JP5007412B2 - Method for using extracorporeal circuit and switch for liquid heating and / or cooling - Google Patents

Description

  The present invention relates to an extracorporeal circuit for circulating a fluid, particularly blood, dialysate, replenisher, filtrate or plasma. The invention further relates to an extracorporeal circuit for heating and / or cooling the liquid in particular. The present invention also relates to a method of using the switch in the extracorporeal circuit for heating and / or cooling the liquid.

  In recent years, in the treatment of diseases such as kidney diseases and multiple organ failure that have serious circulatory system complications, blood purification methods, which are collectively called continuous blood purification methods, have become widespread, especially in the field of emergency and intensive care. , Has been clinically effective.

  Specific examples of the continuous blood purification method include continuous hemofiltration (hereinafter referred to as “CHF”), continuous hemodialysis (hereinafter referred to as “CHD”), and continuous hemofiltration dialysis. There is a method (continuous hemofiltration, hereinafter referred to as “CHDF”), etc., which are used according to the purpose of treatment.

  Here, CHF means that blood is passed through a blood purifier containing a semipermeable membrane, and the filtrate containing waste products is discharged from the blood through the filtration membrane, while the replacement fluid is continuously replenished into the body. And it is a method of slowly enforcing. Further, CHD is a method of continuously and slowly performing correction of acid-base balance and the like by diffusion through a semipermeable membrane. The CHDF is a method in which the CHF and the CHD are combined so that a dialysis solution is flowed to the filtrate side in order to improve the small molecular weight removal capability of the CHF, and a dialysis effect is also obtained.

  Moreover, as blood purification therapy for liver failure, plasma exchange therapy (hereinafter referred to as “PE”), double filtration therapy (hereinafter referred to as “DFPP”), plasma adsorption therapy (plasma adsorption), (Hereinafter referred to as “PA”) and other apheresis therapies are used according to the purpose of treatment and have a clinical effect.

  Here, PE is a method of removing harmful substances that are metabolized and detoxified by the liver and supplementing useful substances synthesized by the liver. Further, DFPP is a method that makes it possible to reduce the replenisher of the useful substance using a plasma separator and a plasma component separator. PA is a method in which separated plasma is perfused through an adsorption column to specifically and selectively remove a pathogenic substance.

  It is preferable to heat and / or cool a treatment solution such as a dialysis solution, a replacement fluid, or fresh frozen plasma used for treatment in order to maintain a temperature balance with the body fluid during treatment.

  As an example of a warmer and a warming apparatus that efficiently heats these treatment solutions, Patent Document 1 describes a warming bag in which two soft sheets are bonded together to form a flow path. FIG. 2 shows a schematic diagram of the heating bag. The heating bag is configured by connecting a liquid introduction tube 11 and a liquid outlet tube 12 to a flow path portion 13 formed by laminating two film sheets provided with a partition for forming a continuous liquid passage.

  Next, a schematic diagram of the treatment state is shown in FIG. The blood taken out from the patient by the blood pump 41 passes through the arterial line 51 and is introduced into the blood purifier 61 in which the semipermeable membrane 62 is accommodated. On the other hand, the dialysate stored in the dialysate bag 63 passes through the dialysate line 54 by the dialysate pump 43 and is sent to the side opposite to the blood of the semipermeable membrane 62 of the blood purifier 61. Then, blood is dialyzed through the semipermeable membrane 62 in the blood purifier 61, and at the same time, low molecular weight components in the blood are filtered. The dialysate exiting the blood purifier 61 is fed by the filtration pump 42 and drained through the filtration line 53. The blood purified by the blood purifier 61 is returned to the patient through the vein line 52.

  When these series of treatments are performed, a warming bag having the flow path portion 13 is provided in the middle of the dialysate line 54, and the dialysate is warmed to around the body temperature, whereby blood is returned to the patient. It is possible to prevent the temperature of the blood from lowering and not to place an extra burden on the patient.

  However, since this warming bag is composed of a soft sheet, when the inside of the circuit is under negative pressure, the soft sheets stick to each other and block the flow path. Further, when used for treatment, it is necessary to expel the air in the circuit out of the circuit and replace it with a physiological saline solution or the like in order to prevent air from entering the patient and to maintain the heating efficiency. In order to release the air in the warming bag, there was a liquid flow direction in which physiological saline was injected from below the warming bag and drained from above.

  On the other hand, when the blood purifier is washed with physiological saline, as shown in Patent Document 2, the physiological purifier is washed by flowing the physiological saline from the inside to the outside of the hollow fiber of the blood purifier. FIG. 4 shows a schematic diagram. By rotating the blood pump 41 in the direction opposite to the time of treatment, the physiological saline from the physiological saline bag 25 connected to the end of the venous line 52, the blood line of the venous line 52, the blood purifier 61, It flows in the order of the arterial line 51 and drains from the end of the arterial line 51.

  In order to fill the filtration line 53 with physiological saline, the filtration pump 42 is rotated in the same direction as the treatment, but in order to fill the dialysate line 54 with physiological saline, the dialysate pump is reversed in the direction opposite to the treatment. 43 is rotated. Therefore, the physiological saline solution will flow in the direction opposite to the direction in which air is expelled from the inside of the heating bag described above.

  As an example of a heating bag for solving such a problem, a schematic diagram is shown in FIG. A female connection connector 21 is connected to the end of the liquid introduction tube 11 connected to the flow path portion 13, a male connection connector 22 is connected to the end of the liquid lead-out tube 12, and the liquid introduction tube 11 and the liquid lead-out tube 12 are connected. In the closed state, switches 11 and 32 are provided that mechanically crush the tubes 11 and 12 to stop liquid feeding and open the tubes 11 and 12 when in the liquid passing state.

  One end of a filling tube 14 for flowing a physiological saline solution into the warming bag is connected to a male connector 23 that can be connected to the female connector 21, and the other end is filled with a physiological saline bag. A needle 24 that can be connected to 25 is connected. The female connection connector 21 and the male connection connector 23 are connected, the switches 31 and 32 are opened, and the physiological saline solution bag 25 is disposed at a higher position than the male connection connector 22 in the vertical relationship. When the needle 24 is connected to the physiological saline solution bag 25, the physiological saline solution in the physiological saline solution bag 25 is moved by the drop to fill the filling tube 14, and the liquid introduction tube 11, the flow path unit 13, and the liquid outlet tube are filled. 12 are sequentially filled.

  Then, after closing the switch 31 and the switch 32, the connection of the female connection connector 21 and the male connection connector 23 is disconnected. The connection connectors 21 and 22 are connected in the middle of a line already filled with a physiological saline solution that is heated or cooled during treatment. After the connection, the switch 31 and the switch 32 are opened. With the above operation, filling of the warming bag with the physiological saline is completed.

Utility Model Registration No. 3056439 JP 2005-253555 A

  However, when the treatment is started by forgetting to open the switch 32 in this series of operations, the liquid is sent to the flow path section 13 by the pump, so that the liquid accumulates in the flow path section 13 and expands. In the worst case, the flow path portion 13 may be ruptured.

  The present invention solves the above-mentioned problems of the prior art, and when operating an extracorporeal circulation apparatus incorporating an extracorporeal circulation circuit for liquid heating and / or cooling, for liquid heating and / or It is an object of the present invention to provide an extracorporeal circulation circuit for liquid heating and / or cooling which can avoid dangers such as leakage and rupture of the extracorporeal circulation circuit for cooling. Another object of the present invention is to provide a method for using a switch that can avoid dangers such as leakage and rupture of an extracorporeal circulation circuit for liquid heating and / or cooling.

  As a result of intensive studies to solve the above-mentioned problems, the present inventors have found that the liquid introduction tube, the flow path section, and the liquid outlet tube are liquid-tightly connected in this order for liquid heating and / or cooling. In the extracorporeal circuit, the present inventors have found that the above problem can be solved by providing a switch that simultaneously opens and closes the liquid introduction tube and the liquid outlet tube, and the present invention has been completed. That is, this invention is comprised from the following invention.

(1) In an extracorporeal circuit for heating and / or cooling a liquid in which at least a liquid introduction tube, a flow path section, and a liquid outlet tube are liquid-tightly connected in this order,
An extracorporeal circuit for heating and / or cooling a liquid, comprising one switch that simultaneously opens or closes the liquid introduction tube and the liquid outlet tube.

  (2) The extracorporeal circulation for liquid heating and / or cooling according to (1), wherein the flow path part is formed by bonding two plastic sheets to form a flow path between the sheets. circuit.

  (3) The extracorporeal circuit for heating and / or cooling a liquid according to (1) or (2), wherein a switch for opening and closing only the liquid outlet tube is not provided.

(4) At least the liquid introduction tube, the channel portion, and the liquid outlet tube are liquid-tightly connected in this order, and the liquid inlet tube and the liquid outlet tube are arranged at positions facing each other across the channel portion. A method of using a switch in an extracorporeal circuit for heating and / or cooling a liquid comprising :
When the extracorporeal circuit is filled with physiological saline, the connection part between the liquid introduction tube and the flow path part is disposed below, the connection part between the liquid lead-out tube and the flow path part is disposed above, and the downward direction At least a part of the liquid introduction tube positioned is bent and expanded upward, adjacent to the liquid outlet tube positioned above, and the liquid inlet tube and the liquid outlet are provided using one switch at the adjacent portion. A switch characterized by simultaneously closing the liquid introduction tube and the liquid outlet tube using the one switch after the extracorporeal circuit is filled with physiological saline by simultaneously opening the tube. How to use .

(5) At least the liquid introduction tube, the channel portion, and the liquid outlet tube are liquid-tightly connected in this order, and the liquid inlet tube and the liquid outlet tube are arranged at positions facing each other across the channel portion. In the extracorporeal circuit for heating and / or cooling the liquid
The liquid introduction tube has a portion adjacent to the liquid lead-out tube at least partially bent and disposed at a position facing the flow passage portion;
An extracorporeal circuit for heating and / or cooling a liquid, comprising: one switch that simultaneously opens or closes the liquid introduction tube and the liquid outlet tube at the adjacent portion .

  The extracorporeal circuit for heating and / or cooling the liquid according to the present invention is simple in a line used for treatment by simply closing one switch after filling with physiological saline (solution for priming the circuit). In the operation of the extracorporeal circulation device, the liquid introduction tube of the extracorporeal circulation circuit for liquid heating and / or cooling is blocked even if it is forgotten to open the switch. No liquid is fed to the part, and the flow path part is not pressurized, so there is no risk of leakage or rupture of the flow path part, and it can be used safely, and the flow path can be opened only at one switch. Therefore, a simple extracorporeal circuit for heating and / or cooling the liquid was obtained.

  Further, according to the method of using the switch in the extracorporeal circuit for heating and / or cooling the liquid according to the present invention, the liquid introduction tube and the liquid outlet tube can be reliably opened or closed at the same time. Even if it is forgotten to open the vessel, the liquid introduction tube of the extracorporeal circulation circuit for liquid heating and / or cooling is blocked, so that liquid is not sent to the flow path section and the flow path section is heated. Since it is not pressed, there is no risk of leakage or rupture of the flow path, and it can be used safely.

  Hereinafter, embodiments of the extracorporeal circuit for liquid heating and / or cooling according to the present invention will be described with reference to the drawings, but the present invention is not limited to these embodiments. In addition, in the structure similar to what was mentioned above, description is abbreviate | omitted by attaching | subjecting the same code | symbol.

(Embodiment of extracorporeal circuit for liquid heating / cooling)
FIG. 1 is a schematic diagram showing an embodiment of an extracorporeal circuit for liquid heating and / or cooling according to the present invention.

  In FIG. 1, the extracorporeal circuit for heating and / or cooling the liquid is bonded to two film sheets provided with a partition in which one end of the liquid introduction tube 11 and the liquid outlet tube 12 forms a continuous liquid passage. Are connected to the flow path portions 13 respectively. A female connection connector 21 is connected to the other end of the liquid introduction tube 11, and a male connection connector 22 is connected to the other end of the liquid lead-out tube 12. The extracorporeal circuit includes a switch 33 that simultaneously closes or opens the two tubes of the liquid introduction tube 11 and the liquid outlet tube 12.

  The switch 33 needs to have a function of simultaneously closing and opening the flow paths of the liquid introduction tube 11 and the liquid outlet tube 12. For example, a Robert clamp, a roller clamp, a pinch clamp with a structure that can close the flow path by mechanically sandwiching two soft tubes forming the flow path and open the flow path by opening the pinch, Etc., and can be selected from these groups.

  It is preferable that the flow path unit 13 is formed by bonding two plastic sheets to form a flow path between the sheets. The plastic sheet is preferably made of a material having biocompatibility and biological safety because it directly or indirectly contacts the body fluid of the patient.

  The material is preferably a synthetic resin, particularly a thermoplastic resin, from the viewpoint of manufacturing cost, processability, and operability. Thermoplastic resins include polyolefin resins, polyamide resins, polyester resins, polyurethane resins, fluorine resins, silicon resins, ABS (acrylonitrile-butadiene-styrene copolymer) resins, and polyvinyl chloride. Polycarbonate, polystyrene, polyacrylate, polyacetal and the like can be exemplified, and any of them can be suitably used. Among these, a soft material is preferable because it is resistant to bending and cracking and has excellent flexibility during operation, and soft vinyl chloride is particularly preferable for the reason of assembly.

  The material of the liquid introducing tube 11 and the liquid outlet tube 12 is also preferably a synthetic resin, particularly a thermoplastic resin, from the viewpoint of manufacturing cost, workability, and operability. Thermoplastic resins include polyolefin resins, polyamide resins, polyester resins, polyurethane resins, fluorine resins, silicon resins, ABS (acrylonitrile-butadiene-styrene copolymer) resins, and polyvinyl chloride. Polycarbonate, polystyrene, polyacrylate, polyacetal and the like can be exemplified, and any of them can be suitably used. Among these, a soft material is preferable because it is resistant to bending and cracking and has excellent flexibility during operation, and soft vinyl chloride is particularly preferable for the reason of assembly.

  The method of joining the liquid introduction tube 11 and the flow path portion 13, joining the liquid outlet tube 12 and the flow path portion 13, and joining the two film sheets constituting the flow path portion 13 are not particularly limited. In general, hot melt bonding or bonding by bonding is used for bonding synthetic resins. For example, in hot melt bonding, high frequency welding, induction heating welding, ultrasonic welding, friction welding, spin welding, hot plate welding, hot wire welding, etc. can be used, and the type of adhesive is cyanoacrylate, epoxy Examples thereof include polyurethane, polyurethane, synthetic rubber, ultraviolet curable, modified acrylic resin, and hot melt type. What is necessary is just to select suitably in consideration of operating temperature, flow volume, etc. from these.

  The material of the female connection connector 21 and the male connection connector 22 may be any of synthetic resin, metal, glass, etc., but a synthetic resin, particularly a thermoplastic resin is preferable from the viewpoint of manufacturing cost, workability, and operability. . Thermoplastic resins include polyolefin resins, polyamide resins, polyester resins, polyurethane resins, fluorine resins, silicon resins, ABS (acrylonitrile-butadiene-styrene copolymer) resins, and polyvinyl chloride. Polycarbonate, polystyrene, polyacrylate, polyacetal and the like can be exemplified, and any of them can be suitably used.

  For the connection method of the female connection connector 21 and the male connection connector 22 and the tube, a connection method capable of maintaining the mechanical strength may be selected according to each material. The material of the switch 33 may be any of synthetic resin, metal, glass and the like, but synthetic resin, particularly thermoplastic resin is preferable from the viewpoint of manufacturing cost, workability and operability. Thermoplastic resins include polyolefin resins, polyamide resins, polyester resins, polyurethane resins, fluorine resins, silicon resins, ABS (acrylonitrile-butadiene-styrene copolymer) resins, and polyvinyl chloride. Polycarbonate, polystyrene, polyacrylate, polyacetal and the like can be exemplified, and any of them can be suitably used.

  With the above configuration, the extracorporeal circuit for heating and / or cooling liquid according to the present invention only closes one switch after filling with physiological saline (circuit priming solution). Easy connection to the line used for treatment. When operating the extracorporeal circulation device, even if it is forgotten to open the switch, the liquid introduction tube of the extracorporeal circulation circuit for liquid heating and / or cooling is closed, so that the liquid is supplied to the flow path section. In other words, the flow path is not pressurized. For this reason, there is no worry about leakage and rupture of the flow path, and it can be used safely, and the flow path can be opened easily by operating only one switch. Can do it.

  In order to further prevent leakage and rupture of the flow path, the extracorporeal circuit for heating and / or cooling the liquid according to the present invention may not have a switch that opens and closes only the liquid outlet tube. preferable.

  The extracorporeal circuit for liquid heating and / or cooling according to the present invention is used when performing various blood purification therapies such as continuous blood purification therapy, plasma exchange therapy, double filtration plasmapheresis therapy, and plasma adsorption therapy. It is useful because it can be safely supplied to the extracorporeal circulation device while controlling the temperature of various liquids. The method of using the switch in the extracorporeal circuit for heating and / or cooling liquid according to the present invention includes various methods such as continuous blood purification therapy, plasma exchange therapy, double filtration plasmapheresis therapy, and plasma adsorption therapy. It is useful when performing blood purification therapy.

It is a schematic diagram which shows the embodiment of the extracorporeal circuit for liquid heating and / or cooling of this invention. It is a schematic diagram of a heating bag. It is a schematic diagram which shows the embodiment of a treatment. It is a schematic diagram which shows the embodiment of the washing | cleaning of a blood purifier. It is a schematic diagram which shows the conventional embodiment.

Explanation of symbols

  DESCRIPTION OF SYMBOLS 11 ... Liquid introduction tube, 12 ... Liquid lead-out tube, 13 ... Channel part, 14 ... Filling tube, 21 ... Female connector, 22, 23 ... Male connector, 24 ... Needle, 25 ... Saline bag , 31, 32, 33 ... switch, 41 ... blood pump, 42 ... filtration pump, 43 ... dialysate pump, 51 ... arterial line, 52 ... vein line, 53 ... filtration line, 54 ... dialysate line, 61 ... blood Purifier 62 ... Semipermeable membrane 63 ... Dialysate bag

Claims (5)

In an extracorporeal circulation circuit for liquid heating and / or cooling in which at least a liquid introduction tube, a flow path section, and a liquid outlet tube are liquid-tightly connected in this order,
An extracorporeal circuit for heating and / or cooling a liquid, comprising one switch that simultaneously opens or closes the liquid introduction tube and the liquid outlet tube.   2. The extracorporeal circuit for heating and / or cooling liquid according to claim 1, wherein the flow path part is formed by bonding two plastic sheets to form a flow path between the sheets.   The extracorporeal circuit for heating and / or cooling a liquid according to claim 1 or 2, wherein a switch for opening and closing only the liquid outlet tube is not provided. At least the liquid introduction tube, the flow path portion, and the liquid discharge tube are liquid-tightly connected in this order, and the liquid supply tube and the liquid discharge tube are arranged at positions facing each other across the flow path portion. A method of using a switch in an extracorporeal circuit for warming and / or cooling comprising :
When the extracorporeal circuit is filled with physiological saline, the connection part between the liquid introduction tube and the flow path part is disposed below, the connection part between the liquid lead-out tube and the flow path part is disposed above, and the downward direction At least a part of the liquid introduction tube positioned is bent and expanded upward, adjacent to the liquid outlet tube positioned above, and the liquid inlet tube and the liquid outlet are provided using one switch at the adjacent portion. A switch characterized by simultaneously closing the liquid introduction tube and the liquid outlet tube using the one switch after the extracorporeal circuit is filled with physiological saline by simultaneously opening the tube. How to use . At least the liquid introduction tube, the flow path portion, and the liquid discharge tube are liquid-tightly connected in this order, and the liquid supply tube and the liquid discharge tube are arranged at positions facing each other across the flow path portion. In the extracorporeal circuit for warming and / or cooling,
The liquid introduction tube has a portion adjacent to the liquid lead-out tube at least partially bent and disposed at a position facing the flow passage portion;
An extracorporeal circuit for heating and / or cooling a liquid, comprising: one switch that simultaneously opens or closes the liquid introduction tube and the liquid outlet tube at the adjacent portion .

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