DE202019103500U1 - Spike - Google Patents

Abstract

Piercing spike (1), in particular for a drug mixing and administration set for infusion therapy or for dialysis applications, for removing a fluid from a container, the piercing spike (1) having a tip (2), in particular for piercing the container, and a first Connection (3), the tip (2) and the first connection (3) being connected to one another by a first fluid channel (4) for fluid guidance, a closure element (5) being arranged within the first fluid channel (4) such that the flow of fluid between the tip (2) and the first connection (3) through the first fluid channel (4) is prevented in a first position of the closure element (5) and is made possible in a second position of the closure element (5), the piercing spike in addition has a second connection (6), the second connection (6) being fluidically connected to the tip (2).

Description

The present invention relates to a further development of a as for example in EP 1 277 490 B1 disclosed piercing spike.

Piercing spikes are known to be used for removing fluids from containers, for example, in particular for removing liquids from infusion bags or the like in the field of infusion therapy or for applications in the field of dialysis. In the prior art, in addition to that in EP 1 277 490 B1 disclosed piercing spike a variety of other piercing spikes known, for example in the, EP 0 245 119 A1 or EP 0 327 519 A1 .

The object of the present invention consists in a further development of the from EP 1 277 490 B1 known piercing spike.

The piercing spike according to the invention has a point, in particular for piercing into a container, and is used to remove a fluid from this container. In this context, a fluid is understood in particular to be a liquid and / or a gas, in particular air. Furthermore, the piercing spike has a first connection which is connected to the tip via a fluid channel for guiding fluid. A closure element is arranged within the fluid channel. In a first position of the closure element, this prevents the flow of fluid through the fluid channel, while the flow of fluid is enabled in a second position. In addition, the piercing spike has a second connection. The second connection is particularly suitable for guiding fluid and is connected to the tip.

The guiding of a fluid is understood in particular to be the guiding of a liquid and / or gas, in particular air.

In an advantageous embodiment of the piercing spike according to the invention, the second connection is arranged laterally and / or perpendicularly to the longitudinal extension of the fluid channel and is connected to the fluid channel. Alternatively, the second connection is connected to the tip via a second fluid channel, in particular not connected to the first fluid channel.

The first and second connections are advantageously Luer or Luer lock connections, the first connection advantageously being a Luer or Luer lock female and / or the second connection advantageously being a Luer or Luer lock male . However, other common connector connections would also be conceivable, whereby it is only essential that these are suitable for guiding fluid.

Furthermore, the fluid channel advantageously tapers conically starting from the tip in the direction of the first connection.

The second connection is advantageously arranged between the tip and the closure element.

In a further advantageous embodiment of the piercing spike according to the invention, a, in particular fluid-impermeable, barrier, such as a membrane, a septum, in particular made of silicone, or a silicone plug, is arranged within the second connection. Furthermore, an air filter, in particular for pressure equalization, can be connected to the second connection. The air filter is designed in such a way that the air filter pierces the barrier when it is connected to the second connection. Alternatively, with the aid of a syringe or a cannula, the barrier for adding a further fluid to the fluid channel or the container can be pierced.

A lock also enables the spike and the air filter to be sterilized separately from one another. The piercing spike can be sterilized by autoclaving, in particular at temperatures above 100 ° C., while this would damage an air filter.

The closure element advantageously has a passage opening. The passage opening can be set up in such a way that the passage opening is in line with the fluid channel, in particular completely, in the second position.

The closure element can advantageously be a shut-off valve, in particular a plug valve. Alternatively, the use of a valve as a closure element can also be advantageous since, depending on how far the valve is opened, the fluid flow can also be controlled or controlled, for example with respect to volumes, and in this respect can be controlled, for example, to set a specific dosage.

The object according to the invention is also achieved by a system comprising a piercing spike according to the invention and an air filter insert. The air filter insert has an air duct between an air inlet and an air outlet, an air filter being arranged in the air duct between the air inlet and air outlet and the air outlet being designed with a piercing tip.

The air filter insert and / or the piercing spike is / are advantageously formed in and / or on the second connection set, in particular fixed permanently, in particular to be screwed.

Furthermore, the system is advantageously packaged sterile and sterile, in particular the piercing spike and the air filter insert being packaged separately in a sterile manner and / or in particular the piercing spike being sterilized by autoclaving, in particular at temperatures above 100 ° C., and / or being suitable and / or the Air filter insert is in particular not suitable for sterilization by autoclaving, in particular at temperatures above 100 ° C, and / or is sterilized by means of an ethylene oxide (EO) sterilization process and / or is suitable for this.

The advantages of the spike according to the invention that have been described also apply to the system according to the invention and advantages of the system according to the invention apply to the spike according to the invention.

• 1 einen Einstechdorn mit eingesetztem Hahn in geschlossener Position und
• 2 einen Einstechdorn mit eingesetztem Hahn in geöffneter Position und
• 3 ein System aus einem Einstechdorn mit zwei Fluidkanälen und einem Luftfiltereinsatz und
• 4 zwei Durchschnitte eines Luftfiltereinsatz in einer relativen Orientierung von 90° zueinander.

The figures show a particularly advantageous embodiment of the spike according to the invention. Here shows:

• 1 a piercing spike with inserted stopcock in the closed position and
• 2 a spike with inserted cock in the open position and
• 3 a system consisting of a spike with two fluid channels and an air filter insert and
• 4th two sections of an air filter element in a relative orientation of 90 ° to each other.

The 1 to 3 show a piercing spike 1 which about a tip 2 and a first connector 3 disposes. First connection 3 and tip 2 are here through a fluid channel 4th connected to one another in such a way that fluid guidance can be made possible. The tip is suitable here 2 in particular for piercing a container, so that by means of the piercing spike 1 a fluid can be removed from this container. At the first connection 3 For example, an infusion tube can then be connected, for example for a drug mixing and administration set for infusion therapy. In all figures is the first connection 3 a Luer connection, especially female. However, other connections such as, for example, a Luer lock connection or other common connector connections would also be conceivable, it being only essential that these are suitable for guiding fluid.

The piercing spike 1 also has a locking element 5 . This closure element 5 is in the 1 and 2 a rooster with a chick 8th , which also has a flow opening 7th and a handle portion 9 having.

By means of the handle section 9 can the chick 8th within the closure element 5 to be turned around. This also changes the position of the flow opening. The 1 and 2 show two different turning positions of the chick 8th within the closure element or two different orientations of the passage opening 7th and fluid channel 4th relative to each other. In a first position, which is in 1 is shown, a fluid guide through the position of the passage opening 7th and fluid channel 4th each other prevented. Here are the longitudinal extension of the passage opening 7th and fluid channel 4th perpendicular to each other, creating the fluid channel 4th by the chick 8th or the closure element 5 is interrupted. Rotation of the chick 8th by 90 ° leads to the opening 7th into the fluid channel 4th inserts (see 2 ; the boundary between the passage opening 7th and fluid channel 4th to identify the individual components is represented by a dotted line), so that the fluid is guided through the fluid channel between the tip 2 and first connection 3 is made possible. Out 2 it can be seen that passage opening 7th and fluid channel 4th are designed such that they are aligned with one another. Furthermore, in 1 and 2 clearly that the fluid channel 4th starting from the top 2 to the first connection 3 tapered towards.

The piercing spike 1 still has a second connection 6th . In the 1 and 2 it is the second connection 6th around a Luer connection, especially male. However, other connections such as, for example, a Luer lock connection or other common connector connections would also be conceivable here, whereby it is only essential that these are suitable for guiding fluid. With the help of the second connection 6th it is possible to apply further fluids in order to use this way several fluids within the spike 1 or to be able to mix with one another at its tip. For this purpose, it would be conceivable to close the second connection with a barrier, such as a silicone, a membrane or a septum, it being possible for this barrier to be pierced with a syringe, cannula or the like for introducing a fluid.

3 shows an advantageous embodiment of a system according to the invention with a piercing spike 1 with an air filter element 12 . Here is the second port 6th via a second fluid channel 10 with the tip 2 connected, the first fluid channel 4th and second fluid channel 10 are not connected to each other. The second connection also has 6th via a, fluid-impermeable terminal and predominantly exposed, barrier 11 in the form of a silicone septum. There is also an air filter element 12 With an air duct 13 shown, which, for example, for pressure equalization, can be connected to the second port. The air filter is designed in such a way that the air filter insert 12 when connecting to the second port 6th the lock by means of its hollow needle 11 pierces.

4th shows the air filter element 12 in two sections a) and b), the sections a) and b) having a relative orientation of 90 ° to one another. The air filter element shown 12 contains a piercing means, this being designed as a hollow needle. The hollow needle consists of an air channel 13 and piercing tip 14th is fluidically connected to a first side of the air filter 15th connected, the other side in turn with the ambient air through the air inlets 16 is in fluidic connection. In 4b) there are only two air inlets 16 shown, however, is the number of air inlets 16 of air use 12 variable. Furthermore, the piercing means also has at least one air outlet 17th on. Through the air outlet 17th the air filter element stands 12 by piercing the hollow needle through the barrier 11 and thus by connecting the air filter element 12 with the second connection 6th aerodynamically in connection with the tip 2 of the piercing spike 1 (see. 3 ).

The handle section 18th consists of a grip plate, which enables the air filter element to be attached 12 to the second port 6th of the piercing spike 1 simplified. From the two views a) and b) in 4th it can be seen that the handle section is narrow. This means that the air filter insert can be easily gripped by hand.

Alternatively, with the aid of a syringe or a cannula, the membrane can be pierced to add a further fluid to the fluid channel or the container (in 3 Not shown).

Such a lock can also be, for example, autoclaving the piercing spike 1 regardless of the sterilization of the air filter. This would be necessary, for example, since autoclaving with an attached air filter may not be possible, since the air filter would be damaged by autoclaving and sterilizing the piercing spike in a process such as that used for the air filter is associated with increased effort.

List of reference symbols

1

Spike

2

top

3

first connection

4th

first fluid channel

5

Closure element

6th

second connection

7th

Passage opening

8th

chick

9

Handle section

10

second fluid channel

11

Lock

12

Air filter element

13

Air duct

14th

Piercing tip

15th

Air filter

16

Air inlet

17th

Air outlet

18th

Handle section

QUOTES INCLUDED IN THE DESCRIPTION

This list of the documents listed by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent literature cited

• EP 1277490 B1 [0001, 0002, 0003]
• EP 0245119 A1 [0002]
• EP 0327519 A1 [0002]

Claims (14)

Piercing spike (1), in particular for a drug mixing and administration set for infusion therapy or for dialysis applications, for removing a fluid from a container, the piercing spike (1) having a tip (2), in particular for piercing the container, and a first Connection (3), the tip (2) and the first connection (3) being connected to one another by a first fluid channel (4) for fluid guidance, a closure element (5) being arranged within the first fluid channel (4) such that the flow of fluid between the tip (2) and the first connection (3) through the first fluid channel (4) is prevented in a first position of the closure element (5) and is made possible in a second position of the closure element (5), the piercing spike in addition has a second connection (6), the second connection (6) being fluidically connected to the tip (2). Spike after Claim 1 , characterized in that the second connection (6) is arranged laterally and / or perpendicular to the longitudinal extent of the fluid channel (4) and is connected to the fluid channel (4), and / or that the second connection (6) is via a second fluid channel (10 ) is connected to the tip (2), wherein in particular the first fluid channel (4) and the second fluid channel (10) are not connected and / or the second connection (6) is suitable for guiding fluid. Piercing spike according to one of the preceding claims, characterized in that the first connection (3) is a Luer or Luer lock connection, in particular a female connection. Piercing mandrel according to one of the preceding claims, characterized in that the second connection (6) is a Luer or Luer-Lock connection, in particular a male. Piercing spike according to one of the preceding claims, characterized in that the first fluid channel (4) tapers, in particular conically, starting from the tip (2) in the direction of the first connection (3). Piercing spike according to one of the preceding claims, characterized in that the second connection (6) is arranged between the tip (2) and the closure element (5). Piercing spike according to one of the preceding claims, characterized in that within the second connection (6), in particular at the end and / or at least partially exposed, a, in particular fluid-impermeable, barrier (11) is arranged, in particular a silicone plug or a membrane or a septum, especially made of silicone. Spike after Claim 7 , characterized in that an air filter insert (12) containing an air filter (15), in particular for pressure equalization, is connected to the second connection (6), the air filter (12) being designed in such a way that the air filter insert (12) when connected to the second connection (6) pierces the barrier (11) so that the first fluid channel (4) or the second fluid channel (10) is fluidically connected to the air filter (15). Piercing spike according to one of the preceding claims, characterized in that the closure element (5) has a passage opening (7), wherein the passage opening (7) is set up so that the passage opening (7) in the second position of the closure element (5) with the first fluid channel (4), in particular completely, is in alignment. Piercing spike according to one of the preceding claims, characterized in that the closure element (5) is a shut-off valve, in particular a plug valve. Piercing mandrel according to one of the preceding claims, characterized in that the piercing mandrel (1) is suitable for being sterilized by autoclaving, in particular at temperatures above 100 ° C. System comprising a piercing spike (1) Claim 7 or 8th and an air filter insert (12) having an air duct (13) between an air inlet and an air outlet, an air filter (15) being arranged in the air duct (13) between the air inlet (16) and air outlet (17) and the air outlet with piercing means, in particular a piercing tip (14), wherein the air filter insert (12) is set up, after piercing the lock (11) with the piercing means, to connect the air filter (15) fluidically to the tip (2) of the piercing spike (1), in particular by means of the second Fluid channel (10), in particular for this purpose the piercing means is designed in particular as a tube, in particular a hollow needle. System according to Claim 12 , wherein the air filter insert (12) and / or the piercing spike (1) is / are designed to be fixed in and / or on the second connection (6), in particular fixed in a non-detachable manner, in particular screwed. System according to Claim 12 or 13 , the system being sterile and being packaged in a sterile manner, in particular the piercing spike (1) and the air filter insert (12) being packaged separately and / or in a sterile manner in particular the piercing spike (1) is sterilized by autoclaving, in particular at temperatures above 100 ° C, and / or is suitable for this and / or the air filter insert (12) is in particular not suitable for sterilization by autoclaving, in particular at temperatures above 100 ° C and / or is sterilized by means of an ethylene oxide (EO) sterilization process and / or is suitable for this.

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