CN103417325A - Mild hypothermia therapy-endovascular heat exchange temperature adjustment control device - Google Patents

Mild hypothermia therapy-endovascular heat exchange temperature adjustment control device Download PDF

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Publication number
CN103417325A
CN103417325A CN2013103760276A CN201310376027A CN103417325A CN 103417325 A CN103417325 A CN 103417325A CN 2013103760276 A CN2013103760276 A CN 2013103760276A CN 201310376027 A CN201310376027 A CN 201310376027A CN 103417325 A CN103417325 A CN 103417325A
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heat exchange
temperature
temperature control
salt water
blood vessel
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CN2013103760276A
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CN103417325B (en
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王磊
徐胜普
沙洪
胡勇
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Foshan Bo Jun Biotechnology Co., Ltd.
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Institute of Biomedical Engineering of CAMS and PUMC
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Abstract

The invention discloses a mild hypothermia therapy-endovascular heat exchange temperature adjustment control device. The device comprises three parts of an endovascular catheter system, an in vitro salt water circulating system and a heat exchange controller, wherein the endovascular catheter system is connected with the in vitro salt water circulating system through a pipeline to form a closed-loop salt water flow channel; a circulating water pump controls sterile salt water to flow in the closed-loop salt water flow channel, while a heat exchange coil is soaked in refrigerant, and the temperature of the refrigerant can be changed by heating refrigeration equipment, so that the temperature of the sterile salt water is adjusted; and the heat exchange controller consists of the heating refrigeration equipment, a temperature control system and a display operation unit which are connected through a circuit. The heat exchange controller can change the temperature of the salt water in the in vitro salt water circulating system, thus temperature controlled salt water is obtained in the endovascular catheter system; and therefore, the heat is exchanged with blood of a patient through the balloon surface of the catheter system, thus the purpose of core body temperature regulation for central nervous system high-risk patients or low body temperature patients is achieved.

Description

Heat exchange temperature control set for adjusting in mild hypothermia therapy-blood vessel
Technical field
The invention relates to the key technology of medical instruments field, relate in particular to heat exchange temperature control set for adjusting in a kind of mild hypothermia therapy-blood vessel.
Background technology
Mild hypothermia therapy refers to by controlled reduction patient core temperature avoids the method for damage influence with armour.The method for multiple brain injury disease, and finds also may have certain protective effect when other organ injury as a kind of brain guard method gradually.The mild hypothermia therapy method is listed in recommend method in the cardio-pulmonary resuscitation of American Heart Association and the cerebral trauma guide of blood vessel first aid guide (American Heart Association guideline for CPR and ECC) and U.S. neurosurgery association (American Association of Neurological Surgeons.Guidelines for the management of severe traumatic brain jury).Nearest questionnaire survey shows, in the U.S., has 61% emergency authorities to adopt inferior cryotherapy.Research find inferior low temperature to cerebral blood flow regulating action arranged, reduce CMRO2 and improves cellular energy metabolism, reduce excitatory amino acid release, reduce oxygen-derived free radicals generation, reduce intracellular calcium overload, reduce neuronal necrosis and apoptosis, the conduction of promotion intercellular signal recovery, reduce cerebral infarction area, alleviate cerebral edema and reduce intracranial pressure etc.Research also find inferior low temperature on blood pressure, blood oxygen pressure, partial pressure of carbon dioxide, blood pH value and blood glucose without impact, the laboratory animal heart, lung, kidney, small intestinal are also had no to pathologic lesion, illustrate that inferior low temperature does not increase the infringement of other histoorgan.Confirmed first from the nineties that in the world inferior low temperature can significantly reduce the dead residual rate of experimental brain injury in rats animal, at present, domestic and international hospital with good conditionsi has classified the mild hypothermia therapy method as the conventional therapy of Severe Craniocerebral Injury Undergoing.Inferior cryotherapy has significant effect, but cool-down method commonly used has run into many problems in clinical use procedure at present.At present clinically, the most frequently used mild hypothermia therapy method mostly is the surface cooling method, as passed through ice blanket, alcohol bath, ice bag, circulate cold air processing etc.Although these inferior low temperature induction methods can reach target temperature, its operating process is comparatively loaded down with trivial details, Induction Process is longer, and even the longer time just can reach target temperature mostly to need 3~8 hours.Also there is larger difficulty in above-mentioned cool-down method maintaining and control aspect target temperature in addition, the situations such as temperature fluctuation range is larger usually occur.The time that the average induced low temperature of surface cooling method reaches 33 degree is 3.5 hours, has part the cooling over-education phenomenon to occur simultaneously.And perfusion cool-down method in another kind of blood vessel reaches the purpose that reduces core temperature by a large amount of cooling liquids of quick infusion.This cool-down method is effective fast, but can form huge challenge to patient's the heart, lung and renal function, and the adjustment process of temperature maintains comparatively very complicated in addition, so its clinical practice is very limited.These traditional methods are restricting the universal of mild hypothermia therapy.
Summary of the invention
For above-mentioned prior art, the invention provides heat exchange temperature control set for adjusting in a kind of mild hypothermia therapy-blood vessel, regulate temperature by hot swapping in blood vessel and realize the accurate control to patient's core temperature.Be mainly used in treating in the cardiovascular and cerebrovascular disease operation process and brain injury post-operative recovery process that cerebral trauma produces in, this invention by heat exchange in blood vessel lower the temperature rapidly, the program rewarming, can reach accurate control patient core temperature.
In order to solve the problems of the technologies described above, heat exchange temperature control set for adjusting in mild hypothermia therapy-blood vessel of the present invention, comprise catheter in blood vessel system, external brine circulation system and heat exchange controller, described catheter in blood vessel system comprises body inner catheter and body temperature trans; Described external brine circulation system comprises Sterile Saline bag, water circulating pump, air trap and cryogen vessel, in described refrigerator container, is provided with heat exchange coil, and described heat exchange coil is immersed in cold-producing medium; Described heat exchange controller comprises heating and cooling device, temperature control system and demonstration and operating unit; Described Sterile Saline bag, water circulating pump are connected by pipeline in turn with air trap, and an end of described heat exchange coil is connected to described air trap, and the other end of described heat exchange coil is connected to an end of described body inner catheter by inflow catheter; Described Sterile Saline bag is connected to the other end of described body inner catheter by flowing out conduit, the circulation that has formed thus Sterile Saline is closed circuit, described outflow conduit is provided with current meter, and it is 1000-3000 ml/hour at the closed circuit flow velocity of circulation that described water circulating pump is controlled Sterile Saline; Air during described air trap is closed circuit in order to the removal circulation; Described temperature sensor, described temperature control system and described water circulating pump are electrically connected to, and described temperature control system and described heating and cooling device and described demonstration and operating unit are electrically connected to, thus the formation temperature control loop.
Further, apparatus of the present invention also comprise warning system, described warning system comprises vascular pressure detection part and alarm controller, described vascular pressure detection part is transferred to alarm controller by the vascular pressure value detected, described alarm controller by the described vascular pressure value detected and default threshold value relatively, whether the vascular pressure value detected with judgement is abnormal, if so, and by showing and operating unit warning indication.
Compared with prior art, the invention has the beneficial effects as follows:
The present invention adopts Endovascular Heat Exchange Cooling (endovascular heat exchange cooling) can effectively avoid shortcoming of the prior art.In mild hypothermia therapy-blood vessel of the present invention, the heat exchange temperature control set for adjusting is comprised of catheter in blood vessel system, external brine circulation system and heat exchange controller three parts.Wherein the catheter in blood vessel system is connected with external brine circulation system; form the closed cycle of a Sterile Saline; and heat exchange controller can change the mesohalobic temperature of external brine circulation system; thereby the saline of temperature control is input in the catheter in blood vessel system; make it to carry out heat exchange by balloon surface and the blood samples of patients of body inner catheter, thereby be reached for the purpose that cental system high-risk patient or hypothermia patient carry out the core temperature adjusting.
Advantage of the present invention is:
(1) in blood vessel the speed of cooling be 3-4 degree centigrade per hour, faster than traditional method, within average more than 80 minutes, reach target temperature;
(2) can maintain preferably target temperature range, avoid the fluctuation up and down of temperature, guarantee therapeutic effect;
(3), even patient is clear-headed, can quick and precisely not reach target temperature during tracheal intubation yet.The rewarming process carries out accurately controlling simultaneously;
(4) amyostasia incidence rate and occurrence degree reduce, and principle is the temperature receptor (temperature receptor can " be cheated " in the application of insulation blanket simultaneously) that the skin below has been avoided in cooling from inside to outside.Reduce the use of sedation anesthesia medicine and muscle relaxant, then reduced the use of respirator, made the incidence rate of pulmonary infection greatly reduce;
(5) apparatus structure advanced person, and control simple.
The accompanying drawing explanation
Accompanying drawing is heat exchanger temperature precise control device structural representation in mild hypothermia therapy blood vessel of the present invention
In figure: 1-catheter in blood vessel system, 11-body inner catheter, 12-body temperature trans, the external brine circulation system of 2-, 21-Sterile Saline bag, 22-current meter, the 23-water circulating pump, 24-air trap, 25-cryogen vessel, the 26-heat exchange coil, 3-heat exchange controller, 31-heating and cooling device, the 32-temperature control system, 33-demonstration and operation, 41-flows out conduit, 42-inflow catheter.
The specific embodiment
Below in conjunction with the specific embodiment, the present invention is described in further detail.
In order to make those skilled in the art better understand technical scheme of the present invention, below in conjunction with the drawings and the specific embodiments, technical scheme of the present invention is described in further detail.
As shown in the figure, the present invention, for heat exchange temperature control set for adjusting in the mild hypothermia therapy blood vessel, comprises catheter in blood vessel system 1, external brine circulation system 2 and heat exchange controller 3.
Described catheter in blood vessel system 1 comprises body inner catheter 11 and body temperature trans 12, and body temperature trans 12 is positioned over patient's catheter, and rectum or esophagus can be measured patient's body temperature.
Described external brine circulation system 1 comprises Sterile Saline bag 21, water circulating pump 23, air trap 24 and cryogen vessel 25, described Sterile Saline bag 21 adopts medical Sterile Saline bag, be provided with heat exchange coil 26 in described refrigerator container 25, described heat exchange coil 26 is immersed in cold-producing medium, described heat exchange coil 26 is for the cold and hot transmission of Sterile Saline, when Sterile Saline flows through heat exchange coil 26, with cold-producing medium generation heat exchange.Heat exchange coil 26 should adopt the metal parts with better heat conductivility.
Described Sterile Saline bag 21, water circulating pump 23 and air trap 24 are connected in turn by pipeline, one end of described heat exchange coil 26 is connected to described air trap 24, and the other end of described heat exchange coil 26 is connected to an end of described body inner catheter 11 by inflow catheter 42; Described Sterile Saline bag 21 is connected to the other end of described body inner catheter 11 by flowing out conduit 41, the circulation that has formed thus Sterile Saline is closed circuit, described outflow conduit 41 is provided with current meter 22, and it is 1000-3000 ml/hour at the closed circuit flow velocity of circulation that described water circulating pump 23 is controlled Sterile Saline; The present invention adopts Sterile Saline as the conduction of heat medium, is because Sterile Saline has good biocompatibility, if body inner catheter 11 leaks, can reduce the injury to patient as far as possible.Described water circulating pump 23, when making Sterile Saline mobile in the circulation of Sterile Saline is closed circuit, may produce some air in pipeline, by air trap 24, can remove ducted air.Air trap 24 is plastic containers.
Described heat exchange controller 3 comprises heating and cooling device 31, temperature control system 32 and demonstration and operating unit 33.
Described temperature sensor 12, described temperature control system 32 and described water circulating pump 23 are electrically connected to, and described temperature control system 32 and described heating and cooling device 31 and described demonstration and operating unit 33 are electrically connected to, thus the formation temperature control loop.The temperature of the body inner catheter 11 that described temperature control system 32 reception temperature sensors 12 collect, and according to the target temperature of setting by the temperature of described heating and cooling device 31 and the closed circuit middle Sterile Saline of water circulating pump 23 controlled circulation, this temperature control system 32 is according to the body temperature of the current patient recorded by body temperature trans 12 and the target body temperature of default, control heating and cooling device 31 to regulate the temperature of Sterile Saline, the information that temperature control system 32 shows according to current meter 22 is controlled described circulating pump 23 to regulate the flow velocity of Sterile Saline.
Described heat exchange controller 3 in the present invention adopts advanced semiconductor refrigerating technology, accurately to control the Sterile Saline temperature.Described heat exchange controller 3 can be controlled the change of the temperature of Sterile Saline in described external brine circulation system 2; and the Sterile Saline of temperature control is input in described catheter in blood vessel system 2; make it to carry out heat exchange by balloon surface and the blood samples of patients of body inner catheter 11, be reached for the purpose that cental system high-risk patient or hypothermia patient carry out the core temperature adjusting.
Apparatus of the present invention also comprise warning system, in whole process, regularly detect vascular pressure, find fortuitous event and alarm, to prevent the adverse consequences caused because of system itself or other reasons.Described warning system comprises vascular pressure detection part and alarm controller, described vascular pressure detection part is transferred to alarm controller by the vascular pressure value detected, described alarm controller by the described vascular pressure value detected and default threshold value relatively, whether the vascular pressure value detected with judgement is abnormal, if so, by showing and operating unit warning indication.
Described demonstration and operating unit 33 are a panel computer, and described demonstration is connected with described temperature control system 32 with operating unit 33.Described demonstration and operating unit 33 are for user's operation and demonstration, and this demonstration and operating unit 33 can be achieved as follows function: the power supply indication; Report to the police and indicate; Start/stop; Real-time displays temperature change curve; The target setting temperature, this target temperature is the 31-38 degree; Refrigerating/heating speed is set; Pressure detecting, be connected with serial ports of computers.
Connection in the present invention between all parts adopts plastic conduit, the closed circuit disposable material that all uses of the circulation of whole saline flow.
Adopt heat exchange temperature control set for adjusting in mild hypothermia therapy-blood vessel of the present invention to carry out lowering the temperature in blood vessel to 20 routine hypertensive cerebral hemorrhage postoperative patients, and observe the curative effect.The right lateral thigh retaining venipuncture, to postcava (the lower location of perspective), links condensation pipe, and temperature sensor probe is as for anus, for keeping nutrition and water-electrolyte balance, prevent complication, adopt and fall cranium pressure-controlled cerebral edema, steadily blood pressure, promote the brain cell metabolism.Mild hypothermia therapy persistent period 48~72h, without skull pressure rising high is 48h, that skull pressure rising high is arranged is 72h, target temperature is the 33-35 degree, indices in patient's temperature-fall period: cooling fore-anus temperature: 38.7 ± 0.5 ℃, reduction time: 30 ± 8min appears in the anus temperature, average cooling rate: 2 ± 0.2 ℃/h, reach target temperature time: 140 ± 30min.Rewarming is to determine the whether successful key of mild hypothermia therapy, be progressively slowly and steady rewarming, control rewarming and be approximately per hour 0.5 degree, about rewarming to 36.5 degree.By clinical observation, find: in blood vessel, the generation of cooling amyostasia and degree significantly reduce with respect to surface cooling, can effectively avoid Secondary brain edema, cerebral hernia and centra failure.
Although top, in conjunction with figure, invention has been described; but the present invention is not limited to the above-mentioned specific embodiment; the above-mentioned specific embodiment is only schematic; rather than restrictive; those of ordinary skill in the art is under enlightenment of the present invention; in the situation that do not break away from aim of the present invention, can also make a lot of distortion, within these all belong to protection of the present invention.

Claims (4)

1. the interior heat exchange temperature control set for adjusting of mild hypothermia therapy-blood vessel, comprise catheter in blood vessel system (1), external brine circulation system (2) and heat exchange controller (3), it is characterized in that,
Described catheter in blood vessel system (1) comprises body inner catheter (11) and body temperature trans (12);
Described external brine circulation system (2) comprises Sterile Saline bag (21), water circulating pump (23), air trap (24) and cryogen vessel (25), be provided with heat exchange coil (26) in described refrigerator container (25), described heat exchange coil (26) is immersed in cold-producing medium;
Described heat exchange controller (3) comprises heating and cooling device (31), temperature control system (32) and demonstration and operating unit (33);
Described Sterile Saline bag (21), water circulating pump (23) and air trap (24) are connected in turn by pipeline, one end of described heat exchange coil (26) is connected to described air trap (24), and the other end of described heat exchange coil (26) is connected to an end of described body inner catheter (11) by inflow catheter (42); Described Sterile Saline bag (21) is connected to the other end of described body inner catheter (11) by flowing out conduit (41), the circulation that has formed thus Sterile Saline is closed circuit, described outflow conduit (41) is provided with current meter (22), and it is 1000-3000 ml/hour at the closed circuit flow velocity of circulation that described water circulating pump (23) is controlled Sterile Saline; Air during described air trap (24) is closed circuit in order to the removal circulation;
Described temperature sensor (12), described temperature control system (32) and described water circulating pump (23) are electrically connected to, described temperature control system (32) and described heating and cooling device (31) and described demonstration and operating unit (33) are electrically connected to, thus the formation temperature control loop.
2. heat exchange temperature control set for adjusting in mild hypothermia therapy-blood vessel according to claim 1, it is characterized in that, described temperature control system (32) receives the temperature of the body inner catheter (11) that temperature sensor (12) collects, and according to the target temperature of setting by the temperature of described heating and cooling device (31) and the closed circuit middle Sterile Saline of water circulating pump (23) controlled circulation; Described demonstration and operating unit are a panel computer, and described demonstration is connected with described temperature control system (32) with operating unit.
3. according to claim 1 for heat exchange cooling control device in the mild hypothermia therapy blood vessel, it is characterized in that, described demonstration and operating unit are used for start/stop system, target setting temperature, the speed of refrigerating/heating are set; Real-time display body indoor duct temperature change curve is indicated, reached to power supply.
4. control and treat heat exchange temperature control set for adjusting in the ?blood vessel according to the low temperature in any one described Asia in claims 1 to 3, it is characterized in that, this device also comprises warning system, described warning system comprises vascular pressure detection part and alarm controller, described vascular pressure detection part is transferred to alarm controller by the vascular pressure value detected, described alarm controller by the described vascular pressure value detected and default threshold value relatively, whether the vascular pressure value detected with judgement is abnormal, if so, by showing and operating unit warning indication.
CN201310376027.6A 2013-08-26 2013-08-26 Mild hypothermia therapy-endovascular heat exchange temperature adjustment control device Active CN103417325B (en)

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Cited By (8)

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CN104473714A (en) * 2014-12-08 2015-04-01 刘思伯 Extravascular cooling and mild hypothermia treatment control system and application thereof
CN108814803A (en) * 2018-06-14 2018-11-16 中国医学科学院生物医学工程研究所 A kind of body temperature regulation method, apparatus, equipment and storage medium
CN111388183A (en) * 2014-02-07 2020-07-10 佐尔循环公司 Heat exchange equipment, heat exchange method and heat exchange system
CN111658304A (en) * 2020-06-29 2020-09-15 北京中关村水木医疗科技有限公司 Control method of lower computer, lower computer and readable medium
CN111685927A (en) * 2020-06-29 2020-09-22 北京中关村水木医疗科技有限公司 Temperature control system and method of operating the same
CN113397806A (en) * 2021-05-25 2021-09-17 南昌大学第二附属医院 Intravascular heat exchange temperature regulation control device for sub-hypothermia treatment
CN113662740A (en) * 2015-03-31 2021-11-19 佐尔循环服务***公司 Cold plate design in heat exchanger for intravascular temperature management catheter and/or heat exchange pad
CN117838426A (en) * 2024-03-06 2024-04-09 中山大学附属第五医院 Brain perfusion machine for sub-low temperature treatment

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CN102727338A (en) * 2012-07-11 2012-10-17 首都医科大学 Brain fixed-point sub-hypothermia control device
CN203408155U (en) * 2013-08-26 2014-01-29 中国医学科学院生物医学工程研究所 Mild hypothermia therapy-endovascular heat exchange temperature regulating and control device

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US20050060012A1 (en) * 2003-09-17 2005-03-17 Voorhees Marc E. Method and apparatus for providing non-invasive ultrasound heating of the preoptic anterior hypothalamus
CN102727338A (en) * 2012-07-11 2012-10-17 首都医科大学 Brain fixed-point sub-hypothermia control device
CN203408155U (en) * 2013-08-26 2014-01-29 中国医学科学院生物医学工程研究所 Mild hypothermia therapy-endovascular heat exchange temperature regulating and control device

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111388183A (en) * 2014-02-07 2020-07-10 佐尔循环公司 Heat exchange equipment, heat exchange method and heat exchange system
CN104473714A (en) * 2014-12-08 2015-04-01 刘思伯 Extravascular cooling and mild hypothermia treatment control system and application thereof
CN113662740A (en) * 2015-03-31 2021-11-19 佐尔循环服务***公司 Cold plate design in heat exchanger for intravascular temperature management catheter and/or heat exchange pad
CN108814803A (en) * 2018-06-14 2018-11-16 中国医学科学院生物医学工程研究所 A kind of body temperature regulation method, apparatus, equipment and storage medium
CN111658304A (en) * 2020-06-29 2020-09-15 北京中关村水木医疗科技有限公司 Control method of lower computer, lower computer and readable medium
CN111685927A (en) * 2020-06-29 2020-09-22 北京中关村水木医疗科技有限公司 Temperature control system and method of operating the same
CN111685927B (en) * 2020-06-29 2022-03-15 北京中关村水木医疗科技有限公司 Temperature control system and method of operating the same
CN113397806A (en) * 2021-05-25 2021-09-17 南昌大学第二附属医院 Intravascular heat exchange temperature regulation control device for sub-hypothermia treatment
CN113397806B (en) * 2021-05-25 2022-08-30 南昌大学第二附属医院 Intravascular heat exchange temperature regulation control device for sub-hypothermia treatment
CN117838426A (en) * 2024-03-06 2024-04-09 中山大学附属第五医院 Brain perfusion machine for sub-low temperature treatment

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