JPH0563381B2 - - Google Patents

Abstract

An easy-open container for the storage of blood components is a bag of flexible material having a body (10) provided with frangible seams (20) which join at an apex (22) of the body; a closure seam (24) transversely intersects the apex (22) and is designed to be ruptured at the apex (22) so that the body (10) can be torn open along the frangible seams (20) to separate it from its contents, when the bag is gripped to either side of the apex (22) and pulled apart.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to the field of blood component therapy, and more particularly to an apparatus for collecting, storing and dispensing plasma for processing blood components such as albumin and globulins.

A relatively modern medical technique known as blood component therapy involves giving blood in the most appropriate manner to the patient's actual needs. Doctors determine which parts of blood or which components of blood are needed by a patient and give only those blood components to the patient, rather than the whole blood. Physicians thus avoid many of the risks associated with using whole blood. This procedure is not only better for the patient in reducing certain risks associated with whole blood transfusions, but also allows one unit of blood supply to be used for more than one patient. For example, a whole unit of blood that is eventually fractionated yields blood cells, platelets, fresh plasma, frozen or stored plasma, albumin, globulins, etc.

Furthermore, in modern medical technology, cell separators separate blood into its components while leaving the donor to undergo the donation process. Modern medical technology allows blood banks to take specific components of the supplier needed by the patient and simultaneously return other components to the supplier.

In a treatment technique known as plasmapheresis, plasma is separated from the cellular components of the blood and the cells are returned to the supplier. The plasma is then later used to expand blood volume in the form of stored plasma or fresh frozen blood. This plasma also contains albumin, globulin,
It can be processed into any number of useful products such as anti-hemophilic factors. The present invention is provided for this purpose.

Blood is collected from a donor into a connected and sealed collection system, then centrifuged and separated into cells and plasma. The cells are returned to the donor and the plasma is then frozen in a collection bag. In the frozen state, plasma can be stored for many months before being removed for production of plasma components. As a result, large quantities of plasma, ie plasma from multiple donors, are processed in batches.

Contamination through this batch process is obviously dangerous. Whole blood is first collected into a collection channel that remains sealed while it is subsequently centrifuged and frozen. However, the collection bag must ultimately be cut open, and the plasma must be collected manually.
or must be removed either by automatic action. During this cutting and extraction operation, the plasma becomes contaminated.

Current procedures collect blood from a donor into a collection line and centrifuge it so that the plasma is collected into one of the collection bags in the collection line. The bags containing the plasma are then frozen and stored away from the rest of the collection line, all prior to processing weeks or months later. Subsequently, a number of collection bags are opened and the plasma is placed in containers for batch processing. The present invention provides an easy-to-open plasma bag that does not require cutting to remove plasma.

The easy-to-open collection bag that stores plasma is a sealable container made of flexible material. The collection bag consists of a main body with a releasable seam (hereinafter referred to as a releasable seam) that joins at the apex. The closed seam is
The closure seam is ruptured at the apex by applying a manually applied force directly to the apex, and the body is torn along the release seam without the need to cut the collection bag with a knife or any other tool, removing it from the frozen plasma. It is configured as follows. In certain embodiments, the collection bag is provided with means for manually applying a breaking force without cutting or otherwise puncturing it. According to a further particular embodiment of the invention, the collection bag is
Made of a material that remains flexible at temperatures up to The foragers can be made in a number of ways, such as heat sealing or spray molding, without departing from the spirit of the invention.

Other features of the invention will be described in detail below with reference to the drawings. The specific quick-open bags embodying the invention are illustrated for illustrative purposes only and are not intended to limit the invention. The principles and features of the invention apply to many embodiments within the scope of the invention.

FIG. 1 shows a collection bag embodying the present invention. The collection bag was part of a multi-bag collection system and contained frozen plasma in an overturned position ready to be opened at any time. The main body 10 of the collection bag communicates with a blood donation bag (not shown) through a flexible tube 12. This flexible tube is closed by a conventional seal 14. The collection bag has a hanging hole 16 which is used when the blood donation bag is full. The collection bag is made of a sealable container of flexible plastic material such as polyolefin having a thickness of 6 mils. This 6 mil thickness allows it to remain flexible at temperatures from -25°C to -80°C, the temperature range at which plasma is frozen and stored.

The body 10 of the container has a pair of release seams 20 extending from the top to the bottom (as viewed in Figure 1).
These release seams meet at apex 22.

As shown in FIGS. 2 and 3 (somewhat based on perspective drawings only for the open end of the collection bag), the release seams 20 are on both sides of the body 10 and on the plane that bisects the body. The closing seam 24, which laterally intersects the apex 22 of the release seam 20, has a width greater than the width of the release seam. (Hereinafter, the vertex 22 is referred to as the intersection point) In the structures shown in FIGS. 1, 2, and 3,
A pair of ears 26 meet at a crossing point 22 on opposite sides (in this example, at the top) of the closing seam 24 facing the release seam 20.
lying on the side of The edges of the ears 26 are rounded and extend toward the intersection point 22. Closed seam 24
is essentially a straight line sealing the top of the collection bag and separating the inner portion of the body from the ear 26.

As shown again in FIGS. 1 and 2, the rib 2
8 (hidden in Figure 3) is formed on the main body,
It extends from the closing seam from the intersection point 22 to the edge of the main body 10 in the direction of divergence. The ribs 28 form a portion 30 of the body lateral to the intersection point 22. This portion is sealed from the inner portion of the body and therefore does not contain plasma.

To open the body, the ears 26 alone, or the ears may be closed and the seams 24 and/or portions 30 pinched and pulled apart as shown in either FIG. 2 or FIG. 3 to direct force toward the intersection point. In this case, since the body portion 30 is free of plasma, this unfilled area can be held firmly by hand, allowing stronger tearing forces to be directed toward the intersection point 22. Therefore, frozen plasma can be taken out from the collection bag more quickly and more reliably. The collection bag is separated at the intersection point 22, tearing the body 10 along the release seam 20, thereby peeling the flexible polyolefin from the frozen plasma within the collection bag;
The plasma can fall into the collection container without touching it with a knife or other cleaving tool or even with the hands. The collection bag is then reversed from the position shown in FIGS. 1, 2 and 3. Although FIGS. 2 and 3 show a flexible bag torn with bare hands, gloves may be worn to provide insulation from the cooled contents.

In some known structures, the bag is opened by cutting the bag with a knife to expose the plasma, or by slightly loosening the bag from the outside inward to release the frozen plasma from the inside of the bag. That was needed. According to the configuration of the present invention, there is no need to cut the bag. Since the bag is inherently peeled from frozen plasma, there is no need to warm it with the skin prior to opening the bag.

FIG. 4 shows another structure of the open part of the collection bag.
The closing seam 24 in the structure of FIG. 1 is the release seam 2.
It intersects the apex 22 of 0 and essentially forms a straight line passing through the top of the collection bag. The closing seam 24 has a crossing point 22
There is a notch 34 aligned with the cross section 22 to concentrate the breaking force at the intersection point 22. The body has no ears, but is optionally provided with ribs 28 that define sealed pockets 30 that do not contain plasma.

FIG. 5 shows another structure of the main body. In this structure, the closing seam 24 has a V-shape consisting of seam portions 24a and 24b converging toward the intersection point 22. Rib 28 forms the same region, ie, subsection 30, as the like-numerated portion in the structure of FIG. The provision of ribs 28 and this unfilled portion 30 is also optional. However, since there is no ear here, it is the small portion 30 and the joint portions 24a, 24b that are pinched and separated, and the breaking force is concentrated at the intersection point and the tearing of the release seam 20 begins.
It is.

FIGS. 6 and 7 show yet another structure. A seam 24, similar to that shown in FIG. 5, is V-shaped and converges at the apex of the release seam 20. Ribs 28a, 28b also converge at intersection point 22 to form an unfilled region or sub-portion 30, similar to the structure described above.

To simplify the structure, the ribs 28a, 28b converge at the intersection. Closed seam portion 24a and rib 28a are mutually aligned linear extensions, as are closed seam portion 24a and rib 28b. Due to this shape, a substantially triangular portion 40 is formed by the closed seam portions 24a, 2 facing the small portion 30, indicated by the reference numeral 42, consisting of folded and overlapping corners of a portion of the bag.
Place it on the opposite side of 4b. These corners are secured together by connecting seams 44.

The triangular portion 40 remains attached to the collection bag until it can be opened at any time. As can be seen in FIG. 6, a straight punching 46 extends along the closed seam portions 24a, 24b. The presence of the triangular portion 40 provides additional strength to the collection bag and prevents premature breakage at the intersection point 22.

To ensure that the collection bag can be opened at any time,
The triangular section 40 is torn from the collection bag along straight cutouts 46 to form what is shown in FIG. The small portions 30 and/or the closed seam portions 24a, 24b are grasped and pulled apart to concentrate the breaking force at the intersection point 22 as in the previously described structure.

Various structures can be created in various ways.
The bag structure is made by cutting polyolefin material from a continuous long tube and heat-sealing it at the release seam 2.
0, forming the bottom 36, the closing seam 24 and the ribs. Another method is to start with folded sheets and heat seal them to create various ribs and seams.

Another possibility is to form the entire bag by blow molding. Various ribs and seams can also be created in molded cavities and attached to the bag by blow molding.

[Brief explanation of the drawing]

1 is a perspective view of a ready-open sealable container or bag of flexible material embodying the invention; FIGS. 2 and 3 show the bag of FIG. 1 opened; FIGS. FIG. 5 shows another structure of the bag shown in the first figure, and FIGS. 6 and 7 show still other structures of the bag shown in the first figure. DESCRIPTION OF SYMBOLS 10...Main body, 20...Dissociation seam, 22...Cross point, 24...Closing seam, 26...Ear, 28...
Ribs, 30...small portion.

Claims (1)

[Claims] 1. A bag body 10 having front and rear surfaces, and a closing seam 24 provided at or near the end of the bag body.
and opposing release seams 20 on the front and rear surfaces of the bag body extending to and aligned with each other at the closing seam, and the bag body tearing at the intersection point 22 of the closing seam and the release seam. extending from the closing seam as one means for concentrating tearing forces at the intersection point to cause the bag body to tear along the release seam and to separate the contents from the bag body. A ready-open bag for blood storage made of flexible material in which an unfilled area 30 is formed by ribs 28. 2. A bag according to claim 1, further comprising a rib (28) extending from the closing seam (24) and extending in a divergent direction from the intersection point (22) to form an unfilled area (30) of the bag body. 3 Ribs 28a, 28b are V-shaped closed seams 2
3. A bag according to claim 2, wherein the bag has four aligned linear extensions. 4. A portion 26 of flexible material is disposed lateral to the intersection point 22 on the side of the closing seam 24 opposite the release seam 20 to absorb tearing forces when the lateral portions 26 are pulled apart. The bag according to any one of claims 1 to 3, which is formed so as to be concentrated at the intersection point. 5. A bag according to any one of claims 1 to 4, wherein the closing seam 24 is substantially straight. 6. A bag according to any one of claims 1 to 4, wherein the closing seam 24 converges in a V-shape at the intersection point 22 to concentrate tearing forces. 7. Bag according to any one of claims 1 to 6, in which the closing seam 24 has a notch 34 for concentrating the tearing force at the point of intersection 22. 8. According to any one of claims 1 to 7, the bag body 10 is made of a sheet, and the release seam 20 and closing seam 24 of the bag body are formed by heat sealing. Bag as described. 9. The bag according to any one of claims 1 to 7, wherein the bag body 10 is formed by blow molding. 10. A bag according to any one of claims 1 to 9, made of a plastic material capable of remaining flexible in the temperature range from -25°C to -80°C. 11. On the side of the closing seam 24 opposite to the release seam 20, separable parts 40, 42 are provided to strengthen the bag and prevent it from accidentally breaking prematurely. The bag according to any one of items 1 to 10. 12 a V-shaped closing seam 24 that intersects at a crossing point 22, the closing seam defining a V-shaped separable portion 40 of the bag body on the side of the closing seam opposite the release seam 20; Thereby, after cutting into the V-shaped parts, the closing seam is broken at the intersection point and the bag body 10 is torn along the release seam so as to separate it from the contents. A bag according to any one of claims 1 to 10. 13. The bag according to claim 12, wherein the separable portion 40 is separated from the rest of the bag body 10 by a punch line 46.