US2950716A - Fluid handling method and apparatus - Google Patents

Description

g 1950 D. BELL/AMY, JR. EI'AL 2,950,716

FLUID HANDLING METHOD AND APPARATUS Filed Jan 23, 1956 tet fine 2,950,716 Patented Aug. 30, 1960 I 2,950,716 mum HANDLING METHOD AND APPARATUS David Bellamy, in, Framingham, and Carl W. Walter, Holliston, Mass, assignors to Fenwal Laboratories, 1110., Framingham, lviass., a corporation of Massachusetts Filed Jan. 23, 1956, Ser. No. 560,675

10 Claims. (Cl. 128-214) This invention relates to the handling or collecting, storing, and administering of blood and other therapeutic fluid, and more particularly to improved method and apparatus for obtaining and employing a pilot sample of a Whole blood or other fluid donation, The invention is concerned more particularly with sample obtaining conjointly and also non-interferently with the collection and storage of the sampled donation. The invention aims at securing and administering both donation and sample at a single phlebotomy and in simple, sterile, air-free manner. The invention intends further the handling of the donation and sample in the same closed, sealed system assuring identity but precluding interference one with the other. Yet another invention object is the obtaining and use of the main or donation and pilot or sample fluids via or through a common inlet-outlet of such single closed sealed system, and without ailecting or violating, by the collecting or dispensing of the one, the sterile hermetic sealed storage of the other of said main donation and pilot sample. The invention will be seen still further to provide for collecting the pilot sample first, and for taking the main donation following and in a unitary system with said pilot sample collecting.

The invention will be better understood from a consideration of the following specification taken in conjunction with the accompanying drawings in which:

Fig. l is an assembly view of a representative apparatus of the invention, as shown in pre-use condition;

Fig. 2 is a like view on a larger scale of the integral pilot tube, in part broken away to show the communication with the integral donor tube; and

Fig. 3 is a section taken along the line 33 of Fig. 2.

Numerous problems and requirements attend the obtaining and handling of therapeutic fluids, particularly blood. In the case of whole blood, coagulation, clotting, and chemical change of the fluid are to be prevented or minimized. This will be understood to require a method and apparatus which is sterile, which excludes contact with air, and which presents only inert, impermeable, hemorepellent surfaces to the blood. Those skilled in the art will appreciate also that in the obtaining of the blood, as for blood banking or the like, the testing or sampling of the blood is commonly required, and generally for typing, cross matching, or culturing purposes. Thus in connection with the collection and storage of whole blood a separate pilot sample of the particular donation is commonly obtained.

The handling of this separate pilot sample should generally be under the same sterile, air-free, chemical-changeretarding conditions as required for the main donation. In other words, the obtaining and use of the pilot sample should be incident to the air-free collection of, but should not disaffect the sterile sealed preservation of the main donation. The safe or preferred handling of the main donation and pilot sample thus requires common method and means, and more particularly an integrated technique and apparatus assuring identity while precluding interference one with the other.

These several sampling objects and requirements are novelly met by the improved method and means of this invention now to be described, and which will be seen to afford the obtaining of a separate pilot sample in the same closed, sealed system as employed for the collection of the main donation, and to provide for the dispensing of the sample from, and without violating the blood preserving storage of the main donation in, said system.

In Fig. 1 there are shown representative means for collecting, storing, and dispensing a blood donation and a pilot sample in accordance with the invention and comprising generally a donation storage vessel or container 10, a collecting assembly or tube 20, and a pilot or sample storage device or chamber 30. The container 10, tube 29, and chamber 30 are seen as arranged as an integral apparatus, and with the tube 20 as inlet to the donation container 10, and as both inlet and outlet for the pilot chamber 30. Further, the entirety or at least the blood containing and conducting elements of the apparatus are fashioned of polyvinyl chloride or other flexible, light weight, sterilizable, fusible plastic material or suitable strength and toughness and presenting only inert, impermeable, hemorepellent surfaces to the blood.

As herein embodied, then, the container 10 comprises a flexible walled enclosure and more particularly a sleeve or tube or folded or doubled sheet presenting opposed walls and being flatted and fused at the sides and/or ends, as herein at the bar seals 11, 12. The sleeve or opposed sheet enclosure 10 is thus defined as a collapsible bag capable of being evacuated prior to use. This main blood storing bag or pack 10 may have a capacity of say, 500 cc.

The blood container or bag 10 may further comprise one or more fluid outlets, herein of a preferred form providing a tubing projection 13 adapted for coupling to fluid administering means, not shown. These outlet projections 13 are sealingly enclosed by pairs of integrally projecting cutor pull-apart tabs or strips 14 fused together outwardly of the bag 10 and so as to define sealed pockets for the projections. In use these strips 14, which may have separated manipulating ends, are cut or pulled apart to open the pockets and permit the coupling of the fluid administering means.

The blood bag 10 may be provided, as at one of the end seals 11, 12 with a grommet or other opening 15 engageable with or by support or hanging means, as for fluid storage, or in collecting or dispensing use.

The blood or other therapeutic fluid collecting assembly tube 20 comprises a suitable length of flexible collapsible tubing 21 which tubing integrally joins and opens at its one end to the bag 10, as at and through the bar seal 11. The integral donor tube 20 comprises further a stainless steel or equivalent phlebotomy or blood letting needle 22 of known construction, and arranged with its seating hub seized in the free end of the tubing 21 and with its cannula enclosed in a rubber or other plastic sealing sheath 23. For non-reaction with the blood the lumen of this needle 22 may comprise a hemorepellent film, as may be applied from'a dilute aqueous dispersion of dicocodimethyl ammonium chloride.

In accordance with the invention, control valve means are associated with the donor tube 20 and conveniently proximate the blood bag inlet. In a preferred form herein such openable close off means is seen as a stainless steel bead 24 slightly oversized to and seized in the tubing 21. This valve bead 24 may be coated similarly as the needle 22 with a hemorepellent film. In the illustrated embodiment also, the control valve 24 is seen as entirely contained and sealed within thee integral donor tube 20, and yet manipulable, as later mentioned, from without and without violating the integrality of the apparatus.

Those skilled in the art will appreciate also that within samples may be 'marked for common identity with a particular donation, as by imprinting or applying to the tubing 21 suitable duplicate indicia 26. V

'The pilot or sample storage device or chamber 30 of the invention is integrally'associated with and for inletoutlet throughthe' collecting tube 20, via which it may also communicate with the donation storage container 10. Further, the chamber 30 may comprise, similarly as 30 may be variously accomplished, and by means including those externally applied, as by a pinch clamp.

said container 10, a'flexible .walled enclosure such as may be formed from a sleeve of tube, or variously from folded or doubled sheet layers, all as presenting opposed walls integrally connected or sealingly to be joined at their sides and/ or ends. .As herein embodied, the pilot chamber 30 is formed from a sleeve or tube smaller than but of the similar closed end construction as said donation container, and so providing also a collapsible evacuable bladder or pouch. The storage cavity of this pilot or sample chamber or pouch may have a volume or capacity of, say, 10 cc..

The integral pilot tube 30 is herein formed more .particularly by closing one or'the free end of the said sleeve, as at the flatted or bar seal 31, and by dividing or parting its other end 32, and so as to present parallel flatwise opposed walls or strips 33, 34, Fig; 3. These sleeve or tube wall strips, 33, '34 are seen as integrally joined to the tubing 21, and more particularly as passed oppositely over'and clamped and sealed about said tubing, and bonded also to each other at both sides of and in intimate sealing engagement with the same.

it may here be noted that where the pilot tube 39 is fashioned from a single sheet it may be folded and sealed around the tubing 21, and the pouch completed by sealing its projecting sidm and ends. Similarly, where the integral pilot tube is constructed of doubled sheets or'strips, the opposed layers will be passed over and fashioned and sealed to the tubing 21, and the chamber 30 closed by sealing the projecting sheet sides and ends.

In any case, and referring to Fig. 1, it will be seen that the pilot tube 30 is desirably joined to the donor tube at or within one of the separable segments 25, the indicia 26 of "which is visible through, or it may be adjacent to, the- transparent strips 33, 34, and so identifies also the pilot sample. p 7 p p i 7 As above noted, the pilot tube 30 is integrallyassociated with the donor tube 20 and is arranged also for communication, whether directly orthrough said donor tube 20, withthe' blood bag 10. For the direct connection, a tubing length may be integrally installed at and for communication through the walls of the container and chamber 10, 30. Vari0usly,'and as in the preferred arrangement herein shown, fluid passage means may be provided in the integral pilot tube 30 and for closed sealed communication with and through the integral donor tube 20. 'More'particularly, a short tubing length 35 is formed and/or fused at a mating openingin and to define a branch in the tubing 21. The pilot'tube end seal 32 is seen to embrace also thistubing branch, the

" strips 33, 34 being flatted and fused about, or they may form, the member 35, and so as to define also a pilot cavity end wall funnelling-toward and merging with the same.

, Further in accordance with the invention, control valve means are provided for sealing or closing 0E the integral pilot tube ;30 from the donor tube 20. It will 'be understood that this valving of the integral pilot tube Herein, however, and similarly as with the donation container it there is employed for the pilot chamber control valve a stainless steel head 36, which may be treated for hemorepellence, which is oversized for gripping by and normal partitioning or closure of the branch tubing 35, and which like container valve 24 is sealed wholly within and for manipulation from without the apparatus.

From the foregoing it shouldbe understood that the invention provides a tough durablelight weight economical apparatus affording an'integral closed sealed fluid system adapted for safe certain simple sterile collection of a whole blood or other fluid donation with minimum physiologic disturbance of the donor, and with the fluid or blood safeguarded against exposure to air and conditioned to resist degradation and chemical change. All the blood conducting or storing elements of the apparawe have been indicated also as fashioned or treated for non-reaction with the blood, and as sterilizable and fusible by conventional means and method. The integral donor set here concerned will be understood further as v lending itself to easy and economical manufacture according to specifications providing desired storage volumes and flow rates, as for blood banking purposes.

The invention apparatus is readied for use, as in the blood banking practice, by adding to the suitably clean system the appropriate quantity of anti-coagulant solution. The apparatus is then sterilized in medically acceptable manner.

The invention apparatus is further prepared for blood or other therapeutic fluid handling use by tieing a loose overhand knot 27 in the donor tube 20 below the pilot tube 30, and supporting or suspending the pack 10 in desired manner.

In obtaining a supply of the blood a phlebotomy site is first prepared by washing and disinfecting the skin, and inducing, as by tourniquet means, the desired pressure. The protective sheath or cover 23 is then withdrawn from the needle 22, and phlebotomy made by inserting the needle into the donors Vein. Flow of the blood into the tube 20 and at least to pilot tube 30 is permitted and promoted by pinching or distending the tubing 21 at the pack valve 24 to a degree sufficient to permit fluid or tube air passage over or past the head 24.

Those skilled in the art will appreciate that the first few cubic centimeters of blood flowing from a venipuncture or the like wound are characterized in their elements by a greater tendency to induce clotting, and that this increased clottability may be desirable for the pilot sample, whereas it is disadvantageous to the'main donation. Accordingly, in a preferred practice of the invention method, the first flow of the blood is directed to the pilot'tube 30. This practice of collectingthe first blood as the pilot sample will be understood to insure also that the sample is obtained without opening or entering the blood pack 10, as might be required where said pilot sample is collected last, as when the donors blood flow ceases before the pack is filled.

More particularly, the pack 10 having been closed by release of the tubing 21 about bead 24, the apparatus is manipulated or pinched in the region of the branch member 35 to open the pilot tube, or in other words to provide a passage past valve head 36, and the blood is allowed to flow to and fill said pilot tube 30. The pilot 'tube 30 is then closed, as by the release of the tubing 35 to reseal about head 36, and so that the following blood flow is directed or diverted to the tubing 21. The pack bead 24 is'then forced or milked down into the bag 10, which allows the desired flow of the blood down the length of the donor tube and into and filling theblood pack.

Those skilled in the art will appreciate that during this charging or filling of the blood pack 10 the blood is caused to be mixed with the anti-coagulant solution therein, as by kneading the bag walls both during and after collection.

When the collection is completed, the donor tube 20 is sealed ofi intermediate the pack and pilot tube 30 as by pulling tight the knot 27 in the tubing 21. This will be seen to permit the use of the common or single inlet or donor tube in dispensing from and as outlet for the pilot tube 30, and without disturbing or atfecting the separate sealed blood pack 19.

Further to the practice of the invention method, the pilot sample may be employed for retyping, cross matching, or culturing use. In this the needle 22 may immediately upon the completion of the phlebotomy be applied to a vacuum device, such as an evacuated tube with pierceable stopper closure, and the valve 36 opened as above mentioned to permit the desired flow from the pilot tube 30 to said stoppered tube. It will be understood that this described sample dispensing may be repeated with several such vacuum devices, and to the limit of the capacity of the pilot tube 30.

It will be appreciated also that some of the blood may be retained in the pilot tube 30 and the donor tube 20 sealed ofi between said pilot tube 30 and the donor needle 22, for retyping or other later use of the retained or sample blood.

Cross matching and culturing samples may additionally be provided from the integral, numbered donor tube 20, as by the means and method shown and described in the co-pending application of David Bellamy, In, Ser. No. 462,239, filed October 14, 1954 now Patent No. 2,896,619. If one or more samples of the serum are desired, the donor tube 20 is merely closed off, as above described, between and to define it as the separate sealed segments 25.

If samples of the citrated blood are required, the donor tube 20 is first manipulated to strip the contained blood into the pack. Then the tube 20 is released to allow a reflux or return flow of the resultantly citrated blood into the same. Finally the donor tube is sealed or fused as just mentioned to provide the desired individual separable sample segments.

It will be understood that our invention is not limited to the particular embodiments thereof illustrated and described herein, and we set forth its scope in our following claims:

We claim:

1. In combination with an integral closed sealed blood handling system having a blood collecting tube, a donation storing container having inlet through said tube, and means for closing said container; a collapsible sample storing chamber integral and communicating with said tube, and means for closing said chamber, said container and chamber closing means manipulable for non-interferent filling and sealing of the donation and sample, and for dispensing said sample through said tube without disturbing said donation.

2. In combination with an integral closed sealed blood handling system having a blood collecting tube, a donation storing container having inlet through said tube, and means for closing said container; a collapsible sample storing chamber integral and communicating with said tube and said container, and means for closing said chamber, said container and chamber closing means manipulable for non-interferent filling and sealing of the donation and sample, and for dispensing said sample through said tube Without disturbing said donation.

3. A closed sealed blood handling system comprising a flexible collecting tube, a donation storing container having inlet through said tube, a sample storing chamber having inlet and outlet through said tube, said tube, container and chamber integrally and collapsibly formed from flexible plastic material, and control valve means associated with said tube and operable to open and close said container and separately said chamber to and from said tube, whereby a donation and sample may be noninterferently collected and sealed in and dispensed from said system.

4. In an integral closed sealed blood handling apparatus including a conducting tube and a blood donation storing container having inlet through said tube, means for collecting a blood sample comprising a flexible collapsible chamber connected in a branch of and for inlet and outlet through said conducting tube, and control valve means at said branch and for opening and closing said chamber to and from said tube.

5. The apparatus of claim 4 wherein said control valve means comprises a hemorepellent bead sized in said branch, and wherein said branch is manipulable from without the apparatus to permit fluid passage past said bead.

6. The apparatus of claim 4 wherein said conducting tube and sample chamber are of plastic construction and wherein the chamber comprises a tube flatted and sealed at its opposite ends and at one end divided and sealed around the conducting tube and said branch.

7. A closed sealed system for collecting and storing blood and other therapeutic fluid comprising a storage container, a collecting tube opening into said container, a sample chamber for communication with said collecting tube, and valve means normally closing 01f said sample chamber from said collecting tube and manipulable to effect said communication, whereby a sample may be collected and sealed in said chamber non-interferently with the storing and sealing of fluid in the container, and the container, chamber, and tubes integrally formed from a tough, flexible, light weight, sterilizable, scalable plastic material presenting only inert, impermeable, hemorepellent surfaces to the fluid.

8. Apparatus for handling blood and other therapeutic fluid comprising a sealed storage container, a collecting tube closed at one end and arranged at the other for opening into said container, a branch in the tube, a flexible collapsible pouch integrally joined to said branch, and control valve means in said branch, whereby upon closing said tube intermediate said container and branch and opening said tube end and valve means a sample of the fluid may be collected in said pouch, upon closing said valve means and opening said tube intermediate the container and branch a fluid supply may be directed to said container, and upon reclosing said tube intermediate the container and branch and reopening said valve means the fluid sample may be dispensed from said pouch without disturbing said supply.

9. Blood handling apparatus comprising a closed collapsible donation container and a collecting tube for said container, means for sealing the container and tube, a collapsible pouch, a conducting member connected between said pouch and said tube, and valve means normally closing and manipulable from without said apparatus for opening said conducting member, whereby a donation may be collected in said container without violating the sealed storage of a sample first collected in said pouch, and whereby the sample may be dispensed from said pouch without violating the sealed storage of said donation.

10. Apparatus for handling thereapeutic fluids including whole blood comprising a collecting tube, a donation storing container having inlet through said tube, a sample storing chamber having inlet and outlet through said tube, said tube, container and chamber integrally and collapsibly formed from flexible plastic material, and means for closing the inlet to said container and sepparately the inlet to said chamber, whereby a donation may be collected in the container without violating the sealed storage of a sample earlier collected in the chamber, and the sample may later be dispensed from the chamber without violating the sealed storage of the dona tion in the container.

(References on following page) 7' f r s 7 References Cited in the file 9f this patqnt I 2,674,265 Dennis Apr. 6, 1954 UNITED STATES'PATENTS 2,702,034 WaIfECI 15, 1955 605,178 Ferguson '111218 ),1898 1958 815,192 "Mercer Mar. 13, 1906 5 OTHER REFERENCES r r 2,230,218 Asche Feb- 4, 1941 Walter et a1.: Surgery, Gynecology and,0bstetrics, vo1. 2,489,394 Austin N V- 2 1 94, No, 6, June 1952. (Available'in Science Library.)

2,518,165 Millard Aug. 8, 1950

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