CA1227553A - Differential occlusion sensing method and apparatus - Google Patents

Differential occlusion sensing method and apparatus

Info

Publication number
CA1227553A
CA1227553A CA000454614A CA454614A CA1227553A CA 1227553 A CA1227553 A CA 1227553A CA 000454614 A CA000454614 A CA 000454614A CA 454614 A CA454614 A CA 454614A CA 1227553 A CA1227553 A CA 1227553A
Authority
CA
Canada
Prior art keywords
pressure
value
alarm
initial
tubing
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.)
Expired
Application number
CA000454614A
Other languages
French (fr)
Inventor
Michael O. Pekkarinen
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.)
Baxter International Inc
Original Assignee
Baxter Travenol Laboratories 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=23976578&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA1227553(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Baxter Travenol Laboratories Inc filed Critical Baxter Travenol Laboratories Inc
Application granted granted Critical
Publication of CA1227553A publication Critical patent/CA1227553A/en
Expired legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means 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
    • A61M5/16831Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/16854Monitoring, detecting, signalling or eliminating infusion flow anomalies by monitoring line pressure
    • YGENERAL 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
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00Surgery
    • Y10S128/13Infusion monitoring

Abstract

DIFFERENTIAL OCCLUSION SENSING
METHOD AND APPARATUS

ABSTRACT OF THE DISCLOSURE

The present invention provides an accurate method and apparatus for sensing and monitoring any buildup in the downline tubing pressure in a fluid infusion system. The initial fluid pressure as indicated by the tubing location is sensed after a delay period and is utilized as a base pressure if it is within allowable limits. The infusion tubing location or pressure is then moni-tored and compared with the base location or pres-sure. The system will alarm if a preset differen-tial location or pressure change is exceeded.

Description

DIFFERENTIAL OCCLUSION SENSING
METHOD AND APPARATUS

BACKGROUND OF THE INVENTION

The present invention relates generally to fluid infusion systems and more particularly is directed to a method and apparatus for accurately detecting small changes in tubing dimensions to prevent high pressure infusion into the fluid infusion system.
The infusion of 1uids into the human body is usually accomplished by means of an administration set in conjunction with metering apparatus which controls the rate of flow of fluid through the set. Peristaltic-type pumps, which function by repetitively compressing and expanding a section of tubing, have proven particularly attractive for use in metering apparatus since they do not intro-duce the possibility of leakage or contamination into the system, while providing positive control fo fluid flow through the system.
: One form of peristaltic-type pump which is particularly well adapted for infusion applica-tions is described in U.S. Patent No. 4,155,362.
Basically, this pump construction includes indi-vidually spring-biased rollers in the pump rotor which provide a uniform compression force, and a spring-biased plunger which restricts the lumen of the administration set downline of the pump rotor 7~S3 to provide a back pressure against which the pump must work. This prevents the release of dissolved gas in the tubing section, assists in restoring the tubing to its original shape following com-pression by the pump, and prevents uncontrolledgravity flow in the event of pump ailure.
A potential problem with this and other types of infusion systems relates to detecting pressure increases downline of the pump or pump restrictor in order to avoid patient harm which may occur as a consequence of excessive fluid pressure. Some prior systems have included sensing means with the pumping system, but these are ineffective downline of pumping systems which are isolated from down-line pressure variations by some type of restric-tor.
one prior attempt at solving this problem was the use of a push rod microswitch system. As the tubing would swell from the increase in pressure caused by an occlusion downline of the pump, the rod would activate the microswitch and cause an alarm and/or stop the pump. A basic problem with this type of microswitch system is that the cali-bration of the system requires that the switch respond at a specific position. Therefore, any-thing which afects the alignment and contact pressure betweencthe push rod and the tubing has the capability of changing significantly the in-ternal pressure which is required to cause the tubing to swell sufficiently in order to trigger the microswitch. Further, the stability of the mechanical system and the microswitch has to be accurate enough to measure as little as .001 inch
2~7~5S3 travel. Variations such as spring fatigue and friction variations introduce other deviations in the operation. The cross sectional shape that the tubing has at the time of insertion into the pump can vary from circular to extremely elliptical.
This can result in differences as large as two to one in the dimension which is sensed by the push rodO
Further, the tubing itself will vary in wall thickness and inside diameter by about .01 inch.
In addition the tubing material itself will vary in the pressure it takes for it to swell a certain amount. The operating temperature range and age of the tubing will cause variations in the amount of swelling per unit of pressure. These many variations can cause the actual pressure at which the push rod system will alarm to vary widely from infusion set to infusion set and with each inser-tion of the same tubing into the pump.

~.~f~7~5~

SUMMARY OF THE INVENTIOW
.
In accordance with the present invention, a method and apparatus is provided to sense the downline pressure variations in the infusion tub-ing of a fluid infusion system on a differential S basis. The invention allows for normal operation of the infusion system while monitoring any change in the tubing, swelling, and hence the internal pressure from the moment of pump initiation.
Thus, the initial location of the tubing is sensed a set time period after initiation of the infusion. The initial sensed location value is compared against a predetermined allowable range and is stored if it is within that range. The initial value thus takes all present factors into accord and is utilized as the base value. If the pressure changes by a preset differential amount from the base value amount as determined by sen-sing the change in the tubing location, the system will alarm.

~L2;~7~S3 .

various aspects of this invention are as follows:
A method of sensing and monitoring downline fluid pressure in a fluid infusion system, comprising:
providing a fluid tubing;
providing a positive fluid flow in said tubing;
sensing an initial base value at a location of said tubing;
monitoring the value at said tubing location;
comparing the monitored value against the initial base value; and setting an alarm if said monitored value exceeds a predetermined value differential.

An apparatus for sensing and monitoring downline fluid pressure at a specific location in the fluid tubing of a fluid infusion system, comprising:
means adapted to be coupled to the fluid tubing at said specific location for sensing the value of pressure therein;
means coupled to said sensing means for monitoring said sensed value and comparing it to an initial sensed value; and means for setting an alarm if said sensed value exceeds a precletermined value clifferential.
BRIEF DESCRIPTION OF THE DRAWINGS
. .
Fig. 1 is a schematic diagram of an infusion system; and Fig. 2 is a schema-tic diagram of a differential pressure sensor of the present invention.

v -~227~53 DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to Fig. 1, there is shown diagram-matically an infusion system 10, which can incor-porate the present invention of a differential pressure sensing system 12. A fluid to be infused or injected into a vein or artery is contained in a fluid source or reservoir 14. The fluid is coupled through a standard fluid set which in-cludes a flexible, collapsible tubing 16, which can be in one or more segments as desired.
The tubing 16 couples the fluid through a drip chamber 18 and into a pump assembly 20. Al-though a peristaltic pump assembly 20 is pre-ferred, and hereinafter described, the invention is not limited to any particular type of pumping system. after passing through the pump 20, the tubing is coupled through the pressure sensor 12 and then to the vein or artery (not shown) into which the 1uid is to be infused. Although the sensor 12 is illustrated as a separate unit down-line of the pump 20, it preferably can be part ofthe pumping assembly rather than a separate unit.
However, the sensor 12 operates independently of the particular pumping system, which is at least partially isolated, as by a restrictor, from the downstream pressure changes to be monitored.
Referring to Fig. 2, the pressure sensor 12 is best illustrated. The sensor 12 includes a fixed block 22, against which the tubing 16 is pressed by a location indicator 24. The indicator 24 can be pneumatic, hydraulic or electronic, but functions to transmit the location or swelling of 755~

the tubing 16 to a transducer 26O The transducer 26 transmits a signal indicating the sensed loca-tion to a controller 28, such as a microproces-sor. The controller 28 converts the location of 5 the indicator 24 Jo a value indicative of the pressure in the tubing 16. The transmitter 24 and transducer 26 can be separate units as shown, or can be one integral unit.
In operation, the pump 20 is activated caus-ing an initial operating pressure to be developed,which may cause the tubing 16 to swell. The tub-in position due to the tubing configuration or caused by the swelling is sensed by the indicator 24 and transducer 26 which transmits a signal to the controller 28. The controller 28 converts the position sensed to a pressure and compares the initial pressure value to an allowable pressure range, such as up to 20 psi. If the initial pres-sure value is within the allowable range, the value is stored and if it is outside the range, the controller 28 will cause the system 10 to alarm.
The controller 28 then utilizes the base location as the standard location to monitor the infusion process. If the location and hence the pressure varies at any time beyond a predetermined differential amount from the base pressure, such as 5 psi, then the system will alarm. The alarm limit can include a predetermined change ;n pres-sure from the base pressure and can include amaximum operating pressure for the system, such as 7~53 Thus, an initial base location and hence pressure is obtained which eliminates variations in the tubiny position, thickness, diameter and shape. In a hydraulic system the transmitter 24 will be formed from a tlexible material such as silicone and will contain an incompressible fluid to transmit the location in the form of pressure to the transducer 26.
Modifications and variations of the present invention are possible in light ot the above teachings. The controller preferably converts the sensed location to pressure which then can ye displayed t`or operator use; however, the controller also can operate directly on location changes without conversion. It is therefore to be understood that within the scope of the appended claims the invention may be practiced9 otherwise than as specifically described.
In one embodiment of the invention, a delay means is provided for sensing an initial infusion value after a predetermined time delay.

Claims (15)

THAT WHICH IS CLAIMED IS:
1. A method of sensing and monitoring downline fluid pressure in a fluid infusion system, comprising:
providing a fluid tubing;
providing a positive fluid flow in said tubing;
sensing an initial base value at a location of said tubing;
monitoring the value at said tubing location;
comparing the monitored value against the initial base value; and setting an alarm if said monitored value exceeds a predetermined value differential.
2. The method as defined in claim 1 including:
sensing said initial base value after a predetermined time delay.
3. The method as defined in claim 1 including:
providing an absolute alarm value;
comparing the monitored value against the absolute alarm value; and setting an alarm if said monitored value exceeds said absolute alarm value.
4. The method as defined in claim 1 including:
providing an allowable initial value range;
comparing said initial infusion operating base value against said allowable value range; and setting an alarm if said initial value is outside of said allowable value range.
5. The method as defined in claim 1 including:
converting said initial base value and said monitored value to a value indicative of the internal tubing pressure; and setting said alarm if said monitored pressure exceeds a predetermined pressure differential.
6. The method as defined in claim 5 including:
sensing said initial infusion pressure after a predetermined time delay;
providing an allowable initial pressure range;
comparing said initial infusion operating pressure against said allowable pressure range; and setting an alarm if said initial pressure is outside of said allowable pressure range.
7. The method as defined in claim 6 including:
providing an absolute alarm pressure;
comparing the monitored pressure against the absolute alarm pressure; and setting an alarm if said monitored pressure exceeds said absolute alarm pressure.
8. An apparatus for sensing and monitoring downline fluid pressure at a specific location in the fluid tubing of a fluid infusion system, comprising:
means adapted to be coupled to the fluid tubing at said specific location for sensing the value of pressure therein;
means coupled to said sensing means for monitoring said sensed value and comparing it to an initial sensed value; and means for setting an alarm if said sensed value exceeds a predetermined value differential.
9. The apparatus as defined in claim 8 including;
delay means for sensing said initial infusion value after a predetermined time delay.
10. The apparatus as defined in claim 8 including:
means for comparing the monitored value against an absolute alarm values; and means for setting an alarm if said monitored location exceeds said absolute alarm location.
11. The apparatus as defined in claim 8 including:
means for comparing said initial infusion operating value against a predetermined allowable initial value range; and means for setting an alarm if said initial location is outside of said allowable value range.
12. The apparatus as defined in claim 8 wherein:
said value sensing means includes a fluid transducer adapted to he fluidly coupled to the tubing.
13. The apparatus as defined in claim 8 including:
means for converting said sensed value to a value indicative of the internal tubing pressure; and means for setting said alarm if said monitored pressure exceeds a predetermined pressure differential.
14. The apparatus as defined in claim 13 including:
delay means for sensing said initial infusion pressure after a predetermined time delay;
means for comparing said initial infusion operating pressure against an allowable initial pressure range; and means for setting an alarm if said initial pressure is outside of said allowable pressure range.
15. The apparatus as defined in claim 14 including:
means for comparing the monitored pressure against an absolute alarm pressure; and means for setting an alarm if said monitored pressure exceeds said absolute alarm pressure.
CA000454614A 1983-05-23 1984-05-17 Differential occlusion sensing method and apparatus Expired CA1227553A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US06/497,369 US4526574A (en) 1983-05-23 1983-05-23 Differential occlusion sensing method and apparatus
US497,369 1983-05-23

Publications (1)

Publication Number Publication Date
CA1227553A true CA1227553A (en) 1987-09-29

Family

ID=23976578

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000454614A Expired CA1227553A (en) 1983-05-23 1984-05-17 Differential occlusion sensing method and apparatus

Country Status (7)

Country Link
US (1) US4526574A (en)
EP (1) EP0149618B1 (en)
JP (1) JPS60501393A (en)
AU (1) AU571521B2 (en)
CA (1) CA1227553A (en)
DE (1) DE3482550D1 (en)
WO (1) WO1984004685A1 (en)

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Also Published As

Publication number Publication date
AU2823084A (en) 1984-12-18
EP0149618A4 (en) 1987-02-03
DE3482550D1 (en) 1990-07-26
AU571521B2 (en) 1988-04-21
JPH0432666B2 (en) 1992-05-29
EP0149618A1 (en) 1985-07-31
JPS60501393A (en) 1985-08-29
WO1984004685A1 (en) 1984-12-06
US4526574A (en) 1985-07-02
EP0149618B1 (en) 1990-06-20

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