FLOW-OPTIMIZED SUPPLY TO A BALLOON ELEMENT THAT SEALS DYNAMICALLY AND IN SYNC WITH ORGANS

Abstract

The invention relates to a device for the dynamically adapting sealing of an organ or a body cavity, e.g. the windpipe (trachea) of an intubated and ventilated patient, wherein the sealing balloon element is produced via particularly rapid shifting of filling medium from an extracorporeal reservoir or an extracorporeal source to the sealing balloon, and wherein, in the dynamic sealing of the trachea according to the example case, a balloon-type foil body preferably formed with residual material in the diameter, i.e. exceeding the tracheal diameter, is in contact with the inner wall of the trachea in a sealing manner and with a pressure that is as constant as possible, wherein fluctuations in the balloon volume, caused by fluctuations in the intrathoracic pressure relating to the mechanics of breathing, are compensated as quickly as possible by supplying volume from an extracorporeal reservoir or an extracorporeal source, and the tracheal secretion sealing of the balloon is thereby kept continuous. This is both made possible by a sufficiently high-volume supply of the balloon filling medium to the cuff, and also prevents steps, gaps or ridges in the supply system, whereby volume flow directed towards the balloon can be minimised, which is crucial for a rapid-as-possible stabilising of the filling volume in the balloon, in particular with small pressure differences between 15 and 30 mbar that are driving the volume flow.

Claims

1. A device for the volume-compensating sealing of a hollow organ or an anatomical space that is in sync with organs, comprising (i) an intracorporeal balloon-type foil body (3) formed to a residual dimension, i.e., exceeding the anatomical dimension of the organ or the respective space, and having sealing surfaces, which contact the wall of the respective hollow organ or space when the unexpanded balloon-type foil body (3) is free of tension at least in regions while forming folds, while the foil-type balloon body (3) is itself filled with a filling medium under a maximum target pressure of 50 mbar, preferably under a maximum target pressure of 40 mbar, in particular under a maximum target pressure of 30 mbar, (ii) a tube (1) or other shaft, which rests on the balloon-type molded body (3), (iii) an extracorporeal regulating device (29) with a volume reservoir (26, R) and/or a pressure source (Qi) for the filling medium, as well as (iv) a flow connection (4a, 4b, 7, 13, 15, 35) between the intracorporeal balloon-type foil body (3) and the extracorporeal regulating device (29), which runs at least in regions in or along the tube (1) or other shaft, characterized in that the flow connection (4a, 4b, 7, 13, 15, 35) between the intracorporeal balloon-type foil body (3) and the extracorporeal regulating device (29) in the region of its progression in or along the tube (1) or other shaft including a transition region from the tube (1) or other shaft to a progression that is detached therefrom, is free of right-angled deflections, so that a laminar flow can form there and within a latency period of 200 ms or less, for example of 100 ms or less, preferably of 50 ms or less, in particular of 25 ms or less, the additional filling quantity of the filling medium needed in the balloon-type foil body (3) can be supplemented, in order to compensate for fluctuations of the balloon filling pressure and/or of the balloon volume and/or of the pressures and forces bearing on the balloon-type foil body (3), so that the sealing or the space-filling tamponade of the hollow organ or of the space is maintained under dynamically alternating fluctuations of the balloon filling pressure with a pressure drop in the balloon-type foil body (3) of 30 mbar.

2. The device according to claim 1, characterized in that the tube (1) or the other shaft consists of a material that is flexible in a such a restricted manner that it can bend but cannot kink.

3. The device according to claim 1, characterized in that the flow connection (4a, 4b, 7, 13, 15, 35) in the region of the tube (1) or of the other shaft and/or in the region of a transition between different components (4a, 4b, 7, 13, 15, 35) is free of kinks and/or free of edges and/or free of steps and/or free of gaps and/or free of ridges and/or free of other abrupt elevations or depressions, so as not to impair the laminar flow.

4. The device according to claim 1, characterized in that the flow connection (4a, 4b, 7, 13, 15, 35) in the region of the tube (1) or of the other shaft is free of bends, whose bending radius in the longitudinal direction of the flow is less than 0.5 cm, for example less than 1 cm, preferably less than 2 cm, in particular less than 5 cm.

5. The device according to claim 1, characterized in that the cross-sectional area of the flow connection (4a, 4b, 7, 13, 15, 35) does not decrease starting from the region of the tube (1) or of the other shaft up till the extracorporeal regulating device (29).

6. The device according to claim 1, characterized in that the cross-sectional area of the flow connection (4a, 4b, 7, 13, 15, 35) increases in the transition region from the tube (1) or other shaft to a progression that is detached therefrom.

7. The device according to claim 1, characterized in that the cross section of the flow connection (4a, 4b, 7, 13, 15, 35) in or along the tube (1) or other shaft comprises an arch-shaped form, which preferably tangentially nestles a functional lumen inside the tube (1) or other shaft, or coaxially surrounds it.

8. The device according to claim 1, characterized in that the flow connection (4a, 4b, 7, 13, 15, 35) in the region of the tube (1) or other shaft is configured as one on whose outer side a line or hose line can be attached.

9. The device according to claim 8, characterized in that a trough-shaped groove or depression is formed in the outer side of the tube (1) or other shaft for accommodating an attachable line or hose line.

10. The device according to claim 9, characterized in that the trough-shaped groove or depression comprises lateral undercuts, so that a line or hose line, which can be pressed in or inserted there, is fixed and cannot detach spontaneously.

11. The device according to claim 8, characterized in that the line or hose line that can be attached to the outer side of the tube (1) or of the other shaft is preformed in such a way that it fills the trough-shaped groove or depression and thereby supplements the adjacent outer contours of the tube (1) or the other shaft in a manner than maintains the contour.

12. The device according to claim 1, characterized in that a component (17, 17a) with a ramp-shaped or arch-shaped progression is provided, in particular inserted, in the transition region of the flow connection (4a, 4b, 7, 13, 15, 35) from a flow channel section (4a) formed in or integrated into the tube (1) or in another shaft to a progression of the flow channel (4b, 7, 13, 15, 35) that is detached therefrom.

13. The device according to claim 12, characterized in that a detachable component (17, 17a) is inserted, by means of a rearward, preferably mandrel-like prolongation (17) arranged on a side facing away from the ramp (17a), into a depression aligning with the flow channel section (4a) formed in or integrated into the tube (1) or in another shaft.

14. The device according to claim 1, characterized in that a component (18) made of a thin-walled material that nestles the outlet of the flow channel (4a) in the tube (1) or other shaft is inserted in the transition region of the flow connection (4a, 4b, 7, 13, 15, 35) from a flow channel section (4a) formed in or integrated into the tube (1) or in another shaft to a progression of the flow channel (4b, 7, 13, 15, 35) that is detached therefrom.

15. The device according to claim 1, characterized in that a component (19) with a tubular form and a gently bent progression made of a kink-resistant material is inserted in the transition region of the flow connection (4a, 4b, 7,13, 15, 35) from a flow channel section (4a) formed in or integrated into the tube (1) or in another shaft to a progression of the flow channel (4b, 7, 13, 15, 35) that is detached therefrom.

16. The device according to claim 15, characterized in that the outer cross section of the component (19) with a tubular form is larger than the inner cross section of the flow channel section (4a) formed in or integrated into the tube (1) or in another shaft, preferably in such a way that it can be frictionally fixed there under local widening of the flow channel section (4a).

17. The device according to claim 1, characterized in that a hood-shaped component (18a) with lateral, saddle-like planar extensions (18b) is attached or inserted in the transition region of the flow connection (4a, 4b, 7,13, 15, 35) from a flow channel section (4a) formed in or integrated into the tube (1) or in another shaft to a progression of the flow channel (4b, 7, 13, 15, 35) that is detached therefrom, wherein the extensions (18b) can preferably be connected in a stabilizing manner, for example adhesively, to the tube shaft covered therewith.

18. The device according to claim 17, characterized in that a component (17, 17a) with a ramp-shaped or arch-shaped progression is covered by a hood-shaped component (18a).

19. The device according to claim 12, characterized in that a component (17, 17a, 18, 18a, 19) arranged in the transition region of the flow connection (4a, 4b, 7, 13, 15, 35) from a flow channel section (4a) formed in or integrated into the tube (1) or in another shaft to a progression of the flow channel (4b, 7, 13, 15, 35) that is detached therefrom, is provided in the region of the proximal end of said component with a socket for attaching or inserting a hose.

20. The device according to claim 1, characterized in that a filter and/or a vapor barrier (20) is preferably provided extracorporeally in the flow connection (4a, 4b, 7, 13, 15, 35).

21. The device according to claim 1, characterized in that a connector (6) with an inner lumen is provided extracorporeally in the flow connection (4a, 4b, 7, 13, 15, 35), wherein the inner lumen preferably comprises a constant cross-sectional area over the entire length of the connector in a connected state of the subcomponents thereof.

22. The device according to claim 1, characterized in that the minimum clear inside cross-sectional area in the extracorporeal flow connection (4b, 7, 13, 15, 35) is larger than the minimum clear inside cross-sectional area of the intracorporeal flow channel section (4a) formed in or integrated into the tube (1) or in another shaft, for example at least 1.1 times as large as the minimum clear inside cross-sectional area of the intracorporeal flow channel section (4a), preferably at least 1.2 times as large as the minimum clear inside cross-sectional area of the intracorporeal flow channel section (4a), in particular at least 1.3 times as large as the minimum clear inside cross-sectional area of the intracorporeal flow channel section (4a).

23. The device according to claim 1, characterized in that the pressure in a volume reservoir (26, R) of the extracorporeal regulating device (29) is set to the target pressure value for the balloon-type foil body (3).

24. The device according to claim 1, characterized in that an element (23) with a valve function and/or a flow-directing function is provided in the flow connection (4a, 4b, 7, 13, 15, 35), which element is preferably oriented in such a way that it opens in the case of a negative pressure in the balloon-type foil body (3) as compared to the pressure in a volume reservoir (26, R) of the extracorporeal regulating device (29) and allows a rapid volume flow into the balloon-type foil body (3), in particular even without an active regulation.

25. The device according to claim 24, characterized in that a throttling element is connected in parallel with the element (23) with a valve function and/or a flow-directing function, in particular in such a way that an excess pressure in the balloon-type foil body (3) as compared to the pressure in a volume reservoir (26, R) of the extracorporeal regulating device (29) can gradually dissipate.

26. The device according to claim 1, characterized in that the pressure of a pressure source (Qi) for the filling medium in the extracorporeal regulating device (29), in particular upstream of a regulating valve, is set to a pressure value above the target value for the balloon-type foil body (3), for example to a pressure value of 100 mbar or more, preferably to a pressure value of 200 mbar or more, preferentially to a pressure value of 500 mbar or more, in particular to a pressure value of 1 bar or more, or even to a pressure value of 2 bar or more.

27. The device according to claim 1, characterized in that a pressure sensor is arranged in the balloon-type foil body (3) so that the actual pressure value in the balloon-type foil body (3) can be detected.

28. The device according to claim 27, characterized in that the pressure sensor in the balloon-type foil body (3) is connected or can be connected via cable to the extracorporeal regulating device (29), preferably wherein the connecting cable is laid inside the tube (1) or other shaft in a possibly additional lumen or inside the flow connection (4a).

29. The device according to claim 1, characterized in that the extracorporeal regulating device (29) comprises an active regulator, preferably an electronic regulator, in particular a two-point regulator, which in particular is designed in such a way that, in order to adjust the pressure inside the balloon-shaped foil body (3) that was detected as an actual value as constantly as possible to a predetermined or predeterminable target value.

30. The device according to claim 29, characterized in that the two-point regulator is operated with a fixed timing frequency of for example between 100 Hz and 1000 Hz, wherein respectively a valve, for example a piezo valve, is alternatingly opened and closed between a pressure source (Qi) for the filling medium with an appropriate frequency, wherein preferably the pulsation ratio between the opening phase and the closing phase can be influenced by the regulator, in particular as a reaction to the difference between a predetermined or predeterminable target pressure value, on the one hand, and the actual pressure value measured inside the balloon-type molded body (3), on the other hand.

31. The device according to claim 1, characterized in that the sealing surfaces of the balloon-type foil body (3) fit closely on the wall of the respective organ or space with a sealing pressure of the balloon-type foil body (3) that acts as constantly as possible, in a sealing manner on all sides and/or in a manner that minimizes as much as possible a remaining residual space between the balloon-type foil body (3) and an adjacent structure.

32. The device according to claim 1, characterized in that the hollow organ or the anatomical space is the trachea or the esophagus of a patient.

33. The device according to claim 1, characterized in that in the case of a tracheal tube (1), a defined high-volume, flow-optimized supply of the filling medium to the tracheal tube cuff (3) is provided.

34. The device according to claim 1, characterized in that in the case of a tracheal tube (1), the length of a shaft-integrated supply line (4a) to the sealing balloon-type foil body (3) is reduced to a minimum, preferably such that the structural transition region from the tube (1) or shaft to the filling hose (4b) is approximately 1 to 2 cm above the level of the vocal folds (glottis).

35. The device according to claim 1, characterized in that in the case of a tracheal tube (1), a turbulent flow is prevented when moving the filling medium between the reservoir or regulator (35) and the cuff (3).

36. The device according to claim 1, characterized in that in the case of a tracheal tube (1) in the region of the transition from the shaft-integrated lumen (4b) in the tracheal sealing cuff (3), and/or in the region of the transition from the shaft-integrated supply lumen (4a) in the supply hose (4b) that extends extracorporeally, as well as between the connector parts (6), the flow properties are optimized to the extent that a sealing-pressure-maintaining extracorporeal volume compensation that acts in a synchronous manner can be achieved in the sealing balloon element (3).

37. The device according to claim 1, characterized in that in the case of a tracheal tube (1) between connector parts (6), and/or in the region of integrated filter components or valve components (20, 23), the flow properties are optimized to the extent that a sealing-pressure-maintaining extracorporeal volume compensation that acts in a synchronous manner can be achieved in the sealing balloon element (3).

38. The device according to claim 1, characterized in that the sealing balloon element or the balloon-type foil body (3) consist of a thin-walled balloon foil made of polyurethane, which in the segment directed towards the respective surface to be sealed has a wall thickness of 5 to 30 μm, preferably of 10 to 20 μm.

39. The device according to claim 1, characterized in that the sealing balloon element or the balloon-type foil body (3) consists of PUR with a material durometer according to Shore of 70 A to 95 A, and/or with a material durometer according to Shore of 54 D to 60 D.

40. The device according to claim 1, characterized in that the sealing balloon element or the balloon-type foil body (3) comprises a multilayer wall structure, wherein at least one material layer has special barrier properties for water vapor and/or air, wherein the barrier layer consists for example of EVOH.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0065] The following figures explain the inventive content based on concrete structural embodiments, which show:

[0066] FIG. 1 An exemplary structural form of a tracheal tube according to the invention, which integrates a selection of flow-optimizing components and features, which facilitate a rapid shifting of filling medium to the sealing balloon even with a small pressure difference driving the volume flow from the extracorporeal to the intracorporeal, or facilitate a dynamically adapting sealing of the trachea synchronous to the breathing work of the patient.

[0067] FIG. 2a A transversal section through the shaft of a tracheal tube, with a special design of the lumina integrated into the shaft, wherein the overall cross-sectional area of the supply line to the tracheal sealing cuff, which supply line is integrated into the wall of the tube, is designed to optimally large, and wherein transient, lumen-occluding relocations of the supply line from water condensation that penetrate into the supply line are prevented due to a special, barbell-shaped profile.

[0068] FIG. 2b A structural variation of the embodiment depicted in FIG. 2a, wherein the supply to the cuff takes place through a separately manufactured hose, which comprises the barbell-shaped cross section described in FIG. 2a, but is inserted into a congruently shaped recess of the dorsal tube shaft and fixed there.

[0069] FIG. 3a A depiction of the distal section of a tracheal tube shaft according to the invention, which distal section bears the balloon, comprising a flow-optimized transition from a filling line integrated into the wall of the tracheal tube shaft to the inner space surrounding the balloon component via a ramp-like component.

[0070] FIG. 3b A further embodiment of a flow-optimized transition from the shaft-integrated, channel-like supply line to sealing balloon, wherein the transition is designed in the form of a shell-like supporting component, which nestles on the outer perimeter of the tube shaft around the opening region of the shaft-integrated supply line and thus stabilizes the shaft wall in the opening region or prevents the shaft from kinking.

[0071] FIG. 4a An embodiment of the invention with a flow-optimized or current-optimized transition from a filling hose to the shaft-integrated, channel-like supply line lumen.

[0072] FIG. 4b Another embodiment of the transition from the filling hose to the shaft-integrated supply line lumen, comprising a hood-like component connecting the supply line and the filling hose to each other, which establishes a step-less, flow-optimized transition towards both connected lumina.

[0073] FIG. 5A longitudinal section of the vapor barrier and/or microbe barrier integrated into the filling hose.

[0074] FIG. 6A structural form of a flow-optimized connector between the proximal end of the filling hose and the regulator.

[0075] FIG. 7A longitudinal section through a smooth-running valve element with an optional retrograde volume equalization function.

[0076] FIG. 8 An extracorporeal volume reservoir with isobaric volume expansion characteristics.

[0077] FIG. 9 An electronic/electromechanical regulating system coupled back in a direct manner with a tracheal sealing cuff, which accelerates the inflow of the filling medium, and optionally also the outflow thereof, over the hose line and channel line reaching from the regulator to the sealed cuff, via a flow-resistant compensating differential pressure, or wherein the pressure generated by the regulator exceeds the target pressure in the tracheal sealing cuff, and wherein the pressure in the cuff is recorded by an electronic sensor positioned inside the cuff and is fed to the regulator unit.

[0078] FIG. 10 An alternative, electronic/electromechanical regulating system, wherein the electronic sensor components recording the cuff pressure are integrated in the regulator unit.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0079] FIG. 1 describes by way of example a catheter according to the invention on the basis of a tracheal tube 1, consisting of a shaft element 2, which bears a tracheal sealing cuff 3 on the distal end, wherein this is connected via a shaft-integrated channel-like supply line 4a, which merges outside of the shaft into a filling hose 4b, to an extracorporeal volume reservoir 5a, which keeps the cuff pressurized with filling pressure or keeps a gaseous filling medium available with a tracheal target sealing pressure, or connects to an electronically regulated volume source 5b, which adjusts the tracheal target sealing pressure via a pressure difference generated by the volume source, or the pressure generated by the volume source exceeds the tracheal target sealing pressure. The reservoir or the source is attached by a connector 6 to the filling hose 4b. In addition to a leg 7 that concludes with the connector 6, the filling hose 4b comprises a further leg 8, which merges into a pilot balloon 9, which is provided with a filling valve 10. Built into the leg 7 is a closing mechanism 11 that optionally can be operated manually by the user, which mechanism makes it possible to connect the reservoir unit or source unit to a tube pressurized with filling pressure that is already intubated in the patient without a pressure drop in the tracheal sealing cuff. To prevent the transfer of condensation water from the supplying system into the respectively pressure-regulating unit, a correspondingly gas-permeable element 12 which has water-repellant properties is optionally integrated into the leg 7. As an alternative or a supplement to the water-repellent function, the element 12 can also act as a microbial filter. The overall cross-sectional area of the shaft-integrated channel 4b corresponds to a circular cross section of at least 2 mm, preferably 3 to 4 mm. The cross-sectional area of the inner lumen of the filling hose 4b, as well as of the leg 7, and of the hose line connecting to the leg up to the reservoir corresponds to a circular diameter, which preferably exceeds 2.0 mm, preferably more than 3.0 mm and especially preferably comprises more than 3.5 mm.

[0080] FIG. 2a shows a design of the shaft element 2, wherein the supply line 4a integrated into the shaft wall comprises a special barbell-shaped profile 13 in a transversal section, which maximizes the overall cross section of the supply line, which cross section determines the flow resistance in an optimal manner. The supply line is extruded into the dorsal portion 2a of the tube shaft i.e., in the case of the usual design of a tracheal tube according to Magill, lies in the so-called large curvature of the shaft, which rests on the broad base of the vocal fold trigonum. The overall profile of the shaft SQ produced by the barbell-shaped filling line comprises a corresponding broadening of the dorsal “base” of the tube profile. The wide base of the large curvature makes it possible for the ventilating lumen 14 of the tracheal tube, which is integrated ventrally in the shaft, to be able to be maintained in terms of its round or slightly oval shape as well as its cross-sectional area. The terminal enlargements 13a of the filling line lie respectively in the outer angles of the base of the shaft profile that is directed dorsally. In the case of a properly intubated tube position, the broadened rear wall thereof fits closely on the wide base of the glottis in an approximately congruently-shaped manner. The lateral enlargements of the profile are connected by a tapered, bridge-like, center segment 13b. The communication of the enlargements through the center bridge prevents condensation water that penetrates into the filling line from causing an occlusion of the lumen that supplies the cuff due to capillary forces, whereby the continuous connection of the regulating unit to the cuff can be impaired. A fluid level that forms in a barbell-shaped profile normally travels through the bridge-like connection of the one profile enlargement to the enlargement arranged in parallel, whereby a flow-effective occlusion of the filling line can be precluded to a large extent. In the preferred design, the enlargements 13a each have a diameter of 1.5 to 2.5 mm, preferably of 1.5 to 2.0 mm. The bridge 13b connecting the lumina has a height of approx. 0.5 to 1.0 mm.

[0081] FIG. 2b shows a structurally modified design of the profile 13 described in FIG. 2a, wherein, as a separately manufactured hose 15, the barbell-shaped supply line is inserted into a congruently-shaped recess 15a in the dorsal wall of the tube or in the large curvature thereof, and fixed there. The advantage of this design is that the hose can be guided out of the shaft of the tube above the level of the vocal folds and can be guided further as the filling hose without a structural interruption. The hose element 15 thus connects the cuff of the tube to the elements of the supply line that are integrated extracorporeally in a continuous, flow-optimized manner, wherein flow-inhibiting transitions are prevented. To maximize the inner diameter, the hose element 15 can consists of a thin-walled material that spontaneously elastically straightens, such as polyurethane for example, wherein preferably material hardnesses in a range of 90 A to 95 A or 55 D to 60 D are used. The tube shaft itself consists preferably of non-elastically plastically deforming PVC.

[0082] FIG. 3a shows the transition from the shaft-integrated filling line 4a to the tracheal sealing cuff 3, wherein flow-inhibiting effects from turbulence when transferring the filling medium from the supplying lumen into the cuff are minimized, in that the deflection of the medium in an angle that is as flat as possible occurs or a transfer in a steep angle or right angle is avoided, such as is typically caused with the conventional design of tracheal tubes due to a simple tangential cut of the wall of the filling line.

[0083] The cut 16 of the filling line 4a is therefore lengthened in axial expansion thereof from 1 to 2 mm for conventional tubes to 4 to 10 mm, preferably 5 to 8 mm. Inserted into the distally extending opening of the cut of the supply line 4a is a component 17 closing the supply line, which forms a proximally descending ramp 17a in the opening, which guides the medium flowing to the cuff in a turbulence-free into the cuff. The ramp extends overs an axial length of 4 to 6 mm.

[0084] FIG. 3b shows a component 18, which as a supplement to the component 17 described in FIG. 3a, is integrated in the region of the lengthened cut in the region of the opening 16 of the supply line for axial stabilization of the tube shaft. The component 18 consists of an especially thin-walled material with a high hardness, and circularly nestles the outer contour of the section, in a saddle-like manner on the lateral surfaces 18a thereof. The component is preferably produced in an injection molding process. The previously described, lumen-closing and flow-guiding component 17 can be structurally connected to the component 18 or be integrated into said component.

[0085] FIG. 4a shows a special transition element 19, which leads the shaft-integrated supply line 4a to the filling hose 4b or connects the lumen of the supply line to the lumen of the filling hose. The supply line 4a is cut tangentially in the transition region and open over a length of approximately 5 mm. The transition element 19 is preferably fabricated of a kink-resistant material that is designed to be thin-walled, and can be glued with solvent, and comprises a distally directed prolongation 19a, whose outer dimension is enlarged in relation to the dimension of the diameter of the filling line integrated into the shaft of the tube, and thus is inserted with a certain tension into the supply line 4a opened by the tangential cut. The inner lumen of the mandrel-like prolongation corresponds to that of the supply line, whereby the formation of step-like structures or a turbulent flow arising in the transition region can be prevented.

[0086] In the proximal region of the transition element 19, said element optionally comprises a sleeve-like receptacle for the filling hose 4b, wherein the hose is inserted into the receptacle in such a way and fixed by adhesion so that the inner lumen of the element 19 corresponds to the inner lumen of the filling hose 4b. The element 19 therefore ensures also in the region of the proximal connection that caliber transitions from the shaft-integrated supply line to the filling hose are prevented, and flow-reducing step formations are ruled out. In this especially flow-critical region, the element makes a laminar flow of the filling medium possible from the reservoir or the source to the tracheal sealing cuff. Furthermore, because of the element 19, transitions from circular cross sections of the filling hose 4b to flattened, oval, flat oval, or even barbell-shaped cross sections of the distal portion 19a of the transition element can be smoothed in a flow-optimizing manner.

[0087] The cross-sectional area of the filling hose 4b corresponds at least to the overall cross-sectional area of the shaft-integrated supply line 4a, but exceeds it in preferred embodiments.

[0088] FIG. 4b shows a hood-like component 18a, which nestles the dorsal perimeter of the tracheal tube with a custom fit and covers the cut of the supply line 4a in a tightly sealing manner. The component comprises lateral, saddle-like, planar extensions 18b, which connect to the lateral wall of the tube shaft in a manner that stabilizes the tube shaft in the region of the cut. The hood-like component comprises a connecting piece 18c going off towards the proximal in a flat angle, which receives the filling hose 4b. The figure furthermore shows a component 17, which is inserted directed proximally into the supply line channel 4a, and closes it. Analogous to the ramp-like design in FIG. 3a, the connecting piece 18 forms a flow-optimizing ramp 17a, which extends from the proximal to the distal into the cut of the supply line, and is thereby correspondingly beveled.

[0089] FIG. 5 shows an optional vapor barrier 20 integrated into the filling hose 4b or the leg 7. The surface of the respective separating layer 21 is thereby selected to be so large that the flow resistance caused by the barrier function is compensated for and delays during pressure equalization in the cuff are prevented. The barrier layer comprises a diameter of at least 10 to a maximum of 25 mm, preferably 15 mm. The housing 22 is flat and designed to be discoid and thus reduces the residual space around the separating layer. The function of the vapor barrier ensures that water vapor and condensate are not able to penetrate into the region of the regulating unit and negatively impact the opening and closing behavior of the valves installed there. As an alternative or addition to the vapor barrier 20, a microbe-tight barrier layer can be installed in the housing 22.

[0090] FIG. 6 shows a special connector 6, which comprises a constant cross-sectional area over its entire inner lumen. By inserting the male part 6a into the female part 6b, a step-less, gap-less and ridge-free transition is thereby facilitated. The cross sections of the lumina connected to each other are identical in the region of the connection.

[0091] FIG. 7 shows a unit 23 with a valve function, wherein the flow-directing function is preferably produced by a lobe-like, film-thin valve plate 24. In an open state of the valve, a cross-sectional area of the valve opening is adjusted which corresponds at least to the diameter of the line arranged distally to the valve, but preferably exceeds said line. The valve plate preferably has a hole-like perforation 25, which even in a closed state of the valve makes possible a reduced volume flow from the cuff to the regulating unit that opposes the main flow, so that transient excess pressure situations in the cuff can be balanced out by an appropriately delayed volume outflow from the cuff.

[0092] A backflow function acting in a correspondingly manner can occur alternatively with a channel-like connection arranged parallel to the valve plate, which makes a specific throttled outflow of medium from the cuff to the reservoir or to the source possible.

[0093] FIG. 8 shows a volume reservoir 26, which has a specifically volume-expandable reservoir balloon 27, which receives the filling medium with a constant isobaric pressure over a specific radial expansion region 27a of the balloon shell. The plateau pressure that adjusts during the expansion of the balloon shell is defined by the specific design or the material used and the geometry of the balloon. The respective plateau pressure in the reservoir corresponds to the target pressure prevailing in the balloon of for example 30 mbar. The pressure generated by the expanded reservoir balloon drives the volume flow to the sealing balloon element in the moment of a pressure drop in the balloon. The reservoir can be filled by a fill valve 28 preferably with air as the filling medium.

[0094] FIG. 9 shows a back-coupled regulating system 29, which is attached to a flow-optimized catheter 1 of the design type according to the invention. Inside the sealing balloon, the catheter has an electronic pressure sensor 30 permanently integrated there, which is connected via a cable connection 31 to the regulating system. The regulator itself consists of a pump module 32 with an optionally integrated reservoir 33 and at least one regulating valve module 34 with an integrated control unit. The user can enter target values and alarm values into the controller. As a option, the regulator can also have two pump systems, with a respectively attached reservoir, wherein the one reservoir keeps an excess pressure available and the other a negative pressure. The gradients or the differential pressure from the target value kept available in the regulator in the cuff are adjusted autonomously by the regulator in an optional design by a learning algorithm in such a way that the latency until reaching the target value in the cuff is in a range of 10 to 20 ms. Both the pump functions and the valve functions are preferably based on piezo-electric components, which can be operated precisely and rapidly, as well as quietly and in an energy-saving manner.

[0095] The supply line 35 to the leg 7 of the catheter preferably comprises an inner diameter which exceeds the diameter of the leg, and in an ideal case exceeds it by 30%, in order to thereby keep resistance-induced flow losses as small as possible. As an alternative to the cuff-integrated pressure sensor, a peripheral pressure-converting sensor 36 can be integrated into the supply line and be positioned in the immediate vicinity of the connector 6. With this design, it is possible to dispense with a sensor integrated in the cuff, wherein a certain delay in the regulating time must be accepted.

[0096] FIG. 10 describes another regulator unit 37 for continuously maintaining a sealing balloon filing pressure. The cuff of the tracheal tube is already formed during manufacturing to its required working dimension. The filling of the balloon takes place in the previously described flow-optimized or resistance-minimizing manner. The balloon is filled with gaseous medium. The hose supply line 35 from the regulator to the connector 6 should comprise a circular lumen with a diameter of at least 5 mm, in order to prevent flow-induced pressure losses and dampening effects between the balloon and regulator. The regulator unit consists of a single valve Voi that operates piezo-electrically, which both directs volume to the tamponading balloon as well as discharges volume therefrom. Connected upstream of the valve on the patient side is an electronically pressure-measuring component 38, which continuously detects the pressure in the balloon body and conveys it to the control unit C. The regulator unit does not have a measuring function of a pressure electronically measured directly in the balloon. Connected upstream of the valve on the side facing away from the patient is a pressure reservoir R integrated into the device or an external pressure source Qi, which keeps the filling medium available for example in a pressure range of 1 to 2 bar. The piezo valve Voi reduces this reserve pressure to approx. 10 to 30 mbar sealing pressure in the balloon. If the target pressure set by the user in the balloon is exceeded, it is detected by the component 38. The control unit C then opens the valve Voi, then discharges the filling medium, following the respective gradient, via an opening 39 to the environment. The unit has an adjustment option for the tracheal sealing target pressure 40 and a possibility for setting the respective volume flow 41 to or from the balloon.

TABLE-US-00001 List of Reference Numbers  1 Tracheal tube  2 Shaft element  2a Rear-wall portion  3 Cuff  4a Channel-like supply line  4b Filling hose  5a Volume reservoir  5b Volume source  6 Connector  6a Male part  6b Female part  7 Leg  8 Leg  9 Pilot balloon 10 Filling valve 11 Closing mechanism 12 Gas-permeable element 13 Barbell-shaped profile 13a Terminal enlargement 13b Center segment 14 Ventilated lumen 15 Hose 15a Recess with a congruent shape 16 Cut 16a Distal opening 17 Component 17a Ramp 18 Component 18a Lateral surface 18b Planar extension 19 Transition element 19a Distal portion 20 Vapor barrier 21 Separating layer 22 Housing 23 Unit 24 Valve plate 25 Hole-like perforation 26 Volume reservoir 27 Reservoir balloon 27a Filing region 28 Fill valve 29 Regulating system 30 Pressure sensor 31 Cable connection 32 Pump module 33 Reservoir 34 Valve model 35 Supply line 36 Sensor 37 Regulator unit 38 Component 39 Opening 40 Target pressure 41 Volume flow C Control unit Qi External pressure source R Pressure reservoir SQ Shaft profile Voi Valve