DE2439392A1 - DEVICE AND METHOD FOR ASEPTIC COLLECTION OF FLUIDS BY VACUUM PRESSURE - Google Patents

Description

August 16, 1974

A 15574 pp / ib

SORENSON RESEARCH CO., INC., 4 ^ 87 Atherton Drive,
PO Box 15588, Salt Lake City, Utah 84107, USA

Device and method for aseptic collection of
Fluids through negative pressure

The invention relates to a vacuum collection device using a flexible container that is inside
a fixed box is arranged. In particular concerns the
Invention a two-chamber system in which one chamber primarily collects blood and can be separated from the other chamber in order to be used with a catheter for re-infusion of the collected blood.

Up until now, it has been common practice in medical offices to use a negative pressure collection device when a patient is out a wound bleeds or if an internal cavity or cut is free of blood or other material during an examination or surgery.

A commonly used vacuum collection system consists of a rigid plastic canister with a flexible one

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Telegram address: patent senior

Container hanging from a lid in the canister. The space between the canister and the container is evacuated, to prevent the container from collapsing, and the inner space of the container is connected to a suction pipe and is also in fluid communication via a second tube with the position where tissue and fluid are collected target. This type of known suction device is advantageous because of its low cost and aseptic disposal capability. Such a device is described in US Pat. No. 3,719,197.

A major deficiency in the above-mentioned known device is the fact that all collected Fluids, especially pure blood, can only be removed and that there is no possibility of a still pure, collected Give blood back to the patient. Often the collection device is used in connection with surgery where blood is collected in a form that would be able to infuse the blood directly back into the cardiovascular system of the patient.

A device that allows immediate re-infusion of the withdrawn blood in an essentially aseptic manner Form is not yet known. Even if it were also conceivable that in conventional systems that in a vacuum container collected blood by hand to a second container for

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an infusion could be given, it would be the Risk of contamination extremely high, and the expenditure of time and money such handling would be an obstacle,

Accordingly, it has become desirable to have a negative pressure collection system to use which is suitable for collecting the withdrawn blood in a separate container, which is essentially automatic can be closed aseptically.

The present invention provides an apparatus and a method for collecting blood by negative pressure, wherein in one the first container of a two-container system, the blood is collected and transferred to a second container and the second Container is separated from the first container and sealed. The present invention also provides an automatic locking mechanism in order to immediately and aseptically close the second container after removing it from the first container. the The device optionally adapts to the formation of a pressure difference between the first and second container in order to achieve the Make it easier to pump blood from the first to the second container.

It is therefore the primary object of the invention to provide an aseptic vacuum collection device with two containers one container is completely separable from the rest of the system.

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Another object of the invention is to provide an automatic sealing mechanism that can protect the severed Blood container completely closed when removed from the collection container.

Another object of the invention is to provide a vacuum collection device to provide with two chambers, in which the collected fluid pneumatically from a collecting container into a Blood container is pumped.

Another object of the invention is to provide a vacuum accumulator with two chambers, with a container for direct re-infusion of blood into the patient can be used.

Finally, it is an object of the invention to provide an improved method for vacuum collection.

These and other objects and features of the invention will become apparent upon the following description in conjunction with the FIG subsequent claims clearly.

Embodiments of the invention are shown in the drawing for example, show:

Fig. 1 shows a cross section of a preferred embodiment of the invention, in which in particular the inner Structure shown while fluid is being drawn into the unit;

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Pig. 2 shows a cross section of a preferred embodiment of the invention, in particular the inner Fig. 11 shows construction while a fluid is being pumped into the blood container;

Figure 3 is a perspective view of a preferred one Embodiment of an automatic sealing plug;

4 is a perspective view of a second embodiment of an automatic sealing plug;

Fig. 5 is a schematic cross section of the in Figs 2 when the two-container arrangement is in the situation of separation;

6 is a perspective view of the severed

Blood container when used for reinfusion of blood into a patient; and

7 shows a perspective detail illustration of a another preferred embodiment of the two-chamber container, in which in particular the use of a separable heat-seal strip for the union of the two chambers is shown.

A preferred embodiment of the invention is in Drawing shown. In the embodiment shown in Fig. 1, a can 20 is used. The can 20 can be made relatively be made of solid and essentially translucent plastic material and is open on its upper side, but locked at the bottom. The can does not come into contact with the fluids, which are highly infectious or even contagious so that it can be used repeatedly without having to be sterilized repeatedly. The can 20 is suitably cylindrical, although its shape is of no great importance, and it has an inlet 22 in the side wall

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and a nipple 24 which mounts in the inlet 22 of the can wall is.

A lid 26 with a flange 28 dependent on the circumference of the can can encompass the upper end of the can 20 so that a airtight seal can be made. The lid 26 is made of a rigid plastic material similar to that of the can 20. Two F ^ uid connection nipples 30 and 32 run through the Lid 26, on the one hand to establish a connection to a vacuum system (nipple 30) and on the other hand to a suction plate (nipple 32). A collecting container 34 is sealed on the lid 26 hung up. The cover 26 thus serves as a seal for the collecting container 34, and the nipples 30 and 32 provide the fluid connection with the inside of the container 3 ^.

In addition, a filter 36 is hung on the cover 26, which is arranged between the nipple 32 and the remainder of the container in order to allow the into the chamber via the nipple 32 filter incoming fluid. The filter can be made from a wide variety of materials. A finely woven nylon net in the form of a bag with a closed end has been found useful in practicing the invention. aside from that it has proven expedient to attach only part of the open end of the filter bag 36 to the cover 26, see above that a segment 37 of the nylon filter remains, which is separated from the cover 26. The air passage formed in this way sees an opening before, which makes it possible to deal with the entering fluid

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allowing mixed air to escape while the incoming fluid flows through the filter. The end 58 of the collection container 34 has an opening 40 to which a short plastic tube 42 is attached. The plastic tube 42 is integral with the Container 34 connected.

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A blood container 44 occupies the lower part of the can 20

and is made of the same flexible plastic material ^ like the collection container 34. The blood container 44 has an after inwardly directed sleeve 46, which the from the collecting container 34 enclosing outgoing tube 42 in a telescopic manner. The tube 42 normally protrudes slightly beyond the end of the sleeve 46.

In the embodiment of FIGS. 1 and 2 is a Force distribution 45 in the tube 42 between the containers 3 ^ and 44 used. The power distribution sleeve puller 45 becomes this used to exert a force on the blood container 44 when the two containers are to be separated.

can

The tube 42 / is provided with one or more openings 48 which are mounted at a location slightly above the open end of the tube 42 (see Fig. 4). A self-sealing one Plug 50 is inserted into the open end of tube 42 within blood container 44.

In Fig. 4 is a more detailed "representation of the" automatic Sealing plug 50 reproduced. The plug 50 has one

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cylindrical, three-step training. The smallest cylinder 52 has a diameter that is a snug fit in the inner diameter of the tube 42 allows. The middle cylinder 54 of the plug 50 has the same diameter as the outer jacket of the tube 42 and can therefore be telescoped into the sleeve 46 of the blood container 44 with a good snug fit. The largest barrel portion 56 of the plug 50 can be any Have size or shape and only needs to be slightly larger than the second cylinder portion 54 in order to avoid the plug 50 slips through sleeve 46 when containers 34 and 44 be separated.

It should be noted that when the plug 50 is inserted into the end of the tube 42 (FIG. 4) there is fluid communication therebetween the collection container 34 and the fluid container 44 through the openings 48 in the sides of the tube 42 is maintained.

A second embodiment of an automatic sealing plug 51 is shown in FIG. 3. The main difference in structure between the sealing plug according to FIG. 3 and that according to FIG. 4 lies in the fact that the tube insertion ends 58 (FIG. 3) are essentially are flat and solid extensions extending from the central cylinder portion 62. On each side of the flat extension 58 a flange 60 is formed which is a distance slightly above the connection between extension 58 and central cylinder 62 leaves. The flange 60 does not extend diametrically beyond the width of the central cylinder 62.

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The plug 51 shown in FIG. 3 can be used the omission of the openings 48 in the sides of the tube 42. The extension 58 is inserted into the tube 42. Of the Flange 60 prevents tube 42 from resting on cylinder 62. Accordingly, there remains a passage for the fluid connection between the collecting container ^ 4 and the blood container 44 via the tube 42, along the flat sides of extension 58 and through the space maintained by flange 60.

The extension 58 points outward at its free end directed and opposite lugs 59 which bear against the inner surface of the tube 42. When the tube 42 by means of the corresponding sleeve 46 is pulled, the lugs 59 will accordingly hold the plug 5I in the tube 42 until it passes through the leading edge 47 of the sleeve 46 is forced out of the tube 42.

The blood container 44 also has an infusion withdrawal tube 64 (see Fig. 6). The infusion tube 64 is on the blood container 44, but with the container end of tube 64 normally compressed to provide fluid communication with the Avoid containers.

As shown in Fig. 6, the tube 64 is aligned for to include the infusion assembly 66 closely enclosing it and to hold on by friction. The tip 70 of the infusion assembly pierces the container surface at the end of the infusion

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Withdrawal tube 64. A sterile cap 72 (see Pig. 5) is over the outer end of the infusion tube is pulled to the sterile condition of the tube 64 until it is used for a blood infusion to preserve in a patient. A bracket 73 made of flexible plastic is attached diametrically across the bottom of the blood container 44, The bracket 73 has two functions, once as a handle when separating of the two containers and then as a hanger for hanging the container 44 in an inverted position for a re-dispensing of the blood to the patient.

In the embodiment shown in FIG. 5, the blood container is 44 to the collecting container 34 physically only via the connecting pipe 42 connected. To aid in assembling and separating the vacuum collection unit and an undesirable one As an alternative, it is possible to report the two containers falling apart a connection seam formed from a heat seal (see Fig. 7) 74 can be provided on the periphery of the adjacent ends of the two containers. A divider tab 76 is also preferred attached to the blood container 34. Merging the Units can be readily effected by any conventional technique involving separation of containers 34 and 44 without adversely affecting the integrity of the container.

With reference to Figure 7, it should be recalled that tab 76 can be used to separate containers J> K and 44 after blood container 44 is filled with blood and

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ready to be used as an infusion supply container. Although the two containers are physically connected to each other can like the Pig. 7 shows the fluid connection and automatic sealing plug remain as shown in FIGS. 1, 2 and 5 same. In general, however, the force distribution extractor 45 is not used when welding the two containers together are.

Intended as a negative pressure blood collection device A vacuum line 80 is used on nipples 24 and 30 (see Fig. 1) attached. The vacuum on nipple 24 creates a partial vacuum in the space between can 20 and the containers and 44. The vacuum on nipple 30 causes a continuous one Air flow from the interior of the sump 34 through the nipple 30. A suitable safety valve (not shown) can between 8o vacuum line and any permanent vacuum system available in a hospital, to prevent the possibility of fluid from flowing from the nipple 30 gets into the vacuum system. '

The nipple 32 is via a suitable pipe 82 with a. connected to an open end of a suction collecting rod (not shown), which can optionally be brought to any area from which blood or other fluids are to be collected.

When the device of the invention according to the above loading. Writing is completely composed, it can be collected

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and storing blood or other fluids. Figures 1 and 2 particularly illustrate a preferred embodiment of the invention in two main positions, the device being used as a vacuum collection system. Fig. 1 shows the invention during the time when the suction rod (not shown) connected to the tube 82 is in the fluid to be collected has joined. A vacuum is established in the collection chamber 34, and the fluid is drawn into the chamber via tube 82 as indicated by arrow 84. During the time that the Tube 82 is filled with fluid, is the air space in chamber 34 essentially evacuated. Accordingly, the air is also withdrawn from the lower chamber 44, since the pressure between the two Compensates chambers. While the fluid uptake is in progress, collect

86
melt see the fluid / within the collection chamber 34, as shown in FIG. 1, and does not flow directly into the lower blood container 44.

When the suction wand, and with it the tube 82, begin to suck up air instead of fluid (see FIG. 2), a sudden one occurs Decrease in vacuum within chamber 34 (or increase in print). Accordingly, the pressure in the blood container 44 is measurably lower than the pressure in the collecting container 34. The pressure difference between the two containers causes the fluid 86 to flow into the lower blood container 44, as indicated by the directional arrows 85 is displayed.

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As shown in FIGS. 1 and 2, a occurs some change in the shape of the intermediate layer between the two containers as a result of the pressure difference. Of course would the "pump! action of the pressure difference between reach through the chambers even with fixed chambers ^ and the in The change in shape shown in the figures is merely a consequence of the effect of the difference! ichen pressure with flexible Chamber walls.

It should be noted that by transferring the blood from container j54 to container 44, blood collection devices occurring main problem is avoided. It has been found that severe air turbulence, such as that found in negative pressure accumulators can cause dangerous haemolysis and clot the blood, even if the blood has previously been heparinized. The transfer of the blood into the relatively calm and turbulent-free blood tank 44 therefore reduces the risk of hemolysis due to blood turbulence and reduces the likelihood of harmful clot formation.

After the blood container 44 is completely filled with blood according to the method described above, the two containers can be removed from the can 20 together with the lid 26, as shown in FIG. Now there is a separation of the two containers possible. The puller 45 * the between the two containers is arranged, serves as a handle to exert a force on the loading

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to exercise container 44, while the lid 26 for a Counterforce on the container 34 is used.

From Fig. 5 it can also be seen that if the tube 42 is pulled off through the sleeve 46 on the upper part of the container 44, the stopper 50 or 51 on the guide edge 47 the sleeve 46 strikes, whereby the plug 50 or 51 his Seat within the sleeve 46 gets. Thus, when the tube 42 has been fully withdrawn, the container 44 becomes accordingly be completely closed.

If, however, the embodiment shown in FIG. 7 is welded is used, it would of course be necessary to first interrupt the connection seam before the tube 42 through the Sleeve 46 is pulled out, but the closing process of the stopper 50 in the container 44 would proceed in the same way, as described above.

The closed container 44 (FIG. 6) can be used as an infusion supply container for blood or self-infusion be turned over on a patient. As described above, an infusion assembly 66 may include a Needle tip 70 is used, which is the closed end of the The supply tube 64 is pierced and there is complete fluid communication between the suspended container 44 and the dispensing tube 68 manufactures.

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It is emphasized that, although the invention has been described in terms of use for blood collection, it can be used with many other fluids that occur with the use of vacuum collection. An important feature of the invention is to be seen in the fact that the quality of an absorbed fluid is retained. The use of the lower container as shown in FIG. 6 has been described with regard to re-infusion. Of course, it is also possible to use the chamber 44 in a corresponding manner for checking and testing purposes ¹¹ of the fluid located in the chamber.

The invention can also take other specific forms are carried out without deviating from the characteristic features of the inventive concept. The described Embodiments are only illustrative in all points and not to be regarded as limiting.

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Claims (1)

P A TENTAN PRESS (J C HE 1. / vacuum collection device, characterized by a first container (34) and elements (80,30) for evacuation this first container, by conveying elements (82,52), which a fluid from a remote location in the first container (34) bring, through a second container (44), optionally separable from the first container, through between the first and second container arranged connecting elements (40,42,46,48) which provide a fluid connection between the two containers and alternately adapt to a pressure difference and a pressure equalization between the first and second containers, and by a sealing element (50; 51) * which the second container (44) automatically closes when the connecting elements (40, 42) are removed therefrom. 2. vacuum collecting device according to claim 1, characterized by an outer box (20) with elements (80,22,24) to maintain a negative pressure in this; a first collecting container (34), elements (80, 30) for evacuating this container, Elements for drawing in a fluid at a remote location, conveying elements (82,32) which deliver the fluid to the first container deliver a second, enclosed by the can (20) 509817/0684 Container (44) having an opening (46), one integral with the first Container (34) molded and inserted into the second container (44) fluid line (42) protruding through the opening (46) and an element (50; 51) belonging to the fluid line (42) for closing the opening (46) when the conduit is separated therefrom. 3. vacuum collection device according to claim 2, gämarks through a fluid filter (36) through which the fluid entering the first container (34) passes and which has an air passage (37) for adapting the free air flow between conveyor elements (82,32) and the interior of the first container (34) provides. 4. vacuum collecting device according to claim 2, characterized in that that the fluid line (42) is arranged essentially centrally on the underside of the first collecting container (34) and by a cylindrical sleeve (46) formed integrally with the second container (44) and aligned with the opening protrudes through, the fluid line (42) having a fluid passage limited, which has a smaller fluid transfer capacity ^ than the funding elements (80,30,32,82). 5 · vacuum collecting device according to claim 2, characterized in, that the closure element consists of a plug (5O; 51), which is initially in the fluid line (42) to the fluid 509817/0684 _ 18. Connection between the first and second container is arranged and which has a diametrically enlarged part, which in the opening of the second container sits as soon as the fluid line 42 is deducted from this. 6. vacuum collecting device according to claim 5 *, characterized in that that the plug (51) has a substantially solid cylindrical body (62) with a substantially flat surface and a flat forward protrusion (58) and spacers attached to the surface having one end of the fluid conduit (42) away from the flat surface for fluid flow between the plug (51) and the fluid conduit (42), the forwardly directed projection (58) has securing elements (59) for attaching the plug in the fluid line (42). 7. vacuum collecting device according to claim 2, characterized in that that a substantially flat extractor (45) the fluid line (42) for easier separation of the line from the surrounds the second container (44). 8. vacuum collecting device according to claim 2, characterized in that - that the second container (44) has a bracket (73) integrally connected to the bottom of the container for hanging of the second container in an inverted position for fluid dispensing. 509817/0684 9. vacuum collecting device according to claim 2, characterized in that that the second container (44) has an initially sealed dispensing spout (64) which is of a conventional Infusion arrangement (66) for dispensing the contents of the second container (44) is penetrable, even if the closure element (50; 51) is inserted in the opening. 10. vacuum collection device according to claim 2, characterized by a circumferential seam (74) which the first and second Connects container on its outer periphery, the seam being made of a welded plastic material, and by elements (76) for optionally breaking the heat seal and opening the seam to cause separation of the first and second containers. 11. A method of isolating a fluid in a vacuum collection device with an evacuated, fixed outer box, two separable containers contained therein and fluid connection elements between the containers, characterized in that the first container is evacuated, a fluid from a remote one Place in the first container is conveyed to accumulate, a pressure difference between the first and second container periodically is made to convey the fluid from the first container to the second, and the second container is separated from the first is, wherein the second container is at the same time tightly closed to isolate the fluid contained therein. 509817/0684 -20- 12. The method according to claim 11, characterized in that a fluid is sucked into the first container for the pressure build-up and at the same time air is drawn from the second container into the first and that air is subsequently drawn into the first container thereby increasing the pressure therein and forcing the fluid into the second container. 15. The method according to claim 11, characterized in that the air turbulence in the fluid is reduced by the fluid in the second container from direct contact with Air is isolated, which in a stream into the interior of the first Container is brought. 509817/0684