Flow-optimized delivery lines to organ synchronously and dynamically sealing balloon elements

Abstract

The invention relates to a device for dynamically adapting sealing of organs or body cavities, for example sealing of the trachea of a patient who has been intubated and who has been using a breathing machine, wherein a sealing balloon element is generated by particularly rapid movement of a filling medium from an extracorporeal reservoir or extracorporeal source to the sealing balloon, and wherein in the exemplary case of dynamic sealing of the trachea, a balloon-like membrane body which is shaped in the diameter, i.e. which exceeds the diameter of the trachea, seals against the inner wall of the trachea with as constant a pressure as possible, wherein fluctuations in the volume of the balloon caused by breathing mechanics-related fluctuations in the intrathoracic pressure are compensated for by delivery of volume from the extracorporeal reservoir or extracorporeal source with as short a time delay as possible, and the tracheal secretion seal of the balloon is maintained at all times. The above-mentioned solution is achieved, on the one hand, by a sufficiently large delivery line for the inner lumen of the balloon filling medium leading to the cuff, and on the other hand, by avoiding steps, gaps or burrs in the delivery line in order to achieve minimization of the volume flow towards the balloon, which is crucial for as rapid a stabilization as possible of the filling volume in the balloon, particularly in the case of a relatively small pressure difference of 15 to 30 mbar driving the volume flow.

Description

Technical Field

[0001] This invention relates to a device for the synchronous and dynamic occlusion, sealing, and / or filling of hollow organs using a cuff-like element, particularly for dynamically adaptable, aspiration-proof seal of the trachea of ​​an intubated patient, both for spontaneously breathing patients and those mechanically ventilated in assisted spontaneous breathing modes. Specifically, the invention relates to a device for dynamically adaptably sealing organs or body cavities, such as the trachea of ​​an intubated and ventilated patient, particularly by means of a sealing cuff element. In exemplary cases of dynamic tracheal sealing, a cuff-like membrane, preferably with a residual diameter exceeding the trachea diameter, is sealed against the inner wall of the trachea at a pressure as constant as possible. In this case, the cuff volume fluctuations caused by respiratory mechanics-related intrathoracic pressure fluctuations should be compensated for with the shortest possible time delay by delivering volume from an external reservoir or extracorporeal source, so as to maintain a constant seal of tracheal secretions against the cuff. Background Technology

[0002] Regarding organ compatibility, effective sealing, or the filling of organs or cavities by means of externally filled pneumatic elements, the main problem lies in the continuous, more or less significant kinetic forces of the organ itself. Organs or cavities defined by muscle and connective tissue typically exhibit characteristic kinematic dynamics or are often exposed to the dynamics of adjacent organs or structures. To achieve continuous and effective closure of organ cavities, these inherently voluntary organs require special regulatory mechanisms that respond rapidly to and compensate for fluctuations in organ diameter and / or changes in organ wall tension. This mechanism must act as synchronously as possible with the corresponding changes in diameter or tension within the organ and maintain its sealing or sealing properties through optimal and rapid delivery or removal of the filling medium into the pneumatic element.

[0003] The human trachea can be used as an example to illustrate the dynamic adaptive sealing problem of hollow organs. The trachea is a tubular structure composed of cartilage, connective tissue, and muscular connective tissue. It extends from the lower end of the larynx to the branches of the two main bronchi. The anterior and lateral portions of the trachea are stabilized by a clamp-like, roughly horseshoe-shaped structure, which is interconnected longitudinally by layers of connective tissue. The tracheal lumen is sealed on the posterior wall by a membranous portion, which consists of a continuous layer of muscular connective tissue without integrated reinforcing elements. This membranous portion is then attached to the muscular connective tissue esophagus (esophagus) on the dorsal side.

[0004] The upper third of the trachea is usually located outside the thoracic cage (chest), while the lower two-thirds are located within the thoracic cavity defined by the thoracic cage and the diaphragm. Therefore, the lower chest of the trachea is specifically exposed to pressure fluctuations within the thoracic cavity, which are part of the "work of breathing" in patients who breathe spontaneously and unsupported or are mechanically assisted in ventilation.

[0005] When a patient inhales, the chest volume increases due to the elevation of the ribs and the simultaneous descent of the diaphragm, causing a decrease in intrathoracic pressure. This decrease in pressure in the chest allows air to flow into the elastically expanding lungs at the back of the chest.

[0006] The decrease in intrathoracic pressure associated with increased chest volume causes pressure fluctuations in sealed and / or packed cuff elements that correspond to the patient's thoracic breathing. These cuff elements are located within the thoracic cavity and are subjected to a specific filling pressure there. This is observed, for example, in the sealed cuff elements (cuffs) of endotracheal tubes and tracheostomy tubes, which seal the deep airway to prevent pharyngeal secretions from entering and enable positive pressure ventilation (PPV) of the patient's lungs.

[0007] The periodic fluctuations in intrathoracic pressure generated during thoracic breathing can shift the sealing pressure in the ventilator cuff to areas where adequate sealing of pharyngeal and digestive secretions is no longer guaranteed. Within the range of spontaneous thoracic breathing, cuff pressure can also be assumed to be below atmospheric pressure in some cases, roughly equivalent to the corresponding chest pressure. See Badenhörst CH, Changes in tracheal cuff pressure in respiratory support; 15 / 4: 300-302, published in CritCareMed in 1987.

[0008] The sealing performance of conventional endotracheal tube cuffs made of PVC is closely related to the current filling pressure in the cuff, which leads to a decrease in sealing performance when the pressure drops to the range of 30 mbar to 15 mbar. However, endotracheal tube cuffs made of polyurethane with particularly thin walls have significantly stable sealing efficiency when the filling pressure in the cuff drops from 30 mbar to 15 mbar (see Bassi GL, CritCareMed, 2013; 41: 518-526).

[0009] However, a filling pressure range of 15 to 5 mbar is particularly important for the secretion sealing efficiency of the tracheal cuff, and this range can be achieved through moderately accelerated breathing from one breath to the next. Even at a filling pressure of approximately 10 mbar, the seal-optimized micro-thin-walled PUR cuff provides good sealing performance, but it cannot prevent subglottic secretions from entering when the pressure drops below 10 mbar or to intrathoracic pressure values ​​below atmospheric pressure.

[0010] A tracheal closure technique that achieves efficient, non-invasive, and low-cost sealing by using a cuff-like sealing cuff to time-synchronize with the patient's spontaneous breathing over a sufficiently wide range of filling pressures has not yet been available. Although various embodiments of external filling pressure regulating devices for endotracheal ventilation tubes are described in the prior art, the prior art currently does not have an effective adaptation of the sealing pressure to the actual time synchronization with, for example, the alternating chest pressure generated during the patient's spontaneous breathing, i.e., from one stroke to another.

[0011] In conventional ventilation tubes, the endotracheal sealing cuff is typically filled via a channel-like delivery line that is squeezed into a small lumen within the wall of the tube shaft. The small cross-section of this filling line, approximately 0.5 mm, is usually insufficient to ensure a sufficiently large volumetric flow rate of the filling medium pressurizing the cuff to maintain an endotracheal seal throughout the patient's respiratory cycle. Even with more sophisticated electronically controlled regulating mechanisms, such as the Logomed GmbH CDR 2000 device (no longer commercially available), insufficient sealing efficiency can be achieved due to the traditionally small lumen of the delivery line between the sealing cuff element and the externally placed regulator.

[0012] US 5,235,973 describes a relatively complex electronically controlled regulation technique aimed at rapidly regulating pressure within a sealed catheter cuff element. Furthermore, the document describes a preferred cross-section of the delivery line connecting the catheter cuff to the pressure regulating device. The diameter mentioned is in the range of approximately 2 to 3 mm. To reduce flow resistance within the delivery line leading to the tracheal sealing cuff, PCT / IB2015 / 002309 and PCT / IB2016 / Ö01643 propose corresponding dimensions for the delivery line cross-section, the cuff being essentially determined by the delivery lumen integrated or extruded into the catheter stem.

[0013] However, it has been shown that the cross-sectional area of ​​the delivery pipeline alone cannot guarantee the fastest possible pressure equilibrium within the in-body sealing bladder. Rather, the overall structural design of the flow channel between the in-body sealing bladder and the external regulating device affects the achievable flow rate, which in turn affects the temporarily movable filling pressure volume. This issue is not addressed in US 5,235,973, PCT / IB2015 / 002309, and PCT / IB2016 / 001643. Summary of the Invention

[0014] The problem that led to this invention arises from these shortcomings of the prior art: the design of the flow channel between the in-body sealing airbag and the external adjustment device to enable pressure equalization to be achieved in the in-body sealing airbag as quickly as possible.

[0015] Within the scope of devices for sealing hollow organs or anatomical cavities in a manner that provides volume compensation synchronously with the organ, the solution to this problem lies in the device comprising: (i) an in vivo sac-like membrane body shaped to a residual size, i.e., exceeding the anatomical size of the organ or corresponding cavity, having a sealing surface that, when the sac-like membrane body is uninflated without tension, at least partially abuts against the wall of the corresponding hollow organ or cavity in the form of folds, while the membrane-like sac body itself is filled with a filling medium at a nominal pressure of up to 50 mbar, preferably up to 40 mbar, particularly up to 30 mbar; (ii) a conduit or other rod located on the sac-like sac body; (iii) an external adjustment device having a volume reservoir and / or pressure source for the filling medium; and (iv) The fluid connection between the in vivo pneumatic membrane and the external conditioning device, extending at least partially into or along the conduit or other rod, is characterized in that the fluid connection between the in vivo pneumatic membrane and the external conditioning device does not undergo right-angle deflection in its direction region extending into or along the conduit or other rod, including in the transition region from the conduit or other rod to a direction separating from the conduit or other rod. Therefore, laminar flow can be formed there, and additional filling of the required filling medium in the pneumatic membrane can be replenished within a waiting time of 200 milliseconds or less, for example, within 100 milliseconds or less, preferably 50 milliseconds or less, particularly 25 milliseconds or less, to compensate for fluctuations in pneumatic filling pressure and / or pneumatic volume and / or pressure and force applied to the pneumatic membrane, thereby sealing or filling hollow organs or cavities in a space-filling manner under dynamically alternating fluctuations, even when the pressure in the pneumatic membrane drops by 30 mbar.

[0016] Therefore, the present invention takes into account the special requirements of avoiding transitions and obstacles located in the delivery line leading to the airbag that reduce flow or hinder optimal and rapid pressure balance between the sealing airbag and the regulator.

[0017] The inventors have recognized that specific structural embodiments, particularly those concerning the transition from the delivery line integrated into the rod to the flexible delivery line connected to the rod, or specific structural designs concerning the discharge of the filling medium from the delivery line integrated into the rod to the discharge area in the cuff, can reduce volumetric flow rate and consequently delay the seal. During pressure equalization from an external reservoir pressurized at equal pressure with the sealing cuff, the main problem lies in the flow-impeding transitions, as the pressure differential driving the volumetric flow rate is typically small. The delay in achieving pressure equalization between the two interconnected compartments, the reservoir and the cuff, prevents a consistently reliable seal from being achieved. The periodically generated pressure gradient varies in the range of a few millibars, typically ranging from approximately 5 to 30 mbar. Therefore, a prerequisite for driving the pressure gradient of the volumetric flow rate from the reservoir or volumetric source to the cuff is the flow-optimized design of all components described below, and all transitions between these components, which constitute the entire delivery line between the reservoir and the cuff.

[0018] It has proven advantageous that the catheter or other rod is constructed of a material with limited flexibility, making it relatively flexible but not bendable. This allows the catheter or other rod to be optimally adapted to the patient's anatomy without impairing its function. Bending points, in particular, can significantly delay volume transfer, or even prevent it altogether.

[0019] Since, for example, steps, burrs, uneven surfaces or other non-smooth structures can disrupt the laminar flow of the filling medium in a vortex manner, the present invention proposes that fluid connections located in the region of a conduit or other rod and / or in the transition region between different components do not have bends and / or edges and / or gradations and / or gaps and / or burrs and / or any other protrusions or recesses, so as not to impair laminar flow.

[0020] An advantageous improvement of the invention is that the fluid connection located in the region of the conduit or other rod does not have bends, with a bending radius in the longitudinal direction of flow of less than 0.5 cm, for example less than 1 cm, preferably less than 2 cm, and particularly less than 5 cm. Like bends, narrower directional changes in the flow path can also negatively affect the achievable flow velocity, particularly because they increase the tendency to form vortices; therefore, such narrower bends should be avoided.

[0021] Within the scope of this invention, the cross-sectional area of ​​the fluid connection does not decrease from the region of the conduit or other rod to the external regulating device. Any backflow within the flow channel will reduce the achievable flow rate and therefore should be avoided.

[0022] A particular advantage is that the cross-sectional area of ​​the fluid connection increases in the transition region from the conduit or other rod to its separation path. In this case, potentially higher pressure within the regulating device can diffuse almost unrestricted into the transition region where it connects to the conduit, thereby achieving maximum pressure differential there to drive maximum volume transfer within the limited flow cross-section.

[0023] It has proven advantageous that the cross-section of the fluid connection extending into or along the conduit or other rod has an arcuate shape, preferably being substantially tangentially abutting against or coaxially surrounding the functional lumen within the conduit or other rod. On the one hand, this design allows for maintaining a relatively round overall cross-section of the conduit, based on the fact that the lumen is generally also substantially circular in cross-section in most cases. On the other hand, the advantage of the arcuate, elongated cross-sectional shape of the fluid connection is that the permeated fluid cannot completely seal the flow path across its entire cross-sectional area, which is associated with impaired pressure balance.

[0024] Only by employing delivery components with the largest possible internal cavity and often the shortest possible length, combined with transition sections that minimize eddy currents between these components, can optimal, non-delayed, and as laminar as possible flow of the sealing medium from the volume storage unit or an electronically / electromechanically regulated volume source to the sealing bladder be achieved, thereby maintaining a sufficiently rapid and dynamic seal of the trachea from one breath to the next.

[0025] The invention also allows for an implementation in which the fluid connection in the region of the conduit or other rod is constructed as a line or hose that can be joined to the outside of the conduit or other rod, thereby potentially reducing the number of transitions between different components of the flow channel that may trigger vortices.

[0026] To accommodate such connectable tubing or hoses, recessed grooves or recesses can be constructed on the outside of the conduit or other rod. The advantage of this is that the flow channels, which are crucial for the sealing airbag, are not exposed in the area of ​​the conduit and are therefore not compressed; instead, they are protected and arranged within the recesses of the conduit.

[0027] In a preferred embodiment of the invention, the recessed groove or recess may have a lateral undercut, so that the tubing or hose that can be pressed or inserted therein is secured and will not come loose on its own, thereby simplifying the operation.

[0028] Furthermore, tubing or hoses that can be attached to the outside of a catheter or other rod can be pre-formed such that the tubing or hose fills a recessed groove or depression and complements the adjacent external contour of the catheter or other rod in a manner that maintains its outline. In this case, the relevant catheter or rod can also be placed non-invasively into the body cavity within the area of ​​the hose.

[0029] An improvement of the invention involves providing a component with a ramp-like or arc-shaped orientation in the transition region from the integrated or formed flow channel section in the conduit or another rod to the flow channel direction separated from it. This component is particularly inserted into the transition region. The function of such a component is to smoothly and without eddies deflect the flow of the filling medium (e.g., air) in the transition region so as not to impair laminar flow.

[0030] Furthermore, according to the concept of the invention, the detachable component can be inserted into a recess aligned with a flow channel section integrated into or formed into a conduit or other rod by means of a rearward, preferably spinny, protrusion arranged on the side facing away from the slope. This ensures that the component is always optimally oriented and does not produce gaps or edges due to tilting, which could affect flow. Of course, the component can also be additionally secured in place by means of an adhesive.

[0031] Furthermore, a component made of a bend-resistant material with a tubular shape and a gently curving direction can be inserted in the transition region from the integrated or formed flow channel section in the conduit or another rod to the flow channel direction separated from it. The main task of this component is also to ensure a gentle change in flow direction in the transition region and to suppress the generation of eddies there.

[0032] If the outer cross-section of a tubular component is larger than the inner cross-section of a flow channel section integrated or formed into a conduit or another rod, the tubular component can be fixed there by friction fit in the event of local expansion of the flow channel section, thereby undergoing longitudinal guidance and orientation of the flow channel formed into the conduit or another rod.

[0033] A preferred embodiment of the invention is characterized by inserting a component made of a thin-walled material in the transition region from the integrated or formed flow channel section in the conduit or other rod to the flow channel direction separate from it, the material being in close contact with the outlet of the flow channel located in the conduit or other rod. The function of this component is to act as a reinforcement in the area cut into the conduit or other rod (and thus structurally locally weakened) to prevent undesirable bending at that location.

[0034] A particular technical solution of the present invention involves engaging or inserting a cap-like component with transverse saddle-shaped flat extensions in the transition region from the integrated or formed flow channel section in the fluid connection to the flow channel direction separated from it. These extensions are preferably capable of being stably connected to the covered tube or rod, for example, by adhesive bonding. These transverse saddle-shaped flat extensions serve both for orientation relative to the tube or rod sheath and for securing it to the tube or rod sheath.

[0035] Within the scope of a particularly preferred embodiment of the invention, components having a sloping or arcuate orientation are covered by a cap-like component. According to the invention, multiple such components can be combined with each other, particularly combining transition components inserted into a flow channel or its extension within a conduit with transition components abutting against the outside of the conduit or other rod.

[0036] Similar geometry to all the transition elements described above can also be provided at the transition region between the distal end of the flow channel integrated into the conduit or rod and the sealing airbag applied to the conduit or rod there.

[0037] Components located in the transition region from the integrated or formed flow channel section in the fluid connection to the flow channel direction separate from it can typically be fitted with a sleeve in its proximal region for inserting or connecting a hose. If the hose has a radial extension on its inner side at this location, gradation in this region can be avoided.

[0038] In the external segments or components of the delivery line, the design of the delivery line can generally be adapted to maximize flow rate, and the structural design or size of these segments or components is not limited by anatomical specifications. In particular, larger delivery line cross-sections can be achieved in this area. In the described example of an endotracheal tube or tracheostomy cannula, there are anatomically relevant limitations in the delivery line leading to the endotracheal sealing cuff, primarily in the area of ​​the flexible or tubular rod component that carries the cuff. The plane of the glottis, in particular, limits the size of the rod. The glottis is the narrowest point in the airway and gives a correspondingly possible outer diameter of the tube, thus essentially also giving the diameter of the internal lumen squeezed into the rod. The cross-sectional area of ​​the lumen used for pulmonary ventilation should, in principle, be maximized because the respiratory resistance during ventilation must be kept as low as possible. In the glottal plane of the intubation tube, a certain amount of remaining space is typically left in the dorsal region leading to the tube shaft. This glottal plane opens the glottis in a tent-like, triangular manner from the ventral to the dorsal side in the form of a curtain, and releases a wedge-shaped area between the outer wall of the tube shaft and the bottom of the glottis at the bottom of the tent-like curtain or glottis. This area can be used for additional and / or enlarged cavities integrated into the tube shaft for flow-optimized delivery lines or for discharging filling media into the cuff. To this end, the invention also proposes an approximately dumbbell-shaped profile for the delivery line located in the rear wall of the tube shaft on the dorsal side, with a special lateral extension of its dumbbell-shaped cross-section filling or utilizing the remaining space.

[0039] In the ideal configuration of the catheter or cannula, the length of the delivery line integrated into the stem leading to the sealing cuff element is implemented in the shortest possible manner and extends from the opening of the delivery line into the cuff until it reaches, for example, a point directly above the glottis, 2 to 3 cm away. In the supraglottic and hypopharyngeal regions, connections to the significantly enlarged lumen of the tubing or other tubing relative to the lumen integrated into the stem can be made with the aid of correspondingly reduced flow resistance.

[0040] The filter and / or vapor barrier are preferably disposed externally in the fluid connection. The vapor barrier, for example, can protect the external conditioning device from the effects of permeated moisture.

[0041] If a connector with an inner cavity is provided in the external fluid connection, then in the connected state of the sub-components of the connector, the inner cavity of the connector preferably has a constant cross-sectional area over the entire length of the connector.

[0042] It has proven advantageous that the minimum net internal cross-sectional area in the external fluid connection is greater than the minimum net internal cross-sectional area of ​​the internal flow channel section integrated or formed into the conduit or another member, for example, at least 1.1 times the minimum net internal cross-sectional area of ​​the internal flow channel section, preferably at least 1.2 times the minimum net internal cross-sectional area of ​​the internal flow channel section, and particularly at least 1.3 times the minimum net internal cross-sectional area of ​​the internal flow channel section. This cross-sectional expansion allows for further optimization of flow rates.

[0043] To maintain a stable pressure in the endotracheal cuff to a preset target value that can be adjusted by the user or fixed by a specific structure of the device, preferably 30 mbar and in the range of 20 to 40 mbar, this invention aims to achieve a maximum time delay of approximately 10 to 20 milliseconds, from the initial deflection of the chest pressure during the patient's active inspiration, from the mechanical resting position of the respiratory mechanics to the pressure level below that resting position. After a maximum of 20 milliseconds (ms), the corresponding shift in the cuff seal pressure from one breath to another should return to the target value.

[0044] The specific method for achieving a simple structural layout involves adjusting the pressure in the volume storage of the external conditioning device to a target pressure value for the bladder-like membrane. In this case, even without active adjustment, it can be ensured that the pressure in the sealed bladder does not rise to an excessively high value.

[0045] In this case, a component with valve and / or flow guiding function can be provided in the fluid connection. This component is preferably oriented such that it opens when the pressure in the volume reservoir relative to the external conditioning device is negative in the bladder-like membrane body and allows the volumetric flow rate to flow rapidly into the bladder-like membrane body, especially in the absence of active conditioning.

[0046] In order to gradually eliminate the negative pressure that appears in the bladder-like membrane body relative to the pressure in the volume storage relative to the external conditioning device, the element with valve function and / or flow guiding function should be connected in parallel with a throttling element.

[0047] In the composite of the sealing airbag according to the invention, the volume transfer for the sealing airbag component required for pressure stabilization is driven by means of an external volume reservoir loaded with constant pressure or by a reservoir that provides volume in any other way under constant pressure and / or a pump-like permanent action mechanism, through a flow-optimized delivery line to the sealing airbag integrated into the rod hose of the conduit to the airbag.

[0048] For example, a gravity- or elastic mechanism can be used to generate and maintain a sealing pressure in a composite structure consisting of an airbag and delivery lines, which compresses or pressurizes the filling medium contained within the storage component by means of a force acting on the outer sheath of the storage component. The airbag, delivery lines, and storage unit are thus connected to form a closed system. This system is filled and emptied via a filling valve, preferably integrated into the storage unit.

[0049] The storage components can also be pressurized by a pump-like or electromechanically driven (e.g., piezoelectric) valve mechanism that is permanently connected to the storage.

[0050] As an alternative, the filling pressure present in the system can also be achieved using a storage bubble that expands elastically in a specific manner. The sheath of this bubble-like component transitions to an expanded state when filled with a specific initial volume, placing the volume contained within the bubble under a structurally specific pressure equivalent to the desired sealing target pressure in the system. As the filling volume of the bubble increases, it further expands in a characteristic "isobaric" manner, where the fault pressure generated within the storage bubble does not increase within a certain volume range and maintains the corresponding target pressure. Thus, the storage bubble "reserves" volume, where the pressure of the filling medium in the "isobaric reserve region" remains constant. In the case of using such a volume-expandable storage bubble, for example, made of polyisoprene, the external force acting on the storage sheath can be eliminated. A corresponding technique is described, for example, in PCT / EP / 2013 / 056169.

[0051] Alternatively, electronically or electromechanically regulated components can be used to form a closed system connected to the airbag and the delivery lines leading to the airbag. These components, in the form of a "source," constantly (isobarically) deliver the volume pressure required to regulate the airbag seal to the system or provide it to the system without the need for intermediate "buffer" reservoir-like components.

[0052] In addition to constant pressure sources that generate pressure corresponding to the required sealing pressure in the endotracheal cuff, regulated reservoir-like or source-like systems can be connected to a complex consisting of an inflator and delivery lines leading to it. These systems operate using pressure gradients or pressure ranges exceeding 20 to 40 mbar. Such systems, for example, maintain a reserve pressure of 100 mbar and, driven by a gradient higher than the target sealing pressure, move the filling medium in a correspondingly accelerated manner. The accelerated volumetric flow rate toward the cuff can be regulated, for example, by an electronically controlled proportional valve. Precise piezoelectrically driven valves provide a foundation for this. These valves are small, silent, and consume little energy. Furthermore, piezoelectrically driven pumps can be installed upstream of these valves, which can also silently build up reservoir pressures up to 100 mbar.

[0053] The pressure of the filling medium pressure source in the external control device, particularly upstream of the regulating valve, can be adjusted to a pressure value higher than the target value of the bladder-like membrane, for example, to 100 mbar or higher, preferably to 200 mbar or higher, more preferably to 500 mbar or higher, particularly to 1 bar or higher, or even to 2 bar or higher. In this case, the pressure difference relative to the significantly reduced pressure in the sealed bladder is substantially reduced by the regulating valve, which, depending on the specific implementation, may be slightly opened only when needed or operated at intervals, thereby regulating the pressure downstream of the valve.

[0054] To detect the actual pressure value inside the air-filled membrane, a pressure sensor can be placed inside the air-filled membrane.

[0055] The pressure sensor, located within the sac-like membrane, should be connected to or be able to connect to an external regulating device via a cable. Preferably, the connecting cable is laid inside a conduit or other rod, in an additional cavity as appropriate, or within a fluid connection. Alternatively, a wireless connection, such as via Bluetooth, can be used, but this is considerably more complex and more susceptible to interference compared to a cable connection.

[0056] Furthermore, the present invention proposes that the external conditioning device has an active regulator, preferably an electronic regulator, and in particular a dual-position regulator, which is specifically designed to adjust the pressure detected as an actual value within the air-filled membrane to a preset or presettable target value as constant as possible.

[0057] By incorporating an active electronic control regulator, a specially optimized closed-loop control circuit can be established, in which pressure-recording sensors are integrated within the sealed airbag component, and these sensors are preferably connected to the regulator unit's control device via cables. This type of feedback system can also be used to actively remove volume from the airbag, where a negative pressure gradient is generated by the regulator parallel to the overpressure gradient, allowing volume to flow out of the sealed airbag towards the regulator at an accelerated rate, as needed.

[0058] An electronic two-position regulator used within the scope of this invention can be operated at a fixed clock frequency, for example, between 100 Hz and 1000 Hz, wherein valves, such as piezoelectric valves, are alternately opened and closed at corresponding frequencies between pressure sources of the filling medium, wherein the pulse ratio between the opening and closing phases is preferably influenced by the regulator, particularly as a response to the difference between a preset or presettable pressure target value and the actual pressure value measured inside the bladder-shaped body. Due to the regulating valve used in this case, the pressure difference between the high pressure that may exist upstream of such a valve and the low pressure that is regulated downstream by pulsation is relatively large.

[0059] The hollow organ or anatomical cavity is preferably the patient's trachea or esophagus. However, the aforementioned principles of flow optimization, delay minimization, volume compensation, or stabilization in a sealing cuff placed in the trachea can also be applied in a similar manner to the esophagus of a spontaneously breathing patient, sealing it in place. Pressure fluctuations in a cuff placed in the esophagus and functioning in a sealing manner, corresponding to the patient's spontaneous breathing, are generally more pronounced than those in a cuff placed in the trachea. These pressure fluctuations are very close to the present intrathoracic pressure. To achieve the most effective possible sealing of the cuff in the esophagus, the present invention proposes a segmented sealing cuff as a structural variant. While the distal segment of the sealing esophagus extends within the range of the esophagus between the superior and inferior sphincter muscles, a tapering cuff segment connects proximally, optionally extending to the proximal end of the catheter carrying the cuff. The size of the gap created between the stem and the proximal cuff segment can be relatively large. This gap allows for filling of the distal balloon end substantially around the catheter stem and enables corresponding flow optimization and rapid volume transfer, even with small pressure differentials driving the volumetric flow rate from outside the body to inside. This type of dynamically pressure-regulated balloon tamponade is particularly applicable to esophageal probes for gastric feeding and / or gastric decompression. Connection to a volume reservoir operating in an isobaric manner or a volume source regulated by pressure differential can be achieved in embodiments similar to a tracheal seal.

[0060] Furthermore, the present invention proposes that the sealing airbag element is composed of a thin-walled airbag film made of polyurethane, the airbag film having a wall thickness of 5 to 30 μm, preferably 10 to 20 μm, in segments facing each surface to be sealed. Additionally, the sealing airbag element can be made of PUR with a Shore A hardness of 70A to 95A and / or a Shore A hardness of 54D to 60D. This material can be readily pre-formed, thus eliminating the need to convert it to an elastically expanded state for sealing.

[0061] Finally, according to the technical principles of the present invention, the sealing airbag element has a multi-layered wall structure, wherein at least one material layer has special barrier properties against water vapor and / or air, wherein the barrier layer is, for example, composed of EVOH. This, for example, prevents moisture penetration, which could condense in the delivery line and hinder rapid volume transfer there. Attached Figure Description

[0062] The following figures illustrate the invention with reference to specific structural embodiments. Wherein:

[0063] Figure 1 An exemplary structural form of the endotracheal tube according to the invention is shown, which integrates the selection of flow optimization components and features that enable the filling to be rapidly moved to the sealing cuff or to seal the endotracheal tube in a dynamic and adaptive manner in sync with the patient’s work of breathing, even when the pressure differential driving the volumetric flow rate from outside to inside the body is small.

[0064] Figure 2a The cross-section of the rod portion of the endotracheal tube is shown, including a particular embodiment of the lumen integrated into the rod portion, wherein the total cross-sectional area of ​​the delivery line leading to the endotracheal sealing cuff integrated into the wall portion of the tube is optimally large, and wherein the lumen of the delivery line is temporarily sealed due to condensation penetrating into the delivery line by a special dumbbell-shaped profile.

[0065] Figure 2b Show Figure 2a The illustrated embodiment features a structural variation in which the delivery line to the cuff is achieved via a separately manufactured hose, which has... Figure 2a The dumbbell-shaped cross section described in the text is embedded in a groove of the same shape as the back side tube and fixed there;

[0066] Figure 3a This is an illustration of the distal section of the support cuff of the endotracheal tube rod according to the present invention, including a flow-optimized transition section through a ramp-shaped component from the filling tubing integrated into the wall of the endotracheal tube rod to the internal space surrounded by the cuff component.

[0067] Figure 3bAnother embodiment of a flow-optimized transition from a channel-like delivery line integrated into the rod to a sealed airbag is provided, wherein the transition is implemented in the form of a shell-shaped support component that fits tightly against the outer periphery of the rod around the opening area of ​​the delivery line integrated into the rod, thereby stabilizing the rod wall in the opening area and preventing the rod from bending.

[0068] Figure 4a In one embodiment of the invention, there is a flow-optimized transition from the filling hose to the inner cavity of the channel-shaped delivery line integrated in the rod.

[0069] Figure 4b Another embodiment of the transition from the filling hose to the delivery line cavity integrated in the stem includes a cap-like component that interconnects the delivery line and the filling hose, which creates a stepless, flow-optimized transition toward the two connected cavities.

[0070] Figure 5 A longitudinal profile of a vapor barrier and / or microbial barrier integrated into a filled hose;

[0071] Figure 6 The structural form of a flow-optimized connector located between the proximal end of the filling hose and the regulator is shown;

[0072] Figure 7 A longitudinal section of a flexible valve element with optional reverse volume compensation.

[0073] Figure 8 An external volume storage device with isobaric volume expansion characteristics is shown;

[0074] Figure 9 An electronic / electromechanical external conditioning device is shown that provides direct feedback via a tracheal sealing cuff, which accelerates the inflow of filling medium and optionally the outflow of filling medium by compensating for the pressure difference across a hose and channel delivery line extending from the regulator to the sealing cuff, or wherein the pressure generated by the regulator exceeds the nominal pressure in the tracheal sealing cuff, and wherein the pressure in the cuff is recorded by an electronic sensor located within the cuff and transmitted to the regulator unit;

[0075] Figure 10 Another electronic / electromechanical external conditioning device is shown, in which an electronic sensor component for recording cuff pressure is integrated into the regulator unit. Detailed Implementation

[0076] Figure 1The endotracheal tube according to the invention is described exemplarily with reference to an endotracheal tube comprising a rod element 2, which distally carries an endotracheal sealing cuff in the form of a bladder-like membrane body 3. This cuff is connected to an external volume reservoir 5a via a channel-like delivery line in the form of a flow channel section 4a integrated within the rod. This delivery line transitions externally to a delivery hose 4b outside the rod. The volume reservoir either applies a filling pressure to the cuff or stores a gas-filled medium at the nominal endotracheal sealing pressure, or the cuff is connected to an electronically regulated volume source 5b, which regulates the nominal endotracheal sealing pressure via a pressure differential generated by the volume source, or generates a pressure exceeding the nominal endotracheal sealing pressure. This reservoir or source is connected to the delivery hose 4b via a connector 6. In addition to a branch 7 that is closed via connector 6, the delivery hose 4b has another branch that transitions to an indicator bladder 9 equipped with a filling valve 10. Optionally, a user-operable closure mechanism 11 is installed in the branch 7, which connects the reservoir or source unit to a catheter already inserted into the patient and under filling pressure without causing a pressure drop in the endotracheal sealing cuff. To prevent condensate from transferring from the delivery system to the pressure regulating unit, a corresponding breathable element 12 is optionally integrated into the branch 7, which has hydrophobic properties. As an alternative or supplement to the hydrophobic function, the breathable element 12 can also be used as a microbial filter. The total cross-sectional area of ​​the flow channel section 4a integrated in the stem is equivalent to a circular cross-section of at least 2 mm, preferably 3 to 4 mm. The cross-sectional area of ​​the lumen of the delivery hose 4b, as well as the branch 7 and the hose connecting the branch to the reservoir, is equivalent to a circular diameter preferably greater than 2.0 mm, preferably greater than 3.0 mm, and particularly preferably greater than 3.5 mm.

[0077] Figure 2aAn embodiment of the rod element 2 is shown, wherein the delivery line in the form of a flow channel segment 4a integrated into the rod wall has a special profile 13 with a dumbbell-shaped cross-section, which maximizes the total cross-sectional area of ​​the delivery line in an optimal manner to achieve a defined flow resistance. This delivery line is extruded into the rear wall portion 2a of the rod, that is, in the conventional structure of a Magill endotracheal tube, the delivery line is located in the so-called greater curvature of the rod, which is located at a wider base in the vocal cord triangle. The overall rod profile SQ of the rod produced by the dumbbell-shaped filling line has a correspondingly widened back "base" of the tube profile. This wider base with greater curvature allows the ventilation lumen 14 of the endotracheal tube integrated into the rod on the ventral side to maintain its circular or slightly elliptical shape and its cross-sectional area. The end extension 13a of the filling line is located at the outer corner of the back-facing base of the rod profile. When the cannula is correctly inserted into the catheter position, the widened rear wall of the rod conforms to the wider base of the glottis in a generally uniform shape. The lateral extensions of this profile are connected by a tapered connecting tab-shaped central section 13b. This connection between the extensions, achieved through the central connecting tab, prevents condensate seeping into the filling line from causing capillary action that could close the delivery cavity to the cuff, potentially impairing the continuous connection between the adjustment unit and the cuff. The fluid level formed in the dumbbell-shaped profile typically travels through the connecting tab-shaped connection between the profile extensions and the parallel-arranged extensions, thereby effectively preventing the flow of fluid into the filling line. In a preferred embodiment, the diameter of the end extension 13a is 1.5 to 2.5 mm, preferably 1.5 to 2.0 mm. The height of the connecting tab-shaped central section 13b connecting the cavity is approximately 0.5 to 1.0 mm.

[0078] Figure 2b Show Figure 2a In a modified embodiment of the profile 13 described herein, a dumbbell-shaped delivery line is inserted as a separately manufactured hose element 15 into a uniformly shaped groove 15a in the back wall of the conduit or into a larger bend of the conduit and secured therein. The advantage of this structure is that the hose can be drawn from the stem of the conduit above the vocal cord plane and can continue to extend as a filler hose without structural interruption. Thus, the hose element 15 connects the conduit cuff to the externally integrated delivery line in a continuous and flow-optimized manner, avoiding transitions that inhibit flow. To maximize the inner diameter, the hose element 15 can be constructed from a self-elastically correcting material (e.g., polyurethane) in a thin-walled manner, preferably with a material hardness in the range of 90A to 95A or 55D to 60D. The stem itself is preferably constructed from PVC that is inelastically plastically deformable.

[0079] Figure 3aThe diagram shows the transition from a filling line integrated into the flow channel section 4a of the rod to a tracheal sealing cuff in the form of an airbag-like membrane body 3. The flow inhibition effect caused by eddies is minimized when the filling medium is transferred from the delivery cavity into the cuff. Specifically, the medium is deflected at the flattest possible angle or deflected at a steep angle or right angle, which is usually caused by simple tangential cutting on the wall of the filling line in the case of a conventional tracheal tube structure.

[0080] Therefore, the inlet 16 of the filling line in the form of flow channel section 4a extends axially from 1 to 2 mm in the case of a conventional conduit to 4 to 10 mm, preferably 5 to 8 mm. A component 17 of the closed delivery line is inserted into the distally extending opening of the inlet of the delivery line in the form of flow channel section 4a. This component extends into the opening to form a ramp 17a descending from the distal to the proximal side, which guides the medium flowing towards the cuff into the cuff without turbulence. This ramp extends in the range of 4 to 6 mm in axial length.

[0081] Figure 3b Thin-walled component 18 is shown, which serves as Figure 3a The supplementary component 17 described herein is integrated into the region of the inlet 16 of the delivery pipeline to achieve axial stability of the tube in the extended inlet region. The thin-walled component 18 is made of a material with high hardness and particularly thin walls and is circumferentially and saddle-shaped, closely abutting the outer contour of the inlet on the transverse surface 18a of the inlet. This component is preferably manufactured by injection molding. The aforementioned closed-cavity and flow-guiding component 17 can be structurally connected to or integrated into the thin-walled component 18.

[0082] Figure 4a A special tubular component 19 is shown that transfers a delivery line in the form of a flow channel section 4a integrated into the stem to a delivery hose 4b, or connects the inner cavity of the delivery line to the inner cavity of the delivery hose. The delivery line in the form of a flow channel section 4a is tangentially cut in the transition region and opens over a length of approximately 5 mm. The tubular component 19 is preferably made of a thin-walled, flexurally resistant material that can be bonded with a solvent and has a distally extending portion whose external dimensions are larger than the diameter of the filling line integrated into the conduit stem, thereby pushing the extension with tension into the delivery line in the form of a flow channel section 4a, which is opened through a tangential inlet. The inner cavity of the spiked extension corresponds to the inner cavity of the delivery line, thereby preventing the formation of a stepped structure or eddies in the transition region.

[0083] In the proximal region of the tubular component 19, the tubular component optionally has a sleeve-shaped receiving portion for the delivery hose 4b, into which the hose is inserted and secured by adhesive, such that the inner cavity of the tubular component 19 corresponds to the inner cavity of the delivery hose 4b. Therefore, the tubular component 19 also ensures in the proximal connection region that the transition from the delivery line integrated in the stem to the diameter of the filling hose is avoided and that a stepped structure reducing flow rate is eliminated. In this region, particularly where flow rate is critical, this element allows the filling medium to flow laminarly from the reservoir or source to the endotracheal sealing cuff. Furthermore, the tubular component 19 can be used to smooth the transition from the circular cross-section of the delivery hose 4b to the flat, elliptical, oval, or dumbbell-shaped cross-section of the distal portion 19a of the transition element in a flow-optimized manner.

[0084] The cross-sectional area of ​​the delivery hose 4b is at least equivalent to the total cross-sectional area of ​​the delivery line in the form of the flow channel section 4a integrated in the stem, but in a preferred embodiment, the cross-sectional area of ​​the filling hose exceeds this total cross-sectional area.

[0085] Figure 4b A cap-like component with a transverse surface 18a is shown, which fits precisely against the dorsal circumference of the endotracheal tube and seals over the inlet of a delivery line in the form of a flow channel section 4a. The component has a transverse, saddle-shaped, flat extension 18b that connects to the sidewall of the tube in a manner that stabilizes the tube in the inlet region. The cap-like component has a connector 18c extending proximally at a flat angle, which accommodates the delivery hose 4b. The figure also shows a component 17, which is inserted proximally into and seals the delivery line flow channel section 4a. Similar to... Figure 3a The sloping structure in the joint forms a flow-optimized slope 17a that extends from the proximal side to the distal side into the inlet of the delivery pipeline and is inclined accordingly.

[0086] Figure 5 An optional steam barrier 20 integrated into the delivery hose 4b or branch 7 is shown. In this case, the area of ​​each separation layer 21 is chosen to be large enough to compensate for the flow resistance caused by the barrier function and to avoid delays in achieving pressure balance in the sleeve. The diameter of the barrier layer is at least 10 to a maximum of 25 mm, preferably 15 mm. The housing 22 is flat and disc-shaped, thereby reducing the residual space around the separation layers. The function of the steam barrier ensures that water vapor and condensate do not penetrate into the area of ​​the regulating unit and do not impair the closing and opening performance of the valves installed there. As an alternative to or supplement to the steam barrier 20, a microbial-impermeable barrier layer may also be installed in the housing 22.

[0087] Figure 6A special connector 6 is shown, which has a constant cross-sectional area throughout its entire internal cavity. A stepless, gapless, and burr-free transition is achieved by inserting the male part 6a into the female part 6b. The cross-sections of the interconnected cavities are identical in the connection area.

[0088] Figure 7 An element 23 with valve and / or flow guiding functions is shown, wherein the flow guiding function is preferably generated by a thin, sheet-like membrane valve plate 24. In the open state of the valve, a cross-sectional area of ​​the valve orifice is generated, which corresponds at least to the diameter of the pipeline disposed away from the valve, but preferably is larger than that pipeline. The valve plate preferably has perforated perforations 25, which, in the closed state of the valve, also reduce the volumetric flow rate from the cuff to the regulating unit in the opposite direction to the mainstream flow, so that temporary overpressure in the cuff can be compensated by correspondingly delaying the volumetric overflow from the cuff.

[0089] As an alternative, the corresponding reflux function can be achieved through a channel-like connection arranged parallel to the valve plate, which enables a certain degree of throttling and overflow of the medium from the sleeve to the reservoir or source.

[0090] Figure 8 A volumetric reservoir 26 is shown, comprising a storage bubble 27 expandable to a specific volume. This storage bubble absorbs the filling medium under constant isobaric pressure across a specific radial expansion region 27a of the bubble sheath. The plateau pressure generated during the expansion of the bubble sheath is defined by a specific structure or material used, as well as the geometry of the bubble. The corresponding plateau pressure in the reservoir corresponds to the nominal pressure present in the bladder, for example, 30 mbar. The pressure generated by the expanding storage bubble drives the volumetric flow rate to the sealed bladder element at the moment a pressure drop occurs in the bladder. The reservoir can be filled, preferably with air, via a filling valve 28.

[0091] Figure 9An external regulating device 29 with feedback is shown connected to a flow optimization conduit 1 of the type according to the invention. The conduit has an electronic pressure sensor 3c fixedly integrated within a sealed bladder, which is connected to the external regulating device via a cable connection 31. The regulator itself consists of a pump module 32 with an optional integrated reservoir 33 and at least one regulating valve module 34 with an integrated control unit. Target values ​​and alarm values ​​can be input into the control device by the user. Optionally, the regulator may also have two pump systems, each connected to a reservoir, one storing overpressure and the other storing negative pressure. In an optional embodiment, the regulator independently adjusts the gradient for the target value in the cuff or the differential pressure stored in the regulator for that target value using a learning algorithm, such that the waiting time before reaching the target value in the cuff is in the range of 10 to 20 milliseconds. Both the pump and valve functions are preferably based on piezoelectric components, which can operate precisely, quickly, quietly, and energy-efficiently.

[0092] The delivery line 35 leading to branch 7 of the conduit preferably has an inner diameter larger than the diameter of the branch, and ideally, 30% larger, to minimize resistance-related flow losses. As an alternative to a pressure sensor integrated in the cuff, a peripheral pressure conversion sensor 36 can be integrated into the delivery line, adjacent to connector 6. With this embodiment, the sensor integrated in the cuff, which involves a certain delay in adjustment time, can be omitted.

[0093] Figure 10Another regulator unit for maintaining continuous sealing cuff filling pressure is described. The endotracheal tube cuff is shaped to the required working size during manufacturing. The cuff is filled in a flow-optimized or resistance-minimized manner as described above. The cuff is filled using a gaseous medium. The hose delivery line 35 from the regulator to connector 6 should have a circular inner cavity with a diameter of at least 5 mm to avoid flow-related pressure losses and damping effects between the cuff and the regulator. The regulator unit consists of a single piezoelectric valve Voi that both directs and discharges volume from the filled cuff. Upstream of this valve, on the patient side, is an electronic pressure measuring component 38 that continuously monitors the pressure in the cuff body and transmits it to the control unit C. This regulator unit does not have the function of measuring pressure directly in the cuff electronically. Upstream of this valve, on the patient-averse side, is an accumulator R or external pressure source Qi integrated into the device, which stores the filling medium, for example, in a pressure range of 1 to 2 bar. The piezoelectric valve Voi reduces the storage pressure in the airbag to a sealing pressure of approximately 10 to 30 mbar. If the pressure exceeds the user-set nominal pressure in the airbag, component 38 detects this pressure. The control unit C then opens the valve Voi, and the filling medium is discharged into the environment through opening 39 according to the corresponding gradient. This unit can adjust the nominal airbag sealing pressure 40 and the corresponding volumetric flow rate 41 flowing into or out of the airbag.

[0094] Appendix Label Table

[0095] 1 catheter

[0096] 2-bar element

[0097] 2a Rear wall portion

[0098] 3. Gas-filled thin film body

[0099] 4a flow channel section

[0100] 4b delivery hose

[0101] 5a volume storage

[0102] 5b volume source

[0103] 6 connectors

[0104] 6a male component

[0105] 6b mother component

[0106] 7 branches

[0107] 9 indicator airbags

[0108] 10 Filling valve

[0109] 11 Closed Institutions

[0110] 12 breathable elements

[0111] 13 profile

[0112] 13a End Extension

[0113] 13b Connecting plate-like central segment

[0114] 14 Ventilation chamber

[0115] 15 Hose Components

[0116] 15a Uniformly Shaped Grooves

[0117] 16-gauge mold inlet

[0118] 17 parts

[0119] 17a slope

[0120] 18 thin-walled components

[0121] 18a Transverse Surface

[0122] 18b Flat Extension

[0123] 19 tubular components

[0124] 19a distal portion

[0125] 20 Steam Barrier

[0126] 21 Separation Layer

[0127] 22 shell

[0128] 23 Components with valve function and / or flow guiding function

[0129] 24 valve plate

[0130] 25-hole perforation

[0131] 26-volume storage

[0132] 27 Storage Bubbles

[0133] 27a Expansion Region

[0134] 28 Filling Valve

[0135] 29 External Regulation Device

[0136] 3C pressure sensor

[0137] 31 Cable Connection

[0138] 32-pump module

[0139] 33 storage units

[0140] 34 valve module

[0141] 35 delivery pipeline

[0142] 36 sensors

[0143] 38 parts

[0144] 39 openings

[0145] 40 nominal pressure

[0146] 41 volumetric flow rate

[0147] C control unit

[0148] Qi external pressure source

[0149] R accumulator

[0150] SQ rod profile

[0151] Voi valve

Claims

1. A device for sealing a hollow organ or anatomical cavity in a manner that allows for organ-synchronous volume compensation, the device comprising: (i) an in vivo sac-like membrane body (3) shaped to a residual size, i.e., exceeding the anatomical size of the hollow organ or anatomical cavity, having a sealing surface that, when the sac-like membrane body (3) is uninflated without tension, at least partially abuts against the wall of the hollow organ or anatomical cavity in the form of folds, while the sac-like membrane body (3) itself is filled with a filling medium at a nominal pressure of up to 50 mbar; (ii) a conduit (1) or other rod located on the sac-like membrane body (3); (iii) an external conditioning device (29) having a volume reservoir (26, R) and / or a pressure source (Qi) for the filling medium; and (iv) a fluid connection (4a, 4b, 7, 13, 15, ...) between the sac-like membrane body (3) and the external conditioning device (29). 35), which extends at least partially into or along the conduit (1) or other rod, characterized in that the fluid connection (4a, 4b, 7, 13, 15, 35) between the bladder-like membrane (3) and the external adjustment device (29) does not undergo right-angle deflection in the direction region in which it extends into or along the conduit (1) or other rod, including the transition region from the conduit (1) or other rod to the direction separated from the conduit (1) or other rod, thus enabling laminar flow to be formed there and additional filling of the required filling medium in the bladder-like membrane (3) to compensate for fluctuations in bladder filling pressure and / or bladder volume and / or pressure and force applied to the bladder-like membrane (3), thereby reducing the pressure drop in the bladder-like membrane (3) by 30% in the event of dynamic alternating fluctuations in bladder filling pressure. In the case of mbar, the sealing or space-filling tamponade of the hollow organ or anatomical cavity is maintained, wherein the fluid connections (4a, 4b, 7, 13, 15, 35) do not have bends, edges and gradations in the region of the conduit (1) or other rod and in the transition region between different components so as not to impair laminar flow.

2. The apparatus according to claim 1, characterized in that, The air-filled film (3) is filled by a filling medium under a nominal pressure of up to 40 mbar.

3. The apparatus according to claim 1, characterized in that, The air-filled film (3) is filled by a filling medium under a nominal pressure of up to 30 mbar.

4. The apparatus according to claim 1, characterized in that, The fluid connection (4a, 4b, 7, 13, 15, 35) between the airbag-like membrane (3) and the external conditioning device (29) does not undergo right-angle deflection in its direction region extending into or along the conduit (1) or other rod, including the transition region from the conduit (1) or other rod to the direction separated from the conduit (1) or other rod. Therefore, laminar flow can be formed there and additional filling of the required filling medium in the airbag-like membrane (3) can be replenished within a waiting time of 100 milliseconds or less.

5. The apparatus according to claim 1, characterized in that, The fluid connection (4a, 4b, 7, 13, 15, 35) between the airbag-like membrane (3) and the external conditioning device (29) does not undergo right-angle deflection in its direction region extending into or along the conduit (1) or other rod, including the transition region from the conduit (1) or other rod to the direction separated from the conduit (1) or other rod. Therefore, laminar flow can be formed there and additional filling of the required filling medium in the airbag-like membrane (3) can be replenished within a waiting time of 50 milliseconds or less.

6. The apparatus according to claim 1, characterized in that, The fluid connection (4a, 4b, 7, 13, 15, 35) between the airbag-like membrane (3) and the external conditioning device (29) does not undergo right-angle deflection in its direction region extending into or along the conduit (1) or other rod, including the transition region from the conduit (1) or other rod to the direction separated from the conduit (1) or other rod. Therefore, laminar flow can be formed there and additional filling of the required filling medium in the airbag-like membrane (3) can be replenished within a waiting time of 25 milliseconds or less.

7. The apparatus according to claim 1, characterized in that, The conduit (1) or other rod is made of a material with limited flexibility, which allows it to bend but not bend.

8. The apparatus according to claim 1, characterized in that, The fluid connections (4a, 4b, 7, 13, 15, 35) in the region of the conduit (1) or other rod do not have bends with a radius of curvature of less than 0.5 cm in the longitudinal direction of flow.

9. The apparatus according to claim 1, characterized in that, The fluid connections (4a, 4b, 7, 13, 15, 35) in the region of the conduit (1) or other rod do not have bends with a bending radius of less than 1 cm in the longitudinal direction of flow.

10. The apparatus according to claim 1, characterized in that, The fluid connections (4a, 4b, 7, 13, 15, 35) in the region of the conduit (1) or other rod do not have bends with a radius of curvature of less than 2 cm in the longitudinal direction of flow.

11. The apparatus according to claim 1, characterized in that, The fluid connections (4a, 4b, 7, 13, 15, 35) in the region of the conduit (1) or other rod do not have bends with a bending radius of less than 5 cm in the longitudinal direction of flow.

12. The apparatus according to claim 1, characterized in that, The cross-sectional area of ​​the fluid connections (4a, 4b, 7, 13, 15, 35) does not decrease from the area of ​​the conduit (1) or other rod to the external adjustment device (29).

13. The apparatus according to claim 1, characterized in that, The cross-sectional area of ​​the fluid connections (4a, 4b, 7, 13, 15, 35) increases in the transition region from the conduit (1) or other rod to the direction from which they diverge.

14. The apparatus according to claim 1, characterized in that, The fluid connections (4a, 4b, 7, 13, 15, 35) have an arcuate shape in or along the cross-section of the conduit (1) or other rod, the arcuate shape being generally tangentially attached to or coaxially surrounding the functional cavity located within the conduit (1) or other rod.

15. The apparatus according to claim 1, characterized in that, The fluid connections (4a, 4b, 7, 13, 15, 35) in the region of the conduit (1) or other rod are configured to engage with a hose or other line on the outside of the conduit (1) or other rod.

16. The apparatus according to claim 15, characterized in that, A recessed groove or recess is constructed on the outside of the conduit (1) or other rod to accommodate a hose or other line that can be joined.

17. The apparatus according to claim 16, characterized in that, The recessed groove or recess has a lateral undercut, which secures any hoses or other lines that can be pressed or inserted into it and prevents them from coming loose on their own.

18. The apparatus according to any one of claims 16 to 17, characterized in that, A hose or other line capable of engaging with the outside of the conduit (1) or other rod is preformed such that the hose or other line fills the recessed groove or recess and complements the adjacent outer contour of the conduit (1) or other rod in a manner that maintains the contour.

19. The apparatus according to claim 1, characterized in that, In the fluid connection (4a, 4b, 7, 13, 15, 35), in the transition region from the flow channel section (4a) integrated or formed in the conduit (1) or other rod to the flow channel (4b, 7, 35) separated therefrom, there are components (17, 17a) with a sloping or arcuate orientation.

20. The apparatus according to claim 19, characterized in that, The component (17, 17a) having a sloping or arcuate orientation is detachably inserted into a recess aligned with a flow channel section (4a) integrated or formed in the conduit (1) or other rod by means of a rearward protrusion arranged on the side opposite to the sloping orientation.

21. The apparatus according to claim 1, characterized in that, A thin-walled component (18) made of thin-walled material is inserted in the fluid connection (4a, 4b, 7, 13, 15, 35) in the transition region from the flow channel section (4a) integrated or formed in the conduit (1) or other rod to the flow channel (4b, 7, 35) separated therefrom, the thin-walled component being in close contact with the outlet of the flow channel section (4a) integrated or formed in the conduit (1) or other rod.

22. The apparatus according to claim 1, characterized in that, A tubular component (19) made of a bending-resistant material with a tubular shape and a gentle curvature is inserted in the fluid connection (4a, 4b, 7, 13, 15, 35) in the transition region from the flow channel section (4a) integrated or formed in the conduit (1) or other rod to the flow channel (4b, 7, 35) separated therefrom.

23. The apparatus according to claim 22, characterized in that, The tubular component (19), having a tubular shape, has an outer cross section that is larger than the inner cross section of the flow channel section (4a) integrated or formed in the conduit (1) or other rod, such that the tubular component (19) can be fixed there by friction fit in the event of local expansion of the flow channel section (4a).

24. The apparatus according to claim 1, characterized in that, In the fluid connection (4a, 4b, 7, 13, 15, 35), a cover-like component with a transverse saddle-shaped flat extension (18b) is joined or inserted in the transition region from the flow channel section (4a) integrated or formed in the conduit (1) or other rod to the flow channel (4b, 7, 35) separated therefrom, wherein the flat extension (18b) is capable of being stably connected to the rod covered thereto.

25. The apparatus according to claim 19 or 20, characterized in that, The components (17, 17a) with a sloping or arcuate orientation are covered by a cover-like component.

26. The apparatus according to any one of claims 19 to 24, characterized in that, Components (17, 17a, 18, 18a, 19) arranged in the transition region of the fluid connection (4a, 4b, 7, 13, 15, 35) from the flow channel section (4a) integrated or formed in the conduit (1) or other rod to the flow channel (4b, 7, 35) separated therefrom are provided with sleeves for inserting or connecting hoses in their proximal regions.

27. The apparatus according to claim 1, characterized in that, A filter and / or vapor barrier (20) is provided in the fluid connection (4a, 4b, 7, 13, 15, 35).

28. The apparatus according to claim 1, characterized in that, A connector (6) with an inner cavity is provided in the outer portion of the flow channel (4b, 7, 35) which is separate from the flow channel section (4a) integrated or formed in the conduit (1) or other rod, wherein the inner cavity has a constant cross-sectional area over the entire length of the connector when the sub-component of the connector is connected.

29. The apparatus according to claim 1, characterized in that, The minimum net internal cross-sectional area of ​​the external portion of the flow channel (4b, 7, 35), which is separate from the flow channel section (4a) integrated or formed in the conduit (1) or other rod, is greater than the minimum net internal cross-sectional area of ​​the flow channel section (4a) integrated or formed in the conduit (1) or other rod.

30. The apparatus according to claim 1, characterized in that, The minimum net internal cross-sectional area in the external portion of the flow channel (4b, 7, 35), which is separate from the flow channel section (4a) integrated or formed in the conduit (1) or other rod, is at least 1.1 times the minimum net internal cross-sectional area of ​​the flow channel section (4a) integrated or formed in the conduit (1) or other rod.

31. The apparatus according to claim 1, characterized in that, The minimum net internal cross-sectional area in the external portion of the flow channel (4b, 7, 35) that is separate from the flow channel section (4a) integrated or formed in the conduit (1) or other rod is at least 1.2 times the minimum net internal cross-sectional area of ​​the flow channel section (4a) integrated or formed in the conduit (1) or other rod.

32. The apparatus according to claim 1, characterized in that, The minimum net internal cross-sectional area in the external portion of the flow channel (4b, 7, 35) that is separate from the flow channel section (4a) integrated or formed in the conduit (1) or other rod is at least 1.3 times the minimum net internal cross-sectional area of ​​the flow channel section (4a) integrated or formed in the conduit (1) or other rod.

33. The apparatus according to claim 1, characterized in that, The pressure in the volume storage (26, R) of the external conditioning device (29) is adjusted to the target pressure value for the air bladder-like membrane body (3).

34. The apparatus according to claim 1, characterized in that, An element (23) with valve function and / or flow guiding function is provided in the fluid connection (4a, 4b, 7, 13, 15, 35).

35. The apparatus according to claim 34, characterized in that, The element (23) having valve function and / or flow guiding function is connected in parallel with a throttling element.

36. The apparatus according to claim 1, characterized in that, The pressure of the pressure source (Qi) of the filling medium in the external conditioning device (29) is adjusted to a pressure value higher than the target value of the airbag-shaped film body (3).

37. The apparatus according to claim 1, characterized in that, The pressure of the pressure source (Qi) of the filling medium in the external conditioning device (29) is adjusted to a pressure value of 100 mbar or higher.

38. The apparatus according to claim 1, characterized in that, The pressure of the pressure source (Qi) of the filling medium in the external conditioning device (29) is adjusted to a pressure value of 200 mbar or higher.

39. The apparatus according to claim 1, characterized in that, The pressure of the pressure source (Qi) of the filling medium in the external conditioning device (29) is adjusted to a pressure value of 500 mbar or higher.

40. The apparatus according to claim 1, characterized in that, The pressure of the pressure source (Qi) of the filling medium in the external conditioning device (29) is adjusted to a pressure value of 1 bar or higher.

41. The apparatus according to claim 1, characterized in that, The pressure of the pressure source (Qi) of the filling medium in the external conditioning device (29) is adjusted to a pressure value of 2 bar or higher.

42. The apparatus according to claim 1, characterized in that, A pressure sensor is arranged in the airbag-shaped membrane (3) so as to detect the actual pressure value in the airbag-shaped membrane (3).

43. The apparatus according to claim 42, characterized in that, The pressure sensor located in the airbag-shaped film body (3) is connected to or can be connected to the external adjustment device (29) via a cable.

44. The apparatus according to claim 1, characterized in that, The external conditioning device (29) has an active regulator designed to keep the pressure detected as actual within the airbag-like membrane (3) as constant as possible to a preset or preset target value.

45. The apparatus according to claim 1, characterized in that, The sealing surface of the airbag-like membrane (3) is fully sealed by means of the sealing pressure of the airbag-like membrane (3) acting as constantly as possible and / or in a manner that minimizes the remaining space between the airbag-like membrane (3) and the adjacent structure, as appropriate.

46. ​​The apparatus according to claim 1, characterized in that, The hollow organ or anatomical cavity is the patient's trachea or esophagus.

47. The apparatus according to claim 1, characterized in that, In the case of an endotracheal tube, a flow-optimized feeder with a defined large lumen is provided to feed the filling medium to the endotracheal tube cuff.

48. The apparatus according to claim 1, characterized in that, In the case of endotracheal tubes, the length of the flow channel section (4a) that leads to the sealed air sac-like membrane body (3) integrated or formed in the tube (1) or other rod is reduced to a minimum.

49. The apparatus according to claim 1, characterized in that, Regarding endotracheal tubes, eddies should be avoided between the reservoir or regulator and the cuff when moving the filling medium.

50. The apparatus according to claim 1, characterized in that, In the case of the endotracheal tube, in the transition area between the flow channel section (4a) integrated or formed in the tube (1) or other rod and the endotracheal sealing cuff and / or in the transition area between the flow channel section (4a) integrated or formed in the tube (1) or other rod and the delivery hose (4b) extending outside the body, and between the components of the connector (6), the flow characteristics are optimized in such a way that extracorporeal volume compensation for maintaining the sealing pressure is achieved in the sealing cuff element in a time-synchronous manner.

51. The apparatus according to claim 1, characterized in that, In the case of endotracheal tubes, flow characteristics are optimized between components of connector (6) and / or in the area of ​​integrated filter and / or vapor barrier (20) or element (23) with valve and / or flow guiding function in such a way that extracorporeal volume compensation for maintaining sealing pressure is achieved in the sealing bladder element in a time-synchronous manner.

52. The apparatus according to claim 1, characterized in that, The sealing airbag element or the airbag-shaped film body (3) is composed of a thin-walled airbag film made of polyurethane, the airbag film having a wall thickness of 5 μm to 30 μm in the portion facing each surface to be sealed.

53. The apparatus according to claim 1, characterized in that, The sealing airbag element or the airbag-shaped film body (3) is composed of a thin-walled airbag film made of polyurethane, the airbag film having a wall thickness of 10 μm to 20 μm in the portion facing each surface to be sealed.

54. The apparatus according to claim 1, characterized in that, The sealing airbag element or the airbag-shaped film (3) is made of PUR material with a Shore hardness of 70A to 95A.

55. The apparatus according to claim 1, characterized in that, The sealing airbag element or the airbag-shaped film body (3) is made of PUR with a Shore hardness of 54D to 60D.

56. The apparatus according to claim 1, characterized in that, The sealing airbag element or the airbag-like film body (3) has a multi-layer wall structure, wherein at least one material layer has special barrier properties against water vapor and / or air.

57. The apparatus according to claim 34, characterized in that, The element (23) having valve function and / or flow guiding function is oriented such that when the pressure in its volume reservoir (26, R) relative to the external conditioning device (29) is negative in the air bladder-like membrane body (3), it opens and allows the volume flow rate to flow rapidly into the air bladder-like membrane body (3).

58. The apparatus according to claim 57, characterized in that, Without active adjustment, the element (23) with valve function and / or flow guiding function opens when the pressure in the volume storage (26, R) relative to the external adjustment device (29) is negative in the air bladder membrane body (3) and allows the volume flow rate to flow rapidly into the air bladder membrane body (3).

59. The apparatus according to claim 35, characterized in that, The element (23) having valve function and / or flow guiding function is connected in parallel with a throttling element so as to gradually eliminate the overpressure that occurs in the air bladder-like membrane body (3) relative to the pressure in the volume storage (26,R) of the external regulating device (29).

60. The apparatus according to claim 43, characterized in that, The connecting cable is laid inside the conduit (1) or other rod in an additional cavity as appropriate, or in a flow channel section (4a) integrated or formed in the conduit (1) or other rod.

61. The apparatus according to claim 44, characterized in that, The active regulator of the external regulation device (29) is an electronic regulator or a dual-position regulator.

62. The apparatus according to claim 61, characterized in that, The dual-position regulator is operated at a fixed clock frequency, wherein valves are alternately opened and closed at corresponding frequencies between the pressure sources (Qi) of the filling medium, wherein the pulse ratio between the opening and closing phases can be affected by the regulator as a response to the difference between a preset or presetable pressure target value and the actual pressure value measured inside the bladder-like membrane (3).

63. The apparatus according to claim 62, characterized in that, The fixed clock frequency is between 100 Hz and 1000 Hz.

64. The apparatus according to claim 62, characterized in that, The valve is a piezoelectric valve.

65. The apparatus according to claim 50, characterized in that, The structural transition area from the catheter (1) or other rod to the delivery hose (4b) extending outside the body is located approximately 1 to 2 cm above the glottis plane.

66. The apparatus according to claim 56, characterized in that, The material layer with special barrier properties against water vapor and / or air is composed of EVOH.

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