US 3211144 A
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Description (OCR text may contain errors)
Oct. 12, 1965 J. R. NEHRING TRANSFUSION AND STORAGE SET 2 Sheets-Sheet l ZNVENTOR. .ra/m xa flW/P/A/G Filed June 21, 1962 Oct. 12, 1965 J. R. NEHRING TRANSFUSION AND STORAGE SET 2 Sheets-Sheet 2 Filed June 21, 1962 INVENTOR.
BY at wm MZQ United States Patent 3,211,144 TRANSFUION AND STORAGE SET John R. Nehring, Linden, NJ, assignor to Heston, Dickinson and Company, Rutherford, NJ, a corporation of New Jersey Filed June 21, 1962, Ser. No. 204,211 8 Qlaims. (Cl. 128-214) This invention relates to a structurally and functionally improved assembly used in the collection and dispensing of blood and in which such use will maintain a sterile condition.
It is an object of the invention to provide an assembly which will include a receptacle of improved characteristics and within which blood or similar liquids may be safely stored for proper periods.
Another object is that of designing an assembly in which manifold functions compatible with modern collecting, storage and dispensing techniques may be accomplished in improved manners.
An additional object is that of furnishing a transfusion set and assembly embracing a relatively simple design capable of economical manufacture and use, which may moreover be readily and compactly stored for relatively long periods of time without detriment to its sterility or functioning.
With these and other objects in mind reference is had to the attached sheets of drawings illustrating practical embodiments of the invention and in which:
FIG. 1 is a side elevation partly in section of a complete transfusion assembly;
FIG. 2 is a fragmentary enlarged sectional view taken along the line 22 in the direction of the arrows as indicated in FIG. 1;
FIG. 3 is-a sectional plan view along the line 33 in the direction of the arrows also indicated in FIG. 1;
FIG. 4 is an edge view of the same in its initial or collapsed condition;
FIG. 5 is a similar view showing the receptacle distended or filled;
FIG. 6 is a fragmentary sectional view in enlarged scale showing the end of the collecting tube in its initial position;
FIG. 7 is a similar view showing that tube after it has been projected.
The parts in these several views except where otherwise designated will preferably be manufactured of flexible material. Different materials may be used in various locations in the assembly. While in many instances rubber may be employed, it is preferred to produce the parts from suitable plastics such as vinyl and polyethylene.
Referring primarily to FIGS. 1 through 5, two forms of receptacles are shown. These include walls 25 and 26 formed of suitable flexible materials and which are joined together adjacent their edges as indicated at 27 by, for example, heat sealing. It is apparent that in lieu of employing superposed separate sheets as shown a single sheet may be utilized, the free edges of which are sealed and that sealing or joining adjacent the edge zones may be accomplished by procedures other than heat sealing. In all events it is preferred to furnish a receptacle body which as in FIG. 4 will be flat when collapsed or empty. Accordingly, a number of units may be conveniently stacked one upon the other to occupy a minimum amount of space.
To prevent cohesion between the inner faces of the layers providing the receptacle the present invention contemplates having at least one of these faces roughened as indicated at 28 in FIG. 2. Such roughening may be achieved by employing a similarly surfaced forming roll in the production of sheet or layer 26. Also, etching and sand blasting will produce the desired result. If a single sheet is not employed to produce the receptacle, then the inner surface of layer or sheet 25 may embrace a smooth surface. Thus, even under long periods of storage with the inner surfaces in face to face contact, they will not adhere one to the other.
As shown in FIG. 1 the base zone of the receptacle, as at 29, is conveniently defined by a greater area of adhesion between the layers than adjacent the side edges of the latter. Within this zone, as at 30 in FIG. 1, a slit may be formed. This will furnish loop portions by means of which the receptacle may be suspended or, if desired, transported. Secured to the outer side faces of sheets 25 and 26 is a receptacle support. It is preferred that a pair of elements be embodied in the support and secured one to each of the outer layers providing the receptacle. However, in certain instances a lesser or greater number might be employed. These elements will embody a sheet of material 32, as in FIG. 1; this sheet being relatively rigid and secured to the outer face of a receptacle layer only adjacent its upper edge. So secured and with the receptacle in collapsed condition, as in FIGS. 1 and 4, the lower edges of the sheets 32 will lie above the base zone of the receptacle. As illustrated in FIG. 5, supporting sheets 33 corresponding to sheets 32 might be employed and could be provided with score lines 34 to define areas of bending. Regardless of the details of the structure, it is apparent that as the receptacle is filled and assumes a shape, as generally illustrated in FIG. 6, the base zone of that receptacle will be relatively retracted as a consequence of its becoming rounded. Therefore, the lower edges of the sheets 32 or '33 will function as legs or supports at the opposite sides of the receptacle with the base zone of that receptacle also assisting in its support incident to hearing against the upper surface of a support or deck at a point substantially midway between the supporting legs 32 or 33. Under these circumstances and as shown in FIG. 6, the extended zone 29 may flex and project in a lateral direction.
As in FIGS. 1 and 2, the upper edge zone of the receptable is defined by what might be termed a header portion embracing an extended area 35 of adhesion between the layer or layers providing the receptacle. Parts extend through this zone and are defined by capped tubes 36 in sealing contact with the layers to afford communication with the interior of the receptacle. The walls of the latter within the area of the outer tube ends are extended, as indicated at 37. Otherwise, separate layers are secured to the outer faces of the receptacle. In both instances tabs are provided. Conveniently midway of the side edges of the tabs, an opening 38 may be formed to furnish a finger hold for transporting the receptacle or else permitting the latter to be otherwise supported. The tab may also be formed with a slit or score line 39' along which it can be divided by the user. Heat seals 39 secure the layers against accidental separation at points short of their outer ends and further seals 40 inwardly of the same may extend around the outer ends of tubes 36 through to zone 35. The latter is conveniently formed with slits 41 which are in line with straps 42 of any suitable material secured to the outer side faces of the receptacle. In this manner stoppered and evacuated tubes (not shown) may be mounted to be included as part of the assembly.
Otherwise, and as illustrated in FIG. 4, if desired, there may be suitably attached to the outer faces of the receptacle manipulating portions 45. These may be grasped by the operator to pull the surfaces defining the receptacle in opposite directions and thus create an aspirating action. In the structure shown in FIG. 1, the inner end of donor tube 46 is fixed against movement with respect to the receptacle. It extends through a bore defined by an interruption in the zone of receptacle sealing and into an inward pocket portion 47 defined by a lightly heat sealed zone or line 47'.
At the time of filling, heat seal line 47 is eliminated by separating the receptacle layers adjacent their zones of engagement in line with the tube.
Returning to FIG. 1, the donor tube 46 has a thickened portion 48 mounting a cannula 49. The latter has a hub 50 over which a section of tubing 46 is forced fitted. A manipulating plate 51 is disposed at this zone and may be formed of any suitable material. Beyond this point tube 46 may slidably mount a suitable clamp, as indicated at 52. At its outer end a hub section 53 is disposed within the bore of tube 46. Section 53 supports at its outer end a metallic cannula 54 by being force fitted over the hub of the latter. A sheath 55 conveniently encloses this cannula and is in contact with manipulating portion 56 forming a part of hub 53. Needle 54 should be of the veinous type. It will be seen that the section of tubing 46 between its inner end and part 48 provides a compartment for the retention of a suitable solution.
The wall of tubing 46 may be scored as indicated at 57 to permit separation of the tube at this point by exerting a twisting force on the tubing. So separated, it may be divided at thickened portion 48 to expose needle 49. Accordingly, the latter may be coupled to one of the containers 44 for the transfer of blood from the tube 46. Finally with respect to this part of the apparatus it will be observed that an eyelet type of clamp 58 preferably formed of metal encircles tube 46 at a point adjacent the receptacle body. This clamp may be rendered effective to close the bore of the tube and thus seal the receptacle when desired.
As shown in FIGS. 6 and 7, it may be preferable to have the inner end of tubing 46 terminate in a relatively rigid portion 76 for penetrating the pocket 47, defined by seal 47', as the tube is projected inwardly of the receptacle. Under these circumstances unit 76 may be formed, if desired, of a relatively rigid plastic and include the manipulating portion 59 by means of which it is conveniently shifted from the position shown in FIG. 6 to that illustrated in FIG. 7.
In using an assembly of the type shown in FIG. 1, it will be apparent that it may be packaged, stored, and handled without affecting the sterility of its critical surfaces. The inner end of the tube 46 may be projected as shown in FIGS. 6 and 7 to establish communication between the tube bore and receptacle interior. By opening the seal defining pocket 47 in FIG. 1, tube 46 communicates with its receptacle. If solution is contained within the tube, as in FIG. 1, then under the action of gravity that solution will flow into the receptacle. If necessary, sheath 55 may be removed so that proper venting will occur. It is equally obvious that, if desired, the solution may be contained within the receptacle interior and not within the adjacent section of tubing. With having at least a mat surface 28 defining the inner face of layer 26, the presence of liquid will be readily apparent to the user in that the liquid will render the layer almost transparent. An absence of liquid will be evidenced by the mat surface presenting a translucent unit.
The assembly is conveniently supported by virtue of the opening 38 within the handle portion provided by the tabs. With sheath 55 removed, needle 54 may be introduced into the vein of the donor.- Accordingly, blood will flow through the bore of the tube, the cannula 49 and so into the interior of the receptacle. The receptacle being disposed upon its base zone and a support such as 32 being preferably employed, the blood will begin to fill the receptacle thus distending it and causing the lower edges of the supports to firmly bear against a deck surface if the receptacle is not suspended by the opening 38 or its equivalent. Under the circumstances and as shown in FIG. 5, a stable supporting structure is provided with the supports 33 being each defined by a series of surfaces 4 incident to the score lines 34. In the structure shown in FIG. 1 the lower edges of the supports 32 will be generally curvcd throughout their entire lengths.
When it is desired to remove blood from the receptacle or to administer blood from the receptacle by injection, the outer ends of one tab pair 37 are separated to disrupt the seal at 39. Continued separation destroys the seal at 40 and thereby exposes the cap enclosed within that zone of sealing. The cap may now be removed and the stopper-needle of a blood administration set introduced into the exposed end of tube 36 through diaphragm 36'. The receptacle is then inverted and blood flows from its interior to the recipient. Identifying indicia may be associated with the receptacle either by way of a label applied to one of the supports 32 or 33 or by directly inscribing on the surfaces of these supports. This indicia may include, for example, the name of the donor, his blood type, the date of donation, etc.
The technique as aforedescribed may be followed with respect to the assembly shown in FIGS. 4 and 6. The flaps or tabs 45 in this view may be employed to draw apart walls 25 and 26 to thus create aspirating action where desired. The blood within the main receptacle may be retained therein for proper periods free from contamination. While it is preferred to employ seals such as 39 to prevent accidental separation of the tabs together with safety seals 40 enclosing the access ends of the ports defined by tubes 36, it is obvious that only a single one of these seals may be incorporated within the assembly.
Thus, among others, the several objects of the invention as specifically aforenoted are achieved. Obviously numerous changes in construction and rearrangement of the parts may be resorted to without departing from the spirit of the invention as defined by the claims.
1. A transfusion set comprising a flexible receptacle for receiving and holding blood and formed with a pair of walls made of flexible material inert to and unaffected by blood secured together around their side, top and lower edges to form an enclosed envelope with at least one passageway extending therethrough for the reception and dispensing of blood, said envelope being in relatively flat and more elongated condition when it is empty and collapsed and being in relatively more foreshortened and distended condition when fluid is contained therein, and means for supporting said receptacle in upright position when it is at least partially filled including a plurality of relatively stiff strips secured along their upper edges to the opposite side walls of the receptacle and extending downwardly therealong to points spaced above the lower edge of the receptacle when the receptacle is in collapsed condition but so that they are positioned adjacent the lower edge of the receptacle when the receptacle is at least partially filled.
2. A transfusion set as set forth in claim 1 in which the walls are made of flexible thermoplastic material and they are heat sealed around their edges.
3. A transfusion set as set forth in claim 1 in which the strips of the supporting means are made of a relatively stiff thermoplastic material which will bend sufficiently to assume the distended configuration of the receptacle when it is at least partially filled and they are heat sealed to the side walls of the receptacle.
4. A transfusion set as set forth in claim 1 in which the receptacle is provided with a flexible tube having a cannula at its outer end and having communication with the interior of the receptacle at its inner end and additionally, said receptacle is provided with at least one tubular member extending between the walls thereof and having its outer end encased between sealed flaps.
5. A transfusion set as set forth in claim 1 in which a lightly heat sealed zone in the form of a pocket is positioned below said passageway so that fluid does not flow into said receptacle when not in use.
6. A transfusion set including in combination a flexible receptacle for receiving and holding blood and formed with a pair of walls made of flexible material inert to and unaffected by blood secured together around their side, top and lower edges to form an enclosed envelope, a passageway encased in and extending through one of the secured edges and communicating with the interior of said receptacle, an elongated flexible tube filled with an anti-coagulant material having a cannula at its outer end and in communication with said passageway at its other end, a pocket formed in said receptacle and positioned 'be low said passageway so that the material contained in the tube is sealed therein when the transfusion set is not in use, at least one tubular member extending between the walls of said receptacle and having its outer end encased between sealed flaps, and means for supporting said receptacle in upright position when it is at least partially filled including a plurality of relatively stifl strips secured along their upper edges to the opposite side walls of the receptacle and extending downwardly therealong to points spaced above the lower edge of the receptacle when the receptacle is in collapsed condition but so that they are positioned adjacent the lower edge of the receptacle when the receptacle is at least partially filled.
7. A transfusion set as set forth in claim 1 wherein means is provided for retaining a sample tube adjacent a wall of said receptacle, said means including an opening through one of the sealed edges and a flexible loop heat sealed to said wall and in spaced alignment with said opening.
8. A transfusion set as set forth in claim 6 wherein means is provided for retaining a sample tube adjacent a wall of said receptacle, said means including an opening through one of the sealed edges and a flexible loop heat sealed to said wall and in spaced alignment with said opening.
References Cited by the Examiner UNITED STATES PATENTS 2,525,139 10/50 Ligon.
2,695,129 1 l/ 54 Stahrner 229-55 2,780,225 2/57 Barr et a1 128-214 X 2,894,510 7/59 Bellamy 128-272 2,896,619 7/59 Bellamy 128-214 2,950,716 8/60 Bellamy et al 128-214 3,063,614 1 1/62 Orsini 229-55 X 3,079,919 3/ 63 Harrison et al 128-272 FOREIGN PATENTS 1,082,035 6/54 France. 1,228,983 3/60 France.
RICHARD A. GAUDET, Primary Examiner. JORDAN FRANKLIN, Examiner.