US 2842124 A
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July 8, 1958 J. M. JAMES BLOOD TRANSFUSION SYSTEM 2 Sheets-Sheet 1 FIEL- m T m V m .De. JOSEPH M. JA M55 ATTORNEY y 1958 J. M. JAMES 2,842,124
BLOOD TRANSFUSION SYSTEM Filed Dec. 10, 1956 I 2 Sheets-Sheet 2 llllllll I m i 2 INVENTOR D2 J05EPH M JAMfS BYWZW ATTORNEY United States Patent BLOOD TRANSFUSION SYSTEM Joseph M. James, Wilmington, N. C. Application December 10, 1956, Serial No. 627,471
3 Claims. (Cl. 128-214) The purpose of my system is: 1) to simplify the mechanics of the therapy of erythroblastosis fetalis, (2) to reduce the morbidity and mortality inherent in the therapy, and (3) to render the sterilization and preparation of the necessary instruments less time consuming and less expensive. 7
Erythroblasrosis feralis is the result of the sensitization of an Rh negative mother to her Rh positive child inutero; that is, she forms an Rh antibody which finds its way into the blood stream and body fluids of her infant. This "antibody causes the destruction of Rh positive red blood cells and results in the formation of Bilirubin, which is toxic to the newborn.
The basic concept of the therapy is fourfold. It consists, insofar as is possible, of the removal of Bilirubin, the removal of antibody, the removal of susceptible Rh positive red blood cells, and the replacement of these cells with non-susceptible .Rh negative red blood cells.
Therapy consists of alternately removing small amounts of the infants blood and replacing it with an equal amount of fresh Rh negative blood. After 40 or 50 such manipulations the blood volume of the infant is unchanged, but the Bilirubin, the antibody, and the susceptible Rh positive red blood cells are diluted to a tolerable concentration.
My system is designed to simplify the operation so that the operator may pay less attention to mechanics and pay more attention to the condition of his patient. My system does this in that there are only three fluid flow arrangements possible, as compared to nine possible combinations (only three of which are actually used) of the arrangement now generally used, known as the B-D system, which consists of two 3-way Becton-Dickens valves in series. My system also markedly reduces the very large and inefficient dead space of other systems generally used in the past and yet maintains equivalent simplicity.
My system is designed to prevent complications which result in increased morbidity and mortality. It is not possible with the new valve to connect the infants vein to the donor blood supply nor is it possible to connect the vein to the discard receptacle. These two conditions are possible when using the systems known'in the art and represent a very real danger. The danger is that if the infant is connected to the donor blood he will receive an unknown excess of blood, by way of gravity, or if connected to the discharge receptacle will lose an unknown amount of blood as the result of syphoning. Thus by an inadvertency in operation of prior art systems the infants blood volume may be increased, resulting in congestive heart failure, or may be decreased, resulting in shock from blood loss, and the operator will have no good estimate of the deficit to make up or the excess to remove. In other words, when shock or congestive heart failure occurs, the operator is at a loss as to the amount of blood to give or remove to correct the danger.
My system prevents any inadvertent and uncontrolled 2,842,124 Patented July 8, 1958 connection of the infant to the donor or to the discharge receptacle; the operator has the invaluable advantage of knowing that the only exchange of blood which can occur is when he causes same by operation of the syringe.
My invention also has the advantage of maintaining a system in which donor blood is not exposed to contamination by air as the result of continual changing of syringes, necessitated by the other commonly used arrangements.
This system comprises three conduit means which are connectible to the infant, a donor blood source, and a discharge receptacle. The other ends of the conduit means are connected to three separate passageways in a casing. A control assembly moves in the casing between three positions. system for conducting blood between a single passageway and a syringe. Means are provided for forming a sealed zone at the point of connection of the control assembly conduit system with a single passageway. Means are also provided for facilitating movement of the control assembly between the three passageways in a manner which prevents leakage and which aids the operator in safely conducting the transfusion.
The units of the system may be made out of various materials such as metals, plastics and the like.
Various other objects and meritorious features of the invention will be apparent from the following descriptiontaken in conjunction with the drawings wherein like numerals refer to like parts throughout the several figures and wherein:
' Fig. l is a perspective view of my system for exchange blood transfusion;
Fig. 2 is a plan view of the central part of my system;
Fig. 3 is a plan view of the control assembly with a portion of the luer syringe being cut away; and
Fig. 4 is a plan View similar to that of Fig. 2 with a portion being cut away on a horizontal center plane.
As seen in Figs. 1-4, my invention includes a casing 14 which has a cylinder 15 in which is slidably mounted a control assembly 15 which may be positioned to enable the Withdrawal of blood from a baby 17, the discharge of the withdrawn blood into receptacle 18, the withdrawal of donor blood from a donor blood bottle unit 19, and injection of the donor blood into the baby.
The casing 14, as seen in Figs. 2 and 4, has three passageways 2t), 21 and22 from its outer surface to the wall of the cylinder, these passageways terminating at three longitudinally spaced positions on the wall of the cylinder-15 in accordance with predetermined design as will be further explained. The control assembly 16 comprises a luer syringe 23 at its outer end, a control device 24 at the intermediate portion, and a piston 25 at its inner end;
The luer syringe 3 is connected to the control device 24 by a suitable fitting of known design enabling simple and eflicient connection; anddisconnection. The control device 24 includes a control pin 26 which operatively coacts with an open slot,27 in collar 28 to control the positioning of the piston 25 in the cylinder 15. The col lar 28 is preferably formed as an outward extension of the casing 14. The open slot 27 at the outer end of the collar 28 extends longitudinally inwardly and is designed to-provide three longitudinally spaced seats 29, 30 and 31 for .the control pin 26. These seats 29, 3t) and 31 are spaced apart at predetermined longitudinal distances in conformity with the longitudinally spaced positions of the three passageways 20, 21 and 22 at the cylinder wall 15. The control device 24 also includes a ring 32 for facilitating hand movement of the control assembly 16; this movement may also be accomplished by using the luer syringe .23 as ahandle of the control assembly 16.
The control assembly has a conduit In the preferred embodiment the cylinder and piston 25 are round in cross section. The piston 25 has a transverse opening or transverse conduit 33 extending from its outer surface transversely inwardly and a longitudinal hole or longitudinal conduit 34 extending from the inner end of the transverse conduit 33 outwardly through the piston 25 and control device 24 to the syringe 23. In the preferred embodiment shown, this longitudinal conduit 34 is centrally disposed in the piston 25. A plurality of openings forming four transverse conduits 33 are provided in the piston 25 by drilling two holes completely through the piston 25 at right angles to each other. The four inner ends of the four transverse conduits 33 connect with the inner end of the longitudinal conduit 34. The outer openings of the transverse conduits 33 lie in a single transverse plane normal to the longitudinal axis of the piston 25. An annular transverse blood groove 35 is provided in the piston 25 in the same transverse plane as the four outer openings of the transverse conduits 33, this blood groove 35 defining an annular channel for the flow of blood.
The piston 25 is also provided with sealing grooves 36 along its length on either side of the annular channel 35, these grooves 36 being outer annular transverse grooves of suitable size for the receipt of O-rings 37 which sealingly engage the wall of the cylinder 15. The longitudinal distance between a transverse conduit 33 and either closely adjacent O-ring 37 is less than the longitudinal distances at the cylinder wall 15 between adjacent passageways and 21 or adjacent passageways 21 and 22 to provide a sealed zone around the selected passageway, such as passageway 20 as shown in Fig. 4. In this manner no interchange of blood can take place between the three passageways 20, 21 and 22 unless the operator causes such interchange by moving the control assembly 16 from one position to another as indicated and controlled by the control pin 26 and pin seats 29, 30 and 31.
As seen in Figs. 1, 2 and 4, the casing 14 at the first passageway 20 is provided with a first fitting 40 over which is frictionally received an end of a flexible tube 41; this tube 41 includes a polyethylene catheter (not shown) which canulizes the umbilical vein of the infant 17. This provides a first conduit means whereby blood may be withdrawn from the baby, and a donors blood may be delivered to the baby. A second conduit means is provided for discharging the babys blood from the system into a container 18, this including at second passageway 21 a second fitting 42 to which is connected a flexible tube 43 which conducts the blood to the container 18. A third conduit means, connected to the third passageway 22, is provided for withdrawing donors blood from the donor blood bottle unit 19, this including a third fitting 43 and tube 44. I
In operation, the polyethylene catheter on tube 41 is inserted into the infants umbilical vein. With the control pin 26 in position marked B for baby, the plunger 45 of the luer syringe 23 is carefully pulled outwardly with a slight rotational action to withdraw 10 cc. (cubic centimeters) of blood from the baby into the syringe, the blood flowing through the first passageway 20 to the syringe. The control assembly 16 which includes the syringe 23 and piston and control device 24 is then pulled longitudinally outwardly and rotated slightly to engage the control pin 26 in the second seat identified as D for discharge in the collar 28. The syringe plunger 45 is then pushed inwardly to cause discharge of the babys blood through longitudinal conduit 34, transverse conduits 33, passageway 21 and through tube 43 into discharge receptacle 18.
The control assembly 16 is then rotated back and moved outwardly until the control pin 26 seats in the third seat 31 identified as I for intake. This connects the syringe 23 through longitudinal conduit 34, transverse conduits 33, passageway 22 and tube 44 to the donor blood bottle unit 19.
Ten cc. of donor blood is then drawn into the syringe 23 by outward movement of the plunger 45. The control assembly 16 is then moved longitudinally inwardly to seat control pin 26 at the first seat 29 identified by B. This reestablishes the initial condition of the system, and the plunger 23 is moved inwardly to inject donor blood through transverse passageway 20 and tube 41 into the baby.
The process is then repeated about fifty times. The blood and plasma of the infant containing Bilirubin, Rh antibody 4 Rh positive red blood cells are thereby diluted approximately with a blood and plasma containing no noxious substances.
It will be readily appreciated that this system accomplishes safely and effectively the required transfusion with equipment designed for easy and rapid disassembly. The parts of the system are effectively sterilized in standard sterilizers along with other surgical apparatus without special attention, this having been clearly established by actual use. Lubrication of moving surfaces is accomplished by applying the usual silicone lubricant used on other surgical instruments.
Various other modified forms of the invention will be apparent from the foregoing description and for that reason I wish to limit myself only within the scope of the appended claims.
1. A system for blood exchange transfusion in infants having the disease of erythroblastosis comprising a casing having a cylinder therein and three passageways from the outer surface of said casing to longitudinally spaced positions on the wall of said cylinder, a control assembly slidably positioned for longitudinal movement in said cylinder, said control assembly having a syringe at its outer end, a control device intermediate its ends and a piston at its inner end positioned in said cylinder, said piston having an opening extending from its surface transverselyinwardly and defining a transverse conduit, said piston and said control portion having a longitudinal hole defining a longitudinal conduit in fluid communication with said transverse conduit and said syringe, a control means mounted on said casing for operative coaction with said control device to connect selectively said syringe through said longitudinal conduit and said transverse conduit to one of said three passageways, said piston having spaced outer annular transverse grooves on opposite sides of and very near to said transverse conduit, O-rings positioned in said grooves and sealingly engaging the wall of said cylinder, the longitudinal distance between said transverse conduit and either closely adjacent O-ring being less than either longitudinal distance between adjacent passageways in the cylinder wall to provide a sealed zone around the selected passageway, first conduit means connected to one of said passageways for conducting a babys blood from the baby and a donors blood to the baby, second conduit means connected to the second of said passageways for discharging the babys blood from the system, third conduit means connected to the third of said passageways for taking donors blood into the system.
2. A system for blood exchange transfusion in infants having the disease of erythroblastosis as defined in claim 1 and wherein said piston has a plurality of openings forming a plurality of transverse conduits, the openings of the transverse conduits at the surface of said piston being in a single transverse plane, said piston having an annular transverse groove at said single transverse plane defining an annular channel.
3. A system for blood exchange transfusion in infants having the disease of erythroblastosis as defined in claim 1 and wherein said control device includes a control pin extending transversely outwardly from the intermediate portion of said control assembly and said control means comprises a collar connected to and extending longitudinally outwardly from said casing and sur- 2,842,124 5 6 rounding said intermediate portion of said control as- References Gited in the file of this patent sembly, said collar having an open slot at its outer end extending longitudinally inwardly, said slot having three UNITED STATES PATENTS seats, said seats being longitudinally spaced in conformity 2,485,842 Pennington Och 1949 with said longitudinally spaced positions of said three 5 passageways to align said transverse conduit with the se- FOREIGN PATENTS lected one of said three passageways when said control 387,157 Great Britain Feb. 2, 1933 pin is positioned at a selected one of said three seats. 463,963 Italy June 14, 1951