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WO2018123958A1 - Cathéter à ballonnet pour une pompe à ballonnet intra-aortique (pbia) - Google Patents

Cathéter à ballonnet pour une pompe à ballonnet intra-aortique (pbia) Download PDF

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Publication number
WO2018123958A1
WO2018123958A1 PCT/JP2017/046404 JP2017046404W WO2018123958A1 WO 2018123958 A1 WO2018123958 A1 WO 2018123958A1 JP 2017046404 W JP2017046404 W JP 2017046404W WO 2018123958 A1 WO2018123958 A1 WO 2018123958A1
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WO
WIPO (PCT)
Prior art keywords
balloon
temperature
iabp
fluid
heat exchange
Prior art date
Application number
PCT/JP2017/046404
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English (en)
Japanese (ja)
Inventor
高橋　克明
貴樹 石田
秀洋 黒木
貴史 藤畑
Original Assignee
日本ゼオン株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by 日本ゼオン株式会社 filed Critical 日本ゼオン株式会社
Priority to JP2018559452A priority Critical patent/JPWO2018123958A1/ja
Publication of WO2018123958A1 publication Critical patent/WO2018123958A1/fr

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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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/295—Balloon pumps for circulatory assistance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12—Devices for heating or cooling internal body cavities
    • 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
    • A61M25/10—Balloon catheters
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/13—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
    • A61M60/139—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/36—Medical purposes thereof other than the enhancement of the cardiac output for specific blood treatment; for specific therapy
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/884—Constructional details other than related to driving of implantable pumps or pumping devices being associated to additional implantable blood treating devices

Definitions

  • the present invention relates to a balloon catheter used for IABP (balloon pumping in the aorta).
  • IABP intra-aortic balloon pumping
  • a balloon catheter is inserted into the aorta and the balloon is inflated and deflated according to the heart beat to assist the cardiac function.
  • An IABP balloon catheter (see Patent Document 1) used for IABP is inserted from the femoral artery or brachial artery and used in a state where the balloon is placed in the descending aorta of the chest.
  • a balloon catheter for hypothermia therapy in which a catheter having a heat exchange balloon is inserted into a blood vessel, a heat exchange fluid is circulated, and blood is cooled through the balloon. (See Patent Document 2).
  • hypothermia therapy is a patient immediately after resuscitation from cardiopulmonary arrest, etc. Because it is often applied to patients with reduced cardiac function, it is necessary to consider simultaneously applying cardiac function assistance via the aorta such as IABP, so it must be placed in the central vein It is a fact. In addition, inserting a balloon catheter for IABP into the aorta and inserting a balloon catheter for hypothermia into the central vein and carrying out each independently is burdensome for the patient, and improvement is required. Yes.
  • JP 2016-189921 A JP-T-2002-523138
  • the present invention has been made in view of such a situation, and an object thereof is to provide a balloon catheter for IABP that is minimally invasive and can control body temperature with high efficiency.
  • an IABP balloon catheter comprises: A catheter tube having a distal end and a proximal end and inserted into the aorta; An IABP balloon that is provided near the distal end of the catheter tube and controls blood flow by inflation and deflation; A heat exchanging part that is provided in a part of the extending direction of the catheter tube, and exchanges heat between blood flowing outside and the temperature control fluid flowing inside;
  • the catheter tube is A pressure fluid passage for conducting a pressure fluid for inflating and deflating the IABP balloon; A temperature-controlled fluid supply path for supplying a temperature-controlled fluid to the heat exchange unit; And a temperature control fluid discharge path for discharging the temperature control fluid heat-exchanged by the heat exchange unit.
  • IABP balloon catheter since the IABP balloon and the heat exchange section are provided, IABP and hypothermia can be performed with a single catheter. For this reason, when IABP and hypothermia therapy are used in combination, the blood flow in the aorta can be controlled (cooled or warmed), the body temperature can be controlled with high efficiency, and the patient at the time of treatment Can reduce the burden.
  • the heat exchanging section includes a heat exchanging balloon, and the distal end of the temperature regulating fluid supply path and the distal end of the temperature regulating fluid discharge path include the heat exchanging path.
  • the temperature control fluid inside the balloon and the outside blood exchange heat through the inflated balloon membrane, so that the temperature control of the blood can be performed with high efficiency, and if necessary
  • the thrombosis can be suppressed by contracting the heat exchange balloon.
  • the heat exchange balloon can be provided on the proximal end side or the distal end side of the IABP balloon.
  • the blood flow can be controlled on the proximal end side or the distal end side of the IABP balloon.
  • the distal end of the temperature adjustment fluid supply path and the distal end of the temperature adjustment fluid discharge path are directly connected to each other inside the catheter tube,
  • the temperature-controlled fluid and blood that circulates in the fluid-conditioning supply path can exchange heat through the tube wall of the catheter tube as the heat exchange unit. Since heat exchange is performed using the tube wall of the catheter tube as a heat exchange part, the configuration is simpler and costs can be reduced compared to the case where a heat exchange balloon is provided as the heat exchange part.
  • FIG. 1 is a plan view of an IABP balloon catheter according to an embodiment of the present invention.
  • 2A is a cross-sectional view taken along line IIa-IIa in FIG. 2B is a cross-sectional view taken along the line IIb-IIb in FIG.
  • FIG. 3 is a block diagram showing a schematic configuration of the drive device for the IABP balloon catheter of FIG. 4 is a view showing a modification of the catheter tube of FIG. 1, and is a cross-sectional view taken along the line IIa-IIa of FIG.
  • FIG. 5 is a view showing another modification of the catheter tube of FIG. 1, and is a cross-sectional view taken along the line IIa-IIa of FIG.
  • FIG. 6 is a plan view of an IABP balloon catheter according to another embodiment of the present invention.
  • FIG. 7 is a plan view of an IABP balloon catheter according to still another embodiment of the present invention.
  • 8A is a cross-sectional view taken along line VIIIa-VIIIa in FIG. 8B is a cross-sectional view taken along line VIIIb-VIIIb in FIG.
  • a catheter 1 according to an embodiment of the present invention shown in FIG. 1 is a balloon catheter used in an IABP (intra-aortic balloon pumping) method.
  • the catheter 1 includes a catheter tube 2, an IABP balloon 3, and a heat exchange balloon 4.
  • the catheter tube 2 is composed of a long flexible tube having a distal end inserted into the body and a proximal end disposed outside the body. The distal end of the catheter tube 2 is inserted from the brachial or femoral aorta and placed in the descending thoracic aorta.
  • an IABP balloon 3 In the vicinity of the distal end of the catheter tube 2, an IABP balloon 3 is provided.
  • the IABP balloon 3 repeatedly expands and contracts in accordance with the pulsation of the heart in order to control the blood flow in the aorta (thoracic descending aorta).
  • the IABP balloon 3 is formed of a thin film having a thickness of about 20 to 200 ⁇ m.
  • the material of the thin film is not particularly limited, but is preferably a material excellent in bending fatigue resistance, and is made of, for example, polyurethane.
  • the outer diameter and length of the IABP balloon 3 are determined according to the inner volume of the IABP balloon 3 that greatly affects the assisting effect on the cardiac function, the inner diameter of the arterial blood vessel, and the like.
  • the internal volume of the IABP balloon 3 is not particularly limited, but is 5 to 50 cc.
  • the outer diameter of the IABP balloon 3 is preferably 8 to 20 mm when inflated, and the length is preferably 80 to 250 mm.
  • the distal end and the proximal end of the IABP balloon 3 are attached to the outer periphery of the catheter tube 2 by means such as heat fusion or adhesion.
  • the structure of the catheter tube 2 at the portion where the IABP balloon 3 is attached will be described in detail later.
  • the pressure fluid is introduced and led out into the IABP balloon 3 through the pressure fluid passage 23 (see FIG. 2A) formed in the catheter tube 2 so that the IABP balloon 3 is inflated and deflated. It has become.
  • the IABP balloon 3 is deflated and wound around the outer circumference of the catheter tube 2 when the catheter 1 is inserted into the artery.
  • a heat exchanging balloon 4 is provided as a heat exchanging part for exchanging heat with the temperature control fluid.
  • the heat exchange balloon 4 is formed of a thin film having a thickness of about 20 to 200 ⁇ m.
  • the material of the thin film is not particularly limited, but is preferably a material excellent in bending fatigue resistance and pressure resistance, and is made of, for example, polyurethane, polyurethane elastomer, polyamide, polyamide elastomer, polyethylene terephthalate, or the like.
  • the outer diameter and length of the heat exchange balloon 4 are determined in consideration of the blood cooling effect and thrombus suppression.
  • the internal volume of the heat exchange balloon 4 is not particularly limited, but is 1 to 10 cc.
  • the outer diameter of the heat exchange balloon 4 is preferably 4 to 12 mm when expanded, and the length is preferably 10 to 150 mm.
  • the distal end and the proximal end of the heat exchange balloon 4 are attached to the outer periphery of the catheter tube 2 by means such as heat fusion or adhesion.
  • the balloon 4 for heat exchange includes a supply amount of the temperature adjustment fluid supplied via the temperature adjustment fluid supply path 24 formed inside the catheter tube 2, and a temperature adjustment fluid discharge similarly formed inside the catheter tube 2. By controlling the discharge amount of the temperature-controlled fluid discharged through the passage 25, the fluid is expanded and contracted. As with the IABP balloon 3, the heat exchange balloon 4 is contracted and wound around the outer circumference of the catheter tube 2 when the catheter 1 is inserted into the artery.
  • the catheter tube 2 includes a wire passage 22 through which a guide wire (not shown) is inserted, a pressure fluid passage 23 that conducts a pressure fluid that expands and contracts the IABP balloon 3, and heat exchange.
  • the temperature adjustment fluid supply path 24 that supplies the temperature adjustment fluid that has been temperature adjusted to the balloon 4 for heating and the temperature adjustment fluid discharge path 25 that discharges the temperature adjustment fluid that has been heat exchanged by the heat exchange balloon 4 are roughly provided. Yes.
  • a branch portion 26 is connected to the proximal end portion of the catheter tube 2.
  • the branch portion 26 is formed separately from the catheter tube 2 and is connected to the catheter tube 2 by means such as heat fusion or adhesion.
  • the branch portion 26 includes a first port 26 a communicating with the wire passage 22, a second port 26 b communicating with the pressure fluid communication path 23 in the catheter tube 2, and a third port 26 c communicating with the temperature control fluid supply path 24. And a fourth port 26d communicating with the temperature regulating fluid discharge path 25 is formed.
  • the second port 26b is connected to a pressure generating device (pump device) 52 provided in the driving device 5 shown in FIG. 3 so that the pressure fluid is introduced and led out into the IABP balloon 3 by the pressure generating device 52. It has become. Although it does not specifically limit as a pressure fluid, Helium gas with small viscosity and mass can be used so that the balloon 3 for IABP may expand
  • the third port 26c and the fourth port 26d are connected to a temperature adjustment fluid circulation device 53 provided in the drive device 5 shown in FIG. 3, and the temperature adjustment fluid supplied by the temperature adjustment fluid circulation device 53 is a temperature adjustment fluid supply path.
  • the temperature control fluid is supplied to the heat exchange balloon 4 through the temperature control fluid 24 and is collected through the temperature control fluid discharge passage 25.
  • the temperature control fluid is not particularly limited, but is preferably a liquid that is easy to handle and harmless to the human body. For example, physiological saline can be used.
  • the pressure fluid communication path is left over the same length as the length of the IABP balloon 3, leaving only the tube wall constituting the wire passage 22. 23, the tube walls constituting the temperature adjustment fluid supply path 24 and the temperature adjustment fluid discharge path 25 are removed. Although a detailed description is omitted, a tip end 21 is provided at the distal end of the catheter tube 2 (a portion where only the tube wall constituting the wire passage 22 is present).
  • a pressure sensor (not shown) for measuring the pressure is provided.
  • a signal from the pressure sensor is transmitted to a fifth port (not shown in FIG. 1, see FIG. 3) provided in the branch portion 26 via an optical fiber (not shown), and via an optical connector (not shown).
  • the control device 51 converts the pressure signal sent to blood pressure, controls the pressure generating device 52 according to the heartbeat based on the blood pressure fluctuation, and balloons for IABP in a short cycle of 0.4 to 1 second. 3 is adapted to expand and contract.
  • the catheter tube 2 is not particularly limited, but is made of a synthetic resin such as polyurethane, polyvinyl chloride, polyethylene terephthalate, or polyamide, and may be embedded with a stainless steel wire or the like.
  • the outer diameter of the catheter tube 2 is not particularly limited, but is preferably 2 to 4 mm.
  • the inner diameter of the portion other than the portion where the temperature adjustment fluid supply path 24 and the temperature adjustment fluid discharge path 25 are disposed is preferably The thickness is 1.5 to 4.0 mm, and the wall thickness is preferably 0.05 to 0.4 mm.
  • the length of the catheter tube 2 is preferably 300 to 800 mm.
  • the inner diameter of the wire passage 22 formed in the catheter tube 2 is preferably 0.5 to 1.5 mm, and the inner diameters of the temperature adjustment fluid supply path 24 and the temperature adjustment fluid discharge path 25 are Preferably, the thickness is 0.3 to 1.5 mm.
  • the wire passage 22 does not communicate with the inside of the IABP balloon 3, the inside of the heat exchange balloon 4, and other passages (the pressure fluid conduction passage 23, the temperature adjustment fluid supply passage 24, and the temperature adjustment fluid discharge passage 25). It is formed and opens at the distal end of the catheter tube 2 (the distal end of the tip 21) and communicates with the first port 26 a of the branch portion 26.
  • the wire passage 22 is a lumen for inserting a guide wire serving as a guide when the catheter tube 2 is inserted into an artery.
  • the pressure fluid passage 23 is It opens toward the distal end side at the proximal end of the portion where the tube wall is removed.
  • the distal end of the IABP balloon 3 is the distal end of the catheter tube 2 (the portion where only the tube wall constituting the wire passage 22 is present), and the proximal end of the IABP balloon 3 is the pressure fluid.
  • the inside of the IABP balloon 3 and the pressure fluid communication path 23 communicate with each other by being airtightly joined to the distal end of the tube wall constituting the conduction path 23.
  • the IABP balloon 3 When a positive pressure is applied by the pressure generating device 52 included in the driving device 5 of FIG. 3, the IABP balloon 3 is inflated through the second port 26b and the pressure fluid communication path 23, and a negative pressure is applied. As a result, the IABP balloon 3 is deflated.
  • the distal end 24a of the temperature regulating fluid supply path 24 (indicated by a dotted line in FIG. 1) of the catheter tube 2 reaches the vicinity of the distal end inside the heat exchange balloon 4, A through hole is provided in the tube wall of the catheter tube 2 at the position of the distal end 24a, and the temperature adjusting fluid supply path 24 and the inside of the heat exchange balloon 4 communicate with each other.
  • the distal end 25a of the temperature regulating fluid discharge path 25 shown by a dotted line in FIG.
  • the catheter tube 2 reaches the vicinity of the proximal end inside the heat exchange balloon 4, and the distal end 25a In the position, a through hole is provided in the tube wall of the catheter tube 2, and the temperature control fluid discharge path 25 and the inside of the heat exchange balloon 4 communicate with each other.
  • the lumens corresponding to the temperature adjustment fluid supply path 24 and the temperature adjustment fluid discharge path 25 formed in the catheter tube 2 are respectively the temperature adjustment fluid supply path 24 and the temperature adjustment fluid discharge path 25 and the heat exchange balloon 4.
  • the temperature control fluid is not circulated in the cavity of the catheter tube 2 that is blocked by an adhesive or the like at a position on the distal end side of the through hole that communicates with the catheter, and that is on the distal end side of the through hole. Has been.
  • the temperature-controlled fluid that is temperature-controlled (cooled or heated) to a desired temperature supplied from the temperature-controlled fluid circulation device 53 of the drive device 5 of FIG. 3 via the third port 26 c passes through the temperature-controlled fluid supply path 24. It flows and flows out into the heat exchange balloon 4 through the through hole of the distal end 24a, and the temperature of the blood outside the heat exchange balloon 4 is controlled through the balloon membrane of the heat exchange balloon 4.
  • the temperature-controlled fluid whose temperature has changed with this temperature control is introduced from the through hole of the distal end 25a of the temperature-controlled fluid discharge path 25, flows through the temperature-controlled fluid discharge path 25, and passes through the fourth port 26d.
  • the temperature control fluid circulation device 53 is returned to.
  • the temperature adjustment fluid returned to the temperature adjustment fluid circulation device 53 is adjusted to a desired temperature by the temperature adjustment device 54 and circulated in the same manner.
  • the supply amount (supply pressure) of the temperature adjustment fluid supplied via the temperature adjustment fluid supply path 24 is set to a predetermined value, and the heat exchange balloon 4 is inflated. While maintaining this state, supply of the temperature control fluid is continued.
  • the heat exchange balloon 4 can be temporarily contracted by the blood pressure.
  • the heat exchange balloon 4 may be contracted by positively sucking the temperature adjustment fluid discharged through the temperature adjustment fluid discharge passage 25.
  • each passage (wire passage 22, pressure fluid conduction passage 23, temperature adjustment fluid supply passage 24, and temperature adjustment fluid discharge passage 25) is configured as a catheter tube 2 inside a single wire. It is assumed that a lumen is used, but the catheter tube 2 may be composed of an inner tube and an outer tube through which the inner tube is inserted.
  • the inner tube lumen may be a wire passage 22, the outer tube lumen may be a pressure fluid conducting path 23, and the temperature adjustment fluid supply path 24 and the temperature adjustment fluid discharge path 25 may be formed in the tube wall of the outer tube.
  • the inner peripheral surface of the outer tube and the outer peripheral surface of the inner tube are preferably fixed with an adhesive or the like.
  • the adhesive used for fixing is not particularly limited, and adhesives such as cyanoacrylate adhesives and epoxy adhesives can be used, and it is particularly preferable to use cyanoacrylate adhesives.
  • the catheter tube 2 is composed of an inner tube and an outer tube
  • the outer tube is made of the same material as the catheter tube 2 described above
  • the inner tube is made of, for example, polyurethane, polyvinyl chloride, polyethylene, polyamide, polyetheretherketone. It can be composed of a synthetic resin tube such as (PEEK), a nickel titanium alloy capillary, a stainless steel capillary, or the like. Further, when the inner tube is formed of a synthetic resin tube, a stainless steel wire or the like may be embedded.
  • FIG. 3 is a block diagram showing a schematic configuration of the driving device 5 for driving the IABP balloon catheter 1.
  • the drive device 5 generally includes a control device 51, a pressure generation device 52, and a temperature control fluid circulation device 53. Although not shown, the drive device 5 is also provided with an input device for performing various settings and data input, a monitor for displaying various data and operating states, and the like.
  • the output port of the pressure generator 52 is connected to the second port 26b of the branching section 26.
  • the pressure generating device 52 includes a diaphragm. By driving the diaphragm under hydraulic control, the pressure fluid filled in the pressure fluid communication path 23 of the catheter tube 2 is pushed out to the IABP balloon 3 side, thereby IABP use. The balloon 3 is inflated and, conversely, by drawing the pressure fluid, the IABP balloon 3 is deflated.
  • the pressure generating device 52 is controlled by the control device 51 based on a pressure signal sent through the fifth port 26e of the catheter tube 5, and inflates and deflates the IABP balloon 3 according to the heartbeat.
  • the temperature control fluid circulation device 53 includes a temperature control device 54, the output port of which is connected to the third port 26 c of the catheter tube 2, and the input port of which is connected to the fourth port 26 d of the catheter tube 2.
  • the temperature adjustment device 54 is a device that changes the temperature of the temperature adjustment fluid to a desired temperature, and has cooling and heating functions.
  • a heat pump, a Peltier device, or the like can be used as the temperature control device 54.
  • the temperature adjustment fluid circulation device 53 supplies the temperature adjustment fluid set to a desired temperature to the heat exchange balloon 4 via the third port 26c of the catheter tube 2 and the temperature adjustment fluid supply path 24, and is used for heat exchange.
  • the temperature-adjusted fluid that flows through the balloon 4 and exchanges heat with the surrounding blood (blood flow) through the balloon membrane, and the temperature-adjusted fluid that changes in temperature is supplied to the temperature-adjusted fluid discharge path 25 and the fourth port 26d of the catheter tube 2.
  • the temperature is continuously controlled by the temperature control device 54 and is circulated in the same manner.
  • the temperature control fluid circulation device 53 is controlled by the control device 51 based on a preset temperature (target body temperature) set and inputted in advance and the current body temperature of the patient that is separately measured. When so-called hypothermia therapy is performed, the set temperature (target body temperature) may be set in the range of 32 to 34 ° C., for example.
  • the IABP balloon catheter 1 includes a heat exchange balloon 4 in addition to the IABP balloon 3, and distributes a temperature-controlled fluid in the heat exchange balloon 4, thereby allowing the balloon to flow. Since the blood circulating through the membrane can be temperature-controlled (cooled or heated), IABP and hypothermia can be performed with a single catheter 1. For this reason, even when IABP and hypothermia therapy are used in combination, the blood flow in the aorta can be controlled, and body temperature can be controlled (changed) with high efficiency. In addition, compared with the conventional technique in which catheters are inserted into both the aorta and the vena cava, the burden on the patient during treatment can be reduced, and minimally invasive treatment can be realized.
  • the temperature of the blood can be controlled with high efficiency, and if necessary or periodically In particular, by contracting the heat exchange balloon 4, it is possible to reduce the stagnation of blood flow and suppress the generation of thrombus.
  • both can be performed with a single balloon catheter.
  • the cost can be reduced, and the weight can be reduced and the storage space can be saved when transporting by a doctor car or a doctor helicopter.
  • the drive device 5 is configured with the pressure generating device 52 and the temperature regulating fluid circulation device 53 as a single drive device 5, and therefore, compared with a case where each is configured independently. Thus, it is possible to reduce the weight and save the storage space when transporting by a doctor car or a doctor helicopter.
  • the driving device 5 is preferably configured to be battery-driven.
  • the configuration of the catheter tube 2 (cross-sectional shape and arrangement of the lumens constituting the wire passage 22, the pressure fluid conduction passage 23, the temperature adjustment fluid supply passage 24 and the temperature adjustment fluid discharge passage 25) is variously modified. be able to.
  • the catheter tube 2 may be configured as shown in FIG. That is, in FIG. 2A, the wire passage 22 is connected to the catheter tube 2 on the temperature control fluid supply path 24 and the temperature control fluid discharge path 25 side so as to be positioned substantially in the center in the catheter tube 2.
  • the wire passage 22 is connected to the catheter tube 2 on the side opposite to the temperature adjustment fluid supply path 24 and the temperature adjustment fluid discharge path 25.
  • the configuration shown in FIG. 4 may be further modified to be configured as shown in FIG. That is, in FIG. 4, the temperature control fluid supply path 24 and the temperature control fluid discharge path 25 are substantially circular in cross section, and are arranged adjacent to each other, and the temperature control fluid supply path 24 and the temperature control fluid discharge path 25 are In order to arrange, a part of the tube wall of the catheter tube 2 is thickened so as to be convex inward. For this reason, the cross-sectional shape of the pressure fluid communication path 23 is a complicated shape.
  • the wall thickness of the catheter tube 2 is changed so that one side (opposite side to the wire passage 22) is gradually thickened, and the temperature adjustment fluid supply path 24 and the temperature adjustment fluid discharge are changed.
  • the cross-sectional shape of the channel 25 is substantially arc-shaped, and these are provided in the portion where the tube wall is thick.
  • the cross-sectional shape of the pressure fluid communication path 23 is simpler than that shown in FIG.
  • the heat exchange balloon 4 is provided on the proximal end side of the IABP balloon 3, and the blood flow in the aorta is controlled on the proximal end side of the IABP balloon 3.
  • these may be arranged in reverse as shown in FIG. That is, a heat exchange balloon 4 is provided in the vicinity of the distal end of the catheter tube 2, and an IABP balloon 3 is provided in the vicinity of the proximal end side of the heat exchange balloon 4 in the vicinity of the distal end of the catheter tube 2. You may make it temperature-control the blood flow in an aorta in a distal end side rather than the balloon 3.
  • FIG. In the judgment of the doctor, a person who is considered appropriate for treatment may be used.
  • the heat exchange balloon 4 is provided as the heat exchange unit, but the configuration of the heat exchange unit is not limited thereto.
  • the heat exchange balloon 4 is omitted, and the distal end 24 a of the temperature adjustment fluid supply path 24 and the distal end 25 a of the temperature adjustment fluid discharge path 25 are connected to the IABP balloon 3.
  • the distal ends 24 a and 25 a are directly connected to each other inside the catheter tube 2, and the temperature control fluid flowing in the temperature control fluid supply path 24 and the blood flowing outside the catheter tube 2 are connected to each other.
  • the heat exchange may be performed via the tube wall of the catheter tube 2.
  • the tube wall of the catheter tube 2 serves as a heat exchange unit.
  • the configuration of the catheter tube 2 in this case (the cross-sectional shape and arrangement of the lumens constituting the wire passage 22, the pressure fluid conduction passage 23, the temperature adjustment fluid supply passage 24, and the temperature adjustment fluid discharge passage 25) is not particularly limited.
  • a configuration as shown in FIG. 8A is preferable. That is, the temperature control fluid supply path 24 and the temperature control fluid discharge path 25 are formed so that each cross-sectional shape is a thin semicircular arc, and the tube of the catheter tube 2 having a substantially uniform thickness. It can provide so that it may become mutually symmetrical in a wall.
  • the thicknesses of the outer portions of the temperature control fluid supply path 24 and the temperature control fluid discharge path 25 are thin, and the portions of the temperature control fluid supply path 24 and the temperature control fluid discharge path 25 corresponding to the outside of the catheter tube 2 are thin. Since the area is large, heat exchange with the bloodstream can be performed with high efficiency. Also, the structure for connecting the distal end 24a of the temperature adjustment fluid supply path 24 and the distal end 25a of the temperature adjustment fluid discharge path 25 is not particularly limited. For example, the structure shown in FIG. 8B is used. be able to.
  • the temperature control fluid supply passage 24 and the temperature control fluid discharge passage 25 formed so as to have a substantially semicircular cross-sectional shape are communicated with each other at one end side of the semicircular arc at a portion connecting them. It can be set as the structure connected.
  • the configuration of the catheter tube 2 as shown in FIG. 8A is applied to the configuration shown in FIG. 1 or FIG. 6 so that heat is exchanged with blood in both the heat exchange balloon 4 and the tube wall of the catheter tube 2. It may be. By comprising in this way, the temperature of blood can be adjusted more effectively.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Mechanical Engineering (AREA)
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  • Transplantation (AREA)
  • Pulmonology (AREA)
  • Thermal Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Child & Adolescent Psychology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • External Artificial Organs (AREA)

Abstract

[Problème] Le problème décrit par la présente invention est de fournir un cathéter à ballonnet pour PBIA qui est minimalement invasif et qui permet d'effectuer un contrôle de température corporelle avec une efficacité élevée. [Solution] La solution selon l'invention porte sur un cathéter à ballonnet pour PBIA qui est pourvu : d'un tube de cathéter 2 destiné à être inséré dans une aorte; d'un ballonnet de PBIA 3 disposé au voisinage d'une extrémité distale du tube de cathéter 2; et un ballonnet d'échange de chaleur 4 qui est disposé dans une partie du tube de cathéter 2, dans la direction d'extension de celui-ci, et qui échange de la chaleur entre le sang s'écoulant vers l'extérieur de celui-ci, et un fluide régulé en température s'écoulant à travers l'intérieur de celui-ci. Le tube de cathéter 2 comprend : un trajet de conduction de fluide de mise sous pression à travers lequel un fluide de mise sous pression est conduit pour amener le ballonnet de PBIA 3 à se dilater et se contracter; un trajet d'alimentation en fluide régulé en température 24 qui fournit le fluide régulé en température, dont la température a été régulée, au ballonnet d'échange de chaleur 4; et un trajet d'évacuation de fluide régulé en température 25 qui évacue le fluide à température régulée qui a été soumis à un échange de chaleur par le ballonnet d'échange de chaleur 4.
PCT/JP2017/046404 2016-12-27 2017-12-25 Cathéter à ballonnet pour une pompe à ballonnet intra-aortique (pbia) WO2018123958A1 (fr)

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JP2018559452A JPWO2018123958A1 (ja) 2016-12-27 2017-12-25 Ｉａｂｐ用バルーンカテーテル

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JP2016253512 2016-12-27
JP2016-253512 2016-12-27

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3479706B2 (ja) * 1998-06-23 2003-12-15 インナークール セラピーズ インコーポレーティッド 選択的臓器冷却装置
JP2005507695A (ja) * 2001-10-26 2005-03-24 レイディアント　メディカル　インコーポレイテッド 低体温を伴う大動脈内バルーンカウンターパルセイション
US7144407B1 (en) * 2002-05-30 2006-12-05 Alsius Corporation Cardiovascular intra aortic balloon pump catheter with heat exchange function and methods of use

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3479706B2 (ja) * 1998-06-23 2003-12-15 インナークール セラピーズ インコーポレーティッド 選択的臓器冷却装置
JP2005507695A (ja) * 2001-10-26 2005-03-24 レイディアント　メディカル　インコーポレイテッド 低体温を伴う大動脈内バルーンカウンターパルセイション
US7144407B1 (en) * 2002-05-30 2006-12-05 Alsius Corporation Cardiovascular intra aortic balloon pump catheter with heat exchange function and methods of use

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