US2969063A - Parenteral fluid administration equipment - Google Patents

Description

Jan. 24, 1961 ll /4 a c. R. BROMAN 2,969,063

PARENTERAL FLUID ADMINISTRATION EQUIPMENT Filed Feb. 10, 1958 //VVE/VTOR-' lav 19M zhmtw ATTORNEYS.

Unite PARENTERAL FLUID ADMINISTRATION EQUIPMENT Cyrus R. Broman, Evanston, 111., assignor to Baxter Laboratories, llnc., Morton Grove, 111., a corporation of Delaware Filed Feb. 10, 1958, Ser. No. 714,422

10 Claims. (Cl. 128-214) ume and the entire contents of a bottle may be administered to an adult patient over a period of several hours. Where a smaller quantity than the entire contents of the container is desired to be administered, close personal supervision is required, and even then, there is no guarantee that the prescribed lesser amount is given.

For example, when treating infants with a parenteral solution, is it desirable to be able to quickly administer smaller amounts from a bulk parenteral solution, with confidence that no excess is given. A device for that purpose is shown in the co-owned copending application of Theo dore H. Gewecke, Serial No. 561,461, filed January 26, 1956, and reference is hereby made to that application.

There is a need, however, to be able to administer smaller amounts from a bulk parenteral source where the smaller amounts themselves are dispensed in increments. To fully meet this need, it is necessary that the increments be dispensed either simultaneously or sequentially.

It is a general object of this invention to provide a de vice that meets the need set forth above. Another object is to provide a device for sequentially delivering equal amounts of a parenteral fluid from a fluid source to a tube and needle administration set. Still another object is to provide a device that permits administration of a predetermined quantity of parenteral fluid in equal increments. Other objects and advantages of this invention can be seen as this specification proceeds.

This invention will be explained, in an illustrative embodiment, in conjunction with the accompanying draw ing, in which- Fig. 1 is a perspective view of the device of this invention shown in combination with a parenteral solution bottle and a tube and needle administration set; Fig. 2 is an enlarged front elevational View of the device shown in Fig. l; and Fig. 3 is an enlarged cross-sectional view taken alonjq the line 3--3 of Fig. 2.

In the illustration given, the numeral designates generally a bulk parenteral solution container which usually takes the form of a glass bottle equipped with a suitable closure 11 and suspending means generally designated 12. Through the use of suspending means 12, which includes a band 13 mounted in an annular recess 14 ad jacent the bottom of bottle 10, and a bail 15, bottle 10 can be supported from a hook 16 or like means. All of the foregoing is well known to those skilled in the art, so

further details of the construction and arrangement of a tates Patent bulk parenteral solution container is deemed unnecessary. Also, it is well known to provide closure 11 with a passage extending therethrough which permits the dispensing of the liquid contents 16 of bottle 10 when the bottle 10 is mounted in a mouth-downward condition as shown. The dispensing ordinarily is performed through a tube and needle set, which is designated in Fig. 1 generally by the numeral 17.

Administration set 17 is seen to include a length of flexible tubing 18 equipped at one end with a hypodermic needle 19 intended to be inserted beneath the skin of a recipient and at the other end with a drip meter 20. The upper end of dripmeter 20 is equipped with a plug-in connector (shown in dotted lines) and designated 21, which, when the device 22 of this invention is not employed, is inserted into the above mentioned passage in closure 11.

The device 22 includes an elongated tubular envelope equipped with a flow port 23 at the upper end thereof and an analogous flow port 24 at the bottom end thereof. Device 22 may be constructed of a flexible, translucent plastic resinous material such as polyvinyl chloride. Preferably, a thermoplastic material is employed for this purpose so as to permit a construction of the envelope by heat-sealing two sheets of flat material along the longer edges thereof. In this respect, the device here presented partakes of the nature of the device described in the above mentioned application of Theodore H. Gewecke.

Device 22 is equipped with a plurality of neck-like portions 25 disposed intermediate flow ports 23 and 24. Neck-like constricted portions 25 are provided by notching-out :at corresponding opposed portions the two sheets of thermoplastic material which are employed to form the lay-flat envelope included within device 22. An envelope of the character shown in Figs. 1 and 2lcan be conveniently constructed in a single heat-sealing and diecutting operation by placing two flat, flexible sheets of translucent thermoplastic material in face-to-face relation and then bringing mating dies together while on opposite sides of the face-to-face sheets. The die-defining edges can be suitably energized with electrical energy so as to fuse edge portions of the two sheets together while at the same time weakening the sheets outside the fused edges so as to permit detachment of the formed envelope from the parent sheets.

Excellent results are obtained when the constricted portions 25 are spaced apart in a manner that gradually diminishes from the top to the bottom of the device 22. The decrease in spacing is represented in Fig. 2 by the dimension arrows about the letters A, B, C, D and E. For example, in a device capable of holding 50 ml. of a parenteral fluid, the dimensions identified above by letter may take the following values:

TABLE Letter: Value, inches 1 C 1 D 1% E 1 By the foregoing variation in the height of the various chambers 26 included between adjacent constricted portions 25, the difference in hydrostatic head on adjacent chambers is compensated for.

The lower end of device 22 is equipped with a tubular outlet 27 which may be conveniently constructed of a thermoplastic flexible material and heat-sealed to the main body of the device as at 28. United to conduit 27 as by solvent sealing is a second conduit 29 which prior to use is closed by a sleeve-type of stopper cap 30.

The upper end of device 22 is coupled to a flow conduit 31 by means of a heat-seal 32, much the same as conduit 27 is attached by means of heat-seal 28 to the lower end of device 22. The upp r end of conduit 31 receives a rigid plastic plug-in connector 33 which is adapted to be inserted into the passageway of closure 11 as seen in Fig. 1. Prior to use, connector 33 is provided with a protector 34 which is essentially a sleeve of flexible plastic material closed at one end by a cotton plug 35 and equipped at the other end with a pull-tab 36. Disposed intermediate the ends of conduit 31 is a resilient rubber connector 36 which may be employed for the introduction of supplemental medication inasmuch as the resilient nature of the rubber material of which the connector 36 is constructed permits it to reseal itself after puncture by a hypodermic needle. To establish suitable connections between connector 36 and the two portions of conduit 31 shown in Fig. 2, polyethylene bushings (shown in dotted lines) and designated 37 may be employed.

It is believed that a brief description of the use of device 22 in a typical environment will be helpful for the further understanding of this invention, and for such purpose the following is set forth:

Operation In the employment of the device 22 in the parenteral solution administration set-up pictured in Fig. 1, the stopper 30' and protector 34 are first removed from the device 22. Thereafter, connector 33 is inserted into a previously provided passageway in closure 11 and connector 21 of drip device 20 is is inserted into conduit 29. A roller clamp 38 provided on tubing 18 is then closed and bottle inverted and suspended as shown in Fig. 1. At this moment, device 22 is in a substantially flat condition and devoid of any air. Upon the inversion of bottle 10, liquid flows through connector 33 and port 23 into device 22 to fill the same. The bottom end of device 22 is effectively closed by the quantity of air in drip housing 20 which cannot escape upwardly through the column of liquid in bottle 10 and device 22, nor downwardly because of the closed condition of clamp 38. Thus, in effect, device 22 becomes an extension of bottle 10. The liquid exiting from bottle 10 to fill device 22 is replaced by air entering bottle 10 from the outside to air tube 39.

Thereafter, administration set 17 is filled in a conventional manner and the drip level in drip housing 20 also provided. In the illustration given, this can be done by milking or pumping the resilient lower closure 20a of drip housing 20 to force air therefrom upwardly through. device 22 and into bottle 10 and be replaced with liquid from bottle 10. When about half of the air from drip device 20 has been so replaced, a suitable drip level is established and further pumping of end closure 20a is stopped. Thereafter, clamp 38 is opened and liquid from drip device 20 is allowed to fill tubing 18 and needle 19, purging the set of air. As liquid flows out of drip device 20 for this purpose, it is simultaneously replaced with liquid from bottle 10 flowing through device 22. When the entire set 17 is purged of air except for the air pocket remaining in drip device 20 needed for the maintenance of a drip level, clamp 38 is once again closed and the entire system is ready for use.

At this point, it is possible to insert needle 19 into the arm or other portion of the body of an intended recipient. To insure proper location of needle 19, a flashback indicator 4!) is provided that may be flexed and thus aspirate blood back into the set from a vein if needle 19 is so positioned. Flashback indicator 4 is essentially similar to connector 36 and permits at any time the introduction of supplemental medication as the occasion might require.

Where a discrete but minor amount of parenteral fluid is desired to be administered, say 20 ml., it possible to achieve the same by clamping device 22 as shown by means of a hemostat 41. Since each chamber 26 of device 22 contains a known quantity of fluid, it is possible in this manner to dispense any desired incremental quantity merely by thereafter opening clamp 38 and permitting liquid outflow from the bottom portion of device 22 to set 17. It is to be appreciated that only the liquid from the lower portion of device 22 will be dispensed, since there will always be liquid remaining in set 17 by virtue of the fact that the air pocket within device 20 exerts a hydrostatic force on the liquid in set 17 to prevent discharge of the liquid in set 17. Only the lower portion of device 22 collapses to permit the outflow of liquid, the drip device 20 being substantially rigid and maintaining its shape. Thus, the drip level in device 20 is maintained. Further, the action of hemostat 41 effectively seals the bottom portion of device 20 and set 17 against entry of further liquid from bottle 10 or escape of air from drip device 20 into bottle 10. For this purpose, the indented portions may assume the configuration shown with very successful results. In the illustration given, the constricted neck-like portions 25 are provided by indentations 42 which are essentially V-shaped at their inner ends and which indentations provide at their outer end laterally-extending shoulders as at 43. Laterallyextending shoulders 43 not only serve as a support for hemostat 41, but in addition substantially limit the tendency of device 22 to balloon. Thus, exact incremental amounts of fluid can be provided by the collapse of each chamber 26 of device 22.

In the course of an administration, should it be necessary to administer other incremental amounts of parenteral fluid, all that is necessary is to clamp device 22 at an appropriate constricted portion as at 44. For this purpose, a second hemostat (not shown) can be employed. Thereafter, by opening hemostat 41 the contents of chamber 26a (seen only in Fig. 1) can be dispensed. Removal of all hemostats from device 22 and closure of clamp 38 permits refilling of device 22 in the manner described above. Because of the stepwise or incremental administration permitted by device 22, it is to be appreciated that device 22 can be favorably used in the admisnistration of anesthetics where small discrete amounts are required over a period of time. In many instances, it is desirable to admisnister an anesthetic as part of a parenteral regimen. When this is the case, the anesthetic can be conveniently introduced into device 22 through connector 36.

While, in the foregoing specification, a detailed description of the invention has been given for the purpose of illustration, it will be apparent to those skilled in the art that numerous changes may be made in these details without departing from the spirit and scope of the invention.

I claim:

1. In a device for sequentially delivering equal amounts of parenteral fluid from a fluid source to a tube and needle administration set, an elongated envelope constructed of two sheets of thermoplastic flexible material arranged in face-to-face relation and perimetrically united, the perimetric union being interrupted at each end of said envelope to provide fluid flow ports, a rigid fitting connected to one of said flow ports and providing means for connecting said envelope to a fluid source, the other of said flow ports being equipped with a conduit adapted to communicate said envelope with a tube ads; needle adminstration set, and removable closure means for said fitting and conduit, the longer side of said envelope being provided with a plurality of spaced, opposed, indented portions etective to define a plural' y of waistlike constricted portions adapted to be sequentially clamped to bring about the sequential delivery of equal amounts of parenteral fluid.

2. The structure of claim 1, in which the said indented portions are V-shaped at their inner ends.

3. In parenteral administration equipment, a flexible lay-flat envelope constructed of two generally elongated sheets of thermoplastic resinous material arranged in face-to-face relation and sealed together about their edges, flexible tubes at each end of said envelope communicating with the interior of said envelope, one of said tubes being equipped with a rigid flow fitting adapted to be coupled to a source of parenteral fluid and the other of said tubes being adapted to telescopingly receive a second rigid flow fitting, the longer edges of each of said generally elongated sheets being characterized by a plurality of spaced-apart, notched-out portions, the spacing of at least some of said notched-out portions gradually diminishing when proceeding from the end equipped with said fitting to the other end of said envelope.

4. The structure of claim 3, in which each of said notched-out portions is equipped with a laterally-extending shoulder.

5. In parenteral fluid administration equipment, a flexible elongated tubular envelope equipped with flow ports at the ends thereof and adapted to collapse to a lay-flat condition, at least one integral, neck-like constricted portion in said envelope intermediate the ends thereof, one of the flow ports of said envelope being equipped with a stopper-puncturing fitting, the chamber defined by said envelope between the said one flow port and the said constriction portion being slightly smaller than the chamber defined by the said envelope between the other of said flow ports and the said constricted portion.

6. In parenteral fluid administration equipment, a flexible elongated tubular envelope equipped with flow ports at the ends thereof and adapted to collapse to a lay-flat condition, the said envelope being equipped with a plurality of constricted portions intermediate the ends thereof defining, with the remainder of said envelope, a plurality of chambers, some of said chambers gradually diminishing in size from one end to the other of said envelope.

7. In combination, a container source of parenteral fluid and a flow conduit connected at one end to said Source and equipped with needle means at the other end,

said source being elevated relative to said other end for gravity dispensing of fluid through said conduit, said conduit including in the length thereof a flexible elongated tubular envelope equipped with flow ports at the ends thereof and adapted to collapse to a lay-flat condition, and at least one integral, neck-like constricted portion in said envelope intermediate the ends thereof.

8. The structure of claim 6 in further combination with removably attached fluid flow shutoif means, said means being operative to shut off fluid flow through said envelope by clamping together the faces of said envelope at said constricted portion.

9. In a parenteral administration system, an elevated source of parenteral solution adapted to dispense said solution by gravity, a tube and needle set communicating with said source for dispensing said solution, said tube and needle set including along the length thereof a flexible elongated tubular envelope equipped with flow ports at the ends thereof and adapted to collapse to a lay-flat condition, said envelope being equipped with a plurality of constricted portions intermediate the ends thereof, defining, with the remainder of said envelope, a plurality of chambers.

10. The structure of claim 9 in which the said source is equipped with a puncturable stopper and the upper of said flow ports is equipped with a stopper-puncturing fitting, said fitting extending through said stopper to communicate said envelope with said source, the said envelope being positioned in said length adjacent said source.

References Cited in the file of this patent UNITED STATES PATENTS 450,383 Wolfi Apr. 14, 1891 937,311 Leyner Oct. 19, 1909 2,483,636 Hardesty Oct. 4, 1949 2,883,985 Evans Apr. 28, 1959 2,900,979 Bishop Aug. 25, 1959 2,907,495 Brous Oct. 6, 1959

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