WO1999024145A1 - Dispositif d'alerte signalant une separation du circuit de sang pour circuits extracorporels - Google Patents

Dispositif d'alerte signalant une separation du circuit de sang pour circuits extracorporels Download PDF

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Publication number
WO1999024145A1
WO1999024145A1 PCT/US1998/019266 US9819266W WO9924145A1 WO 1999024145 A1 WO1999024145 A1 WO 1999024145A1 US 9819266 W US9819266 W US 9819266W WO 9924145 A1 WO9924145 A1 WO 9924145A1
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WO
WIPO (PCT)
Prior art keywords
blood
patient
needle
electrodes
sensing device
Prior art date
Application number
PCT/US1998/019266
Other languages
English (en)
Inventor
Carl M. Kjellstrand
Original Assignee
Aksys, Ltd.
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 Aksys, Ltd. filed Critical Aksys, Ltd.
Priority to AU93927/98A priority Critical patent/AU9392798A/en
Publication of WO1999024145A1 publication Critical patent/WO1999024145A1/fr

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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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/16836—Monitoring, detecting, signalling or eliminating infusion flow anomalies by sensing tissue properties at the infusion site, e.g. for detecting infiltration
    • 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
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3656—Monitoring patency or flow at connection sites; Detecting disconnections
    • 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
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm

Definitions

  • This invention relates to the subject of extracorporeal blood circuits, such as typically found in artificial kidney systems. More particularly, the invention relates to a device for detecting the separation of a blood line of the extracorporeal circuit from a fistula needle that is inserted into the patient's body, or for detecting the separation of the fistula needle from the patient.
  • Dialysis machines are used for treating patients with inadequate kidney function.
  • Hemodialysis machines include, among other things, an extracorporeal blood circuit typically comprising an arterial line, a blood pump, a dialyzer and a venous line. Blood is removed from the patient via the arterial line and pumped by the blood pump to the dialyzer, where blood-borne toxins and excess fluids are removed from the patient's blood. The blood is then returned to the patient via the venous line.
  • a dialysis machine particularly suitable for use outside of a conventional dialysis clinic setting is set forth in the patent of Rodney S. Kenley et al., U.S. No. 5,591,344, assigned to the assignee of the present invention, which is incorporated by reference herein.
  • the arterial and venous lines of the extracorporeal circuit are typically connected to separate blood access sites on the patient's body.
  • a fistula needle is employed for this purpose at each access site, with the tip thereof inserted into a blood vessel and the other end thereof connected to the respective arterial or venous line.
  • a potentially life-threatening situation can occur if the venous fistula needle should accidentally become separated from the patients body, or if the venous line becomes disconnected form the venous fistula needle, during the dialysis treatment. If this occurs, and the arterial fistula needle remains in the body with the blood pump still operating to remove blood from the patient, a rapid and potentially catastrophic loss of the patient's blood can occur.
  • the invention is also applicable to other types of medical equipment having extracorporeal blood circuits connected to the patient's circulatory system, such as found in heart-lung machines and liver-support machines.
  • a blood line separation device comprising first and second electrodes that are applied to the patient's body in the vicinity of the insertion of the fistula needle into the patient.
  • the electrodes may be incorporated into an adhesive patch applied to the patient's skin.
  • the electrodes may, alternatively, be incorporated into a cuff that encircles the patient's arm adjacent to the needle access site.
  • the electrodes are normally electrically isolated. If the needle separates from the patient, blood is ejected out of the tip of the needle onto surrounding surfaces, such as the adhesive patch or the cuff containing the electrodes. The blood creates a conductive path between the two electrodes.
  • the electrodes are coupled to conductors that lead to a fluid sensing circuit that is incorporated into a dialysis machine computer system or, alternatively, an alarm circuit.
  • the dialysis machine computer system shuts off the blood pump when the fluid sensing circuit senses the presence of a conductive path between the two electrodes.
  • the operation of the invention is essentially the same in other types of machines having an extracorporeal circuit, in which case the alarm circuit or machine computer system is incorporated into the pertinent machine, whether it be a heart-lung machine, a liver- support machine or otherwise. Additionally, the alarm circuit may be entirely separate from the machine itself, such as a buzzer circuit positioned next to the patient or in a nurses station.
  • Figure 1 is an illustration of a dialysis patient connected to a dialysis machine, showing the relationship of a preferred embodiment of the inventive needle withdrawal warning device in relationship to the patient and the machine.
  • FIG 2 is a detailed perspective view of a preferred embodiment of the needle withdrawal warning device of Figure 1, with the adhesive patches shown partially broken away in order to show the electrodes embedded therein;
  • FIG. 3 is a detailed perspective view of alternative embodiment of the needle withdrawal warning device of Figure 2.
  • Figure 4 is a cross-section of the cuff embodiment of Figure 3;
  • Figure 5 is a perspective view of an alternative embodiment of the invention in which a fluid detection device is placed at the connection of the venous line to the venous fistula needle;
  • Figure 6 is a perspective view of an alternative embodiment of the invention in which a fluid detection device is placed at the connection of the venous line to the venous fistula needle and at the connection between the arterial line and the arterial fistula needle;
  • FIG 7 is a block diagram of the computer control system of the dialysis machine of Figure 1, showing the relationship of the inventive needle withdrawal warning device of Figures 2- 6 in relation to host and backup microprocessors.
  • FIG. 1 is an illustration of a dialysis patient 8 connected to a hemodialysis machine 10, showing the relationship of a preferred embodiment of the inventive needle withdrawal warning device 11 in relationship to the patient and the machine.
  • the hemodialysis machine 10 includes an extracorporeal circuit having an arterial line 13 connected to the patient at an "arterial" access site via an arterial fistula needle 15, and a venous line 17 connected to the patient at a "venous" access site via a venous fistula needle 19.
  • the arterial and venous lines 13 and 17 connect to the rest of the extracorporeal circuit which is located inside the cabinet 26 behind a door 27.
  • a blood pump inside the cabinet 26 is placed in the arterial line for pumping blood through the extracorporeal circuit to a dialyzer in the cabinet 26, and returning the blood to the patient via the venous line 17.
  • the dialyzer has a membrane having a blood side thereof in communication with the arterial and venous lines and a dialysate side thereof.
  • the dialysis machine includes a dialysate preparation system 25 having a source of dialysate solution and a dialysate pump for circulating the dialysate solution through a dialysate circuit to the dialysate side of the dialyzer membrane.
  • the machine has a water treatment system 23 for treating water supplied to the dialysate circuit 25.
  • a central computer control system is provided in the machine governing the operation of the blood pump, the dialysate preparation system and dialysate pump, and the other aspects of the dialysis machine.
  • the machine also has a user interface 12 for allowing the patient to input information and commands into the machine.
  • the user interface 12 includes a touch sensitive screen 14 and a set of three colored hard keys or physical buttons 16, 18, 20 that are pushed by the patient 8 in response to prompts displayed on the touch screen 14.
  • the user interface 12 rotates about a tilt axis T, a vertical axis A, and the arm 30 pivots about a hinge 28 along axis H.
  • the entire extracorporeal circuit housing 26 rotates about a vertical axis.
  • the details of the dialysis machine 10 per se are not particularly important, and are l ⁇ iown in the art.
  • the reader is directed to the patent to Rodney S. Kenley, et al., U.S. No. 5,591,344, for a description of a presently preferred hemodialysis machine 10, which is incorporated by reference herein.
  • the invention may be used with virtually any hemodialysis machine, such as the one described in the patent of Grogan, et al., U.S. No. 5,326,476.
  • the problem of potential catastrophic loss of blood from the patient described above occurs when the venous fistula needle 19 becomes disconnected from the patient 8.
  • the problem also can occur if the venous blood line 17 becomes disconnected from the venous fistula needle 19. In either scenario, if the arterial line 13 and fistula needle 15 is connected to the patient 8 and the blood pump continues operation, blood will continue to be removed from the patient but not be returned, a life-threatening situation.
  • a blood line separation warning device 11 comprising a fluid sensor having a pair of electrodes adapted for installation on the patient's body adjacent to the location at which the venous fistula needle 19 is inserted into the patient's body.
  • Conductors are provided as part of a leak detection circuit that connect the electrodes of the fluid sensing device to the central computer control system for the dialysis machine. The presence of blood between the electrodes is sensed by the leak detection circuit, which respc. lively causes the computer control system to take corrective action to minimize blood loss, such as by stopping the blood pump.
  • the computer control system may take other action, such as operating an audio or visual alarm.
  • the device 11 comprises a fluid sensor that is suited for installation adjacent to the location at which the venous fistula needle 19 is inserted into the patient's body 8. As shown in Figure 3, the device 11 is also suitable for use to detect the separation of the arterial fistula needle 15 from the patient's body 8.
  • the device 11 has first and second nominally isolated electrodes (items A and B, respectively) applied to a flexible material such as a patch 40 having an adhesive backing suitable for placement on the patient's body 8 or clothing immediately adjacent to the location where the fistula needles 15, 19 are inserted into the body.
  • First and second conductors 42A, 42B from a leak detection circuit in the central computer control system are connected to the first and second electrodes, respectively.
  • the conductors 42A, 42B supply a signal indicative of the presence of fluid between the first and second electrodes to the central computer system of the dialysis machine. More specifically, the presence of blood between the first and second electrodes A and B closes a circuit between the electrodes or otherwise causes the signal indicative of the presence of blood adjacent to the fistula needle insertion site to be supplied to the dialysis machine 10.
  • the computer control system responsively stops the operation of the blood pump to prevent a potentially catastrophic loss of blood from the patient.
  • the electrodes A and B may implemented as a mesh structure spread evenly in the adhesive patch 40 or they may be separated as shown. They should be nominally isolated from each other (i.e., not in electrical contact), such that the presence of blood within the patch creates a conductive path between electrode A and electrode B in order to close a circuit and send a signal along conductors 42A and/or 42 B that blood is present at the needle insertion site.
  • the fluid sensing device is constructed as a wrap-around cuff-like member 50 that is installed surrounding to the venous fistula needle 19 access site.
  • the cuff 50 has a slot 52 and a small aperture 54 to assist in the placement of the needle 19.
  • the cuff has an end portion 56 which has a NELCRO ® hook patch on its lower surface which is secured to a complimentary pile patch 58 on the cuff.
  • the cuff 50 is shown in cross section in Figure 4.
  • the bottom of the cuff 50 placed adjacent to the patient's skin is a first conductor 60 formed as a mesh.
  • the first conductor is separated from a second conductor 64 by a hydrophilic material 62.
  • the top surface of the cuff is a light hydrophilic cloth material 66.
  • the cuff includes two electrodes 42 A and 42B, which lead to a leak detection circuit in the dialysis machine computer system or to an alarm circuit. Electrode 42A is connected to the first mesh conductor 60 in the cuff 50, and the electrode 42B is connected to the second mesh conductor 64.
  • blood will pass out of the tip of the needle 18 into the area in the cuff 50 between the electrodes. This will establish a conductive path between the two electrodes and allow the leak detection circuit to sense the presence of blood and enable the computer control system to stop the blood pump or take other corrective action.
  • FIG. 5 is a perspective view of an alternative embodiment, in which a disconnection of the venous line 17 from the venous fistula needle 19 is detected.
  • the device comprises clamshell-type enclosure 70 having two halves 71, 72 connected by a hinge 73 which snaps closed by means of any suitable snap 74 or other type of fastener for closing the two halves 71 ,72.
  • Each half of the enclosure 70 has its respective conductor, shown as a first mesh conductor A in half 71 and mesh conductor B positioned in half 72.
  • Each conductor A, B is connected to its respective first and second conductor 42A, 42B leading to suitable leak detection circuitry in an alarm circuit or in the dialysis machine central computer system.
  • FIG. 6 shows an embodiment in which a single enclosure is provided for both the arterial and venous lines and their associated arterial and venous fistula needles. The principle of operation of the device is as described above.
  • FIG 7 is a block diagram of a computer control system 100 of the dialysis machine 10 of Figure 1, showing the relationship between the conductors 42 A, 42B of the inventive needle withdrawal warning device of Figure 1 and the system 100.
  • the central computer control system 100 is installed within the machine 10 and governs all aspects of the operation of the machine 10.
  • the use of a central computer control module to control active components of a dialysis machine is well known in the art and described in the above-referenced Kenley et al. and Grogan et al. patents, and hence the description here is merely representative of one possible control system.
  • the computer control system 100 controls the operation of user interface display 14' to display messages and information concerning the status of the machine and treatment.
  • the module 100 operates the user interface display 14' to prompt the user to touch the touch screen 14 and hard keys 16, 18, 20 in the process of changing parameters or inputting information into the computer system 100.
  • the touch screen 14 inputs commands or information from the patient user into a human interface (HI) board 108.
  • the hard keys 16, 18 and 20 are each a pair of physical switches and provide additional signals to the HI board 108 and a redundant or backup safety central processing unit (CPU) 116.
  • One switch in the hard keys 16, 18, and 20 is preferably directly hard wired to the safety CPU 116, and the other switch is connected to a host CPU 110 via the HI board 108.
  • the emergency stop hard key 20 is preferably directly hard wired to both the host CPU 110 and the safety CPU, as shown by the dashed lines 101.
  • a set of indicators 104 including lights and audio indicators, a buzzer 121, and a speaker 106, alert the patient to abnormal conditions in the machine 10 (such as disconnection of the venous fistula needle from the patient or the fistula needle from the venous line), and provide information as to the status of the modes of operation of the machine.
  • the indicators 104 receive input signals from the host or safety CPU via the HI board 108.
  • the buzzer 121 receives input signals from the safety CPU 116.
  • the host CPU 110 is connected via high speed digital data busses 111 and 113 to a driver board 112 and an analog board 114.
  • the host CPU 110 comprises a microprocessor and implements a software program governing the operation of the machine stored in a hard disk memory 130 or a read only memory (not shown).
  • the hard disk 130 stores other operational information, such as the patient's prescription, data from the passive components, and data input from the patient via the touch screen.
  • An analog board 114 contains analog to digital converters for converting incoming analog signals from the passive sensors in the machine 22 (such as thermistors, pressure sensors and conductivity cells) into digital signals.
  • the analog board 114 also includes a leak detection circuit responsive to signals on the conductors 42A, 42B from the fluid sensing device.
  • the driver board 112 receives commands from the CPU 110 and sends the commands to the valves, pumps, heaters, motors, and other active components of the machine (represented by 120) to cause the components to change their status, e.g., commence or cease operation or change rate, as in the case of a pump, or open and close, as in the case of a valve.
  • the signals from the passive components 122 of the system for example, the conductivity sensors, pressure transducers, thermistors, etc. provide their inputs to the analog boards 114 and 118.
  • the CPU 110 and driver board 112 together act as a controller for the active components.
  • the analog board 118 for the safety CPU 116 received inputs from the passive sensors in the dialysis machine 10 and also includes a leak detection circuit responsive to signals on the conductors 42A, 42B from the fluid sensing device.
  • the analog board 118 provides digital information on a bus 117 to the safety CPU 116.
  • the safety CPU 116 comprises a microprocessor and acts as watchdog of critical system sensors, and provides enable signals to the driver board 112 that allow certain driver commands to issue to the active components 120 (such as signals to the blood pump to cease operation of the blood pump in the extracorporeal circuit). Communications between the safety CPU 116 and host CPU 110 are passed on data bus 107.
  • the safety CPU 116 activates a buzzer or other suitable alarm 121 if certain alarm conditions .are present in
  • Both the host and safety CPUs 110 and 116 have an associated random access memory 132 and 134, respectively, for use in processing input information from the touch screen 14, for temporary storage of data, and for performing other tasks.
  • the host CPU 110 and hard disk 130 are based on an off-the- shelf IBM compatible personal computer platform based on an Intel 386 or 486 microprocessor, or the equivalent.
  • a similar microprocessor platform may be used for the safety CPU 116.
  • the safety CPU 116 also has its own hard disk memory 123. Note that the Safety and Host CPUs 116 and 110 do not share a hard disk, but rather have their own hard disk, for safety and redundancy reasons.
  • the host CPU 110 preferably has a modem and telephone line interface, a local area network (LAN) gateway card and interface and/or an RS-232 serial port (not shown) for allowing the machine 10 to receive and send messages to remote locations by a suitable communication link.
  • LAN local area network
  • RS-232 serial port (not shown) for allowing the machine 10 to receive and send messages to remote locations by a suitable communication link.
  • the choice of which type of input/output interface will depend on where the machine 10 is installed (e.g., the home (modem), in a hospital (LAN interface), in a nursing home (modem and or RS-232 and/or LAN).
  • Potential entities that may wish to access information from the machine include a physician or nurse, the machine manufacturer, a service technician, and a remote monitoring facility such as a central station monitoring a plurality of machines.
  • machine status and treatment information is stored in the hard disk 130 and is accessible to the outside via the modem and host CPU 110 using an interactive program running on the host CPU 110 and at the remote site.
  • the host CPU computing platform 110 also preferably implements a Microsoft TM graphical user interface operating system, and also Internet access software to allow messages to be sent to and retrieved from the machine 10 via the Internet.
  • the leak sensing circuit implemented on the analog boards 114 and 118 could be one of any number of known fluid leak detection circuits used for treating enuresis. Representative circuits are described in the patents to Brown, U.S. Patent 4,738, 260; Wilson, U.S. Patents 4,356,479 and 4,271,406, and Blakely, U.S. Patent 5,043,704, and Smith, U.S. Patent 5,341,127, the contents of each of which is incorporated by reference herein in its entirety. The adaptation of such circuits to a computer control system of a dialysis machine, such as the one shown in Figure 7, is considered to a well within the abilities of a person of ordinary skill in the art of electrical engineering and control systems.
  • the host and safety CPUs are notified of the condition and a signal is sent to the driver board 112 which responsively stops the blood pump of the extracorporeal circuit.
  • Activation of an audio and or visual alarm may also occur to alert the patient of the condition.
  • the alarms 121, 104 that are responsive to the leak detection circuit in the analog boards are part of the patient protective systems programmed into the dialysis machine.

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  • Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un dispositif (11) de détection de fluide servant à détecter si une aiguille (15, 19) à fistule connecte un patient (8) à un circuit extracorporel de sang d'un appareil de dialyse. Le dispositif (11) de détection de fluide comporte deux électrodes (A, B) qui sont placées sur la surface du corps (8) du patient de manière adjacente à l'endroit où l'aiguille (15, 19) à fistule est insérée dans le corps du patient (8). Les électrodes (A, B) sont connectées par deux fils (42A, 42B) à un circuit de commande d'ordinateur et d'alarme de l'appareil de dialyse. Si l'aiguille (15, 19) à fistule se détache du patient (8), les électrodes (A, B) vont détecter la fuite de sang et un signal est envoyé au circuit de commande d'ordinateur et d'alarme. Le circuit de commande d'ordinateur et d'alarme arrête immédiatement la pompe de sang et active une alarme, ce qui permet d'éviter une perte de sang potentiellement catastrophique.
PCT/US1998/019266 1997-11-07 1998-09-11 Dispositif d'alerte signalant une separation du circuit de sang pour circuits extracorporels WO1999024145A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU93927/98A AU9392798A (en) 1997-11-07 1998-09-11 Blood line separation warning device for extracorporeal circuits

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US96595097A 1997-11-07 1997-11-07
US08/965,950 1997-11-07

Publications (1)

Publication Number Publication Date
WO1999024145A1 true WO1999024145A1 (fr) 1999-05-20

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WO2002102441A1 (fr) * 2001-06-15 2002-12-27 Gambro Lundia Ab Procede et dispositif pour detecter la sortie de l'aiguille de la veine d'un patient pendant une dialyse
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WO2015011065A1 (fr) * 2013-07-25 2015-01-29 Fresenius Medical Care Deutschland Gmbh Revêtement de tuyau pour système médical de conduit en tuyau souple
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CN104812295A (zh) * 2012-09-27 2015-07-29 乔纳森·P·古奇 用于检测套管位移的设备和方法
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