WO2018161627A1

WO2018161627A1 - Intravascular mild hypothermia treatment apparatus

Info

Publication number: WO2018161627A1
Application number: PCT/CN2017/109578
Authority: WO
Inventors: 张晓康; 张晓平
Original assignee: 佛山博骏生物科技有限公司
Priority date: 2017-03-08
Filing date: 2017-11-06
Publication date: 2018-09-13
Also published as: CN106859843A

Abstract

An intravascular mild hypothermia treatment apparatus comprises: a normal saline storage tank (1), a first tube (2), an electronic refrigerator (3), a second tube (4), a central venous catheter (5), and a third tube (6). The normal saline storage tank (1) communicates with the electronic refrigerator (3) by means of the first tube (2). The electronic refrigerator (3) communicates with the central venous catheter (5) by means of the second tube (4). The central venous catheter (5) communicates with the normal saline storage tank (1) by means of the third tube (6). The second tube (4) is provided with an infusion pump (15). A liquid inlet of a cellular mesh heat exchange tube (9) in the electronic refrigerator (3) communicates with the first tube (2), and a liquid outlet of the cellular mesh heat exchange tube (9) communicates with the second tube (4). Normal saline in the normal saline storage tank (1) is delivered to the cellular mesh heat exchange tube (9) by the infusion pump (15), and cooled to low-temperature normal saline by an electronic cooling fin (8). One end of the central venous catheter (5) enters the inferior vena cava through a human femoral vein puncture. The circulating normal saline has a temperature different from that of the blood in the vena cava, and a surface of the central venous catheter (5) exchanges heat with blood in the vessel of a patient.

Description

Intravascular cryotherapy device

Technical field

The invention relates to the technical field of medical instruments, in particular to an intravascular cryotherapy device.

Background technique

The sub-hypothermology technology has experienced more than 70 years of development history, and a large number of studies at home and abroad have confirmed the clinical role of appropriate low temperature and method of brain protection. At present, the international medical community divides low temperature into mild hypo-pothmia 33-35 ° C, moderate low-temperature (modergte hypothermia) 28-32 ° C, and deep hypothermia below 16 ° C. In 1993, Chinese scholars divided the former two into sub-hypothermia, and this concept was subsequently widely quoted by domestic and foreign counterparts. The sub-hypotherm technology developed and matured in the 1950s and 1960s. In the mid-to-late 1980s to the 1990s, the experimental study of mild hypothermia for severe craniocerebral injury achieved remarkable results. It has been confirmed that the hypothermia at 28-33 ° C has an exact neuroprotective effect. Clinical studies have also found that mild hypothermia treatment does not produce any serious complications, which indicates that sub-hypothermia treatment of patients with severe craniocerebral injury has the advantages of positive efficacy and safety. Regarding the mechanism of action of hypothermia brain protection, the study suggests that there are mechanisms for delaying the depletion of energy metabolism and reducing intracellular acidosis under low temperature conditions. Low temperature inhibits the release of excitotoxic neurotransmitters after ischemia, which further reduces the influx of intracellular calcium ions. Low temperature can inhibit the biosynthesis of oxygen free radicals. Protecting ischemic-induced cell membrane and organelle damage, reducing reperfusion injury, and inhibiting blood-brain barrier (BBB) disruption, thereby reducing vasogenic edema, and may also reduce the incidence of secondary hemorrhagic transformation. The protective effect on BBB is partly related to the inhibition of matrix metalloproteinase activity by low temperature. The mechanism of mild hypothermia brain protection is generally: 1.1) inhibition of metabolic rate low temperature can inhibit the oxygen metabolism rate of brain tissue, preserve high-energy phosphate compounds, inhibit lactic acid accumulation, and maintain the pH value inside and outside the cell. 1.2) inhibit free radical production and promote free radical scavenging. Low temperature inhibits excitatory amino acids (EAA) and catecholamine-mediated oxidative stress. Experimental studies have found that hypothermic ischemia significantly inhibits EAA release and reduces catecholamine release by 60% during cerebral ischemia. Low temperature can improve the degree of acidosis in brain tissue, reduce the formation of reactive oxygen species (ROS) and lipid peroxides, and inhibit the formation of jaundice. Via low temperature also reduces the Ca ² + influx. It inhibits the activation and adhesion of neutrophils, reduces the consumption of endogenous antioxidants, and reduces the production of free radicals. 1.3) Low temperature inhibits the biosynthesis, release and reuptake of excitatory amino acids (EAA). Low temperature maintains the integrity of the plasma membrane structure, reduces the increase in cytoplasmic Na+ and extracellular K+ concentrations, and reduces the reuptake of glutamate. Studies have found that hypothermia reduces glutamate and glycine concentrations in brain tissue after ischemia. 1.4) Low temperature can alter the activity of various enzymes after ischemia. Studies have found that low temperature can affect the activity of various enzymes such as phospholipase A2 (PLA2), calmodulin-dependent protein kinase II (CaM PKII), protein kinase C (PKC), and nitric oxide synthase. During cerebral ischemia-reperfusion, activation of phospholipase A2 can lyse the cell membrane, resulting in the destruction of neuronal integrity. Hypothermia promotes Na + -K + -ATP enzyme, Ca ² + -ATP enzyme activity recovery, reduce intracellular calcium overload, thereby inhibiting the activation of phospholipase A2. Low temperature also protects protein kinase C, calmodulin-dependent protein kinase II activity, and reduces ischemic neuronal damage.

Low temperature can change the transmission of genetic information, and low temperature can promote the expression of immediate early gene (IEG) such as c-fos, c-jun and the like. The study found that the expression levels of c-fosf and Fos-B protein at 1 h after hypothermic ischemia were equivalent to the expression level after 6 h of normal temperature ischemia. The effect of low temperature on different IEC expressions was different. It was found that the level of fos-B mR-NA was significantly increased, the levels of jun-B and jun-C mRNA were moderately elevated, and the levels of c-fos, fra-1 and fra-2 mRNA were observed. There is no significant change. Low temperature can also improve the binding activity of DNA and transcription factors in tissue of cerebral ischemia, inhibit DNA cleavage and promote the recovery of protein synthesis. 1.6) Low temperature can activate the anti-inflammatory mechanism. Recent studies have confirmed that hypothermia can increase the survival rate of comatose patients after cardiac arrest and significantly improve neurological prognosis. The mechanism of action of hypothermia involves activation of the cytoprotective pathway. For example, hypothermia induces expression of heat shock protein 70 (HSP70), leading to a shift in the inflammatory cascade during cardiopulmonary bypass, reducing pro-inflammatory mediators and increasing the level of the anti-inflammatory cytokine interleukin-10 (IL-10). The study also found that hypothermia can reduce inflammation, increase liver IL-10 levels, and reduce liver cell necrosis. Studies have further confirmed that signaling activation is enhanced, transcriptional activation of the enzyme (STAT)-3 pathway is enhanced, and cytokine signaling is enhanced. Inhibitor 3 (suppressor of cytokine Signaling, SOCS-3) expression. The above two signaling events are of great significance because they have an anti-inflammatory effect in addition to low temperatures. It is known that STAT-3 activation can increase IL-10 levels, and IL-10 and activated STAT-3 can increase the expression of SOCS-3 and decrease the expression of TNF-α. Therefore, it is widely used in the surgical treatment of intracranial aneurysms, brain resuscitation of cardiac arrest caused by various reasons, acute stroke, and brain protection treatment of acute myocardial infarction. The American First Aid Association, the Heart Association, the Neurosurgical Association, and China have used it as a clinical guide. Since the 1990s, traditional cooling measures, such as infusion of 4 ° C salt water, ice cubes, alcohol rubbing bath, water circulation cooling blanket, application of hibernation mixture, etc., patients with chills, muscle tremors, arrhythmia, blood pressure, blood coagulation disorders The incidence rate is high, and the effect of lowering the central temperature is poor. The existing hypothermia treatment instrument is cumbersome to operate, and the medical staff has a high work intensity.

It can be seen that the prior art still has certain defects.

Summary of the invention

In view of this, in order to solve the problems in the prior art, the present invention proposes an intravascular cryotherapy device.

The present invention solves the above problems by the following technical means: an intravascular cryotherapy device comprising: a saline storage tank, a first conduit, an electronic refrigerator, a second conduit, a central venous catheter, a third conduit; the physiological saline The storage box is connected to the electronic refrigerator through a first conduit; the electronic refrigerator is connected to the central venous conduit through a second conduit; the central venous conduit is connected to the physiological saline storage tank through a third conduit; There is a bolus pump; the electronic refrigerator includes a box body, an electronic refrigerating sheet, and a honeycomb reticulated heat exchange tube, wherein the electronic refrigerating sheet and the honeycomb reticulated heat exchange tube are housed in a box body, and the box body stores propylene glycol The honeycomb mesh heat exchange tube is immersed in the propylene glycol, and the liquid inlet end of the honeycomb mesh heat exchange tube is connected with the first pipeline, and the liquid outlet end of the honeycomb mesh heat exchange tube is connected with the second pipeline.

Further, the honeycomb network heat exchange tube comprises an outer tube and a honeycomb mesh tube disposed in the outer tube, the outer tube wall of the honeycomb mesh tube is in contact with the inner tube wall of the outer tube, and the honeycomb mesh tube is provided with The through-hole column vertically penetrates the honeycomb mesh tube, and the through-hole columns are vertically parallel arranged, and the horizontal cross-section of the through-hole column is square, circular or regular hexagon.

Further, the outer tube of the heat exchange tube has the same length as the honeycomb mesh tube, and the horizontal cross-sectional area of the through-hole column is not less than 2 mm ² .

Further, the honeycomb mesh heat exchange tube has a cylindrical spiral shape. Further, the wall thickness between the adjacent through-hole columns is 0.5 mm, and the wall thickness of the outer tube of the heat exchange tube is 1 mm.

Further, the number of the electronic refrigeration sheets is six, and the electronic refrigeration sheet specifications are ATL-25W.

Further, the central venous catheter is provided with three balloons at the end. Further, the intravascular hypothermia treatment device further includes a computer control system, and the computer control system includes: a monitoring module, a touch screen display, a storage module, a communication module, and an alarm module;

The monitoring module can detect ECG, blood pressure, blood oxygen, and pulse in real time, and the detected parameters are displayed on the touch screen display; the storage module stores ECG, blood pressure, blood oxygen, and pulse parameters obtained by the monitoring module; The communication module can transmit ECG, blood pressure, blood oxygen and pulse parameters to the hospital emergency center; the alarm module includes a circulating liquid pressure module, a circulating liquid temperature module, an abnormal bubble detecting module, a blood temperature detecting module, and the circulating fluid pressure The module is used for detecting the pressure of the circulating liquid pipeline, the circulating liquid temperature module is used for detecting the temperature of the circulating liquid, the abnormal bubble detecting module is for detecting whether there is abnormal air bubbles in the circulating liquid, and the blood temperature detecting module includes the blood temperature sensor and the blood temperature detecting The module is used to detect the temperature of the blood.

Further, the intravascular hypothermia treatment device further includes a lithium battery, and the lithium battery is used as a backup battery for the case of no power source.

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

The physiological saline storage tank stores physiological saline, and the physiological saline flows in a physiological saline storage tank, a first pipeline, an electronic refrigerator, a second pipeline, a central venous conduit, and a third pipeline, and the bolus pump is a circulating power of physiological saline. The electronic refrigerator has an electronic refrigeration chip for propylene glycol refrigeration, and the physiological saline is cooled to a low temperature physiological saline by heat exchange with propylene glycol through the honeycomb network heat exchange tube, and one end of the central venous catheter enters the human body by the human femoral vein puncture. The vein is then introduced into the central vein of the inferior vena cava. There is a temperature difference between the circulating saline in the central venous catheter and the blood in the central venous blood vessel. The surface of the central venous catheter exchanges heat with the blood in the patient's blood vessel to achieve intravascular hypothermia. Temperature regulation.

DRAWINGS

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly described below. It is obvious that the drawings in the following description are only some embodiments of the present invention. Other drawings may also be obtained from those of ordinary skill in the art in light of the inventive work.

Figure 1 is a schematic view of the structure of the present invention;

Figure 2 is a cross-sectional view showing a top view of the honeycomb reticulated heat exchange tube of the present invention;

Figure 3 is a cross-sectional view showing a front view of the honeycomb reticulated heat exchange tube of the present invention;

Figure 4 is a schematic structural view of a computer control system in the present invention;

Fig. 5 is a schematic structural view of an alarm module in the present invention.

Description of the reference signs:

1, saline storage tank; 2, the first pipeline; 3, electronic refrigerator; 4, the second pipeline; 5, the central venous conduit; 6, the third pipeline; 7, the box; 8, electronic refrigeration; Honeycomb mesh heat exchange tube; 10, outer tube; 11, honeycomb mesh tube; 12, through hole column; 13, balloon; 14, blood temperature sensor; 15, push pump.

detailed description

The above described objects, features, and advantages of the present invention will be more apparent from the aspects of the appended claims. It should be noted that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments, based on the embodiments of the present invention, all of which are obtained by those skilled in the art without creative efforts. Other embodiments are within the scope of the invention.

It is to be understood that the orientation or positional relationship of the terms "top", "bottom" and the like is based on the orientation or positional relationship shown in the drawings, and is merely for the convenience of the description of the invention and the simplified description, rather than indicating or implying The device or component must have a particular orientation, configuration and operation in a particular orientation, and thus is not to be construed as limiting the invention.

The terms "first", "second", and "third" are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, features defining "first", "second", and "third" may include one or more of the features, either explicitly or implicitly. In the description of the present invention, the meaning of "a group" is two or more unless otherwise stated.

Example

As shown in Figure 1-5, an intravascular cryotherapy device includes: a saline storage tank 1, a first conduit 2, an electronic refrigerator 3, a second conduit 4, a central venous catheter 5, and a third conduit 6;

The physiological saline storage tank 1 is connected to the electronic refrigerator 3 through the first conduit 2; the electronic refrigerator 3 is connected to the central venous conduit 5 through the second conduit 4; the central venous catheter 5 and the physiological saline storage tank 1 are passed The third pipe 6 is connected to the second pipe 4; the second pipe 4 is provided with a bolus pump 15; the electronic refrigerator 3 includes a casing 7, an electronic refrigerating sheet 8, and a honeycomb reticulated heat exchange tube 9, and the electronic refrigerating sheet 8 The honeycomb reticulated heat exchange tube 9 is housed in the tank 7, the propylene glycol is stored in the tank 7, and the honeycomb reticulated heat exchange tube 9 is immersed in the propylene glycol, and the liquid inlet end of the honeycomb reticulated heat exchange tube 9 is The first pipe 2 is connected, The liquid outlet end of the honeycomb reticulated heat exchange tube 9 is in communication with the second duct 4. The physiological saline storage tank 1 stores physiological saline, and the physiological saline flows through the physiological saline storage tank 1, the first duct 2, the electronic refrigerator 3, the second duct 4, the central venous catheter 5, and the third duct 6, and the bolus is injected. The pump 15 is a circulating power of physiological saline. The electronic refrigerator 3 has an electronic refrigeration sheet 8 for cooling the propylene glycol. When the physiological saline passes through the honeycomb network heat exchange tube 9, it is cooled by heat exchange with propylene glycol to become a low temperature physiological saline, and the central venous catheter. One end of the 5 is inserted into the human femoral vein by the puncture of the human femoral vein, and then introduced into the central vein of the lower cavity. The temperature of the circulating saline in the central venous catheter 5 and the blood in the central venous blood vessel are present, and the surface of the central venous catheter 5 is passed through The blood in the patient's blood vessels undergoes heat exchange to achieve temperature regulation of the sub-hypothermia in the patient's blood vessels.

The second conduit 4 is provided with a bolus pump 15. The bolus pump 15 ensures that the physiological saline flowing into the central venous catheter 5 is stabilized within a certain flow rate and flow rate range. The patient's body temperature can be lowered to the sub-hypothermic target temperature within 30 minutes.

Preferably, the honeycomb reticulated heat exchange tube 9 comprises an outer tube 10 and a honeycomb mesh tube 11 disposed in the outer tube 10, an outer tube 10 wall of the honeycomb mesh tube 11 and an inner tube of the outer tube 10 When the wall is in contact, the honeycomb mesh tube 11 is provided with a through-hole column 12 vertically penetrating the honeycomb mesh tube 11. The through-hole columns 12 are vertically arranged in parallel, and the horizontal cross-section of the through-hole column 12 is square. Round or regular hexagon.

Preferably, the outer tube 10 of the heat exchange tube has the same length as the honeycomb mesh tube 11, and the horizontal cross-sectional area of the through-hole column 12 is not less than 2 mm ² .

Preferably, the honeycomb reticulated heat exchange tube 9 has a cylindrical spiral shape. The cylindrical spiral shape is longer relative to the linear path, increasing the time during which the physiological saline exchanges heat with the propylene glycol.

Preferably, the wall thickness between the adjacent through-hole columns 12 is 0.5 mm, and the wall thickness of the outer tube 10 of the heat exchange tube is 1 mm.

As a preferred embodiment, the number of the electronic refrigerating sheets 8 is six, and the electronic refrigerating sheet 8 is a model number ATL-25W. The electronic cooling sheet can reduce the normal temperature liquid to 1 degree Celsius in 820 minutes.

Preferably, the central venous catheter 5 is provided with three balloons 13 at the end. The balloon 13 is introduced into the central vein of the lower cavity of the human body. When the liquid enters the filling balloon 13 in the central venous catheter 5, the balloon 13 will open, and the balloon 13 will increase and blood in the central venous blood vessel. Contact surface. And the balloon 13 of the central venous catheter 5 exchanges heat with the blood, and the liquid does not enter the blood of the blood vessel, thereby avoiding the risk to the heart, the kidney and the like compared with the previous intravenous infusion of the cooling liquid. Compared with the existing body surface cooling technology, the way in which the central venous catheter 5 exchanges heat with blood greatly reduces the incidence of chills and muscle twitches in patients.

Preferably, the intravascular hypothermia treatment device further comprises a computer control system, the computer control system comprising: a monitoring module, a touch screen display, a storage module, a communication module, and an alarm module;

The monitoring module can detect ECG, blood pressure, blood oxygen, and pulse in real time, and the detected parameters are displayed on the touch screen display;

The storage module stores ECG, blood pressure, blood oxygen and pulse parameters obtained by the monitoring module; the communication module can transmit ECG, blood pressure, blood oxygen and pulse parameters to the hospital emergency center; the alarm module includes circulating fluid pressure The module, the circulating liquid temperature module, the abnormal bubble detecting module, the blood temperature detecting module, the circulating liquid pressure module is used for detecting the pressure of the circulating liquid pipeline, the circulating liquid temperature module is used for detecting the temperature of the circulating liquid, and the abnormal bubble detecting module is used. In order to detect whether there is abnormal air bubble in the circulating liquid, the blood temperature detecting module includes a blood temperature sensor 1414, and the blood temperature detecting module is used to detect the temperature of the blood. The alarm module detects an abnormality, such as when the pressure of the circulating liquid line, the temperature of the circulating liquid exceeds the normal range, or when an abnormal bubble is detected, the alarm module transmits data to the touch screen display, and the touch screen display is an audible and visual alarm.

Preferably, the intravascular hypothermia treatment device further comprises a lithium battery, and the lithium battery is used as a backup battery for the case of no power source.

The above-mentioned embodiments are merely illustrative of several embodiments of the present invention, and the description thereof is more specific and detailed, but is not to be construed as limiting the scope of the invention. It should be noted that a number of variations and modifications may be made by those skilled in the art without departing from the inventive concept. Improvements, these are within the scope of the invention. Therefore, the scope of protection of the present invention shall be subject to the appended claims.

Claims

An intravascular hypothermia therapeutic apparatus, comprising: a physiological saline storage tank, a first conduit, an electronic refrigerator, a second conduit, a central venous conduit, and a third conduit;

The physiological saline storage tank and the electronic refrigerator are connected through the first pipeline;

The electronic refrigerator is connected to the central venous catheter through a second conduit;

The central venous catheter is connected to the physiological saline storage tank through a third conduit;

a second injection pipe is provided on the second pipe;

The electronic refrigerator includes a box body, an electronic refrigeration sheet, and a honeycomb network heat exchange tube. The electronic refrigeration sheet and the honeycomb network heat exchange tube are housed in a box body, and the box body stores propylene glycol and a honeycomb network change. The heat pipe is immersed in the propylene glycol, and the liquid inlet end of the honeycomb mesh heat exchange tube is in communication with the first pipe, and the liquid outlet end of the honeycomb mesh heat exchange pipe is connected to the second pipe.
The intravascular hypothermia therapeutic apparatus according to claim 1, wherein said honeycomb reticulated heat exchange tube comprises an outer tube and a honeycomb mesh tube disposed in the outer tube, and an outer tube wall of the honeycomb mesh tube The inner tube wall of the outer tube is in contact with each other, and the honeycomb mesh tube is provided with a through-hole column vertically penetrating the honeycomb mesh tube, and the through-hole columns are vertically parallel arranged, and the horizontal cross-section of the through-hole column is square and round. Shape or regular hexagon.
The intravascular hypothermia therapeutic apparatus according to claim 1, wherein the outer tube of the heat exchange tube has the same length as the honeycomb mesh tube, and the horizontal cross-sectional area of the through-hole column is not less than 2 mm 2 .
The intravascular hypothermia therapeutic apparatus according to claim 1, wherein said honeycomb reticulated heat exchange tube has a cylindrical spiral shape.
The intravascular hypothermia therapeutic apparatus according to claim 1, wherein a wall thickness between said adjacent through-hole columns is 0.5 mm, and a wall thickness of said outer tube of said heat exchange tube is 1 mm.
The intravascular hypothermia therapeutic apparatus according to claim 1, wherein the number of the electronic refrigerating sheets is six, and the electronic refrigerating sheet specifications are ATL-25W.
The intravascular cryotherapy device according to claim 1, wherein said center There are three balloons at the end of the venous catheter.
The intravascular cryotherapy device of claim 1 further comprising a computer control system, the computer control system comprising:

Monitoring module, touch screen display, storage module, communication module, alarm module;

The monitoring module can detect ECG, blood pressure, blood oxygen, and pulse in real time, and the detected parameters are displayed on the touch screen display;

The storage module stores ECG, blood pressure, blood oxygen and pulse parameters obtained by the monitoring module;

The communication module can transmit ECG, blood pressure, blood oxygen and pulse parameters to a hospital emergency center;

The alarm module includes a circulating liquid pressure module, a circulating liquid temperature module, an abnormal bubble detecting module, a blood temperature detecting module, the circulating liquid pressure module is used for detecting the pressure of the circulating liquid pipeline, and the circulating liquid temperature module is used for detecting the cycle. The temperature of the liquid, the abnormal bubble detecting module is used to detect whether there is abnormal air bubble in the circulating liquid, the blood temperature detecting module includes a blood temperature sensor, and the blood temperature detecting module is used to detect the temperature of the blood.
The intravascular hypothermia therapeutic apparatus according to claim 1, wherein the intravascular hypothermia treatment device further comprises a lithium battery, and the lithium battery is used as a backup battery for the case of no power source.