Device and method for the dynamically sealing occlusion or space-filling tamponade of a hollow organ
A device ( 1 ) for the tracheal intubation of and the administration of ventilation to a patient for rapid volume-compensating sealing of the trachea, wherein the sealing surfaces of a preferably fully and residually formed balloon-like film body ( 4 ) abut the wall of the trachea with a sealing pressure of the balloon ( 4 ) which is as constant as possible and follow the thoracic pressure acting on the balloon with the least possible time latency with regard to corresponding fluctuations of the balloon inflation pressure, and the trachea is kept sealed under such dynamic fluctuations or respiration synchronously alternating fluctuations of the balloon inflation pressure. This is enabled by a defined large lumen ( 7, 5 ) supply of the balloon inflation medium, the supplying lumen being measured in such a way that a sealing pressure-maintaining extracorporeal volume compensation that works in a time synchronous manner can be achieved in the sealing balloon element.
1. A device for the dynamically sealing intubation of a hollow organ, comprising a tube in the form of a shaft that can be inserted into the hollow organ, with a primary lumen to provide access through or to the hollow organ in question, and comprising an intracorporeal sealing balloon, which surrounds a distal region of the shaft of said tube in the manner of a cuff for the purpose of sealing it against the hollow organ, wherein one or more secondary lumens for filling said intracorporeal sealing balloon are integrated into the wall of at least a proximal region of said shaft, wherein, within each cross-sectional plane that is intersected perpendicularly by the local longitudinal direction of the device, the following applies for the overall interior cross-section Q1 of the primary lumen and the sum Q2 of the interior cross-sections of all secondary lumens:
Q 2/( Q 1+ Q 2)±0.06,
wherein a connection for an extracorporeal filling tube, which connection communicates with all secondary lumens, is provided at a proximal end of the tube, and
wherein, in said extracorporeal filling tube,
a) a one-way valve is disposed which permits a flow in case of a pressure gradient from an extracorporeal reservoir balloon, which is or can be connected to the extracorporeal filling tube, in a direction toward the intracorporeal sealing balloon, but not in the opposite direction, and
b) a flow constriction is arranged which permits only a limited flow in every flow direction,
wherein the one-way valve and the flow constriction are arranged in parallel.
2. The device according to claim 1 , characterized in that the proximal region of said shaft comprises a tubular shaft element, wherein the intracorporeal sealing balloon or a proximal region of the intracorporeal sealing balloon ends at an end face of said tubular shaft element consisting of a tube material, in which the primary lumen continues as an interior opening radially within said tubular shaft element, while the one or more secondary lumens continue in the form of one or more channels molded into the tube material of said tubular shaft element.
3. The device according to claim 2 , characterized in that the minimal overall cross-section of all channels molded into the tube material of said tubular shaft element as the one or more secondary lumens is greater than or equal to the maximum cross-section of an annular secondary lumen in the proximal region of the balloon.
4. The device according to claim 1 , characterized in that an annular structure acting as a collecting channel, with which all secondary lumens communicate, is located in a region of the proximal end of the tube.
5. The device according to claim 4 , characterized in that the connector for the extracorporeal filling tube, which communicates with all secondary lumens, is provided on the annular structure acting as the collecting channel.
6. The device according to claim 1 , characterized in that the pressure in the extracorporeal reservoir balloon is actively controlled or regulated.
7. The device according to claim 6 , characterized in that the pressure in the extracorporeal reservoir balloon is actively regulated such that the pressure in the intracorporeal sealing balloon is kept constant.
8. The device according to claim 7 , characterized in that the pressure in the intracorporeal sealing balloon is measured and serves as an actual value for a control loop, which exerts an influence on the pressure in the extracorporeal reservoir balloon.
9. The device according to claim 1 , characterized in that, within each cross-sectional plane that is intersected perpendicularly by the local longitudinal direction of the device, the following applies for the overall interior cross-section Q1 of the primary lumen and the sum Q2 of the interior cross-sections of all secondary lumens:
Q 2/( Q 1+ Q 2)≥0.08,
or
Q 2/( Q 1+ Q 2)≥0.10,
or
Q 2/( Q 1+ Q 2)≥0.12.
10. The device according to claim 1 , characterized in that the intracorporeal sealing balloon has a radially widened distal region for making a seal and a proximal region, which adjoins the distal region and tapers radially relative to it, as an envelope for the secondary lumen(s) for filling the distal sealing region.
11. The device according to claim 1 , characterized in that the intracorporeal sealing balloon is performed with different outer diameters in its distal and proximal regions.
12. The device according to claim 1 , characterized in that, in a proximal region of the intracorporeal sealing balloon, only one secondary lumen is provided which concentrically externally surrounds the primary lumen.
13. The device according to claim 1 , characterized in that a proximal region of the intracorporeal sealing balloon does not extend all the way to the proximal end of the tube but ends before that.
14. The device according to claim 1 , characterized in that the extracorporeal reservoir balloon has a larger volume in its freely deployed state than the intracorporeal sealing balloon in the distal region of the shaft of the tube.
15. The device according to claim 1 , characterized in that the extracorporeal reservoir balloon is charged with a constant or near-constant pressure, for instance by a weight or a spring element.
16. A method for the dynamically sealing intubation of a hollow organ, the method comprising inserting a device into the hollow organ, the device comprising a tube in the form of a shaft that can be inserted into the hollow organ, with a primary lumen to provide access through or to the hollow organ in question, and comprising an intracorporeal sealing balloon, which surrounds a distal region of the shaft of said tube in the manner of a cuff for the purpose of sealing it against the hollow organ, wherein one or more secondary lumens for filling said intracorporeal sealing balloon are integrated into the wall of at least a proximal region of said shaft, wherein, the pressure within the intracorporeal sealing balloon is kept nearly constant in such a way that when the volume of the hollow organ changes, a corresponding amount of the filling medium flows through one or more secondary lumens, wherein, within each cross-sectional plane that is intersected perpendicularly by the local longitudinal direction of the device, the following applies for the overall interior cross-section Q1 of the primary lumen and the sum Q2 of the interior cross-sections of all secondary lumens:
Q 2/( Q 1+ Q 2)≥0.06,
wherein a connection for an extracorporeal filling tube, which connection communicates with all secondary lumens, is provided at a proximal end of the tube, and
wherein, in said extracorporeal filling tube,
a) a one-way valve is disposed which permits a flow in case of a pressure gradient from an extracorporeal reservoir balloon, which is or can be connected to the extracorporeal filling tube, in a direction toward the intracorporeal sealing balloon, but not in the opposite direction, and
b) a flow constriction is arranged which permits only a limited flow in every flow direction,
wherein the one-way valve and the flow constriction are arranged in parallel.
17. The method according to claim 16 , characterized in that the one or more secondary lumens to the intracorporeal sealing balloon are dimensioned such that, at a pressure level within a balloon system comprising the intracorporeal sealing balloon and the extracorporeal reservoir balloon of 20 to 35 mbar above atmospheric pressure, initial pressure differences within the balloon system have reduced to a residual pressure difference of 5 mbar or less, or to a residual pressure difference of 2 mbar or less, or to a residual pressure difference of 1 mbar or less after a compensation time of max. 20 ms, or after a compensation time of max. 10 ms.