CN110575573A - Disposable pipeline installation system for continuous purification treatment of artificial cerebrospinal fluid - Google Patents
Disposable pipeline installation system for continuous purification treatment of artificial cerebrospinal fluid Download PDFInfo
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- CN110575573A CN110575573A CN201910903540.3A CN201910903540A CN110575573A CN 110575573 A CN110575573 A CN 110575573A CN 201910903540 A CN201910903540 A CN 201910903540A CN 110575573 A CN110575573 A CN 110575573A
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- A61M1/0058—
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- A61M1/0062—
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
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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
- A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
- A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
- A61M27/006—Cerebrospinal drainage; Accessories therefor, e.g. 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
- A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
- A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
- A61M2027/004—Implant devices for drainage of body fluids from one part of the body to another with at least a part of the circuit outside the body
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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
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/04—Liquids
- A61M2202/0464—Cerebrospinal fluid
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- Heart & Thoracic Surgery (AREA)
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Abstract
the invention relates to the field of lumbar vertebra purification equipment, in particular to a disposable pipeline installation system for continuous purification treatment of artificial cerebrospinal fluid. The infusion device comprises a storage device, an infusion constant volume device, a liquid outlet constant volume device, a waste liquid bag and a double-cavity catheter; the storage device comprises a storage bag for storing artificial cerebrospinal fluid, a liquid storage connecting pipe connected with a liquid outlet of the storage bag, and a filter arranged on the liquid storage connecting pipe and used for filtering the artificial cerebrospinal fluid in the liquid storage connecting pipe; one end of the first liquid outlet pipe is communicated with the liquid inlet of the double-cavity catheter, and the other end of the first liquid outlet pipe is communicated with the liquid outlet of the first injection pump through the first liquid outlet one-way valve, so that the artificial cerebrospinal fluid flows to the double-cavity catheter from the first injection pump. The invention can be matched with the existing special artificial continuous cerebrospinal fluid purification equipment and is applied to the cerebrospinal fluid in-vitro purification treatment of the central nervous system diseases causing the change of the components, properties and circulation dynamics of the artificial cerebrospinal fluid.
Description
Technical Field
The invention relates to the field of lumbar vertebra purification equipment, in particular to a disposable pipeline installation system for continuous purification treatment of artificial cerebrospinal fluid.
Background
with the improvement of neurosurgical technology, the probability of death caused by primary morbidity is reduced, and death and severe neurological deficit caused by secondary brain damage are high. The drug treatment effect of chronic degenerative nervous system diseases and neuroautoimmune diseases is limited; effective drug delivery means for the central nervous system are still under investigation; the problems of control and management of cranial hypertension, cerebral edema and cerebral injury, rapid purification of the internal environment of cerebrospinal fluid, smooth implementation of local subhypothermia treatment and the like become bottlenecks which restrict the development of neurology at present and are urgently needed to be solved.
Acute intracranial lesions such as brain trauma, cerebrovascular accident, intracranial infection, acute Guillain-Barre syndrome and the like all cause changes of chemical components of cerebrospinal fluid and circulation dynamics thereof, generate a series of pathophysiological reactions, cause early brain damage and delayed brain damage, and even endanger life. The pathophysiology mechanism of brain injury is abnormally complex, so the research is not clear at present, and no effective measure is provided for improving the prognosis clinically.
the solute transport of cerebrospinal fluid is an important way for clearing toxic molecules and metabolites in the brain and delivering nutrients to brain cells, and plays an important role in the pathophysiological processes of the central nervous system. The cerebrospinal fluid and the brain tissue fluid are communicated with each other, so that the living environment of central nerve cells is directly influenced. Correction and management of homeostasis in cerebrospinal fluid may be one therapeutic direction to ameliorate secondary brain damage.
For nearly half a century, many medical scientists have attempted to design various devices for the in vitro purification treatment of human cerebrospinal fluid, roughly divided into three design directions:
1. discharging cerebrospinal fluid: the cerebrospinal fluid purification management method mainly used for discharging the cerebrospinal fluid is developed from the earliest cerebrospinal fluid discharge through lumbar puncture to intraspinal single-cavity catheterization drainage (LD) or ventricular catheterization drainage (EVD) which is widely applied clinically at present, and an IRRAS-flow system (patent number: US8398581B 2) on the market of 2019. Although the clinical application shows that the method has the advantages of shortened cerebrospinal fluid purification time (average 5-10 days), relieved high intracranial pressure and headache symptoms, shortened ICU (intensive care unit) holding time and the like, the effectiveness of the method is not provided with a definite basis, and random control studies show that cerebrospinal fluid discharge has no influence on the 6-month-old recovery. Due to the limitation of factors such as daily production of cerebrospinal fluid, intracranial pressure, lumbar cistern drainage tube and the like, the method has low efficiency of purifying cerebrospinal fluid, especially cerebrospinal fluid in cranial cavity. Therefore, the aim of completely purifying cerebrospinal fluid cannot be fulfilled at an early stage, and a series of complications are caused.
2. And (3) filtering cerebrospinal fluid for treatment: since the 1980 s, german physicians invented a cerebrospinal fluid filtration therapy (CSFF) system for clinical patients with guillain barre syndrome, which opened the precedent for cerebrospinal fluid purification therapy. However, the material engineering technology falls behind, pipe blockage events of the pipeline occur frequently, and the efficiency of the filter is low, so that the clinical effect is not obvious, and the filter is cooled down once.
A WLCSFPS-777 type cerebrospinal fluid purification system (patent number 200520110390.4) is designed and invented by a teacher's professor of King champion in 2001, and the device principle of blood purification is referred, so that the design aspects of pipelines and filters are improved, but the system belongs to lumbar single-lumen drainage filtration treatment, and the incidence rate of tube blockage is high; and the filter design can only remove cells and macromolecular substances in cerebrospinal fluid, and cannot remove small molecular pathological components such as inflammatory medium, blood soluble products, excitatory amino acid, neurotransmitters, electrolyte acid-base disorder and the like which really cause neuropathological damage, so the filter cannot be clinically popularized.
In 2009, Americans designed an extracorporeal biofilter (patent No.: US20090131850A 1) and a lateral ventricular external drainage single-cavity circulation pipeline. The inner wall of the biological filter is provided with a biological adsorption immune probe and ion exchange resin for specific pathological components. But for pathological components which are complex and diverse and not well researched, the complete elimination of the pathological components and the restoration of the electrolyte acid-base balance are difficult to realize; moreover, the biological filter has high components and saturated adsorption is difficult to judge.
In 2013, Americans improve the design of long and short pipes for double-cavity pipelines in a vertebral canal (the patent number is US8435204B 2), so that the filtering and purifying range and efficiency are improved, but the purifying range is still limited in the vertebral canal.
Neuropheresis ™ developed in 2017 adopts a double-cavity tube to place the tube through a lumbar cistern, and the performance of a filter is improved, so that small molecular inflammatory mediators are eliminated; however, the long lumen of the catheter only reaches the thoracic vertebra stage, and the cerebrospinal fluid dynamics research on the purification of the catheter shows that the purification range is only limited to the vertebral canal below the thoracic vertebra, and the disorder of the electrolytic alkali-hyaluronate can not be corrected. In 2019, the short life of the early filter is found in clinical preliminary studies, and continuous purification treatment is difficult to realize.
3. Artificial cerebrospinal fluid purification treatment: since the successful preparation of artificial cerebrospinal fluid in 1949, the artificial cerebrospinal fluid has become more and more widely used in scientific research and clinical practice. Particularly, along with the development of ventriculoscope, the nerve safety of clinical intracerebral perfusion liquid is more and more emphasized, and many animal studies show that the artificial cerebrospinal fluid has good nerve safety compared with ringer's solution and normal saline. Studies in many animal models of artificial cerebrospinal fluid perfusion intervention have shown that artificial cerebrospinal fluid can alleviate the edematous state of brain trauma, protect nerve cell damage, and alleviate blood brain barrier permeability, thus providing opportunities for cerebrospinal fluid purification treatments as a substitute for cerebrospinal fluid.
In 2003, Americans designed a cerebrospinal fluid purification system (patent number: WO03/015710A 2) which injects liquid through a lateral ventricle catheter and drains cerebrospinal fluid through a lumbar cistern catheter, but the catheter in the ventricle system has many complications related to catheter blockage and infection and is accompanied with complications of ventricular injury.
until now, no safe and efficient artificial cerebrospinal fluid purification equipment and installation pipeline is developed and applied.
Disclosure of Invention
The invention aims to: the disposable pipeline installation system for the continuous purification treatment of the artificial cerebrospinal fluid can be matched with the conventional special continuous purification equipment of the artificial cerebrospinal fluid and is applied to the external purification treatment of the cerebrospinal fluid of the central nervous system diseases causing the change of the components, properties and circulation dynamics of the artificial cerebrospinal fluid.
the invention is realized by the following technical scheme: the utility model provides a disposable pipeline installing the system that is used for artifical cerebrospinal fluid to continuously purify treatment which characterized in that: comprises a storage device, an infusion constant volume device, a liquid outlet constant volume device, a waste liquid bag and a double-cavity catheter;
The storage device comprises a storage bag for storing artificial cerebrospinal fluid, a liquid storage connecting pipe connected with a liquid outlet of the storage bag, and a filter arranged on the liquid storage connecting pipe and used for filtering the artificial cerebrospinal fluid in the liquid storage connecting pipe;
The transfusion constant volume device comprises a first injection pump, a first liquid inlet pipe, a first liquid outlet pipe, a first liquid inlet one-way valve and a first liquid outlet one-way valve; one end of the first liquid inlet pipe is communicated with the liquid storage connecting pipe, and the other end of the first liquid inlet pipe is communicated with the liquid inlet of the first injection pump through the first liquid inlet one-way valve, so that the artificial cerebrospinal fluid in the storage bag flows into the first injection pump in one way; one end of the first liquid outlet pipe is communicated with the liquid inlet of the double-cavity catheter, and the other end of the first liquid outlet pipe passes through the space between the first liquid outlet one-way valve and the liquid outlet of the first injection pump, so that the artificial cerebrospinal fluid flows to the double-cavity catheter from the first injection pump;
The liquid outlet constant volume device comprises a second injection pump, a second liquid outlet 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 communicated with the liquid outlet of the double-cavity catheter, and the other end of the second liquid inlet pipe is communicated with the liquid inlet of the second injection pump through a second liquid inlet one-way valve, so that the artificial cerebrospinal fluid flows into the first injection pump from the double-cavity catheter in one way; one end of the second liquid outlet pipe is communicated with the liquid outlet of the second injection pump through the second liquid outlet one-way valve, and the other end of the second liquid outlet pipe is communicated with the waste liquid bag, so that the artificial cerebrospinal fluid flows out to the waste liquid bag from the second injection pump in one way.
For better implementation of the scheme, the following optimization scheme is also provided:
The dredging device comprises a first branch pipe, a second branch pipe, a first three-way electromagnetic valve and a second three-way electromagnetic valve;
One end of the first branch pipe is communicated with the first liquid outlet pipe, the other end of the first branch pipe is communicated with the second liquid inlet pipe, and one end of the second branch pipe is communicated with the second liquid inlet pipe, and the other end of the second branch pipe is communicated with the first liquid outlet pipe;
The first three-way electromagnetic valve is arranged at the interaction part of the first liquid outlet pipe and the first branch pipe and is used for controlling the artificial cerebrospinal fluid flowing in through the first injection pump to flow to the double-cavity catheter or to the first branch pipe;
The second three-way electromagnetic valve is arranged at the interaction position of the second liquid inlet pipe and the second branch pipe and is used for controlling the flow of the artificial cerebrospinal fluid flowing through the second liquid inlet pipe or the second branch pipe to the second injection pump.
Further, the double-lumen catheter comprises a long catheter and a short catheter;
The long catheter consists of a first intrathecal extension tube section, a first intrathecal tube section and a first subcutaneous tube section from front to back in sequence; the short catheter consists of a second sheathed inner tube section and a second sheathed inner extension tube section from front to back in sequence; the first sheath inner pipe section and the second sheath inner pipe section are integrally connected together along the extension direction to form a double-cavity pipe 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.
Furthermore, the cross section of the double-cavity tube body is circular, the cross section of the tube cavity of the first intrathecal tube section is crescent-shaped, and the cross section of the tube cavity of the second intrathecal tube section is elliptical.
Furthermore, the pipe orifice of the second intrathecal tube section is a wedge-shaped pipe orifice; and the pipe wall at the front end of the second sheath inner pipe section is provided with a plurality of side holes.
preferably, the long catheter and the short catheter are both made of polyethylene, the outer wall surfaces of the long catheter and the short catheter are coated with hydrophilic coatings, and a nickel-titanium alloy wire woven mesh layer is arranged inside the wall surfaces of the long catheter and the short catheter.
Further, the storage device further comprises a first monitoring exhaust branch pipe communicated with the liquid storage connecting pipe, and a first pipe clamp is arranged on the first monitoring exhaust branch pipe.
Furthermore, a hydraulic sensor for monitoring the pressure of liquid in the first liquid outlet pipe is arranged on the first liquid outlet pipe.
furthermore, a buoyancy valve is arranged between the second liquid outlet pipe and the waste liquid bag.
furthermore, go out liquid constant volume device still include with the second monitoring exhaust branch pipe of second drain pipe intercommunication, be equipped with the second pipe clamp on the second monitoring exhaust branch pipe.
Compared with the prior art, the invention has the beneficial effects that:
1. the artificial cerebrospinal fluid is used as the replacement fluid to carry out single-cycle equivalent replacement on the cerebrospinal fluid, so that all harmful substances are thoroughly removed, the quick correction on the water electrolysis acid-base disorder of the cerebrospinal fluid is realized, and the consideration of complicated and expensive filter design and short service life is avoided;
2. Artificial cerebrospinal fluid replacement, which is combined with the design of the long and short pipes of the double-cavity, so that the purification dynamics and the purification range of the cerebrospinal fluid are mastered to the maximum extent, the purification efficiency is maximized, and particularly, the rapid purification of the cerebrospinal fluid in the cranial cavity can be realized;
3. the design of the anti-blocking auxiliary passage avoids the problems of tube drawing resetting, treatment interruption and the like caused by the blockage of the drainage pipeline, and solves the problem of pipeline blockage;
4. the synchronous equivalent replacement is adopted to avoid low intracranial pressure and brain injury caused by cerebrospinal fluid discharge, 5, perfect pipelines and intracranial pressure monitoring, and an intelligent perfusion and drainage control system, thereby realizing rapid and safe external cerebrospinal fluid purification treatment.
drawings
FIG. 1 is a schematic structural view of the present invention;
FIG. 2 is a schematic view of a waste liquid bag;
FIG. 3 is a schematic view of the flow of artificial cerebrospinal fluid during normal operation of the present invention;
FIG. 4 is a schematic view of the artificial cerebrospinal fluid flow direction when the back flushing procedure of the present invention is initiated;
FIG. 5 is a schematic view of a double lumen catheter;
FIG. 6 is a cross-sectional view taken along line A-A of FIG. 5;
Fig. 7 is a sectional view taken along line B-B in fig. 5.
Description of reference numerals: 11-storage bag, 12-liquid storage connecting pipe, 121-first monitoring exhaust branch pipe, 122-first pipe clamp, 13-filter, 21-first injection 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 injection 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-first three-way electromagnetic valve, 44-second three-way electromagnetic valve, 51-first intrathecal extension pipe section, 52-first intrathecal interior, 53-first subcutaneous pipe section, 61-second intrathecal pipe section, 611-side hole, 612-wedge-shaped pipe orifice, 62-second sheath inner extension pipe section, 7-nickel titanium alloy wire woven mesh layer, 8-pressure sensor, 9-waste liquid bag and 91-buoyancy valve.
Detailed Description
The invention is described in detail below with reference to the following description of the drawings:
as shown in fig. 1, the invention comprises a storage device, an infusion constant volume device, a liquid outlet constant volume device, a waste liquid bag 9 and a double-cavity 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 filter 13 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 comprises a first monitoring exhaust branch pipe 121 communicated with the liquid storage connecting pipe 12, and a first pipe clamp 122 is arranged on the first monitoring exhaust branch pipe 121.
The transfusion constant volume device comprises a first injection pump 21, a first liquid inlet pipe 22, a first liquid outlet pipe 23, a first liquid inlet one-way valve 24 and a first liquid outlet one-way valve 25;
The first liquid inlet one-way valve 24, the first liquid outlet one-way valve 25 and the first injection pump 21 all belong to disposable consumables, the first injection pump 21 can adopt various micro-injection pumps on the market, and the first injection pump 21 adopted in the embodiment comprises a 304 stainless steel piston rod, a tail disc, a polytetrafluoroethylene piston, a high-precision scale high borosilicate glass cylinder body and a double-end one-way valve. The high borosilicate glass cylinder body with high precision scales is characterized in that: the high borosilicate transparent glass tube body is a slender cylinder, the maximum capacity of the high-precision calibrated capacity scale is 25ml, the size of the tube body is stable, the tube body is not easy to deform, and the condition in the tube body can be conveniently observed due to the transparency of the tube body. The top and the bottom of the cylinder are sealed by Teflon materials, a piston push rod moving hole is reserved in the middle of the bottom, and two internal thread holes for installing the one-way valve are reserved in the middle of the top. The 304 stainless steel piston push rod and the tail disc are characterized in that: the piston push rod is made of solid stainless steel, the rod body is straight and smooth, the diameter of the rod body is 0.5cm, the head end of the rod body is tightly connected with the polytetrafluoroethylene piston, the tail end of the rod body is integrally cast into a disc shape, the diameter of the rod body is about 1.5cm, and the thickness of the rod body is about 0.3 cm. During installation, the tail disc is placed into the tail disc fixing clamping groove of the linear guide rail sliding block, so that the piston rod stretches along with the movement of the sliding block.
the double-end one-way valve, namely the first liquid inlet one-way valve 24 and the first liquid outlet one-way valve 25, is characterized in that: two one-way valves which are respectively connected with the two drainage holes at the top of the high borosilicate glass injector through threads. Wherein, the first liquid inlet one-way valve 24 at the inlet can only enter but not exit, the first liquid outlet one-way valve 25 at the outlet can only exit but not enter, and the valve body marks the passing direction.
And pressure sensors 8 for monitoring the pressure of liquid in the pipes are arranged on the first liquid outlet pipe 23, the second liquid inlet pipe 33 and the second liquid outlet pipe 32. The pressure sensor 8 is characterized in that: is a Teflon hard disk-shaped structure which is integrally connected with a pipeline, and the center of the bottom of the hard disk-shaped structure is a waterproof and good-toughness membrane structure. The pressure buckle is matched and fixed with the pressure sensor through the upper half-turn pressure of the instrument, and pressure data in a corresponding pipeline are obtained in a non-contact manner through pressure transmission between the bottom membrane structure and the pressure probe. A pressure sensor 8 on the input pipeline monitors the pipeline pressure at the input end, and the pipeline pressure is slight positive pressure under the normal condition; a pressure sensor 8 on the pipeline at the output end monitors the pipeline pressure at the output end, and the pipeline pressure is light negative pressure under the normal condition; pressure sensor 8 in the waste line, second outlet pipe 32, monitors the fullness of the waste bag, 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 injection pump 21 through a first liquid inlet one-way valve 24, so that the artificial cerebrospinal fluid in the storage bag 11 flows into the first injection pump 21 in one way; one end of the first liquid outlet pipe 23 is communicated with the liquid inlet of the double-cavity catheter, and the other end of the first liquid outlet pipe passes through the space between the first liquid outlet one-way valve 25 and the liquid outlet of the first injection pump 21, so that the artificial cerebrospinal fluid flows from the first injection pump 21 to the double-cavity catheter;
The artificial cerebrospinal fluid output firstly intercepts solution particles which can cause adverse reactions through a high-precision filter 13 on the pipeline, and the aperture of a filter membrane is about 2 um. Before entering the priming cycle container, i.e., the first syringe pump 21, the tubing has a normally closed first monitoring exhaust manifold 121 for bleb drainage and manual cerebrospinal fluid sample sampling.
As shown in fig. 2, the liquid outlet constant volume device comprises a second injection pump 31, a second liquid outlet pipe 32, a second liquid inlet pipe 33, a second liquid inlet one-way valve 34 and a second liquid outlet one-way valve 35; one end of the second liquid inlet pipe 33 is communicated with the liquid outlet of the double-cavity catheter, and the other end is communicated with the liquid inlet of the second injection pump 31 through a second liquid inlet one-way valve 34, so that the artificial cerebrospinal fluid flows into the first injection pump 21 from the double-cavity catheter in one way; one end of the second liquid outlet pipe 32 is communicated with the liquid outlet of the second injection pump 31 through a second liquid outlet one-way valve 35, and the other end is communicated with the waste liquid bag 9, so that the artificial cerebrospinal fluid flows out from the second injection pump 31 to the waste liquid bag 9 in one way.
the waste liquid bag 9 is characterized in that: the waste bag 9 is a three liter capacity bag construction with the input spout located at the upper middle of the bag wall, not the top. A buoyancy valve 91 is further arranged between the second liquid outlet pipe 32 and the waste liquid bag 9, the buoyancy valve 91 is designed into a rigid cylindrical grid cage structure at the end of the pipeline, and a buoyancy ball is arranged in the buoyancy valve. When the liquid level in the waste liquid bag does not reach the input port level, the buoyancy ball is stopped at the bottom of the grating cage, the input pipeline is kept smooth, and the pressure of the waste liquid pipeline is monitored to be 0 or slight positive pressure; when the liquid level of the waste liquid bag reaches above the plane of the input port, the buoyancy ball floats upwards to prop against the input port, so that the resistance of the waste liquid pipeline is increased, a blue sound alarm is caused, medical personnel are reminded to empty the waste liquid bag, and the waste liquid can be continuously input by overcoming the resistance under the driving of the injector. If the waste liquid bag cannot be emptied in time, the resistance is continuously increased, and finally the pressure of the waste liquid pipeline is increased to a critical value, yellow alarm is generated, and treatment is interrupted.
the liquid outlet constant volume device further comprises a second monitoring exhaust branch pipe 36 communicated with the second liquid outlet pipe 32, and a second pipe clamp 361 is arranged on the second monitoring exhaust branch pipe 36. The second pipe clamp 361 is arranged between the pressure sensor 8 and the waste liquid bag 9, and the second monitoring exhaust branch pipe 36 is used for collecting and testing cerebrospinal fluid samples.
the main path and the bypass of the pipeline are characterized in that: the main circulation path of purification treatment is that artificial cerebrospinal fluid is injected from the medulla oblongata pool end and is led out from the lumbar pool end; otherwise, the bypass is realized. The main road runs through the normally open circuit of the three-way electromagnetic valve, and the bypass runs through the normally closed circuit of the three-way electromagnetic valve and is converged into the main road of the other side.
the functional characteristics of the pipeline main circuit and the bypass are as follows: the patency of the inner passage drainage tube is the key point of the cerebrospinal fluid purification safety and the persistence. Because the input end is flushed by positive pressure, blockage cannot occur; blockage often occurs at the drainage tube opening of the lumbar cistern in vivo due to factors such as negative pressure suction, cerebrospinal fluid contents, cauda equina and the like. To solve this problem, we have designed a bi-directional circulation mechanism and a timed back flush procedure in which the main path and the bypass constitute an internal path.
As shown in FIGS. 3-4, the circulation of artificial cerebrospinal fluid is as follows: the artificial cerebrospinal fluid enters and exits from the storage bag 11 through the precise filter 13 and the first volume fixing device, namely the first injection pump 21, of the perfusion cycle through the first liquid inlet one-way valve 24 and the first liquid outlet one-way valve 25 on the two sides; the input pipeline channel is divided into a main path and a bypass path after passing through the first three-way electromagnetic valve 43, and the main path, namely the first liquid outlet pipe 23, extends to be connected with a double-cavity catheter in the medullary oblongata pond of the cerebellum of the human body and is input with artificial cerebrospinal fluid; the bypass, i.e. the first branch 41, opens into the second inlet pipe 33 in the outlet channel.
The first liquid outlet pipe 23 is connected with a double-cavity catheter which is placed in the human body lumbar, an output pipeline is divided into a main pipeline and a bypass pipeline through a second three-way electromagnetic valve 44 on the second liquid inlet pipe 33, the main pipeline continuously extends, enters and exits a drainage period fixed container, namely a second injection pump 31 through a second liquid inlet one-way valve 34 and a second liquid outlet one-way valve 35, and is finally connected to a waste liquid bag 9; the outgoing bypass, second branch 42, opens onto the section of the first outlet conduit 23 between the first three-way one-way valve and the double lumen catheter. Thus forming an external passage for purifying artificial cerebrospinal fluid and a purification internal passage of the subarachnoid cavity double-cavity drainage tube, and forming a single-circulation closed system from an artificial cerebrospinal fluid bag, a subarachnoid cavity and a waste fluid bag.
The main path and the bypass constitute a bidirectional circulation mechanism of an internal path and a timing back flushing program, namely a dredging device, wherein the dredging device comprises a first branch pipe 41, a second branch pipe 42, a first three-way electromagnetic valve 43 and a second three-way electromagnetic valve 44;
One end of the first branch pipe 41 is communicated with the first liquid outlet pipe 23, the other end of the first branch pipe is communicated with the second liquid inlet pipe 33, one end of the second branch pipe 42 is communicated with the second liquid inlet pipe 33, and the other end of the second branch pipe is communicated with the first liquid outlet pipe 23;
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 for controlling the flow of the artificial cerebrospinal fluid flowing in through the first injection pump 21 to the double-cavity catheter or to the first branch pipe 41;
The second three-way solenoid valve 44 is disposed at the intersection of the second fluid inlet pipe 33 and the second branch pipe 42 and is used to control the flow of the artificial cerebrospinal fluid through the second fluid inlet pipe 33 or the second branch pipe 42 to the second syringe pump 31.
the bidirectional circulation mechanism and the timing back flushing program are characterized in that: when the bustle pipe is blocked, the negative pressure of the output main path is increased, the two three-way electromagnetic valves are activated by feedback to change the path, the first liquid outlet pipe 23 at the input end carries out back flushing on the bustle pipe through the first bypass branch pipe 41, and the second liquid inlet pipe 33 at the output end carries out drainage from the medulla oblongata pond pipe through the second bypass branch pipe 42. After 3 cycles of positive pressure flushing, the electromagnetic valve automatically resets to start the main circuit cycle therapy. In the process, the common tube plugging factor can be solved, the treatment is not interrupted due to the blockage of the pipeline, and the safety of the patient is not endangered. But if the pipeline is compressed and collapsed, the problem cannot be solved by flushing. To prevent line blockage, the program sets a 3-cycle back flush sequence automatically for each 10-cycle main loop treatment.
in this embodiment, each pipeline in the system adopts transparent tetrafluoride tube, the tube cavity does not expand or collapse under the action of suction pressure, the inner diameter of the pipeline is about 2mm, and the wall thickness is about 1 mm.
as shown in fig. 5-7, further in this embodiment, the double lumen catheter includes a long catheter and a short catheter;
the long catheter consists of a first intrathecal extension tube section 51, a first intrathecal tube section 52 and a first subcutaneous tube section 53 from front to back in sequence; the short catheter consists of a second intrathecal tube section 61 and a second intrathecal extension tube section 62 from front to back in sequence; the first intrathecal tube section 52 and the second intrathecal tube section 61 are integrally connected together along the extending direction to form a double-cavity 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.
the cross section of the double-cavity tube body is circular, the cross section of the tube cavity of the first intrathecal tube section 52 is crescent-shaped, and the cross section of the tube cavity of the second intrathecal tube section 61 is elliptical.
The orifice of the second intrathecal tube section 61 is a wedge-shaped orifice 612; the front end tube wall of the second sheath inner tube section 61 is provided with a plurality of side holes 611.
in addition, in the embodiment, the double-lumen catheter in the vertebral canal comprises a long catheter and a short catheter which are both made of flexible materials with good biocompatibility, the outer wall surface of the double-lumen catheter is coated with a hydrophilic antibacterial coating, and a nickel-titanium alloy wire braided net layer 7 is arranged inside the wall of the double-lumen catheter. The catheter was placed into the subarachnoid space through the L5 intervertebral space, under DSA surveillance and guided by a 0.014 "microcatheter, the catheter was advanced gently and slowly along the dorsal spinal subarachnoid space, finally the long-tubular end was located at the level of the C1C2 vertebral body near the cisterna magna and the short-tubular end was located near the lumbar L1 vertebral body.
The use process of the device comprises the following steps:
1. The equipment is started up, enters a pipeline installation program, and installs corresponding pipelines as shown in figure 1.
2. Preparing artificial cerebrospinal fluid: packaging artificial cerebrospinal fluid in disposable storage bag 11, mixing, and introducing mixed gas (95% O)2,5%CO2) Fully foaming and inflating to saturation, and hanging on an infusion support; communicating a liquid storage connecting pipe 12 with a liquid outlet of a storage bag 11 for storing artificial cerebrospinal fluid; the artificial cerebrospinal fluid is extracted through the first monitoring exhaust branch pipe 121 and can be used after being qualified by blood gas analysis and monitoring;
3. pre-filling a main pipeline of artificial cerebrospinal fluid: according to the beginning preliminary filling, synchronous start fills constant volume device and drainage constant volume system, artifical cerebrospinal fluid begins to flow into along the pipeline and fills constant volume system (in being the first syringe pump 21, the same below) and flows out, flows into drainage constant volume system (in being the second syringe pump 31, the same below) along the preliminary filling connecting pipe, flows into waste liquid bag 9 at last, advances the preliminary filling of several cycles, makes gas evacuation in main line and two constant volume devices completely.
4. pre-filling an artificial cerebrospinal fluid auxiliary pipeline: pre-charging according to an auxiliary pipeline, synchronously starting a filling constant volume device and a drainage constant volume system, and synchronously starting two three-way electromagnetic valves for changing the channel; the artificial cerebrospinal fluid flows to the starting end of the second liquid inlet pipe 33 through the liquid storage connecting pipe 12 and reversely flows into the drainage constant volume system through the terminal end of the first liquid outlet pipe 23 through the pre-filling connecting pipe section; and repeating a plurality of cycles to completely exhaust the gas in the auxiliary passage and the two fixed containers, so that the whole in-vitro purification pipeline is filled with the artificial cerebrospinal fluid, wherein the perfusion constant volume device is in a full-load state, and the drainage constant volume device is in an emptying state.
5. Preparing an intravertebral catheter: the artificial cerebrospinal fluid is extracted from the first monitoring exhaust branch pipe 121 to respectively suck, exhaust and replace the double-lumen catheter in the vertebral canal in an equivalent manner, so that the air tightness and the smoothness of the double-lumen catheter are maintained, and the pipe clamp is clamped for standby.
6. connect patient to start treatment: after the pre-filling is finished, pipe clamps at the terminal end of the first liquid outlet pipe 23 and the starting end of the second liquid inlet pipe 33 are respectively clamped; and removing the pre-filling connecting pipe section, respectively communicating the terminal of the first liquid outlet pipe 23 with the outer interface of the long catheter tube cavity and the starting end of the second liquid inlet pipe 33 with the outer interface of the short catheter tube cavity, and opening the pipe clamp to keep the pipeline smooth. And (5) starting pressing, and carrying out purification treatment by the equipment according to set parameters.
7. Pressure monitoring and alarming: when the pipelines of the first liquid outlet pipe 23 and the second liquid inlet pipe 33 are subjected to pressure loss alarm, the untight connection between the pipelines and a patient is prompted; when high pressure alarm occurs, the device prompts that the front end pipeline is blocked or oppressed. At this time, the first three-way solenoid valve 43 and the second three-way solenoid valve 44 are activated and re-routed, and simultaneously close the main path to be connected with the bypass, that is, simultaneously close the first liquid outlet pipe 23 and the second liquid inlet pipe 33, and simultaneously connect the first branch pipe 41 and the second branch pipe 42 to carry out the reverse flushing procedure, that is, change the original liquid inlet of the dual-cavity catheter into a liquid outlet, and then change the liquid outlet into a liquid inlet, so that the flow direction of the artificial cerebrospinal fluid in the dual-cavity catheter is opposite, and the solenoid valves are. If the high-pressure alarm is not released, the possibility of prompting the pipeline compression is high.
A high pressure alarm appears on the second liquid outlet pipe 32 to prompt 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 plastics and extends into the middle upper 1/3 horizontal position of the bag from the bottom 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 hollow side wall, and a buoyancy valve 91 with a diameter larger than the input pipe diameter is arranged in the cylinder. 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, so that the pressure of the second liquid outlet pipe 32 rises to alarm, and medical personnel are reminded to empty the waste liquid bag; if the waste liquid bag is not emptied in time, the resistance will continue to increase, eventually leading to the road pressure rising to a critical value and the treatment is interrupted.
While the invention has been illustrated and described with respect to specific embodiments and alternatives thereof, it will be understood that various changes and modifications can be made without departing from the spirit and scope of the invention. It is understood, therefore, that the invention is not to be in any way limited except by the appended claims and their equivalents.
Claims (10)
1. The utility model provides a disposable pipeline installing the system that is used for artifical cerebrospinal fluid to continuously purify treatment which characterized in that: comprises a storage device, an infusion constant volume device, a liquid outlet constant volume device, a waste liquid bag (9) and a double-cavity 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 filter (13) arranged on the liquid storage connecting pipe (12) and used for filtering the artificial cerebrospinal fluid in the liquid storage connecting pipe (12);
The transfusion constant volume device comprises a first injection pump (21), a first liquid inlet pipe (22), a first liquid outlet pipe (23), a first liquid inlet one-way valve (24) and a first liquid outlet one-way valve (25); one end of the first liquid inlet pipe (22) is communicated with the liquid storage connecting pipe (12), and the other end of the first liquid inlet pipe is communicated with the liquid inlet of the first injection pump (21) through a first liquid inlet one-way valve (24), so that the artificial cerebrospinal fluid in the storage bag (11) flows into the first injection pump (21) in a one-way mode; one end of the first liquid outlet pipe (23) is communicated with the liquid inlet of the double-cavity catheter, and the other end of the first liquid outlet pipe is communicated with the liquid outlet of the first injection pump (21) through a first liquid outlet one-way valve (25), so that the artificial cerebrospinal fluid flows to the double-cavity catheter from the first injection pump (21);
The liquid outlet constant volume device comprises a second injection pump (31), a second liquid outlet pipe (32), a second liquid inlet pipe (33), a second liquid inlet one-way valve (34) and a second liquid outlet one-way valve (35); one end of the second liquid inlet pipe (33) is communicated with the liquid outlet of the double-cavity catheter, and the other end of the second liquid inlet pipe is communicated with the liquid inlet of the second injection pump (31) through a second liquid inlet one-way valve (34), so that the artificial cerebrospinal fluid flows into the first injection pump (21) from the double-cavity catheter in one way; one end of the second liquid outlet pipe (32) is communicated with the liquid outlet of the second injection pump (31) through a second liquid outlet one-way valve (35), and the other end of the second liquid outlet pipe is communicated with the waste liquid bag (9), so that the artificial cerebrospinal fluid flows out of the second injection pump (31) to the waste liquid bag (9) in one way.
2. a disposable tubing set system for continuous purification treatment of artificial cerebrospinal fluid according to claim 1, characterized in that: the dredging device comprises a first branch pipe (41), a second branch pipe (42), a first three-way electromagnetic valve (43) and a second three-way electromagnetic valve (44);
One end of the first branch pipe (41) is communicated with the first liquid outlet pipe (23), the other end of the first branch pipe is communicated with the second liquid inlet pipe (33), one end of the second branch pipe (42) is communicated with the second liquid inlet pipe (33), and the other end of the second branch pipe is communicated with the first liquid outlet pipe (23);
The first three-way electromagnetic valve (43) is arranged at the interaction part of the first liquid outlet pipe (23) and the first branch pipe (41) and is used for controlling the flow of the artificial cerebrospinal fluid flowing in through the first injection pump (21) to the double-cavity catheter or 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 for controlling the flow of the artificial cerebrospinal fluid passing through the second liquid inlet pipe (33) or the second branch pipe (42) to the second injection pump (31).
3. a disposable tubing set system for continuous purification treatment of artificial cerebrospinal fluid according to claim 1, characterized in that: the double-cavity catheter comprises a long catheter and a short catheter;
the long catheter consists of a first sheathed extension pipe section (51), a first sheathed pipe section (52) and a first subcutaneous pipe section (53) from front to back in sequence; the short catheter consists of a second intrathecal tube section (61) and a second intrathecal extension tube section (62) from front to back in sequence; the first intrathecal tube section (52) and the second intrathecal tube section (61) are integrally connected together along the extension direction to form a double-cavity 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 sheath inner extension pipe section (62).
4. a disposable tubing set system for continuous purification treatment of artificial cerebrospinal fluid according to claim 3, characterized in that: the cross section of the double-cavity pipe body is circular, the cross section of the pipe cavity of the first intrathecal tube section (52) is crescent, and the cross section of the pipe cavity of the second intrathecal tube section (61) is oval.
5. A disposable tubing set system for continuous purification treatment of artificial cerebrospinal fluid according to claim 3, characterized in that: the orifice of the second intrathecal tube section (61) is a wedge-shaped orifice (612); the front end pipe wall of the second sheath inner pipe section (61) is provided with a plurality of side holes (611).
6. A disposable tubing set system for continuous purification treatment of artificial cerebrospinal fluid according to claim 3, characterized in that: the long catheter and the short catheter are both made of polyethylene, the outer wall surfaces of the long catheter and the short catheter are coated with hydrophilic coatings, and a nickel-titanium alloy wire woven mesh layer (7) is arranged inside the catheter walls of the long catheter and the short catheter.
7. A disposable tubing set system for continuous purification treatment of artificial cerebrospinal fluid according to claim 1, characterized in that: the storage device further comprises a first monitoring exhaust branch pipe (121) communicated with the liquid storage connecting pipe (12), and a first pipe clamp (122) is arranged on the first monitoring exhaust branch pipe (121).
8. a disposable tubing set system for continuous purification treatment of artificial cerebrospinal fluid according to claim 1, characterized in that: and pressure sensors (8) used for monitoring the pressure of liquid in the pipes are arranged on the first liquid outlet pipe (23), the second liquid inlet pipe (33) and the second liquid outlet pipe (32).
9. a disposable tubing set system for continuous purification treatment of artificial cerebrospinal fluid according to claim 1, characterized in that: a buoyancy valve (91) is also arranged between the second liquid outlet pipe (32) and the waste liquid bag (9).
10. A disposable tubing set system for continuous purification treatment of artificial cerebrospinal fluid according to claim 1, characterized in that: the liquid outlet constant volume device further comprises a second monitoring exhaust branch pipe (36) communicated with the second liquid outlet pipe (32), and a second pipe clamp (361) is arranged on the second monitoring exhaust branch pipe (36).
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