WO2016125313A1 - Dispositif de circulation de liquide de purge pour pompe sanguine, et système cardiaque artificiel auxiliaire - Google Patents

Dispositif de circulation de liquide de purge pour pompe sanguine, et système cardiaque artificiel auxiliaire Download PDF

Info

Publication number
WO2016125313A1
WO2016125313A1 PCT/JP2015/053443 JP2015053443W WO2016125313A1 WO 2016125313 A1 WO2016125313 A1 WO 2016125313A1 JP 2015053443 W JP2015053443 W JP 2015053443W WO 2016125313 A1 WO2016125313 A1 WO 2016125313A1
Authority
WO
WIPO (PCT)
Prior art keywords
purge
pressure
purge liquid
sliding member
blood pump
Prior art date
Application number
PCT/JP2015/053443
Other languages
English (en)
Japanese (ja)
Inventor
妃咲 木下
智哉 北野
Original Assignee
株式会社サンメディカル技術研究所
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.)
Filing date
Publication date
Application filed by 株式会社サンメディカル技術研究所 filed Critical 株式会社サンメディカル技術研究所
Priority to PCT/JP2015/053443 priority Critical patent/WO2016125313A1/fr
Priority to JP2016573166A priority patent/JP6343821B2/ja
Publication of WO2016125313A1 publication Critical patent/WO2016125313A1/fr

Links

Images

Classifications

    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04D—NON-POSITIVE-DISPLACEMENT PUMPS
    • F04D7/00—Pumps adapted for handling specific fluids, e.g. by selection of specific materials for pumps or pump parts
    • F04D7/02—Pumps adapted for handling specific fluids, e.g. by selection of specific materials for pumps or pump parts of centrifugal type
    • 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
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/827—Sealings between moving parts
    • A61M60/829—Sealings between moving parts having a purge fluid supply
    • 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
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
    • 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
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • 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
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/408—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
    • A61M60/411—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
    • A61M60/416—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor transmitted directly by the motor rotor drive shaft
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04D—NON-POSITIVE-DISPLACEMENT PUMPS
    • F04D13/00—Pumping installations or systems
    • F04D13/12—Combinations of two or more pumps
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04D—NON-POSITIVE-DISPLACEMENT PUMPS
    • F04D29/00—Details, component parts, or accessories
    • F04D29/06—Lubrication
    • F04D29/061—Lubrication especially adapted for liquid 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
    • A61M60/10—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
    • A61M60/148—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 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices

Definitions

  • the present invention relates to a purge fluid circulation device for a blood pump for circulating a purge fluid having a function of maintaining lubrication performance, cooling performance and sealing performance inside the blood pump, and an auxiliary artificial device using the purge fluid circulation device for the blood pump. Relates to the kidney system.
  • auxiliary artificial heart system is a medical device used for patients with severe heart failure, and refers to a system that supplements a part of the function of the heart in order to maintain the life of the patient.
  • the liquid which consists of the water which circulates through the inside of a blood pump, physiological saline, etc. may be called a cool seal liquid or a purge liquid. In this specification, it will be expressed as “purge liquid”.
  • FIG. 8 is a cross-sectional view of a conventional blood pump 900.
  • FIG. 8A is a cross-sectional view of blood pump 900
  • FIG. 8B is an enlarged view of the range indicated by symbol A in FIG. 8A.
  • a conventional blood pump 900 includes a sliding device 901 as shown in FIG.
  • the sliding device 901 includes a stationary sliding member 912 having an annular first sliding surface 914 and a rotating sliding member 922 having an annular second sliding surface 924, and the first sliding surface 914 is provided. And the second sliding surface 924 are opposed to each other, and the outer peripheral sides of the stationary-side sliding member 912 and the rotating-side sliding member 922 are in contact with blood.
  • This sliding device 901 is also a component of a mechanical seal.
  • the conventional blood pump 900 includes a fixed unit 910, a rotating unit 920, a rotation driving device 930, and a purge fluid circulation path 940 in the blood pump 900 in addition to the sliding device 901.
  • the purge fluid circulation path 940 in the blood pump 900 is referred to as “blood pump purge fluid circulation path 940”.
  • the fixed-side sliding member 912 is also a member that constitutes the fixed portion 910.
  • the rotation side sliding member 922 is also a member that constitutes the rotation unit 920.
  • the rotating unit 920 includes an impeller 926 and a rotating shaft 928 in addition to the rotating side sliding member 922.
  • the blood pump purge fluid circulation path 940 is a path for circulating the purge liquid in the blood pump 900.
  • the blood pump purge fluid circulation path 940 includes a purge fluid inlet 942, a purge fluid supply chamber 944, a purge fluid passage chamber 946, and a purge fluid outlet 948.
  • the purge liquid passage chamber 946 is located on each inner peripheral side of the fixed side sliding member 912 and the rotation side sliding member 922 in the sliding device 901.
  • the blood pump 900 configured in this way is a blood pump that is used while allowing purge liquid to pass through the inner peripheral sides of the stationary sliding member 912 and the rotating sliding member 922 in the sliding device 901.
  • the auxiliary artificial heart system is provided with a purge liquid circulating device for circulating the purge liquid, and the purge liquid is circulated by the purge liquid circulating device. ing.
  • the purge fluid circulation device (referred to as a conventional purge fluid circulation device) has a purge fluid circulation unit used outside the user's body, and a tube (feed-side tube) between the purge fluid circulation unit and the blood pump 900. And the purge solution through the return side tube).
  • the purge liquid stored in the purge liquid storage section also referred to as a reservoir
  • the purge liquid is circulated in such a manner that after passing through the respective inner peripheral sides of the fixed-side sliding member 912 and the rotation-side sliding member 922 in the apparatus 901, it is returned to the reservoir and sent out again by the purge liquid circulation pump.
  • the purge liquid circulation unit is also provided with a filter for removing blood mixed in the purge liquid. .
  • the operational stability is to stabilize power consumption necessary for the operation of the blood pump 900 and to stabilize the rotation of the rotating unit 920.
  • the lubrication performance of the sliding device 901 is increased, and secondly, the sealing performance of the sliding device 901 is increased.
  • the sealing performance is also referred to as sealing performance or leakage performance, and is performance that suppresses blood on the outer peripheral side of the sliding device 901 from entering (leaking) the inner peripheral side of the sliding device 901. Say.
  • the sliding device 901 has a fixed sliding member 912 and a rotating sliding member 922 on each inner peripheral side. It is important to set the pressure of the existing purge liquid to an appropriate pressure and supply the purge liquid between the first sliding surface 914 and the second sliding surface 924 in a stable state. This is because when the pressure of the purge liquid in the sliding device 901 is low, blood enters between the first sliding surface 914 and the second sliding surface 924, and further, the fixed-side sliding member 912 in the sliding device 901. This is because there may be a case where the rotation side sliding member 922 enters the inner peripheral side. Note that increasing the lubrication performance of the sliding device 901 and increasing the sealing performance of the sliding device 901 are abbreviated as “increasing the lubrication performance and sealing performance of the sliding device 901”.
  • the purge liquid stored in the reservoir is circulated by being sent out by the purge liquid circulation pump, passing through the blood pump, and then returning to the reservoir.
  • the sliding device 901 is generally at a substantially intermediate position between the feed side tube and the return side tube, each inner periphery of the fixed side sliding member 912 and the rotation side sliding member 922 in the sliding device 901 is provided.
  • the pressure of the purge liquid existing on the side is approximately an average value of the pressure of the purge liquid in the vicinity of the outlet in the purge liquid circulation unit and the pressure of the purge liquid in the reservoir (this is atmospheric pressure, which is 0 KPa).
  • the pressure of the purge liquid existing on each inner peripheral side of the fixed side sliding member 912 and the rotation side sliding member 922 in the sliding device 901 is referred to as “the pressure of the purge liquid in the sliding device 901”. Abbreviated.
  • the pressure of the purge liquid in the vicinity of the outlet in the purge liquid circulation unit can be set in a range of 10 KPa to 100 KPa, depending on the performance of the purge liquid circulation pump.
  • the pressure of the purge liquid in the moving device 901 is 15 KPa.
  • the pressure of the purge liquid in the vicinity of the outlet in the purge liquid circulation unit (in this case, 30 KPa) is relative to the pressure of the purge liquid in the reservoir as atmospheric pressure and the pressure in the reservoir as a reference (0 KPa). Pressure.
  • the pressure of the purge liquid in the sliding device 901 is almost 1 ⁇ 2 of the pressure of the purge liquid near the outlet of the purge liquid circulation unit.
  • the human blood pressure the average blood pressure in the systole and the diastole
  • the pressure of the purge liquid in the sliding device 901 is about 15 KPa in many cases. Since the pressure of the purge fluid is superior to the blood pressure, the purge fluid overcomes the blood resistance and is supplied between the first sliding surface 914 and the second sliding surface 924.
  • the blood pressure may exceed the pressure of the purge solution.
  • the purge solution is difficult to be supplied between the first sliding surface 914 and the second sliding surface 924. Therefore, there is a problem that the lubrication performance and sealing performance of the sliding device are lowered.
  • the present invention has been made in view of the above circumstances, and by setting the pressure of the purge liquid in the sliding device to an appropriate pressure, the lubricating performance and sealing performance of the sliding device can be improved as compared with the conventional purge liquid circulating device.
  • An object of the present invention is to provide a purge fluid circulating device for a blood pump that can be made high. It is another object of the present invention to provide an auxiliary artificial heart system including the blood pump purge fluid circulation device of the present invention.
  • a purge solution circulating apparatus for a blood pump according to the present invention is provided inside a blood pump embedded in a user's body, and has a fixed-side sliding member having an annular first sliding surface and an annular second slide.
  • a rotation-side sliding member having a moving surface, wherein the first sliding surface and the second sliding surface are opposed to each other, and the fixed-side sliding member and the rotation-side sliding member A sliding device that is used in a state where each outer peripheral side of the blood pump is in contact with blood, and a purge solution having a function of maintaining the lubrication performance, cooling performance, and sealing performance inside the blood pump, and the fixed-side sliding member and A purge liquid circulation unit that circulates through each inner peripheral side of the rotation side sliding member, and the purge liquid circulation from the purge liquid circulation unit through each inner peripheral side of the fixed side sliding member and the rotation side sliding member.
  • Purge fluid circulation configured to return to the unit
  • a purge fluid circulation device for a blood pump comprising a path, wherein the purge fluid circulation unit is unidirectional to a purge fluid reservoir that stores the purge fluid and a purge fluid that is stored in the purge fluid reservoir.
  • a purge liquid circulation pump that provides a moving force of the purge liquid, and a purge liquid reservoir that is provided in the vicinity of the purge liquid inlet of the purge liquid reservoir and passes through the inner peripheral sides of the fixed-side sliding member and the rotating-side sliding member.
  • a flow rate adjusting valve capable of adjusting the flow rate of the purge liquid when returning to the section.
  • the purge solution circulating apparatus for a blood pump of the present invention in addition to the purge solution circulation pump, there is a flow rate adjustment valve capable of adjusting the flow rate of the purge solution when returning to the purge solution storage part.
  • the pressure of the purge liquid existing on each inner peripheral side of the fixed side sliding member and the rotation side sliding member is set to an appropriate pressure (for example, The pressure is surely higher than the pressure of blood existing on the outer peripheral surface of the sliding device.
  • controlling the purge liquid circulation pump means controlling the amount of purge liquid delivered per unit time by controlling the number of revolutions of the purge liquid circulation pump.
  • controlling the flow rate adjusting valve means controlling the opening of the flow rate adjusting valve (the flow rate of the purge liquid flowing through the flow rate adjusting valve).
  • the pressure of the purge fluid in the sliding device is set to an appropriate pressure (for example, The pressure is surely higher than the blood pressure existing on the outer peripheral surface of the sliding device. Therefore, the purge liquid can be forcibly supplied between the first sliding surface of the fixed-side sliding member and the second sliding surface of the rotating-side sliding member. A lubricating film can be stably formed between the sliding surface and the second sliding surface of the rotating side sliding member. Thereby, blood can be prevented from entering the inner peripheral side of the sliding device, and the lubrication performance and sealing performance of the sliding device can be made higher than those of the conventional purge liquid circulating device.
  • the first sliding surface and the second sliding surface in contact with each other are formed by the fixed sliding member and the rotating sliding member.
  • the pressure of the purge liquid at the non-contact state due to the pressure of the purge liquid existing on each inner peripheral side is the divergence pressure of the purge liquid
  • each of the fixed side sliding member and the rotation side sliding member Purge liquid circulation having a function of controlling at least one of the purge liquid circulation pump and the flow rate adjusting valve so that the pressure of the purge liquid existing on the circumferential side is slightly lower than the pressure of the purge liquid divergence It is preferable to further include a unit controller.
  • the pressure of the purge liquid in the sliding device can be set to a value slightly lower than the detachment pressure of the purge liquid.
  • the pressure of the purge liquid in the sliding device is compared with the case where the purge liquid is simply circulated. And higher values.
  • the purge liquid can be forcibly supplied between the first sliding surface of the fixed-side sliding member and the second sliding surface of the rotating-side sliding member.
  • a lubricating film can be stably formed between the sliding surface and the second sliding surface of the rotating side sliding member. Thereby, blood can be prevented from entering the inner peripheral side of the sliding device.
  • the purge solution circulation unit controller keeps the flow rate adjusting valve closed and the purge solution circulation pump continues to send the purge solution at a constant flow rate.
  • the pressure of the purge liquid when the increase of the pressure of the purge liquid existing on each inner peripheral side of the fixed side sliding member and the rotation side sliding member stops and the pressure of the purge liquid starts to rapidly decrease It is preferable to further have a function of measuring as the dissociation pressure.
  • the pressure slightly lower than the divergence pressure of the purge solution is preferably in the range of 85% to 95% of the divergence pressure.
  • the pressure of the purge liquid in the sliding device is set to an appropriate pressure (for example, the pressure of blood existing on the outer peripheral surface of the sliding device). Higher pressure).
  • the pressure slightly lower than the divergence pressure of the purge liquid is more preferably about 90% in the range of 85% to 95%.
  • the purge solution circulation unit is provided on the downstream side of the purge solution circulation pump, and is included in the purge solution circulating through the purge solution circulation path.
  • a filter for removing unnecessary substances a first pressure detection unit for detecting the pressure of the purge liquid in the vicinity of the purge liquid inlet of the filter, and a second pressure detection unit for detecting the pressure of the purge liquid in the vicinity of the purge liquid outlet of the filter
  • a third pressure detector for detecting the pressure of the purge liquid in the vicinity of the purge liquid inlet of the flow rate adjusting valve.
  • a filter as a component of the purge fluid circulation unit, unnecessary substances such as blood and bacteria contained in the circulating purge fluid can be removed. Further, the clogging of the filter can be detected by providing the first pressure detection unit as a component of the purge liquid circulation unit.
  • the second pressure detector as a component of the purge liquid circulation unit detects the pressure of the purge liquid in the vicinity of the purge liquid outlet of the filter.
  • the second pressure detector is in the vicinity of the purge liquid outlet of the filter.
  • the pressure of the purge liquid can be detected as the outlet side pressure of the purge liquid circulation unit.
  • the filter outlet side pressure detected by the second pressure detector can be referred to as “the outlet side pressure of the purge liquid circulation unit”.
  • the purge fluid circulation path connecting tube connecting the purge fluid circulation unit and the blood pump
  • the purge fluid circulation path existing between the purge fluid circulation unit and the blood pump is bent or twisted. It is also possible to detect stenosis due to.
  • the third pressure detector as a component of the purge fluid circulation unit, the pressure of the purge fluid flowing into the flow rate adjustment valve can be detected.
  • the pressure of the purge liquid in the sliding device is determined based on the pressure detected by the third pressure detector and the pressure detected by the second pressure detector. You can know what the pressure is.
  • the valve inlet side pressure detected by the third pressure detection unit is “purge liquid circulation unit”. It can be said that "the inlet side pressure”.
  • At least one of the fixed-side sliding member and the rotating-side sliding member is made of silicon carbide.
  • Silicon carbide is a material excellent in hardness, durability and biocompatibility, and can be used safely in blood. For this reason, by adopting the configuration as described above, it is possible to increase the hardness and durability of the fixed-side sliding member and the rotating-side sliding member, and to suppress the influence caused by elastic deformation of the sliding surface. It becomes possible.
  • both the fixed-side sliding member and the rotating-side sliding member are sliding members made of silicon carbide, but one of the fixed-side sliding member and the rotating-side sliding member is made of silicon carbide, and the other is A sliding member made of carbon is also preferable.
  • Carbon is a relatively soft material suitable for use with silicon carbide, has excellent biocompatibility, and can be used safely in blood.
  • the sliding member made of silicon carbide may have been subjected to a “familiarization treatment” which is a treatment for forming a hydrate of silicon oxide on the sliding surface before being assembled as a sliding device.
  • a “familiarization treatment” is a treatment for forming a hydrate of silicon oxide on the sliding surface before being assembled as a sliding device.
  • the sliding surface of the sliding member made of silicon carbide has “highly hydrophilic silicon oxide hydrate” by a tribochemical reaction. For this reason, it becomes difficult for blood to adhere to the sliding surface, and as a result, sliding resistance when used in blood can be reduced as compared with a sliding device that is not subjected to the “familiar treatment”.
  • “Family processing” refers to a process of applying friction to the sliding surface while increasing the load according to a predetermined procedure.
  • the conforming process increases the load by a predetermined value (for example, 50 N) after applying friction to the sliding surface until the rate of change of the friction coefficient is within a predetermined value (for example, 5%) at a constant load.
  • a predetermined value for example, 50 N
  • the familiar process is performed in water, for example.
  • the maximum load applied during the conforming process is preferably larger than the load applied when the sliding device is actually used, and more preferably 10 times or more of the load.
  • the antithrombotic treatment include coating treatment with MPC (2-methacryloyloxyethyl phosphorylcholine) polymer.
  • the auxiliary artificial heart system of the present invention includes a blood pump implanted in the body, an artificial blood vessel for connecting the blood pump and the blood flow of the heart, and a blood pump control for driving and controlling the blood pump.
  • An auxiliary artificial heart system comprising a device and a blood pump purge fluid circulation device for circulating a purge fluid inside the blood pump, wherein the blood pump purge fluid circulation device comprises the above [1] to [7]. ]
  • the purge solution circulating device for a blood pump according to any one of the above.
  • the auxiliary artificial heart system of the present invention since the purge fluid circulating device for the blood pump of the present invention described in any one of [1] to [7] is provided, any of [1] to [7] described above. This has the same effect as the purge solution circulating apparatus for the blood pump of the present invention. Thereby, the auxiliary artificial heart system of the present invention becomes a reliable auxiliary artificial heart system.
  • FIG. 4 is a diagram schematically showing a relationship between purge liquid and blood between a first sliding surface and a second sliding surface. It is sectional drawing of the conventional blood pump 900.
  • FIG. 4 is a diagram schematically showing a relationship between purge liquid and blood between a first sliding surface and a second sliding surface. It is sectional drawing of the conventional blood pump 900.
  • FIG. 1 is a diagram for explaining an auxiliary artificial heart system 100 according to an embodiment.
  • FIG. 2 is a cross-sectional view of blood pump 110 used in assistive artificial heart system 100 shown in FIG.
  • FIG. 3 is a view for explaining the sliding device 1 used in the blood pump shown in FIG. 3A is a perspective view of the sliding device 1 and its vicinity
  • FIG. 3B is a cross-sectional view of the sliding device 1 and its vicinity.
  • FIG. 4 is a view for explaining the purge solution circulating apparatus 200 of the blood pump according to the embodiment.
  • an auxiliary artificial heart system 100 includes a blood pump 110 (see FIG. 2 for details) implanted in the body, and an artificial for connecting the blood pump 110 and the blood flow of the heart.
  • the blood vessels 120 and 130, a portable auxiliary artificial heart system main body 300, and a connection cable 400 for connecting the blood pump 110 and the portable auxiliary artificial heart system main body 300 are provided.
  • the sliding device 1 (see FIG. 3 for details) provided in the blood pump 110 and the auxiliary artificial heart system main body 300.
  • a purge fluid circulation unit 210 (see FIG. 4 for details) housed in the body
  • a purge fluid circulation unit controller 220 housed in the auxiliary artificial heart system main body 300.
  • the purge fluid circulation tube 410 (see FIG. 4), which is one of the components of the cable 400, is used for the purge fluid circulation device of the blood pump of the present invention (here, the purge fluid circulation device 200 of the blood pump according to the embodiment). Is configured).
  • the auxiliary artificial heart system main body 300 also stores a blood pump control device for driving and controlling the blood pump 110, although not shown.
  • a control signal line (not shown) for the blood pump control device to drive and control the blood pump 110 is included in the connection cable 400.
  • the blood pump 110 includes a fixed portion 10, a rotating portion 20, a rotation driving device 30, and a blood pump chamber 32.
  • the blood pump 110 configured as described above is disposed in purge liquid passage chambers 46 (described later) located on the inner peripheral sides of the stationary sliding member 12 and the rotating sliding member 22 in the sliding device 1. This pump is used while passing the purge liquid.
  • the fixed portion 10 includes a cylindrical fixed-side sliding member 12 (so-called seat ring).
  • the rotating unit 20 includes a rotating side sliding member 22 (so-called seal ring), an impeller 26 and a rotating shaft 28.
  • the impeller 26 applies a moving force to the blood.
  • the rotation shaft 28 is connected to the rotation drive device 30, and when used, the rotation drive device 30 applies a rotational force to rotate the entire rotation unit 20.
  • the fixed sliding member 12 and the rotating sliding member 22 constitute the sliding device 1.
  • the sliding device 1 is one of the components constituting a mechanical seal in the blood pump.
  • the sliding device 1 is also one of the components of the purge solution circulating device 200 of the blood pump according to the embodiment.
  • the sliding device 1 will be described in detail later.
  • symbol, and detailed description are abbreviate
  • a mechanical seal is predetermined in the direction in alignment with the rotating shaft a (refer FIG. 3) of the rotation side sliding member 22 besides the sliding apparatus 1.
  • FIG. It includes components necessary for the mechanical seal, such as a load applying mechanism (for example, using a magnet) that applies the above load, and a cushion ring disposed between the rotation-side sliding member 22 and the impeller 26.
  • the rotation drive device 30 includes a rotation motor and applies a rotational force to the impeller 26.
  • the blood pump chamber 32 is a place where blood is given a moving force by the impeller 26.
  • the blood pump 110 is provided with a path 40 (referred to as a blood pump purge liquid circulation path 40) through which the purge liquid circulates.
  • the purge fluid circulation path 40 in the blood pump allows purge fluid to pass through the blood pump 110 in the order of the purge fluid inlet chamber 42, the purge fluid supply chamber 44, and the purge fluid passage chamber 46, and is discharged from the purge fluid outlet 48.
  • the purge liquid has a function of maintaining lubrication, cooling, and sealing performance in the blood pump 110. Specifically, the function of performing lubrication and cooling between the rotating shaft 28 and the fixed portion 10, the first sliding surface 14 of the fixed-side sliding member 12 and the second sliding surface 24 of the rotating-side sliding member 22. A function of suppressing blood from entering through a gap between the first sliding surface 14 and the second sliding surface 24.
  • the sliding device 1 includes a stationary sliding member 12 having an annular first sliding surface 14 and a rotating sliding member 22 having an annular second sliding surface 24. .
  • the sliding device 1 is in a state where the first sliding surface 14 and the second sliding surface 24 are opposed to each other, and the outer peripheral sides of the stationary-side sliding member 12 and the rotating-side sliding member 22 are in contact with blood. It is a sliding device used in the state made to do.
  • the sliding device 1 is one of the components of the blood pump 110, but is also a component of the purge solution circulating device 200 of the blood pump according to the embodiment.
  • the sliding device 1 is in contact with the first sliding surface 14 and the second sliding surface 24 when not in use.
  • the first sliding surface 14 and the second sliding surface 24 in the sliding device 1 have the same inner diameter and outer diameter in design. Yes. For this reason, the 1st sliding surface 14 and the 2nd sliding surface 24 contact in the whole surface (refer FIG.3 (b) and FIG.3 (c)).
  • the first sliding surface 14 and the second sliding surface 24 are configured so as to rotate with the fixed-side sliding member 12 using a load applying mechanism of a mechanical seal. This can be realized by applying a load to the side sliding member 22.
  • the magnitude of the load depends on the areas of the first sliding surface 14 and the second sliding surface 24, but can be, for example, 10 KPa to 200 KPa.
  • the sliding device 1 is a sliding device to be used in a state where a predetermined load is applied between the fixed sliding member 12 and the rotating sliding member 22 in the direction along the rotation axis a of the rotating sliding member 22.
  • a moving device a sliding device having a so-called thrust bearing structure.
  • the sliding device 1 allows the purge liquid to pass through the inner peripheral sides of the stationary-side sliding member 12 and the rotating-side sliding member 22, that is, the purge liquid passage chamber 46 (see FIG. 2). use.
  • the fixed side sliding member 12 is made of silicon carbide, and the rotation side sliding member 22 is made of carbon.
  • Anti-thrombotic treatment is performed on the outer peripheries of the stationary-side sliding member 12 and the rotating-side sliding member 22.
  • An example of the antithrombotic treatment is a coating treatment with MPC (2-methacryloyloxyethyl phosphorylcholine) polymer.
  • the blood pump purge fluid circulation device 200 (hereinafter, “blood pump” may be abbreviated as “purge fluid circulation device 200”) is provided in the blood pump 110 as shown in FIG. And a purge fluid circulation unit 210 that circulates the purge fluid in the blood pump 110, and a purge fluid circulation unit controller 220 that controls the purge fluid circulation unit 210.
  • the purge fluid circulation unit controller 220 mainly controls the purge fluid circulation pump 212 and the flow rate adjustment valve 214 provided in the purge fluid circulation unit 210, and is packaged on a circuit board (not shown), for example. It is mounted as an electronic circuit.
  • the purge fluid circulation unit 210 of the purge fluid circulation device 200 is connected to the purge fluid circulation path 40 in the blood pump in the blood pump 110 via a flexible connection cable 400 (see FIG. 1). Yes.
  • the connection cable 400 includes the purge solution circulation tube 410 for circulating the purge solution and the control signal line (not shown) from the blood pump control device (not shown). ing.
  • the purge fluid circulation tube 410 includes a feed-side tube 411 for sending the purge fluid delivered from the purge fluid circulation unit 210 to the blood pump 110, and the purge fluid circulated through the purge fluid circulation path 40 in the blood pump.
  • the return side tube 412 is connected to the purge liquid inlet 42 (see FIG. 2), and the return side tube 412 is connected to the purge liquid outlet 48 (see FIG. 2). ing.
  • the purge fluid circulation unit 210 is detachably stored in the auxiliary artificial heart system main body 300. For this reason, the purge liquid circulation unit 210 can be replaced as necessary.
  • the purge liquid circulation unit 210 includes a purge liquid storage unit (hereinafter referred to as a reservoir) 211 that stores the purge liquid, and a moving force in one direction against the purge liquid stored in the reservoir 211.
  • a purge liquid circulation pump for example, a diaphragm pump
  • the flow rate adjusting valve 214 capable of setting the pressure of the purge liquid in the sliding device 1 to a predetermined pressure by adjusting the flow rate of the purge liquid returning to the reservoir 211, and the purge liquid inlet of the filter 213
  • a second pressure detector 216 that detects the pressure of the purge liquid in the vicinity as the outlet side pressure of the purge liquid circulation unit, and the pressure of the purge
  • the purge liquid circulation pump 212 is a pump capable of sending the purge liquid per unit time with an arbitrary delivery quantity within a predetermined range by controlling the rotation speed.
  • the flow rate adjusting valve 214 can adjust the flow rate of the purge liquid by adjusting the opening degree of the valve. Therefore, for example, “decreasing (or increasing) the flow rate of the purge liquid in the flow rate adjusting valve 214” may be expressed as “decreasing (or increasing) the opening degree of the flow rate adjusting valve 214”. is there.
  • a purge liquid circulation path (referred to as an in-unit purge liquid circulation path) inside the purge liquid circulation unit 210 includes an in-unit feed-side circulation path 218 that passes from the reservoir 211 through the purge liquid circulation pump 212 and the filter 213, and a flow rate.
  • the in-unit feed-side circulation path 218 is connected to the feed-side tube 411 of the purge liquid circulation tube 410, and the in-unit return-side circulation path 219 is connected to the return-side tube 412 of the purge liquid circulation tube 410.
  • the in-unit feed side circulation path 218 and the in-unit return side circulation path 219 in the purge liquid circulation unit 210, the purge liquid circulation path 40 in the blood pump (see FIG. 2), and the feed of the purge liquid circulation tube 410 are sent.
  • the entire purge liquid circulation path 420 including the side tube 411 and the return side tube 412 is referred to as a “purge liquid circulation path 420”. Therefore, in this specification, when it is simply expressed as “purge liquid circulation path 420”, it indicates the whole.
  • the first pressure detector 215 detects the pressure of the purge liquid in the vicinity of the purge liquid inlet of the filter 213 (referred to as filter inlet side pressure P1).
  • the second pressure detector 216 detects the pressure of the purge liquid in the vicinity of the purge liquid outlet of the filter 213 (referred to as filter outlet side pressure P2).
  • the third pressure detector 217 detects the pressure of the purge liquid in the vicinity of the purge liquid inlet of the flow rate adjustment valve 214 (referred to as valve inlet side pressure P3).
  • the second pressure detection unit 216 detects the pressure of the purge liquid in the vicinity of the purge liquid outlet of the filter 213 as the outlet side pressure of the purge liquid circulation unit 210. For this reason, the filter outlet side pressure P2 detected by the second pressure detector 216 can be referred to as “the outlet side pressure of the purge liquid circulation unit 210”.
  • the third pressure detector 217 detects the pressure of the purge liquid in the vicinity of the purge liquid inlet of the flow rate adjustment valve 214 as the inlet side pressure of the purge liquid circulation unit 210. For this reason, the valve inlet side pressure P3 detected by the third pressure detector 217 can be said to be “the inlet side pressure of the purge liquid circulation unit 210”.
  • the valve inlet side pressure (inlet side pressure of the purge fluid circulation unit 210) P3 is given to the purge fluid circulation unit controller 220, respectively.
  • the first pressure detection unit 215 detects clogging of the filter 213, and the second pressure detection unit 216 has a function of detecting the outlet side pressure of the purge liquid circulation unit 210.
  • the second pressure detection unit 216 also has a function of detecting stenosis due to bending or twisting of the connection tube 411 existing between the purge fluid circulation unit 210 and the blood pump 110.
  • the detection of clogging of the filter 213 and the detection of constriction due to bending or twisting of the connection tube 411 are performed by the purge liquid circulation unit control unit 220 using the filter inlet side pressure P1 detected by the first pressure detection unit 215 and the second pressure. This can be performed by monitoring the filter outlet side pressure (the outlet side pressure of the purge liquid circulation unit 210) P2 detected by the pressure detector 216. That is, as a result of detecting the filter inlet side pressure P1 and the filter outlet side pressure, the purge liquid circulation unit control unit 220 generates an alarm when the filter inlet side pressure P1 is equal to or higher than a predetermined value and An alarm is also generated when the side pressure P2 is greater than or equal to a predetermined value.
  • examples of the alarm include turning on a lamp and generating an alarm sound from an alarm sound generation unit.
  • the lamp lights up colors corresponding to the filter inlet side pressure P1 and the filter outlet side pressure P2, respectively, and the alarm sound generates sounds corresponding to the filter inlet side pressure P1 and the filter outlet side pressure P2, respectively.
  • Such a lamp and an alarm sound generating unit are provided at predetermined positions of the auxiliary artificial system main body 300 (see FIG. 1), although not shown.
  • the pressure on the filter outlet side (the outlet side of the purge liquid circulation unit 210) It is assumed that the pressure P2 can be set in the range of 10 KPa to 100 KPa. Note that, as described above, the filter outlet side pressure P2 can be said to be the outlet side pressure of the purge liquid circulation unit 210, and therefore the filter outlet side pressure P2 indicates the outlet side pressure of the purge liquid circulation unit 210.
  • the pressure P2 on the outlet side of the filter can be set to a value larger than 100 KPa by using a higher-capacity purge liquid circulation pump, but the purge liquid circulation is considered in consideration of practicality such as cost and size. It is necessary to select a pump.
  • the purge fluid circulation pump 212 employed in the purge fluid circulation device 200 of the blood pump according to the embodiment has a filter outlet side pressure P2 of 10 KPa to 100 KPa. A range can be set.
  • the pressure of the purge liquid at the filter outlet side pressure P2 is 10 KPa to 100 KPa relative to the case where the pressure of the purge liquid in the reservoir 211 is the atmospheric pressure and the pressure in the reservoir 211 is the reference (0 KPa). Pressure. The same applies to the pressure of the purge liquid at other positions.
  • the purge liquid circulation unit controller 220 is based on the filter outlet side pressure P2 detected by the second pressure detector 216. This is made possible by controlling the purge liquid circulation pump 212. That is, the purge liquid circulation unit controller 220 monitors the filter outlet side pressure P2, and controls the purge liquid circulation pump 212 so that the filter outlet side pressure P2 becomes a predetermined pressure. Thereby, the filter outlet side pressure P2 can be set to a predetermined pressure (for example, 30 KPa).
  • the pressure of the purge liquid existing on each inner peripheral side of the stationary sliding member 12 and the rotating sliding member 22 in the sliding device 1 (this pressure is also referred to as “sliding device 1
  • the pressure of the purge liquid in the above is abbreviated as “the pressure of the purge liquid” in FIG. 2), because the sliding device 1 is at a substantially intermediate position between the feed side tube 411 and the return side tube 412. Almost average value.
  • the sliding device 1 is provided at a position where the pressure of the purge liquid in the sliding device 1 is approximately an average value of the filter outlet side pressure P2 and the valve inlet side pressure P3.
  • the pressure of the purge liquid in the sliding device 1 is approximately an average value of the filter outlet side pressure P2 and the valve inlet side pressure P3.
  • the valve inlet side pressure P3 of the flow rate adjusting valve 214 is substantially equal to the pressure of the purge liquid (0 KPa) in the reservoir 211. It becomes approximately 1/2 of the side pressure P2. For example, when the filter outlet side pressure P2 is 30 KPa, the pressure of the purge liquid in the sliding device 1 is approximately 15 KPa.
  • the pressure of the purge fluid in the sliding device 1 is set to a value slightly lower than the purge fluid detachment pressure (see below).
  • the divergence pressure of the purge liquid means that the first sliding surface 14 of the fixed-side sliding member 12 and the second sliding surface 24 of the rotating-side sliding member 22 are in sliding contact with each other.
  • the pressure of the purge liquid in the sliding device 1 when the non-contact state (disengaged state) is caused by the pressure of the purge liquid in the apparatus 1.
  • first sliding surface 14 of the fixed side sliding member 12 and the second sliding surface 24 of the rotating side sliding member 22 are brought into contact with the first sliding surface 14 and the second sliding surface 24.
  • a pressing force is applied to cause the first sliding surface 14 and the second sliding surface 24 to be in contact with each other with a relatively strong force.
  • the pressing force for bringing the first sliding surface 14 and the second sliding surface 24 into contact works between the fixed-side sliding member 12 and the rotating-side sliding member 22 by a mechanical seal load applying mechanism.
  • a load (pressing force by a magnet) and a pressing force by blood pressure can be mentioned, and a pressing force by a variable element is added to the sum of these pressing forces.
  • Examples of the fluctuation factors include the effects of wear on the first sliding surface 14 and the second sliding surface 24, plasma proteins in blood, and the like.
  • first sliding surface 14 and the second sliding surface 24 are in contact with each other with a relatively strong force, the first sliding surface 14 and the second sliding surface 24 are in contact with each other when the pressure of the purge liquid in the sliding device 1 is increased.
  • the first sliding surface 14 of the fixed-side sliding member 12 and the second sliding surface 24 of the rotating-side sliding member 22 that are in a non-contact state due to the pressure of the purge liquid in the sliding device 1 Divergence state).
  • the pressure of the purge liquid in the sliding device 1 is increased, the load (between the fixed-side sliding member 12 and the rotating-side sliding member 22 (preferably, the pressure of the purge liquid in the sliding device 1)
  • the total value of the pressing force by the magnet), the pressing force by the blood pressure, and the pressing force by the variable element is zero.
  • the 1st sliding surface 14 and the 2nd sliding surface 24 will be in a non-contact state (separated state).
  • the pressure of the purge liquid in the sliding device 1 at this time is referred to as “purge liquid separation pressure”.
  • the purge pressure of the purge liquid is denoted by “Ps”.
  • the dissociation pressure Ps of the purge liquid can be measured as follows. In the following description, “the divergence pressure of the purge solution” may be simply expressed as “the divergence pressure”.
  • FIG. 5 shows a change in pressure when the purge liquid circulation pump 212 is operated so as to send the purge liquid at a low flow rate (constant flow rate) with the flow rate adjustment valve 214 closed (the opening degree is zero).
  • FIG. 5 the horizontal axis indicates time, and the vertical axis indicates the pressure of the purge liquid in the sliding device 1.
  • the flow rate adjustment valve 214 When measuring the divergence pressure, first, the flow rate adjustment valve 214 is closed (opening is zero). In this state, if the purge liquid is continuously fed at a low flow rate (the flow rate is constant), the pressure of the purge liquid in the sliding device 1 increases in the process of continuously feeding the purge liquid. Thereafter, when the first sliding surface 14 of the stationary sliding member 12 in contact and the second sliding surface 24 of the rotating sliding member 22 are in a non-contact state (dissociated state), the stationary sliding is performed. The purge liquid leaks to the blood side existing on the outer peripheral side of the member 12 and the rotation-side sliding member 22, and the increase of the pressure of the purge liquid in the sliding device 1 stops and the pressure of the purge liquid starts to decrease rapidly. .
  • the pressure at this time pressure when the pressure of the purge liquid in the sliding device 1 stops increasing and the pressure of the purge liquid starts to rapidly decrease
  • the pressure at this time pressure when the pressure of the purge liquid in the sliding device 1 stops increasing and the pressure of the purge liquid starts to rapidly decrease
  • Ps separation pressure
  • the operation of increasing the pressure of the purge liquid in the sliding device 1 (the operation of gradually increasing the purge liquid pressure in the sliding device 1 to reach the separation). ) Is repeated a plurality of times, the pressure acquired each time (the pressure Pmax when the pressure of the purge liquid begins to drop rapidly) may be slightly different. In that case, the average of the pressures acquired every time (the pressure Pmax when the pressure of the purge liquid starts to drop rapidly) may be taken.
  • the pressure of the purge liquid in the sliding device 1 is slightly lower than the separation pressure Ps (this pressure is referred to as “Ps ′”).
  • Ps ′ the separation pressure
  • at least one of the purge liquid circulation pump 212 and the flow rate adjustment valve 214 is controlled.
  • controlling the purge fluid circulation pump 212 means controlling the number of revolutions of the purge fluid circulation pump 212 as described above
  • controlling the flow rate adjusting valve 214 means that the flow rate is adjusted. This means that the opening degree of the adjusting valve 214 is controlled.
  • the pressure Ps ′ slightly lower than the divergence pressure Ps is preferably a pressure in the range of 85% to 95% of the divergence pressure Ps, and more preferably about 90% of the range.
  • the pressure Ps ′ slightly lower than the divergence pressure Ps is 90% of the divergence pressure Ps, and the divergence pressure Ps is 28 KPa as described above, the pressure Ps ′ slightly lower than the divergence pressure Ps is It becomes approximately 25 KPa.
  • measuring the divergence pressure Ps and making the pressure of the purge liquid in the sliding device 1 become a pressure Ps ′ slightly lower than the divergence pressure Ps is: It is assumed that the purge liquid circulation unit control unit 220 automatically performs the operation.
  • the purge liquid circulation unit controller 220 automatically measures the divergence pressure Ps and makes the pressure Ps ′ slightly lower than the measured divergence pressure Ps, the purge pressure
  • the rotational speed of the purge liquid circulation pump 212 can be controlled by the control signal from the liquid circulation unit controller 220, and the opening degree of the flow rate adjustment valve 214 can be controlled.
  • the control performed by the purge liquid circulation unit controller 220 will be described. First, the case where the deviation pressure Ps is measured will be described.
  • the purge liquid circulation knit control unit 220 controls the purge liquid circulation pump 212 so that the purge liquid circulation pump 212 is constant at a low rotation, and the flow rate adjustment valve 214 is controlled with a valve. Control to close (opening degree is zero).
  • valve inlet side pressure P3 detected by the third pressure detector 217 is monitored, the valve inlet side when the increase of the valve inlet side pressure P3 stops and the valve inlet side pressure P3 starts to decrease rapidly.
  • the pressure P3 (“Pmax” in FIG. 5) is measured.
  • the valve inlet side pressure P3 (Pmax) when the valve inlet side pressure P3 starts to drop rapidly is the pressure of the purge liquid in the sliding device 1 at this time, and this is defined as the separation pressure Ps. By doing in this way, deviation pressure Ps can be measured automatically.
  • the purge liquid circulation pump 212 When measuring the detachment pressure Ps, the purge liquid circulation pump 212 is configured to send the purge liquid at a constant flow rate with the flow rate adjustment valve 214 closed as described above. In the path 420, the pressure of the purge liquid is the same between the second pressure detection unit 216, the sliding device 1, and the third pressure detection unit 217. Therefore, the divergence pressure can be measured by detecting either the second pressure detection unit 216 or the third pressure detection unit 217.
  • the purge liquid circulation unit controller 220 is configured so that the purge liquid pressure in the sliding device 1 is At least one of the purge liquid circulation pump 212 and the flow rate adjustment valve 214 is controlled so that the pressure Ps ′ is slightly lower than the deviation pressure Ps. That is, the purge liquid circulation unit controller 220 monitors the valve inlet side pressure P3 detected by the third pressure detector 217, and purges the valve inlet side pressure P3 so as to become a predetermined pressure based on the monitoring result. At least one of the liquid circulation pump 212 and the flow rate adjustment valve 214 is controlled.
  • the purge liquid circulation unit control unit 220 sets the target 25 KPa in the state in which the purge liquid is circulating.
  • the value is set in the purge liquid circulation unit controller 220 as a value.
  • the purge liquid circulation unit controller 220 controls at least one of the purge liquid circulation pump 212 and the flow rate adjustment valve 214 so that the pressure of the purge liquid in the sliding device 1 is 25 KPa.
  • the valve inlet side pressure P3 displayed on the third pressure detecting unit 217 is not the value of the pressure of the purge liquid in the sliding device 1 when the purge liquid circulates. Is also a low value. Accordingly, in order to temporarily set the pressure of the purge liquid in the sliding device 1 to 25 KPa, what value should be set for the valve inlet side pressure P3 is obtained, and the valve inlet side pressure P3 is set to the obtained value. Thus, at least one of the purge liquid circulation pump 212 and the flow rate adjustment valve 214 is controlled.
  • the pressure of the purge liquid in the sliding device 1 is to be set to 25 KPa
  • the filter outlet pressure P2 detected by the second pressure detector 216 is 30 KPa
  • the third pressure detection The valve inlet side pressure P3 displayed in the part 217 may be 20 KPa. Therefore, in this case, the flow rate adjustment valve 214 may be controlled so that the valve inlet side pressure P3 becomes 20 KPa.
  • the filter outlet pressure P2 is kept constant at 30 KPa, and the valve inlet side pressure P3 is controlled so that the pressure of the purge liquid in the sliding device 1 is slightly lower than the separation pressure Ps.
  • the pressure of the purge liquid in the sliding device 1 is set to a pressure Ps ′ slightly lower than the deviation pressure Ps. May be.
  • the pressure of the purge liquid in the sliding device 1 can be set to a pressure Ps' that is slightly lower than the deviation pressure Ps.
  • FIG. 6 is a diagram schematically showing the state of the pressure of the purge liquid in the sliding device 1.
  • the purge liquid pressure in the sliding device 1 is set to the target value in the purge liquid circulation unit controller 220.
  • at least one of the purge liquid circulation pump 212 and the flow rate adjustment valve 214 is controlled.
  • the pressure of the purge liquid in the sliding device 1 can be maintained at a pressure Ps' that is slightly lower than the deviation pressure Ps, as shown in FIG.
  • the pressure of the purge liquid in the sliding device 1 is a pressure Ps ′ slightly lower than the separation pressure Ps, the pressure of the purge liquid in the sliding device 1 is changed to an appropriate pressure (for example, sliding The pressure can be set higher than the pressure of blood existing on the outer peripheral surface of the device 1.
  • the purge liquid can be forcibly supplied between the first sliding surface 14 of the fixed-side sliding member 12 and the second sliding surface 24 of the rotating-side sliding member 22.
  • a lubricating film can be stably formed between the first sliding surface 14 of the member 12 and the second sliding surface 24 of the rotation-side sliding member 22.
  • blood can be prevented from entering the inner peripheral side of the sliding device 1, and the lubrication performance and sealing performance of the sliding device can be made higher than those of the conventional purge liquid circulating device.
  • FIG. 7 is a diagram schematically showing the relationship between the purge liquid and blood between the first sliding surface 14 and the second sliding surface 24.
  • FIG. 7A shows a case where at least one of the purge liquid circulation pump 212 and the flow rate adjustment valve 214 is controlled so that the pressure of the purge liquid in the sliding device 1 becomes a pressure Ps ′ slightly lower than the deviation pressure Ps. It is a figure which shows the relationship between the purge liquid and the blood between the 1st sliding surface 14 and the 2nd sliding surface 24.
  • FIG. 7B shows the first sliding surface 14 and the first sliding surface 14 when the purge liquid circulation pump 212 delivers the purge liquid at a constant pressure (30 KPa) and the flow rate adjustment valve 214 is fully opened. It is a figure which shows the relationship between the purge liquid and the blood between 2 sliding surfaces.
  • the pressure of the purge liquid in the sliding device 1 is about 15 KPa as described above, and therefore is a pressure lower than the pressure Ps ′. ing.
  • 7 (a) and 7 (b) the purge solution is shown in light gray and the blood is shown in black.
  • 7A and 7B show the relationship between the purge liquid and blood on the first sliding surface 14, and the second sliding surface 24 is not shown.
  • 7 (a) and 7 (b) show the relationship between the purge liquid and blood on the first sliding surface 14, and therefore other components (the first sliding surface 14) ( For example, the rotation shaft 28 and the like are not shown.
  • At least one of the purge liquid circulation pump 212 and the flow rate adjustment valve 214 is set so that the pressure of the purge liquid in the sliding device 1 becomes a pressure Ps ′ slightly lower than the deviation pressure Ps.
  • the pressure of the purge liquid in the sliding device 1 becomes such a pressure that the purge liquid forcibly enters between the first sliding surface 14 and the second sliding surface 24.
  • the space between the first sliding surface 14 and the second sliding surface 24 is almost occupied by the purge liquid.
  • the purge is forced to enter between the first sliding surface 14 and the second sliding surface 24. Due to the pressure of the liquid, it can enter only a small portion near the outer periphery of the first sliding surface 14 and the second sliding surface 24. Thereby, blood can be reliably prevented from entering the inner peripheral side of the sliding device 1.
  • the fixed-side sliding member 12 and the rotation-side sliding member are moved. Although it may reach the outer peripheral side of the moving member 22 and enter the blood, as described above, since the purge solution is made of water, physiological saline, or the like, there is no particular problem even if it enters the blood. .
  • the pressure of the purge liquid in the sliding apparatus 1 is slightly lower than the divergence pressure Ps.
  • the pressure of the purge liquid in the device 1 can be set to an appropriate pressure (for example, a pressure that is surely higher than the pressure of blood existing on the outer peripheral surface of the sliding device 1).
  • the purge liquid can be forcibly supplied between the first sliding surface 14 of the fixed-side sliding member 12 and the second sliding surface 24 of the rotating-side sliding member 22.
  • a lubricating film can be stably formed between the first sliding surface 14 of the member 12 and the second sliding surface 24 of the rotation-side sliding member 22.
  • the control method for setting the pressure of the purge liquid in the sliding device 1 to be a pressure Ps ′ slightly lower than the deviation pressure Ps is the control method described in the above embodiment, that is, the pressure Ps ′.
  • the purge liquid circulation pump 212 and the flow rate adjustment are performed so that the pressure of the purge liquid in the sliding device 1 becomes the target value.
  • the control method is not limited to controlling at least one of the valves 214, and the following control method may be employed.
  • the rotational speed of the purge liquid circulation pump and the opening degree of the flow rate adjustment valve 214 are acquired so that the pressure of the purge liquid in the sliding device 1 becomes a pressure Ps ′ slightly lower than the deviation pressure Ps.
  • At least one of the number of revolutions of the purge liquid circulation pump and the opening of the valve is set in the purge liquid circulation unit controller 220.
  • the purge liquid circulation unit controller 220 adjusts the purge liquid circulation pump and the flow rate based on at least one of the rotation speed of the purge liquid circulation pump and the opening of the valve set in the purge liquid circulation unit controller 220. At least one of the valves 214 is controlled. Even with such control, the pressure of the purge liquid in the sliding device 1 can be set to a pressure Ps' that is slightly lower than the deviation pressure Ps. For example, when the divergence pressure Ps is updated for some reason, the rotational speed of the purge fluid circulation pump and the valve opening are set so that the pressure Ps ′ is slightly lower than the updated divergence pressure Ps. Just set it again.
  • the purge liquid circulation unit controller 220 monitors the filter outlet side pressure P2.
  • a predetermined pressure for example, 30 KPa
  • the purge liquid circulation pump 212 is controlled, the present invention is not limited to this.
  • the number of revolutions of the purge liquid circulation pump 212 necessary for the filter outlet side pressure P2 to become a predetermined pressure is set in the purge liquid circulation unit control unit 220, and the purge liquid circulation unit control unit 220 is set.
  • the purge liquid circulation pump 212 may be controlled so that the purge liquid supply pump 212 operates at a set rotation speed.
  • the silicon carbide sliding members (fixed-side sliding member and rotating-side sliding member) are made of silicon oxide water before being assembled as a sliding device.
  • a “familiarizing process” that is a process of forming a Japanese product on the sliding surface may be performed.
  • the sliding surface of the sliding member made of silicon carbide has “a highly hydrophilic silicon oxide hydrate” by a tribochemical reaction. For this reason, blood becomes difficult to adhere to the sliding surface, and as a result, sliding resistance when used in an aqueous liquid containing blood is reduced compared to a sliding device that does not perform the “familiarization treatment”. Is possible.
  • the purge fluid circulation device in the blood pump has been described.
  • the present invention is not limited to the technical field of the blood pump used in the auxiliary artificial heart system.
  • the present invention can also be applied to the technical field of pumps that handle aqueous liquids (blood component-containing liquids) in which components (blood cell components, plasma proteins, etc.) are dispersed.
  • the divergence pressure is slid by continuously feeding the purge liquid at a low flow rate (with a constant flow rate) in a state where the flow rate adjustment valve 214 is closed (a state where the opening degree is zero).
  • the filter outlet pressure P2 is set to a predetermined pressure (for example, 30 KPa), and the purge liquid is circulated with the opening of the flow rate adjustment valve 214 fully opened.
  • a predetermined pressure for example, 30 KPa
  • the pressure of the purge liquid in the sliding device 1 increases.
  • the first sliding surface 14 of the fixed-side sliding member 12 in contact and the two sliding surfaces 24 of the rotating-side sliding member 22 are in a non-contact state (dissociated state)
  • the increase in the pressure of the purge liquid stops and the pressure of the purge liquid starts to decrease rapidly.
  • the pressure at this time pressure when the pressure of the purge liquid in the sliding device 1 stops increasing and the pressure of the purge liquid starts to rapidly decrease
  • Pmax pressure when the pressure of the purge liquid in the sliding device 1 stops increasing and the pressure of the purge liquid starts to rapidly decrease
  • the pressure of the purge liquid in the sliding device 1 is approximately an average value of the valve inlet side pressure P3 and the filter outlet side pressure P2.
  • the method as shown in (7) above can measure the divergence pressure without stopping the circulation of the purge solution. Therefore, the divergence pressure can be measured even after the blood pump 110 is implanted in the body. It becomes.
  • the divergence pressure Ps can be periodically performed, for example, once a day at a predetermined time, or can be performed at the timing when an alarm for notifying some abnormality is generated. Here, for example, some abnormality can be exemplified when the power consumption suddenly increases. Further, since the measured divergence pressure may be different depending on the situation at that time, it can be constantly updated to the latest divergence pressure.
  • SYMBOLS 1 Sliding device, 10 ... Fixed part, 12 ... Fixed side sliding member, 14 ... 1st sliding surface, 20 ... Rotating part, 22 ... Rotating side sliding Member 24 ... second sliding surface 26 ... impeller 28 ... rotating shaft 30 ... rotation drive device 32 ... blood pump chamber 40 ... purge solution in blood pump Circulation path, 100 ... assisting artificial heart system, 110 ... blood pump, 120, 130 ... artificial blood vessel, 200 ... purge fluid circulation device of blood pump, 210 ... purge fluid circulation unit, 211 ... Purge fluid reservoir (reservoir), 212 ... Purge fluid circulation pump, 213 ... Filter, 214 ... Flow rate adjusting valve, 215 ...
  • First pressure detector 216 ... Second Pressure detection unit, 217... Third pressure detection unit, 218.
  • In-unit feed-side circulation path 219...
  • In-unit return-side circulation path 220...
  • Purge liquid circulation unit controller 400... Connection cable, 410.
  • Side tube 412 ... Return side tube, 420 ... Purge solution circulation path

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Engineering & Computer Science (AREA)
  • External Artificial Organs (AREA)
  • Structures Of Non-Positive Displacement Pumps (AREA)
  • Mechanical Sealing (AREA)

Abstract

La présente invention concerne un dispositif de circulation de liquide de purge pour une pompe sanguine, la performance d'étanchéité d'un dispositif coulissant étant améliorée par rapport aux pompes sanguines conventionnelles. Le dispositif de circulation de liquide de purge (200) pour une pompe sanguine est pourvu : d'un dispositif coulissant (1) qui est utilisé pendant qu'une première surface coulissante d'un élément coulissant côté fixe et une seconde surface coulissante d'un élément coulissant côté rotation se font face l'une par rapport à l'autre, et les côtés périphériques externes respectifs de l'élément coulissant côté fixe et de l'élément coulissant côté rotation sont dans un état de contact avec le sang ; une unité de circulation de liquide de purge (210) qui entraîne la circulation d'un liquide de purge jusqu'à l'élément coulissant côté fixe et l'élément coulissant côté rotation ; et un trajet de circulation de liquide de purge (420) qui est configuré de façon à permettre au liquide de purge de circuler. L'unité de circulation de liquide de purge (210) est pourvue : d'une pompe de circulation de liquide de purge (212) permettant d'appliquer une force mobile au liquide de purge ; et d'une valve de réglage de débit (214) pouvant ajuster le débit du liquide de purge lorsque le liquide de purge, passé le long des côtés périphériques internes respectifs de l'élément coulissant côté fixe et de l'élément coulissant côté rotation est ramené à l'unité de stockage de liquide de purge.
PCT/JP2015/053443 2015-02-06 2015-02-06 Dispositif de circulation de liquide de purge pour pompe sanguine, et système cardiaque artificiel auxiliaire WO2016125313A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/JP2015/053443 WO2016125313A1 (fr) 2015-02-06 2015-02-06 Dispositif de circulation de liquide de purge pour pompe sanguine, et système cardiaque artificiel auxiliaire
JP2016573166A JP6343821B2 (ja) 2015-02-06 2015-02-06 血液ポンプのパージ液循環装置及び補助人工心臓システム

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2015/053443 WO2016125313A1 (fr) 2015-02-06 2015-02-06 Dispositif de circulation de liquide de purge pour pompe sanguine, et système cardiaque artificiel auxiliaire

Publications (1)

Publication Number Publication Date
WO2016125313A1 true WO2016125313A1 (fr) 2016-08-11

Family

ID=56563676

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2015/053443 WO2016125313A1 (fr) 2015-02-06 2015-02-06 Dispositif de circulation de liquide de purge pour pompe sanguine, et système cardiaque artificiel auxiliaire

Country Status (2)

Country Link
JP (1) JP6343821B2 (fr)
WO (1) WO2016125313A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018085390A (ja) * 2016-11-21 2018-05-31 株式会社サンメディカル技術研究所 ケーブル保護具
JP2019098007A (ja) * 2017-12-06 2019-06-24 株式会社サンメディカル技術研究所 補助人工心臓システム及び血液ポンプ用コントローラ
WO2020170942A1 (fr) * 2019-02-19 2020-08-27 テルモ株式会社 Dispositif de pompe
JP2021529499A (ja) * 2018-08-28 2021-10-28 ボストン サイエンティフィック サイムド，インコーポレイテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｓｃｉｍｅｄ，Ｉｎｃ． 経皮的循環器系補助装置用アキシャルフラックスモータ

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61500058A (ja) * 1983-09-28 1986-01-16 ニムバス，インコ−ポレ−テツド 凝血抑制血液ポンプ
US5263825A (en) * 1992-10-26 1993-11-23 Ingersoll-Dresser Pump Company Leak contained pump
JP2013085913A (ja) * 2011-10-22 2013-05-13 San Medical Gijutsu Kenkyusho:Kk 摺動装置、メカニカルシール、回転装置、ポンプ及び補助人工心臓システム

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61500058A (ja) * 1983-09-28 1986-01-16 ニムバス，インコ−ポレ−テツド 凝血抑制血液ポンプ
US5263825A (en) * 1992-10-26 1993-11-23 Ingersoll-Dresser Pump Company Leak contained pump
JP2013085913A (ja) * 2011-10-22 2013-05-13 San Medical Gijutsu Kenkyusho:Kk 摺動装置、メカニカルシール、回転装置、ポンプ及び補助人工心臓システム

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018085390A (ja) * 2016-11-21 2018-05-31 株式会社サンメディカル技術研究所 ケーブル保護具
JP2019098007A (ja) * 2017-12-06 2019-06-24 株式会社サンメディカル技術研究所 補助人工心臓システム及び血液ポンプ用コントローラ
JP2021529499A (ja) * 2018-08-28 2021-10-28 ボストン サイエンティフィック サイムド，インコーポレイテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｓｃｉｍｅｄ，Ｉｎｃ． 経皮的循環器系補助装置用アキシャルフラックスモータ
US11632015B2 (en) 2018-08-28 2023-04-18 Boston Scientific Scimed, Inc. Axial flux motor for percutaneous circulatory support device
US20230216371A1 (en) * 2018-08-28 2023-07-06 Boston Scientific Scimed Inc. Axial flux motor for percutaneous circulatory support device
WO2020170942A1 (fr) * 2019-02-19 2020-08-27 テルモ株式会社 Dispositif de pompe
JPWO2020170942A1 (ja) * 2019-02-19 2021-12-23 テルモ株式会社 ポンプ装置
JP7422730B2 (ja) 2019-02-19 2024-01-26 テルモ株式会社 ポンプ装置

Also Published As

Publication number Publication date
JP6343821B2 (ja) 2018-06-20
JPWO2016125313A1 (ja) 2017-12-07

Similar Documents

Publication Publication Date Title
JP6343821B2 (ja) 血液ポンプのパージ液循環装置及び補助人工心臓システム
US7004924B1 (en) Methods, systems, and kits for the extracorporeal processing of blood
US10850020B2 (en) Dialysis machine support assemblies and related systems and methods
JP5645820B2 (ja) 配管内に流体を導くための蠕動ホースポンプをモニタするための方法および装置
JP6335311B2 (ja) 圧力ポッドダイヤフラムの自動検出及び調整
JP6758181B2 (ja) カテーテルポンプ
JP5208753B2 (ja) 内視鏡装置への膨張媒体の供給を制御する注入システム、方法、及びコンピュータが読取り可能な記録媒体
JP2007529282A (ja) カセットベースの透析医療用流体治療システム、装置および方法
JP2017510396A (ja) 携行用血液透析機械と使い捨てカートリッジ
EP4115919B1 (fr) Élément d'amortissement pour système de gestion de fluide
TW200823367A (en) Drug liquid supply device
US8568288B2 (en) Slide device, mechanical seal, rotary device, pump and auxiliary artificial heart system
WO2023226779A1 (fr) Pompe cardiaque à intervention par cathéter
JP2016508841A (ja) 医療機器用安全装置ポンプに関する方法、システム及び装置
JP5899528B2 (ja) 摺動装置、メカニカルシール、ポンプ及び補助人工心臓システム
US20110036768A1 (en) Continuous blood purification system provided with syringe pumps
JP5873859B2 (ja) 少なくとも１つの濾過値の制御のための装置、血液透析装置、並びにそのための方法及びその使用
WO2016125314A1 (fr) Dispositif d'alimentation en liquide de purge pour pompe sanguine, et système de cœur artificiel auxiliaire
KR20240063916A (ko) 체외막 산소화 중 심실 보조 지원 시스템 및 방법
Kitano et al. Long-term durability test for the left ventricular assist system EVAHEART under the Physiologic Pulsatile Load
JP2003113782A (ja) ローラーポンプ
US11311659B2 (en) Blood treatment device comprising a metering line having a membrane pump and a valve and method for metering
WO2016027852A1 (fr) Système de circulation sanguine
WO2015097916A1 (fr) Pompe à sang et système d'assistance ventriculaire
WO2018088438A1 (fr) Système de fluide, système médical, capteur, élément de canalisation de circuit, gabarit de fixation et procédé de fixation

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 15881130

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2016573166

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 15881130

Country of ref document: EP

Kind code of ref document: A1