Transfusion equipment

Nov. 20, 1962 w. h. corcoran etal 3,064,652

TRANSFUSION EQUIPMENT Filed Feb. 11, 1960 2 Sheets-Sheet 1

FIG. /. FIG. 3.

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ALLAN N. GOLDBERG DONALD A. HANILTON BY

W. H. CORCORAN ET AL

TRANSFUSION EQUIPMENT

Nov. 20, 1962

Filed Feb. 11, 1960

FIG. 5.

3,064,652

Sheets-Sheet 2

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FIG. 7.

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FIG. 6.

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INVENTORS WILLIAM H. C0R00RAH ALLAH M. GOLDBERG DOHALD A. HAMILTON BY

3,164,652

Patented Nov. 20, 1962

United States Patent Office

3,064,652 TRANSFUSION EQUIPMENT

William H. Corcoran, San Gabriel, Allan M. Goldberg, Ariefa, and Donald A. Hamilton, Burbank, Calif., assignors to Don Baxter, Inc., Glendale, Calif., a corporation of Nevada

Filed Feb. 11,1960, Ser. No. 8,064

Claims. (CI. 128—272)

This invention relates to transfusion equipment and particularly to a container for drawing, storing, and administering blood or blood plasma.

Flexible plastic containers have many advantages in the collection, storage, and administration of blood. They are unbreakable, light in weight, and require little shipping and storage space. Their use however, is complicated by several serious problems. For example, it is difficult to provide such containers with a suitable, resealable inlet through which the container can be filled. If the inlet does not completely reseal, the container may leak under pressure, or contaminating organisms may enter the container.

Another problem in the use of flexible plastic containers, is the need for a tamperproof, sterile surface over the inlet and outlet of the container. Many of the containers now in use require the surface of the container to be swabbed with an antiseptic solution before use.

Also, a flexible plastic container cannot be used with an administration set which has a strainer-type of connector. The reason for this is that the flexible container must be held firmly while the connector is inserted into the container outlet. Squeezing the flexible walls develops pressure inside the container, and this pressure causes the contents of the container to squirt out through the relatively long slots of the strainer-type connector as the connector is inserted.

Plastic containers are often used with administration sets made by several diSerent manufacturers. The connectors of these sets may differ considerably from the connectors actually designed for use with the container. Therefore the administration set used frequently does not empty the container completely. Moreover, there is usually some air in a flexible plastic container. When this air reaches the connector, it is drawn into the administration set. Subsequent efforts to administer the liquid remaining in the container may force the air down the administration set toward the patient.

It is therefore an object of this invention to provide a flexible, plastic, transfusion container having-an improved, resealable inlet.

Another object of the invention is to provide a transfusion container having an improved tamperproof, sterile cover over the inlet and outlet.

A further object of the invention is to provide a flexible, plastic container having an improved prestraining device.

A still further object of the invention is to provide a transfusion container which will be uniformly emptied by administration sets having a wide variety of connectors.

The objects and advantages of the invention will be more fully understood from the following description- of the preferred form of the invention. The description is given in connection with the accompanying drawings, in which:

FIGURE 1 is an elevational view of the invention;

FIGURE. 2 is a sectional view of the fitment 4;

FIGURE 3 is an elevational view of the container in position for the administration of its contents;

FIGURE 4 is a sectional view of the fitment 4 with an administration set attached;

FIGURE 5 is a top view of fitment 4 before attachment to the container;

FIGURE 6 is an exploded sectional view of fitment 4 and rubber plug 28 prior to assembly;

FIGURE 7 is a sectional view on the line Ί—7 of FIGURE 6;

FIGURE 8 is a top view of the invention.

As shown in the drawings, the transfusion container 1 has a body 2 made of a flexible, heat sealable, plastic such as polyvinyl chloride or polyethylene. The plastic should be in the form of a thin film or sheet so that body 2 is of the layflat type. That is, the walls of the body collapse against each other in the absence of fluid to hold them apart.

Body 2 has a top section 3 and a fitment 4 is attached to the inner surface of said top section. The sides of body 2 are closed by vertical heat-seals 5, 6 and a horizontal heat-seal 7 closes the bottom. Diagonal heat-seals 8, 9 connect the vertical seals 5, 6 to the top section 3. Flaps IG, 11 extend from diagonal seals 8, 9. The flaps 10, 11 are relatively small, their base along the diagonal seals 8, 9 being not more than about one-half the length of said seals. Holes 12, 13 in flaps 10, 11 provide a means for suspending the container in an upright position, as in the refrigerator after the container is filled with blood.

Bottom seals 7 and 14 form a flap 15 having a suspension slit 16. Holes 17, 18 located at each end of slit 16 prevent the slit from tearing through the flap 15.

Fitment 4 has a thin, flexible base 19. An inlet tube 20 and an outlet tube 21 project from base 19. Fitment 4 is attached to the inner surface of top section 3, by the annular seals 22, 23 around the inlet and outlet tubes respectively.

The walls of inlet tube 20 define a longitudinal passage 24 opening into container body 2. The end of passage 24 near to body top section 3 is closed off by a diaphragm 25 to form a pocket 26, having undercut walls 27. A rubber pad 28 is held in an aluminum retaining ring 29 having a top flange 30 and a crimped bottom flange 31. Retaining ring 29 and flanges 30, 31 fit tightly around rubber pad 28, compressing or deforming it inwardly. Since the retaining ring 29 is in direct contact with pad 28, this compression is not relieved during sterilization. Retaining ring 29 and rubber pad 28 are coated with adhesive and the assembly forced into pocket 26.

Below diaphragm 25, the walls of inlet tube 20 have a thick section 40 and taper to a relatively thin section 41. A passage 42 connects the longitudinal passage 24 at a point just below diaphragm 25 with the space 32 between the inlet and outlet tubes 20, 21. The walls of passage 42 slant downwardly toward the axis of tube 20 so that a needle passing through rubber plug 28 cannot also pass through passage 42.

Outlet tube 21 has a longitudinal passage 43 extending therethrough. The base section 44 of tube 21 is adapted to fit tightly around the shaft of an administration set connector 45. The lower end of passage 43 is closed by the end wall 46. Below the base section 44, the walls of inlet tube 21 are provided with slots 47 connecting passage 43 with the interior of container body 2.

Fitment 4 is preferably made of a plastic material which can be easily sealed to body 2. For example, polyvinyl chloride and polyethylene plastics may be used. The fitment 4 preferably is made of the same formulation as the body 2 so that there can be no interaction between the solution in the container and two different plastic materials. Fitment 4 should also be made of a somewhat stretchable material so that section 44 of outlet tube 21 will deform and fit tightly around connector 45.

Preferably, fitment 4 is provided with a tab 33, formed during molding by a tab gate. Tab 33 serves to relieve strains in the fitment. This is particularly desirable when

3,064,652 fitment 4 is made of materials which may distort on heating, since the container is generally sterilized by autoclaving in an atmosphere of pressurized steam. Tab 33 is preferably removed before attachment of fitment 4 to top section 3.

The outer surface of top section 3 is provided with a sterile cover 51 located immediately over inlet tube 20. A second sterile cover 52 is provided over outlet tube 21 and is fastened to top section 3 by an annular seal 23. Each sterile cover 51, 52 has a bottom layer 53, a top layer 54 and a tab 55.

The material forming bottom layer 53 must be attachable easily and firmly to top section 3. Preferably, bottom layer 53 is made of the same material as the container body 2. Top layer 54 must be stronger than the bond between layer 53 and layer 54. Suitable sterile covers for use on containers of polyvinyl chloride may be made of laminates of polyvinyl chloride with aluminum or other metals, or with certain plastics such as nylon, polyvinylidine chloride, or Mylar. During sterilization of the container, the area between bottom layer 53 and top layer 54 is sterilized.

Sterile cover 52 represents a modified form of sterile cover and is attached to top section 3 only around the seal 23. Directly over the center of outlet tube 21, bottom layer 53 of tile sterile cover touches top section 3, but is not attached to it. For this modification, a laminate of polyvinyl chloride 0.0003 inch thick with aluminum 0.002 inch thick has been found ideal. During sterilization of the container, the area 56 between the top section 3 and bottom layer 53 is sterilized. If desired, this type of sterile cover can also be used over inlet tube 20 in place of sterile cover 51.

In use, the container of our invention is filled with blood in the following manner. First, the sterile cover 51 is grasped by the tab 55 and pulled upwardly off the container. Bottom cover layer 53 is attached to the body top section 3 more firmly than it is attached to top cover layer 54 and top layer 54 is stronger than the bond between layers 53 and 54. Thus, the top cover layer 54 separates from bottom cover layer 53, exposing a sterile surface. Once detached, top layer 54 cannot be replaced so that the covers 51, 52 are, in effect, tamperproof.

A hypodermic needle connected to a donor set is then pushed through bottom cover layer 53, the container wall located over inlet tube 20 and through rubber pad 28 and diaphragm 25 into inlet passage 24. Top flange 30 of retaining ring 29 outlines the area of rubber pad 28 to be pierced and thereby assures that the needle will not pierce the wall of inlet tube 20. Container 1 is then suspended at a position below the blood donor by slit 16 and blood is drawn by gravity from the donor into the container. When container 1 is full, a clamp on the donor set is closed off and the hypodermic needle removed from inlet tube 20. When the needle is removed, diaphragm 25 and rubber pad 28 reseal around the needle hole. The container of blood is then suspended in an upright position, as from the flaps 10, 11, in the refrigerator until use.

To administer the blood, sterile cover 52 is removed from its location on top section 3. As tab 55 of cover 52 is pulled off the container, both layers 53 and 54 follow until annular seal 23 is reached. At this point, bottom cover layer 53 is attached to top 3 more firmly than it is attached to top cover layer 54, so that bottom cover layer 53 tears along the outer edge of seal 23. The thin bottom layer 53 is weaker than the bond between the layers 53 and 54 so that inner layer 53 also tears along the inner edge of seal 23. Thus, the entire sterile cover, with the exception of a ring of bottom layer 53 around the seal 23, is removed from the top section 3. This ring of bottom layer 53 clearly marks the sterile area 56 over outlet tube 21.

The connector 45 of an administration set is then thrust through sterile area 56 into the outlet tube 21. The base 44 of tube 21 seals tightly around the shaft of the connector and the end wall 46 limits the distance the connector can go into the container. This prevents possible puncturing of body wall 2 and also assures that openings 60 of connector 45 will be relatively near the bottom of the inverted container so that it will drain completely. A clamp on the administration set is opened and excess air in the set is replaced with blood from container 1. Venipuncture is then made and the administration started. Blood flows through the slots 47 into the connector openings 60, the slots straining out any large clots of fibrinous material which may be present. As the blood is withdrawn, atmospheric pressure collapses the walls of the container.

In some cases, the operator may wish to separate the plasma from the blood cells. This can be done by placing the container in an upright position with fitment 4 at the top. The contents of the container are then centrifuged, or allowed to settle, to separate the blood cells from the plasma. A donor set having two hypodermic needles connected by a plastic tube is then connected to the container by forcing one of the needles through the rubber pad 28. The other needle is then connected to an evacuated blood bottle and the plasma drawn off. As the plasma is withdrawn, the bag collapses and forces the remaining contents upwardly. When the level of the plasma reaches the lower end of inlet tube 20, the plasma continues to flow through passage 42, thus allowing considerably more plasma to be withdrawn than would otherwise be the case.

While we have described the preferred form of the invention, it should be understood that those skilled in the art may make various changes in its construction without departing from the spirit of the invention.