US3205889A

US3205889A - Parenteral fluid container and port structure

Info

Publication number: US3205889A
Application number: US211568A
Authority: US
Inventors: James E Alder; Glenn L Beall
Original assignee: Abbott Laboratories
Current assignee: Abbott Laboratories
Priority date: 1962-07-23
Filing date: 1962-07-23
Publication date: 1965-09-14
Anticipated expiration: 1982-09-14
Also published as: GB1027288A

Description

Se t. 14, 1965 J. E. ALDER ETAL 3,205,889

PARENTERAL FLUID CONTAINER AND PORT STRUCTURE 5 Sheets-Sheet l Filed July 23, 1962 a fi g PARENTERAL FLUID CONTAINER AND PORT STRUCTURE Filed July 23, 1962 Sept. 14, 1965 J. E. ALEDER E'E'AL 5 Sheets-Sheet 2 FIGQ PARENTERAL FLUID CONTAINER AND PORT STRUCTURE Filed July 23, 1962 Sept.'14, 19% J. E. ALBER ETAL 5 SheetsSheet 3 FiG'IO PIC-3.11

Geyemfl llgeaf J. E. ALQER ETAL Sept. 14, m5

PAP-.EEQEERAL FLUID COE'TAIETER AND PO51? STRUCTURE Filed July 25, 1962 Sept. 14, 1965 J. E. ALQER FETAL gygfisaggg PARENTERAL FLUID CONTAINER AND PORT STRUCTURE 5 Sheets-Sheet 5 Filed July 25, 1962 United States Patent 3,205,889 PARENTERAL FLUID CONTAINER AND PGRT STRUCTURE James E. Alder, Grayslake, and Glenn L. Beat], Wildwood, Ill., assignors to Abbott Laboratories, North Chicago, 'Ill., a corporation of Illinois Filed July 23, 1962, Ser. No. 211,568 8 Claims. '(Cl. 128-272) This invention relates to a bag having at least one port assembly.

In the prior art, a bag which is employed in the administration of a liquid parenteral solution generally has at least one port assembly. Liquid communication from the bag to the patient is established by a tube which is normally connected at one end to a port assembly on the bag and at the other end to a hypodermic needle. The tube is either integrally connected directly to the port assembly or the tube is suitably connected by a connector to the port assembly of the bag by the user shortly before use. A bag which is employed to collect blood from a donor is conventionally provided with a donor tube which is normally connected at one end to a port assembly on the bag and at the other end to a hypodermic needle. After the blood has been collected from the donor through the donor tube, the donor thbe is clamped off or knotted since by this time the donor tube has fulfilled its function. In the main, the blood, termed whole blood, is administered to a donee without centrifuging to separate the plasma and red cells, although in the event it is desired to administer either plasma or red cells, the whole blood is centrifuged. Then either the plasma or the red cells are extracted through another port assembly on the bag. The bag is then ready to be employed to administer either the plasma or the red cells whichever by choice remains in the bag after the extraction. Generally then, a bag which is employed for the collection of blood and the administration of whole blood, plasma or red cells has one more port assembly than a bag which is employed for the administration of a parenteral solution. It will be readily apparent that some of the features of the invention are especially useful in connection with bags which are adapted to contain a liquid such as Whole blood, plasma or red cells, While the same features are also useful in a bag which is adapted to contain a liquid such as a parenteral solution.

In accordance with one of the features of the invention, the port assembly preferably has a tubular body and a flexible port flange secured at the transverse end of the bag wall. The port flange is of sufficient longitudinal extent and flexibility to provide a finger shield so that when a piercing pin is inserted through the port assembly and the bag wall, the piercing pin will not pass through both the bag wall and the port flange to injure a finger of the user. It is preferred to provide the port flange with one or more projections which serve both to stiffen the port flange and to provide a roughened surface for facilitating the gripping of the bag.

In accordance with another feature of the invention there is provided a closure for a port assembly which has formed integrally therewith a supporting member which supports the bag wall at the diaphragm.

In accordance with another feature of the invention, there is provided a port assembly which is secured to a transverse end of the bag, the bag wall of the bag defining a chamber which is substantially free of air. A tube, for example, specifically a donor tube, is received by the port assembly and it extends into the chamber, the terminal end of the tube defining a drop former. The port assembly has a port flange which provides sufiicient stiffness to maintain the bag wall at that transverse end in a spacedapart relationship.

r: CC

It is another feature of the invention to provide a closure for the port assembly which has a closure flange retained in seating engagement with the port flange. The closure is of a character to be removable from the port assembly but is incapable of being reseated against the port flange.

It is another feature of the invention to provide means in addition to a retainer for preventing the closure flange from being unseated from the port flange during the centrifuging of the liquid, for example blood, contained in the bag.

In connection with a port assembly which is employed to fill or partially fill the bag with a liquid such as an anticoagulant through a tube which is received by the port assembly, there is provided a closure having means for assisting both the insertion into and withdrawal of the closure from a marginal end of the tube.

In accordance with another feature of the invention there is provided a hanger assembly whereby the bag is supportable. The hanger assembly is secured at its ends to each port assembly, the port assemblies providing a reinforcement of the bag at space-d intervals. In addition, the hanger assembly provides a retainer for retaining the closure flange of the closure seated against the port flange of the port assembly.

In accordance with another feature of the invention there is provided a closure having a portion thereof sealed to the port flange. The closure serves to retain that portion of the port assembly and diaphragm formed by the bag wall through which .a piercing needle is adapted to pass, in a sterile condition. The closure fits over the terminal end of the port assembly. The closure has a rupturable portion which is spaced from the terminal end of the port assembly. The ruptura-ble portion enables the one portion of the closure to be separated from the other portion of the closure at the rupturable portion, thereby exposing the terminal end of the port assembly.

. In accordance with another feature of the invention, there is provided for a bag having a flexible bag wall, the bag wall having a pair of transverse ends terminating at a pair of longitudinal marginal sides. A port assembly is disposed at one transverse end near one longitudinal marginal side. The one transverse end having the port assembly extending obtusely and obliquely from the one longitudinal marginal side to the other longitudinal marginal side which is disposed nearer the port assembly. It is therefore readily apparent, that during the extraction of the plasma from the red cells, for example while the bag is in an extractor, the last traces of plasma are con- [fined to one corner of the blood bag. This feature also facilitates efficient drainage of the bag when the liquid to be administered is whole blood, plasma, red cells, a parenteral solution or the like.

By an alternative construction, the transverse end of the bag is of a character to be disposed generally perpendicularly to the longitudinal marginal sides. In the event that it is desired to confine the last traces of for example the plasma to near one of the port assemblies as it is during the extraction of the plasma from the red cells, a pair of spaced hangers are empl-oyable, the effective extents of which are unequal. One manner of bringing this into accomplishment is to provide a hanger assembly having a pair .of hangers, the ends of which are connected to a port assembly. In this case, one of the hangers is longer than the other of the hangers so that the bag hangs canted with respect to the horizontal. Another manner of accomplishing this purpose is to provide apertures at each of the opposed longitudinal marginal sides which are disposed at unequal effective levels or extents from the terminal end of the bag having the port assemblies.

spon es -In the diagrammatic, illustrative drawings:

FIGURE 1 is a side elevation view, partly cutaway, showing the bag of the invention;

FIGURE 2 is a fragmentary view showing three port assemblies arranged on the web of flexible material;

FIGURE 3 is a perspective view showing a hanger assembly of one embodiment of the invention;

FIGURE 4 is a fragmentary view showing the manner in which the hanger assembly is disposed in relationship to the port assemblies;

FIGURE 5 is an enlarged fragmentary view showing the manner in which a closure is disposed in a marginal end of .a tube;

FIGURE 6 is a fragmentary view, mainly in crosssection, showing the manner in which a piercing needle is adapted to enter a diaphragm in the spread-apart bag wall through a port assembly;

\FIGURE 7 is a fragmentary view, mainly in crosssection, showing a closure of one embodiment of the invention and the manner in which it is seated against a port flange of the port assembly;

FIGURE 8 is a side elevation view of the bag of the invention shown in conjunction wit-h conventional administration equipment;

FIGURE 9 is a fragmentary perspective view showing one manner of extracting the plasma from the red cells in the bag of the invention;

FIGURE 10 is a fragmentary view, partly in crosssection, showing a manner in which a closure is adapted to be inserted into and withdrawn from a marginal end of a tube which is received by the port assembly;

FIGURE 1 1 is a fragmentary view, mainly in crosssection, showing a marginal end of a tube extending into a chamber defined by a bag wall of the bag and showing a closure disposed in the marginal end of the tube which lies in the chamber beyond the bag wall;

FIGURE 12 is .an alternative form of closure from that illustrated in FIGURES 10 and 11;

FIGURE 13 is still another alternative form of closure from that illustrated in FIGURES 10, 11 and 1 2;

FIGURE 14 is a cross-sectional side elevation view of an alternative form .of closure in accordance with the invention;

FIGURE 15 is a side elevation view, mainly in crosssection, showing a mold wherein the closure shown in FIGURE 14 is adapted to be molded;

FIGURE 16 is a fragmentary perspective view of the closure shown in FIGURE 14 shown attached to a retainer of the hanger assembly;

FIGURE 17 is a fragmentary view, partly in crosssection, showing the manner in which one portion of the closure of FIGURE 14, for example, is removable from the other portion of the closure;

FIGURE 1 8 is a perspective View of an alternative form of closure like that shown in FIGURES 14, 16 and 17, but having a roughened outer surface;

"FIGURE 19 is a fragmentary view showing the bag of the invention having an alternative form of hanger assembly, whereby a transverse end of the bag having a .port assembly is adapted to be hung canted with respect to the horizontal in an extractor;

FIGURE 20 is a side elevation view of an alternative form .of hanger assembly having a pair of spaced hangers with apertures there-in, .at least one aperture in one hanger being disposed at a different level with respect to an aperture in the other of the hangers by which a transverse end of the bag having at least one port assembly is adapted to be disposed canted with respect to the horizontal;

FIGURE 21 is a side elevation view, partly broken away, showing an alternate construction whereby a transverse end of the bag is adapted selectively to be canted with respect to the horizontal;

Referring now to FIGURE 1 of the illustrative drawings, there is shown a substantially rectangular bag 25 which is adapted to contain a liquid, for example an anticoagulant A. The bag 25 is composed of a flexible material which is compatible with the liquid adapted to be contained therein. The bag 25 has a bag wall 2 5a which is shown to have a pair of opposed transverse ends 26 and 27 which terminate at opposed longitudinal

marginal sides

28 and 29. The bag wall 25a defines a chamber 25b in which the liquid is adapted to be contained. A trans- Verse seal 30 at the transverse end 27 is shown to join

longitudinal seals

31 and 32 at the longitudinal

marginal sides

28 and 29, respectively. Within the transverse seal 30 there is disposed an aperture 33 near the longitudinal seal 31, an aperture 34 near the longitudinal seal 32, and an elongated aperture 35 between the

apertures

33 and 34. A port assembly 36 is shown'to be disposed at the transverse end 26 near the longitudinal marginal side 28, while a port assembly 37 at the transverse end 26 is shown to be disposed near the longitudinal marginal side 29. A :port assembly 38 is shown to be disposed between the port assemblies 36 and 37' at the transverse end 26 of the bag 25. The transverse end 26 of the bag wall 25a is shown, for example in FIGURE 6, to have a generally U-shaped configuration.

In the event the bag 25 is to contain a parenteral solution, it is obvious that only one port assembly such as the port assembly 36 need be provided.

As best shown in FIGURE 5 of the illustrative drawings, the port assembly 38 is shown to include a tubular body 39 and a port flange 40 which is formed integrally therewith. The port flange 40 is suitably secured for example by dielectric sealing or chemical sealing to the transverse end 26 of the bag wall 25a. Each port flange 40 is preferably provided with one or more projections 40:: which help to hold the bag wall 25a, at the transverse end 26, spaced-apart, in the event the port flange 49 is too thin or flexible to adequately accomplish this purpose. By the employment of dielectric sealing it is convenient to extrude the projection 49a from the port flange 4d during the dielectric sealing of the port flange 40 to the bag wall 25a. Extruding the projections 40a at the time of sealing the port flange 40 to the bag wall 25a enables the seal to be made which is bubble-free, that is, no air bubbles are formed between the bag wall 25a and the port flange 40. Also, the projection 40a stiilens the port flange 46 so that the bag wall 25a is held in a spacedapart relationship. A tube 41 is received in the tubular body 39 of the port assembly 33 and it extends slightly beyond the bag wall 25a. The tube 41 is sealed in the tubular body 39 by chemical scaling for example.

The

port assemblies

36 and 37 are similar to each other in construction as is readily apparent from FIGURES 1, 2 and 4 of the illustrative drawings and hence like reference characters are employed to designate like components. The port assembly 36 and the port assembly 37 each are shown to have a tubular body 42 and a port flange 43. Each port flange 4-3 is shown to have a pair of

enlarged portions

44 and 45 which have a sufiicient longitudinal extent, thickness and flexibility to provide a protective finger shield. Each port flange 43 enables the transverse. end 26 of the bag wall 25a to have a generally U-shaped configuration even though each port flange 43 is composed of a flexible material. Each port flange 43 is preferably slightly more rigid, although still flexible, than the bag wall 25a. Each port flange 43 is preferably provided with one or more upstanding projections 43a which serve the dual function of stiflening the port flange 43 and of roughening the surface of the port flange 43 to facilitate the gripping thereof. By the employment of dielectric sealing, it is convenient to extrude the projections 43a from the port flange 43 during the dielectric sealing of the port flange 43 to the bag wall 25a. Extruding the projections 43:; at the time of sealing the port flange 36, for example, to the bag wall 25a enables a seal to be made which is bubble-free, that is, no air bubbles are formed between the bag wall 25a and the port flange 43'. The projections 43a on the port flange 43 also enable the user to grip the

enlarged portions

44 and 45 quite easily when a piercing needle is employed to pierce a port diaphragm 25c which forms a part of the bag wall 25a. It is to be understood that the port flange 43 will flex somewhat when grasped between the thumb and the index finger of one hand of the user during the insertion of the piercing needle. The port flange 43 also serves to prevent the bag wall 25a from tearing beyond the place of the port diaphragm 250.

A hanger assembly 46, which is shown to have a pair of hangers 46a and 46b, is provided for supporting the bag 25. As best shown in FIGURE 3 of the illustrative drawings, the hanger assembly 46 is shown to be a strip of flexible material 47 having

retainers

48 and 49 at opposed ends and a central retainer 50. The

retainers

48 and 50 are considered to form the opposed ends of 48 and 5t) areconsidered to form the opposed ends of the hanger 46a, while the

retainers

49 and 50 are considered to form the opposed ends of the hanger 46b. Inwardly of peripheral

marginal edges

51 and 52 of the

retainers

48 and 49 there are provided upstanding

marginal flange portions

53 and 54 which define

apertures

55 and 56, respectively. The retainer 50 has a central aperture 57. The

retainers

48, 49 and 50 are received by the

tubular bodies

42, 42 and 39 of the

port assemblies

36, 37 and 38, respectively. The retainer 50 is secured at its entire undersurface to the port flange 40 of the port assembly 38 while only the peripheral

marginal edges

51 and 52 of the

retainers

48 and 49 are secured to the port flanges 43 of the

port assemblies

36 and 37, respectively.

As best shown in FIGURE 7 of the illustrative drawings, there is shown the port assembly 36 (which is identical to the port assembly 37) provided with a closure 60 having a closure body 61 and closure flange 62 formed integrally therewith. The retainer 48 overlies and is in abutment with the closure flange 62, while the closure flange 62 overlies and is in abutment with the port flange 43. The retainer 48 serves to hold the closure 60 seated against the port flange 43. The closure flange 62 is, therefore, locked between the retainer 48 and the port flange 43. The upstanding marginal flange portion 53 embraces a portion of the closure body 61 of the closure 69. A resilient ring 63 which is shown to be of somewhat greater width than the upstanding marginal flange portion 53 urges the upstanding marginal flange portion 53 in hoop compression against a portion of the closure body 61 of the closure 60. The resilient ring 63 is preferably composed of rubber but other resilient materials suitable for the purpose are employable. The primary purpose of the ring 63 is to insure that there is no possibility that the closure 60 will be unseated during centrifuging in the event that the bag 25 is to serve as a blood bag and during sterilization in the event the bag 25 is to serve as a solution bag, but the resilient ring 63 also improves the seal between the retainer 48 and the closure 60 to maintain sterility and prevent leakage during any and all handling. The closure body 61 has formed integrally therewith an inwardly projecting supporting member 61a which has an outside diameter which is less than the inside diameter of the tubular body 42 to provide clearance for removing the closure 60 from the port assembly 36 (or 37 A terminal end 61b of the supporting member 61:: is shown to be in supporting contact with the portdiaphragm 25c. When the port flange 43 is placed on the bag wall 2517 with the closure 60 in place, the terminal end 61b of the supporting member 61a is spaced from the bag wall 2511. When the port flange 43 is sealed to the bag wall 25b and the extrusions 43a are made and completed, the terminal end 61b of the supporting member 61:: just contacts the diae phragm 25c of the bag wall 25a. The purpose of the supporting member 61a is to prevent the port diaphragm 25c from flexing or bulging outwardly to form a dimple during centrifuging, autoclaving or the like. Such a dimple would serve to weaken the bag wall 25a at the diaphragm 25c. When it is desired to remove the closure 60, the closure body 61 is grasped for example by the thumb and index finger of one hand of the user. When a bending followed by a pulling force is exerted on the closure 60, the retainer 48 and the closure flange 62 each flex to enable the closure 66 to be removed through the aperture to beyond a terminal end 42a of the tubular body 42. The resilient ring 63 remains embraced on the closure body 61. The retainer 48 and the closure flange 62 are made suitably flexible for this purpose. If desired, a relatively rigid closure flange 62 is employable provided that the retainer 48 has sufficient flexibility to enable the closure flange 62 to flex the retainer 48 sufliciently to permit the removal of the closure 66. Conversely, the retainer 48 is of a character to be made relatively rigid and in that event a more flexible closure flange 62 is provided. The projections 43:: assist the user in gripping the port flange 43 during the removal of the closure from the tubular body 42. Once the closure flange 62 has been removed out of seating engagement with the port flange 43 to beyond the retainer 48, the closure flange 62 canot be reseated against the port flange 43. It is therefore readily apparent that the retainer 48 makes the closure 60 tamper-proof. It is also readily apparent that the hanger assembly serves a dual function of providing a pair of hangers 46a and 46b whereby the bag is supportable and it also serves to retain the closures in seating engagement with the port flange.

As best shown in FIGURE 10 of the illustrative drawings there is shown a closure generally indicated at 64 which is disposed at the marginal end 65 of the tube 41. The closure 64 is shown to have a spherical closure portion 66 and a handle portion 67 which extends into the chamber 25b defined by the bag wall 25a as is shown in FIGURES 10 and 11 of the illustrative drawings. The handle portion 67 of the closure 64 enables the user to insert the spherical closure portion 66 of the closure 64 into the marginal end 65 of the tube 41 to close off communication between the chamber 251) and tube 41 and it also enables the user to withdraw the spherical closure portion 66 0f the closure 64 from the marginal end 65 of the tube 41. In the event that there is liquid in the chamber 25b the closure 64 prevents the liquid from escaping into the tube 41. The bag wall 25a is sufliciently flexible to enable the bag to be wrinkled locally as indicated in FIGURE 10 so that the closure 64 can be easily inserted into and withdrawn from the marginal end 65 of the tube 41.

As best shown in FIGURE 11 of the illustrative drawings the marginal end 65 of the tube 41 preferably extends beyond the bag wall 25a into the chamber 25b. The portion of the marginal end 65 which extends beyond the bag wall 25a is preferably made sufliciently long to enable the effective place of closure to be made beyond the bag wall 25a in the chamber 25b. In the event that the spherical closure portion of the closure 64 is inserted into the marginal end 65 of the tube 41 to the place where the port assembly 38 surrounds the spherical por- .tion 66 as shown in FIGURE 5 of the illustrative drawings, added resistance to insertion of the closure 64 is encountered due to the fact that the spherical closure portion 66 is forced to expand not only the marginal end 65 of the tube 41 but also the tubular body 39 of the port assembly 38. In the embodiment of FIGURE 11 of the illustrative drawings the spherical portion 66 can be slightly larger with respect to the inside diameter of the marginal end 65 of the tube 41 than in the embodiment of FIGURE 5 of the illustrative drawings due to the fact that only the marginal end 65 of the tube 41 need be expauded. Before the closure 64 is inserted into the marginal end 65 of the tube 41 and after the closure 64 has been removed therefrom, the closure 64 simply remains 7 in the chamber 25b as shown in phantom in FIGURE 1 of the illustrative drawings.

A terminal end 65a of the tube 41 defines a drop former during the collection of blood from a donor. The port flange 40 with its projection 40a is of sufficient extent and provides sufficient stiffness to the transverse end 26 of the bag wall 25a to maintain the transverse end 26 of the bag Wall 2511 in a spaced-apart relationship. The port flange 41) maintains the bag wall 25a at the transverse end 26 spaced-apart even though the chamber 25b defined by the bag 25 is substantially free of air. It is therefore readily apparent that the user is able to determine at a glance whether or not blood is still flowing through the tube 41 from the donor.

FIGURE 12 of the illustrative drawings illustrates an alternative form of closure generally indicated at 64A having a closure portion 66a and a handle portion 67a. A tapered end 661) of the closure portion 66:: facilitates the insertion of the closure portion 66a into the marginal end 55 of the tube 41, while roughening, which is shown to be in the form of circumferential grooves 72, insures better gripping engagement with the handle portion 67a.

FIGURE 13 of the illutsrative drawings illustrates still another alternative form of closure generally indicated at 6413. A handle portion 671) has a spherical closure portion 66c and 66d at each end. Two

closure portions

660 and 66d are provided so that the closure 6413 will not have to be rotated more than 90 degrees before its insertion into the marginal end 65 of the tube 41. It is readily apparent that either the closure portion 660 of the closure portion 66d is employable to close off communication between the chamber 25b and the tube 41.

Referring now to FIGURES l, 8 and 9 of the illustrative drawings, the bag 25 is shown to have its transverse end 26 extending obliquely and obtusely from the marginal side 28 to the marginal side 29. The transverse end 26 makes an obtuse angle with the marginal side 28, while the transverse end 26 makes an acute angle with respect to the longitudinal marginal side 29. The longitudinal

marginal sides

28 and 29 and their

longitudinal seals

31 and 32 are disposed gene-rally parallel to each other. There is shown in FIGURE 9 of the illustrative drawings a fragmentary portion of an extractor generally indicated at 73 of a type shown and described on page 43 of the publication The Use of Blood published in 1961 under the direction of Abbott Laboratories. The extractor 73 has a fixed plate 7 3a and a movable plate 73b which is adapted to exert pressure on the bag 25. The bag 25 is hung by the hanger assembly 46 on

hooks

75 and 76 of equal height after the red cells RC, for example, have been separated from the plasma P during the centrifuging. The blood in the bag 25 is centrifugable so that the plasma P is at the upper end of the bag while the adjacent red cells RC are at the lower end of the blood bag, or vice versa. Throughout the discussion, it will be assumed that the plasma P is in the upper portion of the bag 25. A bag 25A identical to the bag 25 is supported by its hanger asembly 46a on

hooks

75a and 76a. A tube 41a is connected at one end to a port as sembly 38a which is identical to the port assembly 38, while the tube 41a is connected at the other'end by a piercing needle 37A to the port assembly 37. As the movable plate 73b is moved toward the fixed plate 73a of the extractor 73, the red cells RC act upon the plasma P so that eventually the last traces of the plasma are confined to that portion of the bag 25 which is closely adjacent the port assembly 37. In this manner it will be assured that effective transfer of the last traces of the plasma P into the bag 25A from the bag 25 is accomplished.

When for example the red cells RC are ready to be administered to the patient, the bag 25 is supported by a hook 79 which passes through either the aperture 35 or the aperture 33 when the port assembly 37 is employed to serve as the port assembly through which, in this case, the red cells RC pass to the patient. When the port assembly 36 is to be employed, the hook 79 is passed through the aperture 34 to facilitate etficient drainage of the bag 25 of the red cells RC, and a piercing needle 80 is passed into the tubular body 42 to pierce the port diaphragm 250 in the wall 25a. The piercing needle 80 is frictionally held in place by the tubular body 42. The piercing needle 80 is connected to a drip chamber 81 which has a filter 82. A length of tubing 83 is connected at one end to the drip chamber 81 and at the other end to a hypodermic needle 84. A tubing clamp 85 along the tubing 83 is employable to regulate flow therethrough.

There is shown in FIGURE 14 of the illustrative drawings an alternative closure which includes a closure body 91 and a closure flange 92 which are joined by a continuous, uninterrupted, annular rupturable portion 93. The closure flange 92 is shown to be sealed to the port flange 43 of the closure assembly 36. If desired, the closure flange is of a character to be secured to the retainer 48 as shown in FIGURE 16 of the illustrative drawings. In this event the retainer 48 is secured throughout its undersurface to the port flange 43. The closure body 91 has formed integrally therewith an inwardly projecting supporting member 91a, a terminal end 91b of which is in supporting contact with the port diaphragm 250 for the purpose explained in reference to the construction shown in FIGURE 7 of the illustrative drawings.

The closure 90 is preferably, although not necessarily, made in a mold such as a mold 94 of an injection molding machine (not shown). The mold 94 is composed of a cavity block 95 and a cavity block 96. The cavity block 95 is shown to be provided with a cavity 97. The cavity 97 has a cavity portion 97a the outline of which forms the outer surface of the closure body 91 and a cavity portion 9721 which forms the closure flange 92. The cavity block 95 has a runner 98 which communicates directly with the cavity portion 97a. The cavity block 95 has a bore 99 which opens into a smaller bore 1%. The cavity block 96 is provided with a shoulder 101 against which a core pin 102 is adapted to be seated. The core pin 102 and an annular face 103 on the cavity block 96 form what may be termed the inner surfaces of the closure 90. The core pin 102 is provided with a recess 1020 which forms the supporting member 91a The rupturable portion 93 is formed by a restriction 104 at the place where the cavity portions 97a and 97b of the cavity 97 meet. During the molding of the closure 90 an injection moldable material is passed through the runner 98 and directly into the cavity portion 97a After the cavity portion 97a has been filled the pressure exerted by the molding machine (not shown) forces the injection moldable material into the cavity portion 97b. A high degree. of stress is established at the place of a restriction 104 so that not only isthe rupturable portion 93 relatively thin but it is of character that is weak so that it can be ruptured manually, although it is strong enough to withstand ordinary handling.

FIGURE 16 illustrates the manner in which the closure 90 appears before it has been ruptured while FIG- URE 17 illustrates the manner in which the closure 90 appears after the closure body 91 has been ruptured from the closure flange 92.

The outer surface of the closure body 91 is of a character to be roughened to assist the gripping thereof, as illustrated in FIGURE 18 of the illustrative drawings. Other ways of toughening a portion of the outer surface of the closure 90 .are also employable.

Referring now to FIGURE 19 of the illustrative drawings, there is shown an alternative form of hanger assembly generally indicated at 46A which is identical in construction to the hanger assembly 46, save one exception, namely that the effective length of a hanger 63a is less 9 than the effective length of a hanger 64a. This simple construction enables the transverse end of the bag 25 to be hung canted with respect to the tating the extraction of the plasma P, for example, from one container 25 into another container like the container 25A. It is apparent from FIGURE 19 of the illustrative drawings that the effective distance of the hanger 63a from the transverse end 26 is less than the effective distance of the hanger 64a from the transverse end 26.

Referring now to FIGURE of the illustrative drawings, there is shown a hanger assembly 46B which includes a pair of hangers 63b and 64b. Each of the hangers 63b and 64b is secured for example by dielectric or chemical scaling to the transverse end 26 of the bag 25. The hanger 63b has spaced apertures .110 and 111 while the hanger 64b has spaced

apertures

112 and 113. When it is desired to hang the bag on the extractor 73 so that the port assembly 37 is at a higher elevation with respect to the horizontal than is the port assembly 36, the

hooks

75 and 76 are passed through

apertures

113 and 110, respectively, while when the port assembly 36 is desired to be disposed at a higher elevation with respect to the horizontal than is the port assembly 37, the

hooks

75 and 76 are passed through the apertures 111 and 112, respectively.

The transverse end 27 of the bag 25 is shown to be provided with an aperture 114 near the longitudinal marginal side 28 while an aperture 115 is disposed near the longitudinal marginal side 29. An aperture 116 is disposed generally medially bet-ween the

apertures

114 and 115, while apertures 117 and .118 are disposed between the aperture 114 and the aperture 116 and between the aperture 116 and the aperture 115, respectively. A hanger assemblygenerally indicated at 119 includes a pair of

hangers

120 and 121. The hanger 120 has an aperture 122 while the hanger 121 has an aperture 123. The apertures 117 and 122 are shown to be generally longitudinally aligned, and the

apertures

118 and 123 are also shown to be generally longitudinally aligned. In the event that the bag 25 is to be supported in the position shown in FIGURE 8 of the illustrative drawings for the administration for example of whole blood into the patient, and the bag 25 is to be canted with respect to the horizontal to afford efficient drainage, and two hooks similar to the hook 79 are to be employed, then one hook can be passed through the aperture 118 while the other of the hooks can be passed through the aperture 122. In this event the port assembly 36 will assume a lower position than will the port assembly 37. In the event that it is desired to have the port assembly 37 at a lower position than the port assembly 36 during the administration of whole blood or the like then the hooks are passed through the apertures 117 and 123.

In the event that a single hook, such as the hook 79, is to be employed, any one of the

apertures

114, 115, 117, 118, 122 and 123 is employable.

Referring now to the embodiment of FIGURE 21 of the illustrative drawings, there is shown a hanger assembly 460 provided with longitudinally spaced

apertures

125 and 126 at the longitudinal seal 31, while longitudinally spaced

apertures

127 and 128 are provided at the longitudinal seal 32. In the event that it is desired to dispose the port assembly 36 at a higher level than the port assembly 37 in the extractor 73, the hooks 75 and '76 are passed through the

apertures

126 and 127, respectively, while if it is desired to dispose the port assembly 37 at a higher level than the port assembly 36 in the extractor 73, then the hooks 75 and '76 are passed through the

apertures

123 and 125, respectively.

At the transverse end 27 and near the longitudinal seal 31, there are disposed longitudinally aligned

apertures

129 and 130, while near the longitudinal seal 32 there are disposed longitudinally aligned apertures 131 and 132. An aperture 133 is disposed generally medially between the

apertures

130 and 132. In the event that horizontal thereby facili- 10 a liquid, for example red cells RC, is to be administered and assuming two horizontally aligned hooks such as the hook 79 are to be employed, the bag 25 shown in FIG- URE 21 of the illustrative drawings is disposed in the same manner as is the bag 25 in FIGURE 8 of the illustrative drawings. In the event the port assembly 36 is to be disposed at a lower level than is the port assembly 37, one of the hooks is passed through the aperture 131 and the other of the hooks is passed through the aperture 130. If it is desired to dispose the port assembly 37 at a lower level than the port assembly 36, then one of the hooks is passed through the aperture 129 and the other of the hooks is passed through the aperture 132.

The bag wall 25a of the bag 25 is constructable of any suitable flexible, heat sealable material of construction, for example polyvinyl chloride, compatible with the liquid, for example parenteral solution, blood and the like which is adapted to be contained therein. The

port assemblies

36, 37 and 38 are preferably formed by injection molding, and a plastic such as polyvinyl chloride is employable. The

port assemblies

36, 37 and 38 are composed of a heat sealable, flexible, extrudable thermoplastic material. The closures 6tl, 64, 64A, 64B and are of a character to be composed of plastics like polypropylene, nylon, vinyl, polycarbonate or polyethylene. The closure flanges 62 and 92 are preferably relatively thin and flexible.

The above-described embodiments and method being exemplary only, it will be understood that modifications in form, detail or procedure can be made without departing from the spirit and scope of the invention. Accordingly, the invention is not to he considered as limited save as is consonant with the scope of the following claims.

What is claimed is:

1. A bag unit for a parenteral solution comprising in combination: a bag having a flexible bag wall, a port assembly including a tubular body defining a passage and a port flange securing said tubular body to said bag wall, a closure received by said tubular body and having a closure flange seated against a portion of said port flange, and means secured to said port flange and overlying said closure flange for retaining said closure flange locked in removable seating engagement with said port flange and for preventing said closure flange from being reseated in underlying relation to said retaining means.

2. For a bag having a flexible bag wall: a port assembly including a tubular body defining a passage and a port flange for securing said tubular body to said bag wall, a closure received by said tubular body and having a closure flange overlying a portion of said port flange, a relatively flexible retainer secured to said port flange and overlying said closure flange, said retainer having an upstanding marginal flange portion which embraces a portion of said closure, and means for urging said upstanding marginal portion in hoop compression against said closure.

3. For a bag having a flexible bag wall: a port assembly including a tubular body defining a passage and a port flange for securing said tubular body to said bag wall, a closure received by said tubular body and having a flange overlying a portion of said port flange, a flexible retainer secured to said port flange and overlying said flange of said closure, said retainer having an upstanding marginal flange portion which embraces a portion of said closure, a resilient ring encircling said upstanding marginal portion.

4. For a bag having a flexible bag wall: a port assembly including a tubular body defining a passage and a port flange for securing said tubular body to said bag wall, a tube having a marginal portion and a terminal end, said marginal portion being received by said tubular body, a closure means disposed in said marginal end of said tube for closing off communication through said tube, said closure means having a handle extending beyond the terminal end of the said tube and into the bag 1 1 chamber to be gripped through the medium of the flexible bag wall for insertion and removal.

5. A bag unit for a parenteral solution comprising in combination: a bag having a flexible bag wall, a pair of spaced port assemblies each including a tubular body defining a passage and a port flange securing the tubular body to said bag wall, a closure received by each tubular body and having a closure flange seated against a portion of a respective port flange, and means secured to said port flanges for retaining said closure flanges seated against the respective port flanges and for providing a bag supporting hanger assembly.

6. A bag unit for a parenteral solution comprising in combination: a bag having a flexible bag wall, three spaced port assemblies each including a tubular body defining a passage and a port flange securing said tubular body to said bag wall, a hanger assembly having three spaced apertures therein, each of said apertures received by one of said tubular bodies, said handle assembly being locally secured to each of said port flanges,

7. A bag unit for a parenteral solution comprising in combination: a sheath of flexible plastic material having generally rectangular shape and defining two substantially like overlying faces connected at one edge by the material, the faces of said sheath being secured to each other along the other three edges to define a closed bag, the edge opposite said one edge being adapted to support the bag pendulously with said one edge in down position, at least one port structure on said sheath, said port structure being affixed to said sheath on said one edge and being defined by finger-receiving plastic flanges on the outside of the bag and straddling said one edge and a tube affixed to said flanges at said edge and extending outwardly from said edge, said flanges being of dimension and material to support said tube in outwardly extending position when sandwiched between the fingers and being on opposite sides of the extension of the lumen of said tube to shield the fingers from a pointed cannula extending through said tube, whereby with the said flanges held between the fingers a rigid cannula may be inserted in the port tube and forced through the bag wall adjacent thereto to provide a safe and sterile entry.

8. A bag unit for a parenteral solution comprising in combination: a sheath of flexible plastic material having generally rectangular shape and defining two substantially like overlying faces connected at one edge by the material, the faces of said sheath being secured to each other along the other three edges to define a closed bag, the edge opposite said one edge being adapted to support the bag pendulously with said one edge in down position, at least one port structure on said sheath, said port structure being afl'lxed to said sheath on said one edge and being defined by finger-receiving plastic flanges on the outside of the bag and straddling said one edge and a tube affixed to said flanges at said one edge and extending outwardly therefrom, a delivery tube sealingly secured to said one edge and extending into said bag, said flanges being of dimension and material to separate said faces of said sheath proximate said delivery tube, whereby blood introduced into said bag through said delivery tube will not wet the faces of the bag proximate said delivery tube thereby enabling the observation of flow rate through said delivery tube into said bag.

References Cited by the Examiner UNITED STATES PATENTS 2,323,629 7/43 Spanel 8 X 2,777,490 1/57 Munk 150-8 2,838,046 6/58 Butler 128-272 2,894,510 7/59 Bellamy 128-272 2,940,444 6/60 Beall 128-4214 2,969,102 1/61 Cunningham 150.5 2,999,387 9/61 Andelin 128295 X 3,006,341 10/61 Poitras 128214 3,022,613 2/62 Powers 5328 3,030,955 4/62 Gossett et a1. 128-272 3,057,129 10/62 Meissner 53-28 3,073,307 1/63 Stevens 128221 3,105,613 10/63 Barton et al. 128272 X 3,110,411 11/63 Golde 22039 RICHARD A. GAUDET, Primary Examiner.

JORDAN FRANKLIN, Examiner.

UNITED STATES PATENT OFFICE CERTIFICATE OF CORRECTION Patent Non 3,205,889 September 14, 1965 James E, Alder et al It is hereby certified that error appears in the above numbered patent requiring correction and that the said Letters Patent should read as corrected below.

Column 1, line 26, for "thbe" read tube column 5, line 16, strike out "48 and 50 are considered to form the opposed ends of"; column 6, line 23, for "canot" read cannot column 7, line 23, for "illutsrative" read illustrative line 59, for "asembly" read assembly column 11, line l9, for "handle" read hanger Signed and sealed this 24th day of May 1966,

(SEAIJ Anna:

ERNEST W. SWIDER EDWARD J. BRENNER Attesting Officer Commissioner of Patents

Claims

6. A BAG UNIT FOR A PARENTERAL SOLUTION COMPRISING IN COMBINATION: A BAG HAVING A FLEXIBLE BAG WALL, THREE SPACED PORT ASSEMBLIES EACH INCLUDING A TUBULAR BODY DEFINING A PASSAGE AND A PORT FLANGE SECURING SAID TUBULAR BODY TO SAID BAG WALL, A HANGER ASSEMBLY HAVING THREE SPACED APERTURES THEREIN, EACH OF SAID APERTURES RECEIVED BY ONE OF SAID TUBULAR BODIES, SAID HANDLE ASSEMBLY BEING LOCALLY SECURED TO EACH OF SAID PORT FLANGES.