US3006341A - Medical fluids handling and administering apparatus - Google Patents

Description

Oct. 31, 1961 E. J. POITRAS 3,006,341

MEDICAL FLUIDS HANDLING AND ADMINISTERING APPARATUS Filed March 29, 1954 5 Sheets-Sheet 1 E. J. POITRAS Oct. 31, 1961 MEDICAL FLUIDS HANDLING AND ADMINISTERING APPARATUS 5 Sheets-Sheet 2 Filed March 29, 1954 l'zwenior Eda/(12 d cll'aifia cw,

I I M 1 WM my 332590 Oct. 31, 1961 E. J. POITRAS 3,006,341

MEDICAL FLUIDS HANDLING AND ADMINISTERING APPARATUS Filed March 29, 1954 5 Sheets-Sheet 3 laavezaoa": Edzvard JPQifJM, 6y g ff; MI /%rl(/MM M 7 flitlys United States Patent 3,006,341 MEDICAL FLUIDS HANDLING AND ADMINISTERING APPARATUS Edward J. Poitras, 198 Highland St., Holliston, Mass. Filed Mar. 29, 1954, Ser. No. 419,496 9 Claims. (Cl. 128-214) My present invention relates to medical equipment and techniques, and more particularly to an improved method and apparatus for handling medical fluids. It aims to provide an integral, unitary, closed, sealed system for such handling and with minimum chance for the con-v tamination of the fluids. In one embodiment here concerned it aflects more particularly the sterile, anti-coagulant collecting, storing and infusing of blood.

The invention will be better understood from the following description taken in conjunction with the accompanying drawing in which:

FIG. 1 is an assembly view of the embodiment of the invention adapted to handling and administering blood;

FIG. 2 shows an alternative form of one of the features of FIG. 1;

FIG. 3 is a plan of another embodiment of the medical fluids handling equipment; and

FIGS. 4 and 5 show the embodiment of FIG. 3 as fitted for shipping and storage.

A primary objective in the design and construction of apparatus for handling medical fluids is reducing and holding to a minimum the possibility of contamination of the fluids. Ideally the apparatus should be of unitary or one piece construction, thus providing an integral passage sealing the fluids against any exposure to atmosphere or contaminating influence throughout the handling and administering of the same. In the case of blood, for example, a completely sealed apparatus and a sterile technique is required for the necessary preservation of shed blood against coagulation and degradation. It has been established also that medical fluids handling equipment should be non-toxic, non-reactive, and susceptible of sterilization under medically acceptable conditions. My present invention provides new and improved means and methods which meet these requirements and specifications.

Generally considered, the apparatus of the invention comprises a unitary hermetic-sealed fluid handling systern. It incorporates centrally a closed collapsible container defining a storage means or reservoir for the fluid. Integrally associated therewith are sterile sealed assemblies for supplying and administering the fluids to and from the reservoir. Further, the unitary fluid container and conduits and associated fluid contacting elements of the invention system are fashioned of a flexible light weight material which is non-reactive to the fluids, particularly blood, and which provides a compact, inexpensive and durable apparatus.

In its embodiments adapted specially to the handling of blood, the apparatus of the invention comprises more particularly integrally associated means for the sterile collection, anti-coagulant storage, and filtered infusion of the blood. Such means are predeterminedly and importantly hemo-repellant, by which is meant that the surfaces which they present for contact with the blood are chemically inert or non-reactive, and exert repulsive forces to fend off the formed elements and proteins concerned in the blood-clotting mechanism.

In its every form, the invention system may be placed and preserved in completely sterile condition, and eifectively seals the blood or other medical fluid against contamination from any source.

Referring now more particularly to the drawing, one embodiment of the blood handling form is shown in FIG. 1, with the means for the anti-coagulant storage of the blood indicated generally at 10. Integrally associated therewith in the unitary donor-recipient set of FIG. 1 are a collecting assembly indicated generally at A and a filtering and infusing assembly identified generally at B. In accordance with the invention, in the manufacture of the central storage means 10 and also the integrally associated donor-recipient assemblies A B, a flexible, lightweight material providing inert, impermeable, glossy and non-toxic surfaces and chaarcterized also and importantly by the above defined quality of heme-repellence is employed. Other characteristics desired for and provided in the appaartus of the invention include tensile and flexural strength, or a general toughness, together with stability to sterilizing temperatures of at least C. and capacity for hermetic sealing by heat. I prefer to use materials selected from the elastomeric thermoplastic resins class and more particularly from the polyvinyl chloride group as best exemplifying these qualities and characteristics.

The blood storing means 10 comprises a deformable, collapsible contanier, vessel, or bag formed from a tubular envelope or sleeve which is closed and more particularly dielectrically heat-sealed or fused at its ends along the bands or margins 11, 12. The bag 10 is manufac tured from thin, manually manipulable stock in the tough flexible plastic material above mentioned and with a suitable volume, which may be that accommodating an adult donation together with the appropriate quantity of anti-coagulant. In one comemrcial embodiment, for example, the bag is sized for a donation of 500 cc. collected into 75 cc. of acid citrate dextrose. The described bag construction is seen to be one which is completely collapsible flatwise, and thus adapted to evacuation prior to use as desired for minimum liquid gas interface. And in use it provides a compact, lightweight and relatively indestructible blood storing means which lends itself to quick and certain handling both in the hospital and in the field.

Integrally associated with the bag 10 in my novel system is a collecting tube 13, one end of which is passed through the end wall or flatted closure 11 before it is heat sealed, or fused together and about the said tube end. The said one or inner end of the tube 13 may be stoppered or closed for a reason hereinafter apparent by a slightly oversized hemo-repellent bead 14, lodged in the same in the region of the closure 11. The free end of the tube 13 is seized over a phlebotomy needle 15 of a type adapted specially for use with the invention apparatus and shown to comprise handling and manip ulating means including a central gripping portion 150, conical hubs 15b, 15c extending oppositely thereof; and a blood letting tube or cannula 15d extending longitudinally from the hub 150. The cannula may project within the manipulating portion 15a,b,c, for the full length of the needle and may be coated interiorly with a hemo-repellent film or liner in accordance with known practice. Surrounding the said cannula 15d and tightly drawn over the proximate hub 150 is a sealing sheath 16, the outer end of which has been flatted and fused about the tip of the cannula, thereby effecting desired sterile, hermetic sealing of the needle tip and also of the entire system in unitary association therewith.

Integrally connected also to the central blood bag 10 is the outlet or infusing assembly indicated generally at B and shown more particularly to comprise outlet tube 17, which is passed through and similarly fused to the bag wall at the end seal 12. This integral outlet tube 17 is provided with a novel closure or seal located within the bag 10 but manipulated, disengaged, or removed from without the bag, and without requiring the opening of the same or the destroying or disturbing of the hermetic seal obtaining throughout the system. Such novel outlet seal is shown as a fragment of the bag material formed as a tear tab 17a supported across and detachably fused to the tube end projecting within the bag.

Further in accordance with the invention, means are provided intermediate the infusing or recipient assembly B for filtering and detecting or observing the flow of the blood. Referring still to FIG. 1, such means are seen as the drip chamber and filter assembly indicated generally at 18. My novel drip chamber and filter comprises a sleeve or larger tube flatted and fused at one end margin 19 and at an intermediate lateral band 20. The end closure 19 is sealed about the outlet tube 17, the free end of which is seen to project within the sleeve 18. A nylon mesh screen 21 of appropriate gauge is received in the chamber defined between the end and the intermediate seals 19, 20. The lower or outermost portion of this assembly or sleeve 18 is formed as a relatively rigid chamber by collapsing and fusing the lower sleeve end or margin 22 in a plane at right angles to that of the upper and intermediate lateral margins or bands 19, 20. Fluid passage between the filter and drip chambers is afforded by a tube 23 fused in and extending through the intermediate seal 20.

Outward of the described filter drip chamber in the recipient assembly is an infusing tube 24 having one end integrally received within the drip chamber and seized at the other to a suitable infusing needle 25, which latter has drawn over it a sealing sheath 26 similarly as with the collecting tube 13. The flow of the blood through the infusing or recipient tube 24 may be regulated by any suitable means, such as the control clamp or clip 27.

The collapsible blood storing and preserving means central to the described blood handling form may be provided with additional or alternative means for the outlet or discharge of the blood or blood fraction. Such means may comprise for example a relatively short tube 28, entering and fused to the bag in the same manner as and adjacent the outlet tube 17, and closed off in the region of said bag by a puncturable diaphragm 28a. The exposed, outwardly projecting portion of the tube 28 is encased with a removable sealing sheath or pouch 29 such as originally shown and described in the co-pending application of David Bellamy, S.N. 412,549, filed February 25, 1954, now Patent No. 2,894,510 and comprising duplicate strips of the bag material received and fused between the opposed walls defining the lower bag margin 12 and fused together also about said projecting tube portion so as to define a sterile sealed region or pocket 29a.

It may here be noted that for the diaphragm closures 17a, 28a there may be substituted a manually displaceable, hemo-repellent bead such as already described for the collecting assembly. In FIG. 2 the blood storing bag 30 has an outlet tube 32, into which is seized an oversized head 33, positionedoutwardly of the bag margin 31, and additionally retained by an elastic ring or clamping band 34 proportioned normally to compress the tube 32 and to contract the same about the head 33. The band 34 incorporates a manipulating tab 34a whereby the same is conveniently withdrawn from the indicated clamping position and the bead freed for manual ejection from the tube 32 into the blood pack 30.

The integral blood handling or donor recipient set of FIG. 1 is prepared for use by evacuating it and charging the bag and donor tube 13 with the indicated quantity of anti-coagulant solution, commonly acid citrate dextrose solution A, U.S.P. The apparatus is fully assembled or sealed and then sterilized according to medically accepted practice. Finally, it is folded or rolled into a compact lightweight and relatively indestructible package or kit.

In use and for collection of the blood, the bag is hung inverted, so that the blood will flow into the ACD solution. A loose knot is formed in the donor tube 13, the

sheath 16 is removed, and the needle applied for phlebotomy at a site prepared in known manner. Influx of air into the system and also efilux of the ACD solution is prevented by the bead 14, which is manually worked or milked out of the tube and into the bag 10 to permit the blood flow. The blood bag having been filled by gravity, the knot in the collecting tube 13 is pulled tight before the needle 15 is removed, thereby sealing the bag and contents against contamination. For storage of the blood, the donor tube is conveniently dielectrically sealed olf near the bag. The bag is then suspended or hung up in any convenient manner for storage, refrigerated at 4 C. i 1. It will be appreciated that by the method and with the apparatus just described, safe storage of whole blood is had for the maximum period, or for up to 25 days.

It should here be noted also that one may alternatively employ for the sterile anti-coagulant collection of the blood a blood pack equipped with an ion exchange column, such as shown and described in the co-pending application of Carl W. Walter, S.N. 174,891, filed July 20, 1950, now Patent No. 2,702,034, dated February 15, 1955.

In infusing practice, the red cells and plasma are first thoroughly mixed. The outlet closure 17a is then removed by appropriate manipulation of the bag 10 and the filter chamber squeezed and then released to establish a halfway blood level therein. The infusion needle sheath 26 may then be removed and the blood flowed to thoroughly expel the air from the recipient tube 24. When the venipuncture is made the blood is flowed by gravity, being filtered as at the screen 21, observed as at the drip chamber 219, 23, and regulated as by the control clip 27.

When the blood is outdated, or for extraction of plasma from the bag 10, the outlet tube 28 may be employed. In this the opposing strips of the tab 29 are pulled apart to expose the end of the tube and a coupler needle is inserted and seized in the same with its tip piercing the diaphragm 28a, all as shown and described in the abovementioned co-pending application of Bellamy. It will be understood that where desired such tab-sealed tube 28 may also be employed as an inlet. The same or additional blood or other fluid solutions might be desired to be introduced into the pack during or after emptying or administering the fluid originally filled. The present system permits, of course, the administering of more than one solution without removing the recipient needle from the patient. The filling of the pack through the tube 28, identical with that just described requires but the pulling apart of the opposing strips of the tab 29 to expose the ends of hte tube and the insertion of a coupler needle so as to' seize in the tube and pierce the diaphragm 28a.

Another form of the compact, lightweight, sterile sealed medical fluids handling equipment of the invention, and more particularly a unitary parenteral solution pack and intravenous set is illustrated in FIGS. 3, 4 and 5. In the embodiment therein shown the pack comprises a sleeve designated generally at 40 and formed as a collapsible bag by sealing its ends 41, 42 similarly as with the blood pack 10 already described. The opposing walls of the bag 40 are seen to be fused together at one end 41 about an inlet tube 43 and also about an outlet tube 44 forming part of a unitary infusing assembly. Said assembly further comprises a drip chamber 45 integrally coupled to the tube 44 and defined like the drip chamber of FIG. 1 by a relatively short length of larger tubing flatted and sealed at its ends in longitudinal planes which are predeterminedly normal, one to the other. Integrally coupled to the outer end of said chamber is an infusing tube 46, mounting a needle 47, the latter encased in a sealing sheath 48.

The parenteral solution pack and intravenous set of FIG. 3, is prepared for use in the same manner as the blood pack of FIG. 1, namely, by first evacuating and filling it with the desired solution and then sterilizing it in ac cordance with known practice. The bag 40 is filled through the inlet 43, which is shown as sealed off as at 43a after filling. With respect to the embodiments of FIGS. 1 and 3 it will be understood that the elements and appendages of the one may be employed interchangeably with those of the other, without departing from the invention. For example, and as will be obvious, the FIG. 3 form may be provided with fluid inlet-outlet means additional to the inlet and outlet 43, 44 there shown, as for example the upper end inlet such as illustrated at A, FIG. 1.

My present invention further comprises means for storing and preserving my novel parenteral pack without solution vapor loss and without kinking of the infusing tube prior to use. As illustrated in FIGS. 4 and 5, such means.

comprise a can or container 50 of desired proportions and in which the bag 40 is deposited, upper end 42 first. In accordance with the invention the container 50 provides in combination with the bag 40 a humid atmosphere or vapor barrier preventing the undesired drying out of the pack in storage. A protective spacer or cup 51 is next inserted in the can. The cup 51 is seen to have a bottom opening 51a such that it may he slipped down over the infusing assembly to engage, and to be of a height to confine the bag 40 in the position shown in FIG. 5. An incomplete or parti-cylindrical ring or form 52 having a radius slightly smaller than the cup 51 is next inserted in the can and positioned with its vertical wall opening opposite the drip chamber 45, FIG. 4. Kinking of the infusing tube 46 is prevented in accordance with the invention by confining it to the periphery of the can 50 and more particularly by coiling it to lay flat about and between the concentric form 52 and cup 51, FIGS. 4 and 5. The storage assembly of the parenteral pack is completed by seating the needle 47 in the complementary recesses 52a in the upper rim of the holder 52 and then applying the can cover 50a, FIG. 5. The parenteral pack is thus ordered for shipping and storage is desired vapor sealed and confined conditions and in uniquely compact lightweight assembly.

In use my novel parenteral pack is manipulated similarly as the blood pack according to a simple, sure and thorough technique. The apparatus is first arranged with the pack 40 supported for gravity or pressure flow to the patient or recipient. The sheath 48 is then removed and venipuncture eifected at a prepared site. Flow of the parenteral fluid is initiated by removing the infusing column closure, which may comprise for example a tear tab 44a sealing the bag outlet 44. The flow of the parenteral solution will be observed at the chamber 45, and may additionally be controlled in known manner.

From the foregoing it will be appreciated that my present invention provides a simple sure method and compact lightweight and durable apparatus for the handling and administering of medical fluids. Further, the collection, storage and infusion of blood has been shown to be conducted under the invention in a closed, heme-repellent, sterile sealed system, wherein air-blood interface, platelet aggregation, and contamination *of the blood is eliminated or retarded throughout its passage from donor to storage reservoir to recipient. The invention apparatus will be understood additionally to comprise apparatus for the storage and transport of the medical fluid handling equipment in desired sterile-preserving and substantially indestructible condition.

It will be understood that my invention either as to means or method is not limited to the exemplary embodiments or steps here illustrated or described, and I set forth its scope in the following claims:

I claim:

1. Apparatus for handling and administering medical fluids, comprising a collapsible bag, a fluid outlet on the bag, a fluid administering set permanently sealingly connected at said outlet and incorporating therein a drip chamber, means removably sealing the administration set at the end remote from the bag, and a closure element positioned within the apparatus at said outlet and maintaining said bag closed when said sealing means is removed to open said administration set, said closure element manipulable from without and through the walls of the apparatus to remove it from its outlet closing position and thereby to open said bag to said administration set.

2. The apparatus of claim 1 wherein said closure element is an oversized bead lodged in the outlet and which is removed by manually working it out into the bag.

3. Apparatus for the collection, storage and infusion of blood comprising storing means including a collapsible container; collecting means including a tube adapted at one end for connection to a blood supply and at the other end sealingly aifixed and admitting into the container; infusing means including a tube sealingly alfixed to and communicating with the container and means integrally associated therewith for dripordering, observing and regulating the flow of the blood; means removably sealing the outer ends of said collecting and infusing means and whereby said storing container and collecting and infusing means are integrally connected in a closed, sterile sealed system presenting a continuous donor-to-recipient passage for the blood; and closure means positioned within said system and for sealing said collecting and infusing tubes in the region of said container, said closure means manip ulable from without and through the walls of said system for removal from the sealing position and to open said collecting and infusing tubes to said container.

4. Apparatus for the collection, storage and infusion of blood comprising storing means including a collapsible container; collecting means including a tube adapted at one end for connection to a blood supply and at the other end sealingly aflixed and admitting into the container; infusing means including a tube sealingly affixed to and communicating with the container and means integrally associated therewith for drip-ordering, observing and regulating the flow of the blood; means removably sealing the outer ends of said collecting and infusing means and whereby said storing container and collecting and infusing tubes are integrally connected in a closed, sterile sealed system presenting a continuous donor-to-recipient passage for the blood; and closure means positioned within said system and for sealing said collecting and infusing tubes in the region of said container, said closure means manipulable from without and through the walls of said system for removal from the sealing position and to open said collecting and infusing tubes to said container, and at least one said closure means comprising an over-sized hemorepellent bead lodged in the associated tube.

5. Apparatus for the collection, storage and infusing of blood comprising storing means including a collapsible container; collecting means including a tube adapted at one end for connection to a blood supply and at the other end sealingly affixed and admitting into the container; in fusing means including a tube sealingly affixed to and communicating with the container and means integrally associated therewith for drip-ordering, observing and regulating the flow of the blood; means removably sealing the outer ends of said collecting and infusing means and whereby said storing container and collecting and infusing tubes are integrally connected in a closed, sterile sealed system presenting a continuous donor-to-recipient passage for the blood; and closure means positioned within said system and for sealing said collecting and infusing tubes in the region of said container, said closure means manipulable from without and through the walls of said system for removal from the sealing position and to open said collecting and infusing tubes to said container, and at least one said closure means comprising a hemorepellent bead lodged in the associated tube, a clamping ring expanded over said bead and tube, and a manipulating tab on said ring.

6. Apparatus for the collection, storage and infusion of blood comprising a collapsible bag evacuated and partially filled with an anticoagulant solution, an inlet and a plurality of outet tubes having integral connection to and defining passages opening into said bag, means re movably sealing the outer ends of said inlet and outlet tubes, and means positioned within the apparatus and removably closing said inlet and outlet tube passages in the region of said bag, said closing means being engageable to open said passages without disturbing the integral connection of said tubes to said bag.

7. Apparatus for the collection, storage and infusion of blood comprising a collapsible bag evacuated and partially filled with an anticoagulant solution, an inlet and a plurality of outlet tubes having integral connection to and defining passages opening into said bag, means removably sealing the outer ends of said inlet and outlet tubes, and means positioned within the apparatus and removably closing said inlet and outlet tube passages in the region of said bag, said closing means being engageable to open said passages Without disturbing the integral connection or" said tubes to said bag, the means closing the inlet tube being an oversized hemorepellent bead lodged in the tube and which may be manually worked out of the tube and into the bag, and the means closing one said outlet tube being a puncturable diaphragm.

8. Apparatus for the collection, storage and infusion of blood comprising a collapsible bag evacuated and partially filled with an anticoagulant solution, an inlet and a plurality of outlet tubes having integral connection to and defining passages opening into said bag, means removably sealing the outer ends of said inlet and outlet tubes, and means positioned within the apparatus and removably closing said inlet and outlet tube passages in the region of said bag, said closing means being engageable to open said passagm without disturbing the integral connection of said tubes to said bag, the means closing the inlet tube being an oversized hemorepellent bead lodged in the tube and which may be manually worked out of the tube and into the bag, and the means closing one said outlet tube being a tear tab detachably sealed across its end and manipulable for removal from without the apparatus.

e 9. Apparatus for collecting and storing blood comprising a collapsible storage bag, a flexible collecting tube permanently sealingly joined and communicating to said bag, a needle at the free end of the collecting tube, a sealing sheath removably installed on said needle, fluid delivery means permanently sealingly joined and communieating to said bag, means positioned within the apparatus and removably closing said collecting tube and said delivery means in the region of said bag, and means closing said delivery means outside said bag, said outside closing means having projecting portions adapted to be grasped between the fingers and pulled apart to open said delivery means.

References Cited in the file of this patent UNITED STATES PATENTS 714,544 Wertz Nov. 25, 1902 920,225 Van Denburgh et al May 4, 1909 2,452,644 Fields Nov. 2, 1948 2,625,264 Edwards Jan. 13, 1953 2,663,298 Rose Dec. 22, 1953 2,702,034 Walter Feb. 15, 1955 2,848,995 Ryan Aug. 26, 1958 2,894,510 Bellamy July 14, 1959 2,949,712 Bieberdorf et a1 Aug. 23, 1960 FOREIGN PATENTS 383,204 Germany Oct. 11, 1923 OTHER REFERENCES Baxter: Intravenous Solutions, Transfusion Equipment, Plasma and Serum, and Preparation Equipment, Apr. 27, 1942, 7 pages, page 3 relied upon. (Copy Div. 55, 128-214.)

Walter et al.: A Closed Gravity Technique for the Preservation of Whole Blood in Acid Solution Utilizing Plastic Equipment, Surgery, Gynecology, and Obstetrics, volume 94, No. 6, June 1952, pages 687692, pages 687- 692 relied upon. (Copy in Scientific Library.)

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