Catheter apparatus with infusion port and valves

The invention relates to a catheter device according to the preamble of claim 1.

Such a catheterization device is known in EP 497 576 B1, in which a combined valve is housed in a catheter holder and on the one hand closes the port opening and, on the other hand, prevents leakage of blood or injection fluid from the catheter holder in the proximal direction. Injectable liquid can be injected into both areas by deforming the respective valve areas.

[0003] Further catheterization devices with port openings and valve elements are known, for example, from EP 0268480, EP 1197242, WO 9640359, US 5098405, WO 2007050553 or US 3416567.

The object of the invention is to design such a catheterization device with the port in such a way that also fluids, in particular blood, can be taken.

[0005] This object is achieved by means of the invention according to claim 1.

[0006] Due to the fact that the second valve element is designed as a two-way valve in such a way that a flow in both directions is possible, liquid or blood can be drawn, if necessary, at the proximal end of the catheter holder.

[0007] The invention will be explained, for example, in more detail on the basis of the drawing. They show this:

1 is a longitudinal section through a first embodiment of a catheterization device with a port according to the invention, Fig. 2 Fig. 3 Fig. 4 Fig. 5a-5e Fig. 7 Fig. 7 offset by 90 ° with respect to Fig. 1 is a longitudinal section of the first embodiment of an embodiment, with a needle mounted on the proximal end, a catheterization device in a cross-sectional view with a valve opening element, an attachment element inserted into the proximal end of a catheter holder according to Fig. 3, perspective views of embodiments of the tubular element, longitudinal section of the catheter device according to the invention with a sinuous element shown in FIG. 5b, a catheterization device with a needle and a needle shielding element,

8a and 8b, a valve actuator, FIGS. 9-12 further catheterization devices.

Reference numeral 1 is a hollow catheter depot marked in the figures, the distal end of which is connected or connectable to a catheter 2. Catheter holder 1 is provided with a proximal end with a connection device, e.g. a Luer 3 connector, to attach a hose infusion or the like. Between the proximal and distal ends is attached to the side of catheter holder 1 and port 4, by means of which a syringe can be connected to deliver infusion fluid through the catheter to the patient 2. In the region of port 4a the port is placed in the catheter holder 1 at least partially flexible, a relatively flexible element 5 in the form of a tube which as the first valve element holds the port opening 4a in the closure, and when applying pressure to the port opening 4a deforms elastically in this way,

[0009] The at least partially flexible tubular element 5 is in the embodiment shown in Fig. 1 closed at the proximal end with a valve disc 6 which is provided with at least one radially extending slot 6a. Fig. 5a shows three slits 6a placed in the form of a star. The valve disc 6 forming the second valve is deliberately made of the same material as the tubular element 5, however, a separate valve element may also be provided at the proximal end or in the proximal region of the tubular element 5, before the port opening 4a.

[0010] The valve disk 6 is shaped as a two-way valve, which allows the flow of the infusion fluid from the proximal side to the distal side and vice versa. In order that the valve disc 6 does not open when the infusion fluid is introduced through the port 4, the valve disc 6 can be shaped as rigid and then opens only for flow in the proximal direction when a sufficiently strong suction pressure is applied to the proximal side which is higher than the pressure applied to port 4. In the variant not according to the invention, a valve actuator is provided in connection with the valve disc 6, which will be explained in more detail later in the description.

[0011] In the embodiment of fig. 1, a radially protruding collar 5a is formed at the proximal end of the tubular element 5, which is held in the groove between the two housing parts 1a and 1b in the axial direction. By means of this device, mounted along its circumference between the two parts of the housing 1a and 1b of the collar 5a of the tubular element 5 and the valve disc 6 stiffening and closing the tubular element at the proximal end, the tubular element 5 can not deform radially at the proximal end if the port opening 4a no pressure is applied, and therefore the tubular element 5 is pressed radially only in the area between the distal end and port opening 4a in such a way that the connection between the port opening 4a and the catheter 2 is released while the connection between the port opening 4a and

The proximal end of catheter carrier 1 remains closed. By virtue of the fact that the valve disk 6 covers the proximal end of the tubular element 5, the outflow of the infusion fluid introduced into the proximal end of the catheter holder can not take place.

FIG. 2 shows a cannula 7 inserted into the catheter device cannula holder 8 that is inserted into the proximal end of the catheter holder 1, the cannula 7 extending through the valve disk 6, expanding the gaps 6a, and through the catheter 2 and protruding the tip from the distal end of the catheter.

In a variant not according to the invention, in the housing part 1b, on the proximal side of the valve disc 6 in diametrically opposed positions a longitudinal groove 1c is formed, which serves to guide the actuation element 9 in the axial direction of the catheter holder 1. Fig. 8b shows an embodiment of such a valve actuating element 9 which has diametrically opposed sides of the head portion 9a having two guide arms 9b which protrude from the more or less conical head portion 9a in the axial direction and engage in guiding grooves 1c.

In Fig. 3 and Fig. 4, equipped with a through hole 9, the head portion 9a has a step 9d so that the actuator 9 can latch into the valve disc 6 after being forced through the radial gap 6a, as shown in Fig. 4. For this purpose, a tubular connection piece 11 is inserted in the proximal end of the catheter holder 11, the face of which extends into contact with the ends of the guide arms 9b and moves them distally so that the head portion 9a of the actuator 9 opens the valve disk 6.

[0015] Figure 7 shows a cannula 7 that is inserted into the catheter device, which extends through the opening 9c in the valve actuator 9 and the valve disc 6, a shielding element being arranged between the cannula holder 8 and the valve actuator 9 on the cannula 7 12 of the cannula, which is held in the catheter holder 1 in the condition illustrated in FIG. 7 on a radial projection 1d extending in the shown example in the circumferential direction between the guide grooves 1c on the inner circumference of the housing part 1b of the catheter holder 1. In Fig. 1 there are shown on both sides of the guide groove 1c of the radial portion of the projection 1d in the form of beads, partly in cross-section. When the cannula 7 of the cannula shield 12 position shown in FIG. 7 is retracted from the catheter holder,

[0016] The tubular element 5 can also be formed as stiffened at the proximal end or in the proximal region by means of a ring 5b placed inside, as shown in Figs. 5b and 5c. Fig. 6 shows a longitudinal section through a catheter device stiffened in

In this embodiment of the tubular element, the catheter holder 1 can also be formed as one piece, as shown in FIG. 6. The non-elastic stiffening ring 5b can be inserted into the tubular element also in some distance from the proximal end of the tubular element, where it is then placed between the proximal end of the tubular element and port opening 4a.

[0017] The stiffening ring 5b or a corresponding stiffening element may also be designed in connection with the flange 5a.

[0018] Fig. 5d shows an embodiment of the tubular element 5, which has an aperture 5c in the axial direction in the region of the port opening 4a, so as to facilitate the opening of the diaphragm element 5 during insertion of the infusion fluid through the port 4 in the embodiment shown in Fig. 5e, the gap extends from port opening area 4a to the distal end of the tubular element 5, whereas according to the embodiment example in FIG. 5d, the slot is formed only in the region of the port opening, thus only infiltrating the distal and distal edges during insertion of infusion fluid through port 4a the section of the tubular element can remain in contact with the inner circumference of the catheter holder.

[0019] If injection is performed through port 4a, the proximal end of catheter holder 1 can be closed with cap 15a (Figure 11).

Instead of the described embodiments of the flexible tubular element 5, which forms both the first valve element at the port opening 4a and the second valve element in the proximal region of the catheter holder 1, separate valve elements can be provided for the port opening and the catheter holder hole each. .

[0021] Instead of one port 4, it is also possible to design a catheterization device with two ports on a catheter holder in which the first valve closes and releases both ports openings. At the same time, it is also possible to provide two separate valve elements for both port openings.

[0022] Figures 9-12 show catheter devices that partly correspond to those in Fig. 1, with the same reference numerals being used for the same or corresponding components.

[0023] Fig. 9 shows a one-piece catheter holder 1 in which the port 4 is closed with a cap

13. The catheter 2 is attached by means of a funnel fastening element 14 in the catheter holder 1 by clamping. The wall thickness of the valve disc 6 is increased in relation to the wall thickness shown on the tubular element 5. By this means, the tubular element 5 during applying pressure to the port opening 4a can, by deforming, open the port opening 4a, while the valve disc 6 remains closed. In the example shown in Fig. 9, a valve actuator 9 is additionally provided that supports the valve disc 6 on the proximal side during application of the distal pressure and thus the valve disc does not open in the proximal direction when applying pressure to port 4a.

[0024] Figure 9a shows a section along the line AA in Figure 9, wherein the star-shaped slots 6a of the valve disk 6 are visible through the through hole 9c of the actuator 9 of the valve. Interlocking in grooves running in the axial direction

The guiding arms 9b are formed on the funnel actuating element 9 of the valve.

In FIG. 10, a two-part catheter holder 1 is shown in an analogous view to FIG. 9, in which the valve disc 6 is shaped as widened in the radial direction and is held by the housing part 1b in the catheter housing part 1 a.

In this example, as the section in Fig. 10a shows, the housing part 1b is not symmetrically rotatable, but is reinforced in the upper area and provided with an outer rib in an axial direction which engages in a corresponding longitudinal groove on the the inner circumference of housing part 1a. This configuration prevents the rotation between the two housing parts when screwing e.g. the connecting element 16.

[0027] Figure 11 shows the needle 7 which is mounted in the holder 7b, which extends through the valve actuator 9, the valve disk 6 and the catheter 2, with the needle guard element 12 with the intersecting wings between the two guide arms 9b on the needle. actuator 9 of the valve. The needle shield 12 in Fig. 11 corresponds to the view in Fig. 7 rotated by 90 °. In the example of FIG. 11, the needle holder 7b is also closed with a cap 15. A removable cap 15a is applied to the proximal end of the catheter device. After removing the needle 7 with its cover element, the cap 15a can be attached to the open proximal end of the catheter holder. The cap 15a is preferably provided with a shortened cone 15b so that the actuator 9 of the valve is not hit by the cap,

[0028] In the example of Figure 11, when the needle 7 is removed from the catheter holder, the needle guard element 12 is held in the catheter holder 1 in such a way that the opposing wings stop at the projection 1e. As soon as the tip of the needle is between the two wings of the needle guard element 12, both wings rotate inwardly and the needle with its cover element 12 on the tip of the needle can be pulled out of the catheter holder 1.

[0029] The needle shield member 12 may also engage with the valve actuator 9 or with its guide arms 9b, so that the needle shield member 12 is held by the valve actuator 9 as long as the needle shield member 12 assumes the tip. needles will not reach the shielding position, after which the clamping connection with the valve actuating member 9 is released and the needle shield member 12 together with the needle 7 can be pulled out of the catheter holder 1.

[0030] Fig. 12 shows a connection member 16 which is screwed to a Luer 3 connector in a catheter device, wherein the tubular protrusion 16a projecting in the distal direction hits the actuator 9 of the valve through the guide arms 9b in such a way that it opens the disc. 6. In this position shown in FIG. 12, blood can be drawn through the conduit 17 connected to the connection element 16.

[0031] In Fig. 11, the actuator 9 of the valve is not impacted by the needle holder 7b, and thus the actuator 9 of the valve remains in the position shown in Fig. 9. Only the needle 7 is guided through the valve disc 6, being between the gaps. 6a valve

The elastic areas of the valve disk 6, e.g. made of silicone, adhere to the outer circumference of the needle 7 and sweep blood from the needle as the needle 7 is pulled out of the catheter holder 1.

[0032] The valve actuator 9 may also be provided with a scraping element as described in DE 20 2006 017 732, for example in the form of a scraping ring surrounding the needle in the through hole 9c (figure 3) of the actuator 9 of the valve.

[0033] Fig. 8a shows a scraper 90 of a liquid impermeable film, e.g. a polyethylene film, which has a substantially circular shape with two notches 91. The notches 91 are measured and shaped so that they can be attached to the actuator. 9 valve and accept guide arms 9b. In one example, the scraper 90 has a continuous central portion (i.e., without a central hole) that is formed to pierce the needle when assembled. When the needle 7 is pulled out of the catheter housing 1, the blood is removed from the circumference of the needle through the scraper 90.

[0034] In such a design with the scraper 90, during blood collection, it may flow on the proximal side of the catheter holder around the valve actuator member, the blood may also flow out of the hole in the scraper 90 that has been punctured with a needle. To facilitate the collection of blood, it is also possible to shape the grooves in the axial direction on the frustoconical shape of the head portion 9a.

[0035] Figure 8b shows a perspective view of the actuator 9 of the valve with the head portion 9a in the form of a truncated cone and two guide arms 9b that are connected to the head portion and extend proximally therefrom. The through hole in the head portion has a funnel-like shape. The two arms 9b extend in this drawing in parallel and are offset relative to the axis which is defined by the center of the through hole; they may, however, also be bent radially outwards, wherein they extend proximally. These two arms can also have a light curve or a slight curvature.

[0036] In Fig. 7, the needle shielding element 12 with the intersecting wings in a top view shown in Fig. 11 is shown in side view. Instead of such a shielding element 12 of the needle with intersecting wings, it is also possible to use a different embodiment of the needle guard element in which the tip of the needle is covered and blocked when the needle is withdrawn, and therefore the tip of the needle can not be hurt.

EP 2 094 342 B1