US 2757669 A
Description (OCR text may contain errors)
s- 7, 1956 T. H. GEWECKE ETAL 2,757,669
APPARATUS FOR BLOOD COLLECTION AND METHOD OF USING THE SAME Filed July 7, 1954 2 INVENTOR. 0 meodore /7! Geu/ecke BY Cyrus 1?. Bra/nan United States Patent Theodore H. Gewecke, Glenview, and Cyrus R. Broman, Evanston, Ill., assignors to Baxter Laboratories, Inc.
Application July 7, 1954, Serial No. 441,953
4 Claims. (Cl. 128-214) This invention relates to an apparatus for blood collection and method of using same, and more particularly, to a collapsible container mounted in an evacuable housing and the method of using the same for blood collection.
In the past, blood collection apparatus has usually included a glass bottle as the storage vessel. Blood is removed from the body of the donor through a hypodermic needle inserted into a vein, the needle being connected to the storage bottle by means of flexible tubing. An out standing advantage of a glass type container is that it may be evacuated prior to blood collection. Vacuum extraction of blood permits the use of a smaller puncture needle and tubing than that used in extraction at atmospheric pressure because the additional frictional losses resulting from the use of smaller tubing are compensated for by the vacuum. Vena-puncture of the donor with a small needle is such less painful than puncture with a large needle.
Notwithstanding the advantage of possibility of evacuation, glass containers are undesirable from the standpoint that they are easily breakable and are not adapted to fit into small or irregular spaces. In particular, the use of glass storage bottles is distinctly limited for military purposes. Transporting and storing them for battlefield use without breakage has brought about extensive investigation for a satisfactory substitute not subject to the aforementioned disadvantages. An expedient struck upon in the past to solve'this problem is the use of a collapsible container for the storage of blood. The most commonly used type of collapsible container is manufactured from a plastic material. However, collapsible containers by their very nature are incapable of being previously evacuated so that the one advantage is offset by the corresponding disadvantage of reduced flow rates and larger puncture needle sizes.
This expedient has proved unsatisfactory for another reason, namely that the plastic materials used thus far have not proved impervious to the transmission of the vapor formed from the anti-coagulant solution contained in the blood storage container which is essential to properly preserve the blood. As a result, the plastic container is not capable of storage for any extended period of time and still maintain the anti-coagulant solution contained therein in suitable liquid form.
The presence of an anti-coagulant solution in the plastic bag has brought about other diflicult problems. Since it is necessary to ascertain whether the anti-coagulant solution is in a proper liquid state prior to introduction of blood into the storage container, the container must be of a transparent nature. This necessarily limits the number of plastic materials which are available for use in the fabrication of such collapsible blood container. Still another problem brought about by the use of a plastic material in the fabrication of the storage container is that when the anti-coagulant solution is incorporated therein, the container must be sterilized by steam rather than any of the gas sterilization procedures now known to the art. Steam sterilization by necessity must be carried out at elevated temperatures generally in the range of from 230 to 250 F., so that the choice of plastic materials is further limited to those capable of withstanding temperatures in that range without being adversely affected. 7
By the apparatus and method of our invention, it is possible to use a collapsible container which is not subject to any of the foregoing disadvantages. Essentially the apparatus of our invention includes a collapsible container for blood collection and storage removably mounted in a housing capable of being evacuated when the container is mounted therein. Incorporated into the aforementioned container is a passage communicating to the atmosphere in which is mounted a self-sealing closure permitting introduction of anti-coagulant material into the container just prior to blood collection, the anticoagulant material being derived from a separate but associated source. The method of our invention involves the utilization of the above apparatus in combination with the separate but associated source of anti-coagulant material in the collection and storage of blood.
It is, therefore, an object of our invention to provide an apparatus combining the foregoing advantages in the collection and storing of blood. A corollary object is to provide a method therefor. Other objects and advantages of our invention will be seen as the specification proceeds.
Our invention will be explained in conjunction with the following drawing, in which Fig. 1 is a perspective view of a blood collection system equipped with the apparatus of our invention; and Fig. 2 is an enlarged elevational view, partially in section, of the blood collection apparatus of our invention.
Referring to the drawing, Fig. 1 shows a blood collection apparatus including collapsible blood storage con tainer 10, evacuable housing 11, and administration set 12, interconnected and arranged for blood collection. In particular, one end 13 of flexible tubing 12a of collection set 12 is removably inserted into container 10, the other end 14 being adapted to be inserted into a vein of a donor (not shown). To facilitate these insertions, the ends 13 and 14 of collection set 12 are provided with needles, 13a and 14a, respectively. Mounted on tubing 12a intermediate the ends thereof is some form of clamping means such as hemostat 15, useful in controlling the flow of blood. Thus, a conduit is established between the donor and container 10 which is intended to store the transfused blood.
Container 10 is removably mounted in housing 11, the arrangement of mounting being adapted to permit evacua tion of housing 11 while permitting connection of set 12 to container 10. Housing 11 is of a rigid nature, and may include, as in the embodiment pictured, a glass container 16 closed in airtight fashion with screw cap 17. It is to be noted that housing 11 may take many forms, but it is desirable that at least a portion of housing 11 be transparent so that the rate of blood collection can be visually ascertained.
In the event the inexpensive and simple form of housing 11 shown in the drawing is used, the seal of container 16 by threadable mounting thereon of cap 17 is improved by the interposition therebetween of gasket 18.
To permit evacuation of housing 11, screw cap is provided with outlet fitting 19 to which is connected vacuum tubing 2%) leading to a vacuum pump (not shown). Valved inlet 21 is also provided in cap 17 to permit destruction of the vacuum in housing 11 by venting.
As mentioned above, container 10 is removably mounted in housing 11 in a manner permitting evacuation of the housing yet permitting connection of set 12 to container 10. This arrangement permits introduction of blood into container 15 while its walls are distended under the influence of the vacuum inside housing 11. For this purpose, an airtight seal must be established between housing 11 and that portion of container external to housing 11 and through which blood is introduced.
Many expedients capable of achieving such a seal will be apparent to those skilled in the art. One such structure would include an integral peripheral flange about the outlet portion of the collapsible container, and means associated with the housing adapted to clamp such flange in an airtight fashion to the housing. However, we prefer a seal achieved by the simple expedient of thread mg.
For this purpose, cap 17 is provided with integral collar 22. Collar 22 is internally threaded; thereby being adapted to removably receive externally threaded neck 23 of container 10, and seal all but inlet passage 24 in neck 23 in an airtight fashion to housing 11. To provide a more effective seal, neck 23 is of a semi-rigid nature permitting it to be tightly threaded into collar 22. Thus, a vacuum condition may be maintained within housing 11 when container 10 is mounted therein, yet fluid from a source external to housing 11 can be introduced into container 10.
In order to adapt container 10 to the collection of blood, passage 24 is provided with self-sealing means which permits the removal after transfusion of needle 13a which was inserted therein prior to blood transfusion while still preventing the introduction of foreign contaminants. In view of the fact that a needle if improperly inserted may puncture the plastic container, neck 23 is of substantial length, providing thereby a protective sleeve for needle 13a. In this connection it is desirable to have collar 22 of cap 17 offset upwardly from the surface of cap 17 so as to accommodate the length of neck 23 without the need of lengthening housing 11 to adequately house container 10 when the same is in an expanded condition.
To achieve the aforementioned design advantages, the structure shown in Fig. 2 is preferred. Referring specifically to Fig. 2, thermoplastic plug 25 is mounted in passage 24 of neck 23. Plug 25 is adapted to fit snugly within neck 23, and, in the preferred embodiment is immovably secured in its mounting by solvent sealing. Plug 25 is provided with axial passage 26 extending therethrough, permitting introduction of blood into container 10. By solvent sealing, we refer to the use of liquid plasticizer materials adapted to dissolve adjacent portions of two assembled plastic elements, and upon drying, creating a tight union therebetween. In the embodiment shown, plug 25 is of a substantially stiff nature, thereby contributing to the stiffness of neck 23 especially desirable for achieving a firm member for threadable engagement with collar 22.
As mentioned above it is desirable to close passage 24 with self-sealing means. For this purpose we prefer to close that portion of passage 24 located in plug 25 and designated 26 by means of a removable cap 27.
Cup-shaped rubber cap, designated generally 27, is removably mounted on neck 23 which is rendered substantially stiffer by the mounting of plug 25 therein. Cap 27 is provided with integral tab 28 extending from the lip portion of the cup-shaped body 29. The lip portion of cup-shaped body 29 is provided with an inwardly extending annular flange 28a adapted to permit cap 27 to be mounted securely but removably on neck 23, as can be seen from the indented portion of neck 23. Integral with and in axial relation to the cup-shaped body 29 is inwardly extending stopper portion 30. Stopper portion 30 of cap 27 is adapted to be removably inserted into passage 26, providing an airtight closure therefor. The airtight closure is not only provided by the close fit between rubber stopper portion 30 and the wall of passage 26 in thermoplastic plug 25, but also by annular lip portion 31 of stopper portion 30. Lip portion 31 also cooperates with flange 28a to act as a guard against inadvertent displacement of cap 27. The length of stopper portion 30 is sufficient to permit self-sealing of the puncture created when needle 13a of administration set 12 is inserted.
Inasmuch as the entire depth of stopper portion 30 is not required to provide the aforementioned self-sealing feature, recessed portions 30a are provided therein. The smaller thickness of stopper that has to be punctured as a result of recessed portions 300, permits easier insertion and removal of needle 13a without detracting from the ability of stopper portion 30 to re-seal itself.
External to cup-shaped body portion 29 and in axial relation thereto is integral tubular portion 32. Tubular portion 32 provides a receptacle for removably receiving flanged closure member 33 so as to keep the portion of top surface of cap 27 relatively sterile prior to needle puncture for blood collection.
Operation The mode of using our operation can be best understood from the following description relating to the embodiment pictured in the drawing. In the usual course of using our invention, it is expected that plastic container 10 will be supplied to the user in a collapsed form. For example, a large number of these plastic bags can be shipped overseas for military use in a relatively small cardboard carton. An additional advantage of this type of container over a glass bottle lies in its lighter weight. It is also contemplated that in the same carton and associated with plastic container 10 will be source of anticoagulant liquid (not shown in the drawing). This source of anti-coagulant liquid may take many forms known to the art, but the primary problem that has to be overcome in this respect is the provision of it in some kind of container which does not permit evaporation of the liquid therefrom. Therefore, it is expected that the most convenient form for providing the necessary elements for blood collection would be a package containing 1) plastic container 10, (2) blood collection set 12 including some kind of clamping means, and (3) a tube or vial of anti-coagulant liquid equipped with outlet means adapted to permit extraction of the anti-coagulant liquid therefrom under substantially sterile conditions.
It is to be noted that the structure of our invention is not restricted to uses wherein the anti-coagulant solution is provided separately from the collapsible container, only that, up to this time, no suitable container has been found that is capable of containing the anti-coagulant liquid for a substantial period without some kind of degradation such as crystallization resulting from evaporation of liquid.
At the site of blood collection, the aforementioned package would be opened and container 10 threadably mounted in housing 11. The contents of the anticoagulant-containing vial are then transferred to container 10 by removing closure member 33, inserting plug-in needle 13a of collection set 12 into stopper portion 30 of cap 27, inserting hypodermic needle 14a into the anticoagulant-containing vial and causing the contents there of to flow through set 12 into container 10 by gravity.
Collection set 12 is then clamped, as by hemostat 15, and a vacuum drawn on housing 11. It is not essential to the method of our invention that container 10 be mounted in housing 11 before the anti-coagulant material is introduced into container 10. It is desirable, however, to leave needle 13a inserted into stopper portion 30 after the initial insertion and until the blood collection process is finished in order to minimize the possibility of contamination. It would therefore be necessary to thread set 12 through collar 22 before neck 23 could be threadably mounted therein.
It is also not necessary to flow the anti-coagulant material from its vial into container 10 by gravity, but the same can be achieved if housing 11 is evacuated prior to such transfer. In that event, collection set 12 must be clamped prior to evacuating housing 11- to prevent drawing of air into container 10.
The container which previously contained the anticoagulant liquid is then removed from donor needle 14c, and donor needle 14a is then inserted into a vein of the donor. The clamping means is then removed from the collection set and the course of blood collection begun. When sufficient blood has been collected, as determined by visual examination of container 10, collection set 12 is once again clamped, and set 12 is disconnected first from the body of the donor and secondly from stopper portion associated with container 10. Inasmuch as inlet 23 of container is provided with a stopper of a selfsealing nature, which may be of the form shown in the pictured embodiment, the collected blood is available for storing in a condition free from contact with the atmosphere.
For ease in storing, integral ear portions 34 are provided on container 10, and holes 35 are provided in integral ear portions 32. Thus, a plurality of filled containers can be stored along a pair of parallel rods extending through holes 35. When the stored blood is to be used for transfusion purposes, container 10 may be inverted and suspended by bail member 36, which may be a plastic band solvent-sealed to the base of container 10.
There are many methods available in the art for fabricating container 10 into the embodiment shown herein. A method We consider especially suitable involves the application of dielectric heating through the use of high frequency electricity to heat seal the edges 37 of the body portion 38 of container 10. Body portion 38 may be either an extruded tube or two lengths of plastic heat-sealed along opposite edges thereof to form a tubular body. In addition, we prefer to use the method of heat sealing to attach neck 23 to body 38.
When it is desired to remove the stored blood from container 10 either for transfusion or extraction of plasma, cap 27 is removed by grasping tab 28 and exerta pulling pressure thereon. This exposes the top portion of plug 25 with passage 26 extending therethrough. Inasmuch as passage 26 is substantially larger than plugin needles conventionally used in extracting blood from stored containers, the possibility of blockage of the extracting apparatus by coagulated elements in the blood is materially lessened. In the usual process of extraction of blood from the storage container, some form of conduit is used, with means affixed to one end suitable for inserting into passage 26.
An additional advantage accrues through the use of a container of the type pictured in that only one passage is necessary for both collecting and extracting blood since there is no need for an additional passage necessary for the introduction of air to take the place of the blood extracted from the collapsible container.
The foregoing detailed description has been set forth for clearness of understanding only, and no unnecessary limitations are to be inferred therefrom, as modifications will be obvious to those skilled in the art.
1. A blood collection apparatus comprising a collapsible container provided with a threaded inlet portion, and an evacuable housing provided with a threaded collar element, said threaded inlet portion being threadably mounted in said threaded collar element to form a unitary device, whereby said container is adapted to be removably mounted in airtight fashion in said housing.
2. A blood collection apparatus comprising a collapsed plastic bag provided with an externally threaded inlet portion, a self-sealing stopper removably mounted in said inlet portion, and an evacuable housing provided with a window and with an internally threaded collar element, said threaded inlet portion being threadably received in said threaded collar element to form a unitary device, whereby all of said container except said selfsealing stopper is releasably sealed within said housing.
3. A blood collection apparatus comprising a collapsible plastic container equipped with an integral, substantially rigid neck having an external threaded portion, self-sealing means removably mounted in said neck, said neck being of such length to prevent puncture of said container when a hollow needle is inserted into said selfsealing means; and a housing having a transparent portion in a side wall thereof and adapted to be evacuated, said housing being provided with a removable end closure, and in said closure an internally threaded collar in which is threadably received said threaded neck, whereby all of said container except said self-sealing means is releasably sealed within said housing.
4. A blood collection apparatus of the character set forth in claim 3 wherein the said housing is a glass bottle and the said end closure is threadably attached thereto.
References Cited in the file of this patent UNITED STATES PATENTS 1,695,076 Zohe Dec. 11, 1928 1,918,307 Webber July 18, 1933 2,597,715 Erikson May 20, 1952