CA1310872C - Fluid recovery and transfer system - Google Patents
Fluid recovery and transfer systemInfo
- Publication number
- CA1310872C CA1310872C CA000606695A CA606695A CA1310872C CA 1310872 C CA1310872 C CA 1310872C CA 000606695 A CA000606695 A CA 000606695A CA 606695 A CA606695 A CA 606695A CA 1310872 C CA1310872 C CA 1310872C
- Authority
- CA
- Canada
- Prior art keywords
- fluid
- containers
- collapsible
- container
- rigid
- 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 - Lifetime
Links
Classifications
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B43/00—Machines, pumps, or pumping installations having flexible working members
- F04B43/08—Machines, pumps, or pumping installations having flexible working members having tubular flexible members
- F04B43/086—Machines, pumps, or pumping installations having flexible working members having tubular flexible members with two or more tubular flexible members in parallel
-
- 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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/247—Positive displacement blood pumps
- A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
- A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
-
- 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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
- A61M60/36—Medical purposes thereof other than the enhancement of the cardiac output for specific blood treatment; for specific therapy
- A61M60/37—Haemodialysis, haemofiltration or diafiltration
-
- 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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/424—Details relating to driving for positive displacement blood pumps
- A61M60/427—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
-
- 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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/424—Details relating to driving for positive displacement blood pumps
- A61M60/427—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
- A61M60/43—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic using vacuum at the blood pump, e.g. to accelerate filling
-
- 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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/424—Details relating to driving for positive displacement blood pumps
- A61M60/427—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
- A61M60/435—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic with diastole or systole switching by valve means located between the blood pump and the hydraulic or pneumatic energy source
-
- 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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/104—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
- A61M60/109—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems
- A61M60/113—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems in other functional devices, e.g. dialysers or heart-lung machines
Abstract
FLUID RECOVERY AND TRANSFER SYSTEM
ABSTRACT OF THE DISCLOSURE
A fluid recovery and transfer system utilizes hydraulic pressure on a plurality of collapsible containers to effect the alternate intake and output of a fluid from the collapsible containers. The hydraulic pressure is generated through the pumping of a pump fluid to and from a plurality of rigid containers within which the collapsible con-tainers are disposed. The pumping of the pump fluid alternately cre-ates positive and negative pressures within the collapsible containers to draw in the body fluid and to subsequently eject the body fluid. The fluids recovered in such a manner may either be stored, processed, or retransfused back to the body.
ABSTRACT OF THE DISCLOSURE
A fluid recovery and transfer system utilizes hydraulic pressure on a plurality of collapsible containers to effect the alternate intake and output of a fluid from the collapsible containers. The hydraulic pressure is generated through the pumping of a pump fluid to and from a plurality of rigid containers within which the collapsible con-tainers are disposed. The pumping of the pump fluid alternately cre-ates positive and negative pressures within the collapsible containers to draw in the body fluid and to subsequently eject the body fluid. The fluids recovered in such a manner may either be stored, processed, or retransfused back to the body.
Description
~ 3~72 FL~JID RECOVERY AND TI~S~R SYST33~M
The present invention generally relates ~o a fluid suetion trans-fer and delivery sys~em and speclfically relates to a medical x1u;d recovery and transfer system having a hydraLIlic pump which alter-nately uses positive and negative pressure to recover body f luids and either store, process, or retransfuse the recovered ~uids.
iBAlC~GRO~ OF TlHlE INVE~QN
In maIly medical procedures, body fluids axe recovered from a pa~ient in order to be stored, processed and treated, or retrans~used back to the body. Perhaps the most well kno~vn of procedwres of th1S
type involve t~e recovery of blood from a patient during sulglCal operations. The patient is coupled to a heart/lung machine which recovers blood from the patient lby means of pumps associated with the machine and subseqluently retransfuses the blood baclc to the patient. However~ pumping machines of this tyl?e a~e generally expens;ve and subJect the blood ~eing collected to SigrllfiCall~ trauma during the pumping cycle. This ;s particularly critical wlhen blood is the recovered fluid since the trauma generated in prior art systems which use either roller pumps or diaph~agm ~umps gen~rate micro emboli which ca~ affect the retransfused blood arld cause harm~l reactions in the patient.~ The trauma may also cause direct pllyslcal damage to a medical fluid, particularly blood.
At present, there is mcreased concern a~out the use o~ donor blood during surgical procedures because of ~e potential of contract-ing various diseases. Althou~ in many instances donor blood is a necessity, the retransfilsi~ of one's own blood off~s a number of advan~ages. I~ere is no need~to mat~ t~e donor w~h ~e pati~, a problem which may arise in the case of an uncommon blood type.
Perhaps more importantly t~ere is a reduced risk o:f introducing ~ :
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potentially harmful substances into the blood.
Autotransfused blood is also fresh and there is no cost associated with its storage and reprocessing as in the case of donor blood.
The recovery of body fluids is not limited to that of blood during surgical procedures. Other procedures include the suction irrigation of join1s for infection, suction irrigation for dialysis (either peritoneal or extra corporeal), gastrointestinal or urological fluid exchange, and suction recovery of cerebral spinal fluid (CSF) in hydrocephalus.
SUMMARY OF THE I~VENTION
It is an object of an aspect of the present invention to provide a fluid recovery and transfer system which is simple to operate and maintain.
It is a further object of an aspect of the present invention to provide a fluid recovery and transfer system which reduces mechanical damage to the recovered fluid during system operation.
It is still a further object of an aspect of the present invention to provide a fluid recovery and transfer system which is compatible with the sterility requirements and standard pac~aging of medical fluid products.
It is still a further object of an aspect of the present invention to provide a fluid recovery and transfer system in which the recovery of body fluids is effected by the application of hydraulic pressure to a collapsible container.
It is still a further object of an aspect of the present invention to provide in an alternate embodiment a fluid recovery and transfer system having a semi-permeable collapsible container which can be operated as a dialysis unit.
According to the present invention a fluid Pecovery and transfer system includes a plurality of rigid containers. A collapsible container is disposed within ~3~87~
2a each of the rigid containers. Each of the collapsible containers is coupled to a common intake and a common output for a fluido A pump means pumps a pump fluid to and from each of the rigid containers to hydraulically effect the alternate intake and output of the fluid from each of the collapsible containers.
According to an aspect of the invention, a ~luid recovery and transfer system comprises:
a plurality of rigid containers;
a collapsible container within each of said plurality of ri~id containers, each of said collapsible containers respectively coupled to a common intake and a common output for a first fluid; and a closed pumping circuit coupling said plurality of rigid containers;
pump means for pumping a second fluid contained in said closed pumping circuit to and from each of said plurality of rigid containers so as to hydraulically effect the alternate intake and output of said first fluid from each of said plurality of collapsible containers.
According to another aspect of the invention, a body fluid recovery and transfer system comprises:
a first and second rigid container;
a first and a second collapsible container respectively disposed within said first and said second rigid containers, said first and said second collapsible containers respectively coupled to a common intake and a common output for a body fluid; and pump means for pumping a pump fluid between said first and second rigid containers so as to hydraulically ~ effect the alternate intake and output of said body fluid : from said first and second collapsible containers.
According to another aspect of ~he invention, in a medical fluid recovery and transfer system including : first and second rigid containers, and first and second ~:- collapsible containers respectively disposed ~ithin said first and said second rigid containers, said irst and ,, ~3~ ~8~2 2b said second collapsible containers respectively coupled to a common intake and a common output for a body fluid, a method effecting the intake and output of said body fluid from said fi.rst and second collapsible containers comprises the alternate steps of:
(a) pumpiny a pump fluid from said first rigid container to said second rigid container to hydraulically effect the output of said body flui.d from said sscond collapsible container while simultaneously effecting the intake of said body fluid to said first collapsible container; and (b) pumping said pump fluid from said second rigid container to said first rigid container to hydraulically effect the output of said body fluid from said first collapsible container while simultaneously effecting the intake of said body fluid to said second collapsible container.
; According to a further aspect of the invention, in a medical fluid recovery and transfer system including first and second rigid containers, first and second semi-permeable collapsible containers respectively disposed within said first and second right containers, said first and said second semi-permeable collapsible containers respectively coupled to a common intake and a common output for a body fluid, a method of dialysis for said ; body fluid comprises the alternate steps of:
(a) pumping a dialysis fluid from said first rigid container to said second rigid container so as to hydraulically effect the output of said body fluid from said second semi-permeable collapsible container while simultaneously effecting the intake of said body fluid to said first semi-permeable collapsible container; and (b) pumping said dialysate fluid from said second rigid container to said first rigid container .. ~ so as to hydraulically effect the output of ~.~
~ 31~72 2c said body fluid from said first semi-permeable collapsible container while simultaneously effecting the intake of saicl body fluid to said second semi-permeable collapsible container;
(c) said dialysate fluid having a suitable composition to establish a concentration gradient for a material to be dialyzed between said body fluid and said dialysate fluid to cause the transfer to said material through said semi-permeable container between said body fluid and said dialysate fluid.
According to a further aspect of the invention, a pumping circuit for use with a medical fluid recovery and transfer system including first and second rigid : containers and first and second collapsible containers respectively disposed within said first and second rigid ; containers, said first and second collapsible containers respectively coupled to a common intake and a common output for a body fluid, said pumping circuit comprises:
tubing for establishing fluid communication between . said first and second rigid containers; and pump means for pumping a pump fluid between said first and second rigid containers through said tubing so ~:~ 25 as to hydraulically effect the alternate intake and output of said body fluid from said first and second collapsible c.ontainers. . : _ :~ /
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BRIEF DESC~[PIIQN OF ll~E ~WINGS
A more complete appreclatlon of the inventioll ~nd mazly of the attendant advantages ~ereof will be readily obtallned as ~e invention becomes better understood by reference to tlhe ~ollowi~
detailed descript;on when considered in connection with the accom-panying drawmgs whereim lFi~ure 1 is a schernatic representatlon of a fllliEI recovery and ~ransfer system according to ~e present inventionO
F;gure 2 is a schematic repr~sentation of a flu;d recovery ~d transfer system according to another embodiment of the present invention.
Figure 3 is a sc~ematic representation of a fluid recovery and ~ransfer system according to a ~urther embodiment of the present invention.
Figure 4 is an overhead view of the rigid enclosures of Pigure 3 showing the vertical p~eats of collapsible containers suit~le fo~
dialysis.
DETAILE;D Dl~CRDPrION OF ~I~E PREFE~ E~ODIMENT
The a~paratus shown in Figure 1 includes two cham~ers, gener-ally indicated as 1 and 2. Chamber l includes a jacket or rigid con-tainer S and a collapsiUe con~n~ 1~. Chamber 2 is similar~y config-ured to include a jacket or rlgid container 6 and a collapsi~1e container l l . The collapsilble containers may be standard intravenous surgical lbags commonly used in hospitals ~Abbott or equivalen~.
Alternatively, the collapsible container may be construeted of a semi-permeable membrane for dialysis a~plications. To ensure sterile co~-ditions, the collapsible containers are replaced a~ter each patient use.
The collapsible containexs are preferably spaced firom the inside wall~
of the rigid containers.
Vents 30 and 31 are coupled to jackets 5 and 6 respectively and serve to release any trapped ~gas or air which may be generated during ~he pumping and/or filling ~perations. Vents 30 and 31 also serve to provide a pressure bypass in the case of over~ressuri~ation of the pumping system, to provide a vacuum lock during ~e suction cycles ) ~3~ ~7~
of containers 10 and 11 and to facilitate drainage upon ~e connpletion of use of the device.
Collaps;ble contamelr~ 10 ~d 11 are respec~ively coupl~ ~
mtake and ou~qput circui~s. Tulbing 60 couI)les coIItaiiner 10 ~o OlltpUt 62 and tubing 61 couples con~iner 11 to output 62. Con~-~e~s 10 and 11 are coupled to commoIl m~ake 40 through ~ulbings 41 and 429 respectively. The pre~erred ~ng par~cularly for blood process1ng applications is heprin impregnatedl polye~hylene ~ing ~yp;cally available in a hospital transplantat;on environment The ~bing slze can be 3/8 or 1/4 inch nominal tubing. Check valves 35, 36, 37, and 38, in tubing ~0, 41, 42 and 61 reslpectively are responsive to pressure changes during the pump;ng olperation and control the Fluid flow in the respective tubings. Valves 35, 36, 37, and 38 are low pressure, low differential pressure activation, and low albrasion type valves. Valves which may be used include cardiac-type valves typically available in hospitals or equivalent valves.
The pumping circuit of tlle present in~rention is generally desig-nated as 14. The pump c;rcuit serves to trans~er a pum~ ~uid between jackets S and 6. The pump fluid used in the pumplng c;rcuit should be a body compatible fluid, e.g. normal saline, Ringer's lactate, glucose and water, etc. In the p~eferred embodiment, the pumpillg circuit is si~ed such that approximately 5 to 7 liters of the pump fluid is charged to the pump system prior to patient connection. Solenoids or gea~ activated valves 15 and 16 control the direction o~ fluid flow ~etween jackets S and 6. An arrangement of tubing, described in more detail below, permits the flow of the pump -fluid between the jac~ets.
This pumping circuit tubing can Ibe standar~ polyetllylene tubing or stainless steel pipe. The tubing size is typically 1/2 inch nomin~l diameter. Fill switches 20 and 21 enable the pumping circuit to be charged with the body compatible pump fluid from a stora~e reservoir and contain the purnp fluid wi~in ~e closed pumping drcuit. Valve 23 is used to con~ol the flow rate from the o~ldet s;de of pump 25. Pump 25 can be any posit;ve displacement pump; ~e design of pump 25 not being a critical feature of fhe present invention. Preferably, those por~ons of the pump which will be in contac~ wi~ the pump llluid are made of or X
~ S -coated with a corrosion resistant material such as stainless ste~9 teflon or ~he like~
Operation of t~e aboYe-descxibed fluid recovery ~d bransiFer system will now lbe described wlth reiFerence ~o l~igure ~. Intal~ 40 is coupled ~o the pa~ient in a manner appropriate to the recovery of IthG
fluid of interest. A ci~a~e mjector lnay be in paralle~ with ~Ihe input ~ubing 40 so ~hat for a given volume of collected blood the correct amount of citrate or o~er anti-coagulant may be i~used to preve~
~e lblood from cloffing. If ~e reco~ered fluid is ~o lbe retulrned ~ tlhe patient, outlet 62 also is appropr~ately coupled to the pat;e~O Altelr-natively, outlet 62 may lbe ex~ernally coupled so as Lo store ~e recov-ered iluid for filture use or to dispose of ~e recovered fluid.
Procedures ~o w~iclh ~is i~nvention may be directedl include9 but are not limited to, the suction irrigation of joints for in~ectioII9 suction irrigation for dialysis (either peritoneal or extra corporeal)9 suction recovery for cerebral spinal fluid (CS~;) in hydraocep~alus, gastrointestinal or urological fluid exchange, and blood recove~y an~
processing during various medical procedures. The system can be used ~or blood collection during ope~ations for retransfuslon during the same procedure or at a later tirne. The system may also lbe used as a complete extracorporeal system while t~e patient is on hear~ lbypass or awaiting heart replacement. The system has particular ut;lity as a blood dialysis unit.
Hydraulic pressure of pump fluid generated by pump 25 in pumping circuit 14 acts on a collapsible bag conta~ning the medical fluid of interest such as blood, Iblood products, and irrigation flllisiS for surgery and other procedures. Pump fluid gauge pressure in the range of about 50 to 150 mm Hg are suitable during operation of the present invention. With ~he pat;ent hooked up to the system, fluid recovery may be e~fected by alternately produc;ng negat;ve and positive pres-sures in containers 10 and 11. These positive and negative pressures are created by tlhe operation of pump 25 cluring the pumpin~g cycle to be described ~elow.
~ mmediately prior to operation, one of the collapsible containers~
e.g. 10, is empt~ and the other, e.g. 11 is filled with approximately )( :~ 3 ~ 2 one liter of body compatible fluid or blood Dur~n~g the first hal~ of the cycle, pump fluid from jacket S is pumped to jacket 6. Pump fluld from jaclcet S enters tubing SO through opening :57 and is pumped ~rom tubing 50 through respect;ve $ulbin~ 709 72 and 51 before ellt~ing jacket 6 through opening 58. The pumping of ~he pump fluid ~rom jacket S causes a negative pressure wi~m cc)ntainer 10 axld d~aws body fluid from the patient, past check valve 36 and into container 10. This intake of body fluid from the patient into con-tainer 10 continues as the lpump ilu;d is be;ng pumped from jacket 50 As pump fluid is pumped iIlto jacket 6, body fluid stored in coIltainer 11 inltially or dur;ng a previous pllmpin~g cycle is forced into outflow tubing 61 through opening 46 and past check valve 38. Check valve 37 prevents any body fluld from con~ainer 11 from entering ~e intalce system ~rough tubing 42~ The body lquid from container 11 passes through twbing 61 to output 62. Openings 45 in container 10 andl 46 ln conta;ner 11 should preferab~y extend to a position proximate to ~he bottom of ~e corresponding container and are approp~iately config-ured to preven~ any obstruction to the egress of the body fluid from ~e cont~iners during operation.
Once container 10 is filled with body fluid and co~ta;ner 11 has been emptie~, so~enoids 15 and 16 reverse d~e flow c~irection of pump fluid so that it is now pumped from jacket 6 to jacket S. Pump iluid from jacket 6 enters tubing 51 v;a opening ~8 and is pumpedl from tubing 51 througlh respective tubings 71, 73, and ~0 from w~e~e it enters jacket S through opening 57. The pumping of pump fluid ~rom jaclcet 6 causes a negative pressure within container 11 and draws body fluid from the patient, past check valve 37 and into container 11. The intake of body fluid from the pa~Lient into container 11 co~nues as ~he pump fluid ;s being pumped from jaclcet 6. As pump fluid is pumped into jacket S, body fluid stored in container 10 during ~e first half of ~e pumping cycle is forced into outflow tu~-ing 60 via opening 45 and past check valve 35. Check valve 36 pre-vents any body fluid in container 10 ~om entering the intake system via tubing 41. The body fluld iFrom container 10 passes throwgh tubing 60 to output 62. Check valve 38 prevents body Fluid from re-entering X
- 7 - ~ 3~ 372 container 11 through tubing 61 while contain~ 10 is bel~g emp~ed and container 11 is being filled~ Similarly, dluring ~e emp~ng of container 11 ~rough tulbmg 619 ~eck valve 35 preve~s body iluid from re-enter;ng con~ainer 10 throu~h tubing 60.
The body fluid recovered at output 62 ~may be treated o~ p~o-cessed in a ~umlber of ways9 par~cularly if it ;s to lbe returned ~ the pa~ent. It may be passed ~rou~ a cyclone filter which allows any air collected with the fluid to escape, or it may be oxygenated as now accomplished in known ~ear~ ~d lung machines~ Pa~cula~ matter may also be filtered. The blood may be rewarmed with a conve~o~a~
blood rewarming u~ if i~ is ~o lbe immediately xetransfilsed ~o tlhe patient. Alternatively, the collec~ed fluid may be stored for fut~lre use.
The presently pre~erred emlbodiments of the inven~on u~lize a unidirectional pump. C)therwise ~le lag time iFor llow direc~ion change would lbe inordinately long and inhibit ~e proper ~unctioI~in~
of ~e medical fluid r~covery system. While unidirectional pumps are used in ffLe presen~y preferred embodlments, ~e inYen~on should be broadly construed to embrace any pump me~anism which can ef~ect rapid cha~ge in flow direc~onO
The fluid recovery and trans~er system described a~ove offers a major advantage over tlhe current tec~nology in preservin~g the quality of ~e blood by avoiding mechanical damage through ~e pumping action. During operation of t~e s~ystem according to &e present invention, uniformly distributed pressures inherently are exerted across ~e collapsible container. This prevents ~igh impact loads or concentrated pressures from acting on the body fluid during forward propul~ion. This minimizes ~auma~ Trauma or mechanical damage generated in prior a~ roller pump or diaphragm pumps genera~0 micro emboli which can adversely affect the quali~ of the colles~ted blood.
In addition, uniformly distributed pressures reduce direct physi-cal damages ~ the medical fluid, notably ~e blood cells. The present invention also is compatible with sterili~ requirements and the con-ventional packaging of medical iluid products in flexible plastic bags~
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The system is simple to operate and maintain and avo;ds ~e use of a large number of moving partsO The system is easily s~er~l~zed ~or ~o use by iFlowing a suitable purgative such a~ e~hylene oxide or, in cer-tain cases, steam through ~e equipmentO
The system opera~ed as des~bed a~ove elimina~es ~e possilbil-i~ of an air emholism m ~e case of a ca~astrophic failure of ~e e~-lapsible conta;ner. If such a eatastrophic failure were ~o oceur9 the pump would continue to pump body compatible flu~ds ~o ~e pa~en~
w~le corrective procedures were lbeing e~fected.
The present invem~don of~ers a ~r~her advantage ove~ t~e pr~or art in ~at pulsatile flow may be provided ~hrough simple modlll~on of the output of the pump wi~ respect to ~e pump flu;do Tlle valving mechanism 23 for providing ~e pulsatile flow is varia~le so as to permit the system to be adjus~ed to ~e requirements of a given patient or other situations. C)ther adjustable parameters include body fluid flow rate, the body fluid ~emperature, and the pressure on the body ~luid.
: ~ The present invention may be modified in a number of wa~s.
Al~ough the above-des~ribed sys~em discloses two chambe~s to per-mit continuous operation of ~e pump system, otlher desirable configu-rations with a plurali~ of chambers exist which permit body ~luid selection and p~ovide for redundanc~ in ~e ~vent of a failure in the system. In addition, although ~e above-described embodiment includes a unidirectional pump for pumping the pump fluid between ~e jackets, other pumps may be used as indicated schematically in Pigure 2 wherein the same reference numerals are used ~o ;ndicate those system components which are common witlh E'igure 1.
The transfer and delivery system of ~e present ;nvention has particular utili~ as a blood dialyzer. When ~e above-described sys-tem is used ~or blood dialys;s, collapsible semi-permealble membr~es 100 and 101 which preferably are of a colTugated configura~on ~o provide a maximum amount of cross sectional area available ~or mass transfer replace containers 10 and 11 as shown ;n :Figure 3 and the system operation remains tlhe same. The semi-permeable membrane should resist passage of substa~ces of molecular weight greatex than ~ 113l~872 about lO~OOOo Suitable memlbrane materials include cupramlmoD~llm cellulose, polyacrylon~ e ~PAN)9 polymethylme~laclyla~e ~PMMA) and polycarbonate, with an appropriate pore s;~e~ e.g. alb~ut 4 microns, ~or dialysis applications. In ~is embcldiment, ~e lpump tlu;d is a dialysate fluid havin~g a composition well l~nown to ~ose s~lled in ~e dialysate ar~ The composition of the dialysa~e fluid is sllch llihat during operation of the system9 body waste products arc transfe~red across ~e membrane from ~e !body fluid (e.g. ~ood) i~o ~e dialysate pump fluid. As recognized by those skilled in ~is arl9 ~e rate at which body was~e pro~ts are remov~ ~rom ~e body fliuid can be controlled by the concentra~on gradie~t established betw2en the body fluid and the pump fluid and also is influenced by tihe lpres-sure gradient developed durin~g operation of t~e pumping circui~. By estalblishing appropriate concentration gradients, bioaf~ecting or bioactive materials also can be trans~erred across the membrane from the pump fluid into ~e body fluld.
One embodiment of ~e semi-permeable dialysls bag fea~ures four ver~cal pleats 170 as shown ;n ihe overhead v;ew of Pigure 4 of ~he rigid enclosures. The ~umber of pleats may be varied and tlhe invendon should not be unders~ood as limited m t~s respect. t)ne of ordinary skill may empirically de~e~mine the most sf~icient num~er of pleats in terms of presenting increased surface area as we;ghed against the cost of manufacture and ~e complexities of opera~on. It is also possible to configure the collapsible dialysis bag with holizontal oriented pleating (not shown).
The invention also may be applied to specialized treatments requiring the expos~e of lbody ~u~ds, par~clllarly blood, to a dru~g or other substance, such as an enzyme (e.g. urease), or a com~ination thereof, which could be swpported or bou~d on the interior surface of the collapsible container or contained in the pump fluid. This would be of prime importa:nce wllere it would be undesirable that the drug or other substance actually be in~roduced into the body of the lpatient.
Detoxification of blood or other ~ody fluids are examples of ~his applicationO
While the for~oing descl~ption is directed ~o a presen~y pre-ferred embodiment, it will be obvious to one of ordinary sldll that X
., - lo- 1310872 various modilScations m~y lbe made wi~out dep~ng iFr~m ~he ~rue spirit olr scope of ~e inven~s)n9 whlch is to be limited o~y lby ~e appended cla~ms.
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The present invention generally relates ~o a fluid suetion trans-fer and delivery sys~em and speclfically relates to a medical x1u;d recovery and transfer system having a hydraLIlic pump which alter-nately uses positive and negative pressure to recover body f luids and either store, process, or retransfuse the recovered ~uids.
iBAlC~GRO~ OF TlHlE INVE~QN
In maIly medical procedures, body fluids axe recovered from a pa~ient in order to be stored, processed and treated, or retrans~used back to the body. Perhaps the most well kno~vn of procedwres of th1S
type involve t~e recovery of blood from a patient during sulglCal operations. The patient is coupled to a heart/lung machine which recovers blood from the patient lby means of pumps associated with the machine and subseqluently retransfuses the blood baclc to the patient. However~ pumping machines of this tyl?e a~e generally expens;ve and subJect the blood ~eing collected to SigrllfiCall~ trauma during the pumping cycle. This ;s particularly critical wlhen blood is the recovered fluid since the trauma generated in prior art systems which use either roller pumps or diaph~agm ~umps gen~rate micro emboli which ca~ affect the retransfused blood arld cause harm~l reactions in the patient.~ The trauma may also cause direct pllyslcal damage to a medical fluid, particularly blood.
At present, there is mcreased concern a~out the use o~ donor blood during surgical procedures because of ~e potential of contract-ing various diseases. Althou~ in many instances donor blood is a necessity, the retransfilsi~ of one's own blood off~s a number of advan~ages. I~ere is no need~to mat~ t~e donor w~h ~e pati~, a problem which may arise in the case of an uncommon blood type.
Perhaps more importantly t~ere is a reduced risk o:f introducing ~ :
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potentially harmful substances into the blood.
Autotransfused blood is also fresh and there is no cost associated with its storage and reprocessing as in the case of donor blood.
The recovery of body fluids is not limited to that of blood during surgical procedures. Other procedures include the suction irrigation of join1s for infection, suction irrigation for dialysis (either peritoneal or extra corporeal), gastrointestinal or urological fluid exchange, and suction recovery of cerebral spinal fluid (CSF) in hydrocephalus.
SUMMARY OF THE I~VENTION
It is an object of an aspect of the present invention to provide a fluid recovery and transfer system which is simple to operate and maintain.
It is a further object of an aspect of the present invention to provide a fluid recovery and transfer system which reduces mechanical damage to the recovered fluid during system operation.
It is still a further object of an aspect of the present invention to provide a fluid recovery and transfer system which is compatible with the sterility requirements and standard pac~aging of medical fluid products.
It is still a further object of an aspect of the present invention to provide a fluid recovery and transfer system in which the recovery of body fluids is effected by the application of hydraulic pressure to a collapsible container.
It is still a further object of an aspect of the present invention to provide in an alternate embodiment a fluid recovery and transfer system having a semi-permeable collapsible container which can be operated as a dialysis unit.
According to the present invention a fluid Pecovery and transfer system includes a plurality of rigid containers. A collapsible container is disposed within ~3~87~
2a each of the rigid containers. Each of the collapsible containers is coupled to a common intake and a common output for a fluido A pump means pumps a pump fluid to and from each of the rigid containers to hydraulically effect the alternate intake and output of the fluid from each of the collapsible containers.
According to an aspect of the invention, a ~luid recovery and transfer system comprises:
a plurality of rigid containers;
a collapsible container within each of said plurality of ri~id containers, each of said collapsible containers respectively coupled to a common intake and a common output for a first fluid; and a closed pumping circuit coupling said plurality of rigid containers;
pump means for pumping a second fluid contained in said closed pumping circuit to and from each of said plurality of rigid containers so as to hydraulically effect the alternate intake and output of said first fluid from each of said plurality of collapsible containers.
According to another aspect of the invention, a body fluid recovery and transfer system comprises:
a first and second rigid container;
a first and a second collapsible container respectively disposed within said first and said second rigid containers, said first and said second collapsible containers respectively coupled to a common intake and a common output for a body fluid; and pump means for pumping a pump fluid between said first and second rigid containers so as to hydraulically ~ effect the alternate intake and output of said body fluid : from said first and second collapsible containers.
According to another aspect of ~he invention, in a medical fluid recovery and transfer system including : first and second rigid containers, and first and second ~:- collapsible containers respectively disposed ~ithin said first and said second rigid containers, said irst and ,, ~3~ ~8~2 2b said second collapsible containers respectively coupled to a common intake and a common output for a body fluid, a method effecting the intake and output of said body fluid from said fi.rst and second collapsible containers comprises the alternate steps of:
(a) pumpiny a pump fluid from said first rigid container to said second rigid container to hydraulically effect the output of said body flui.d from said sscond collapsible container while simultaneously effecting the intake of said body fluid to said first collapsible container; and (b) pumping said pump fluid from said second rigid container to said first rigid container to hydraulically effect the output of said body fluid from said first collapsible container while simultaneously effecting the intake of said body fluid to said second collapsible container.
; According to a further aspect of the invention, in a medical fluid recovery and transfer system including first and second rigid containers, first and second semi-permeable collapsible containers respectively disposed within said first and second right containers, said first and said second semi-permeable collapsible containers respectively coupled to a common intake and a common output for a body fluid, a method of dialysis for said ; body fluid comprises the alternate steps of:
(a) pumping a dialysis fluid from said first rigid container to said second rigid container so as to hydraulically effect the output of said body fluid from said second semi-permeable collapsible container while simultaneously effecting the intake of said body fluid to said first semi-permeable collapsible container; and (b) pumping said dialysate fluid from said second rigid container to said first rigid container .. ~ so as to hydraulically effect the output of ~.~
~ 31~72 2c said body fluid from said first semi-permeable collapsible container while simultaneously effecting the intake of saicl body fluid to said second semi-permeable collapsible container;
(c) said dialysate fluid having a suitable composition to establish a concentration gradient for a material to be dialyzed between said body fluid and said dialysate fluid to cause the transfer to said material through said semi-permeable container between said body fluid and said dialysate fluid.
According to a further aspect of the invention, a pumping circuit for use with a medical fluid recovery and transfer system including first and second rigid : containers and first and second collapsible containers respectively disposed within said first and second rigid ; containers, said first and second collapsible containers respectively coupled to a common intake and a common output for a body fluid, said pumping circuit comprises:
tubing for establishing fluid communication between . said first and second rigid containers; and pump means for pumping a pump fluid between said first and second rigid containers through said tubing so ~:~ 25 as to hydraulically effect the alternate intake and output of said body fluid from said first and second collapsible c.ontainers. . : _ :~ /
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BRIEF DESC~[PIIQN OF ll~E ~WINGS
A more complete appreclatlon of the inventioll ~nd mazly of the attendant advantages ~ereof will be readily obtallned as ~e invention becomes better understood by reference to tlhe ~ollowi~
detailed descript;on when considered in connection with the accom-panying drawmgs whereim lFi~ure 1 is a schernatic representatlon of a fllliEI recovery and ~ransfer system according to ~e present inventionO
F;gure 2 is a schematic repr~sentation of a flu;d recovery ~d transfer system according to another embodiment of the present invention.
Figure 3 is a sc~ematic representation of a fluid recovery and ~ransfer system according to a ~urther embodiment of the present invention.
Figure 4 is an overhead view of the rigid enclosures of Pigure 3 showing the vertical p~eats of collapsible containers suit~le fo~
dialysis.
DETAILE;D Dl~CRDPrION OF ~I~E PREFE~ E~ODIMENT
The a~paratus shown in Figure 1 includes two cham~ers, gener-ally indicated as 1 and 2. Chamber l includes a jacket or rigid con-tainer S and a collapsiUe con~n~ 1~. Chamber 2 is similar~y config-ured to include a jacket or rlgid container 6 and a collapsi~1e container l l . The collapsilble containers may be standard intravenous surgical lbags commonly used in hospitals ~Abbott or equivalen~.
Alternatively, the collapsible container may be construeted of a semi-permeable membrane for dialysis a~plications. To ensure sterile co~-ditions, the collapsible containers are replaced a~ter each patient use.
The collapsible containexs are preferably spaced firom the inside wall~
of the rigid containers.
Vents 30 and 31 are coupled to jackets 5 and 6 respectively and serve to release any trapped ~gas or air which may be generated during ~he pumping and/or filling ~perations. Vents 30 and 31 also serve to provide a pressure bypass in the case of over~ressuri~ation of the pumping system, to provide a vacuum lock during ~e suction cycles ) ~3~ ~7~
of containers 10 and 11 and to facilitate drainage upon ~e connpletion of use of the device.
Collaps;ble contamelr~ 10 ~d 11 are respec~ively coupl~ ~
mtake and ou~qput circui~s. Tulbing 60 couI)les coIItaiiner 10 ~o OlltpUt 62 and tubing 61 couples con~iner 11 to output 62. Con~-~e~s 10 and 11 are coupled to commoIl m~ake 40 through ~ulbings 41 and 429 respectively. The pre~erred ~ng par~cularly for blood process1ng applications is heprin impregnatedl polye~hylene ~ing ~yp;cally available in a hospital transplantat;on environment The ~bing slze can be 3/8 or 1/4 inch nominal tubing. Check valves 35, 36, 37, and 38, in tubing ~0, 41, 42 and 61 reslpectively are responsive to pressure changes during the pump;ng olperation and control the Fluid flow in the respective tubings. Valves 35, 36, 37, and 38 are low pressure, low differential pressure activation, and low albrasion type valves. Valves which may be used include cardiac-type valves typically available in hospitals or equivalent valves.
The pumping circuit of tlle present in~rention is generally desig-nated as 14. The pump c;rcuit serves to trans~er a pum~ ~uid between jackets S and 6. The pump fluid used in the pumplng c;rcuit should be a body compatible fluid, e.g. normal saline, Ringer's lactate, glucose and water, etc. In the p~eferred embodiment, the pumpillg circuit is si~ed such that approximately 5 to 7 liters of the pump fluid is charged to the pump system prior to patient connection. Solenoids or gea~ activated valves 15 and 16 control the direction o~ fluid flow ~etween jackets S and 6. An arrangement of tubing, described in more detail below, permits the flow of the pump -fluid between the jac~ets.
This pumping circuit tubing can Ibe standar~ polyetllylene tubing or stainless steel pipe. The tubing size is typically 1/2 inch nomin~l diameter. Fill switches 20 and 21 enable the pumping circuit to be charged with the body compatible pump fluid from a stora~e reservoir and contain the purnp fluid wi~in ~e closed pumping drcuit. Valve 23 is used to con~ol the flow rate from the o~ldet s;de of pump 25. Pump 25 can be any posit;ve displacement pump; ~e design of pump 25 not being a critical feature of fhe present invention. Preferably, those por~ons of the pump which will be in contac~ wi~ the pump llluid are made of or X
~ S -coated with a corrosion resistant material such as stainless ste~9 teflon or ~he like~
Operation of t~e aboYe-descxibed fluid recovery ~d bransiFer system will now lbe described wlth reiFerence ~o l~igure ~. Intal~ 40 is coupled ~o the pa~ient in a manner appropriate to the recovery of IthG
fluid of interest. A ci~a~e mjector lnay be in paralle~ with ~Ihe input ~ubing 40 so ~hat for a given volume of collected blood the correct amount of citrate or o~er anti-coagulant may be i~used to preve~
~e lblood from cloffing. If ~e reco~ered fluid is ~o lbe retulrned ~ tlhe patient, outlet 62 also is appropr~ately coupled to the pat;e~O Altelr-natively, outlet 62 may lbe ex~ernally coupled so as Lo store ~e recov-ered iluid for filture use or to dispose of ~e recovered fluid.
Procedures ~o w~iclh ~is i~nvention may be directedl include9 but are not limited to, the suction irrigation of joints for in~ectioII9 suction irrigation for dialysis (either peritoneal or extra corporeal)9 suction recovery for cerebral spinal fluid (CS~;) in hydraocep~alus, gastrointestinal or urological fluid exchange, and blood recove~y an~
processing during various medical procedures. The system can be used ~or blood collection during ope~ations for retransfuslon during the same procedure or at a later tirne. The system may also lbe used as a complete extracorporeal system while t~e patient is on hear~ lbypass or awaiting heart replacement. The system has particular ut;lity as a blood dialysis unit.
Hydraulic pressure of pump fluid generated by pump 25 in pumping circuit 14 acts on a collapsible bag conta~ning the medical fluid of interest such as blood, Iblood products, and irrigation flllisiS for surgery and other procedures. Pump fluid gauge pressure in the range of about 50 to 150 mm Hg are suitable during operation of the present invention. With ~he pat;ent hooked up to the system, fluid recovery may be e~fected by alternately produc;ng negat;ve and positive pres-sures in containers 10 and 11. These positive and negative pressures are created by tlhe operation of pump 25 cluring the pumpin~g cycle to be described ~elow.
~ mmediately prior to operation, one of the collapsible containers~
e.g. 10, is empt~ and the other, e.g. 11 is filled with approximately )( :~ 3 ~ 2 one liter of body compatible fluid or blood Dur~n~g the first hal~ of the cycle, pump fluid from jacket S is pumped to jacket 6. Pump fluld from jaclcet S enters tubing SO through opening :57 and is pumped ~rom tubing 50 through respect;ve $ulbin~ 709 72 and 51 before ellt~ing jacket 6 through opening 58. The pumping of ~he pump fluid ~rom jacket S causes a negative pressure wi~m cc)ntainer 10 axld d~aws body fluid from the patient, past check valve 36 and into container 10. This intake of body fluid from the patient into con-tainer 10 continues as the lpump ilu;d is be;ng pumped from jacket 50 As pump fluid is pumped iIlto jacket 6, body fluid stored in coIltainer 11 inltially or dur;ng a previous pllmpin~g cycle is forced into outflow tubing 61 through opening 46 and past check valve 38. Check valve 37 prevents any body fluld from con~ainer 11 from entering ~e intalce system ~rough tubing 42~ The body lquid from container 11 passes through twbing 61 to output 62. Openings 45 in container 10 andl 46 ln conta;ner 11 should preferab~y extend to a position proximate to ~he bottom of ~e corresponding container and are approp~iately config-ured to preven~ any obstruction to the egress of the body fluid from ~e cont~iners during operation.
Once container 10 is filled with body fluid and co~ta;ner 11 has been emptie~, so~enoids 15 and 16 reverse d~e flow c~irection of pump fluid so that it is now pumped from jacket 6 to jacket S. Pump iluid from jacket 6 enters tubing 51 v;a opening ~8 and is pumpedl from tubing 51 througlh respective tubings 71, 73, and ~0 from w~e~e it enters jacket S through opening 57. The pumping of pump fluid ~rom jaclcet 6 causes a negative pressure within container 11 and draws body fluid from the patient, past check valve 37 and into container 11. The intake of body fluid from the pa~Lient into container 11 co~nues as ~he pump fluid ;s being pumped from jaclcet 6. As pump fluid is pumped into jacket S, body fluid stored in container 10 during ~e first half of ~e pumping cycle is forced into outflow tu~-ing 60 via opening 45 and past check valve 35. Check valve 36 pre-vents any body fluid in container 10 ~om entering the intake system via tubing 41. The body fluld iFrom container 10 passes throwgh tubing 60 to output 62. Check valve 38 prevents body Fluid from re-entering X
- 7 - ~ 3~ 372 container 11 through tubing 61 while contain~ 10 is bel~g emp~ed and container 11 is being filled~ Similarly, dluring ~e emp~ng of container 11 ~rough tulbmg 619 ~eck valve 35 preve~s body iluid from re-enter;ng con~ainer 10 throu~h tubing 60.
The body fluid recovered at output 62 ~may be treated o~ p~o-cessed in a ~umlber of ways9 par~cularly if it ;s to lbe returned ~ the pa~ent. It may be passed ~rou~ a cyclone filter which allows any air collected with the fluid to escape, or it may be oxygenated as now accomplished in known ~ear~ ~d lung machines~ Pa~cula~ matter may also be filtered. The blood may be rewarmed with a conve~o~a~
blood rewarming u~ if i~ is ~o lbe immediately xetransfilsed ~o tlhe patient. Alternatively, the collec~ed fluid may be stored for fut~lre use.
The presently pre~erred emlbodiments of the inven~on u~lize a unidirectional pump. C)therwise ~le lag time iFor llow direc~ion change would lbe inordinately long and inhibit ~e proper ~unctioI~in~
of ~e medical fluid r~covery system. While unidirectional pumps are used in ffLe presen~y preferred embodlments, ~e inYen~on should be broadly construed to embrace any pump me~anism which can ef~ect rapid cha~ge in flow direc~onO
The fluid recovery and trans~er system described a~ove offers a major advantage over tlhe current tec~nology in preservin~g the quality of ~e blood by avoiding mechanical damage through ~e pumping action. During operation of t~e s~ystem according to &e present invention, uniformly distributed pressures inherently are exerted across ~e collapsible container. This prevents ~igh impact loads or concentrated pressures from acting on the body fluid during forward propul~ion. This minimizes ~auma~ Trauma or mechanical damage generated in prior a~ roller pump or diaphragm pumps genera~0 micro emboli which can adversely affect the quali~ of the colles~ted blood.
In addition, uniformly distributed pressures reduce direct physi-cal damages ~ the medical fluid, notably ~e blood cells. The present invention also is compatible with sterili~ requirements and the con-ventional packaging of medical iluid products in flexible plastic bags~
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The system is simple to operate and maintain and avo;ds ~e use of a large number of moving partsO The system is easily s~er~l~zed ~or ~o use by iFlowing a suitable purgative such a~ e~hylene oxide or, in cer-tain cases, steam through ~e equipmentO
The system opera~ed as des~bed a~ove elimina~es ~e possilbil-i~ of an air emholism m ~e case of a ca~astrophic failure of ~e e~-lapsible conta;ner. If such a eatastrophic failure were ~o oceur9 the pump would continue to pump body compatible flu~ds ~o ~e pa~en~
w~le corrective procedures were lbeing e~fected.
The present invem~don of~ers a ~r~her advantage ove~ t~e pr~or art in ~at pulsatile flow may be provided ~hrough simple modlll~on of the output of the pump wi~ respect to ~e pump flu;do Tlle valving mechanism 23 for providing ~e pulsatile flow is varia~le so as to permit the system to be adjus~ed to ~e requirements of a given patient or other situations. C)ther adjustable parameters include body fluid flow rate, the body fluid ~emperature, and the pressure on the body ~luid.
: ~ The present invention may be modified in a number of wa~s.
Al~ough the above-des~ribed sys~em discloses two chambe~s to per-mit continuous operation of ~e pump system, otlher desirable configu-rations with a plurali~ of chambers exist which permit body ~luid selection and p~ovide for redundanc~ in ~e ~vent of a failure in the system. In addition, although ~e above-described embodiment includes a unidirectional pump for pumping the pump fluid between ~e jackets, other pumps may be used as indicated schematically in Pigure 2 wherein the same reference numerals are used ~o ;ndicate those system components which are common witlh E'igure 1.
The transfer and delivery system of ~e present ;nvention has particular utili~ as a blood dialyzer. When ~e above-described sys-tem is used ~or blood dialys;s, collapsible semi-permealble membr~es 100 and 101 which preferably are of a colTugated configura~on ~o provide a maximum amount of cross sectional area available ~or mass transfer replace containers 10 and 11 as shown ;n :Figure 3 and the system operation remains tlhe same. The semi-permeable membrane should resist passage of substa~ces of molecular weight greatex than ~ 113l~872 about lO~OOOo Suitable memlbrane materials include cupramlmoD~llm cellulose, polyacrylon~ e ~PAN)9 polymethylme~laclyla~e ~PMMA) and polycarbonate, with an appropriate pore s;~e~ e.g. alb~ut 4 microns, ~or dialysis applications. In ~is embcldiment, ~e lpump tlu;d is a dialysate fluid havin~g a composition well l~nown to ~ose s~lled in ~e dialysate ar~ The composition of the dialysa~e fluid is sllch llihat during operation of the system9 body waste products arc transfe~red across ~e membrane from ~e !body fluid (e.g. ~ood) i~o ~e dialysate pump fluid. As recognized by those skilled in ~is arl9 ~e rate at which body was~e pro~ts are remov~ ~rom ~e body fliuid can be controlled by the concentra~on gradie~t established betw2en the body fluid and the pump fluid and also is influenced by tihe lpres-sure gradient developed durin~g operation of t~e pumping circui~. By estalblishing appropriate concentration gradients, bioaf~ecting or bioactive materials also can be trans~erred across the membrane from the pump fluid into ~e body fluld.
One embodiment of ~e semi-permeable dialysls bag fea~ures four ver~cal pleats 170 as shown ;n ihe overhead v;ew of Pigure 4 of ~he rigid enclosures. The ~umber of pleats may be varied and tlhe invendon should not be unders~ood as limited m t~s respect. t)ne of ordinary skill may empirically de~e~mine the most sf~icient num~er of pleats in terms of presenting increased surface area as we;ghed against the cost of manufacture and ~e complexities of opera~on. It is also possible to configure the collapsible dialysis bag with holizontal oriented pleating (not shown).
The invention also may be applied to specialized treatments requiring the expos~e of lbody ~u~ds, par~clllarly blood, to a dru~g or other substance, such as an enzyme (e.g. urease), or a com~ination thereof, which could be swpported or bou~d on the interior surface of the collapsible container or contained in the pump fluid. This would be of prime importa:nce wllere it would be undesirable that the drug or other substance actually be in~roduced into the body of the lpatient.
Detoxification of blood or other ~ody fluids are examples of ~his applicationO
While the for~oing descl~ption is directed ~o a presen~y pre-ferred embodiment, it will be obvious to one of ordinary sldll that X
., - lo- 1310872 various modilScations m~y lbe made wi~out dep~ng iFr~m ~he ~rue spirit olr scope of ~e inven~s)n9 whlch is to be limited o~y lby ~e appended cla~ms.
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Claims (23)
1. A fluid recovery and transfer system comprising:
a plurality of rigid containers;
a collapsible container within each of said plurality of rigid containers, each of said collapsible containers respectively coupled to a common intake and a common output for a first fluid; and a closed pumping circuit coupling said plurality of rigid containers;
pump means for pumping a second fluid contained in said closed pumping circuit to and from each of said plurality of rigid containers so as to hydraulically effect the alternate intake and output of said first fluid from each of said plurality of collapsible containers.
a plurality of rigid containers;
a collapsible container within each of said plurality of rigid containers, each of said collapsible containers respectively coupled to a common intake and a common output for a first fluid; and a closed pumping circuit coupling said plurality of rigid containers;
pump means for pumping a second fluid contained in said closed pumping circuit to and from each of said plurality of rigid containers so as to hydraulically effect the alternate intake and output of said first fluid from each of said plurality of collapsible containers.
2. The fluid recovery and transfer system according to claim 1 wherein said plurality of rigid containers comprises two rigid containers.
3. The fluid recovery and transfer system according to claim 2 wherein said pump means comprises a unidirectional pump.
4. The fluid recovery and transfer system according to claim 1 wherein at least one of said plurality of collapsible containers is made of semi-permeable dialysis material.
5. The fluid recovery and transfer system according to claim 4 wherein said at least one semi-permeable collapsible container includes a plurality of pleats.
6. The fluid recovery and transfer system according to claim 1 wherein a substance is bound to the interior of at least one of said plurality of collapsible containers for effecting treatment on the first fluid taken therein.
7. The fluid recovery and transfer system according to claim 1 further comprising:
means for selectively charging said closed pumping circuit with said second fluid.
means for selectively charging said closed pumping circuit with said second fluid.
8. A body fluid recovery and transfer system comprising:
a first and second rigid container;
a first and a second collapsible container respectively disposed within said first and said second rigid containers, said first and said second collapsible containers respectively coupled to a common intake and a common output for a body fluid; and pump means for pumping a pump fluid between said first and second rigid containers so as to hydraulically effect the alternate intake and output of said body fluid from said first and second collapsible containers.
a first and second rigid container;
a first and a second collapsible container respectively disposed within said first and said second rigid containers, said first and said second collapsible containers respectively coupled to a common intake and a common output for a body fluid; and pump means for pumping a pump fluid between said first and second rigid containers so as to hydraulically effect the alternate intake and output of said body fluid from said first and second collapsible containers.
9. The fluid recovery and transfer system according to claim 8 wherein at least one of said collapsible containers is semi-permeable.
10. The fluid recovery and transfer system according to claim 9 wherein said at least one same-permeable collapsible container includes a plurality of pleats.
11. The fluid recovery and transfer system according to claim 8 wherein a substance is bound to the interior of at least one of said plurality collapsible containers for effecting treatment on the body fluid taken therein.
12. In a medical fluid recovery and transfer system including first and second rigid containers, and first and second collapsible containers respectively disposed
13 within said first and said second rigid containers, said first and said second collapsible containers respectively coupled to a common intake and a common output for a body fluid, a method effecting the intake and output of said body fluid from said first and second collapsible containers comprising the alternate steps of:
(a) pumping a pump fluid from said first rigid container to said second rigid container to hydraulically effect the output of said body fluid from said second collapsible container while simultaneously effecting the intake of said body fluid to said first collapsible container; and (b) pumping said pump fluid from said second rigid container to said first rigid container to hydraulically effect the output of said body fluid from said first collapsible container while simultaneously effecting the intake of said body fluid to said second collapsible container.
13. The method according to claim 12 wherein in step (a) the pumping of said pump fluid continues until said second collapsible container is empty and said first collapsible container is full; and in step (b) the pumping of said pump fluid continues until said first collapsible container is empty and said second collapsible container is full.
(a) pumping a pump fluid from said first rigid container to said second rigid container to hydraulically effect the output of said body fluid from said second collapsible container while simultaneously effecting the intake of said body fluid to said first collapsible container; and (b) pumping said pump fluid from said second rigid container to said first rigid container to hydraulically effect the output of said body fluid from said first collapsible container while simultaneously effecting the intake of said body fluid to said second collapsible container.
13. The method according to claim 12 wherein in step (a) the pumping of said pump fluid continues until said second collapsible container is empty and said first collapsible container is full; and in step (b) the pumping of said pump fluid continues until said first collapsible container is empty and said second collapsible container is full.
14. The method according to claim 12 wherein said pump fluid is a body compatible fluid.
15. The method of claim 14 wherein said first and second collapsible containers are made of a semi-permeable dialysis material.
16. The method according to claim 15 wherein said body compatible fluid is a dialysate for said body fluid.
17. In a medical fluid recovery and transfer system including first and second rigid containers, first and second semi-permeable collapsible containers respectively disposed within said first and second right containers, said first and said second semi-permeable collapsible containers respectively coupled to a common intake and a common output for a body fluid, a method of dialysis for said body fluid comprising the alternate steps of:
(a) pumping a dialysis fluid from said first rigid container to said second rigid container so as to hydraulically effect the output of said body fluid from said second semi-permeable collapsible container while simultaneously effecting the intake of said body fluid to said first semi-permeable collapsible container; and (b) pumping said dialysate fluid from said second rigid container to said first rigid container so as to hydraulically effect the output of said body fluid from said first semi-permeable collapsible container while simultaneously effecting the intake of said body fluid to said second semi-permeable collapsible container;
(c) said dialysate fluid having a suitable composition to establish a concentration gradient for a material to be dialyzed between said body fluid and said dialysate fluid to cause the transfer to said material through said semi-permeable container between said body fluid and said dialysate fluid.
(a) pumping a dialysis fluid from said first rigid container to said second rigid container so as to hydraulically effect the output of said body fluid from said second semi-permeable collapsible container while simultaneously effecting the intake of said body fluid to said first semi-permeable collapsible container; and (b) pumping said dialysate fluid from said second rigid container to said first rigid container so as to hydraulically effect the output of said body fluid from said first semi-permeable collapsible container while simultaneously effecting the intake of said body fluid to said second semi-permeable collapsible container;
(c) said dialysate fluid having a suitable composition to establish a concentration gradient for a material to be dialyzed between said body fluid and said dialysate fluid to cause the transfer to said material through said semi-permeable container between said body fluid and said dialysate fluid.
18. The method according to claim 17 wherein said first and second semi-permeable collapsible containers include a plurality of pleats.
19. A pumping circuit for use with a medical fluid recovery and transfer system including first and second rigid containers and first and second collapsible containers respectively disposed within said first and second rigid containers, said first and second collapsible containers respectively coupled to a common intake and a common output for a body fluid, said pumping circuit comprising:
tubing for establishing fluid communication between said first and second rigid containers; and pump means for pumping a pump fluid between said first and second rigid containers through said tubing so as to hydraulically effect the alternate intake and output of said body fluid from said first and second collapsible containers.
tubing for establishing fluid communication between said first and second rigid containers; and pump means for pumping a pump fluid between said first and second rigid containers through said tubing so as to hydraulically effect the alternate intake and output of said body fluid from said first and second collapsible containers.
20. The pumping circuit according to claim 19 wherein said tubing is heprin impregnated polyethylene tubing.
21. The pumping circuit according to claim 19 wherein said pump means is a positive displacement pump.
22. The pumping circuit according to claim 19 further comprising:
check valve means positioned in said tubing and responsive to pressure changes during operation of said pump means to control fluid flow in said tubing.
check valve means positioned in said tubing and responsive to pressure changes during operation of said pump means to control fluid flow in said tubing.
23. The pumping circuit according to claim 19 further comprising:
valve means associated with said pump means to effect pulsatile flow by controlling the output of said pump means.
valve means associated with said pump means to effect pulsatile flow by controlling the output of said pump means.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/224,297 US4923612A (en) | 1988-07-26 | 1988-07-26 | Fluid recovery and transfer system |
| US224,297 | 1988-07-26 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1310872C true CA1310872C (en) | 1992-12-01 |
Family
ID=22840048
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000606695A Expired - Lifetime CA1310872C (en) | 1988-07-26 | 1989-07-26 | Fluid recovery and transfer system |
Country Status (2)
| Country | Link |
|---|---|
| US (1) | US4923612A (en) |
| CA (1) | CA1310872C (en) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5591344A (en) * | 1995-02-13 | 1997-01-07 | Aksys, Ltd. | Hot water disinfection of dialysis machines, including the extracorporeal circuit thereof |
| US6086769A (en) * | 1996-09-16 | 2000-07-11 | Commodore Separation Technologies, Inc. | Supported liquid membrane separation |
| US6027441A (en) | 1997-07-01 | 2000-02-22 | Baxter International Inc. | Systems and methods providing a liquid-primed, single flow access chamber |
| WO2004009158A2 (en) | 2002-07-19 | 2004-01-29 | Baxter International Inc. | Systems and methods for performing peritoneal dialysis |
| US8444587B2 (en) | 2007-10-01 | 2013-05-21 | Baxter International Inc. | Fluid and air handling in blood and dialysis circuits |
| US8123947B2 (en) * | 2007-10-22 | 2012-02-28 | Baxter International Inc. | Priming and air removal systems and methods for dialysis |
| US8114276B2 (en) | 2007-10-24 | 2012-02-14 | Baxter International Inc. | Personal hemodialysis system |
| US7905853B2 (en) * | 2007-10-30 | 2011-03-15 | Baxter International Inc. | Dialysis system having integrated pneumatic manifold |
| US8057679B2 (en) | 2008-07-09 | 2011-11-15 | Baxter International Inc. | Dialysis system having trending and alert generation |
| US9486590B2 (en) | 2014-09-29 | 2016-11-08 | Fenwal, Inc. | Automatic purging of air from a fluid processing system |
| CN116206744A (en) | 2015-06-25 | 2023-06-02 | 甘布罗伦迪亚股份公司 | Medical device systems and methods with distributed databases |
| AU2017381172A1 (en) | 2016-12-21 | 2019-06-13 | Gambro Lundia Ab | Medical device system including information technology infrastructure having secure cluster domain supporting external domain |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3570672A (en) * | 1969-08-28 | 1971-03-16 | Bert Bach | Artificial kidney |
| US3673612A (en) * | 1970-08-28 | 1972-07-04 | Massachusetts Inst Technology | Non-thrombogenic materials and methods for their preparation |
| GB8428013D0 (en) * | 1984-11-06 | 1984-12-12 | Flotronics Ag | Double-diaphragm pumps |
-
1988
- 1988-07-26 US US07/224,297 patent/US4923612A/en not_active Expired - Fee Related
-
1989
- 1989-07-26 CA CA000606695A patent/CA1310872C/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| US4923612A (en) | 1990-05-08 |
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| Date | Code | Title | Description |
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| MKLA | Lapsed |