US 3513829 A
Description (OCR text may contain errors)
May 26, 1970 F. DEUSCHLE E AL I 3,513,829
FLUID COLLECTING STRUCTURE I Filed Aug. 11, 196'? 2 Sheets-Sheet 1 Inveni'o 7'5.- J'Z'QZ} Duscle, fignaldsflfzeddfi wait,
W) W, QZZLM May26, 1970 F. DEUSCHLE ETAL 3,513,829
' FLUID COLLECTING STRUCTURE Filed Aug. 11, 196'? 2 Sheets-Sheet 2 United States Patent 3,513,829 FLUID COLLECTING STRUCTURE Fritz Deuschle, St. Augustine, Fla., Reynolds B. Redd, Austin, Tex., and Paul R. Ewalt, Hazelwood, l-/Io., assignors to Brunswick Corporation, a corporation of Delaware Filed Aug. 11, 1967, Ser. No. 659,997 Int. Cl. A61b /14 US. Cl. 1282 13 Claims ABSTRACT OF THE DISCLOSURE A fluid collecting structure such as for collecting blood samples and the like having a container for receiving the fluid and valved means for selectively closing the container. The container is resiliently constrictible to provide a vacuum condition therein when desired as for facilitated transfer thereinto of blood from a patient. The container is provided with one or more crease lines for facilitating folding thereof to effect a desired constriction. The valving means is associated with a cap which closes an open end of the container. Means are provided for tactually indicating the disposition of the valve means as a function of the position of the cap on the container. Gradient beads are provided in the container and may be coated with anticoagulant material.
This invention relates to fluid collecting structures and in particular to structures for collecting fluid such as blood from a patient.
To facilitate the collection of blood samples from patients, collecting structures have been heretofore employed having an evacuated container for effectively positively withdrawing the blood. One such well known structure has employed a rigid glass container in the form of a tube which is maintained in an evacuated condition by a rubber stopper. In use, the stopper is pierced after connection thereof to the patient whereupon the blood is drawn into the tube by the vacuum forces. A more recent development is that shown in the Wilburn Pat. No. 3,181,529 wherein a constrictible container formed of a resilient material such as plastic is substituted for the rigid glass tube, and a valved closure is provided to permit the evacuation to be effected at the time of use by a constriction of the tube with the valve in the open position and a closure of the valve after the desired quantity of air is expelled from the tube by the constriction, whereupon the resiliency of the tube in tending to restore itself to the normal configuration causes the desired vacuum condition to obtain therein.
The present invention comprehends an improved fluid collecting structure of the latter described type which provides a number of improved features and eliminates a number of disadvantages of the presently known collecting structures.
Thus, one feature of the present invention is the provision of an improved valve means for use in such a fluid collecting structure providing facilitated use through a tactual indication of the arrangement of the valve.
The present invention further provides an improved sealed connection of the closure cap to the end of the tube by means of a novel tubular structure providing a resilient connection notwithstanding the use of rigid material in the formation of the cap.
The present invention till further comprehends the provision of an improved fingertip manipulation means on the cap.
Further, the container of the present invention is formed of a highly resilient, rubbery material effectively precluding cracking thereof notwithstanding repeated folding thereof in effecting vacuum conditions. As disclosed, the container is preferably formed of an improved plastic polymer material having less than Shore D- scale hardness.
Still another feature of the invention is the provision in the container of one or more crease lines facilitating the folding of the container into preselected portions for facilitated constriction of the container in providing the evacuated condition thereof.
The invention further comprehends means for providing an improved blood collection in the provision of gradient beads within the plastic container for aiding clotting formation of the blood therein.
The invention further comprehends providing anticoagulant material within the container for preventing coagulation thereof substantially at the time of delivery of the blood into the container.
Still further, the invention comprehends providing the anticoagulant material in the form of a coating on the beads.
The beads are further preselected as to size so as to be larger than the openings in the valve closure mean to effectively preclude interference with the fluid transfer therethrough.
Another feature of the invention is the provision of a new and improved protective cap for protecting the needle connector.
The protective cap is adapted further to be inserted into the cut end of the container for reclosing the container after a partial quantity of the collected blood is withdrawn therefrom such as for making one test of a series thereof.
Other features and advantages of the invention will be apparent from the following description taken in connection with the accompanying drawing wherein:
FIG. 1 is a front elevation of a fluid collecting structure embodying the invention;
FIG. 2 is a side elevation thereof with the protective cap removed;
FIG. 3 is a side elevation thereof with the container portion in a folded, air expelling arrangement;
FIG. 4 is a front elevation thereof with the cap member shown in dotted lines in the closed position;
FIG. 5 is a side elevation illustrating the arrangement of the fluid collecting structure with the container in the evacuated condition and with a needle installed thereron;
FIG. 6 is an enlarged transverse section taken substantially along the line 66 of FIG. 1;
FIG. 7 is an enlarged transverse section taken substantially along the line 77 of FIG. 1;
FIG. 8 is a fragmentary longitudinal section taken substantially along the line 8--8 of FIG. 6;
FIG. 9 is a fragmentary longitudinal section similar to that of FIG. 8, but with the valve in the open position;
FIG. 10 is a fragmentary longitudinal section taken substantially along the line 1010 of FIG. 7;
FIG. 11 is a front elevation of the fluid collecting structure with the needle inserted into a patients body tissue as for collecting blood therefrom, the valve being manipulated to the open position for utilizing the evacuated condition of the container to draw the blood thereinto;
FIG. 12 is a front elevation of the fluid collecting struc ture with the valve in the closed position and with the protective cap reinstalled subsequent to a blood collecting operation;
FIG. 13 is a front elevation of the blood collecting unit in an inverted position illustrating the step of cutting olf the end;
FIG. 14 is a side elevation of the blood collecting structure with the end of the container removed and the container inverted to deliver a portion of the collected blood into a test tube; and
FIG. 15 is a front elevation of the blood collecting unit in an inverted position with the protective cap installed in the cut end for sealingly closing the same.
In the exemplary embodiment of the invention as dis closed in the drawing, a fluid collecting structure generally designated is shown to comprise a container 11 having an open end 12 selectively closed by a cap member 13. In illustrating the invention, the structure 10 will be described with reference to its use in collecting blood samples, it being understood that the structure 10 may be similarly used for collecting other similar fluids.
As indicated briefly above, in collecting fluids such as blood from a patient a needle is inserted into a suitable blood vessel to conduct the blood from the blood vessel into a suitable container. To facilitate the collecting of the blood, it is desirable that the container be under vacuum pressure. In the illustrated embodiment, the container 11 is resiliently constrictible and the cap member 13 defines with the container 11 a valve means generally designated 14 for selectively closing the container end 12 to maintain an evacuated condition thereof as illustrated in FIG. 5.
More specifically, end 12 defines a reduced end portion of the container 11 having an external thread 15 adapted for threaded engagement by an internal thread 16 on the side wall, or skirt, 17 of the cup-shaped cap 13. The container end 12 further defines a transverse wall 18 having at least one, and herein four, ports 19 therethrough of relatively small diameter spaced concentrically about an imperforate axial portion 20. The cap 13 further includes a base wall portion 21 having a first, outer tubular element 22 extending from the base wall 21 and coaxially spaced inwardly of the side wall 17. A second, inner tubular element 23 extends from the base wall 21 and is spaced coaxially inwardly from the element 22. Element 23 has an axial extent slightly greater than that of element 22 to define a projecting distal end portion 24. A frustoconical connector 25 extends coaxially outwardly from cap base wall 21 to define a male Luer connector for connection thereto of a conventional needle hub 26 of a conventional needle 27. An axial passage 28 extends through the element 23, base wall 21, and connector 25 to provide communication between the interior of the needle 27 and the space 29 within container end 12 outwardly of the transverse wall 18 when the element end 24 is spaced from the transverse wall portion 20 as shown in FIG. 9. Alternatively, communication between passage 28 and space 29 is prevented by the engagement of the element portion 24 with the wall portion 20 as shown in FIG. 8.
The cap is sealingly, movably connected to the container end portion 12 by means of an annular inwardly projecting rib 30 on the container end 12 outwardly of the wall 18 slidably engaged by the element 22. Element 22 comprises a relatively thin wall structure. The cap 13 is preferably formed of a relatively rigid material such as a rigid plastic and, illustratively, may be formed of polypropylene. The thin wall characteristics of element 22 permit some deflection thereof in engaging the rib 30 to provide an improved sealed connection of the cap to the container end portion 12.
The container 11 is preferably formed of a rubbery material to permit constriction thereof as by folding while effectively precluding cracking of the container. In the illustrated embodiment, the container defines a bag formed of a flexible plastic. Illustratively, the plastic may comprise a polyethylene-vinyl chloride-cellulose acetate polymer which while being physiologically inert is highly flexible. Preferably, the plastic has a hardness of less than 75 on the Shore durometer D-scale. In the illustrated embodiment, the wall 18 is formed integrally with the container end 12 and, thus, is similarly formed of the flexible plastic material. As shown in FIG. 8, the relatively rigid valve element 24 may deform the Wall portion 20 somewhat in the closed position of the valve to provide a positive sealed closure of the container.
To facilitate use of the valved structure 10, it is desirable to provide to the user some indication of the condition of the valve, i.e. whether the valve is in the opened or closed position. The present invention comprehends the provision of an improved indicating means cooperating with an improved means for effecting the selected disposition of the valve means providing facilitated use. More specifically, the container 11 is provided adjacent end portion 12 with a longitudinally outward opening, segmentally annular recess 31 defined at its opposite ends by shoulders 32 and 33 (FIG. 7). The cap 13 is provided with a pair of flat surfaces 34 and 35 and a longitudinally extending rib 36 intermediate surfaces 34 and 35. The rib 36 extends the length of the cap 13 and beyond the lower end 37 thereof to define a distal interlock portion 38 adapted to be received in the recess 31 for engagement selectively with shoulders 32 and 33. The construction of the portion 38 is correlated with the arrangement of threads 15 and 16 whereby a slight interference occurs between the interlock portion 38 and the annular shoulder 39 of the container in which the recess 31 is provided. However, by virtue of the resilient characteristics of the container material, the interlock portion 38 may be forced over the shoulder 39 to move into the recess 31 and be effectively captive therein between the shoulders 32 and 33. The disposition of the rib 36 and interlock portion 38 on cap 13 is correlated with the threads 15 and 16 and the disposition of the valve means 24-20 whereby the valve is in the closed position of FIG. 8 when the interlock portion 38 is in abutment with shoulder 32 at the inward extreme of the threaded movement of cap 13 on the container thread 15 and is in the spaced, open position of FIG. 9 when the interlock means 38 is in abutment with the opposite shoulder 33. Thus, the user need not visually observe the disposition of the cap, but is advised of the disposition to provide either of the opened or closed positions of the valve by the tactual indication afforded by the abutment of the interlock portion 38 with the respective shoulders. Further, the disposition of shoulder 32 is preselected so as to provide a positive limitation on the inward threading of the cap so as to provide a proper preselected sealing pressure of the valve element 24 with the valve seat portion 20. Thus, the indicating means efiectively defines means for tactually indicating the hit-home condition of the valve means, effectively eliminating overstressing of the valve means as may occur where visual indicating means are provided as the means for indicating the valve disposition. The container 11 may be provided with visual indicating means in addition to the tactual indication means which, as shown in FIG. 1, may comprise a portion 40 on the container 11 providing a closed legend associated with shoulder 32 and a portion 41 providing an open legend associated with the opposite shoulder 33, The alignment of the rib 36 with the legends 40 and 41 may be readily visually determined where desired.
The cap 13 further defines a reduced diameter outer wall portion 42 adjacent the base wall portion 21. The outer portion 43 of the rib 36 is radially enlarged therefor at wall portion 42 whereby an improved manipulation means is defined such as for engaging an annular tool means (not shown) having a suitably cooperating slot to receive the enlarged end 43. To further facilitate rotation of the cap 13 for opening and closing the valve means 2420, external ribbed, or serrated, surfaces 44 and 45 may be provided on the cap laterally outwardly of the surfaces 34 and 35.
To provide facilitated constriction of the bag 11 as by folding the bag into a plurality of portions, the bag 11 is provided herein with a pair of crease lines 46 and 47 for folding the bag into preselected portions whereby facilitated constriction of the several portions may be effected by fingertip squeezing, as illustrated in FIGS. 3 and 4. Crease line 47 may be opposed to crease line 46 to permit the folding of the bag in either direction to obtain the desired preselected folding portions.
In taking samples of blood for certain purposes, it is desirable to prevent coagulation thereof. The present invention comprehends the provision of means in the container 11 for effecting such anticoagulation effectively at the time of withdrawal of the blood from the patient, thus avoiding the coagulation which may occur where the anticoagulant is added subsequently to the blood sample after completion of the collecting operation and removal of the container from the blood collecting means. Thus, an improved, immediate anticoagulation treatment of the blood is effected.
Further, it is desirable to aid clot formation of the blood within the container 11. As discussed above, the container is preferably formed of a resilient plastic and thus presents an effectively unwettable surface to the blood. It has been found that by utilization of gradient beads 48, comprising small plastic beads which may be deposited within the container prior to the closing of the end 49 of container 11 as by heat sealing thereof, clotting of the blood is effectively retarded to thereby simulate the anti-blood-clotting characteristicss of wettable surfaced glass containers. Beads 48- are preferably formed of a plastic such as polystyrene having a specific gravity intermediate the different constituents of the whole blood so as to facilitate separation thereof in a subsequent centrifuging action.
To preclude clogging of the ports 19, it is preferable that the bead size be larger than the port cross section. Thus, during a subsequent centrifuging operation, blood fluid may freely pass through the ports 19 into the annular space 50 between tubular elements 22 and 23 to deflect the element 22 slightly outwardly and thereby provide an enhancement of the seal between element 22 and rib 30.
Thus, the use of fluid collecting structure is extremely simple. The structure may be provided in sterile condition maintained by a protective cap 51 on the connector 25. The user may remove the cap 51 and suitably install a needle 27 thereon in the conventional manner. The container 11 may be evacuated at that time by fold ing the same, as shown in FIG. 3, with the valve 24-20 in the opened arrangement of FIG. 9 thereby to expel air from the interior 52 of the container outwardly through ports 19 and passage 28. The user may then manipulate cap 13 to close valve 24-20 as shown in FIG. 8, the movement of the valve between the opened and closed conditions being automatically tactually indicated to the user by the abutment of the rib portion 38 with the respective shoulders 32 and 33 at the opposite ends of the recess 31. With the vacuum condition in the container 11 being thusly maintained, the user may then insert the needle onto blood collecting association with the patients blood vessel as shown in FIG. 11. Rotation of the cap may then be effected to reposition the valve in the open position of FIG. 9 whereupon blood is drawn into the space 52 within container 11 by the vacuum pressure. The blood is immediately treated by the anticoagulant coating on the gradient beads 48.
The valve 24-20 may then be closed as desired and the needle withdrawn from the patient to complete the blood collecting operation. The fluid collecting structure 10 thusly is extremely simple and economical of construction while yet providing a number of high desirable advantages over the known collecting structures. Not only is the utilization of the structure faciliated, but further positive control of the blood collecting operation is provided.
The protective cap 51 may be reinstalled on the needle connector 25. The blood collecting unit may then be delivered to the laboratory for making the desired tests of the blood collected therein. Thus, as shown in FIG. 13, the end 49 of the container 11 may be cut therefrom by a conventional scissors 53 with the blood collecting unit in the inverted position to retain the blood in the lower portion thereof. Upon removal of the end 49, the desired quantity of the collected blood may then be delivered from the structure 10 into a suitable receiver such as test tube 54. Where a number of tests are to be conducted, the container 11 may be reclosed by removing the protective cap 51 from the needle connector 25 and installing the frusto-conical outer end 55 thereof in the open end of the container 11, as shown in FIG. 15. The base pOrtion 56 of the protective cap is provided with a plurality of ribs 57 for facilitated manipulation of the cap and for abutment with the cut end 58 of the container 11 to limit the insertion of the cap portion 55. The diameter of the cap portion 55 may be accurately preselected to provide a sealing plug of the cut end of the container 11 thereby permitting the reclosed blood collecting unit to be maintained for subsequent sample withdrawals as desired.
While we have shown and described one embodiment of our invention, it is to be understood that it is capable of many modifications. Changes, therefore, in the construction and arrangement may be made without departing from the spirit and scope of the invention as defined in the appended claims.
1. A cap for use in a fluid collecting structure, comprising: V
a cup-shaped member having an annular side wall and a base wall, said side wall having a flat finger-engagement surface, a rib extending longitudinally of the cup-shaped member at said surface, a first tubular element spaced coaxially within said annular wall and carried by said base wall, and a second tubular element spaced coaxially within said first tubular element and carried by said base wall, said base wall having an opening therethrough communicating with the interior of said second tubular element.
2. The cap of claim 1 wherein said rib extends longitudinally beyond said surface to define a projection.
3. The cap of claim 1 including a ribbed surface laterally adjacent said flat surface.
4. The cap of claim 1 wherein said second tubular element extends to beyond the plane of the distal end of said first tubular element.
5. In a fluid collecting structure having means defining a container provided with an opening, means for controlling fluid flow through said opening comprising:
a member movably carried on said container means adjacent said opening, said member being provided with a flat finger-engagement surface;
valve means including a first portion on said container means and a second portion on said member for selectively closing said opening as an incident of movement of said member to a first preselected position; and
means for providing a tactual indication of the disposition of said member in said preselected position and in a second preselected position wherein said valve means permits fluid flow through said opening, said indication means comprising a rib on said flat surface and extending longitudinally beyond said surface to define a projection, and a pair of spaced shoulders on said container means, said projection being disposed to abut one of said shoulders in said first position and the other of said shoulders in said second position.
6. The fluid collecting structure of claim 5 wherein said member is provided with a ribbed surface adjacent said flat surface.
7. The fluid collecting structure of claim 5 wherein said member comprises a cup-shaped cap having an annular side wall and a base wall, said side wall having a reduced diameter portion adjacent said base wall, and said rib having at least a portion thereof on said reduced diameter portion.
8. The fluid collecting structure of claim wherein said member is formed of a rigid material and said container is formed of a resiliently foldable material.
9. The fluid collecting structure of claim 5 wherein said container comprises a resilient constrictible structure adapted to be folded and squeezed for constriction thereof.
10. The fluid collecting structure of claim 9 wherein the container includes a crease line formed therein for guiding a folding of the container into preselected portions.
11. The fluid collecting structure of claim '5 wherein said container includes a tubular portion defining an opening and having an inturned annular rib thereon, and a valve element on said container, and said means for closing the container includes a deflectable member comprising a thin tubular Wall slidably engaging said rib and a rigid valve element for cooperation with said valve element on said container.
12. The fluid collecting structure of claim 5 including a protective cap for covering said valve means.
13. The fluid collecting structure of claim 5 including a protective cap for covering said valve means, said protective cap having means thereon for sealingly closing the container subsequent to removal of an end portion thereof for delivering therefrom a portion of a body of fluid collected therein.
References Cited UNITED STATES PATENTS OTHER REFERENCES Clark et al.: Proc. Soc. Expr. Biol. and Med., vol. 74, 1950, pp. 68-71.
RICHARD A. GAUDET, Primary Examiner K. L. HOWELL, Assistant Examiner US. Cl. X.R.