: US20090131850A1), and a single-lumen circulation circuit for lateral ventricle drainage. Biological adsorption immunoprobes and ion exchange resins are designed on the inner wall of the biofilter for specific pathological components. However, for pathological components with complex and diverse components that have not been thoroughly studied, it is difficult to completely remove the pathological components and restore the acid-base balance of electrolytes. Moreover, the components of biofilters are expensive and saturated adsorption is difficult to judge.

In 2013, Americans improved the design of long and short tubes for the double-lumen tube in the spinal canal (patent number: US8435204B2), which improved the range and efficiency of filtration and purification, but the purification range was still limited to the spinal canal.

The Neurapheresis ^TM developed in 2017 uses a double-lumen tube for translumbar intubation, and improves the filter performance to achieve the removal of small-molecule inflammatory mediators; however, its long lumen only reaches the thoracic spine stage, and its purifying cerebrospinal fluid dynamics Studies have shown that the scope of purification is limited to the spinal canal below the thoracic spine, and the electrolyte acid-base disturbance cannot be corrected. In a preliminary clinical study in 2019, it was found that the lifespan of early filters was short, making it difficult to achieve continuous purification treatment.

3. Artificial cerebrospinal fluid purification treatment: Since the successful preparation of artificial cerebrospinal fluid in 1949, artificial cerebrospinal fluid has been used more and more widely in scientific research and clinical practice. Especially with the development of ventriculoscopy, more and more attention has been paid to the neurological safety of clinical intracerebral perfusion fluid. Many animal studies have shown that artificial cerebrospinal fluid has better neurological safety than Ringer's solution and normal saline. Many animal models of artificial cerebrospinal fluid perfusion intervention have shown that artificial cerebrospinal fluid can reduce the edema state of traumatic brain injury, protect nerve cell damage, and reduce the permeability of the blood-brain barrier, so it has the opportunity to be used as a substitute for cerebrospinal fluid.

In 2003, Americans designed a cerebrospinal fluid purification system (patent number: WO03/015710A2), which can be used to infuse fluid through lateral ventricle and lumbar cistern to drain cerebrospinal fluid (patent number: WO03/015710A2). and complication of ventricular injury.

So far, no safe and efficient artificial cerebrospinal fluid purification equipment and installation pipeline has been developed and applied.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a disposable pipeline installation system for continuous purification and treatment of artificial cerebrospinal fluid, which can cooperate with the existing special continuous purification equipment of artificial cerebrospinal fluid to be applied to cause artificial cerebrospinal fluid composition, properties and circulatory dynamics Cerebrospinal fluid decontamination therapy for altered central nervous system disorders.

The present invention is realized through the following technical solutions: a disposable pipeline installation system for continuous purification and treatment of artificial cerebrospinal fluid, which is characterized by comprising a storage device, an infusion volume-fixing device, a liquid output volume-fixing device, a waste liquid bag and a double-chamber catheter;

The storage device comprises a storage bag for storing artificial cerebrospinal fluid, a liquid storage connection pipe connected with the liquid outlet of the storage bag, and a filter arranged on the liquid storage connection pipe and used for filtering the artificial cerebrospinal fluid in the liquid storage connection pipe;

The infusion constant volume device includes a first syringe pump, a first liquid inlet pipe, a first liquid outlet pipe, a first liquid inlet check valve and a first liquid outlet check valve; one end of the first liquid inlet pipe is connected to the storage tank. The other end of the liquid connecting pipe is communicated with the liquid inlet of the first syringe pump through the first liquid inlet one-way valve, so that the artificial cerebrospinal fluid in the storage bag flows into the first syringe pump in one direction; one end of the first liquid outlet pipe The other end communicates with the liquid inlet of the double-lumen catheter and passes between the first liquid outlet one-way valve and the liquid outlet of the first syringe pump, so that the artificial cerebrospinal fluid flows from the first syringe pump to the double-lumen catheter;

The liquid outlet and constant volume device includes a second syringe pump, a second liquid outlet pipe, a second liquid inlet pipe, a second liquid inlet one-way valve and a second liquid outlet one-way valve; one end of the second liquid inlet pipe is connected to the The other end of the liquid outlet of the double-lumen catheter is connected to the liquid inlet of the second syringe pump through the second liquid inlet one-way valve, so that the artificial cerebrospinal fluid flows from the double-lumen catheter into the second syringe pump in one direction; the second outlet One end of the liquid pipe is connected to the liquid outlet of the second syringe pump through the second liquid outlet one-way valve, and the other end is connected to the waste liquid bag, so that the artificial cerebrospinal fluid flows from the second syringe pump to the waste liquid bag in one direction.

In order to better implement this scheme, the following optimization schemes are also provided:

Further, it also includes a dredging device, the dredging device includes a first branch pipe, a second branch pipe, a first three-way solenoid valve and a second three-way solenoid valve;

One end of the first branch pipe is communicated with the first liquid outlet pipe and the other end is communicated with the second liquid inlet pipe, one end of the second branch pipe is communicated with the second liquid inlet pipe and the other end is communicated with the first liquid outlet pipe;

The first three-way solenoid valve is arranged at the intersection of the first liquid outlet pipe and the first branch pipe and is used to control the artificial cerebrospinal fluid flowing in through the first syringe pump to flow to the double-lumen catheter or to the first branch pipe;

The second three-way solenoid valve is arranged at the intersection of the second liquid inlet pipe and the second branch pipe and is used to control the flow of artificial cerebrospinal fluid through the second liquid inlet pipe or the second branch pipe to the second syringe pump.

Further, the double-lumen catheter includes a long catheter and a short catheter;

The long catheter is composed of a first intrathecal extension tube section, a first intrathecal tube section and a first subcutaneous tube section in sequence from front to back; the short catheter is sequentially composed of a second intrathecal tube section and a second intrathecal extension tube from front to back The tube section is composed; the first inner sheath tube section and the second inner sheath tube section are integrally connected together along the extending direction to form a double-lumen tube body;

One end of the first liquid outlet pipe is communicated with the first subcutaneous pipe section, and the second liquid inlet pipe is communicated with the second intrathecal extension pipe section.

Further, the shape of the cross-section of the double-lumen tube body is circular, the cross-section of the lumen of the first intra-sheath tube segment is a meniscus, and the cross-section of the lumen of the second intra-sheath tube segment is an ellipse. .

Further, the orifice of the second intrasheath tube segment is a wedge-shaped orifice; the front end tube wall of the second intrathecal tube segment is provided with several side holes.

Preferably, the long duct and the short duct are made of polyethylene, the outer walls of the long duct and the short duct are coated with a hydrophilic coating, and the inner wall of the long duct and the short duct is provided with a nickel-titanium alloy Silk woven mesh layer.

Further, the storage device further includes a first monitoring exhaust branch pipe communicating with the liquid storage connecting pipe, and a first pipe clamp is provided on the first monitoring exhaust branch pipe.

Further, the first liquid outlet pipe is provided with a hydraulic sensor for monitoring the liquid pressure in the pipe.

Further, a buoyancy valve is also provided between the second liquid outlet pipe and the waste liquid bag.

Further, the liquid outlet and constant volume device further includes a second monitoring exhaust branch pipe communicated with the second liquid outlet pipe, and a second pipe clamp is provided on the second monitoring exhaust branch pipe.

Compared with the prior art, the beneficial effects of the present invention are:

1. Using artificial cerebrospinal fluid as the replacement fluid to replace the cerebrospinal fluid with the same amount in a single cycle, completely remove all harmful substances, realize the rapid correction of the acid-base disorder of water electrolysis of the cerebrospinal fluid, and avoid the complicated and expensive filter design and short service life concerns ;

2. Artificial cerebrospinal fluid replacement, combined with the design of double-lumen long and short tubes, can control the purification kinetics and purification range of cerebrospinal fluid to the greatest extent, and maximize the purification efficiency, especially the rapid purification of cerebrospinal fluid in the cranial cavity;

3. The design of the anti-blocking auxiliary passage avoids the problems of extubation and reset, interruption of treatment caused by blockage of the drainage pipeline, and solves the problem of pipeline blockage;

4. The use of synchronous equal-volume replacement avoids low intracranial pressure and brain damage caused by cerebrospinal fluid discharge. 5. Perfect pipeline and intracranial pressure monitoring, as well as intelligent perfusion and drainage control systems, to achieve rapid and safe in vitro cerebrospinal fluid purification treat.

Description of drawings

Fig. 1 is the structural representation of the present invention;

Fig. 2 is a schematic diagram of the structure of a waste liquid bag;

3 is a schematic diagram of the flow direction of artificial cerebrospinal fluid during normal operation of the present invention;

4 is a schematic diagram of the flow direction of artificial cerebrospinal fluid when the reverse flushing procedure of the present invention is turned on;

Fig. 5 is a schematic diagram of the structure of a double-lumen catheter;

Fig. 6 is A-A sectional view in Fig. 5;

FIG. 7 is a B-B sectional view of FIG. 5 .

Label description: 11-storage bag, 12-liquid storage connection pipe, 121-first monitoring exhaust branch pipe, 122-first pipe clamp, 13-filter, 21-first syringe pump, 22-first liquid inlet pipe , 23-first liquid outlet pipe, 24-first liquid inlet check valve, 25-first liquid outlet check valve, 31-second syringe pump, 32-second liquid outlet pipe, 33-second liquid inlet Pipe, 34-second liquid inlet check valve, 35-second liquid outlet check valve, 36-second monitoring exhaust branch pipe, 361-second pipe clamp, 41-first branch pipe, 42-second branch pipe, 43-the first three-way solenoid valve, 44-the second three-way solenoid valve, 51-the first extension tube section in the sheath, 52-the first tube section in the sheath, 53-the first subcutaneous tube section, 61-the second tube section in the sheath, 611-Side hole, 612-Wedge-shaped nozzle, 62-Second sheath extension pipe section, 7-Nitinol wire braided mesh layer, 8-Pressure sensor, 9-Waste liquid bag, 91-Buoyancy valve.

Detailed ways

The present invention is described in detail below in conjunction with the accompanying drawings:

As shown in Figure 1, the present invention includes a storage device, an infusion constant volume device, a liquid output constant volume device, a waste liquid bag 9 and a double-lumen catheter;

The storage device includes a storage bag 11 for storing artificial cerebrospinal fluid, a liquid storage connecting pipe 12 connected to the liquid outlet of the storage bag 11, and a liquid storage connecting pipe 12 arranged on the liquid storage connecting pipe 12 and used for filtering the artificial cerebrospinal fluid in the liquid storage connecting pipe 12. The storage device further includes a first monitoring exhaust branch pipe 121 communicated with the liquid storage connecting pipe 12 , and a first pipe clamp 122 is provided on the first monitoring exhaust branch pipe 121 .

The infusion volume constant device includes a first syringe pump 21 , a first liquid inlet pipe 22 , a first liquid outlet pipe 23 , a first liquid inlet check valve 24 and a first liquid outlet check valve 25 ;

The first liquid inlet check valve 24, the first liquid outlet check valve 25 and the first syringe pump 21 are all disposable consumables, and the first syringe pump 21 can use various micro syringe pumps on the market. The first syringe pump 21 used in the embodiment includes: a 304 stainless steel piston rod, a tail plate, a PTFE piston, a high-precision scale borosilicate glass cylinder and a double-ended one-way valve. The features of the high-precision scale high-borosilicate glass cylinder body are: the high-borosilicate transparent glass tube body is a slender cylindrical body, with a high-precision calibration volume scale engraved with a maximum capacity of 25ml, the cylinder body is stable in size and not easily deformed, and the tube body is stable and not easily deformed. The body is transparent for easy observation of the inside of the tube. The top and bottom of the cylinder are closed by Teflon material, there is a piston push rod movable hole in the middle of the bottom, and two internal threaded holes for the installation of the one-way valve are left in the middle of the top. The characteristics of the 304 stainless steel piston push rod and tail plate are: the piston push rod is made of solid stainless steel, the rod body is straight and smooth, the diameter is 0.5cm, the head end is closely connected with the PTFE piston, and the tail end is integrally cast into a disc shape , about 1.5cm in diameter and 0.3cm in thickness. During installation, the tail disc is placed into the tail disc fixing slot of the linear guide slider, so that the piston rod can be extended and retracted with the movement of the slider.

The features of the double-headed one-way valve, namely the first liquid inlet one-way valve 24 and the first liquid outlet one-way valve 25 are: two one-way valves are respectively connected with the two drainage holes at the top of the high borosilicate glass syringe through threads. valve. The first liquid inlet check valve 24 at the inlet can only enter and cannot enter, and the first liquid outlet check valve 25 at the outlet can only enter and exit, and the valve body marks the passage direction.

The first liquid outlet pipe 23 , the second liquid inlet pipe 33 and the second liquid outlet pipe 32 are all provided with a pressure sensor 8 for monitoring the liquid pressure in the pipes. The pressure sensor 8 is characterized in that it is a Teflon hard disk-shaped structure integrally connected with the pipeline, and the center of the bottom is a membrane structure with impermeability and good toughness. Through the semi-rotation pressure buckle on the instrument and the pressure sensor, the pressure data in the corresponding pipeline can be obtained non-contact through the pressure transmission between the bottom membrane structure and the pressure probe. The pressure sensor 8 on the input pipeline monitors the pipeline pressure at the input end, which is a mild positive pressure under normal conditions; the pressure sensor 8 on the output end pipeline monitors the pipeline pressure at the output end, which is normally mild negative pressure; the waste liquid pipe The pressure sensor 8 on the second liquid outlet pipe 32 monitors the filling of the waste liquid bag, which is normally 0 or slightly positive pressure.

One end of the first liquid inlet pipe 22 is communicated with the liquid storage connecting pipe 12, and the other end is communicated with the liquid inlet of the first syringe pump 21 through the first liquid inlet check valve 24, so that the artificial cerebrospinal fluid in the storage bag 11 flows in one direction. In the first syringe pump 21; one end of the first liquid outlet pipe 23 is connected to the liquid inlet of the double-lumen conduit, and the other end passes between the first liquid outlet one-way valve 25 and the liquid outlet of the first syringe pump 21, thereby make the artificial cerebrospinal fluid flow from the first syringe pump 21 to the double lumen catheter;

The output of artificial cerebrospinal fluid is first intercepted by the high-precision filter 13 on the pipeline to intercept the solution particles that may cause adverse reactions, and the pore size of the filter membrane is about 2um. Before entering the fixed container of the perfusion period, that is, the first syringe pump 21, there is a normally closed first monitoring exhaust branch pipe 121 in the pipeline, which is used for air bubble discharge and artificial cerebrospinal fluid sample sampling.

As shown in FIG. 2 , the liquid outlet constant volume device includes a second syringe pump 31 , a second liquid outlet pipe 32 , a second liquid inlet pipe 33 , a second liquid inlet check valve 34 and a second liquid outlet check valve 35; One end of the second liquid inlet pipe 33 is communicated with the liquid outlet of the double-lumen catheter, and the other end is communicated with the liquid inlet of the second syringe pump 31 through the second liquid inlet one-way valve 34, so that the artificial cerebrospinal fluid is connected by the double-lumen catheter. One-way flow into the second syringe pump 31; one end of the second liquid outlet pipe 32 is set to communicate with the liquid outlet of the second syringe pump 31 through the second liquid outlet check valve 35, and the other end is communicated with the waste liquid bag 9 so as to The artificial cerebrospinal fluid is made to flow out from the second syringe pump 31 to the waste fluid bag 9 in one direction.

The characteristics of the waste liquid bag 9 are: the waste liquid bag 9 is a three-liter bag structure, and the inlet pipe opening is located in the upper middle part of the bag wall, not at the top. A buoyancy valve 91 is also provided between the second liquid outlet pipe 32 and the waste liquid bag 9. The buoyancy valve 91 is designed as a rigid cylindrical grid cage structure at the end of the pipeline with a built-in buoyancy ball. When the liquid level in the waste liquid bag does not reach the level of the input port, the buoyancy ball stops at the bottom of the grid cage, the input pipeline is kept unobstructed, and the pressure monitoring of the waste liquid pipeline is 0 or slightly positive pressure; when the liquid level of the waste liquid bag reaches the input level When the mouth level is above, the buoyancy ball floats up against the entrance, causing the resistance of the waste liquid pipeline to increase, causing a blue sound alarm to remind the medical staff to empty the waste liquid bag, but under the drive of the syringe, it can overcome the resistance and continue to input the waste liquid. If the waste liquid bag is not emptied in time, the resistance will continue to increase and eventually the pressure of the waste liquid pipeline will rise to a critical value, a yellow alarm will appear, and the treatment will be interrupted.

The liquid outlet and constant volume device further includes a second monitoring exhaust branch pipe 36 communicated with the second liquid outlet pipe 32 , and a second pipe clamp 361 is provided on the second monitoring exhaust branch pipe 36 . The second pipe clamp 361 is arranged between the pressure sensor 8 and the waste fluid bag 9, and the second monitoring exhaust branch pipe 36 is used for the collection and testing of cerebrospinal fluid samples.

The characteristics of the main path and bypass of the pipeline are: we stipulate that the main circulation path of purification treatment is artificial cerebrospinal fluid injected from the cerebellomedullary cistern and drawn out from the lumbar cistern; otherwise, it is the bypass. The main road runs through the normally open circuit of the three-way solenoid valve, and the bypass runs through the normally closed circuit of the three-way solenoid valve, and merges into the other party's main road.

The functional characteristics of the main circuit and the bypass are: the patency of the inner channel drainage tube is the key to the safety and continuity of cerebrospinal fluid purification. Since the input end is flushed by positive pressure, blockage is impossible; however, blockage often occurs in the lumbar drainage tube orifice in vivo due to factors such as negative pressure suction, cerebrospinal fluid contents, and cauda equina. In order to solve this problem, we designed a two-way circulation mechanism and a timed reverse flushing procedure with the inner channel formed by the main channel and the bypass channel.

As shown in Figure 3-4, the circulation process of artificial cerebrospinal fluid is as follows: artificial cerebrospinal fluid starts from the storage bag 11, passes through the precise filter 13, and passes through the first liquid inlet check valve 24 and the first liquid outlet check valve on both sides. 25 The fixed container for entering and exiting the perfusion cycle is the first syringe pump 21; the input pipeline channel is divided into the main circuit and the bypass after the first three-way solenoid valve 43, and the main circuit is the first liquid outlet pipe 23. The artificial cerebrospinal fluid is input into the double-lumen catheter connected to it; the bypass, that is, the first branch pipe 41 merges into the second liquid inlet pipe 33 in the output pipeline channel.

The first liquid outlet pipe 23 is connected with the double-lumen catheter inserted into the waist pool of the human body, and the output pipeline channel is divided into the main path and the bypass when passing through the second three-way solenoid valve 44 on the second liquid inlet pipe 33, and the main path continues. Extend and pass through the second liquid inlet one-way valve 34 and the second liquid outlet one-way valve 35 into and out of the drainage period container, namely the second syringe pump 31, and finally connect to the waste liquid bag 9; the output bypass is the second branch pipe 42. into the pipe section of the first liquid outlet pipe 23 between the first three-way one-way valve and the double-lumen conduit. Thereby, the outer channel for artificial cerebrospinal fluid purification and the inner channel for purification of subarachnoid double-lumen drainage tube are formed, forming a single-circulation closed system from "artificial cerebrospinal fluid bag-subarachnoid space-waste bag".

The main circuit and the bypass constitute the two-way circulation mechanism and timing reverse flushing procedure of the inner passage, namely the dredging device, the dredging device includes the first branch pipe 41, the second branch pipe 42, the first three-way solenoid valve 43 and the second three-way solenoid valve 43. valve 44;

One end of the first branch pipe 41 is connected with the first liquid outlet pipe 23 and the other end is connected with the second liquid inlet pipe 33 , and one end of the second branch pipe 42 is connected with the second liquid inlet pipe 33 and the other end is connected with the first liquid outlet pipe 23 . connected;

The first three-way solenoid valve 43 is arranged at the intersection of the first liquid outlet pipe 23 and the first branch pipe 41 and is used to control the artificial cerebrospinal fluid flowing in through the first syringe pump 21 to flow to the double-lumen catheter or to the first branch pipe 41;

The second three-way solenoid valve 44 is disposed at the interaction between the second liquid inlet pipe 33 and the second branch pipe 42 and is used to control the flow of artificial cerebrospinal fluid through the second liquid inlet pipe 33 or the second branch pipe 42 to the second syringe pump 31 .

The characteristics of the two-way circulation mechanism and the timing reverse flushing procedure are: when the waist pool pipe is blocked, the negative pressure of the output main circuit increases, the feedback activates the two three-way solenoid valves to reroute, and the first liquid outlet pipe at the input end is 23 The lumbar canal is backwashed through the bypass first branch pipe 41 , and the second liquid inlet pipe 33 at the output end is drained from the cerebellomedullary canal through the bypass second branch pipe 42 . After 3 cycles of positive pressure flushing, the solenoid valve resets automatically and starts the main circuit treatment. In this process, the common factors of tube blockage can be solved, and the treatment is not interrupted due to the blockage of the tube, and the safety of the patient is not endangered. But if the pipeline collapses under pressure, it cannot be solved by flushing. In order to prevent pipeline blockage, the program is set to automatically enter the 3-cycle reverse flushing program after completing 10 cycles of main circuit treatment.

In this embodiment, each pipeline in the system adopts a transparent tetrafluorotube, the lumen does not expand and collapse under the action of suction pressure, the inner diameter of the pipeline is about 2mm, and the wall thickness is about 1mm.

As shown in Figures 5-7, in addition, in this embodiment, the double-lumen catheter includes a long catheter and a short catheter;

The long catheter is composed of the first intrathecal extension tube section 51, the first intrathecal tube section 52 and the first subcutaneous tube section 53 in sequence from front to back; the short catheter is composed of the second intrathecal tube section 61 and the first subcutaneous tube section from front to back Two intra-sheath extension pipe sections 62 are formed; the first intra-sheath pipe section 52 and the second intra-sheath pipe section 61 are integrally connected together along the extending direction to form a double-lumen pipe body;

One end of the first liquid outlet tube 23 communicates with the first subcutaneous tube section 53 , and the second liquid inlet tube 33 communicates with the second intrathecal extension tube section 62 .

The shape of the cross section of the double lumen tube body is circular, the cross section of the lumen of the first intrasheath tube section 52 is meniscus, and the cross section of the lumen of the second intrasheath tube section 61 is oval.

The orifice of the second intra-sheath tube section 61 is a wedge-shaped orifice 612 ; a number of side holes 611 are provided on the front end tube wall of the second intra-sheath tube section 61 .

In addition, in this embodiment, the double-lumen catheter in the spinal canal, including the long catheter and the short catheter, are made of flexible and biocompatible materials, the outer wall surface is coated with a hydrophilic antibacterial coating, and the interior of the tube wall is provided with Nitinol wire braided mesh layer 7. The catheter was inserted into the subarachnoid space through the L5 intervertebral space. Under the supervision of DSA and guided by a 0.014” micro-guide wire, the catheter was gently and slowly advanced along the subarachnoid space on the dorsal side of the spinal cord, and the last long tube end was located at C1C2 near the cisterna magna. At the level of the vertebral body, the end of the short tube is located near the lumbar L1 vertebral body.

The use process of this device is as follows:

1. Turn on the equipment, enter the pipeline installation program, and install the corresponding pipeline as shown in Figure 1.

2. Preparation of artificial cerebrospinal fluid: After the artificial cerebrospinal fluid is packed in a disposable storage bag 11 and mixed evenly, it is fully foamed and saturated with air mixture (95% O ₂ , 5% CO ₂ ), and then hung on an infusion stand; Connect the liquid storage connection pipe 12 with the liquid outlet of the storage bag 11 for storing artificial cerebrospinal fluid; extract the artificial cerebrospinal fluid through the first monitoring exhaust branch pipe 121 and conduct blood gas analysis and monitoring before it is qualified before use;

3. Pre-filling of the main artificial cerebrospinal fluid: press Start to pre-fill, the perfusion volume-fixing device and the drainage volume-fixing system are activated simultaneously, and the artificial cerebrospinal fluid begins to flow into the perfusion volume-fixing system along the pipeline (that is, in the first syringe pump 21, the same below) and flow out, flow into the drainage and constant volume system (ie, the second syringe pump 31, the same below) along the pre-filling connecting pipe, and finally flow into the waste liquid bag 9, and go through several cycles of pre-filling, so that the main line and the two fixed The gas in the container is completely evacuated.

4. Pre-filling of artificial cerebrospinal fluid auxiliary pipeline: according to the auxiliary pipeline, the perfusion volume-fixing device and the drainage volume-fixing system are activated simultaneously, and the two three-way solenoid valves are simultaneously activated for diversion; The starting end of the second liquid inlet pipe 33 flows into the drainage and constant volume system through the end of the first liquid outlet pipe 23 in the reverse direction through the pre-filled connecting pipe section; repeat several cycles to completely empty the auxiliary passage and the two fixed volume. The gas in the container makes the whole in vitro purification pipeline be filled with artificial cerebrospinal fluid, wherein the perfusion container is in a fully loaded state, and the drainage container is in an empty state.

5. Preparation of intraspinal catheter: extract artificial cerebrospinal fluid from the first monitoring exhaust branch pipe 121 to perform suction and exhaust and equal replacement of the double-lumen catheter in the spinal canal, so as to maintain the airtightness and patency of the double-lumen catheter. And clamp the pipe clamp for use.

6. Connect the patient to start treatment: After pre-filling, clamp the end of the first liquid outlet pipe 23 and the pipe clamp at the beginning of the second liquid inlet pipe 33; The outer interface of the long catheter lumen is communicated, the initial end of the second liquid inlet pipe 33 is communicated with the outer interface of the short catheter lumen, and the pipe clamp is opened to keep the pipeline unobstructed. Press to start, and the device performs purification treatment according to the set parameters.

7. Pressure monitoring and alarm: When the pressure loss alarm occurs on the pipelines of the first liquid outlet pipe 23 and the second liquid inlet pipe 33, it will indicate that the pipeline is not tightly connected with the patient; when a high pressure alarm occurs, it will prompt the front-end pipeline. Obstruction or oppression. At this time, the first three-way solenoid valve 43 and the second three-way solenoid valve 44 are activated and redirected, and at the same time, the main circuit is closed and the bypass is connected, that is, the first liquid outlet pipe 23 and the second liquid inlet pipe 33 are closed at the same time, and the second liquid inlet pipe 33 is closed at the same time. One pipe 41 and the second branch pipe 42 perform the reverse flushing procedure, that is, the original liquid inlet of the double-lumen catheter becomes a liquid outlet, and the liquid outlet becomes a liquid inlet, so that the flow direction of the artificial cerebrospinal fluid in the double-lumen catheter is reversed. The solenoid valve resets after 3 cycles. If the high pressure alarm is still not released, it indicates that the possibility of pipeline compression is high.

A high pressure alarm appears on the second liquid outlet pipe 32, indicating that the waste liquid bag 9 is full. The waste liquid bag 9 is a three-liter bag structure, and the liquid storage connecting pipe 12 is made of rigid plastic, and penetrates from the bottom of the bag to the horizontal position of the middle and upper 1/3 of the bag. The pipe end of the liquid storage connecting pipe 12 is a cylinder with a diameter larger than the input pipe diameter and a grid-shaped hollowed-out side wall, and a buoyancy valve 91 with a diameter larger than the input pipe diameter is located inside. When the liquid level reaches above the plane of the hollow cylinder, the buoyancy ball in the buoyancy valve 91 blocks the end of the input pipe under the action of buoyancy, causing the pressure of the second liquid outlet pipe 32 to rise and an alarm to remind the medical staff to empty the waste bag; If the waste bag is emptied in time, the resistance will continue to increase and eventually cause the road pressure to rise to a critical value and the treatment will be interrupted.

Although the present invention has been illustrated and described in terms of specific embodiments and its alternatives, it should be understood that various changes and modifications may be implemented without departing from the spirit and scope of the invention. Therefore, it should be understood that the present invention is not to be limited in any way, except by the appended claims and their equivalents.

Claims (9)

1. a disposable pipeline installation system for artificial cerebrospinal fluid continuous purification treatment, it is characterized in that: comprise storage device, infusion constant volume device, liquid discharge constant volume device, waste liquid bag (9) and double-lumen catheter; The storage device comprises a storage bag (11) for storing artificial cerebrospinal fluid, a liquid storage connecting pipe (12) connected with a liquid outlet of the storage bag (11), and a liquid storage connecting pipe (12) arranged on the liquid storage connecting pipe (12) and used for filtering a filter (13) for artificial cerebrospinal fluid in the liquid storage connecting pipe (12); The infusion volume constant device comprises a first syringe pump (21), a first liquid inlet pipe (22), a first liquid outlet pipe (23), a first liquid inlet check valve (24) and a first liquid outlet check valve (24) valve (25); one end of the first liquid inlet pipe (22) is connected with the liquid storage connecting pipe (12) and the other end is connected to the liquid inlet of the first syringe pump (21) through the first liquid inlet one-way valve (24) communication so that the artificial cerebrospinal fluid in the storage bag (11) flows into the first syringe pump (21) in one direction; one end of the first liquid outlet pipe (23) is communicated with the liquid inlet of the double-lumen catheter, and the other end passes through the first syringe pump (21). between the liquid outlet one-way valve (25) and the liquid outlet of the first syringe pump (21) so that the artificial cerebrospinal fluid flows from the first syringe pump (21) to the double-lumen catheter; The liquid outlet and constant volume device comprises a second syringe pump (31), a second liquid outlet pipe (32), a second liquid inlet pipe (33), a second liquid inlet check valve (34) and a second liquid outlet check valve. Direction valve (35); one end of the second liquid inlet pipe (33) communicates with the liquid outlet of the double-lumen conduit and the other end passes through the second liquid inlet one-way valve (34) and the liquid inlet of the second syringe pump (31) so that the artificial cerebrospinal fluid flows into the second syringe pump (31) unidirectionally from the double-lumen catheter; one end of the second liquid outlet pipe (32) is set through the second liquid outlet one-way valve (35) to be connected with the second injection pump (35). The other end of the liquid outlet of the pump (31) is communicated with the waste liquid bag (9) so that the artificial cerebrospinal fluid flows out of the second syringe pump (31) in one direction to the waste liquid bag (9); Also included is a dredging device, the dredging device comprising a first branch pipe (41), a second branch pipe (42), a first three-way solenoid valve (43) and a second three-way solenoid valve (44); One end of the first branch pipe (41) is communicated with the first liquid outlet pipe (23) and the other end is communicated with the second liquid inlet pipe (33), and one end of the second branch pipe (42) is connected with the second liquid inlet pipe (33) The other end of the communication is communicated with the first liquid outlet pipe (23); The first three-way solenoid valve (43) is arranged at the interaction of the first liquid outlet pipe (23) and the first branch pipe (41) and is used to control the flow of artificial cerebrospinal fluid flowing in via the first syringe pump (21) to the double-lumen catheter Or flow to the first branch pipe (41); The second three-way solenoid valve (44) is arranged at the interaction of the second liquid inlet pipe (33) and the second branch pipe (42) and is used to control the passage of the second liquid inlet pipe (33) or the second branch pipe (42) The artificial cerebrospinal fluid flows to the second syringe pump (31). 2. A disposable pipeline installation system for continuous purification and treatment of artificial cerebrospinal fluid according to claim 1, characterized in that: the double-lumen catheter comprises a long catheter and a short catheter; The long catheter is composed of a first intrathecal extension tube section (51), a first intrathecal tube section (52) and a first subcutaneous tube section (53) in sequence from front to back; the short catheter is sequentially composed of a second intrathecal tube section (53) from front to back The inner sheath tube section (61) and the second inner sheath extension tube section (62) are composed; the first inner sheath tube section (52) and the second inner sheath tube section (61) are integrally connected together along the extension direction to form a double lumen tube body ; One end of the first liquid outlet pipe (23) is communicated with the first subcutaneous pipe section (53), and the second liquid inlet pipe (33) is communicated with the second intrathecal extension pipe section (62). 3. A disposable pipeline installation system for continuous purification and treatment of artificial cerebrospinal fluid according to claim 2, characterized in that: the shape of the cross-section of the double-lumen tube body is circular, and the first sheath is The cross section of the lumen of the tube section (52) is meniscus, and the cross section of the lumen of the second intrathecal tube section (61) is oval. 4. A disposable pipeline installation system for continuous purification treatment of artificial cerebrospinal fluid according to claim 2, characterized in that: the orifice of the second intrathecal tube segment (61) is a wedge-shaped orifice (612) ; A number of side holes (611) are arranged on the front end wall of the second inner sheath tube section (61). 5. a kind of disposable pipeline installation system for continuous purification treatment of artificial cerebrospinal fluid according to claim 2, is characterized in that: described long conduit and short conduit are all made of polyethylene, and long conduit and short conduit are made of polyethylene. The outer wall surfaces are all coated with a hydrophilic coating, and a nickel-titanium alloy wire braided mesh layer (7) is arranged inside the pipe walls of the long conduit and the short conduit. 6. A disposable pipeline installation system for continuous purification and treatment of artificial cerebrospinal fluid according to claim 1, characterized in that: the storage device further comprises a first monitoring drain connected to the liquid storage connecting pipe (12). The air branch pipe (121) is provided with a first pipe clamp (122) on the first monitoring exhaust branch pipe (121). 7. A disposable pipeline installation system for continuous purification and treatment of artificial cerebrospinal fluid according to claim 1, characterized in that: the first liquid outlet pipe (23), the second liquid inlet pipe (33) and The second liquid outlet pipes (32) are all provided with pressure sensors (8) for monitoring the liquid pressure in the pipes. 8. A disposable pipeline installation system for continuous purification and treatment of artificial cerebrospinal fluid according to claim 1, characterized in that: there is also a connection between the second liquid outlet pipe (32) and the waste liquid bag (9). A buoyancy valve (91) is provided. 9. A disposable pipeline installation system for continuous purification and treatment of artificial cerebrospinal fluid according to claim 1, characterized in that: the liquid outlet constant volume device further comprises a liquid outlet pipe (32) that communicates with the second outlet pipe (32). The second monitoring exhaust branch pipe (36) is provided with a second pipe clamp (361).

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