US3898637A - Detection means for gas entering human blood system from extra-corporeal tubing - Google Patents

Detection means for gas entering human blood system from extra-corporeal tubing Download PDF

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US3898637A
US3898637A US383284A US38328473A US3898637A US 3898637 A US3898637 A US 3898637A US 383284 A US383284 A US 383284A US 38328473 A US38328473 A US 38328473A US 3898637 A US3898637 A US 3898637A
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elements
controlled restriction
sensing elements
flow
venturi
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Eugene B Wolstenholme
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Priority to US383284A priority Critical patent/US3898637A/en
Priority to BE146827A priority patent/BE817955A/xx
Priority to GB3296474A priority patent/GB1466594A/en
Priority to JP49085258A priority patent/JPS5071190A/ja
Priority to CA205,718A priority patent/CA1060561A/en
Priority to DE2436140A priority patent/DE2436140A1/de
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    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F17—STORING OR DISTRIBUTING GASES OR LIQUIDS
    • F17D—PIPE-LINE SYSTEMS; PIPE-LINES
    • F17D3/00—Arrangements for supervising or controlling working operations
    • F17D3/01—Arrangements for supervising or controlling working operations for controlling, signalling, or supervising the conveyance of a product
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00—Surgery
    • Y10S128/13—Infusion monitoring

Definitions

  • the gas or bubble detector comprises conductivity detectors positioned along a controlled flow path, such as venturi tube, so as to be in close proximity to the flow through the tube.
  • the conductivity detectors are connected to rate of change of flow detector circuitry which is in turn hooked to alarm and shut-off means to be actuated upon detection of gas bubbles.
  • the invention has utility in medical systems whenever an objective is to prevent gas from entering the human blood system from an external supply system.
  • a few of the examples in which the invention has utility are infusion, transfusion, intravenous feeding and hemodialysis procedures.
  • the object in any of these systems is to set an alarm and cease the procedure upon the detection of the transportation of even small amounts of gas through the external system to prevent its entry into the patient.
  • Optical bubble detectors have also been used. This type of detector is not effective when bubbles are significantly smaller than the inner diameter of the conduit since the blood or other liquid surrounding the bubble may conceal the bubble from the optics of the system. In commercial embodiments of optical systems, as much as 2 cc of gas has been necessary before it could be detected.
  • Rate of change detection has been used in various applications and may be used to advantage in automatic monitoring ofliquid level, as for example, in drip chambers.
  • a monitoring system for fluid flow in drop form which comprises a radio frequency oscillator having a resonant circuit with two electrodes spaced apart axially along the outside of the drip chamber and coupled to the resonant circuit. Downward passage of a drop, frequency modulates the oscillator output and a detector demodulates the frequency modulation to produce electrical pulses as a measure of the drip rate. Upon an alarm condition, shut-off mechanism will stop the flow. While such a system has advantages for use with drop monitors, there is not disclosed a means of detection of gases through flow lines which is the principal object of the present invention.
  • the subject invention is specifically directed to a means of detecting gas bubbles flowing through a liquid medium within extra-corporeal tubing prior to entry into the human blood system.
  • the detection unit in a preferred embodiment may comprise a venturi tube which has a mean diameter to ensure the detection of bubbles of the smallest desired size, and sensing elements which may comprise electrical detectors which are placed in very close proximity to the restricted flow line of the detection area.
  • the sensing elements may be coupled with a radio frequency proximity detector which is operated at a high enough frequency to eliminate the need for direct immersion probes.
  • a rate of change circuitry follows the proximity detector and upon a small signal from the detector, the change will be apparent to detect a bubble of any desired size.
  • FIG. 3 is an end cross-sectional view of the detector taken along the line 33 of FIG. 1.
  • the bubble detector comprises generally the detection means and the circuitry to measure a rate of change in the liquid flow caused by a bubble of gas flowing through one of the various medical systems described above such as that used for hemodialysis.
  • the detector means comprises a housing unit 10 with ingress 11 and egress 12 portions which are to be connected to extracorporeal tubing (not shown) which is part of a flow line leading to the patient and which may be for example a tubing of 0.092 inches (inner diameter).
  • the tubing may be slipped over the ingress and egress portions ll, 12 and is well known for in line connections such as this.
  • Sensing elements comprising a center element 16 and two outer elements 18 and 20 are inserted or molded into the housing unit 10 as shown.
  • a portion of housing 10 comprises a central section 13 of increased diameter in which is included the restricted sensing area such asthe venturi tube 14 of FIG. 2.
  • the sensing elements 16, 18, 20 are sensing rings having a rounded portion 22, 24 and 26 each of which encircle the venturi tube 14 at their respective positions. As seen in FIG. 2, the sensing elements l6, 18, 20 are placed in close proximity to the flow path in the venturi area.
  • venturi 14 Shown passing through venturi 14 is bubble 28 which by means of the constricted venturi is brought into close proximity to the sensing elements 16, 18, 20. It is to be noted that the sensing elements do not probe within the flow line and are electrically insulated from the fluid to be monitored.
  • the thickness of the venturi wall may be on the order of 0.015 inches with the sensing elements abutting the wall.
  • FIG. 2 a preferred embodiment of the proximity detector system is shown by means of the block diagram.
  • the diagram represents, in functional form, a circuit such as that shown in FIG. 311 of the publication How to Build Proximity Detectors and Metal Locators" by .l. P. Shields, published by Bobbs- Merrill Inc. which represents a circuit used in a successfully-tested embodiment.
  • a radio frequency oscillator whose frequency is determined by the capacitance of the sensing elements 16, 18, 20.
  • a frequency discriminator which produces a voltage proportional to the oscillator frequency.
  • a rate of change detector Following the frequency discriminator is a rate of change detector.
  • the frequency discriminator Since very low voltages are involved and the frequency discriminator only puts out an output of about one millivolt in the presence of a bubble. Over a long period of time, the oscillator, due to changes of temperature or supply voltage, will drift and cause a change of output exceeding this magnitude. It is necessary that these long term changes in voltage be disregarded.
  • the rate of change detector which follows the frequency discriminator responds to a voltage level change approximating a millivolt in a short time such as a tenth of a second. However, it will not respond to changes of the same magnitude which occur over a long time period.
  • the output of the rate of change detector is applied to or is integral to a high pass amplifier which rejects slow drift in the radio circuits but amplifies fine frequency changes which will in turn trip the threshold detector following it.
  • a latch following the threshold detector locks an alarm cut-off relay which will stay locked until manually reset.
  • Circuitry for the above system may be along the lines of that I used in aforementioned U.S. Pat. No. 3,500,366.
  • the subject invention is used with kidney hemodialysis machines and the like and the interest is limited to monitoring and not time control as in US. Pat. No. 3,500,366.
  • still other examples of alternative constructions of the various stages may be found in the prior art.
  • a capacitance-tuned oscillator appropriate for such a system is set forth at FIG. 22.4, page 308 of Transistor Circuit Design, published by McGraw-l-Iill.
  • An adaptable discriminator is exemplitied at FIG. 2 A Color TV Sound System Using the p. A703 by L.
  • FIG. 13-6 Blaser Fairchild Semiconductor Corp.; and a typical differentiating circuit is shown at FIG. 13-6 of Electronic Measurements by Terman and Pettit, published by McGraw-Hill.
  • a transistorized amplifier suitable for use with the disclosed invention is shown at ,FIG. 40 of the Fairchild Semiconductor Linear Integrated Circuit Application Handbook published by the Fairchild Semiconductor Corp. and a latching circuit is illustrated at 109, Volume 38; 23 of Electronics see Unit Junction Transistor turns off Latching Relay by D. P. Lynch.
  • detection involves impedance monitoring which includes fluid dielectric constant as well as conductivity and thus, the system has utility for all fluids. While a small bubble may cause only a very small signal from the proximity detector such as 0.1 percent of full output there will nevertheless be a change in signal sufficient to actuate the rate of change detector and set off an alarm condition with the flow being terminated.
  • Bubble detection on an even higher order is made possible by the venturi tube 14 which brings the bubble in close proximity to the sensing elements l6, 18, 20 making it possible to detect bubbles, smaller than the inside diameter of the tubing.
  • the venturi 14 also causes high fluid velocity through the venturi which improves the operation of the rate of change detector.
  • the sensing rings l6, l8 and 20 are made of an electrical conductive material such as beryllium, copper or could even be stainless steel or aluminum. As shown in FIGS. 2 and 3, they encircle the venturi tube 14 and may be molded in placed if a mold is used for the housing structure.
  • the extra-corporeal tubing generally will be PVC, but of course may be any tubing such as rubber, silicone, or polyurethane.
  • Sensing elements 18 and 20 are ground elements and since they are on both sides of the central element 16, the flow may be in either direction. Only one ground element would be necessary but this would restrict proper operation of the detector to one flow direction.-
  • the sensing elements 16, 18, 20 can be placed at a distance from each other on the order of 0.01 inch. The close together they are, the more sensitive is the instrument. A ground is not absolutely necessary since a balanced oscillator may be used in lieu thereof.
  • the sensing elements 16, 18, 20 do not necessarily need to be placed longitudinally to the flow path nor do they need to radially encompass the sensing area. I
  • the orifice diameter is as small as practial for a given flow rate.
  • a diameter on the order of 0.030 inch is desirable to detect a bubble of a diameter of approximately .01 inch.
  • the subject invention may be used for detecting either changes in a liquid medium or a gas medium, an example of the latter being utilized in an air line to detect the presence of impurities such as liquid particles.
  • Apparatus for use with a system to detect discontinuities in a medium in a fluid path comprising:
  • a housing unit having ingress and egress portions adapted to be connected in fluid communication with a flow line, said housing unit further including a central portion having a controlled restriction with which said ingress and egress portions communicate;
  • Apparatus for use with a system to detect discontinuties in a medium in a fluid path comprising:
  • a housing unit having ingress and egress portions adapted to be connected in fluid communication with a flow line, said housing unit further including a central portion having a controlled restriction with which said ingress and egress portions communicate;
  • monitoring means coupled to said sensing elements for detecting changes in the capacitance therebetween occasioned by the passage of a discontinuity through said controlled restriction
  • alarm means coupled to said monitoring means to signal and alarm condition upon the detection of a discontinuity in the medium.
  • monitoring means includes:
  • a frequency discriminator for providing a signal which is a function of the oscillator frequency
  • a rate of change detector responsive to said signal for producing an output when the rate of change of said signal exceeds a given magnitude
  • a high pass amplifier for amplifying signals outputted by said detector representing fine frequency changes
  • a threshold detector adapted to be tripped by said amplified outputs
  • sensing elements are circumferentially disposed around the internal wall of said controlled restriction.
  • Apparatus for use with a system to detect discontinuities in a medium in a fluid path comprising:
  • a housing unit having ingress and egress portions adapted to be connected in fluid communication with a flow line, said housing unit further including a central portion having a venturi with which said ingress and egress portions communicate.
  • monitoring means to detect changes in capacitance between said elements during the flow of fluid through said venturi restriction

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)
  • Measuring Volume Flow (AREA)
US383284A 1973-07-27 1973-07-27 Detection means for gas entering human blood system from extra-corporeal tubing Expired - Lifetime US3898637A (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
US383284A US3898637A (en) 1973-07-27 1973-07-27 Detection means for gas entering human blood system from extra-corporeal tubing
BE146827A BE817955A (fr) 1973-07-27 1974-07-22 Dispositif de detection pour un gaz venant d'une tuyauterie exterieure au corps humain et entrant dans le systeme sanguin
GB3296474A GB1466594A (en) 1973-07-27 1974-07-25 Detection means for discontinuities in medium flowing in a flow path
JP49085258A JPS5071190A (enrdf_load_stackoverflow) 1973-07-27 1974-07-26
CA205,718A CA1060561A (en) 1973-07-27 1974-07-26 Detection means for gas entering human blood system from extra-corporeal tubing
DE2436140A DE2436140A1 (de) 1973-07-27 1974-07-26 Detektor fuer in einer leitung stroemende medien

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US383284A US3898637A (en) 1973-07-27 1973-07-27 Detection means for gas entering human blood system from extra-corporeal tubing

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US (1) US3898637A (enrdf_load_stackoverflow)
JP (1) JPS5071190A (enrdf_load_stackoverflow)
BE (1) BE817955A (enrdf_load_stackoverflow)
CA (1) CA1060561A (enrdf_load_stackoverflow)
DE (1) DE2436140A1 (enrdf_load_stackoverflow)
GB (1) GB1466594A (enrdf_load_stackoverflow)

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US4014206A (en) * 1975-03-31 1977-03-29 Akron City Hospital Apparatus and method for monitoring air emboli during extracorporeal circulation
US4065675A (en) * 1975-06-11 1977-12-27 The British Petroleum Company Limited Flow monitoring devices
US4112773A (en) * 1977-05-02 1978-09-12 Rhode Island Hospital Ultrasonic particulate sensing
US4237720A (en) * 1978-08-07 1980-12-09 Rhode Island Hospital Ultrasonic particulate sensing
US4312342A (en) * 1980-06-09 1982-01-26 Abbott Laboratories I.V. Administration flow rate gauge
US4363321A (en) * 1980-06-09 1982-12-14 Abbott Laboratories I.V. Administration flow rate gauge
US4368478A (en) * 1980-06-06 1983-01-11 Shinshu Seiki Kabushiki Kaisha Ink supply system for ink jet printers
US4406382A (en) * 1981-01-15 1983-09-27 Multiplex Company, Inc. Empty beverage container signaling system
US4432761A (en) * 1981-06-22 1984-02-21 Abbott Laboratories Volumetric drop detector
US4432762A (en) * 1981-06-22 1984-02-21 Abbott Laboratories Volumetric drop detector
US4445012A (en) * 1978-07-24 1984-04-24 Liston Scientific Corporation Moisture sensor for purging system
US4452251A (en) * 1982-11-05 1984-06-05 Medrad, Inc. Syringe content indicating device
US4559831A (en) * 1983-09-26 1985-12-24 Siemens Aktiengesellschaft Method and device for flow measurement of small liquid volumes
US4565500A (en) * 1983-02-24 1986-01-21 Stewart-Riess Laboratories, Inc. Air bubble detecting and discriminating circuit arrangement and method
US4627840A (en) * 1985-01-28 1986-12-09 Cordis Corporation Flow monitoring device
US4627419A (en) * 1984-08-29 1986-12-09 The Board Of Regents, The University Of Texas Blood pump apparatus and method
US4658244A (en) * 1985-03-28 1987-04-14 Imed Corporation Air-in-line detector
US4662540A (en) * 1984-02-16 1987-05-05 Robotics Incorporated Apparatus for dispensing medium to high viscosity liquids with liquid flow detector and alarm
US4821558A (en) * 1987-05-01 1989-04-18 Abbott Laboratories Ultrasonic detector
US5026348A (en) * 1988-06-06 1991-06-25 The General Hospital Corporation Apparatus and method for the detection of IV catheter obstruction and extravasation
US5123275A (en) * 1990-12-07 1992-06-23 Ivac Corporation Air in-line sensor system
US5182938A (en) * 1991-02-22 1993-02-02 Nordson Corporation Method and apparatus for detecting bubbles in pressurized liquid dispensing systems
US5260665A (en) * 1991-04-30 1993-11-09 Ivac Corporation In-line fluid monitor system and method
US5289716A (en) * 1992-08-21 1994-03-01 The United States Of America As Represented By The United States Department Of Energy Monitoring and analyzing waste glass compositions
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US5489265A (en) * 1994-06-15 1996-02-06 Ivac Corporation Restrictor fitting for an infusion pump
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US10046112B2 (en) 2013-05-24 2018-08-14 Icu Medical, Inc. Multi-sensor infusion system for detecting air or an occlusion in the infusion system
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JPH0638853B2 (ja) * 1988-07-04 1994-05-25 シャープ株式会社 輸液注入ポンプの気泡検知装置
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Cited By (105)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3989625A (en) * 1975-02-25 1976-11-02 Ma-De Inc. Detector for air in blood dialysis systems
US4014206A (en) * 1975-03-31 1977-03-29 Akron City Hospital Apparatus and method for monitoring air emboli during extracorporeal circulation
US4065675A (en) * 1975-06-11 1977-12-27 The British Petroleum Company Limited Flow monitoring devices
US4112773A (en) * 1977-05-02 1978-09-12 Rhode Island Hospital Ultrasonic particulate sensing
US4445012A (en) * 1978-07-24 1984-04-24 Liston Scientific Corporation Moisture sensor for purging system
US4237720A (en) * 1978-08-07 1980-12-09 Rhode Island Hospital Ultrasonic particulate sensing
US4368478A (en) * 1980-06-06 1983-01-11 Shinshu Seiki Kabushiki Kaisha Ink supply system for ink jet printers
US4312342A (en) * 1980-06-09 1982-01-26 Abbott Laboratories I.V. Administration flow rate gauge
US4363321A (en) * 1980-06-09 1982-12-14 Abbott Laboratories I.V. Administration flow rate gauge
US4406382A (en) * 1981-01-15 1983-09-27 Multiplex Company, Inc. Empty beverage container signaling system
US4432761A (en) * 1981-06-22 1984-02-21 Abbott Laboratories Volumetric drop detector
US4432762A (en) * 1981-06-22 1984-02-21 Abbott Laboratories Volumetric drop detector
US4452251A (en) * 1982-11-05 1984-06-05 Medrad, Inc. Syringe content indicating device
US4565500A (en) * 1983-02-24 1986-01-21 Stewart-Riess Laboratories, Inc. Air bubble detecting and discriminating circuit arrangement and method
US4559831A (en) * 1983-09-26 1985-12-24 Siemens Aktiengesellschaft Method and device for flow measurement of small liquid volumes
US4662540A (en) * 1984-02-16 1987-05-05 Robotics Incorporated Apparatus for dispensing medium to high viscosity liquids with liquid flow detector and alarm
US4627419A (en) * 1984-08-29 1986-12-09 The Board Of Regents, The University Of Texas Blood pump apparatus and method
US4627840A (en) * 1985-01-28 1986-12-09 Cordis Corporation Flow monitoring device
US4658244A (en) * 1985-03-28 1987-04-14 Imed Corporation Air-in-line detector
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GB1466594A (en) 1977-03-09
JPS5071190A (enrdf_load_stackoverflow) 1975-06-12
BE817955A (fr) 1974-11-18
CA1060561A (en) 1979-08-14

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