WO2009042261A4 - Continuity circuits for detecting access disconnection - Google Patents

Continuity circuits for detecting access disconnection Download PDF

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Publication number
WO2009042261A4
WO2009042261A4 PCT/US2008/066101 US2008066101W WO2009042261A4 WO 2009042261 A4 WO2009042261 A4 WO 2009042261A4 US 2008066101 W US2008066101 W US 2008066101W WO 2009042261 A4 WO2009042261 A4 WO 2009042261A4
Authority
WO
WIPO (PCT)
Prior art keywords
detector
layer
blood
access
pad
Prior art date
Application number
PCT/US2008/066101
Other languages
French (fr)
Other versions
WO2009042261A1 (en
Inventor
Alan W Marttila
William W Chan
Reema Ashok Bhagtani
Original Assignee
Baxter Int
Baxter Healthcare Sa
Alan W Marttila
William W Chan
Reema Ashok Bhagtani
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 Baxter Int, Baxter Healthcare Sa, Alan W Marttila, William W Chan, Reema Ashok Bhagtani filed Critical Baxter Int
Publication of WO2009042261A1 publication Critical patent/WO2009042261A1/en
Publication of WO2009042261A4 publication Critical patent/WO2009042261A4/en

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
    • 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
    • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/02042—Determining blood loss or bleeding, e.g. during a surgical procedure
    • 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
    • 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
    • A61M1/36—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
    • A61M1/3659—Cannulae pertaining to extracorporeal circulation
    • 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
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • 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
    • 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
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1588—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
    • 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
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission

Abstract

A monitor for an extracorporeal therapy access site is disclosed. The monitor includes a bandage atop or adjacent the access site and a sensor for monitoring the bandage. The bandage includes a layer of polymer that expands when wetted with blood. The expansion causes a break in continuity of the sensor, or in an alternate embodiment, causes a sensor to cease detecting a target. When the break occurs, the control circuit monitoring the bandage sends a signal that a break has occurred, and a remote monitor then takes appropriate action, such as ceasing therapy, sending an alert, or sounding an alarm. In another embodiment, connecting wires in a continuity circuit are held apart by a polymer that dissolves when contacted by blood. If a leak occurs and a small portion of the polymer dissolves, the wires make contact, thus detecting a blood leak.

Claims

AMENDED CLAIMS received by the International Bureau on 10 April 2009 (10.04.09)
1. A method for detecting blood leakage, the method comprising: furnishing a pad with an expandable polymer layer and a sensor; placing the pad near an access site for an extracorporeal blood therapy; taking an initial reading of the sensor; monitoring the access site by taking additional readings of the sensor during an extracorporeal blood processing therapy; and sending a signal if a reading of the sensor is consistent with expansion of the expandable polymer layer and a break of continuity of the sensor.
2. The method of Claim 1, wherein the sensor comprises a metallic object or a detection circuit that is broken by the expandable layer.
3. The method of Claim 1 or Claim 2, further comprising sending an alert or sounding an alarm with a local output device.
4. The method of any one of the above claims, wherein the detection circuit comprises a continuity circuit or a circuit for detection of targets by proximity sensors.
5. The method of Claim 4, wherein the proximity sensors are selected from the group consisting of hall-effect sensors, capacitance sensors, and inductance sensors.
6. The method of any one of the above claims, further comprising wicking blood from the access site using a fluid conveyor with a hydrophilic layer.
7. A method according to any one of the above claims, wherein the pad comprises a fluid conveyor comprising at least one outer layer and a hydrophilic inner layer, the hydrophilic inner layer configured to wick blood.
8. The method according to Claim 7, wherein the hydrophilic inner layer is configured for absorbing and wicking blood
9. An access disconnect detector, the detector comprising: a pad having an expandable polymer layer; and a detection circuit mounted near or atop the pad, wherein the pad is configured for placement adjacent an extracorporeal therapy access site, the expandable polymer layer is configured for expanding upon contact with blood, and the detection circuit is configured for wireless communication with an extracorporeal therapy machine or a controller in communication with the extracorporeal therapy machine.
10. The detector according to Claim 9, wherein the detection circuit comprises a continuity circuit, a controller, and a wire communications module.
11. The detector according to Claim 9 or Claim 10, wherein the detection circuit comprises a thin metallic object.
12. The detector according to any one of claims 9-11, wherein the detection circuit comprises at least one metallic or magnetic target and at least one hall-effect or proximity sensor for detecting the target.
13. The detector according to any one of claims 9-12, further comprising a local output device for raising an alert or sounding an alarm.
14. The access disconnect detector according to any one of claims 9-13, further comprising an access needle attached to an access mount, and at least one target on the mount, the target suitable for detection by the detection circuit.
17
15. The access disconnect detector according to any one of claims 9-14, wherein the expandable polymer layer is made from polyvinyl alcohol, a polyvinyl alcohol derivative, acrylic acid, an acrylic acid derivative, or a combination thereof.
16. The access disconnect detector according to any one of claims 9-15, wherein the extracorporeal therapy machine is a hemodialysis machine and further comprising the hemodialysis machine.
17. The access disconnect detector according to any one of claims 9-16, further comprising a fluid conveyor with a hydrophilic layer placed between the access site and the pad.
18. The access disconnect detector according to any one of claims 9-17, wherein the expandable layer is asymmetric.
19. An access disconnect detector according to any one of claims 9-18, wherein the pad comprises, a fluid conveyor comprising at least one outer layer and a hydrophilic inner layer, the hydrophilic inner layer configured to wick blood away from an extracorporeal therapy access site; and further comprising a control circuit in operable communication with the pad, wherein the detector is configured to detect blood in the fluid conveyor and the control circuit is configured to send a signal to alert a user or a caregiver of a presence of blood.
20. The access disconnect detector of any one of claims 9-19, wherein the outer layer is a hydrophilic layer.
21. The access disconnect detector of any one of claims 9-20, wherein the detector is a conductivity or capacitance detector.
18
22. The access disconnect detector of any one of claims 9-21, further comprising a therapeutic amount of anticoagulant on an inside of the fluid conveyor.
23. An access disconnect detector, comprising: a first layer comprising a dissolving polymer and a first plurality of wires; a second layer comprising a second plurality of wires; and a cover over the second layer of wires, wherein the detector is configured for placement near or atop an access site of a patient for an extracorporeal therapy, wherein when the dissolving polymer is contacted by blood, the polymer dissolves sufficiently for at least one wire in the first plurality to make electrical contact with at least one wire in the second plurality.
24. The access disconnect detector of Claim 23, further comprising a control circuit in operable communication with the detector, wherein the control circuit is configured to send a signal to alert a user or a caregiver of a presence of blood.
25. The access disconnect detector of Claim 23 or Claim 24, wherein the detector is configured for wireless communication with an extracorporeal therapy machine or a controller in communication with the extracorporeal therapy machine.
26. The access disconnect detector of any one of Claims 23-25, wherein the dissolving polymer is selected from the group consisting of polyacrylamides, polysaccharides and salts thereof.
19
PCT/US2008/066101 2007-09-27 2008-06-06 Continuity circuits for detecting access disconnection WO2009042261A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/862,984 US8360977B2 (en) 2007-09-27 2007-09-27 Continuity circuits for detecting access disconnection
US11/862,984 2007-09-27

Publications (2)

Publication Number Publication Date
WO2009042261A1 WO2009042261A1 (en) 2009-04-02
WO2009042261A4 true WO2009042261A4 (en) 2009-06-04

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WO (1) WO2009042261A1 (en)

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US8360977B2 (en) 2013-01-29
US20090088613A1 (en) 2009-04-02
US20130123699A1 (en) 2013-05-16
US8696571B2 (en) 2014-04-15
WO2009042261A1 (en) 2009-04-02

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