WO2018145870A1

WO2018145870A1 - System for the sterile collection of bodily fluid

Info

Publication number: WO2018145870A1
Application number: PCT/EP2018/051125
Authority: WO
Inventors: Friedrich Pipelka
Original assignee: Friedrich Pipelka
Priority date: 2017-02-08
Filing date: 2018-01-17
Publication date: 2018-08-16
Also published as: DE112018000725A5; AT519610A1; AT519610B1

Abstract

The invention relates to a system (1) for the sterile collection of bodily fluid and for separating a part of the removed bodily fluid. The system (1) comprises a removal syringe (2) having a housing (3) and a plunger (4), which is mounted on a plunger rod (5) and is displaceable in the housing (3), wherein a plunger channel (12) is formed in the plunger rod (5) and extends in longitudinal direction through the plunger rod, an intermediate element (24), which can be coupled to the plunger rod (5) via a first coupling (30), and a container, which can be coupled to the intermediate element (24) via a second coupling (36). The second coupling (36) comprises a piercing part (27) having a tip (28) and a closure part (9) having a closure (10). The structure of the first coupling (30) is the same as that of the second coupling (36).

Description

SYSTEM FOR STERILE APPROVAL OF BODY LIQUID

The invention relates to a system for the sterile decrease of Kö erflüssigkeit and for separating at least a portion of the removed body fluid after the

Preamble of claim 1.

The document US 5,147,329 discloses a system for the removal of body fluid and for separating a part of the removed body fluid. The system includes a take-off syringe, a container formed by a vacuum container, and an intermediate member. The take-off syringe has a housing and a piston attached to a piston rod, which is displaceable by changing a volume of a bounded by the housing and the piston chamber in the housing. By moving the piston in the chamber, body fluid can be drawn into or discharged from the chamber. For attaching or dispensing body fluid, a cannula is attached to the take-off syringe via a luer connection. In the piston rod, a piston channel is formed, which extends from the piston in the longitudinal direction through the piston rod and opens into a female-luer connection part. The

Intermediate member has a Male-Luer connector and a male part with a tip, wherein the Male-Luer connector and the tip of the male part are connected via a connection channel. The female luer connection part and the male luer connection part form a first clutch, wherein closing the first clutch, the intermediate element is coupled to the take-off syringe and the connecting channel and the piston channel can be brought into fluid communication. The vacuum container has a closure part with a closure. The insertion part and the closure part form a second coupling, wherein the vacuum container can be coupled to the intermediate element by closing the second coupling. Upon closing the second coupling, the tip of the insertion member pierces the closure of the closure member, whereby an interior of the vacuum container is in fluid communication with the connection channel.

When using the system known from the document US Pat. No. 5,147,329, in a first step for drawing up body fluid into the take-off syringe, the female-luer connection part on the piston rod is closed with a stopper in order to draw air through the piston passage when the take-off syringe is pulled on avoid. If a certain amount of body fluid has been drawn into the take-off syringe, the stopper is removed in a further step and the take-off syringe is coupled to the intermediate element by closing the first coupler. Alternatively, body fluid can also be taken off with an intermediate element coupled to the take-off syringe become. Subsequently, by closing the second coupling, the vacuum container is coupled to the intermediate element. Due to the vacuum formed in the vacuum container, body fluid is sucked into the vacuum container until it is full or until the vacuum formed in it has dropped so much that it is no longer sufficient to draw more body fluid into the vacuum container. After filling, the

Vacuum container of the intermediate element by opening the second clutch

decoupled.

In the known from the document US 5,147,329 system has proved to be disadvantageous in that the removal of the plug from the take-off syringe due to its

Training is a very furnmelige affair and entices a person using the system to jerky movements when removing. This not only increases the risk of injury to a person using the system, but also to persons who are in the near field of the person using the system.

Moreover, it has proved to be disadvantageous in the known system that it is between the removal of the plug and the closing of the first coupling to a discharge of Kö erflüssigkeit from the sampling syringe and / or contamination of the

Kö liquid can come in the collection syringe. As a result, it is impossible to ensure a sterile decrease in body fluid and a separation of at least a portion of this removed body fluid in other containers, which there is a risk of transmission of germs and diseases. If the decrease of

Although body fluid coupled to the take-off syringe intermediate element is avoided to change the plug against the intermediate element, there is still the risk that the first clutch inadvertently opens and the intermediate element from the take-off syringe by the movements in the decrease of Kö. A sterile decrease can not be guaranteed here.

It is the object of the present invention to provide a system which is characterized by easy handling and by means of which sterile, without

Contamination and without the risk of contamination

can be removed and at least a portion of the removed Köφerflüssigkeit can be separated into more containers.

The object is achieved by the features of the characterizing part of claim 1. In the system according to the invention, the first coupling has the same elements as the second coupling, wherein the insertion part of the first coupling is formed on the intermediate element and the closure part of the first coupling is formed on the piston rod.

By the system according to the invention the advantage is obtained that due to the closed by the closure piston channel without a mandatory use of

Additional components of body fluid can be sucked into the chamber of the delivery syringe and after the body fluid has been applied, the intermediate element can be coupled directly to the delivery syringe. As a result, the system according to the invention is very light and easy to handle and a decrease in body fluid and a separation of at least a portion of the withdrawn fluid can be performed quickly and safely.

The tip of the male parts is formed very thin, wherein the closure is formed so that an opening formed by the tip when closing one of the clutches in the closure after opening the clutch and the associated

Pulling the tip out of the closure automatically closes again. In this connection, the closure is advantageously formed by an elastomer or a foam. The tip is preferably made of plastic or stainless steel and / or received in the connecting element, that this does not protrude from the connecting element to avoid injury. In this context, the

Einichteileil advantageously on a sleeve which is spaced around the tip and protrudes from the intermediate element further than the tip.

Due to the advantageous coupling system, the sampling syringe and the at least one container after opening the clutches are immediately closed to the outside. Contamination of the body fluid or leakage of Köφerflüssigkeit from the collection syringe or the at least one container is reliably prevented by the closure at any time. Also, after opening the first clutch, superfluous body fluid may be forced directly out of the chamber of the take-off syringe by a movement of the plunger decreasing the volume or further liquid may be directly sucked through a movement expanding the chamber.

Any escape of liquid residues from the intermediate element after opening of the couplings is reliably prevented due to capillary action in the tips of the puncture parts. In a preferred embodiment, each insertion part has a prestressed part

Cover on which covers the tip of the insertion part. When closing a clutch, the tip pierces the cover. When the clutch is reopened, the tip will be fully biased due to the bias of the cover

Cover covered over an exterior. As a result, the advantage is obtained that residues of body fluid after opening the clutches can be enclosed even more reliably in the intermediate element.

The intermediate element expediently has at least one further insertion part with a tip, which tip adjoins the connection channel. As a result, several containers can be connected to the intermediate element at the same time, whereby body fluid can be removed from the take-off syringe by means of several containers at the same time. As a result, not only the handling of the system is further facilitated, but it is also a division of the body fluid into several containers faster.

Advantageously, the at least one container is formed by at least one bearing syringe, by a certain amount of absorbed in the chamber of the collection syringe

Remove Kö liquid from the collection syringe.

A system in which the at least one container is formed by a take-off syringe is advantageously used in body fluids formed by blood. The system is particularly well suited for the sterile separation of the blood collected by the collection syringe into a serum and blood cake centrifuge and to separate it into several containers. By using at least one storage syringe as at least one container, the blood divided into serum and blood cake can be metered in portions from the collection syringe, wherein the respective amount which is separated can be adjusted by the at least one storage syringe.

In a further embodiment, the at least one container is formed by at least one vacuum container.

Further advantageous embodiments of the invention will be explained in more detail below with reference to FIGS.

FIG. 1 shows an embodiment variant of the system according to the invention in FIG

assembled state in a perspective view. FIG. 2 shows the embodiment variant of the system according to the invention according to FIG. 1 in the assembled state in a sectional view.

FIG. 3 and FIG. 4 show a take-off syringe of the embodiment variant of FIG

Inventive system according to Figure 1 with Aufziehelement.

FIG. 5 shows the take-off syringe of the embodiment variant of the system according to the invention according to FIG. 1 with a cannula in a perspective view.

FIG. 6 and FIG. 7 show the take-off syringe of the system according to the invention according to FIG. 1 in the drawn-up state.

FIG. 8 shows the take-off syringe of the system according to the invention according to FIG. 1 with the piston rod in the fixing position in a perspective view.

Figure 9 shows the sampling syringe of the system according to the invention according to Figure 1 without Aufziehelement in a perspective view.

Figure 10 and Figure 11 show the sampling syringe of the system according to the invention according to Figure 1 without Aufziehelement in a centrifuge tube.

FIGS. 12 to 14 show the system according to the invention according to FIG. 1 in sectional views.

FIG. 1 shows a variant of the embodiment of the system 1 according to the invention in an unassembled state in a perspective view. The system 1 comprises a take-off syringe 2, an intermediate element 24, two containers formed by bearing sprayers 25, a cannula 16, a pulling-on element 11, a third insertion part 17 and three second ones

Closure parts 9. The cannula 16, the third insertion part 17 and the mounting element 11 are shown in FIG.

Figure 2 shows the embodiment of the system 1 according to the invention according to Figure 1 in a sectional view.

The bearing syringes 25 each comprise a housing 39 and a piston 40, wherein the piston 40 is movably mounted in the housing 39.

The take-off syringe 2 comprises a housing 3, a cover 44, a piston 4 and a piston rod 5. The piston 4 is connected to the piston rod 5 and is under

Variation of a volume of a limited by the housing 3 and the piston 4 chamber 6 in the housing 3 slidably. The lid 44 is fixedly connected to the housing 3.

The system 1 further comprises a first clutch 30, two second clutches 36, a third clutch 20 shown in FIG. 5 and four fourth clutches 43. The first coupling 30 is formed by a first insertion part 26 and a first closure part 13, wherein the first insertion part 26 on the intermediate element 24 and the first

Closure part 13 is formed on the piston rod 5 of the take-off syringe 2.

The two second clutches 36 are each formed by a second insertion part 27 and by a second closure part 9, wherein a second closure part 9 is connected in each case with a Luer connection formed by a fourth clutch 43 to the housing 39 of one of the bearing sprayers 25 and the two second Einichtile 27 at the

Intermediate element 24 are formed.

The third coupling 20 is shown in FIG. 5 and formed by the third insertion part 17 and by a second closure part 9, the second closure part 9 having a Luer connection formed by a fourth coupling 43 with the housing 3

Acceptance syringe 2 is connected and the third insertion part 17 is connected to a luer connection formed by a fourth coupling 43 with a hose 21 of the cannula 16. The tube 21 of the cannula 16 and the third insertion part 17 are shown in FIG.

The second closure parts 9 each have a closure 10, which by a

Elastomer is formed.

FIG. 3 and FIG. 4 show the take-off syringe 2 of the embodiment variant of FIG

inventive system 1 according to Figure 1 with attached to the piston rod 5

Drawing element 11, wherein Figure 3 shows a side view of the take-off syringe 2 and Figure 4 shows a sectional view of the take-off syringe 2 along the section A-A in Figure 3.

In the piston rod 5, a piston channel 12 is formed, which extends from the chamber 6 in the longitudinal direction through the piston rod 5 and opens into the first closure part 13. The first closure part 13 has a closure 14, which is formed by an elastomer and closes an inlet of the piston channel 12. Further, 5 locking grooves 7 are formed on a shaft of the piston rod.

FIG. 5 shows the take-off syringe 2 of the embodiment variant of the system 1 according to the invention with a cannula 16 in a perspective view according to FIG. The cannula 16 is formed by a butterfly known to those skilled in the art, but may also be formed by a simple needle. The third insertion part 17 has a tip, not shown, which is surrounded by a sleeve 18. Laterally on the third insertion part 17 snap elements 19 are provided.

In a further embodiment, the snap element 19 are formed on the closure part 9.

FIG. 6 and FIG. 7 show the take-off syringe 2 of the system 1 according to the invention in the drawn-up state, FIG. 6 showing a side view of the take-off syringe 2 and FIG. 7 a sectional view of the take-off syringe 2 along the section B-B in FIG.

FIG. 8 shows the take-off syringe 2 of the system 1 according to the invention according to FIG. 1 with the piston rod 5 located in the fixing position in a perspective view. As can be seen in FIG. 8, the cover 44 of the take-off syringe 2 has longitudinal guides 22, in which the shank of the piston rod 5 and a shank of the pull-up element 11 are guided. By turning the piston rod 5 relative to the housing 3, the piston rod 5 is at

Maximum volume of the chamber 6 movable into a fixing position in which the

Piston rod 5 is fixed in a longitudinal direction to the take-off syringe 2 and the

Release element 11 can be solved by the piston rod 5. Advantageously, the fixing of the piston rod 5 in the longitudinal direction and the release of the Aufziehelements 11 of the

Piston rod 5 in a rotational movement, wherein after the release, the mounting element 11 can be removed in the longitudinal direction of the piston rod 5.

In a further embodiment variant, the cover 44 is formed integrally with the housing 3 of the take-off syringe 2.

Figure 9 shows the sampling syringe 2 of the system 1 according to the invention according to Figure 1 without Aufziehelement 11 in a perspective view.

FIG. 10 and FIG. 11 show the take-off syringe 2 of the system 1 according to the invention in FIG. 1 without a pull-off element 11 in a centrifuge tube 23, FIG. 10 a side view of the centrifuge tube 23 and FIG. 11 a sectional view of the centrifuge tube 23

Centrifuge tube 23 along the section C-C in Figure 10 shows.

FIGS. 12 to 14 show the system 1 according to the invention according to FIG. 1 in sectional views. The Einichtile 26 and 27 each have tips 28 which are surrounded by sleeves 29. The sleeve 29 of the first insertion part 26 is in the figures 12 to 14 due to Sectional view not shown. The sleeves 29 protrude further from the intermediate member 24 than the tips 28, thereby preventing inadvertent puncture by the tips 28 by a person using the system 1. At the sleeves 29 of the second Einichtile 27 snap elements 42 are formed.

The system 1 according to the invention further comprises a connecting element 41, by means of which the pistons 40 of the bearing sprayers 25 are connected. By the

Connecting element 41 has the advantage that both pistons 40 of the bearing sprayers 25 can be actuated simultaneously to the same extent, whereby a uniform

Filling with a same amount of Köφerflüssigkeit both bearing sprayers 25 is possible. See Figure 14.

The following is a decrease of

and a separation of at least a portion of the removed body fluid with the system 1 according to the invention described in more detail, wherein the Kö erflüssigkeit is formed by blood.

To remove the blood from a patient, a person using the system 1, hereinafter referred to as a doctor, takes in a first step the delivery syringe 2 with the closure 9 already fastened thereto via the fourth coupling 43 and with it plugged on

Aufziehelement 11 from a sterile, not shown in the figures

As a result, the take-off syringe 2 is present according to FIG. 3 or FIG. As a patient in this context, both a human and an animal is seen.

In a further step, the doctor takes the butterfly with already attached to the butterfly via the fourth clutch 43 third insertion part 17 from another in the figures not shown sterile Ve ackung and couples the butterfly by closing the third clutch 20 with the take-off syringe 2 Closing the coupling 20 pierces the tip of the third insertion part 17 the closure 10 of the second closure part 9 connected to the take-off syringe 2, whereby the chamber 6 is in fluid communication with an interior of the hose 21 of the butterfly. When the clutch 20 is closed, the snap elements 19 fix the third insertion part 17 on the second closure part 9, as a result of which the butterfly is firmly connected to the take-off syringe 2. See figure 5.

Subsequently, the butterfly is introduced by the doctor into a ΚόφεΛεΓείοΙι, in this case a vein, a patient and blood removed by a chamber 6 expanding movement of the piston 4 by means of the Aufziehelements 11. In the present case, the take-off syringe 2 is filled to a maximum volume of the chamber 6 with blood, whereby the piston rod 5 by the doctor after the

Blood collection in the fixing position is rotatable to fix the piston rod 5 in the axial direction relative to the housing 3 of the take-off syringe 2. In a further step, the third clutch 20 is opened again by actuating the snap elements 19 and pulling on the third insertion part 17 and the butterfly is again decoupled from the take-off syringe 2. The butterfly is advantageously disposed of in an external medical waste bin. The closure 10 of the closure part 9 closes immediately after the

Extracting the tip of the third insertion part 17, the opening pierced by the tip into the closure 10, whereby the blood is trapped in the chamber 6 and prevents leakage of blood or contamination of the blood from the outside. See Figures 6 and 7.

In a further step, the Aufziehelement 11 by turning against the

Piston rod 5 is released from the piston rod 5 and the take-off syringe 2 is packed into a centrifuge tube 23. The take-off syringe 2 is centrifuged in a centrifuge, not shown, until the blood divides into its components blood cake and serum. See Figures 10 and 11.

In a further step, the bearing syringes 25 are removed with second fasteners 9 already fastened thereto via the fourth coupling 43 and the intermediate element 24 is removed from further sterile packagings not shown on the figures and coupled together by closing the second couplings 36. When the second couplings 36 are closed, the tip 28 of a second insertion part 27 pierces a closure 10 of the second closure parts 9 of the bearing spraying jigs 25. When the second coupling 36 is closed, in each case an interior 37 of the bearing spraying devices 25 is connected to the connection channel 31 of FIG

Intermediate element 24 in fluid communication and the snap elements 42 prevent inadvertent release of the bearing sprayers 25. See Figure 13 and Figure 14.

After centrifuging, the take-off syringe 2 is removed from the centrifuge tube 23 and coupled to the intermediate element 24 by closing the first coupling 30. When closing the first coupling 30, the tip 28 of the first insertion part 26 pierces the closure 14 of the first closure part 13. When the first coupling 30 is closed, a connection channel 31 formed in the intermediate element 24 and the piston channel 12 are in fluid communication with each other. By mounting the bearing syringes 25, a desired amount of blood cake or serum is taken from the take-off syringe 2, wherein the removal of the blood cake or serum from the take-off syringe 2, a vacuum in the chamber 6 is formed, whereby the piston 4 of the take-off syringe 2 a the chamber 6 decreasing motion completes.

In a final step, the bearing syringes 25 are decoupled from the intermediate member 24 by opening the second clutch 36, whereby the separated blood cake or the separated serum in the bearing syringes 25 can be supplied for further use. This ensures the advantage of easy handling and sterility of the removed body fluid throughout the handling.

Depending on the application and amount of blood in the collection syringe 2, additional bearing syringes 25 can be coupled to the intermediate member 24 to separate blood cake or serum.

Claims

claims:

A system (1) for sterile removal of body fluid and for separating at least a portion of the withdrawn body fluid

an Abnabme syringe (2) having a housing (3) and a piston (4) fixed to a piston rod (4) which changes a volume of a housing (3) and the piston (4) bounded chamber (6) in the Housing (3) is displaceable in order to draw body fluid into the chamber (6) or deliver drawn-up body fluid from the chamber (6), wherein in the piston rod (5) a piston channel (12) is formed, which starting from the chamber (6) extends in the longitudinal direction through the piston rod (5), an intermediate element (24), which via a first coupling (30) with the piston rod (5) is coupled to a in the intermediate element (24) formed connecting channel (31) with the piston channel (12 ) in fluid communication, and

at least one container, which via a second coupling (36) with the

Intermediate member (24) is coupled to bring the connection channel (31) of the intermediate member (24) with an interior (37) of the at least one container in fluid communication, wherein the second coupling (36) formed on the intermediate member (24) insertion part (27) having a tip (28) adjoining the connecting channel (31) and a closure part (9) formed on the at least one container and having a closure (10) and closing the second coupling (36), the tip (28) of the Insertion part (27) pierces the closure (10) of the closure part (9),

characterized in that the first coupling (30) has the same elements as the second coupling (36), wherein the insertion part (26) of the first coupling (30) is formed on the intermediate element (24) and the closure part (26) of the first Coupling (30) on the piston rod (5) is formed.

2. System (1) according to claim 1, characterized in that the intermediate element (24) has at least one further insertion part (27) with a tip (28), which tip (28) connects to the connecting channel (31).

3. System (1) according to claim 1 or 2, characterized in that the at least one container by at least one bearing spray (25) is formed to a certain amount of in the chamber (6) of the take-off syringe (2) mounted body fluid from the

Remove the collection syringe (2).

4. System (1) according to claim 3, characterized in that the closure part (9) by means of a Luer connection (43) with the at least one bearing syringe (25) is connected.

5. System according to any one of claims 1 to 4, characterized in that each insertion part has a prestressed cover which covers the tip of the insertion part, wherein the tip when closing one of the couplings pierces the cover and wherein after opening the clutch, the tip again is completely covered by the prestressed cover.

6. System (1) according to one of claims 1 to 5, characterized in that at least one of the male parts (17, 27) and / or at least one of the closure parts snap elements (19, 42) has / have.

7. System (1) according to any one of claims 1 to 6, characterized in that the system (1) comprises a cannula (16) via a third coupling (20) with the

Detachable syringe (2) can be coupled, wherein the third coupling (20) has the same elements as the second coupling (36) and wherein the closure part (9) with the housing (3) of the take-off syringe (2) is connected and the insertion part (17 ) is connected to the cannula (16).

8. System (1) according to any one of claims 7, characterized in that the system (1) comprises a Aufziehelement (11) which is connected to the piston rod (5) and is detachable from this.