WO2002074364A2 - System for enriching a bodily fluid with a gas - Google Patents

System for enriching a bodily fluid with a gas Download PDF

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Publication number
WO2002074364A2
WO2002074364A2 PCT/US2002/008542 US0208542W WO02074364A2 WO 2002074364 A2 WO2002074364 A2 WO 2002074364A2 US 0208542 W US0208542 W US 0208542W WO 02074364 A2 WO02074364 A2 WO 02074364A2
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
set forth
signal
act
flow
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2002/008542
Other languages
English (en)
French (fr)
Other versions
WO2002074364A3 (en
Inventor
Derek J. Daw
William R. Patterson
Stephen E. Myrick
Jeffrey L. Creech
Jr. Vincent Divino
Gregory P. Watson
Paul J. Zalesky
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Therox Inc
Original Assignee
Therox Inc
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 Therox Inc filed Critical Therox Inc
Priority to JP2002573071A priority Critical patent/JP4156376B2/ja
Priority to EP02719289A priority patent/EP1372759B1/en
Priority to DE60214352T priority patent/DE60214352T2/de
Publication of WO2002074364A2 publication Critical patent/WO2002074364A2/en
Publication of WO2002074364A3 publication Critical patent/WO2002074364A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3663—Flow rate transducers; Flow integrators
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/32—Oxygenators without membranes
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36222—Details related to the interface between cassette and machine
    • A61M1/362227—Details related to the interface between cassette and machine the interface providing means for actuating on functional elements of the cassette, e.g. plungers
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36224—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit with sensing means or components thereof
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
    • A61M1/362262—Details of incorporated reservoirs
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
    • A61M1/362265—Details of valves
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3626—Gas bubble detectors
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3623—Means for actively controlling temperature of blood

Definitions

  • gas-enriched fluid therapies such as oxygen therapies involving the use of hyperoxic or hyperbaric blood
  • delivery techniques are utilized to prevent or minimize the formation of cavitation nuclei so that clinically significant bubbles do not form within a patient's blood vessels.
  • any bubbles that are produced tend to be very small in size, so that a perfusionist would typically have difficulty detecting bubble formation without the assistance of a bubble detection device.
  • known bubble detectors are ineffective for detecting bubbles in an extracorporeal circuit for the preparation and delivery of hyperoxic or hyperbaric blood. This problem results from the fact that the size and velocity of some bubbles are beyond the resolution of known bubble detectors. Therefore, micro bubbles (bubbles with diameters of about 50 micrometers to about 1000 micrometers) and some macro bubbles (bubbles with diameters greater than 1000 micrometers) may escape detection.
  • Fig. 34 illustrates a detailed view of an ultrasonic sensor illustrated in Fig. 33;
  • Fig. 35 illustrates a detailed view of an ultrasonic sensor illustrated in Fig. 33;
  • Fig. 37 illustrates a cross-sectional view taken along line 37-37 in Fig. 36;
  • Fig. 60 illustrates a detailed view of an exemplary pulse dampener
  • the blood is pumped through the draw tube 34 in the direction of the arrow 52 into an oxygenation device 54.
  • the oxygenation device 54 in the system 10 advantageously prepares an oxygen-supersaturated physiologic fluid and combines it with the blood to enrich the blood with oxygen.
  • the oxygenation device 54 is advantageously sterile, removable, and disposable, so that after the procedure on the patient 38 has been completed, the oxygenation device 54 may be removed and replaced with another oxygenation device 54 for the next patient.
  • the host interface 85 may also include various other capabilities.
  • the host interface 85 may include a sound card 97 to drive speakers 98 on the user interface 84.
  • a network adapter 99 may allow the host interface 85 to communicate with an external network, such as a LAN in the hospital or a remote network for providing updates for the system 10, e.g., the Internet.
  • the host interface 85 may include an analog and/or digital I/O device 101, which in this example transmits and receives certain signals such as an enable signal, a "request to stop" signal, a draw pressure signal, and a return pressure signal.
  • the flow rate may be 75 milliliters per minute, or for stroke applications the flow rate may be 300 milliliters per minute.
  • the personality module 120 may be located in the Y-connector 71. Because the information programmed into the personality module 120 may be related to a particular patient or a particular type of patient, and because a new Y-connector 71 is typically used with each patient, the location of the personality module 120 in the Y-connector 71 provides an effective method of customizing the system 10 with each patient treated.
  • the interlock system 44 reads this flow information from the memory 122 and compares it to the flow rate delivered by the flow meter 46 on line 124.
  • check valve 146 has an O-ring seal 148 that is disposed between a lip in the fluid passageway 144 and the nozzle 142.
  • a spring 150 biases a ball 152 into contact with the O-ring seal 148.
  • the ball 152 is pushed against the spring 150 so that fluid may flow into the fluid supply chamber 58.
  • fluid cannot flow in the opposite direction because the ball 152 efficiently seals against the O-ring seal 148.
  • the operation of the actuators for the valves 258 and 260 is similar to the operation of the actuators for the valves 202, 204, and 206.
  • Figs. 31 and 32 illustrate only the actuator for the vent valve 260, it should be understood that the actuator for the vent valve 258 operates in a similar manner.
  • the solenoid 428 in this embodiment is a pull-type solenoid.
  • a spring 440 generally biases the lever arm 432 in the direction of the arrow 442 to move a piston 444 of the solenoid 428 into an extended position.
  • the sleeve 496 may have external screw threads 500 so that the sleeve 496 may be screwed into a threaded bore in the wall 498.
  • a bushing 502 may be provided within the sleeve 496.
  • the sensor body 494 includes an annular flange 504 that abuts against one end of the bushing 502 in order to limit outward movement of the sensor body 494.
  • a spring 506 is disposed in the rear portion of the sleeve 496.
  • the portion of the oxygenation device 54 positioned adjacent the cartridge present sensor 520 is advantageously configured to promote reflection of infrared energy back to the cartridge present sensor 520.
  • the oxygenation device 54 advantageously includes a flat section 524 to ensure that the cartridge present sensor 520 receives a relatively strong reflective signal so that it can properly indicate whether the oxygenation device 54 is present.
  • the cartridge enclosure 26 also includes another interesting feature regarding the manner in which it interfaces with the oxygenation device 54.
  • the oxygenation device 54 includes an oxygen inlet 210 located near the top of the atomizer chamber 62.
  • a supply of oxygen 60 regulated to about 600 psi is coupled to the oxygen inlet 210.
  • the oxygenation device 54 includes a piston assembly 160 that is configured to draw physiologic solution into the chamber 58 and to deliver it under pressure to the atomization chamber 62.
  • the plunger 164 includes a key 176 at one end.
  • the key 176 is configured to fit within a key slot of a device that moves the piston assembly 160 between its extended and retracted positions.
  • the system controller 55 delivers an O 2 vent signal 912 to the solenoid 426 associated with the atomizer chamber 62 and a blood mixing chamber vent signal 914 to the solenoid 428 associated with the mixing chamber 64.
  • the solenoids 426 and 428 respond by retracting the respective pins 422 and 424 to enable the vent valves 258 and 260 to open.
  • the system controller 55 disables a door lock signal 916 which causes the solenoid 348 to retract and withdraw the locking pin 342 from the door latch 310.
  • the system 10 continues to operate in the AO on mode 964 in this manner unless blood flow drops below a predetermined rate, e.g., 50 ml. per minute. In this instance, the system 10 will transfer from the AO on mode 964 to the unload mode 910, which will operate as discussed previously.
  • a predetermined rate e.g. 50 ml. per minute.
  • the DSP 1000 reads the data points for each of the digitized peaks and sums them together.
  • the sum of the digitized peaks correlates to the amount of ultrasonic energy received.
  • the DSP 1000 maintains a running average of the sum of the last 16,000 or more peaks.
  • the current sum is subtracted from the average to provide a high pass filter which effectively removes any DC offset.
  • the DSP 1000 also performs a low pass filter operation by convolving the resulting signal through an FIR array.
  • the FIR array is a 64 point array. The filtering is performed to ensure that the bubbles are discriminated from the noise in the signals.
  • the resulting signals of different sized bubbles is illustrated in Fig. 61.
  • the probe 76 examines the bubbles which are generally of known size and quantity, and the probe 76 delivers corresponding signals to the bubble detector 74.
  • the size and quantity of bubbles recorded by the bubble detector 74 are compared to the size and quantity of the bubbles recorded by the recording device 1160. Typically, such comparison is performed at a plurality of signal strengths and bubble sizes. Thereafter, one skilled in the art of mathematics may graphically represent this relationship and extrapolate the projected signal strengths at a plurality of bubble sizes.
  • the signal- to-bubble size relation is graphically plotted, one skilled in the art of mathematics can calculate one or more calibration constants based on the fit of the signal strength to bubble size relationship.
  • the calibration constant(s) can be programmed into the bubble detector 74 to calibrate the bubble detector 74.
  • flow meter flow probe/ transducer patient's return tube oxygenation device system controller supply first chamber /fluid supply chamber supply second chamber/ atomization chamber third chamber / mixing chamber host/ user interface draw pressure sensor return pressure sensor

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Public Health (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Cardiology (AREA)
  • Emergency Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Urology & Nephrology (AREA)
  • External Artificial Organs (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
PCT/US2002/008542 2001-03-20 2002-03-19 System for enriching a bodily fluid with a gas Ceased WO2002074364A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2002573071A JP4156376B2 (ja) 2001-03-20 2002-03-19 体内流体をガスで富化するためのシステム
EP02719289A EP1372759B1 (en) 2001-03-20 2002-03-19 System for enriching a bodily fluid with a gas
DE60214352T DE60214352T2 (de) 2001-03-20 2002-03-19 System zur anreicherung von einer körperlichen flüssigkeit mit einem gas

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/813,068 US6582387B2 (en) 2001-03-20 2001-03-20 System for enriching a bodily fluid with a gas
US09/813,068 2001-03-20

Publications (2)

Publication Number Publication Date
WO2002074364A2 true WO2002074364A2 (en) 2002-09-26
WO2002074364A3 WO2002074364A3 (en) 2003-03-13

Family

ID=25211373

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/008542 Ceased WO2002074364A2 (en) 2001-03-20 2002-03-19 System for enriching a bodily fluid with a gas

Country Status (7)

Country Link
US (2) US6582387B2 (https=)
EP (1) EP1372759B1 (https=)
JP (1) JP4156376B2 (https=)
AT (1) ATE337808T1 (https=)
DE (1) DE60214352T2 (https=)
ES (1) ES2266479T3 (https=)
WO (1) WO2002074364A2 (https=)

Cited By (4)

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US8192384B2 (en) 2008-12-04 2012-06-05 Therox, Inc. System for enriching a bodily fluid with a gas having a dual-function power switch mechanism
US8246564B2 (en) 2008-12-04 2012-08-21 Therox, Inc. System for enriching a bodily fluid with a gas having automated priming capabilities
US8636952B2 (en) 2008-12-04 2014-01-28 Therox, Inc. System for enriching a bodily fluid with a gas having a removable gas-enrichment device with an information recording element
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JP4156376B2 (ja) 2008-09-24
US20020138034A1 (en) 2002-09-26
EP1372759A2 (en) 2004-01-02
ATE337808T1 (de) 2006-09-15
US6974435B2 (en) 2005-12-13
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EP1372759B1 (en) 2006-08-30
DE60214352T2 (de) 2007-08-16

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