US2925814A - Transfusion apparatus - Google Patents

Description

Feb. 23, 1960 VIBBER E1 AL 2,925,814

TRANSFUSION APPARATUS Filed Oct. 30, 1956 3 Sheets-Sheet 1 IN VEN TORS 22 FOSTER L. VIBBER y ROBERT R. ST. JEAN ATTORNEY 3 Sheets-Sheet 2 Filed 001;. 30, 1956 INVENTORS FOSTER L VIBBER ROBERT R. ST. JEAN W all/AM ATTORNEY Unite States Patent TRANSFUSION APPARATUS Foster L. Vibber, Shrewsbury, and Robert R. St. Jean, Auburn, Mass.

Application October 30, 1956, Serial No. 619,159

I l 1 Claim. (Cl. 128-214) I This invention relates to a device useful in delivering blood, plasma, or the like to a recipient under sterile conditions, at controlled rates, and under controlled pressures.

The invention has among its objects the provision of an improved transfusion device characterized by its accuracy of control as to the rate of flow of the delivered medium.

Another object of the invention is the provision of a transfusion device wherein the sterility of the apparatus is easily insured.

' A further object of the invention is the provision of a transfusion device operating under positive, controlled pressure. Another object is to provide transfusion apparatus wherein the flow of transfusion medium may be observed substantially throughout the full extent of the apparatus including the pressure-generating unit.

Yet another object is to provide a transfusion device of the character indicated wherein the pressure-generating portion of the device is economical and easily replaced, as after eachtransfusion, whereby the mingling of different blood types is obviated.

still furtherobject of the invention is to provide, in

apparatus of the type indicated, a pressure-generating unit which is completely physically and mechanically isolated from its source of motive power. f 'Another object of the invention is the provision of transfusion apparatus wherein the pressure-generating unit thereof is readily controllable so as to be synchronized with the pulse of the recipient.

.A further object of the invention is the provision of apparatus of the type described wherein the rate of delivery, the pressure of the delivered medium, and also the'relationshipof the phase of the pressure cycle of the mediiun-delivering device relative to the pulse of the recipient, may be controlled at a desired location remote from therecipient, if desired. i The above and further objectsof the invention will be more readily understood upon consideration of the specific embodiments of the device of the invention shown in the accompanying drawings and described in detail in the specification. It is to be expressly understood that such described embodiments are illustrative only, and that the i vntion is to be defined primarily in the claim appended hereto.

, In, the drawings: v

Fig. 1 isfa view in elevation depicting an illustrative embodiment of the transfusion apparatus or transfuser of the invention delivering. plasma tov a recipient{ V 2 is an enlarged view in elevation of the apparatus including .a pressure-generating device and controlling mechanismtherefor in condition to be carried, the cover of the apparatus being shown in phantom lines;

Fig. 3 is an enlarged view in longitudinal axial section through thedisposable, medium-contacting unit of the pressure-generating device, certain of the parts of the unitibeing, shown in elevation; 1 4 is a 'viewin end elevation of, the pressure-gen crating device, the view being taken at the delivery end thereof; and i Fig. 5 is a schematic diagram indicating the manner of interaction of the various parts of the transfuser, the control mechanism therefor, and the alternative sources of power supply for the apparatus.

In the embodiment of the apparatus shown in the drawings, the pressure-generating unit is incorporated as one part of a unitary device which includes controls for goveming the frequency of its medium-delivering strokes, the pressure at which the medium is delivered to the recipient, mechanism for correlating the frequency of the mediumdelivering cycle to the pulse of the recipient, and mechanism for recording the total delivered volume of medium in any given transfusion. Such unitary device is readily portable and is thus preferred for mobile transfusing apparatus. It is to be understood, however, that the apparatus lends itself readily to installations wherein the controlling mechanism, or any one or more of its elements, may be located remote from the pressure-generating unit, since the operative connections between the unit and the various mechanisms are primarily electrical. It is also to be understood that in some installations and for types of usage of the apparatus some of the control mechanisms may be dispensed with, as will appear more fully below.

Proceeding now to a detailed description of the apparatus, such apparatus has a driven pressure-generating unit, generally designated 10, which is fed by a source 11 of a medium to be introduced into the blood stream of a recipient. Such medium is led to unit 10 through tube 12, and is fed from unit 10 under pressure through tube 14. Inthe embodiment shown the medium is delivered to a tube-like device or needle 15 adapted to be inserted into either a Vein or an artery of a recipient 16. Preferably tubes 12 and 14 are made of transparent flexible material, such as plastic.

In the apparatus shown the pressure-generating unit 10 is mounted, as a part of an integral portable device, on a top panel 36 of a cabinet 17. A cover 19, which may be secured to the cabinet by means not shown, has a central handle thereon by means of which the apparatus may be carried. The cabinet 17 has a front panel 20 on which are mounted control and indicating devices (to be described in detail hereinafter) for the pressure-generating unit 10. Such-devices are, from right to left in Fig. 2, a pressure regulator 21, an integrator and accumulator 22, a control switch 24, a pulsation regulator 25, and a pulsation comparator 27. I

Pressure-generating unit 10 has an elongated outer generally cylindrical housing 30 made of a suitable nonmagnetic material. Preferably the housing 30 is transparent, to allow the operator to observe the flow of transfusion medium therethrough. A transparent comparatively stifi plastic material, such as methacrylate or an unfilled phenol-formaldehyde resin has proved to be satis- (factory for such housing 30.

The housing is preferably formed in two parts 31 and 32, a forward portion of part '32 of reduced diameter being telescoped with andsealed to the rear end of part 31 at an annular zone 34. Housing 30 has an annular outer flange 35 adjacent its rear end, such flange serving as a means whereby the housing may be retained against longitudinal movement on its support.

1 A fixed L-shaped bracket 37 is attached to upper panel 36, the vertical leg of the bracket having a horizontal opening therethrough snugly receiving the housing 30 as shown. A shouldered split clamp 39, attached to the rear of the vertical leg of bracket 37, is adapted to overlie and snugly receive flange 35 von housing 30, so as to retain the housing against longitudinal movementi Bracket 37 and clamp 39 are made of non-magnetic.

material, such as brass. To the forward vertical face of bracket 37 there is affixed an annular magnet coil 40 which snugly receives housing 30 within it. Coil 40, as will be more fully appreciated hereafter, serves to return the reciprocable inner element 56 of unit to its starting position after each medium delivering stroke of such element.

The forward end of housing 30 is supported by a second, longitudinally adjustable magnet coil 44 within which the housing is also snugly received. Ooil 44 is attached to a bracket 41 which has a bottom guide portion accurately slidable in longitudinally extending guideway 42 secured to panel 36. The longitudinal position of coil 44 relative to housing 30 of unit '10, and thus the length of the operative stroke of element 56 of unit 10, is adjusted by a screw 45 threaded through a fixed vertical standard 46 and having its rear end rotatably secured to bracket 41 against reciprocation relative to the bracket by a bearing 47. Screw 45 may be conveniently rotated by a knob 49 on the forward free end of the screw. Bracket 41 and guideway 42 are preferably provided with an index mark and cooperating calibration indicia 50 and 51, respectively, calibrations 51 conveniently indicating the displacement of reciprocable element 56 at each operative, pressure-generating stroke thereof. The supporting and adjusting mechanism for coil 44 is also made of non-magnetic material.

Theapparatus is provided with a support inthe form of a telescoping standard 52 mounted in the cabinet, such standard being extendable from aposition fully within cabinet 17, as shown in Fig. 2, to one in which the cross rod 54 at the top of the standard lies markedly above the top of the standard, as shown in Fig. 1. In that figure there is shown a container 55 depending from a hook on rod 54, and feeding a medium such'as plasma or whole blood by gravity to tube 12 and then to unit 10.

The unit 10 has a reciprocable pressure-generating member 56 mounted within housing 30, as best shown in Fig. 3. Member 56, which is shorter than the cylindrical chamber in the housing and has a central passage 57 longitudinally therethrough, has an outer sheath 58 4 parts made of I arelatively soft yieldable material. As a result, damage to blood corpuscles by the valves, if the transfusion medium is blood, is minimized while preserving efiicient valve action.

Valve 62 has a seat 65 formed integral with housing part 32, and a valve element 66 in the form of a ball made of yieldable material such as soft rubber or plastic material. Element 66"is normally retained in sealing contact with seat 65 by a plurality of angularly spaced inwardly extending fingers 67 integral with housing part 32. Valve 64 is formed generally similarly to valve 62, the seat 69 of valve 64 being integral with the plastic body of member 56 and surrounding the delivery end of passage 57, a valve element 70 similar to element 66 being normally held in sealing engagement with seat 69 by a plurality (four shown in Fig. 4) of angularly spaced inwardly directed fingers 71 integral with member 56.

The valves are so constructed and arranged that on the return strokeof member 56 valve element 66 is sealingly thrust against its seat 65 while valve element 70 is deformed by the pressure within passage 57 and thus allows the flow of medium into the space in housing 30 forwardly of member 56. On the forward, active stroke of member 56, the reduced pressure within passage 57 causes valve element 66 to be deformed sufficiently to pull away from its seat, thereby allowing a fresh charge to flow int-o housing 30 at the rear of member 56. At the same time, the increased pressure in advance of member 56 causes valve element 70 to be pressed with increased force against its seat, so that member 56 delivers medium in the housing 30 in advance thereof outwardly through tube 14.

and an inner sheath 59. The two sheaths, which are 7 made of non-magentic material such as a stilf, comparatively rigid plastic, are integrally connected'and enclose an annular magnetic core 60 made, for example, of iron. The member 56, which accurately but slidingly fits within housing 30, has a series of shallow annular grooves 61 on its outer surface so that the liquid medium in housing 30 tends to form a seal between the member 56 and the housing. Thus there is but little back leakage of liquid in unit 10.

It will be apparent that, when coil 40 is energized and coil 44 is deenergized, member 55 will be returned to the left, into the position of Fig. 3. When coil 40 is deenergized and coil 44 is energized, member 56 travels to the right to a terminal position determined by the longitudinal adjustment of the coil 44 by means 41, 45, 46, etc. The apparatus is provided with control mechanism 25, to be explained, whereby coils 4t) and 44 are alternately sequentially energized and deenergized at the desired rate, thereby to deliver the transfusion medium to tube 14 atthe desired rate.

Unit 10 is provided mith oppositely acting checkvalves tube 14. One such valve, 62, is positioned on housing 30 inwardly of tube 12, and the other valve, 64, is positioned at the forward, delivery endof member 56. Both suchvalves are preferably of such construction that their interacting seating parts are relatively broad, so'asjto' minimize the-unit contact pressures, and have one ofsuch p In some instances it may be desirable to make the balls or movable elements of valves 62 and 64 relatively unyielding, and to make the retaining fingers therefor resilient to allow the balls to reciprocate into and out of their seats to give them the requisite valving action.

Unit 10, including housing 30, reciprocating member 56 therein, and valves 62 and 64, is simply and economically constructed, so that it is economically feasible to use such unit once and thereafter to discard it. Such practice is advantageous because of its insurance of the sterility of the pressuregenerating portion of the apparatus, and/or the prevention of undesirable mixing of difierent transfusion media. Each unit 10 may, for example, be supplied in a sterile vial or package, and may be filled with a sterile normal saline solution. In Fig. 3 the ends of the housing 30, to which tubes 12 and 14 are to be attached, are shown closed by removable caps 72 to retain the saline solution in the unit until its use.

The manner of control of the pressure-generating apparatus in its illustrative embodiment will be more fully understood by reference to Fig. 5. As there shown, the apparatus has a three-position control switch 24, shown in the form of a two pole, double throw switch having a movableswitch element'74. When element 74 is in a central position, lead wires 75, 76 of the apparatus are deenergized, and the reciprocation of member 56 of unit 10 is stopped. When switch element 74 is'thrown to the left, wires 75, 76 are energized by battery 77. When switch element 74 is thrown to the right, such wires are energized with the same voltage and polarity as that supplied by the battery by a step-down transformer 79, the primary of which is powered by A.C. source L L The secondary of transformer 79 feeds into a full-wave rectifier' 80 which in turn is connected to the respective contacts of switch 74. The battery, transformer, and rectifier may conveniently be mounted in cabinet 17 of the apparatus.

Wire is connected to one side of each of magnet coils.40 and 44. Wire 76 is, in'eifect, connected at intervals in the proper time sequence to the other side of each of coils 40 and 44,- thereby to return the member 56 through its idle stroke and thereafter to impel it in its forward, working stroke. The connection between such other side of coils 40 and 44 and wire 76 is efiected by pulsation regulator mechanism 25 which is, in eifect, an adjustable speed motor (not shown) which drives a rotary switching device (not shown) alternately connectin-g wire 76 to coils 40 and 44. The motor of mechanism 25 is powered by wires 81, 82, connected, respectively, to wires 75 and 76. The speed of the motor is adjusted by a rheostat built into mechanism 25, such rheostat having a movable dial 84 cooperating with a surrounding ring 85 bearing indicia calibrated in the number of working strokes or pulses per minute of unit at each setting of rheostat dial 84. Leading from the rotary switch element of mechanism 25 are wire 86, connected to the other side of coil 40, and wire 87, which energizes the other side of coil 44.

Interposed between wire 87 and such other side of coil 44 are the integrator and accumulator mechanism 22, and the pressure regulating rheostat 21. Such rheostat controls the voltage with which coil 44 is energized, and thus the force with which member 56 is driven in its working direction. This, of course, governs the pressure under which unit 10 delivers the transfusion medium to tube 14. Integrator mechanism 22 is in the nature of an electrically energized resettable counter mechanism, which records the total number of times coil 44 is energized during a period of use of the apparatus. A simple table may be provided to give the total volume of medium which has been delivered in a given period, employing as factors the reading on the dial of mechanism 22 and the volume delivered at each stroke of member 56 at the longitudinal setting of coil 44 being used.

The apparatus thus far described may be advantageously employed to inject plasma, as indicated, or whole blood into the veins or arteries of a recipient. It may also be employed to aid in the transfusion of blood from a donor to a recipient; in the latter case tube 12 is connected to a device similar to element 15, which is connected to an artery of a honor.

In some instances the apparatus may be employed to function temporarily as a portion of the heart of a patient, while the patient is undergoing, for example, an operation upon a failing right ventricle of his heart. In such case, the apparatus would temporarily take over the function of the portion of the heart being operated upon, the blood then flowing from the heart of the patient, into tube 12, through unit 10, into tube 14, and thence returned to the patients heart.

In such latter use of the apparatus it is desirable that the reciprocable pressure-generating member 56 of unit 10 shall be so timed as to deliver transfusion medium (i.e., the patients own blood, a donors blood, or plasma) in synchronism and in phase with the beat of the patients heart. A pulse pick-up element 26, giving a visual reading responsive to the patients pulse, may be employed to allow an operator to govern unit 10 by mechanism 25 in accordance with his observation of element 26 so as to effect such desired frequency and phase of operation of unit 10. In such case element 26 may be a simple dial sphygmanometer, not connected electrically to the control mechanisms of the apparatus.

It is preferable, however, that element 26 be one such as that shown, which as well as giving a visual signal, transmits an electrical impulse, having an amplitude proportional to the recorded pressure, at each pulse of the patients heart. The leads from element 26, shown at 89, are connected to the control circuit by jack 90. As shown in Fig. 5, leads 89 are connected to a frequency comparator 27, which is powered by wires 92 and 94 connected to leads and 76, respectively. A wire 95 connects lead 87 (to coil 44) with comparator 27, thus feeding an electrical impulse to comparator 27 every time coil 44 is energized. An indicator on comparator 27 gives a visual indication of the relative frequencies of the heartbeat of the patient and the reciprocation of member 56 of unit 10, as well as the relation of the phases of such two cycles. When the indicator registers zero the two frequencies are equal and the heartbeat and reciprocation of member 56 are in phase.

Whereas for purposes of illustration we have shown and described preferred embodiments of the transfusion apparatus of the invention and of manners in which it may be operated, it will be understood that such embodiments are illustrative only, and that the invention is cap-able of considerable variation as to details of construction, materials, and manners of use. Thus, for example, the pressure-generating unit 10 is useful in other applications for the transfusing of media, and also for the circulating of blood, being particularly advantageous in such latter application where added pressure and volume of blood flow are required. Because of the ease and accuracy of control of unit 10, for example, and the fact that it can readily be made inert to flesh and secretions, it is possible to mount a unit 10 permanently within a human or animal body, as behind the sternum, the unit being connected to the heart to replace a defective portion thereof. In such case, the magnetic coils which reciprocate member 56 of unit 10 may, for example, be mounted on the chest or back of the patient, the magnetic field between the coils and member 56 acting through the body wall, or the unit mounted within the body may include the magnetic coils, such wires being energized from an external source of power through wires passing through a body wall.

What is claimed is:

Apparatus for delivering a medium such as blood and the like into the blood stream of a living body which comprises a pressure generating unit which delivers the medium periodically in unit quantities, means to detect the pulse of the body, means for comparing the frequency and phase of the pulse of the body with those of the pressure generating unit, and means to vary the frequency and phase of the delivery of the unit quantities to bring them into synchronism with the pulse of the body.

References Cited in the file of this patent UNITED STATES PATENTS 581,204 Heftye Apr. 20, 1897 2,035,159 Henry Mar. 24, 1936 2,293,684 Holthouse Aug. 18, 1942 2,604,851 Archibald July 29, 1952 2,641,188 Aumik et al. June 9, 1953 2,690,178 Bickford Sept. 28, 1954 2,797,703 Edwards July 2, 1957 2,815,715 Tremblay Dec. 10, 1957 2,848,992 Pigeon Aug. 26, 1958 2,851,030 Bouche Sept. 9, 1958 FOREIGN PATENTS 852,671 France Nov. 9, 1939

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