HK1115552B - Arrangement comprising a catheter and connector piece, and valve for passage of a catheter - Google Patents

Description

Device comprising a catheter and a connector and valve for the passage of a catheter

Technical Field

The present invention relates to devices for delivering pharmaceutical preparations and other liquids to the lungs of a patient, and in particular to devices comprising a catheter (cathter) and a connector for infusing finely (finely) dispersed lung surfactant preparation into the lungs, and a valve for passage of the catheter, in particular for receipt in the connector. The device may be attached to a tracheal or endotracheal tube.

Background

In the clinical sector, tracheal or endotracheal tubes are often used to assist the patient in breathing. In most cases, these catheters contain, in addition to the ventilation device, a suction device for removing mucus and other liquids that may accumulate in the trachea and bronchi of the patient. These devices are each attached to an endotracheal tube by a suitable connector.

Furthermore, it is necessary to administer medication to the lungs, for example in the case of lung injury, or in the airways. Treatment and/or administration may be directly to the lungs. Due to their better absorption, suitable drugs, in particular finely divided lung surfactant formulations, are described, for example, in WO95/032992, to which reference is expressly made.

In order to ensure that the delivery of the drug to the lungs is as trouble-free as possible for the patient and that the condition of the patient is not adversely affected, a removably mounted catheter is introduced directly into the endotracheal tube via the connection piece and reaches the desired position within the lungs. Thus, the catheter, the ventilator, or the suction device need not be removed. On its sheath surface, the catheter may be provided with markings allowing monitoring of its insertion depth into the airway. Furthermore, radiopaque markers can be positioned on the sheath surface near the tip of the catheter and allow very precise positioning under X-ray imaging.

Connectors that allow suction devices, ventilation devices and catheters to be attached to endotracheal tubes are described in us patent No. 6,575,944.

In the connectors of the general type, it is important to secure the catheter in such a way that liquid cannot escape from the connector through the catheter. Furthermore, after the desired position has been reached, the catheter must be fixed so that it cannot slide. This is achieved, for example, using a cap provided with a thread, which, when screwed onto the connector, fastens the catheter in the manner of a jaw. The above-mentioned seal is in most cases obtained by using a one-way valve, for example a valve known as a duckbill valve, which is closed under normal conditions (i.e. catheter removal) and which opens upon catheter insertion, allowing its introduction and at the same time tending to tightly seal the catheter. However, in the valves used in the prior art, problems arise due to the fact that the valve has to close the catheter very tightly in order to ensure an adequate seal, but this prevents mobility of the catheter, results in greater forces being applied when inserting the catheter, and thus makes precise positioning of the catheter more difficult and increases the risk of injury. On the other hand, holding the conduit too loosely can lead to undesired escape of liquid and/or ventilation gas, especially in most cases ventilation is performed under positive end-expiratory pressure.

Disclosure of Invention

It is therefore an object of the present invention to allow a sealed access path while allowing mobility and precise positioning of the catheter.

This object is achieved by a device comprising an instillation catheter and an associated connection piece having the features of claim 1, and by a valve having the features of claim 6. Advantageous embodiments are set forth in the dependent claims.

The device according to the invention comprising an instillation catheter and an associated connector can be attached to a tracheal (endotracheal) tube. The valve serves as a passage for the instillation catheter, can be inserted into the connector piece and tightly closes the access path of the catheter when no catheter is inserted. After insertion of the catheter, a minimum flow of fluid between the outer wall of the catheter and the valve opening is ensured.

The device according to the invention therefore comprises an instillation catheter and a connector having a distal end for attachment to a tracheal or endotracheal tube and a proximal end for attachment to a ventilation and/or suction apparatus. The connector further comprises a branch for inserting a catheter, and wherein the valve is arranged in the receptacle. The valve has an elastically deformable material and can be opened by inserting a catheter. The valve further comprises a proximal through-going opening, the inner wall of which has means for sealing axial fluid flow between the catheter and the inner wall, and has a beak part in the distal direction from the through-going opening, the beak part having a normally closed slit at its beak tip. The design with the beak tip and the position in which the valve is mounted in the connector piece allow the insertion of the catheter in the direction of the branch, ensuring that the slits of the beak tip are pressed together by the internal overpressure of the ventilation and/or suction means when the catheter is removed. Thus, the catheter can be inserted through the through-opening of the valve into the connector piece and the valve opened, after which it is passed further through the branch into the connector piece and via the catheter to the desired position in the lungs. The sealing means on the inner wall prevents situations where a liquid or gas filled with the drug (e.g. ventilation gas) can escape through the catheter and as a result the desired dose of the drug is not administered to the patient. It therefore also prevents the entry of unwanted microorganisms into the respiratory organs. The catheter is closed by a sealing means so that the catheter remains easily movable and positionable. In contrast, in the state without the infusion catheter inserted (normal state of the valve), the closed incision at the beak tip of the valve prevents the passage of liquid or gas.

Between a connection cap provided on the distal end of the catheter for attachment to the branch and a connection cap provided in the proximal region of the catheter, the catheter particularly preferably has a protective membrane surrounding the catheter. This construction on the one hand prevents the entry of microorganisms in the vicinity of the connection cap and on the other hand permits sterile handling of the catheter, so that the latter can be guided by hand through the protective membrane. In a more preferred embodiment, the infusion catheter and/or the connector are equipped with a removable protective cap at each end of the liquid and/or gas path, in order to prevent contamination and ingress of microorganisms during packaging, transport, unsealing and handling. The protective cap is preferably removed shortly before final use.

Also, the catheter preferably has markings along its length that indicate to the user the position of the distal end of the catheter relative to the catheter. This allows precise positioning of the catheter and thus targeted local administration of the drug into the lungs. In a further preferred embodiment, the indicia are readable from all sides of the catheter. In a further preferred embodiment, the connector piece will have means for reading the precise location of the catheter, including but not limited to a logo window based on a transparent material that allows visual reading of the marker of the catheter.

The catheter preferably also has a radiopaque indicator near the distal end, which additionally allows visual monitoring of the position of the catheter within the patient's body by X-ray imaging.

The branches present on the connector form an angle of between 20 ° and 70 °, preferably between 25 ° and 55 °, more preferably between 35 ° and 45 °, with the longitudinal axis through the distal end of the connector. This facilitates the insertion of the catheter in the distal direction.

The valve with elastic material according to the invention comprises a proximal through opening, the inner wall of which has means allowing to seal the axial fluid flow between the catheter and the inner wall, and in the distal direction from the through opening the valve has a beak part with a normally closed slit at its beak tip. The catheter can be inserted through the through-opening and the catheter thus opens the valve. At the same time, the sealing means on the inner wall prevents the liquid or gas with the drug from escaping through the catheter and thus also prevents the entry of unwanted microorganisms. The catheter is closed by a sealing means so that the catheter remains easily movable and positionable. In the absence of catheter insertion, the return force of the elastic material closes the slit (normal state of the valve). The closed incision prevents the passage of liquid or gas at the beak tip of the valve. For example, the cut-out is designed such that the opposite long sides bear tightly against each other in the normal state. In this case, the sealing action can be supported by a suitable choice of material, for example silicone.

In the device according to the invention and the valve according to the invention, the inner diameter defined by the sealing means is advantageously between 0.05mm and 0.2mm, preferably between 0.1 and 0.15mm, smaller than the outer diameter of the catheter. The exact configuration depends on the desired fit between the material pairs and the absolute dimensions. The most reliable function has been found to be within a narrower range. Thus, when the catheter is inserted through the valve, the sealing means exert a pressure on the outer wall of the catheter which allows an airtight and watertight closure. However, by choosing the fit within a set range, this pressure is not too high and further provides good slidability of the catheter, which is necessary for the positioning of the latter and in turn prevents sudden movements of the catheter (peristaltic effect) which could injure the airway of the patient.

The through opening in the device according to the invention and the valve according to the invention preferably comprises an outer wall with a flange as a sealing seat for positioning the valve in the receiving seat of the bypass. The precise positioning and sealing achieved by these means is advantageous because they support the function of the inner wall and beak tip. The support also allows a structurally simple device of the corresponding receptacle in the branch.

The flanges preferably have portions defined by lateral platforms that intersect at the center of the portion, the center being circular, and each platform forming a 6 ° angle with a tangent line parallel to the cut in the beak opening and located at the center of the portion. With the aid of such a portion, a precise rotational positioning of the valve in the receptacle can be achieved, so that, for example, the beak tip in its longitudinal extent adjusts to the possible curvature of the catheter inserted into the mounting.

It is also particularly advantageous if the device according to the invention and the sealing means of the valve according to the invention comprise a sealing lip, which is furthermore preferably arranged in the circumferential direction of the inner wall. It has been found that the sealing lip provides a particularly effective seal around the catheter while being easy to produce and thus ensures increased safety against the escape of liquids or drugs and against the entry of microorganisms.

In the device according to the invention and in the valve according to the invention, it is particularly advantageous if the sealing means comprise two sealing lips, which are preferably arranged in the circumferential direction of the inner wall. In this way, the advantages mentioned in the preceding paragraph can still be better exploited. Furthermore, the second sealing lip provides additional protection if the first sealing lip has been damaged, for example by external action of an object or by a previous inadvertent operation.

Preferably, the sealing lip has a substantially bell-shaped cross-section with a certain radius of curvature. This shape can be deformed after insertion of the catheter, so as to ensure low sliding friction, while providing a high seal.

In this case, it is particularly advantageous if the radius of curvature of the sealing lip is at most 0.25 mm. This value has been found to keep the sliding friction sufficiently low while providing a very good seal.

In the case of two or more sealing lips, a "valley" is formed in the region of the connection between the lips, and it also has a certain radius of curvature. This curvature is naturally the inverse of the curvature of the apex of the sealing lip. Particularly preferably, the radius of curvature of the connecting region between the sealing lips is at most 0.1 mm. This ensures that the lips do not get too far apart.

In the distal direction, the lip also meets the inner wall profile of the valve. In the device according to the invention and the valve according to the invention, the radius of curvature of the lip of the part extending towards the beak part and closest to the beak part is at most 0.3 mm. In this way, the effective width of the lip is limited and thus excessive friction during passage of the catheter is limited. The above-mentioned rotation process is simplified.

Starting from a cylindrical basic shape, the device according to the invention and the beak part of the valve according to the invention are preferably narrowed in the form of a wedge by platforms which face one another. This shape of the beak part allows easy opening of the valve during insertion of the catheter by pressing out the opposing platforms. So that the closure when the valve is moved back is also more reliable.

It is particularly preferred that the angle between the longitudinal axis of the valve and each of the two levels of the beak portion is between about 26 ° and 28 °. This value has proven to be the most appropriate value for a satisfactory seal in an easily opened as well as in a closed state. Minor deviations above or below this value have no effect.

In an embodiment of the device according to the invention and of the valve according to the invention, the valve is fixed in the receptacle of the branch by an annular cap. Such a lid allows a quick and simple insertion, replacement and secure fixation of the valve, which is replaced after each use as a disposable valve. The annular cover interacts with a flange on the outside of the valve.

Finally, it is particularly preferred if the receptacle has a snap lip for securely snapping the annular lip into place. This ensures that the cap does not fall off accidentally, allows for a secure fit and seal, and provides a tactile and audible indication that the annular cap has reached its intended position.

In a more preferred embodiment, a one-way valve is also incorporated in the liquid path to further prevent or minimize pressure loss and/or prevent or minimize backflow of the live liquid fluid. The one-way valve may be incorporated at any position or end of the liquid path of the catheter, preferably within the catheter or directly connected to the infusion part of the catheter (6 a of figure 3 a).

In a further preferred embodiment, the connector piece comprises, in addition to the flange for connecting the catheter, a further flange which can be used for connecting a further device (for example a suction device). In the preferred embodiment shown in figure 5, the flange to be connected to the suction device is substantially identical to the flange available for connection to a catheter.

In a more preferred embodiment, the connector piece further comprises means for guiding the device (e.g. an instillation catheter and/or a suction tube) towards the distal end of the connector piece 1 a. In a preferred embodiment, such means for guiding are guiding lips, as shown in figure 4(11a and/or 11b) with a connector for infusing the flange of a catheter, and as shown in figure 6 with a connector with two flanges, one for infusing the catheter (11a and/or 11b) and one for the suction tubes (11a 'and 11 b').

Drawings

The invention is explained below on the basis of the exemplary embodiments according to fig. 1 to 6.

FIG. 1(a) shows a longitudinal cross-section through a connector according to one embodiment of the present invention;

FIG. 1(b) shows an enlarged detail of the branch with the plug-in valve of FIG. 1 (a);

figure 2(a) shows a longitudinal section through a valve according to the invention;

FIG. 2(b) is a longitudinal section through the valve perpendicular to the plane of the section in FIG. 2 (a);

figure 3(a) shows a longitudinal section through a catheter according to one embodiment of the invention;

figure 3(b) shows a side view of the catheter;

FIG. 4 shows a longitudinal section through a connection according to one embodiment of the invention with one flange and guide lips 11a and 11 b;

FIG. 5 shows a longitudinal cross-section through a connection having two flanges according to one embodiment of the invention;

fig. 6 shows a longitudinal section through a flange according to one embodiment of the invention with two flanges and guide lips 11a, 11b and 11a ', 11 b'.

Detailed Description

In fig. 1(a), a connector 1 according to one embodiment of the invention is shown in longitudinal section. The connector comprises a distal opening 1a for attachment to a tracheal (endotracheal) tube (not shown) and an opposite proximal opening 1b for attachment to a ventilation and/or suction device (also not shown). The branch 5 projects laterally from the connection piece 1 and is formed integrally with the latter. The longitudinal axis 51 of the limb 5 is at an angle of 40 to the longitudinal axis 11 of the connector 1. The proximal end 5c of the connector piece 5 may be closed by a cap 4 when no catheter is inserted through the branch 5. For example, the cap may be secured to the branch 5 by a ring 4a so that it is not misplaced when removed. As seen from fig. 1(b), a receptacle 5a is formed along the inner circumference of the branch 5 by stepping and widening the inner diameter, and a valve 2 (e.g., a valve called a duckbill valve) can be inserted into the receptacle 5 a. In the direction from the branch towards the proximal end, a further step 5d is formed along the inner periphery and serves as a seat for receiving the annular cap 3. The valve can be held firmly in the receptacle 5a by means of such a cover. Further in the proximal direction, a bead-like snap lip 5b is provided along the inner circumference, and the annular cap 3 has to be pushed over this snap lip in order to snap into the position provided for fixing the valve 2. This arrangement ensures that the user will always push the lid 3 into the receptacle 5d sufficiently deep, and this also prevents the lid 3 from falling out.

The valve 2 is made in one piece of elastically deformable material (for example silicone) and its walls substantially define a semi-closed hollow body. As can be seen from the mutually perpendicular longitudinal sections of fig. 2(a) and 2(b), a through-opening 21 is provided at the proximal end of the valve and a catheter can be inserted through this through-opening 21 and through the valve. Two substantially bell-shaped sealing lips 25 are formed annularly on the inner wall of the through-opening 21, these sealing lips 25 narrowing the actual diameter to a value D which is 0.1 to 0.15mm smaller than the nominal outer diameter of the catheter.

The next dimensions are based on the nominal outer diameter of the catheter of 3.25 mm. In this case, when D is 3.1mm, the diameter of the inner wall without the seal lip is 3.7 mm. The radius of curvature of the sealing lip 25 itself is R1 ═ R1 ═ 0.25 mm. The radii of curvature R1 and R1' may also be selected to be different from each other. Between the two seal lips, a "valley" having a curvature radius R2 of 0.1mm is disposed. At the location of the distal seal lip and back to the valve inner wall, the associated radius of curvature R3-0.3 mm.

In the distal direction, the opening 21 adjoins the beak portion 22. The latter has a substantially cylindrical basic shape which narrows in the direction towards the beak tip 23 in the form of a wedge by two platforms 27a and 27b opposite each other. Each platform forms an angle α of 27.1 ° with a line lying in the longitudinal direction of the valve. The beak tip itself is flat, although it may also narrow to a point. In the beak tip and parallel to the imaginary intersection line of the two 27a and 27b, a cut 24 is made, which is cut into the beak tip after the valve has been formed (for example by injection moulding). In the normal state (without the catheter inserted), the slit is closed by the elastic material, sealing the valve against the passage of fluid. The length of the slit corresponds substantially to the diameter of the inner wall of the valve 2 (when contracted), in other words 3.7mm in the present exemplary embodiment. After insertion of the catheter, the tips of the latter come into contact with the inner faces of the wedge-shaped platforms 27a and 27b and bend them in such a way that the slit 24 opens like a mouth and can guide the catheter therethrough.

As seen in fig. 2(b) and 2(c), a peripheral flange 26 is formed proximally outside the valve. This flange 26 abuts the receiving seat 5a (step of the inner diameter of the branch) when the valve 2 is fitted into the branch 5 and thus serves to position the valve 2. Furthermore, the circumferential portion of the flange is characterized by lands 26a, 26b, the lands 26a, 26b reducing the effective radius of the other annular flange. The platforms 26a, 26b of the portion are at an angle β of 6 ° to a tangent to the centre of the portion. The intersection point of the platforms (center of the part) is circular and the radius of curvature micror 4 is 3.9 mm. The flange radius through the center is perpendicular to the direction of the cut 24 in the beak tip. Thus, it is possible to use the platforms 26a, 26b to fit the valve 2 with the cut-out 24 to the respective receptacle and to do so in a controlled orientation.

Finally, the catheter 6 itself is shown in fig. 3(a) and 3 (b). It is guided through the openings of the caps 61 and 62, the distal end of which is used for attaching the branch 5 of the connector 1 and the proximal end for attaching to a drug supply line with lung surfactant preparation. The catheter 6 is surrounded by a protective sleeve 63, which protective sleeve 63 is fastened to the connection caps 61 and 62 by clamping or gluing between the cap inner 61a and the cap outer 61b, or between the Luer connector 2a and the cap outer 62 b. Along its length, the catheter 6 has markings 65 giving a visual indication of the depth to which the catheter is inserted into the patient.

Furthermore, near the distal end of the catheter 6, a radio-opaque marker 66 is provided, which allows positioning of the catheter tip in the patient under real-time X-ray imaging.

Those skilled in the art will undoubtedly be able to see more advantageous embodiments which are obtained from the examples shown in the present application and which fall within the scope of the invention.

Claims (32)

1. Device comprising an instillation catheter (6) and a connector (1) for attachment to a tracheal or endotracheal tube, said connector (1) having a distal end (1a) for attachment to said tube and a proximal end (1b) for attachment to an airway and/or suction device, and comprising a branch (5) for insertion of said catheter (6) and in which a valve (2) is arranged, which valve (2) has a proximal through opening (21), is made of elastically deformable material at least in some areas, and is opened by insertion of said catheter (6), characterized in that: the inner wall of the proximal through-opening (21) has sealing means allowing sealing of an axial fluid flow between the catheter (6) and the inner wall, and in the distal direction from the through-opening (21) the valve (2) has a beak part (22), the beak part (22) having a normally closed cut (24) at its beak tip (23).

2. The apparatus of claim 1, wherein: between a distal connection cap (61) for attachment to the branch (5) and a proximal connection cap (62) arranged at the proximal region of the catheter (6), the catheter (6) has a protective membrane (63) which closes the catheter.

3. The apparatus according to claim 1 or 2, characterized in that: the catheter (6) has markings (65) along its length that show the user the position of the distal end of the catheter (6) relative to the catheter.

4. The apparatus according to claim 1 or 2, characterized in that: the catheter (6) has a radiopaque indicator (66) near the distal end.

5. The apparatus according to claim 1 or 2, characterized in that: the angle formed by the longitudinal axis (51) of the branch (5) and the longitudinal axis (11) through the distal end (1a) of the connecting piece (1) is between 35 DEG and 45 deg.

6. The apparatus of claim 1, wherein: the inner diameter (D) defined by the sealing means is 0.05mm to 0.2mm smaller than the outer diameter (A) of the catheter.

7. The apparatus of claim 1, wherein: the through-opening (21) has an outer wall with a flange (26), the flange (26) acting as a sealing seat for positioning the valve (2) in a receiving seat (5a) of the branch (5).

8. The apparatus of claim 7, wherein: the flange (26) has a portion defined by two lateral platforms (26a, 26b) which intersect at the centre of the portion, the centre being circular, and each of the platforms forming an angle of approximately 6 ° with a tangent parallel to the slit of the beak portion and located at the centre of the portion.

9. The apparatus of claim 1, wherein: the sealing means comprises a sealing lip (25) arranged in the circumferential direction of the inner wall.

10. The apparatus of claim 1, wherein: the sealing means comprises two sealing lips (25) arranged in the circumferential direction of the inner wall.

11. The apparatus according to claim 9 or 10, characterized in that: the sealing lip (25) has a substantially bell-shaped cross-section with a constant radius of curvature.

12. The apparatus of claim 11, wherein: the radius of curvature (R, R1') of the sealing lip (25) is at most 0.25 mm.

13. The apparatus of claim 10, wherein: the contact area between the sealing lips (25) is curved with a radius of curvature (R2) of at most 0.1 mm.

14. The apparatus of claim 11, wherein: the valve (2) is curved with a radius of curvature (R3) of at most 0.3mm in the transition region between the beak part and the sealing lip (25).

15. The apparatus of claim 1, wherein: the beak part (22) narrows in a wedge-like manner starting from a cylindrical basic shape through mutually opposing platforms (27a, 27 b).

16. The apparatus of claim 1, wherein: the angle (α) between the longitudinal direction of the valve (2) and each of the two platforms (27a, 27b) of the beak portion is between 26 ° and 28 °.

17. The apparatus of claim 7, wherein: the valve (2) can be fixed in the branch (5) by an annular cover (3).

18. The apparatus of claim 17, wherein: the receptacle (5a) has a snap lip (5b) for securely snapping the annular cover (3) into place.

19. A valve (2) having a proximal through-opening (21), made of an elastically deformable material at least in some areas, and openable by insertion of a catheter (6), characterized in that: the inner wall of the proximal through-opening (21) of the valve (2) has sealing means allowing to seal the axial fluid flow between the catheter (6) and the inner wall, and in the direction from the through-opening (21) towards the distal end, the valve (2) has a beak part (22), the beak part (22) having a normally closed cut (24) at its beak tip (23).

20. The valve of claim 19, wherein: the inner diameter (D) defined by the sealing means is 0.05mm to 0.2mm smaller than the outer diameter (A) of the catheter.

21. The valve of claim 19, wherein: the valve (2) is arranged in a branch (5), the through opening (21) having an outer wall with a flange (26), the flange (26) acting as a sealing seat for positioning the valve (2) in a receiving seat (5a) of the branch (5).

22. The valve of claim 21, wherein: the flange (26) has a portion defined by two lateral platforms (26a, 26b) which intersect at the centre of the portion, the centre being circular, and each of the platforms forming an angle of approximately 6 ° with a tangent parallel to the slit of the beak portion and located at the centre of the portion.

23. The valve of claim 19, wherein: the sealing means comprises a sealing lip (25) arranged in the circumferential direction of the inner wall.

24. The valve of claim 19, wherein: the sealing means comprises two sealing lips (25) arranged in the circumferential direction of the inner wall.

25. A valve according to claim 23 or 24, wherein: the sealing lip (25) has a substantially bell-shaped cross-section with a constant radius of curvature.

26. The valve of claim 25, wherein: the radius of curvature (R, R1') of the sealing lip (25) is at most 0.25 mm.

27. The valve of claim 24, wherein: the contact area between the sealing lips (25) is curved with a radius of curvature (R2) of at most 0.1 mm.

28. The valve of claim 25, wherein: the valve (2) is curved with a radius of curvature (R3) of at most 0.3mm in the transition region between the beak part and the sealing lip (25).

29. The valve of claim 19, wherein: the beak part (22) narrows in a wedge-like manner starting from a cylindrical basic shape through mutually opposing platforms (27a, 27 b).

30. The valve of claim 19, wherein: the angle (α) between the longitudinal direction of the valve (2) and each of the two platforms (27a, 27b) of the beak portion is between 26 ° and 28 °.

31. The valve of claim 21, wherein: the valve (2) can be fixed in the branch (5) by an annular cover (3).

32. The valve of claim 31, wherein: the receptacle (5a) has a snap lip (5b) for securely snapping the annular cover (3) into place.