|Publication number||US3648694 A|
|Publication date||Mar 14, 1972|
|Filing date||Sep 25, 1968|
|Priority date||Sep 25, 1968|
|Publication number||US 3648694 A, US 3648694A, US-A-3648694, US3648694 A, US3648694A|
|Inventors||Ion Mogos, Cormel I Muscel, Nicolaie Dumitrescu|
|Original Assignee||Inst Oncologic Bucharest|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (11), Referenced by (63), Classifications (19)|
|External Links: USPTO, USPTO Assignment, Espacenet|
United States Patent Mogos et a1.
145] Mar. 14, I972  AUTOMATIC SYSTEM WITH PERFUSION PROTECTION AGAINST MALFUNCTION Ion Mogos; Corrnel l. Museel; Nicolai: Dumitreseu, all of Bucharest, Romania Institute] Oncologic Bucharest, Bucharest, Romania Filed: Sept. 25, 1968 Appl. No; 762,588
References Cited UNITED STATES PATENTS Schulz Moeller .....128/214 Mamo ..417/l2l Mauchel ..128/214 3,014,481 12/1961 Rumble et al .128/214 3,252,623 5/1966 Corbin et al. ..222/59 3,450,153 6/1969 Hildebrandt et a1... ..137/486 3,456,648 7/1969 Lee et ..128/214 FOREIGN PATENTS OR APPLICATIONS 1,449,713 8/1966 France...................................128/2 14 494,542 3/1930 Germany. 1 2812M 147,737 11/1962 U.S.S.R. .128/2l4 Primary Examiner-Dalton L. Truluck Attorney-Karl F. Ross 1 1 ABSTRACT A system for performing intravenous perfusions of a treatment liquid propelled by gas under pressure includes a gauge which vents the gas line in the event of excessive gas pressure. In the event of insufficient gas pressure, the gauge actuates a controller for switching a valve to divert the liquid flow from the perfusion implement to a drain, the controller also responding in like manner to gas occlusions sensed by a bubble detector and to a slowdown in the flow rate as measured by a drop counter.
Drop Chamber 6 Claims, 2 Drawing Figures :22 J a @131 Bubble l 15 indicator Bubble R l Detector a, 2|
Valve r Ce trel to perlueion lrnpiernent Flow-rote Indicator 7 Relay is go 23 8 Relay 6 Preeeure Low-pressure Gouge 9 indicator 1O 5 Relay High-pressure Indicator Patented March 14, 1972 3,648,694
2 Sheets-Sheet I DEGREE OF macnvmou INVENTOR W gfR 3 ,64 8 ,694 1 2 AUTOMATIC SYSTEM WITH PERFUSION PROTECTJON the mercury in pressure gauge 5 energizes a relay 6 which ac- AGAINST MALFUNCTION tuates an electromagnetic controller 7 and a signal lamp 8.
The present invention relates to automatic equipment for continuous perfusion with protective electronic circuits designed to prevent accidents that could endanger a patient treated with an intravenously administered liquid.
The object of our invention is to provide means for indicating malfunctions and avoiding accidents during transfusion, such as gas emboly, thrombosis, rupture of bloodvessel or detachment of the needle from the vein.
More specifically, our invention aims at arresting the flow of serum towards the patient and diverting the liquid to a drain under any of the following conditions:
a. when an air bubble appears in the perfusion line, removal of the bubble to the drain and reappearance of the treatment liquid in the circuit returning the valve to its normal operating position;
b. when the pressure of the treatment liquid increases or decreases beyond predetermined limits;
c. when the flow rate of the liquid decreases, owing to thrombosis, conduit clogging or loss of pressure in the perfusion line.
In accordance with this invention, we provide a normally closed first valve for venting a gas line leading from a source of high-pressure gas to a container for the liquid to be intravenously administered, a second valve being disposed in a fluid line originating at that container for normally conveying the treatment liquid to a perfusion implement but for diverting this liquid to a drain, via a line branching off the main fluid line, under potentially dangerous circumstances. Thus, a pressure gauge responsive to the gas pressure in the container generates a first alarm signal whenever this gas pressure rises above an upper limit of a predetermined range, at the same time actuating a controller for the first valve to vent the gas line; when the gas pressure falls beneath a lower limit of that range, a second alarm signal is generated by the gauge which simultaneously actuates a controller for the second valve to divert the liquid flow from the perfusion implement to the drain.
In accordance with other features of our invention, the controller for the second valve responds also to the output of a drop counter, connected to a drop chamber in series with the main fluid line, and to the output of a bubble detector, also in sertcd in the main fluid line, for similarly diverting the liquid flow upon a substantial decrease of the flow rate from a predetermined level and in the presence of gas occlusions.
if an additive, such as a short-lived cytostatic agent or cellgromh inhibitor known as Mustargen (N H), is to be admixed with the treatment liquid, a vessel containing this additive may be connected to the gas line in parallel with the container for the treatment liquid and may be inserted in the main fluid line so that the liquid continuously entrains some additive which is under the same gas pressure; advantageously, the fluid line may be provided with a conduit bypassing this vessel and with valves selectively operable to divide the flow between the vesso! and the bypass.
The invention will be further described hereinafter with reference to the accompanying drawing in which:
FIG. I is a block diagram of a perfusion system embodying our invention; and
FIG. 2 is a graph showing the degree of inactivation of a cytostatic (Mustargen) in a conventional system and in a system according to the invention.
From a diaphragm-type miniature pump 1, actuated by an electromagnet 2 whose supply voltage may be varied by means of a switch 3, air under a pressure of 80-200 mm. Hg. (adjustable through manipulation of the switch I) is introduced into a vessel 4 containing the treatment fluid. The existing pressure in vessel 4 may be read on a mercury pressure gauge 5, provided with contacts at every scale graduation of i0 mm. Hg.
When the pressure in gas line 27 decreases below a predetermined value related to the patients arterial pressure,
Controller 7 thereupon operates a safety valve 28 in fluid line 29 to block the fluid flow to the patient, via a perfusion implement not shown, until the pressure again exceeds the established lower limit (adjustable between and ISO mm. Hg).
In the same manner, when the pressure in vessel 4 exceeds the predetermined upper limit (adjustable between HM) and 200 mm. Hg), pressure gauge 5 energizes a relay 9 activating a signal lamp l0 and an electromagnetic controller ll which opens a safety valve 33 to vent the gas line 27 whereby the gas pressure drops again to its normal range.
The treatment liquid from vessel 4 is thus driven with an adjustable pressure, sensed by means of pressure gauge 5, through line 29 at a rate that is adjustable by a valve 36 in a bypass tube 12; line 29 traverses a drop chamber 13 and a bubble detector 14.
Detector 14 is provided with two platinum contacts between which the treatment fluid flows. When the fluid column is interrupted by the presence of an air bubble in the line 29, a transistor amplifier l5 energizes a relay to to actuate the controller 7 for operating the valve 28 to divert the liquid flow to a drain flask 31.
When the fluid column is reestablished between the contacts of detector 14 and the air bubble has been discharged to the drainage flask 31, controller 7 restores the valve 28 to its working position. The appearance of an air bubble in the perfusion line 29 is indicated by means of a lamp 2! and a buzzer 22 also energized by relay 16.
Drop chamber 13 is also provided with two platinum contacts so arranged that every drop of liquid bridging the two contacts produces an electric pulse fed to a transistor amplifier 17. The amplified pulses are applied via a shaping circuit, not shown, to a flow meter is provided with an instrument counting the number of drops per minute so that the transfusion rate can be read at any time. when the rate is less than two drops per minute, an amplifier 19 controlled by timer l8 actuates a relay 20 which, by means of controller 7 and valve 28, again blocks the circuit leading to the perfusion implement while signaling the condition by means of a lamp 23.
The complete equipment, mounted on a carrier for transporting the patients, is fed from an accumulator battery on a shock-absorbing support. in this manner the system may operate either from the mains or independently thereof.
If a cytostatic subject to rapid inactivation is used in vessel 24, tube 12 is partially closed by clamp-type valve 30 and the fluid is admitted into a vessel 24 in parallel therewith, the cytostatic dropping through a retaining device 34 to the bottom of vessel 24 wherefrorn it is entrained by the treatment liquid at a rate adjusted by means of valves 25, 26 and 32.
Curve A of P10. 2 shows the normal deactivation of Mustar gen, in N/IOO HCl solution, whereas curve B indicates the same upon administration by the system according to the invention, as measured in terms of rate of hydrolysis.
If an accidental supply-voltage breakdown occurs, the electromagnetic controller 7 for valve 28, which normally is held open, is no longer energized so that the valve cuts off the perfusion circuit leading toward the patient.
The system according to the invention presents the following advantages as compared with conventional equipment:
It prevents and warns of the danger of gas emboly and pressure increase with possible rupture of the blood vessel or dislodgement of the needle;
it indicates the occurrence of thrombosis, pressure loss, or reduction in the flow rate;
it allows safe and controlled treatment, with constant pressure and flow-rate, with massive doses of cytostatics and other medications administered intraarterially, interstitially, intralymphatically and intraperitoneally;
it optically and acoustically signals the presence of a failure in the operation of the equipment or trouble with the patient, so that the medical attendants can intervene promptly and efficiently',
it allows perfusion to be performed on both bed and ambulatory patients, without unduly restricting their movements;
finally, it affords efficient utilization of short-lived cytostatics, avoids the waste of treatment fluids and; guards against the danger of harm during perfusion in case of accidental failure of a power supply.
What is claimed is:
l. A perfusion system for intravenously administering a liquid to a patient, comprising a container for said liquid; a source of gas under pressure; a gas line connecting said source to said container for subjecting the liquid therein to the pressure of the gas; a fluid line originating at said container for conveying said liquid to a perfusion implement; normally closed first valve means connected with said gas line; gauge means responsive to the gas pressure in said container for generating a first alarm signal upon said gas pressure rising above an upper limit of a predetermined range and for generating a second alarm signal upon said gas pressure falling beneath a lower limit of said range; drain means branching off said fluid line; second valve means at the junction of said fluid line with said drain means for normally directing said liquid to said perfusion implement; first control means for said first valve means responsive to said first alarm signal for venting said gas line; and second control means for said second valve means responsive to said second alarm signal for diverting said liquid from said perfusion implement to said drain means.
2. A perfusion system as defined in claim I, further comprising a drop chamber in series with said fluid line upstream of said junction and counting means connected to said drop chamber for measuring the rate of liquid flow therethrough, said counting means having an output connected to said second control means for operating said second valve means to divert said liquid to said drain means upon a substantial decrease of said rate from a predetermined level.
3. A perfusion system as defined in claim I, further comprising a bubble detector in series with said fluid line upstream of said junction for ascertaining the presence of gas occlusions in the liquid flow, said bubble detector having an output connected to said second control means for operating said second valve means to divert said liquid to said drain means in the presence of such gas occlusions.
4. A perfusion system as defined in claim I, further comprising a vessel for the storage of an additive to be admixed with said liquid, said vessel being connected to said gas line in parallel with said container for placing said additive under the pressure of said gas, said fluid line passing through said vessel ahead of said junction.
5. A perfusion system as defined in claim 4. further Comprising conduit means bypassing said vessel and further valve means for selectively dividing the flow of said liquid between said vessel and said conduit means.
6. A perfusion system as defined in claim I wherein said second control means is an electromagnetic device effective in a deenergized condition to maintain said second valve means in an off-normal position cutting off the flow of said liquid to said perfusion implement.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US2083965 *||Aug 12, 1935||Jun 15, 1937||Edelmann & Co||Compressed air operated liquid dispensing device|
|US2835252 *||Jun 6, 1955||May 20, 1958||James B Mcfadyen||Monitor apparatus for blood transfusions|
|US3014481 *||May 4, 1955||Dec 26, 1961||Georgia Tech Res Inst||Physiological fluid injection system|
|US3091239 *||Aug 25, 1959||May 28, 1963||Wilhelm Moeller||Apparatus for intravasal injection of gaseous and liquid media|
|US3252623 *||Jul 22, 1965||May 24, 1966||C F Liquidation Corp||Apparatus for monitoring dispensing of liquid|
|US3407748 *||Feb 17, 1967||Oct 29, 1968||Borg Warner Corp Corp||Blood circulating apparatus|
|US3450153 *||Jun 26, 1967||Jun 17, 1969||Gen Electric||Electrical pulse generator and regulator for fluid flow and like control systems|
|US3456648 *||May 3, 1967||Jul 22, 1969||Lpt Corp||Automatic venous infusion monitoring apparatus|
|DE494542C *||Oct 16, 1928||Mar 27, 1930||Sergey S Brukhonenko||Vorrichtung zur Herstellung eines Umlaufs von Blut oder das Leben erhaltenden Fluessigkeiten|
|FR1449713A *||Title not available|
|SU147737A1 *||Title not available|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US3731679 *||Oct 19, 1970||May 8, 1973||Sherwood Medical Ind Inc||Infusion system|
|US3731680 *||Oct 21, 1971||May 8, 1973||F Wright||Pressure regulating controller|
|US3739777 *||May 10, 1971||Jun 19, 1973||D Gregg||Intravenous feeding apparatus and system|
|US3739943 *||Feb 4, 1971||Jun 19, 1973||Sherwood Medical Ind Inc||Infusion system|
|US3838682 *||Dec 29, 1972||Oct 1, 1974||Primary Childrens Hospital||Automated blood analysis system|
|US3892236 *||Apr 2, 1973||Jul 1, 1975||Isaac Djerassi||Apparatus for filtration-leukopheresis for separation and concentration of human granulocytes|
|US3910256 *||Jul 22, 1974||Oct 7, 1975||Primary Childrens Hospital||Automated blood analysis system|
|US4018362 *||Nov 6, 1975||Apr 19, 1977||Union Chimique Continentale-U.C.C.||Automatic control for liquid flow|
|US4029094 *||Feb 17, 1976||Jun 14, 1977||Union Chimique Continentale - U.C.C. Societe Anonyme||Device for regulating perfusion flowrate|
|US4077405 *||Mar 22, 1976||Mar 7, 1978||Siemens Aktiengesellschaft||Apparatus for infusing liquids into human or animal bodies|
|US4106002 *||Dec 6, 1976||Aug 8, 1978||Hogue Jr Robert J||Tourniquet pressure monitor|
|US4382753 *||Sep 10, 1980||May 10, 1983||Avi, Inc.||Nonpulsating IV pump and disposable pump chamber|
|US4391600 *||Sep 15, 1980||Jul 5, 1983||Avi, Inc.||Nonpulsating IV pump and disposable pump chamber|
|US4410322 *||Sep 10, 1980||Oct 18, 1983||Avi, Inc.||Nonpulsating TV pump and disposable pump chamber|
|US4501531 *||Dec 5, 1983||Feb 26, 1985||Baxter Travenol Laboratories, Inc.||Control circuit for a blood fractionation apparatus|
|US4563173 *||Apr 19, 1983||Jan 7, 1986||National Biomedical Research Foundation||Pump-actuated sequencing valve and system|
|US4570639 *||Dec 30, 1982||Feb 18, 1986||Memorial Hospital For Cancer And Allied Diseases||Discontinuity detector|
|US4632275 *||Sep 21, 1984||Dec 30, 1986||Parks Charles K||Palatability stabilizer|
|US4673927 *||Oct 25, 1985||Jun 16, 1987||Hospal A.G.||Apparatus for detecting and controlling the level of a gaseous fluid|
|US4700870 *||Feb 18, 1986||Oct 20, 1987||Accuratio Systems, Inc.||Movable fluid dispenser with air bubble detectors for controlling dispenser movement|
|US4821558 *||May 1, 1987||Apr 18, 1989||Abbott Laboratories||Ultrasonic detector|
|US4857048 *||Mar 21, 1988||Aug 15, 1989||Hewlett-Packard Company||IV pump and disposable flow chamber with flow control|
|US4944191 *||Mar 7, 1989||Jul 31, 1990||Abbott Laboratories||Ultrasonic detector|
|US5328478 *||Feb 20, 1992||Jul 12, 1994||Advanced Surgical Products, Inc.||Laparoscopic irrigation bottle pump|
|US5536254 *||Sep 2, 1993||Jul 16, 1996||Advanced Surgical Products, Inc.||Laparoscopic irrigation bottle pump|
|US6368067 *||Aug 22, 2000||Apr 9, 2002||Chemand Corporation||Dual chamber liquid pump|
|US6572576 *||Jul 7, 2001||Jun 3, 2003||Nxstage Medical, Inc.||Method and apparatus for leak detection in a fluid line|
|US6638263||Oct 12, 1999||Oct 28, 2003||Durect Corporation||Regulation of drug delivery through flow diversion|
|US7008535||Aug 4, 2000||Mar 7, 2006||Wayne State University||Apparatus for oxygenating wastewater|
|US7040142||Jan 4, 2002||May 9, 2006||Nxstage Medical, Inc.||Method and apparatus for leak detection in blood circuits combining external fluid detection and air infiltration detection|
|US7087033||Jul 8, 2002||Aug 8, 2006||Nxstage Medical, Inc.||Method and apparatus for leak detection in a fluid line|
|US7255680||Oct 27, 1999||Aug 14, 2007||Cardinal Health 303, Inc.||Positive pressure infusion system having downstream resistance measurement capability|
|US7294278||Nov 4, 2005||Nov 13, 2007||Wayne State University||Method for oxygenating wastewater|
|US7462161||Jun 17, 2005||Dec 9, 2008||Chf Solutions, Inc.||Method and apparatus for blood withdrawal and infusion using a pressure controller|
|US7674237||Jun 24, 2003||Mar 9, 2010||Chf Solutions, Inc.||Method and apparatus for blood withdrawal and infusion using a pressure controller|
|US7955289||Dec 8, 2008||Jun 7, 2011||Chf Solutions, Inc.||Method and apparatus for blood withdrawal and infusion using a pressure controller|
|US8033157||Oct 1, 2007||Oct 11, 2011||Baxter International Inc.||Medical fluid air bubble detection apparatus and method|
|US8408421 *||Apr 2, 2013||Tandem Diabetes Care, Inc.||Flow regulating stopcocks and related methods|
|US8573027||Feb 26, 2010||Nov 5, 2013||Tandem Diabetes Care, Inc.||Methods and devices for determination of flow reservoir volume|
|US8702638||Aug 24, 2012||Apr 22, 2014||Gambro Uf Solutions, Inc.||Method for blood withdrawal and infusion using a pressure controller|
|US8758323||Jul 29, 2010||Jun 24, 2014||Tandem Diabetes Care, Inc.||Infusion pump system with disposable cartridge having pressure venting and pressure feedback|
|US8926561||Jul 29, 2010||Jan 6, 2015||Tandem Diabetes Care, Inc.||Infusion pump system with disposable cartridge having pressure venting and pressure feedback|
|US8986253||Aug 7, 2009||Mar 24, 2015||Tandem Diabetes Care, Inc.||Two chamber pumps and related methods|
|US9211377||Jul 29, 2010||Dec 15, 2015||Tandem Diabetes Care, Inc.||Infusion pump system with disposable cartridge having pressure venting and pressure feedback|
|US9250106||Nov 4, 2013||Feb 2, 2016||Tandem Diabetes Care, Inc.||Methods and devices for determination of flow reservoir volume|
|US20020193751 *||Apr 2, 2002||Dec 19, 2002||Felix Theeuwes||Regulation of drug delivery through flow diversion|
|US20030126910 *||Jan 4, 2002||Jul 10, 2003||Burbank Jeffrey H.||Method and apparatus for leak detection in blood circuits combining external fluid detection and air infiltration detection|
|US20040030277 *||Jun 24, 2003||Feb 12, 2004||Chf Solutions, Inc.||Method and apparatus for blood withdrawal and infusion using a pressure controller|
|US20040054333 *||Sep 5, 2003||Mar 18, 2004||Felix Theeuwes||Regulation of drug delivery through flow diversion|
|US20050230313 *||Jun 17, 2005||Oct 20, 2005||Chf Solutions Inc.||Method and apparatus for blood withdrawal and infusion using a pressure controller|
|US20060054554 *||Nov 4, 2005||Mar 16, 2006||Spears J R||Method for oxygenating wastewater|
|US20070010779 *||Jul 7, 2005||Jan 11, 2007||Utterberg David S||Blood leak monitoring method and apparatus|
|US20080183120 *||Apr 4, 2008||Jul 31, 2008||Utterberg David S||Blood leak monitoring method and apparatus|
|US20090149795 *||Dec 8, 2008||Jun 11, 2009||Chf Solutions, Inc.||Method and apparatus for blood withdrawal and infusion using a pressure controller|
|US20100065578 *||Oct 29, 2008||Mar 18, 2010||Diperna Paul M||Flow regulating stopcocks and related methods|
|EP0343501A2 *||May 18, 1989||Nov 29, 1989||Fresenius AG||Multiple infusion system|
|EP0838010A2 *||Jun 3, 1996||Apr 29, 1998||Wayne State University||High pressure gas exchanger|
|EP1964584A2 *||Oct 3, 2000||Sep 3, 2008||Cardinal Health 303 Inc.||Positive pressure infusion system having downstream resistance measurement capability|
|EP2286856A2 *||Oct 3, 2000||Feb 23, 2011||Cardinal Health 303 Inc.||Positive pressure infusion system having downstream resistance measurement capability|
|WO1981002979A1 *||Mar 17, 1981||Oct 29, 1981||Baxter Travenol Lab||Blood fractionation apparatus|
|WO1984004044A1 *||Apr 18, 1984||Oct 25, 1984||Nat Biomedical Res Found||Pump-actuated sequencing valve and system|
|WO2001026714A1 *||Oct 12, 2000||Apr 19, 2001||Durect Corporation||Regulation of drug delivery through flow diversion|
|WO2001030422A1 *||Oct 3, 2000||May 3, 2001||Alaris Medical Systems, Inc.||Positive pressure infusion system having downstream resistance measurement capability|
|U.S. Classification||604/118, 222/61, 604/147, 222/55, 128/DIG.120, 604/122, 128/DIG.130, 222/394|
|International Classification||A61M5/155, A61M5/168, A61M5/36|
|Cooperative Classification||A61M5/36, Y10S128/12, Y10S128/13, A61M5/155, A61M5/1689|
|European Classification||A61M5/168M4, A61M5/155, A61M5/36|