US3543753A - Intra-venous infusion device - Google Patents

Description

United States Patent 72 inventor Berel Weinstein New York, New York [21 Appl. No. 747,993

[22] Filed July 26, 1968 [45] Patented Dec. 1, 1970 [73] Assignee Bio-Medical Sciences Inc.

a corporation of New York [54] INTRA-VENOUS INFUSION DEVICE 11 Claims, 7 Drawing Figs.

[52] U.S. C1 128/214 [51] Int. Cl A6lm 5/00 [50] Field of Search 128/244,

(Pressure lnfusion Digest), 21s, 22s

7 [56] I References Cited UNITED STATES PATENTS 3,023,750 3/1962 Baron 128/214 3,054,401 9/1962 Gewecke 128/214 Primary Examiner-Warner 1-1. Camp Attorneylrving Seidman ABSTRACT: A device for the intravenous infusion of fluid under pressure comprising a container having its interior subdivided by an intermediate elastic diaphragm into an upper and a lower chamber, with the infusion fluid contained in and dischargeable from the upper chamber and the lower chamber having an opening for the selective introduction of compressed gas from an independent unit to force the fluid out of the container under constant pressure, in combination with a flow tube and hypodermic needle assembly cooperative with the container having valve means to regulate flow and detect malfunction.

Patented Dec. 1, 1970 3,543,753

l iNTlRA-VENOUS INFUSION DEVICE This invention relates to the field of intravenous feeding and infusion of blood, plasma, liquid medications and the like, and has for its objective the creation of an intravenous infusion device by which such liquids can be infused intravenously into a patient through a controlled, regulated pressure means of forcing the liquid or fluid out of its receptacle or container and, through appropriate tubing and a hypodermic needle, into the vein of the patient. This objective is accomplished by providing a container for the fluid and an independent container for compressed air or gas, and, when infusion is required, coupling the latter container to the former so that the compressed gas in the latter is directed into the former to force its contents out through a tube-connected hypodermic needle. The device further is provided with means to control the rate of flow of the fluid, to adjust the rate of flow, and to detect any obstruction to the flow, such as when the needle slips out of the vein or becomes imbedded in tissue.

in the present state of the art many devices have heretofore been employed for the foregoing purposes. Chief among them is the use of a glass bottle (containing the fluid to be infused) which is suspended upon a stand or a hook situated over the patient (or held by an attendant where no stand or hook is available, or where the patient is being moved from one place to another), and which is provided with a depending tube connected to a hypodermic needle which is inserted into the pa-' tient's vein. The fluid in the bottle flows into the patient by gravity, and hence the bottle must always be held above the patient to accomplish this flow, and to prevent air from entering the vein, with its obvious fatal effect. The disadvantages of this device are obvious, and many. They include the amount of time required to set up the device for use, the additional equipment required, the necessity that the patient be immobilized, the frequent necessity of providing an attendant, the possibility of dislodgement of the hypodermic needle or tube if the patient moves, and others. Such disadvantages become even more obvious when intravenous infusion becomes necessary in military combat zones, under tire, and when the additional equipment is not available.

Other forms of intravenous infusion devices presently known include manual or mechanical pumps to feed the fluid into the vein. The disadvantages thereof, among others, include the necessity for an attendant and constant supervision, as well as the cumbersome and expensive equipment required. A recently developed intravenousinfusion device employs the use of an ampoule or capsule, containing chemical ingredients, which is disposed within an expandable envelope containing a reactive agent or chemical, all disposed with in a flexible fluid container, with the capsule frangible within the envelope to commingle the respective contents to generate a gas which causes the envelope to expand and thereby force the fluid out of the container. The disadvantages of this device include the ever-present possibility of accidental fracture of the capsule before the device is ready for use, such as during handling packing or transportation, the danger of particles of the broken capsule finding their way into the fluid and thence into the tubing, as well as deterioration of the chemicals with the passage of time. The fluid container itself is adapted-to be placed near, but not on the patient adjacent the infusionarea, so that movement of the patient is likely to cause unnoticed disengagement or dislodgeinent of the hypodermic needle.

These, and other, disadvantages of such intravenous infusion devices, are eliminated by the present invention, which provides a fluid container constructed to be attached directly to the body of the patient in the immediate area of infusion,

and provided with an independent container, for compressed.

air or gas, adapted to be coupled to the fluid container so as to I release the air or gas into the fluid container in such a manner as to force the fluid out of the latter, through an appropriate discharge outlet for infusion intothe patient. The air or gas is directed into the fluid container below a separating diaphragm, so that no contact is ever, made between the infusion fluid and the air or gas.

it is therefore the principal object of my invention to provide an intravenous infusion device which will permit the infusion of a fluid intravenously into a patient by pressure instead of gravity.

A second important object of my invention lies in the provision of an intravenous infusion'device by which a fluid can be administered to a patient intravenously at an evenly regulated flow.

A third important object of my invention lies in the provision of an intravenous infusion device by which the flow of fluid into the patient may be adjusted in accordance with the density or viscosity of the fluid.

A fourth important object of my invention lies in the provision of an infusion device of the type described, which will completely eliminate the possibility of air being introduced accidentally into the vein of the patient.

A fifth important object of my invention lies in the provision of an infusion device of the type that requires no supporting equipment for its use.

A sixth important object of my invention lies in the provision of an intravenous infusion device which is inexpensive to manufacture, and hence disposable after initial use, and which is simple to operate.

Still another important object of my invention lies in the provision of a device of the type which permits the patient to be ambulatory while it is being used, and does not compel him to be immobilized.

These and other salient objects, advantages and functional features of my invention, together with the novel features of construction, composition and arrangement of parts, will be more readily apparent from an examination of the following description, taken with the accompanying drawings, wherein:

FIG. 1 is a top, perspective view of my invention, fully assembled;

FIG. 2 is an enlarged cross-sectional view, taken on lines 2-2 of FIG. 1;

FlG. 3 is an enlarged cross-sectional view, taken on lines 3-3 of HG; 1, showing the interior of the fluid container when filled with the infusion fluid;

FIG, 4 is a view similar to FIG. 3, but showing the container after the fluid has been discharged;

FIG. 5 is an enlarged view of the clamp element;

FIG. 6 is an enlarged cross-sectional view of the adjustable valve shown in FIG. 5; and

FlG. 7 is an enlarged cross section view of the connection between the fluid container and the tube.

Similar reference characters designate similar parts throughout the different views.

illustrative of the embodiment shown, my intravenous infusion device comprises a fluid container 10 and a compressed gas container 12, together with a tubing and hypodermic needle assembly 141. The liquid container 10 is preferably composed of a hard, clear plastic, although an opaque plastic may be used as well, and a similar material may be substituted therefor. The container 10 is shaped hemispherically in cross section, as shown by FIG. 1, and is provided with an upper wall '16, a lower'wall 18, end walls 20 and 22, and top walls 24 and 26. The upper wall 16 extends into an integral flat ledge '28. The container 10 is preferably molded in two sections, to permit installation of the interior assembly, as will hereinafter be described, and thereafter permanently sealed as a unit, as is well known in the art. The curvature of the container It) is designed to enable it to be secured around a portion of the patients arm during the infusion process, with the ledge 28 acting as a support for the forearm when the container 10 is secured around the patients upper arm, and as a support for his wrist, when the container it) is secured to the patients.

forearm.

Interiorly the container 10 is provided with an elastic diaphragmflti, whose peripheral edge is sealed diagonally to the interior surface of the container 10, with the front edge adjacent the lower edge of the end wall 20 and the rear edge adjacent the upper edge of the end wall 22, as shown by the dotted lines FlG. 1, thereby an chamber 32a I and a lower chamber 32b,-with in the container 10,

' The-wall 22 of the container is centrally provided with an integral cap 34 having an internal thread ,36, and within the cap 34 a tubular inlet nozzle 38 having a central opening 40 leading into and communicating with lower chamber 32b within the container 10, the nozzle 38 having a slanted and pointed end, as shown lay-FIG. 2. The container 10- is further provided, in its top wall 24, with an inlet opening 42 having a cap 44 threadedly; mounted thereon, and an outlet. or

discharge nozzle 46 provided with an internal thread 48. Both the inlet opening 42andthe'discharge nozzle 46 open into upper chamber 32d of thecontainer 1-0. The-discharge nonle 46 is sealed from the interior of the upper chamber-32a by a sealing element 50, as shown by FIG. 7, which is secured to the inner surface of the top wall 24, coveringthe opening of the discharge nozzle 46.

The container'12,.which maybe 'of metal or plastic, is filled under pressure with compressed air or gas G, and then sealed off across its neck 52 with sealing element 54, as shown in FIG. '2.- The neck 52 is provided with an external thread 56 adapted to mesh with the internal thread 36 of *the cap 34,

when the container 12. is screwed on to the. container 10. As

the neck 52 of the container 12 moves into the cap 34 the angled end of the inlet nozzle 38 is caused to puncture the seal.

54, causing the compressed gas'G to enter into the lower chamber 32a of thecontainer l0, forcing the diaphragm 30 up against the upper wall 16 aswill hereinafter be explained.

Coming now to'the tube and hypodermic needle assembly 14, the tubing or tube 58 is preferably composed of a flexible vided with a flow detectorifl2, comprising a thinned-out sec- 'tion of the'tube' 58.'ln.norinal flow'of the infusion fluid the stancesThe containerl0 is intended to be prefilled with the specific fluid or solution, and the container 12 with air or gas compressed under. suitable pressure. With such fluids as require refrigeration suitable means to maintain them under proper temperature until-required can be provided, as is well knownin the art. The invention is further intended to be packed and shipped as a single unit comprising fluid container 10, gas container 12, and tube and needle assembly 14, all properly sterilized and sealed in a single envelope or compartment together with adhesive or :elastic arm cuffs to secure the device to the patients ann- As is apparent, different infusion. fluids have different densities and viscosities. This willbe compensatedfor in that, ac-

- cording to the specific fluid to be prepacked in the container plastic material, andis provided at one end with a valve cap 60, as shown by FIG. 7, having an external thread 62 adapted to mesh 'with the internal thread 48 of the discharge nozzle 46, an a c ntral opening 64. The base of the cap 60 is provided with a pointed and, perforated puncture element 66 disposed,

when the cap 60 is screwed sufficiently far into the'nozzle 46, to puncture the seal element 50 disposed thereunder, so asto enable the fluid 68 within the container 10 to pass into the tube 58 through the perforations and the central opening 64. To the other end of .the tube 58 is attached a hypodermic needle 70, coupled .to the tube '58 by an intermediate elastic sleeve 72. intermediate these ends the tube 58 is disposed through a clamp member 74, composed of arigid plastic, and

the tube 58 is provided enlarged within the clamp member 74 to form a drip chamber 76, as shown in FlGS. 1 and 5.

The clamp member 74 comprises a flat bas'emember 78, formed integral with a valve housing 80 at one end thereof, and a valve housing 82 at its opposite end, with passageway through the housings 80'and 82 forthe tube 58, as shown. A clamp arm 84 is pivotally secured to the clamp member 74 by 10, the corresponding clamp member 74 will be provided with a calibrated scale 82ato indicate the drops-per-minute flow of that specific fluid. t In some instances it may be desirable or necessary to ship the intravenous infusion device with the container lii unflllc d, to be filled at its destination, such as a hospital or the like. Since any one of many different fluids of varying densities or viscosities may thereafter be used in the device, provision will be made insuch cases for a chart to be imprinted on the outside surface 'of the container 10 indicating, for each type of fluid, thecorrespdnding markings on the calibrated scale 82a for any given number of drops-per-minute flow. This can also be checked by'oio'sing the clamp member 74 to deflate and empty the drip chamber 76, closing the screwvalve 92, and

a hinge 86, so that the arm 84 may be locked against the clamp member 74 by the engagement of the corresponding fingers 88 with grooves 90, to compress the drip'cham'ber 76, when desired.

The housing 80is provided with a screw valve 92, by means of which the tube 58 may be closed off completely, and the housing 82 is provided with a screw valve 94 by which the flow of fluid from the container 10'may be. regulated or closed off. Referring to FIGS. 5 and 6, the-housing 82 is provided interiorly with a spiral groove 96 which is graduated, as shown, and the screw valve 94 is provided on its sidewall with a bead 98 which is adapted to engage the groove96 when the screw valve is inserted therein and rotated, to raise or lower the screw valve 94 and thereby adjust pressure against the tube 58 of the housing 82 is calibratedin terms of drops, and the head of the screw valve 94 is provided with an indicator 100 disposed to cooperate with the calibrated scale82a to indicate the number of drops offluid passing through the tube 58 per minute, as will hereinafter be explained by coming into registry with the appropriate scale marking.

Referring now to FIGS. 1 and 5, the tube 58, intermediate the clamp member'74 and the hypodermic needle 70, is prothen reopening the clamp member 74 to permit the fluid from the container l0.to refill the drip chamber 76. Since the drip chamber 76 is made to hold 20 drops, the time taken to refill the drip chamber 76 will indicate the number of drops-perminute flowing past the screw valve 94 from the container 10.

in the prepacking of my invention, the infusion fluid 68 is introduced into the container 10 through the inlet opening 42 to completely fill the containerl0 above the diaphragm 30, forcing the latter to the inside walls of the containerlO and dispelling all air below the diaphragm 30 (in the lower chamber 32b) out through the nozzle 38, as shown by H6. 3. The inlet opening 42 is then closed off and sealed by the cap 44, and the unit ready for shipment, together with the appropria'te compressed gas container 12 and the tube and needle assembly 14, in the manner heretofore described.

. In the use and operation of my invention, the container 12 is screwed into the rear of container 10 until the nozzle 38 punctures the seal 54, releasing the compressed gas to enter chamber 32b of the container 10, forcing the fluid 68 upward.

. to increase or reduce the flow of fluid therethrough. The wall The container 10 is then secured to the undersurface of the patients arm by means of the adhesive or elastic arm cuffs heretofore mentioned, one holding the container 10 to the arm and another securing the adjoining arm portion to the ledge 28, to prevent bending of the arm at its joint. The tube and needle assembly l4is then secured to the container 10 by screwing the valve cap 60-into the discharge nozzle 46 to puncture the seal element 50, causing the infusion fluid 68 to pass into the tube 58, forced out of the container 10 by the even pressure exerted by the gas G in lower chamber 32b against the diaphragm 30. Screw clamps 92 and 94. are then opened, permitting the fluid to flow past them to the hypodermic needle 70, to dispel any air present in the tube and needle assembly 14. Screw valve 94 is then adjusted for the proper flow rate, and the needle 70 inserted into the appropriate vein of the patient, and held in place with a strip of adhesive.

As is apparent from the'foregoing the flowof fluid into the patients vein will continue at such regulated rate, under the constant pressure of the gas in chamber 32b, until the container It) is emptied, as shown by FIG. 4, or until a sufficient dosage has been administered, at which time the valve 94 can be closed off completely, the needle and device removed from the patients arm, and discarded, or put aside for future use.

From the foregoing it is to be noted that the embodiment shown and described is by way of illustration and not of limita- 6. An intravenous infusion device as described in claim 5,

i the means to discharge-the fluid from the first chamber comtion, and various changes may be made in the construction,

composition and arrangement of parts without limitation upon or departure from the spirit and scope of the invention or sacrificing any of the advantages thereof inherent therein, all of which are herein claimed.

lclaim:

1. An intravenous infusion device comprising a first container, a second container filled with gasunder pressure and a tube and hypodermic needle assembly;

the first container provided interiorly with an oscillatory diaphragm disposed to divide the container into two chambers and selectively to abut opposing walls of the container; means to introduce fluid chamber; and means to discharge the-fluid from the first chamber; j means to seal the fluid temporarily from the discharge means;

means to introduce the gas in the second container into the second chamber of the first container; the tube and hypodermic needle assembly comprising:

a flexible tube;

a coupling engaging one end thereof to thefluid discharge 35 means of the first container; with means to rupture the seal thereof;

a coupling engaging the other end of the tube to a hypodermic needle, the tube being enlarged intermediate its ends to define a drip chamber, and

means surrounding thedrip chamber to regulate the flow of the fluid through the tube.

2. An intravenous infusion device as described in claim 1,

' .with a central opening in which the tube end is'sccured, the

with means provided in the tube adjacent the hypodermic nee 5. An intravenous infusion device as described in claim 4,

the means to introduce the fluid into the first chamber comprising a protruding inlet provided with a sealing cap threadedly mounted thereon.

prising a protruding outlet internally threaded to engage the tube coupling, the tube coupling being provided with a corresponding external thread.

7. An intravenous infusion device as described in claim 6, the means to seal the fluid temporarily from the discharge outlet comprising a seal element secured to the undersurface of the first chamber below the discharge outlet.

8. An intravenous. infusion device as described in claim 7, the means to introduce the gas into the second chamber comprising a pointed inlet nozzle integral with the first container and opening into the second chamber thereof:

an internally threaded cap surrounding the nozzle;

the second container provided with areduced, externallythreaded neck; and

a sealing element across the o enin thereof; and whereby the engagement of t e nec to the cap by rotation thereof causes'the nozzle to pierce the sealing element and. thereby effect admission of the gas into the second chamber.

9. An intravenous infusion device as described in claim 8, the coupling for the engagement of the tube end to the discharge outlet comprising an externally-threaded cap adapted to be threaded into the discharge outlet and provided base of the cap provided centrally with a perforated puncture element disposed to pierce the seal element disposed below the discharge outlet to permit discharge of the fluid from the chamber through the tube.

10. An intravenous infusion device as described in claim 9, the means surrounding the drip chamber to regulate the flow of the fluid through the tube comprising:

a clamp member provided with a flat base member adapted to support the drip chamber;

a valve housing at each end of the base member and integral therewith, with the tube disposed to pass through the valve housing on each side of the drip chamber;

t a screw valve disposed in each of the valve housings to selectively close ofi the tube;

the valvethousing adjacent the first container being further provided on its outer wall with a scale calibrated in dropspenminute, and its screw valve provided with a depending indicator on the cap thereof adapted to come in registry with the scale to indicate the flow rate of the fluid through the tube, within the housing; and

a clamp arm hingedly mounted on the base member and adapted to be selectively engaged thereto to compress the drip chamber and discharge its contents thereby.

ll. An intravenous infusion device as described in claim it), the means to detect flow stoppage comprising a thin section of the tube between the clamp member and the hypodermic needle, adapted to bulge and pulsate when the fluid in the tube backs up.

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