United States Patent: 3552393

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( 14271 of 14271 )

United States Patent	3,552,393
Willgerodt	January 5, 1971

TRANSFUSION DEVICE

Abstract

A blood transfusion device for infusion of blood into a human body and for simultaneous removal of blood therefrom is equipped with two pair of pumps and respective valves arranged in two distinct units whereby, while one unit is removing the blood from the body through a distinct removing conduit, the other is supplying the blood through a distinct infusion conduit, the arrangement being such that a direct connection is made between the body and the receiving vessel through the removing conduit and another direct connection is made between the container holding the infusion fluid and the body through the infusion conduit.

Inventors:	Willgerodt; Werner (Leipzig, DT)
Assignee:	VEB Medizintechnik (Leipzig, DT)
Appl. No.:	04/847,825
Filed:	July 31, 1969

Current U.S. Class: 604/6.12 ; 417/318; 417/341; 604/27

Current International Class: A61M 1/00 (20060101); A61M 1/02 (20060101); A61m 001/02 ()

Field of Search: 128/213,214,273,230,240,276 137/565 103/170,173,227 417/318,341

References Cited [Referenced By]

U.S. Patent Documents


343827	June 1886	Melcher
996697	July 1911	Bode
1127065	February 1915	Milne
2625932	January 1953	Salisbury
2625933	January 1953	Salisbury
2925047	February 1960	Hoffer
3098480	July 1963	Worthington
3291151	December 1966	Loken

Primary Examiner: Truluck; Dalton L.

Parent Case Text

This application is a continuation of application Ser. No. 535,976 filed Mar. 21, 1966, now abandoned.

Claims

I claim:

1. Apparatus for infusing a fluid into a human body while simultaneously removing a waste fluid therefrom, said apparatus comprising a distinct infusion section including a container for said fluid to be infused, first pump means comprising a pair of pumps cooperating in such a way that one of said pair is operating in the suction cycle thereof while the other of said pair is operating in the compression cycle thereof, thereby causing a continuous flow of the pumped fluid, conduit means for connecting said container directly to said first pump means and therefrom directly to the body, first means disposed in said conduit means for isolating the body from each respective one of said pair of pumps during the suction cycle thereof, second means disposed in said conduit means for isolating said container from each respective one of said pair of pumps during said compression cycle thereof, a distinct waste-fluid-removing section including a container for said waste fluid, second pump means comprising a pair of pumps cooperating in such a way that one of said pair is operating in the suction cycle thereof while the other of said pair is operating in the compression cycle thereof thereby causing a continuous flow of the pumped fluid, further conduit means for connecting said waste fluid container directly to said second pump means and therefrom directly to the body, third means disposed in said further conduit means for isolating the body from each respective one of said pair of pumps during the compression cycle thereof, fourth means disposed in said further conduit means for isolating the waste fluid container from each one of said pair of pumps during the suction cycle thereof, said pump means and said isolating means in said infusion section cooperating with said pump means and said isolating means in said waste-fluid-removing section to permit a continuous flow of fluid into said human body and simultaneously a continuous withdrawal of waste fluid therefrom, and drive means for driving said first and said second pump means.

2. Apparatus as claimed in claim 1, wherein said pumps are operable each with a piston, and also comprising coupling means coupling said drive means to respective pairs of said pumps.

Description

The invention relates generally to a blood transfusion device and more particularly to a device for blood exchange treatment of newly borns who may have decomposing substances, such as bilirubin, in their blood. Such substances influence the blood negatively, therefore, in order to prevent debility, blood transfusion or complete exchange of the blood might be necessary.

A blood transfusion or exchange device is known having a blunt cone-shaped housing with a cone member pivotable within a range of 360.degree. disposed in the center of the housing, with valves provided on the outside of the housing. A syringe is mounted on the cone, with a lower bore outlet thereof made to communicate with a desired valve while rotating the lower bore outlet to a position within its range. Respective valves lead to a catheter which is introduced into the navel vein of the child, to a blood container, a waste container and to a liquid container. By means of the described syringe, blood is sucked from the blood container. After a pivotal movement, the lower bore outlet is brought into its next position and blood will be passed onto the child. In the same cone position, blood will be subsequently drawn from the child. After pivoting the cone into its third position, the sick blood which was drawn from the child at the previous operating step is passed into a waste container. The shortcoming of this device is that after each blood exchange all parts of the device have to be cleaned, such as the valves, etc., since they are disposed in the path of the bloodstream and thus, if not cleaned, an inadvertent infusion of the sick blood drawn from the child at the previous transfusion, may be possible, due to a different selection of the cone position during a subsequent transfusion.

A further device is known which is adapted only for a single utilization. Such device comprises two valve systems with connections to navel catheters, two syringes, a blood container and a waste container. One of the syringes sucks blood from the blood container and presses it through the catheter into the navel vein through a valve. Thereafter, the second syringe draws blood from the navel vein through the catheter and a valve system. After opening a valve of the system, the drawn blood will be passed into the waste container. The disadvantage of the last-mentioned device is that due to the various manual valve adjustments and to the manual operation of the syringes, the drawn sick blood may be inadvertently returned into the child.

A further blood exchange device is known which essentially consists of a five-way valve to which a syringe is fixedly connected. A blood container, a catheter for introduction into the navel vein of the child, a waste container, a bottle and a pressure gauge are connected by means of transfer devices to the individual openings of the valve. For setting of the individual position of the valve, a handle is provided on the valve. The five-way valve is first adjusted to draw blood from the conduit which leads from the blood container, whereupon blood is sucked therefrom. After setting the five-way valve to the catheter position thereof, blood is injected into the navel vein, and subsequently blood is drawn from the child's body. Moreover, the five-way valve may be set to a further position for receiving a medicament which may also be introduced into the catheter and into the navel vein of the child.

This device has also shortcomings, since all parts thereof have to be cleaned after each blood transfusion in order to prevent the possibility that the decomposed blood will be infused by a wrong adjustment of the five-way valve during a subsequent transfusion.

Moreover, all the above-mentioned known blood transfusion or exchange devices have their common shortcomings in that they are only manually operable, that the volume to be delivered blood cannot be varied per unit of time, that no constant, but only an intermittent blood transfusion is possible, i.e. blood is alternately drawn and the same amount of blood is replenished. Furthermore, breakdowns, such as clogging of the conduits, cannot be indicated. Thus, it is possible that by a wrong adjustment of the valves, the previously drawn blood may be inadvertently returned into the child's blood stream.

It is, therefore, an object of the invention to provide a blood transfusion device which may be repeatedly used shortly after a previous transfusion.

It is another object of the invention to provide a semiautomatic blood transfusion device which is suitable for intermittent as well as for continuous infusion of blood and also for exchange-type blood transfusion.

It is still another object of the invention to provide a blood transfusion device which is capable of indicating cloggings and may be instantly turned off upon occurrence of operational defects.

It is a further object of the invention to provide a blood transfusion device, wherein the delivery volume is variable per unit of time.

It is still a further object of the invention to provide a blood transfusion device, which is capable of preventing an inadvertent infusion of the drawn blood back into the human body.

With these objects in view, the invention resides broadly in an apparatus for infusing a fluid into a human body while simultaneously removing a waste fluid therefrom, said apparatus comprising an infusion section including a container for said fluid to be infused, first pump means, conduit means for connecting the container to the first pump means and to the body, first means disposed in the conduit means for isolating the body from the container and from the first pump means during suction cycle of the first pump means, second means disposed in the conduit means for isolating the container from the first pump means during the compression cycle of the first pump means, a waste fluid removing section including a container for the waste fluid, second pump means, further conduit means for connecting the waste fluid container to the second pump means and to the body, third means disposed in the further conduit means for isolating the body from the waste fluid container during suction cycle of the pump means, fourth means disposed in the further conduit means for isolating the body from the pump means during compression cycle of the second means, and drive means for driving the first and the second pump means.

More specifically, in accordance with the invention, a plurality of conduits are connected to a piston-type injection system, the conduits being closed or opened by a spring-loaded magnetic valves and lead to a multichannel catheter, to blood containers and to a waste container, respectively.

One end of the conduits is connected to the suction or respective pressure chamber of the piston injection system. The transfusion device is driven by a drive mechanism which through an intermediate drive drives preferably a pair of control rollers formed with curved driving bodies thereon. The driving bodies are coupled to the piston rods of the piston injectors. Each roller preferably controls contacts of an electromagnet which in turn controls spring-loaded magnet valves, the latter effecting opening and closing of the determined branches in the conduits. The safe operation of the devices is ensured by sensors or interruptors provided with the pistons and the control rollers for exercising alternate control over the drive mechanisms and are coupled also to optical and acoustical signal devices for warning the operating personnel. The interruptors break the circuit when cloggings or other operational emergencies occur and also actuate the visible and audible signal devices.

The invention will become more readily apparent from the following description of a preferred embodiment thereof shown, by way of example, in the accompanying drawing, in which:

The single FIG. shows a diagrammatic view of the transfusion device according to the invention.

With reference to the single FIG., it is seen that a multichannel catheter which is illustratively shown as including a pair of catheter branches 12 and 12', is connected with its branch 12' to an infusion section 1 whereas catheter branch 12' leads to a waste fluid section 2. The catheter branches 12 and 12' are adapted to terminate in the body of the person undergoing the blood treatment. Infusion section 1 and waste-fluid-removing section 2 contain substantially the same operating elements, therefore only infusion section 1 will be described in greater detail, whereas only the operational differences between the two sections will be pointed out.

Infusion section 1 includes a fresh blood container 13 to which catheter branch 12 is coupled through a double loop of tubing, each loop serving a pump 9 operable by a piston 8. The catheter, particularly the branches thereof in the vicinity of the pump and in the vicinity of the blood container may be subdivided into suction branches 11b and compression branches 11a. In the illustrative embodiment a pair of arms are shown as operating in opposite phase and being driven by a driving mechanism which includes a motor 23 to which variable gear 24 is coupled in order to provide the motor with a range of speed. The variable drive, through a linkage 25, which is schematically shown, drives a control roller 3, which is provided with a curved driving body 4 having an ascending and a descending guiding surface 5 disposed therearound to form a cam whereby the end portions of guiding pipes 6 of the respective piston rods serve as cam followers to be guided in slidable relationship therewith for reciprocal movement. The arrangement of the guiding surface or guiding projection is such that it has an ascending and a descending semicircle around the control roller, similar to a single-screw thread, the pitch of which is equal to the stroke of the associated pistons. Said guiding projection controls the reciprocal movement of the respective piston rod which in turn controls the reciprocal movements of the respective piston. The control roller 3 has a pair of pistons preferably associated therewith as pointed out above, which pistons are disposed so that they are a full stroke apart during operation, i.e. one piston is in its lowermost position during the suction cycle, while the other is in its uppermost position on a compression cycle. The control roller 3 further carries a projection 22 for purposes hereinafter described.

As pointed out above, one of the main purposes of the present invention is to isolate the fresh blood sections during suction and compression cycles from the waste blood sections. To effect this branches 11b which are the suction branches from the container 13 of the respective sections, include magnetic valves, 16a and 16b, 16d respectively, whereas compression branches 11a in association with each pump include magnetic valves 16b and 16c. When drive roller 3 is in its position which causes pump 9 to be in its suction cycle as shown in the drawing, magnetic valve 16a is opened to provide a free path for the fresh blood from the container to the suction side of the pump, while at the same time magnet valve 16b is closed in order to prevent applying suction to the catheter 12 entering the child's body. Opening of the magnetic valve 16a and closing simultaneously of the magnetic valve 16b is effected by a pair of contacts 17a and by a solenoid 16a', a pair of contacts 17b and an associated solenoid 16b', respectively. The pair of contacts actuates the solenoids in response to mechanical contact with the projection 22 formed on drive roller 3, which projection 22 is arranged on the drive roller 3 in such a manner and is correlated with the operation of the pump in such a way, that each time a suction cycle is about to begin, valve 16a is opened by solenoid 16a', and simultaneously 16b is closed by solenoid 16b'. Since pump 9' is arranged parallel with the pump 9 and operates therewith in a tandem fashion, a similar projection 22' is arranged upon the drive roller opposite to projection 22 to effect similar conditions in the operation of pump 9'. In the illustrative embodiment, the solenoid valve is schematically illustrated as a spring-loaded magnetic valve, in which the solenoids 16a' and 16b' are connected with their respective valves 16a and 16b by mechanical connecting rods A and a, it is however understood that the mechanical connections can be replaced by a single unit in which the pair of contacts 17a and 17b operate a solenoid valve of any known type.

Turning now to the parallelly arranged pump 9' of the infusion section 1, it is seen that while pump 9 is in its suction cycle, pump 9' by virtue of its instantaneous position on the sliding body of the guiding projection 5 will be in its uppermost position, i.e. in its compression cycle. During the compression cycle of pump 9', the magnet valve 16c is open, while the valve 16d, which is in the suction branch of the associated conduit is closed, since it had been opened only during the suction cycle of pump 9'. As will be seen from the drawing, pumps 9 and 9' operate in tandem, i.e., while pump 9 is in its suction position, pump 9' is in its uppermost, i.e., compression cycle.

It is noted that the illustrative embodiment shows only a pair of pumps for each section, i.e., a pair of pumps for the infusion section and another pair of pumps for the removing section. It is to be understood, however, that any number of pumps could be arranged or any number of loops could be formed within the infusion section as well as within the removing section of the device. Operation of the valves 16c and 16d is effected by associated pairs of contacts 17c and 17d actuating a solenoid 16d' and 16c', respectively, which operate in a fashion similar to the pair of contacts and solenoids described in connection with pump 9. It is noted that as soon as the respective pump reaches its uppermost or lowermost position and the cycle of its operation is about to turn, the projection 22 and 22' will reverse the state of valves 16a, 16b, 16c and 16b.

The waste removal section 2 includes, similarly to the infusion section, a pair of pumps 9a and 9a' which are similarly arranged in the loops of catheter 12'. In this latter arrangement the reference numerals correspond to those discussed above.

The operation of the double pump arrangement of the removing section 12' will now be described. The single FIG. represents an instant of such operation, i.e. an instant in which pump 9a is in its compression stroke, and pump 9a' is in its suction stroke. During the suction of pump 9a' valve 16D will be closed and valve 16C will be open. This will result from the fact that projections 22a and 22a', are arranged on the control roller 3' in a similar fashion to that of the projections 22 and 22' on control roller 3 and operate in like manner. Thus, when pump 9a' is in its suction cycle and sick blood is sucked from the person's body through catheter 12' into the pump 9a'. As seen, pump 9a is then in its compression cycle, during which valve 16A is open and valve 16B is closed. Such closing and opening of the valves in the removing section isolates the waste blood container 14 from the pistons and from catheter 12' during the suction cycle, whereas the catheter 12 ' is isolated from the pistons during the compression cycle, at which time however the path to the waste container is open.

In order to insure safe operation of the blood exchange device, the piston rods are provided with sensors 26a--26d, along with similar sensors 27a and 27b provided on the driven axis of the control rollers 3 and 3'. The sensors include circuit-breaking devices which under emergency conditions, such as clogging in the conduits, interrupt the current to drive means 23. The sensors are preferably placed in a series loop 28 which controls through a relay coil 29 a signal loop 30 in which a device for producing an audible signal and a device 19 for producing a visible signal are connected which upon energization of coil 29 through loop 28 become actuated.

The valves 16A and 16D are operated by contacts 17A'--17B' through associated electromagnets 16A'--16B', similarly as in the system described in connection with the infusion section.

It is seen that the invention provides a blood transfusion or exchange device, in which continuous operation is possible without the necessity of shutting down the device for cleaning purposes. The device as pointed out above is provided with separate loops for the fresh blood and for the waste bloodstreams, and means are provided in the respective loops, which prevent any possibility of mixing fresh blood with sick blood or pumping of sick blood back into the body of the person undergoing the treatment. The device in accordance with the invention has a built-in safety control, which shuts down the device in emergency conditions such as clogging of any of the conduits, and provides visual and audible signals for the operating personnel about such conditions.

The device in accordance with the invention is also operable at variable rate of speed.

Although the invention has been described with reference to a specific embodiment thereof, it is not intended that the invention should be limited to such specific embodiments alone, but should be defined by the scope of the appended claims.

* * * * *

Current U.S. Class:	604/6.12 ; 417/318; 417/341; 604/27
Current International Class:	A61M 1/00 (20060101); A61M 1/02 (20060101); A61m 001/02 ()
Field of Search:	128/213,214,273,230,240,276 137/565 103/170,173,227 417/318,341