US 2847007 A
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Description (OCR text may contain errors)
Aug. 12, 1958r s. L.. Fox
FLUID HANDLING UNIT AND APPARATUS IN VEN TOR. Fo Y BY Doro/zyrown A/fv/ /7 Filed July 19. 1954 STANLEYZ TM, A
United States Patent 2,847,007 FLUrD HANDLTNG UNrr AND APPARATUS 19, 1954, serial No. 444,066 12s-214) v'Application July `1-1 Claims. (Cl.
vThis invention has to do with a uid handling unit and apparatus, and is particularly concerned with a unit for collecting, storing, transporting and administering Huids, such as whole blood or plasma, or the like, in a safe, .efficient and sterile manner that eliminates the danger of contamination, breakage and other handling problems.
In hospitals, laboratories, doctors offices or4 like places, it is common practice to extract and to administer whole blood or plasma from or to persons being treated. In the handling of such fluids it is not only necessary to handle a supply thereof, but it is also necessary to take separate samples of the uid being handled so that various tests such as those for cross-matching of blood can be 'made in order'to determine the nature or type of uid being handled. Therefore, it is necessary to associate or identify the test sample with the supply'of uid handled so that the proper sample is always associated and identified with the supply of uid taken.
It is an object of this invention to provide a viluid handling unit and apparatus particularly useful for handling whole blood so that it can be storedin a container that is integrally associated with a sample container of the same whole blood, to the end that the storage container and the sampling container are'never separated thus avoiding danger of loss or confusion as to the type of blood when cross-matching the blood samples.
lt'is also an object of this invention to provide a unit and apparatus of the character referred to which includes supplemental uid containers in the form of fracturable or rupturable capsules, or the like, which contain anticoagulants, preservatives, or other saline solutions adapted to act upon the fluid in the container which is provided.
It is also an object of this invention to provide a unit and apparatus of the character referred to which provides an easily manipulated means which is adapted to be used particularly in cases of emergency when pressure infusion is desired, and the infusion or withdrawal of uid from a person may be expedited without subjecting the person to the danger of air embolism.
It is another object of this invention to provide a unit and apparatus of the character referred to which provides a simple and easily manipulated means for pumping the containers, either to fill or to exhaust uidthere'from.
A further object of this invention is to provide a unit of the character referred to vwhich is convertible in its use, to be useful either as a pressure apparatus or a vacuum apparatus. With the structure of the present invention the infusion or withdrawal of blood may be forced by a simple and easily manipulated means for pumping the containers or the administering or withdrawing of blood may be done under pressure.
It is still another object of this invention to provide a unit and apparatus to be used in the collecting, storing, transporting and administering of whole blood or plasma and which is adapted to be used in connection with a Igt4-mw Patented Aug. 12, 19,58
needle or a conventional or standard blood donor set, comprising a pair of tubular needles connected by a flexible hose or tube,which unit and apparatus is adapted to vhandle a large quantity of whole blood or plasma, as well as a small sample quantity thereof.
It is still a further object of this invention to provide a unit and apparatus as above referred to, which seals the containers handling the whole blood or plasma after the'tubular needle of the blood donor set or the like, has been removed from the unit.
It is also an object of this invention to provide a unit and apparatus'of the character referred to which is completely sterile and can be assembled as a unit and sterilized at the place of manufacture, w 'ch unit is cheap and inexpensive of manufacture so that it is expendable.
The various objects and features of the invention will be fully understood from the following detailed description of typical preferred forms and applications of the invention, throughout which description reference is made tothe accompanying drawings, in which: K A
Figs. l and 2 are elevational sectional views of the apparatus as provided by the invention, Fig. l showing the unit'of the present invention before it is iilled with uid, and Fig. 2 showing the unit of the present invention after it has been filled with iluid. Fig. 3 is an enlarged detailed sectional view of -the upper portion of the unit as shown in Fig. l. Fig. 4 is a plan section taken as indicated by line 4-4 on Fig. 3. Fig. 5 is an enlarged detailed view of a portion of the device, and Figs. 6 and 7 are views of another form of the present invention, Fig. v6 being a view of a portion of the structure similar to a portion of Fig. 2 of the drawings, and Fig. 7 being anenlarged detailed sectional view of a part of the structure shown in Fig. 6. l e
This invention involves, generally, an integral unitary structure or fluid handling unit X adapted to be inserted into a carrier or vessel Y, such as a jar or bottle which is adapted to be pressurized or vacuumized, land a coupling means Z. In accordance with the present invention the several parts of the unit X are integrally joined, that is, the several parts are permanently fastened together so that they cannot become separated. It will be apparent from the drawings that the several parts of uid handling unit X, formed-and related as shown, are such that they can be easily and practically molded or otherwise suitably for'med from a suitable plastic material, such as polyethylene or modifications thereof such as fluorinated polyethylene or chlorinated polyethylene, or various polyvinyl compounds may be used, either acetates, alcohols or chlorides, etc. The particular material or composition used in any particular case may be selected in accordance with the conditions to be met. The materials mentioned are thermo-plastics and are essentially inert at the temperatures required for the class of use indicated. Further, they are capable of being worked or formed by extrusion, injection 'or compression molding or by deposition on forms from dispersions known as plastisols or from solutions in some instances. Furthermore, it is practical to employ a material which can be molded hot so that the formation of the unit X serves to sterilize the elements thereof and may, in practice, supplement initial sterilization which may -be resorted to as circumstances require.
It is to be understood, of course, that although material such as polyethylene or polyvinyl is referred to as the material out of which to form the several parts of the unit X, it is not to be implied that the invention is limited to the use of this or any other particular material, and when the term plastic is used all other materials or combinations of materials are meant to be included within such term that may serve to carry out the inventive concept herein s et forth.
The carrier or vessel Y to which the unit X is to Ibe applied or to be inserted into may be a plunger operated and, for example, may be of a size or capacity to hold syringe-type container but is preferably a simple jar or 500 cubic centimeters of fluid. bottle shaped vessel. As shown in the drawings, the The fluid sampling container C, which may be revessel Y has a cylindrical outer wall 10, a circular bottom ferred to as a pilot, is a cell-like structure or bag, like 11 joining the outer wall at the lower end of the vessel 5 the container B, and is also characterized by a continua top 12 joining the outer wall at the upper end of the ous iinperforate wall 3@ of supple inert hlm-like matevessel, and a neck portion 13 projecting upwardly from rial, such as a vinyl plastic material. It is to be underthe top 12 and terminating in an upwardly faced openstood that there may be one or more fluid sampling coning. tainers C as circumstances require. The container C is The neck portion 13 has a threaded exterior as com- 10 a closed cell having an extension 31 in the form of a tube monly emp oyed in vessels of the type under consideraintegrally formed with the cell and provided to handle tion In the preferred form of the invention the vessel Y fluid as it flows to and from the containei C As shown is made of flexible resilient material such as polyethylene in Fig l of the drawings, the container C is initially coland may be termed a squeeze bottle. The vessel Y or lapsed and is inflatable as shown in Fig 2 and, in pracsqueeze bottle is such that it can be deformed or com- 15 tice, may be of a size to hold only a small amount of fluid pressed by suitable manipulation after which it will resay, for example, 5 to 10 cubic centimeters turn to its original shape. It is to be understood, liow- There is a plurality of connectors D joining the conever, that the Vessel Y may -be of any material. That is, tainers B and C to the head A, and each connector is a it may be a rigid vessel of glass or the like of any desirsimple tube 33 preferably molded integrally with the head able shape. A to depend from the bottom 33 thereof. For each The fluid handling unit X provided by this invention container B and C there is a passage 34 entering the top is a medical or surgical device to be employed in hospi- 22 of the head A and in communication with a tube 33, tals, doctors olces, and laboratories, or the like, for the there being a tube 33 joined to the extension projecting transfer of fluid such as whole blood from or to a donor from each container. As shown in the drawings, a tube or patient as the case may be. Referring to the drawings, 25 33 is joined to the extension 29 of the fluid storing conthe unit X includes a head A, a fluid storing container B tainer B, while a tube 33 is joined to the extension 31 carried by the head, a fluid sampling container C carried of the fluid sampling container C. It is preferred that by the head adjacent the container B, a plurality of conthe fluid containers B and C be senarate parts or elements nectors D permanently joining the containers B and C permanentiy secured to the connectors D as by heat or to the head A, aplurality of seals E at the head A and adhesives as circumstances require. closing the connectors D means F for checking flow of The seals E are provided to close the passages 34 so air through the head A, supplemental fluid supplies G that the interiors of the containers B and C are closed to carried within the containers B and C, and a protector H t e atmospheie surroundin7 the unit X and each seal may provided to cover the active portions of the unit X The be a body or plug 35 of soft yielding material, such as unit X is a complete and usable structure and may be 32 rubber oi the lilte that is easily punctured as by a needle used by itself or, as shown throughout the drawn-ius, it N and which will close together by the self-sealing action may be inserted into a vessel Y for protection and ease of the rubber or like material when the needle N is of handling and manipulation withdrawn therefrom The plugs 35 may be secured in elements of the unit X are permanently attached. That neiitly sealing them with the head A.
is, the containers B and C, the connectors D, the seals E In order to fill or empty the containers B and C, a and the supplemental fluid supplies G are all integrally conventional or standard blood donor set S may be emfastened together through the head A. In order to adapt ployed comprising a pair of tubular needles N and N the unit X to a vessel Y in the nature of a jar or bottle, connected by a flexible fluid conduit or tubin'x Si) When the head A is in the form of a stopper or cap 20 and has 45 it is desired to fill oi empty a container B or C as the a cylindrical exterior 21 proportioned to be frictionally case may be, zur is exhausted from tne donor set and the received in the neck portion 13 of the vessel Y, a flat top needle N is manipulated to punctuie the seal E closing 22 and a flat bottom 23. A laterally projecting flange 24 the container so that the container is in communication is provided at the top 22 which overlies and stops against with the other needle N which may be inserted into the the top of the neck portion 13. In addition to the above flesh of the donor or patient. When the needle N is mentioned parts, the head A is provided with a tubular removed from the seal E, the seal yieldingly closes beextension 2S that projects upwardly from the top 22 hind the needle shutting off the interior of the container forming a chamber 26 As clearly illustrated in the from the atmosphere surrounding the unit X. drawings, the extension 25 is smaller in diameter than the It S a feature 0f this HVCHOH that a Supplemental flange 24 leaving an annular shoulder 27 that faces up- 55 Huid SUPPIY G, for instance, a Secondary Ud Supply 0f wardly anti-coagulants, preservatives or other reagents or salines The Coupling means Z that is provided is adapted to is provided Suitable materials such as powders or fluids secure the fluid handling unit X to the vessel Y and inare prwded m the Supply G ready to be mlxed en hef volves a threaded colla 45 adapted to be threadedly en- Immediately before dunflg or, after use of the devilce' gged with the neck portion 13 of the Vessel Y The COL 60 The supply G may contain anti-coagulants, preservatives lar 45 has an inwardly turned gauge 45 at the upper end or other reagents or any desired saline solution In the thereof which overlies and clamps the flange 24 above case Illustrated I have Shown a Secondary or supple' Tsfed to into sealed engagement Wlth the uppel end of mental fluid container carried by the container C and the neck pom-on 13 of the Vessel Y a secondary or supplemental fluid container 60 carried by The fluid storing container B is a cell-like structure or bag and is characterized by a continuous iinperforate wall 28 of supple inert film-like material, such as a vinyl plastic material. As shown in Figs. l and 2 of the draw- 60 anc'l 60, ings, the container B is a closed cell having an extension tainers 60 and 60 are held between the sealed or joined a ends of the containers. With such an arrangement and from the container B. In preferred practice the fluid relationship 0f parts, initial app' storing container B is initially collapsed as shown in the cell, say at the rear end thereof as indicated by the Fig. l of the drawings and is inflatable as shown in Fig. 2 75 arrows in Fig. l will break the containers and liberate the lcontents thereof so that it mixes or co-,mingles with the contents of the containers. Itwill be apparent, 'however, that by suitable handling of the device the secondary containers- 60 and 60', when employed, need not be fractured or ruptured but can be fractured at any desired time, as circumstances require.
The means F provided for checking the flow of atmosphere to or from the ,vessel Y involves, generally, a simple check valve adapted to control the flow of atmosphere through the head A into or out of the interior of thevessel Y as circumstances require. yIn the preferred form of the invention where a exible vessel or squeeze bottle is employed a vent or port 37 is provided that extends through the head A from the top22 to the bottom 23 thereof, which port is somewhat tapered. When gravity and/ or venous pressure o-f the patient is employed to fill a container the port 37 is left open to allow for free flow of atmosphere from the vessel Y Or, when blood is: being given to a patient the vessel Y .may be elevated and inverted so that gravity acts to aid the liow of fluid whereupon the port 37 allows for free llow of atmosphere into the vessel Y.
A reversible valve body 38 is provided which has like tapered end portions 39 and 40 engageable in the port 37. Either end of the valve body 38 may be engaged in the port 37 so that the valve is carriedin sealed engagement with the head A.v The valve body 38 has a seat, and a valve. element 41 engages the seat checking the llow through the valve body so that the flow can occurin one direction only. It will be readily understood that when it is desired to exhaust the atmosphere from the vessel Y, it is merely necessary to arrange the valve body 38 :so that liow will occur therethrough in a direction to permit air. to be removed from the vessel and so that it cannot re-enter the vessel. When it is desired to pressurize the interior of the vessel Y, it is merely necessary to reverse the valve so that it is in a .position opposite to that above referred to. When a flexible vessel Y is employed it is a simple matter to gain the desired pumping action by manipulation of the cylindrical wall i0 of the vessel, as illustrated by the arrows in Fig, 2 ofthe drawings.
In the form of the invention shown in Figs. 6 and 7 of the drawings, a rigid vessel or substantially rigid vessel Y is employed and a separate pumping means is provided in the form of a bulb 4Z for pressurizing atmosphere Within the vessel. may be connected with the interior -of the vessel Y through a exible tubing or hose, which hose may be provided with a vtapered end portion engageable in the port 37. A valve body 38 is provided, which body Ahas like end portions 39 and 40 engageable in the bulb and the hose respectively. The body 38 has a seat, and a valve element 41' engages the seat checking the flow through the .body 38 so that flow occurs in one directiononly. the invention the valve body 38 is also provided with another seat and a valve element k41 which checks ow from the flow passage that extends through the valve body. The valve element 41 `checks .flow from `the valve body at one `end thereof as shown, so that a pumping action is obtained when the bulb 42 is manipulated to 'force air into the vessel Y as desired. It will be understood that the valve body 38 and the elements therein may be made to be reversed Or arranged in an opposite manner in order to vacuumize the vessel, if so desired.
In accordance with the present invention, a protector H is provided which closes the chamber 26 to the end that the fluid handling elements of the unit X are prevented from coming into contact with foreign objects. That is, the seals E are enclosed in the chamber 26 and are covered by the protector H which may be a simple sheet-like element 70 joined to the end `of the tubular extension 25. In practice, the element 70 is releasably joined to the extension 25 by means of an adhesive and may be removed by lifting a tab 71 with the fingers and may be re-applied to the extension 25 when desired.
--In Fig. 6 of the'drawings there is illustrated a modified formy of vblooddonor setl ,or unit S that involves generally apair of oppositely disposed needles N and a tubular body 50'. The-.tubular body 50 is closed at'. its ends -and-.is'preferably .a vrigid member forming a fluid handling jchamber. The needles N are tubularfparts and .arerigidly fastened to the ends of the body 50 topi-oject therefrom and are both in direct communication with theinterior of the chamber V80. In order to use vthe blood donor zset S it isv merely necessary to insert lone of the needles Npinto.the sealing means E, above ydescribed, whereupon the `otherzneedle N is adapted to be directly engaged withthe patient. As shown, the chamber is filled with a pack of suitable filtering material .so that the fluid lpassingzthrough'the device is cleaned of .any blood clots or foreign particles.
Fromthe foregoing it will be apparent that theiiuid handling unit X isa simple, inexpensive, sterile structure that can be easily applied to a'vessel Y and which can be utilized ,to aid'inthe extraction or administering of fluid, such. as Whole blood or plasma to or from apatent. The pilot orfsamplecontainer C, which is permanently attached tothe storing container B, is always adjacent the said storing container so that cross matching or other testing of `the pilot or sample is always associated or identified with .the-.fluid carried in the storing container.
It will ,also 'be understood from the foregoing, that the apparatusprovided can be inverted and held in an elevated position by means of a bail secured to the vessel Yzto administer'blood by force of gravity, and it will also be .apparent that in emergencies or when it is otherwise desired, it is a simple matter to speed up the ow of blood by manual manipulation ofthe apparatus provided.
Having described .only typicalpreferred forms and applications of the invention, applicant does not wish to be limited or restricted tothe specific details herein set forth, but wishes to reserve .any variations or modifications that may appearto vthose skilled in the art and fall within the scope `of the following claims.
Having .described ythe invention, applicant claims:
Vl. Acuid handling apparatus of the character described, comprising, a flexible vessel of resilient material and adapted to be deformed as by manipulation and having a neck with an opening therein, and a unitary device adapted to be carried by the vessel and including, a head to-be secured in the neck to close the opening in the vessel, a vfluid handling container permanently joined to the head, and a `tubular connector projecting from the head and -in communication .with saidvcontainer.
2. A fluid handling apparatus of the character described, comprising, a llexible vessel of resilient material and adapted to :be deformed as by manipulation and having a .neck with an Vopening therein, and a unitary device adapted to be carried `by the vessel and including, a head to be secured in the -neck to close the opening in the vessel, a lplurality-of fluid handling containers permanently joined to the head, iand a plurality of tubular connectors projecting from .the head and each in communication with a container.
3. A unitary fluid handling device of the character described, including, a single head, a plurality of fluid handling containers permanently joined to the head, there being tubular connectors projecting from the head and in communication with the containers, seals at each connector closing the connector and container in communication therewith, and a supplementary fracturable coutainer within one of the said containers and adapted to release material into the said container.
4. A fluid handling apparatus of the character described, comprising, a vessel having a neck with an opening therein, and a unitary device adapted to be carried by the vessel and including, a head secured in the neck to close the opening in the vessel, and a plurality of collapsible fluid handling containers permanently joined to the head to be carried and supported within the vessel, and
a plurality of seals in within the vessel.
6. A iiuid handling apparatus of the character described, comprising, a vessel having a neck with an opening therein, and a unitary device adapted to be carried supported within 7. A uid handling apparatus of the character described, comprising, a ilexible resilient within the vessel.
8. A fluid handling apparatus of the character described, comprising, a vessel having a neck with an opening therein, and a unitary device adapted to be carried by the vessel and including, a head to close the opening in extension forming a chamber, a plurality of collapsible iluid handling containers permanently joined to the head, tubular connectors projecting communication with the containers and with the said chamber, and
With an opento be carried by the vessel and including, a head secured in the neck in the vessel, a collapsible container 1l. A unitary fluid handling device described, including, a single head, a
of the character plurality of Huid References Cited in the lile of this patent UNITED STATES PATENTS 1,695,076 Zohe Dec. 11, 1928 1,937,566 Hanan et al Dec. 5, 1933 2,109,549 Piquerez Mar. 1, 1938 2,341,114 Novak Feb. 8, 1944 2,564,163 Leperre Aug. 14, 1951 2,757,669 Gewecke Aug. 7, 1956