US3079919A - Parenteral solution equipment and method - Google Patents

Description

March 5, 1963 R. R. HARRISON ETAL 3,

PARENTERAL SOLUTION EQUIPMENT AND METHOD 2 Sheets-Sheet 1 Filed NOV. 10, 1958 INVNTORSJ lay/8km 7*" ATTORNEYS.

March 1963 R. R. HARRISON ETAL ,9

PARENTERAL SOLUTION EQUIPMENT AND METHOD Filed Nov. 10, 1958 2 Sheets-Sheet 2 62 I www w ATTORNEYS.

limited This invention relates to parenteral solution equipment and method and, more particularly, to a novel storage and dispensing container for parenteral fluids and a method of fabricating the same.

The container with which this invention is concerned may be characterized as the collapsible type. Storage containers of this type for parenteral fluids have been known for a long period, although by no means as long as the rigid type of container which is exemplified by a glass bottle. A number of disadvantages has characterized both types, and it is a principal object of this invention to provide a container that avoids these disadvantages while, at the same time, offering new and unusual advantages in all phases of the container operation.

Another object of the invention is to provide a novel container assembly for parenteral fluids which is capable of quick and exact filling, the various elements of the assembly cooperating to define a container that has the advantage of predetermined internal volume characteristic of the previously used rigid containers, butdoes not surfer from the disadvantage of breakability thereof. Because of the cooperation of elements, the container assembly of the invention avoids the disadvantage of previously employed collapsible containers in that accurate filling was difficult to obtain, yet the assembly of the invention possesses the resistance to rupture and destruction of the 'previously employed collapsible containers.

Still another object is to provide a novel container assembly that is readily stored both before and after use. In this connection, it is to be appreciated that the previously employed containers, whether they were rigid or ,collapsible, presented storage problems, particularly if rcfrigeration of the fluid contents was required. The refrigeration space being costly required economical utilization, and such was not forthcoming from the heretofore available container equipment.

Patent 9 Yet another object is to provide a container assembly H especially adapted for the collection, storage and administration of blood, in which the assembly compactly presents all of the elements necessary for these operations. Inasmuch as the use of human blood is a delicate matter requiring, among other things, precise matching of the blood to be administered with that of the recipient, it is vital that the blood to be administered be accurately characterized and this characterization be readily and permanently available to the surgeon or other medicallytrained person intended to use the blood. To serve this need, various governmental, Red Cross, and hospital regulations require that identifying indicia, and means for verifying the identifying indicia, be associated with the blood storage container. This is presented in the inventive structure in a novel and unusual fashion. Further, in the invention, the elements serving this purpose further c0- operate with the other elements in providing a compact and unique structure.

A further object of the invention is to provide a novel container and method of fabricating the same which prointegrity and filling of various connective conduits to insure proper transfer of the fluid. Other specific objects and advantages of the invention will appear as this specification proceeds.

The invention is shown, in an illustrative embodiment, by the accompanying drawings, in which- FIG. 1 is a perspective view of the container assembly of the invention, shown in a condition which it would assume when liquid-filled;

FIG. 2 is a cross-sectional view, taken along the line 2-2 of FIG. 1;

FIG. 3 is an elevational view of the collapsible container portion of the assembly seen in FIGS. 1 and 2 and with the various elements thereof shown in a difierent operative condition;

FIGS. 4 and 5 are elevational views of the elements of an outer receptacle or confining support employed in con junction with the structure seen in FIG. 3 to provide the assembly of FIGS. 1 and 2;

FIG. 6 is an enlarged fragmentary sectional view of the outlet flow fitting portion of the collapsible container and which is seen in reduced elevational form in FIG. 3;

FIG. 7 is an elevational view of the collapsible container portion of the assembly at an early stage of its application;

' FIG. 8 is a perspective view 'of the collapsible container portion of the assembly as seen during a subsequent stage in the fabrication thereof;

- FIG. 9 is a view similar to FIG. 8 and showing a perspective view of the collapsible container portion .of the assembly but at yet a later stage in the fabrication thereof;

' FIG. 10 is a'view' similar to FIGS. 8 and 9 in that it presents perspectively the collapsible container portion of the assembly at a stage of its fabrication and subsequent to that seen in FIG. 9; and FIG. 11 is an enlarged cross-sectional view of a portion of a flow fitting employed in introducing fluid into the collapsible storage container.

In the illustration of the invention given in the drawings, and particularly with reference to FIG. 1, the numeral 10 designates generally a collapsible storage container for parenteral fluids. The numeral 11 designates generally an outer enclosure or receptacle for the container 10, the receptacle 11 being equipped with inelastic walls so as to confine the degree of distension of the flexible walls of container 10.

The container 10, as can be appreciated from'a consideration of FIGS. 1-3, when filled with liquid 12, assumes the shape of a regular polyhedron, more specifically a hexahedron. The container 10, when liquid filled, has in effect a planar base equipped with side walls extending upwardly from the perimeter of the base, the walls being united at the top thereof to provide a discrete third dimension for the figure. As illustrated, the figure could be termed a rectangular solid.

As illustrated, the container 10 is equipped with larger side walls, designated by the numerals 13, 14, 15 and 16 (seen most clearly in FIG. 2). The smaller end walls are designated 17 and 18, corresponding, respectively, to the top and bottom of the container 10. The receptacle 11 is positioned relative to container 10 so that the interior of the walls of receptacle 11 are in confining, abutting relation with the larger sides of container 10. As again best seen in FIG. 2, the receptacle 11 is equipped with four walls, designated by the numerals 19, 20, 21 and 22, which are oriented in parallel, adjacent relation with walls 1346, respectively, of container 10. The receptacle 11 can be conveniently provided in the form of two connected elements 11a and 11b, seen, respectively, in FIGS. 4 and 5. The receptacle element 11a includes walls 20 and 21, while the receptacle element 11b includes walls 22 and 19. The element 11b is equipped with laterally-extending slits 23 and 24, which releasably receive the ear portions 25 and 26, respectively, of tabs 27 and 28'. The tabs 27 and 28' are provided as integral portions of the receptacle element 11a and extend laterally from the longitudinal side edges thereof. One wall of one of the receptacle elements (wall 20 as seen in FIG. 4) is equipped with an integral extension 28 (seen also in FIG. 1) which is adapted to be pivoted into and out of coplanar arrangement with wall 20 about a crease or fold line 29, the purpose of which will be explained in detail hereinafter.

Each of the receptacle elements 11a and 11b is equipped with a centrally positioned, longitudinally-extending fold line 30 and 31, respectively, which permits the faces of each element to be pivoted or articulated relative to each other. The laterally-extending tab portions' 27 and 28 of receptacle element 11 are also equipped with lines of weakening as at 32 and 33, respectively,which permit articulation of the adjacent connecting walls of the two elements when they are in a connected condition. Because of the presence of the various fold lines, the receptacle 11, when assembled, is adapted to assume the generally rectangular shape seen in FIG. 2 when the container which it confines is liquid filled, while, when the container 10 is empty, the receptacle 11 can be collapsed on itself to a substantially lay-fiat condition. It is to be appreciated that a complete lay-fiat condition cannot be achieved whenever the container 10 is positioned within the receptacle 11, inasmuch as the container 10 has a discrete thickness even when collapsed. However, the substantially flat condition of the assembly, including container 10 and receptacle 11, permits efficient storage prior to use of the assembly.

Also because of the articulatable nature of the various sides defining receptacle 11, the assembly A, including both container 10 and-receptacle 11, can be readily filled to yield a predetermined internal volume without the need of manipulating the receptacle 11. In other words, the distension of container 10 from its collapsed condition to that shown in FIG. 2, for example, automatically results in the change of receptacle 11 from its lay-flat condition to the condition shown in FIG. 2.

Effective use of the assembly A can be had when the relatively inelastic walls of receptacle 11 are constructed of a substantially rigid material such as a paperboard. Here, it is to be appreciated that heavy and perfectly rigid Walls are usually not required, inasmuch as the pressure applied to the liquid being introduced into container 10 is relatively low. This would be the venous pressure in the event the container 10 is employed as a blood storage container. The relatively low venous pressure is capable of expanding a collapsed container 10 such as might be constructed of a vinyl plastic, but is incapable of circumferentially expanding the paperboard walls employed in receptacle 11. 7

In the course of a filling operation, the wall extension 28 is initially positioned out of alignment with walls 20 as by being pivoted outwardly to the position shown in dotted line in FIG. 1 and designated by the numeral 28a. As the filling operation nears completion, a slight pressure is exerted on wall 20, causing it to bulge slightly outwardly, which results in immediate pivoting of the extension 28 into the coplanar relationship with wall 20 seen in FIG. 1. Thus, the extension 28 provides an immediate and quickly ascertainable visual indication of the completion of the filling operation. This is of particular utility when the assembly A is used in the collection of blood, since a predetermined and exact amount of blood is required to -be collected. Collecting too much or too little blood may seriously upset the course of therapy of an intended recipient of the blood. Also, the requirements of the National Institutes of Health permit only the donation of 500cc. of blood each six weeks by a given donor. So it is also importantfrom the standpoint of the donor to know how much blood is collected. Further, the blood, because of its perishable nature, must be fortified with an anti-coagulant material, and the effectiveness of an anti-coagulant material is dependent, to large extent, upon its concentration. Initially, the container 10 is charged with a quantity of anti-coagulant material, generally in the form of a solution, intended to effectively preserve a predetermined quantity of blood. An excess of anti-coagulant may cause damage to the red blood cells. An inadequate amount of anti-coagulant material may mean that the red cells deteriorate more rapidly than is expected. Hence, it can be seen that inaccuracy in the amount of blood collected in either direction from that prescribed can result in possible loss of the entire quantity of blood. Ordinarily, blood is expected to be useful even after storage up to about three weeks, and surgeons, relying upon this, may find that the blood so stored is in effective because of the collection of an inaccurate amount. This is all avoided in the invention, since the degree of expansion of the flexible-walled, collapsible container 10 is limited by receptacle 11. At the same time, the advantages of a flexible, unbreakable container are provided.

We have found that the use of the assembly A in the collection of blood, for example, is able to limit the quantity of blood collected to within about 5% of that prescribed. This is well within the tolerance prescribed by governmental and Red Cross regulations, even for glass bottles. In glass bottles, a tolerance is necessary since the bottles are not permitted to be fully filled, merely to a graduation mark, and the bottles themselves are generally somewhat irregular by virtue of the mass manufacturing operations. Hence, the assembly of the invention through the cooperation of the container 10 and the receptacle 11 achieves the long-desired accuracy of filling, while eliminating the danger of loss through breakage of the container.

In this connection, we should like to point out that the open ends of the receptacle 11, i.e., the portions of the receptacle 11 which expose walls 17 and 18 of container 10, permit a slight distention of these walls. However,

these walls are smaller walls and constitute a minor por-.

tion of the outer confinable surface of the container 10.

The container 10,'as previously described, is preferably in the form of a rectangular solid when liquid filled, with the walls 13-16 having the longest dimension. Aiding in eliminating the distension of walls 17 and 18, are the diagonally-oriented ribs 34 and 35, which are provided integral with the end walls 17 and 18 as an incident of the application of container 10. These ribs serve to stiffen the ends walls and limit their distension to a prescribed and ascertainable amount.

Referring now specifically to FIG. 3, it is seen that the container 10 is equipped with integral, laterallyextending tabs or ears 36 and 37. The tabs 36 and 37 are positioned at opposite sides of the container 10 at ends of the longitudinal lines38 and 29, respectivelythe lines 38 and 39 being defined by the intersection between adjacent side walls of container 10. Line 38 is defined by the union of wall 13 with wall 14, While line 39 is defined by the union of wall 15 with wall 16. Joined to tabs 36 is a flap 40, while flap 41 is joined to tabs 37.

' The orientation of these elements, as viewed from above,

can be seen in FIG. 2. The flap 40 serves as an outer wrapper for the assembly A, and can be conveniently imprinted with identifying information for the material stored within container 10. Where container 10 is employed for the collection of blood, the flap 41 can be compartmented to provide pockets 42 which receive serology sample tubes 43. Preferably, the height of flap 41, and thus the pocket 42, is somewhat greater than the height of the serology sample tube 43, so that the tube 43 can be sealed within the pocket 42, thereby insuring that the sample tube 43 will remain with the unit, or, if it is removed, its removal will be apparent. In the course of blood collection, routinely, at least one, and possibly more, serology tubes are filled with the donated blood, so that the blood type and character can be checked just prior to administration. Now it is possible to provide the serology tube as an integral part of the main blood storage container and to keep the tube closely associated throughout the effective life of the blood. This avoids the possibility that the tube may become dissociated from the main storage container and thus the opportunity for cross-matching the blood lost.

In the assembly A, the flap 41 is positioned exteriorly of receptacle 11 and is confined against the outer wall surfaces of receptacle 11 by flap 40, which is equipped with an insert tab 49a, the insert tab 40a being releasably held in place between flap 41 and receptacle 11, as best seen in FIG. 2. The flaps 40 and 41, being also constructed of a flexible material as is container 10, permit the assembly to be provided with the flap 40a in the position seen in FIG. 2 even when the assembly A is in collapsed condition. Thus, the provision of the flaps 40 and 41a cooperate with the receptacle 11 and container in providing a securely attached means for identifying the liquid stored within container 10. The provision of the spaced apart tabs 37, to which flap 41 is connected, facilitates the ready insertion of tab 40a as seen in FIG. 2.

The liquid contents of container 10 are readily removable through a flow fitting designated'generally by the numeral 44, and which is seen most clearly in FIG. 6. The flow fitting 44 is seen to be mounted in a projection 45 provided in the reinforcing rib 35 located in the top end wall 17 of container 10. As will be brought out hereinafter, the container 10 is constructed oftwo flexible sheets which are perimetrically united together. Thus, then, the projection'45 includes two walls derived from these sheets, one of which is designated in FIG. 6 by the numeral46. At the end of projection 45 remote from rib 35, a tube 47 constructed of similar plastic material is positioned between the plastic sheets making up projection 45. Ensleeved about tube 47 is a resilient tube 48 which extends inwardlyof projection 45. The tubes 47 and 48 are secured in fiuid-tight'relation with the sheets making up projection 45 by means of fusing portions of the sheets together about tube 48, as by heat-sealing, the heat-sealed portion being designated by the numeral 49. The sheets, including the sheet 46 shown in FIG. 6, are further united interiorly of the inner end of .tube 48 at a plurality of spaced-apart points 5!). Removably mounted within tube 48 is a bead or ball 51 constructed of a material such as metal that renders the bead manually manipulatable out of the tubing to a position within the chamber 52 defined by projection 45 and the spaced-apart united points 56. The spaced-apart points 50 are so spaced as to prevent the passage of ball 51 therebetween and to serve as a strainer to prevent clots of blood from entering the administration set.

Tube 47, exteriorly of projection 45, is equipped with an extension 53, the extension 53 being housed within a sheath 54, both extension 53 and sheath 54 being constructed of a heat-sealable, thermoplastic material.

Means for introducing liquid into container 10 is provided in the form of an elongated tube designated generally by the numeral 55 and seen best in FIGS. 1 and 3. The flexible tube 55 is secured in rib 35 at a point spaced laterally of the securement of flow fitting 44. For this purpose, a second projection 56 is provided, the projection prior to receipt of the How conduits being pictured in FIG. 8. The tubing 55 in the portion thereof received Within projection 56 may be conveniently united with the sheets forming projection 56 by heat-sealing. Th'eend of tubing 55 remote from container 10 is equipped with a plug closure designated generally by the numeral 57, and which is seen in enlarged, cross-sectional form in FIG. 11. The tubing 55 is seen equipped with telescoping, rigid tubular elements 58 and 59, which can be conveniently constructed of a nonplasticized, vinyl plastic material. Extending around the tubular element 59 is a resilient sleeve 60 which also extends about a rubber end closure 61. The rubber end closure is of sufiicient thickness and resiliency as to reseal itself after being punctured by a hypodermic needle. The provision of the tubular elements 58 and 59 results in an enlarged portion in the tubing 59 and which is designated by the numeral 62. The enlarged portion 62 safeguards the tubing 55 against inadvertent puncture by a needle thrust through closure 61 by providing a space into which the needle can pass, and one equipped with tough side walls.

The fabrication of the container 10 can be best appreciated from a consideration and comparison of FIGS. 7-10 of the drawings. These figures represent various stages of completion of the container 10 and its associated, cooperating elements. In FIG. 7, the initial stage of fabrication is represented. There, a sheet 63 is seen provided with a six-sided contour which might be described as a hexagonal contour. The contour departs from a precise hexagon in that two of the apices 64 and 65 are in the form of right angles, while the remaining four apices 66, 67, 68 and 69 are formed by angles of 135. Two sheets 63 are provided in superposed relation and are perimetrically united except in the areas of the various projections, i.e., 45, 56, 36 and 37. The fact that the two sheets are not secured together in the area of these projections can be appreciated from a consideration of FIG. 8, where the two projections 36 and 37 are clearly seen to have accompanying projections from another sheet. y

In the fabrication of the container 10, two sheets may be superimposed and severed in the contour shown along with the uniting operation, all in a single die. At the same time, we have found it desirable to perforate the apex portions 64 and 65 along bisecting lines 64a and 65a. This, along with perforating through the apex portions 64 and 65.as at 64b and 65b, is helpful in the subsequent manipulation-step which provides a three-dimensional envelope out of the two-dimensional envelope picturedin FIG. 7. The manipulation step involves positioning the apex-forming edges 70 and 71, in the case of apex 64, in superposed relation. This then results in the line of perforation 64a and its companion on the sheet below forming the edges of the apex. The sheets making up the apex are then united together along a line perpendicular to the superposed edges 70 and 71 and which passes through the midpoints of those edges. The line of union just referred to, prior to manipulation of the apex 64 tobring the edges 70 and 71 into superposition, would assume the dotted line configuration designated by the numeral 34 in FIG. 7. After the union along line 34 is achieved and the apex area 64 detached, the configuration of FIG. 8 results, where again the numeral 34 designates the line of union and the numeral 35 desighates the line of union (also a reinforcing rib) that results from the combination of edges 70 and 71. As can be appreciated from a comparison of FIGS. 7 and 8, the union of the sheets along the line 34 brings the two dotted lines of FIG. 7 together to form the single solid line of FIG. 8. The triangular areas 72 and 73 of FIG. 7 are reoriented by this operation to the positions shown andso designated in FIG. 8.

A corresponding operation is provided at the opposite end of the hexagonal figure 63, wherein apex portion 65 is manipulated to bring edges 74 and 75 into superposition. This is effectively achieved by bringing openings 65b into registry, these openings being located equal distances from the perforated line 65a and along the same perpendicular thereto.

In the case of the transverse sealing of the manipulated apex portions 65 along the line 34a, there is no 7 by punching an opening 77 therein, the opening prior to manipulation being designated by the dotted'hne 77a 1n FIG. 7. The rounded contour of the hanger 76, which is designated in FIGS. 8 and 10 by the numeral 78, is

designated by the numeral 7 8a in FIG. 7.

The apex portion 65 is creased along the line 79 which forms an angle 80 of 22 /2 with line 34a. This permits the hanger to be folded inwardly of the container 10 so that the hanger will lay fiat when the bag i empty.

At the time of providing the perimetric union about the sheets illustrated in FIG. 7, the spaced-apart points of union 50 may also be provided, as seen in FIG. 8. In FIG. 9, the structure of FIG. 8 has been further modified by the introduction of tubing 55 into the pro jection 56 and the flow fitting 44 into the projection 45. Preferably, these conduit elements and the container 10 are constructed of heat-scalable plastic material, so that the securement is readily achieved. Thereafter, the flaps 40 and 41 are inserted between the tabs 36 and 37 and the tabs 36 and 37 joined together to complete the closure of the container 10 and also securely afiix the flaps.

In the operation of the assembly A, the container 10 7 portion is fabricated according to the foregoing procedure and prior to the equipping of flow fitting 44 with the sheath 54, a suitable quantity of anti-coagulant solution is introduced. For this purpose, the ball 51 is temporarily displaced from its mounting in tube 48. Thereafter, the ball is returned to the position seen in FIG. 6 and the container 10 is manipulated freely Without fear of loss of the anti-coagulant solution. Thereafter the sheath 54 is applied. After sterilization, the integrity of the container 10 when mounted in receptacle 11 can be readily ascertained merely by applying a collapsing pres sure to the assembly A. In approaching a lay-flat condition, the anti-coagulant solution is forced against the various seals or unions of container 10 and attempts to escape therethrough. The seals or unions most likely to leak are those along lines 34 and 35 and the course in end wall 17 and the corresponding ribs or unions in the other end face 18. These are exposed to view, and visual inspection readily permits the tester to see whether these seals are fluid-tight.

When the assembly A is employed in the collection of blood, the flask needle of a blood donor set (not shown) is inserted through the resilient closure 61. Thereafter, the assembly A is squeezed as inthe testing procedure to direct anti-coagulant into the donor set. As blood is caused to flow into the unit under the venous pressure of the donor, the assembly A appears to be in continual motionan unfolding motion similar to the opening of flower petals. This overcomes a serious drawback in heretofore-employed collapsible containers where cessation of the donated blood flow could only be inferred from the fact that the collapsible unit failed to continue to expand. Inasmuch as the rate of expansion is in'some cases relatively slow, it might :be a considerable period of time before the blood flow cessation was noted. Minimizing of the time of collection is, of course, important, since the red cells deteriorate rapidly unless maintained under refrigeration. Also, the red cells clot rapidly in the absence of an anti-coagulant solution, this being the condition of the donor set where the initial charge of anti-coagulant has been returned to container 10. Thus, rapidity of collection is important. At the close of the collection of blood, discrete amounts of the donated blood can be introduced into one or more of the serology sample tubes 43 for testing to identify the blood both at the time of donation and subsequently-as at the time of administration.

During the course of collection, the blood collection rate can be readily increased through the use of various pumping techniques and devices without impairing the efiective operation of the assembly. Ordinarily, however, a gravity collection is contemplated in which the assembly A is positioned below the donor. Unlike previ- 5 ously employed collapsible containers for this purpose, it is not necessary to employ a reduced pressure vessel to confine the container 10 and exert an opening force on it. Although the container 10 is adapted to collapse to a substantially lay-fiat condition, its organization causes it to readily unfold as liquid is introduced, and tends to assume a regular solid shape.

The completion of the collection of the desired amountof blood is visually noted by the position of the extension 28. Inadvertent collection of too much blood is prevented by the confining action of the receptacle 11 on the container 10. After the collection is completed, it is possible to discard the receptacle 11, this being done by merely opening the flaps 40 and 41 to the condition shown in FIG. 3 and detaching the ears 25 and 26 from the slots 23 and 24. Thereafter, the flaps can be returned to the conditionseen in FIG. 2, since the tab 40a of flap 40 can be inserted into the slot 41a between the spaced-apart tabs 37 mounting flap 41 on container 10. Inthis condition, the blood can be stored for convenient periods in a refrigerator, or like device, with the container 10 remaining in its generally rectangular solid shape. In this way, a minimum of valuable space is lost, since the block-like configuration of container 10 makes for economical and eflicient packing of any storage device. If desired, the tubing 55 may be severed from the container 10 and the stub portion heat-sealed by a suitable sealing iron. Alternatively, the tubing may be severed and the remaining portion knotted. If neither procedure is desired, the closure portion 57 may be inserted into one of th pockets 42 that is not employed for the support of serology samply tubes. Ordinarily, one of the serology sample tubes would be employed immediately so as to characterize the blood for information to be placed on the label flap 40. Thus, an empty pocket is available for this purpose. The space between pockets 42 and further closed by flap 40, such as is designated by the numeral 42a in FIG. 2, may be used as a further chamber for the receipt of the closure 5-7, either before or after collection.

The serology sample tubes 43 during the collection and storage of the blood are maintained in close physical contact with the main body of the blood. This insures that cooling of the blood both in tubes 43 and container 10 proceeds at about the same rate so that clotting due to cooling, for example, is equalized in both. The equality of cooling is further implemented by the fact that the tubes 43 are effectively insulated by the flap 40 in addition to the pocket Wall.

When it is desired to administer the contents of container 10, the flask needle or connective portion of an administration set is introducedinto extension 53 of flow fitting 44. For this purpose, the sheath 54 may either be severed to permit access, or, because of its length, it may be conveniently folded over and the flask needle inserted through the walls of the plastic sheets making up sheath 54. To commence the administration, the ball 51 is removed from its position within tube 48, and liquid 12 from container 10 is permitted to flow out under the influence of gravity to the intended recipient. At any time during the course of the administration, pressure can be applied to the container 10, either manually or otherwise, so as to accelerate the dischargeof liquid 12 from container 10. In most cases, this is not required, since a suitable flow is established by extending the container '10 by means of hanger 76 a suitable distance above the body of the recipient.

If the liquid 12 in container 10 is blood and has not been administered before it has become outdated, the provision of the replaceable bead or ball 51 makes it pos sible to aspirate the plasma portion of the blood from container 10 and thereafter retain the residual red cells in a sterile condition. The container 10 is constructed of a flexible material sufliciently transparent to permit the technician to readily ascertain the line of demarcation be-' tween the plasma and red cells. Prior to use, the transparent walls also permit the anti-coagulant solution to be visually examined for the presence of contaminants such as particulate matter.

In some cases however, it may be desired to dispense with the bead or ball valve 51 while still retaining the spaced seals 50 for their straining action. Closure of the conduit 44 can, in such case, be effected by folding the projection 45 on itself.

While, in the foregoing specification, we have set forth a specific structure in considerable detail for the purpose of illustrating an embodiment of the invention, it will be understood that such details of structure and procedure may be varied widely Without departing from the spirit of the invention.

We claim:

1. Apparatus for the collection, storage and administration of human blood comprising a sterile, collapsible container constructed of a flexible, translucent, heat-scalable material and when liquid-filled assuming generally the shape of a rectangular solid, the end faces of said container being equipped with diagonal ribs defining the union of sheets of said material, one of said ribs at one end of said container being interrupted, an elongated plastic tube mounted in the interrrupted portion with its outer wall in fluid tight relationship with said container, said tube having extensions both inwardly and outwardly of said container of relatively flexible nature, the inward extension removably supporting valve means, means adapting the outward extension for use in the administration of blood, a second elongated plastic tube communicating with said container and extending primarily outwardly, said second tube adapted for the collection of blood, and a collapsible inelastic-walled tubular element, said container positioned within said tubular element so that the container and tubular element may be simul- 10 taneously collapsed when said container is substantially empty and said inelastic element will be effective to limit the increase in the internal volume of the container when said container is liquid-filled.

2. The apparatus of claim 1 wherein the other end of said container is equipped with hanger means for suspending it in an inverted position.

3. The apparatus of claim 1 wherein only the side Walls of said container contact said inelastic element when said container is liquid-filled.

4. The apparatus of claim 1 in which the said element is equipped along one Wall edge with an integral extension, a crease in said element defining the inner end of said extension and permitting said extension to pivot relative to the plane of said one wall, said extension being operative to pivot into coplanar relation with said one wall when said container is liquid-filled thereby providing a visual indication of the completion of blood collection.

References Cited in the file of this patent UNITED STATES PATENTS 2,549,513 Nicolle Apr. 17, 1951 2,551,164 Ringler May 1, 1951 2,584,632 Southwick Feb. 5, 1952 2,597,715 Erikson May 20, 1952 2,618,409 Eisenberger Nov. 18, 1952 2,784,716 Broman Mar. 12, 1957 2,838,046 Butler June 10, 1958 2,848,995 Ryan Aug. 26, 1958 2,853,069 Beacham Sept. 23, 1958 2,855,933 Erikson Oct. 14, 1958 2,894,510 Bellamy July 14, 1959

Claims (1)

1. APPARATUS FOR THE COLLECTION, STORAGE AND ADMINISTRATION OF HUMAN BLOOD COMPRISING A STERILE, COLLAPSIBLE CONTAINER CONSTRUCTED OF A FLEXIBLE, TRANSLUCENT, HEAT-SEALABLE MATERIAL AND WHEN LIQUID-FILLED ASSUMING GENERALLY THE SHAPE OF A RECTANGULAR SOLID, THE END FACES OF SAID CONTAINER BEING EQUIPPED WITH DIAGONAL RIBS DEFINING THE UNION OF SHEETS OF SAID MATERIAL, ONE OF SAID RIBS AT ONE END OF SAID CONTAINER BEING INTERRUPTED, AN ELONGATED PLASTIC TUBE MOUNTED IN THE INTERRUPTED PORTION WITH ITS OUTER WALL IN FLUID TIGHT RELATIONSHIP WITH SAID CONTAINER, SAID TUBE HAVING EXTENSIONS BOTH INWARDLY AND OUTWARDLY OF SAID CONTAINER OF RELATIVELY FLEXIBLE NATURE, THE INWARD EXTENSION REMOVABLY SUPPORTING VALVE MEANS, MEANS ADAPTING THE OUTWARD EXTENSION FOR USE IN THE ADMINISTRATION OF BLOOD, A SECOND ELONGATED PLASTIC TUBE COMMUNICATING WITH SAID CONTAINER AND EXTENDING PRIMARILY OUTWARDLY, SAID SECOND TUBE ADAPTED FOR THE COLLECTION OF BLOOD, AND A COLLAPSIBLE INELASTIC-WALLED TUBULAR ELEMENT, SAID CONTAINER POSITIONED WITHIN SAID TUBULAR ELEMENT SO THAT THE CONTAINER AND TUBULAR ELEMENT MAY BE SIMULTANEOUSLY COLLAPSED WHEN SAID CONTAINER IS SUBSTANTIALLY EMPTY AND SAID INELASTIC ELEMENT WILL BE EFFECTIVE TO LIMIT THE INCREASE IN THE INTERNAL VOLUME OF THE CONTAINER WHEN SAID CONTAINER IS LIQUID-FILLED.

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