WO2008135475A1

WO2008135475A1 - Molded pipe part for infusion devices

Info

Publication number: WO2008135475A1
Application number: PCT/EP2008/055298
Authority: WO
Inventors: Wolfgang Schadt; Harry Pütter
Original assignee: Fresenius Kabi Deutschland Gmbh
Priority date: 2007-05-02
Filing date: 2008-04-30
Publication date: 2008-11-13
Also published as: DE102007020859A1

Abstract

The invention relates to a molded pipe part (1) for infusion devices, having an inlet channel (11) and an outlet channel (12), each of which are designed for connecting to an infusion conduit, and having a spray channel (14) for the spraying of drugs, which is closed on a connection side with a sealing element (10), wherein the inlet channel (11) passes into a bypass channel (13) which opens into the spray channel (14) in the area of the sealing element (10), and the spray channel (14) finally passes into the outlet channel (12). In order to allow the molded pipe part (1) to be operated with a needleless spray instrument, it is proposed according to the invention that the sealing element (10) have a valve element (5) with a closing element (6) which provides a sealed closure in a basic position.

Description

description

Tube fitting for infusion devices

Technical area

The invention relates to a pipe fitting for infusion devices according to the preamble of patent claim 1.

State of the art

Such a pipe fitting is known from European published patent application EP 0 314 856 A1. In the part designated as a Y-tube fitting there, the injection channel is closed with an injection plug made of an elastic material, such as e.g. Latex or the like. This injection plug sealingly closes the injection channel and can be pierced with an injection needle for adding a medicament. With the help of this injection needle access to the injection channel is then created.

In order to avoid the formation of a dead space (a dead end) of the inlet channel is connected via a deflection channel with the injection plug facing the end of the injection channel, and the injection channel opens directly into the outlet channel. Thus, in the case of a connection of an injection run, the entire flow channel, consisting of the inlet channel, the deflection channel, the injection channel and the outlet channel, flows equally through it. Neither can such dangerous air pockets settle in a dead space nor is there the risk of a Keimentwicklung in a standing, non-flow channel section. Finally, when a medicament is injected, it is completely introduced into the fluid flow without the risk that non-calculable fractions of the medicament remain in a dead space and are not supplied to the patient with the infusion solution.

The pipe fitting described in the cited document has proven very well in practical use, but is still in need of improvement. Thus, the injection plug is to pierce only with a hypodermic needle, such needles always entail the risk of injury both for the patient and for hospital staff. Such injuries are particularly high risky if the needles are contaminated with pathogens or in a high dose of toxic drugs.

Presentation of the invention

It is therefore an object of the invention to develop the known from EP 0 314 856 A1 tube fitting to the effect that the above drawback can be eliminated.

This object is achieved by a pipe fitting with the features of claim 1. Advantageous further developments are characterized in the subclaims 2 to 9.

According to the invention is provided in a pipe fitting with the features of the preamble of claim 1 as a sealing element such that has a valve element with a sealing element in a basic position closing closure element.

Such a valve element as a sealing element has the following advantage and technical effect:

It can be introduced through the valve element, the outlet opening of a needle-free injection instrument in the injection port, e.g. the blunt tip of a needle-free injection cannula. This allows a needle-free operation of the injection channel, which represents a significant improvement due to the disadvantages associated with needle Zuspritzinstrumenten, described above disadvantages. In particular, the occupational health and safety and other requirements are increasingly stipulated that a largely needle-free work in the medical field is required and prescribed. This claim is the pipe fitting of the invention.

In a simple variant, the valve element is a membrane which seals in a basic position. This membrane can e.g. a slotted membrane with a biased and sealing in the basic position final slot as a closure element.

In a possible, advantageous development, the pipe fitting according to the invention at the connection side of the injection channel connecting means for connecting to a Zuspritzinstrument, said connecting means are preferably suitable for standardized connection geometries, such as Luer-Lock, designed. In this way, a needle-free Zuspritzinstrument be firmly connected to the connection side of the injection channel, which facilitates the overall handling and in particular simplifies a precise dosage of zuzuspritzenden drug.

A simple and effective guidance of the fluid flow in the channels results when forming the pipe fitting in the preferred embodiment mentioned in claim 4. With the variant mentioned there, that the deflection channel runs parallel to the injection channel with opposite fluid guide, a particularly compact design of the pipe fitting can be achieved.

An executed as in claim 5 embodiment of the sealing element has the advantage that it can be easily and safely mounted with simple production possibility of the sealing element itself and in particular allows a good and reliable sealing of the injection channel at its connection side. In particular, if the sealing plug as a whole consists of an elastic material, this can be formed so that a seal is achieved to the housing parts.

A preferred development of the embodiment variant with the sealing plug as just described is given in claim 6. Characterized in that the deflection channel is passed through the side wall of the sealing plug and opens into the cavity near the valve element, it is ensured that the injection channel is rinsed by the deflected from the inlet channel via the deflection in the former fluid flow substantially over its entire length, so that no dead space remains.

Alternatively, it may be provided in one embodiment of the pipe fitting according to claim 5, that it has a one-sided fixedly connected to a wall of the pipe fitting web-like intermediate wall element which extends with a free end into the cavity of the sealing plug into the separation of on the one hand, the intermediate wall element located deflection and on the other hand, the intermediate wall element located injection channel (claim 7). This embodiment allows for simpler manufacturing technology feasibility to introduce the transition between the deflection channel and injection channel maximum far to the Zuspritzport and thus to avoid a possible dead space particularly reliable.

In the latter solution, the pipe fitting may be formed so that in a portion in which the web-like intermediate wall element lies with its free end within the cavity in the sealing plug, a gap between the wall of the pipe fitting and the web-like intermediate wall element is left, in which the sealing plug is seated with a part of its wall enclosing the cavity and sealingly surrounds the web-like intermediate wall element (claim 8). Alternatively, it can also be provided that in a section in which the web-like intermediate wall element is located with its free end within the cavity in the sealing plug, the sealing plug in its cavity surrounding the cavity side slit-like openings, which sit sealingly above the web-like partition element, wherein For safe separation between the deflection channel and injection channel of the plug with its sealing seated on the intermediate wall member slot must protrude into an area in which the intermediate wall element fluid-tight against the wall of the pipe fitting or is firmly connected thereto. (Claim 9). It is therefore important here that a secure seal is created between the wall of the sealing plug and the web-like intermediate wall element in order to avoid a premature transfer of the infusion fluid from the deflection channel into the injection channel.

The characterized in the claims 7 to 9 solution is also conceivable in an application for classic with needle-leading Zuspritzinstrumenten pipe fittings, and can also provide an inventive improvement there.

In particular, in a preferred embodiment, as in claim 10 is called, a continuous flushing of the injection channel is ensured from its outermost, the connection side end facing forth into the drain channel. As a result, namely, that the deflection channel opens into the injection channel at such an angle that the fluid flow is first directed in the direction of the valve element, the section lying between the mouth of the deflection channel in the injection channel and the valve element is equally forced-flushed, so that here too no Dead spaces or standing fluid columns can form.

A simple production, which also allows easy installation, results for the pipe fitting, if this is constructed as described in the advantageous embodiment described in claim 11.

A one-piece body made of plastic, in particular in

Injection molding process can be easily and inexpensively produced in large quantities. The same applies to the sleeve, by means of which the plug is fixed to the body. During assembly, the plug can simply be placed in the intended position on the body and secured by sliding over the sleeve. The sleeve may be attached to the body e.g. be determined by pressing or gluing or in any other suitable manner.

Instead of a passage of the deflection channel through a wall of a sealing plug, this may e.g. also be guided in a in the region of the valve element in the injection channel opening line piece, in particular a pipe section or a suitable attributable to the body wall geometry, as described according to an embodiment of claim 12.

Brief description of the figures of the drawings

Further advantages and features of the pipe fitting according to the invention will become apparent from the following description of embodiments with reference to the accompanying figures. Showing:

Fig. 1 is a three-dimensional view of a possible embodiment of a pipe fitting according to the invention;

FIG. 2 is a sectional view taken along a longitudinal center plane. FIG a pipe fitting according to FIG 1 in a first possible embodiment of the lying in the interior of the pipe fitting channel guide.

Fig. 3 is a sectional view of the pipe fitting of Figure 1 comparable to the representation in Figure 2 in a second possible embodiment variant of the channel guide in the interior of the pipe fitting.

Fig. 4 in turn comparable in one of Figures 2 and 3

Sectional view of a view of the pipe fitting of Figure 1 in a third possible embodiment variant of lying in the interior of the pipe fitting channel guide.

Fig. 5 as a fourth possible embodiment variant of the channel guide in a sectional view, a view of the pipe fitting of Figure 1 comparable pipe fitting.

FIGS. FIGS. 6 a and b show further views of the embodiment of the arrangement according to the representation in FIG. 5;

FIGS. 7 a and b show a first embodiment of the arrangement according to the illustrations in FIGS. 5 and 6 in two views and

FIGS. 8 a to c show a second embodiment of the arrangement according to the illustrations in FIGS. 5 and 6 in three views.

The figures are purely schematic representations and in particular not to scale. In the figures, the same elements are provided with the same reference numerals.

Way (s) for carrying out the invention

Reference to the accompanying figures will now be described an embodiment of an inventive pipe fitting with a total of three possible variants of the fluid guide in its interior.

In Fig. 1, first, a pipe fitting is shown in a three-dimensional view from the outside and there generally designated by the reference numeral 1. The pipe fitting 1 has an inlet connection 2 and an outlet connection 3, which are each designed for connection to standard infusion lines. Furthermore, the pipe fitting 1 has a designated 4 injection port, the in one protruding "Ann" of the pipe fitting 1. The pipe fitting 1 has so far in an approximately Y-shape.

In essential to the invention is the inside of the

Inlet port beginning inlet channel closed at the connection side with a slotted membrane 5, which has an access slot 6 to the interior of the inlet channel and the valve element with the closure element (the slot) forms. The membrane 5 is made of an elastic material, e.g. Rubber or silicone, formed, and the slot 6 seals in the basic position sealingly.

The pipe fitting 1 is constructed from a body 1 formed in one piece from plastic, to which the membrane 5 formed at the end of a plug 10 (cf., FIGS. 2 to 4) is attached. The plug 10 with the membrane 5 is in turn by a pushed over this, also made of plastic sleeve 8, which on the body 1, for. is securely fixed by pressing or gluing, held in position. For this purpose, the sleeve 8 is tapered over a shoulder and engages with this taper on a taper likewise formed on the stopper 10, so that the stopper 10 is held securely in position with the sleeve 8 by positive engagement.

At the injection port 4, a luer-lock compatible thread 9 is finally formed on the sleeve 8 for setting a Zuspritzinstrumentes with standardized connection part.

In the figures 2 to 5 different possible training variants of lying in the interior of the pipe fitting channel system are shown in similar sectional view along a longitudinal center plane of the pipe fitting 1.

All variants have in common that they are inside a first

Have inlet channel 11 which extends along a connecting line between inlet port 2 and outlet port 3. This inlet channel 11 then merges into a deflection channel 13, which leads essentially in the direction of the membrane 5. The deflection channel 13 in turn opens into an injection channel 14 which can be reached via the slot 6 of the membrane 5 for injecting medicaments. This injection channel 14 runs in the interior of the pipe fitting 1 again in the direction of the connecting axis between inlet port 2 and outlet port 3 and finally flows into an outgoing along said axis outlet channel 12. The embodiments shown in Figures 2 to 4 are different only in the formation of Umlenkkanals and the transition region from the deflection channel in the injection channel.

2, the deflection channel extends outside of the plug 10 along the wall thereof and is guided in the region of a passage 15 through the wall of the plug 10 into a cavity formed in the interior of the plug 10, which belongs to the injection channel 14.

In the embodiment shown in FIG. 3, the deflection channel 13 already enters the side wall of the plug 10 on a lower end face opposite the membrane 5 and initially extends over a longitudinal channel 16 in this wall. Through a guided at an acute angle to the wall of the plug 10 inclined channel 17 of the overflow passage 13 then passes through the wall of the plug 10 into the lying in the interior of the plug 10 cavity, which in turn is part of the injection channel 14. In this case, the course direction of the oblique channel 17 is selected so that its opening is directed towards the underside of the Memran 5 inside the plug 10. This has a technical background to be described later.

In Fig. 4, the deflection channel 13 is not passed through the wall of the plug 10, but extends inside the plug 10 in a tubular extension 18 in the direction of the membrane 5, more precisely the underside thereof. Near the membrane ends the tubular extension 18 and the deflection channel 13 opens into the injection channel 14th

In Fig. 5, the deflection channel 13 is not passed through the wall of the plug 10, but extends inside the plug 10 along a web-like intermediate wall 19 in the direction of the membrane 5, more precisely the underside thereof. Near the membrane ends the intermediate wall 19 and the deflection channel 13 opens into the injection channel 14, on the other hand, the intermediate wall 19 again in the opposite direction to the Deflection channel 13 extends and ultimately opens into the outlet channel 12.

In FIGS. 2 to 5, an infusion solution flow I is schematically indicated by an arrow. It can be clearly seen here that the infusion solution initially flows through the inlet channel 11, then passes into the deflection channel 13 and is guided into the region of the membrane 5 in the interior of the stopper 10. There, the infusion solution passes into the injection channel 14 and runs parallel and opposite to the direction of the flow of infusion solution in the interior of the Umlenkkanals 13 back until it enters the discharge channel 12 and leaves the tube fitting 1 again at the Ausströmanschluss 3. The representation of the infusion solution flow I makes it clear that even without an additional flow through the injection port 4, the tube fitting 1 is always flowed through in its entire cavity by the infusion solution, so that no dead spaces or "dead ends" arise in which accumulate air or germs can accumulate.

In Fig. 6a is a side view of a pipe fitting according to the invention is shown with representation of the for the Fign. 7a and 7b and 8a and 8b, respectively, used section lines A-A and B-B.

In Fig. 6b is comparable to Fig. 5 is a side view of the pipe fitting 1 according to the invention in the embodiment variant with the web-like intermediate wall 19 for dividing the deflection channel 13 and injection channel 14 is shown.

In Figure 7a is a sectional plan view of the pipe fitting 1 from the Zuspritzport 4 ago (section line A - A in Fig. 6a), the arrangement of the plug 10 and the web-like partition wall 19 shown in a first embodiment of this type. A representation of this variant in a sectional view along the section line B - B of FIG. 6a is shown in FIG. 7b. Good to see in these representations that between the side regions of the web-like intermediate wall 19 in the region of the free end 20 (see Fig. 6b) and the wall of the pipe fitting, there is a distance in which the plug 10 is inserted so that he on the one hand with its entire scope the Side regions of the web-like intermediate wall 19 surrounds the other with the wall of the pipe fitting comes into contact or sealingly abuts against this, in order to achieve a sealing separation of deflection channel 13 and injection channel 14 in this transition region. The dimensions of the cavity 22 formed in the interior of the plug 10 and the width extension of the web-like intermediate wall 19 are selected so that the plug 10 sealingly surrounds the intermediate wall and reliably separates the deflection channel 13 from the injection channel 14 and prevents the passage of fluid.

In an alternative embodiment, which is illustrated in Figures 8a to 8c, the seal between web-like intermediate wall 19 and plug 10 is solved differently. Here, the plug 10 is provided with slot-shaped openings 23 (side slits) arranged in its lateral wall (see Fig. 8c). With these openings 23 it sits above the web-like intermediate wall 19, so that the edges of the openings 23 come to rest on the surfaces of the intermediate wall 19 (see Figures 8a and 8b, each of which is a sectional view along the section line A - A and B) - B of Fig. 6a show). The dimensions of the slot-shaped openings 23 are matched in this case, both in terms of Schlitzbereite and the slot height to the dimensions of the web-shaped intermediate wall 19 in the region of its free end 20, that here a fluid-tight system arises. Off Fign. 8a and 8b it can be seen that in the embodiment shown here, the plug 10 extends with its provided with the slot-shaped openings 23 section into a portion in which the intermediate wall 19 is fixedly connected to the wall of the pipe fitting or the plug with his Outer circumference sealing against this wall. Thus, it is also ensured here that deflecting channel 13 and injection channel 14 are securely and sealingly separated from one another at their respective transition into the interior of the plug 10.

The design variants shown in Figures 3 to 8c are designed so that the infusion solution flow at the exit from the deflection channel 13 and entry into the injection channel 14 in the direction of Membrane 5 has pointing pulse. In other words, the infusion solution is specifically directed once again in the direction of this membrane, so that it can be completely ruled out that a standing column of infusion solution can form in this area, which generally entails the risk of microbial contamination.

The design variants shown in Figures 5 to 8c have the advantage that the web-like partition wall 19 can be almost anywhere in the interior of the plug 10 and thereby very close to the membrane 5 zoom out. Thus, even in a "normal" infusion operation (without Zuspritz by Zuspritzport 4, or the membrane 5) flushing the entire interior of the pipe fitting, especially in the transition region from the deflection channel 13 to the injection channel 14, ensured and the formation of dead space avoided.

The membrane 5 as a sealing element on the connection side of

Injection port 4 (or the injection channel 14) has the following effect:

The membrane 5 or the slot 6 formed in it serves to provide access to the injection port 4, which can be used without needles. Through slot 6, e.g. blunt tips of an injection cannula (e.g., a taper) are pushed to provide a desired addition, e.g. to be able to make a drug in the infusion solution stream. The Luer-Lock compatible thread 9 formed on the injection port 4 serves to be able to fix such an injection instrument at the injection port 4, which facilitates accurate metering and overall work.

From the above description has once again become clear which far-reaching advantages are achieved with the inventive design of the sealing element on the connection side of the injection channel 14. The embodiment shown or the design variants mentioned therein are merely illustrative and are not intended to limit the scope of the invention as defined in the following claims. In particular, other embodiments of the Valve element than the slotted membrane 5 shown here conceivable.

This element can e.g. as well be formed by a ball valve or the like.

[0055] Reference list

[0056] 1 pipe fitting 20 free end

2 inlet connection 22 cavity

3 outlet port 23 slot-shaped opening

[0059] 4 injection port

5 membrane / valve element

[0061] 6 access slot / closure element

[0062] FIG. 7 Corpus

8 sleeve

[0064] 9 Luer-Lock compatible thread

10 plug / sealing element

[0066] 11 inlet channel

[0067] 12 discharge channel

[0068] 13 deflection channel

[0069] 14 injection channel

[0070] 15 implementation

16 longitudinal channel

17 inclined channel

18 tubular extension

19 web-like intermediate wall

I infusion solution stream

Claims

claims

1. Pipe fitting for infusion devices with an inlet channel (11) and an outlet channel (12), which are each designed to connect to an infusion line, and with a Zuspritzkanal (14) for the injection of drugs, on a connection side with a sealing element (10 ), wherein the inlet channel (11) merges into a deflection channel (13) which opens into the injection channel (14) in the region of the sealing element (10), which injection channel (14) finally merges into the outlet channel (12), characterized in that the sealing element (10) has a valve element (5) with a closing element (6) sealingly closed in a basic position.

2. Pipe fitting according to claim 1, characterized in that the valve element (5) is a membrane which seals tightly in a basic position.

3. Pipe fitting according to one of the preceding claims, characterized in that on the connection side of the injection channel (14) connecting means (9) for connection to a Zuspritzinstrument, preferably a Luer lock compatible structure comprises.

4. Pipe fitting according to one of the preceding claims, characterized in that the deflection channel (13) runs parallel to the injection channel with opposite fluid guide.

5. Pipe fitting according to one of the preceding claims, characterized in that the sealing element (10) has the shape of a cup-shaped sealing plug used on the connection side with an inner, surrounded by a side wall, on an end face by the valve element (5) closed, on the side opposite this end face open cavity (22), which in any case is part of the Zuspritzkanals (14) in one part.

6. Pipe fitting according to claim 5, characterized in that the deflection channel (13) is passed through the side wall of the sealing plug and opens near the valve element (5) in the cavity.

7. Pipe fitting according to claim 5, characterized in that it has a one-sided fixedly connected to a wall of the pipe fitting web-like intermediate wall element (19), which with a free end (20) extends into the cavity (22) of the sealing plug (10) into the separation of on the one hand of the intermediate wall element (19) located deflection channel (13) and on the other hand of the intermediate wall element (19) located Zuspritzkanal (14).

8. Pipe fitting according to claim 7, characterized in that in a portion in which the web-like intermediate wall element (19) with its free end (20) within the cavity (22) in the sealing plug (10), a gap between the wall of the Pipe fitting and the web-like intermediate wall element (19) is left, in which the sealing plug (10) with a part of its the cavity (22) enclosing wall sits and the web-like intermediate wall element (19) sealingly.

9. Pipe fitting according to claim 7, characterized in that in a portion in which the web-like intermediate wall element (19) with its free end (20) within the cavity in the sealing plug (10), the sealing plug (10) in its the cavity laterally surrounding wall has slot-like openings (23) which sit sealingly above the web-like intermediate wall element (19).

10. Pipe fitting according to one of the preceding claims, characterized in that the deflection channel (13) opens at such an angle in the injection channel (14), that from the deflection channel (13) in the injection channel (14) passing fluid flow initially in the direction of Valve element (5) is passed.

11. Pipe fitting according to one of the preceding claims, characterized in that a body (7) of the pipe fitting with inlet channel (11), deflection channel (13), injection channel (14) and outlet channel (12) is integrally formed from a plastic element, wherein the sealing element (10) on the connection side of a sealing material consisting of an elastic material sealing plug with the valve element (5) on the connection side of the injection channel (14) with a set on this sealing plug and on the body (7) fixed sleeve (8) of a Plastic material is secured.

12. Pipe fitting according to one of claims 1 to 3, characterized in that the deflection channel (13) in a within the Zuspritzkanals (14) arranged line piece (18), preferably a pipe section, up in a region close to the valve element (5) is guided.