Endotracheal tube and incubator

Abstract

The invention relates to an endotracheal tube for supplying the lungs of a premature infant (15) with amniotic fluid, the endotracheal tube comprising a tube section (5) having a proximal end (2) and a distal end (1), the two ends (1, 2) being connected by an amniotic fluid lumen (13) in the tube section (5) for conducting amniotic fluid, wherein, at the proximal end (2) of the tube section (5), the amniotic fluid lumen (13) is connected to an amniotic fluid reservoir (4), or at least the tube section (5) has, at its proximal end (2), a connector (3) for connecting the amniotic fluid lumen (13) to an amniotic fluid reservoir (4), and the tube section (5) has, in an end region before the distal end (1), a sealing device (6) which surrounds the end region and is expandable in cross-section. The invention also relates to an incubator (10) comprising such an endotracheal tube, the amniotic fluid reservoir (4) of which is height-adjustably mounted within or on the incubator.

Description

[0001] Endotracheal tube and incubator

[0002] The invention relates to an endotracheal tube and an incubator.

[0003] Endotracheal tubes are generally known in the prior art and, in the prior art as well as in the invention, serve to create access to the trachea of ​​a patient through the mouth or nose.

[0004] Current technology requires access for invasive mechanical ventilation of a patient. This involves supplying and extracting air through a standard endotracheal tube into the patient's trachea.

[0005] In premature infants, the use of invasive mechanical ventilation, which requires an endotracheal tube, is problematic. Their lungs, in terms of both anatomical structure and molecular cell function, are not yet prepared for breathing air (or engineered respiratory gases). While premature infants can often survive, they typically suffer permanent lung damage (Chronic Lung Disease (CLD), Bronchopulmonary Dysplasia (BPD)). Furthermore, critical oxygen deprivation or insufficient CO2 excretion can occur, damaging other organs, particularly the brain.

[0006] In the prior art, incubators are known that provide premature infants with a controllable environment to enable them to develop outside the womb. For example, the temperature, air composition, and humidity can be set or regulated. In such a prior art incubator, and also in the invention, the premature infants are thus located outside the amniotic fluid on a bed. Against this background, an object of the invention is to provide an endotracheal tube that makes it possible to maintain amniotic fluid in the lungs of premature infants until sufficient lung maturity has been achieved, at which point lung respiration can begin.

[0007] Furthermore, it is an object of the invention to provide an incubator that can be used together with the aforementioned endotracheal tube without the premature infant being immersed in amniotic fluid, while maintaining amniotic fluid filling of the lungs. The invention preferably aims to provide an alternative treatment to mechanical ventilation with gas exchange outside the body via an artificial lung (oxygenator). Preferably, it aims to enable the lungs to be ventilated as in the womb with natural (or artificial) amniotic fluid, possibly also with an oxygen-binding fluid, without requiring the infant to be completely immersed in this fluid.

[0008] This task is solved by the fact that the endotracheal tube is designed to supply the lungs of a premature infant, especially a premature infant with a body mass of less than 1000 grams, with amniotic fluid, especially artificial amniotic fluid.

[0009] According to the invention, the endotracheal tube comprises a tube section with a proximal end and a distal end. The distal end is designed to be inserted into the trachea of ​​a premature infant. The proximal end is the end of the tube section located outside the trachea and thus accessible mechanically or manually.

[0010] Furthermore, the two ends of the tube section are connected by an amniotic fluid lumen in the tube section for amniotic fluid conveyance, wherein the amniotic fluid lumen at the proximal end of the tube section is connected to an amniotic fluid reservoir or at least connectable, preferably wherein the tube section has a connector at its proximal end for connecting the amniotic fluid lumen to an amniotic fluid reservoir and the tube section has a sealing device in an end region before the distal end, surrounding the end region and enlarging in cross-section.

[0011] The sealing device in the area at or in front of the distal end of the tube section is designed to prevent the leakage of amniotic fluid between the tube section and the tracheal wall by means of a seal.

[0012] The amniotic fluid reservoir, preferably sealed off from the environment and preferably flexibly sealed, allows the lungs to be filled with amniotic fluid via the endotracheal tube, which is tightly inserted into the trachea. During respiratory movements, amniotic fluid can be displaced from the lungs through the amniotic fluid lumen of the tube segment into the amniotic fluid reservoir, and the corresponding backflow can occur, without air entering the lungs.

[0013] Preferably, the amniotic fluid reservoir, e.g., in the form of a filled bladder, is attached to or within an incubator. This allows the lung inflation of the premature infant to be maintained via the endotracheal tube in the incubator, even though the infant is no longer immersed in amniotic fluid within the incubator itself.

[0014] Preferably, the amniotic fluid reservoir is mounted in or on the incubator in a height-adjustable manner. This allows for the adjustment of different pressures in the amniotic fluid by changing the height of the reservoir.

[0015] Alternatively, a separate frame can be provided for the incubator, to which the amniotic fluid reservoir can be attached in a height-adjustable manner. In a preferred embodiment, the sealing device comprises a fluid-fillable balloon arranged around the end region in front of the distal end of the tubing section. The balloon can be filled through a filling lumen located at least partially within the tubing section, which opens into the interior of the balloon. Filling can be carried out with a fluid, e.g., a gas, or preferably with a liquid, e.g., a sodium chloride solution, through the filling lumen. The expansion of the balloon causes its outer wall to conform to the tracheal wall, thereby creating a seal.

[0016] Pressure monitoring can be provided, for example, by measuring the pressure in the balloon and signaling it externally. Alternatively, a control balloon can be attached to the endotracheal tube, particularly near the proximal end, which expands along with the balloon at the distal end and can be visually observed.

[0017] It is particularly advantageous if the balloon has a cylindrical, especially circular-cylindrical, balloon section when filled, which transitions distally into a distally tapering, especially cone-shaped, section.

[0018] This has the advantage that the balloon can create a very long axial contact surface over its cylindrical, especially circular, section. Therefore, high pressure is not required to achieve the desired liquid seal.

[0019] Preferably, the terms cylindrical, in particular circular cylindrical and conical, are also understood to include designs that do not exhibit these shapes in the strict mathematical sense, but at least correspond to them substantially. "Substantially" is intended to include the fact that the wall regions of the cylindrical and conical sections bulge outwards when internally pressurized. In particular, it may be provided that the aforementioned sections pass through the aforementioned shapes during filling and exhibit a bulge upon further filling.

[0020] Preferably, the balloon, with its cylindrical, and in particular circular-cylindrical, section, has the section that has the largest cross-section / diameter of the balloon in the expanded state. All other sections, if any, have a smaller cross-section / diameter than the aforementioned cylindrical section.

[0021] The cone-shaped section ensures that a specific diameter on the cone segment can correspond to the inner diameter of the trachea, creating a locally optimized seal. As the trachea grows during treatment, the locally optimized seal will automatically shift axially, since a suitable diameter is always present on the cone-shaped section. The combination of these sections thus results in an optimized and expanding seal.

[0022] Preferably, the cylindrical, in particular circular cylindrical, balloon section has a length of less than or equal to 5 mm and the conical balloon section has a length of less than or equal to 5.5 mm.

[0023] Further advantageous embodiments are identified in the following features a. to d., one or more of which may be present simultaneously. These features can thus be understood as alternatives, but can also occur in combination. a. The balloon preferably forms a trough surrounding the hose section in its proximal region, wherein an outlet opening of a suction lumen, guided at least partially within the hose section, is arranged in the trough or proximal to the trough on the surface of the hose section. This makes it possible to aspirate any liquids / secretions that may have collected in the trachea in front of the balloon or the sealing device, i.e., in a region of the trachea proximal to the sealing device that is in contact with ambient air. b.The balloon is preferably double-walled, with the interior of the double wall filled with a gel, preferably in which at least one pressure sensor is embedded, or which is fluidically connected to a pressure sensor, wherein the inner wall of the double wall surrounds at least part of the fluid-fillable interior of the balloon. This is particularly effective in preventing trauma caused by pressure on the tracheal wall. The pressure can be measured by at least one sensor located in the gel or in fluid communication with the gel. The sensor(s) can be located, for example, in an external sensing device or at least outside the balloon. In such a case, a pressure-transmitting fluid connection preferably exists between the at least one sensor and the gel, for example, by means of a fluid line connected to the sensor that opens into the gel.Preferred signal lines, particularly for transmitting electrical measurements from the at least one sensor, can connect the sensor(s), especially those located within the gel or externally, through the tube section to an external sensing device. Such a sensing device can be used to visualize and / or control the pressure, and in particular to maintain it within a predetermined pressure range. c. The interior of the balloon is preferably divided into at least two compartments, preferably at least two axially adjacent compartments, each of which can be filled with fluid independently of another compartment through its own filling lumen, which is guided at least partially within the tube section.The pressure exerted on the tracheal wall can thus be adjusted; in particular, it can be provided that the pressure of the compartments changes as the trachea grows, especially by transferring the maximum acting pressure from one compartment to another. The interior of the balloon is preferably filled with an open-cell foam whose pores can be filled with fluid through the filling lumen. The volume of such an open-cell foam can be expanded by filling with fluid or reduced by suction. Such a foam can also be self-expanding, in particular by automatically drawing in the fluid after the filling lumen is opened.

[0024] In preferred embodiments, the endotracheal tube according to the invention is adapted with regard to its structural dimensions in order to be used in premature infants (before the 37th week of pregnancy), in particular in extremely premature infants (before the 28th or before the 24th week of pregnancy).

[0025] Preferably, the endotracheal tube is designed such that the tube section has an outer diameter of less than or equal to 3 mm, preferably less than or equal to 2.5 mm, in particular the outer diameter in the area of ​​the sealing device minimized in cross-section, especially the unfilled balloon, is less than or equal to 2.6 mm.

[0026] This ensures that the tube section, in its minimized state when the sealing device, especially the balloon, is not yet in use, is not yet expanded, and that the tube section can be inserted into the trachea of ​​premature infants, especially extremely premature infants, with the distal end and the sealing device leading.

[0027] Preferably, it is further provided that the outer diameter of the sealing device maximized in cross-section, in particular of the filled balloon, is less than or equal to 5 mm.

[0028] Further training may stipulate that the balloon includes limiting devices / elements which define its shape when filling the balloon and / or restrict expansion beyond a predetermined maximum level.Another preferred embodiment provides that the amniotic fluid lumen arranged in the tubal section is non-circular in cross-section, in particular at least substantially semicircular, elliptical, or kidney-shaped, and / or preferably extends equidistantly to the outer wall of the tubal section over an angular extent of at least 100 degrees around the center of the tubal section, preferably wherein the minimum cross-sectional dimension of the amniotic fluid lumen in one direction, in particular in the radial direction, is greater than 0.8 mm, preferably greater than 0.85 mm, preferably wherein the minimum cross-sectional dimension of the amniotic fluid lumen is less than 1 mm, preferably less than 0.95 mm.

[0029] This ensures that there is sufficient space for amniotic fluid flow in the lumen, while still leaving space in the cross-section of the tubal section for additional required lumens.

[0030] Preferably, the amniotic fluid lumen is arranged as the only lumen within one half of the tubal section cross-section, wherein any further lumens of the tubal section are arranged in the other half of the cross-section, in particular wherein all other lumens have a circular cross-section.

[0031] Preferably, the wall thickness of the material of the hose section in areas between adjacent lumens is in the range of 0.15 mm to 0.25 mm, preferably 0.2 mm.

[0032] In a preferred embodiment, the hose section and / or the balloon can have a hydrogel coating on the outside, particularly with a thickness of less than or equal to 15 micrometers.

[0033] The embodiments are explained in more detail with reference to the following figures.

[0034] Figure 1 shows in an overview only the endotracheal tube according to the invention comprising a distal end 1, which may be a beveled end, and a proximal end 2, which here has a connector 3 to be connected to an amniotic fluid reservoir 4 not shown here, but shown in Figure 4.

[0035] The amniotic fluid reservoir 4 is in fluidic communication with the open distal end 1 via an amniotic fluid lumen 13 running in the tube section 5, e.g., as shown in Figure 3, so that a patient is able to exhale amniotic fluid through the endotracheal tube into the amniotic fluid reservoir 4 and re-breathe it from the amniotic fluid reservoir 4 back into the lungs. Furthermore, the lungs of a premature infant can be filled with (artificial) amniotic fluid via the endotracheal tube according to the invention.

[0036] An expandable balloon 6 is arranged in a region in front of the distal end 1. This is designed to seal the space between the tube section 5 at the distal end and the trachea of ​​a premature infant against fluid leakage by filling the initially unfilled balloon 6 with a fluid, preferably a liquid such as NaCl solution, after insertion into the trachea, causing it to expand.

[0037] For filling, a filling lumen 8, e.g., as shown in Figure 3, is provided in at least part of the hose section 5, preferably extending laterally out of the hose section 5 as a filling hose section 8a before the distal end 2. This filling hose section 8a may have a connector, e.g., a Luer connector 8b, at its end.

[0038] The balloon 6 may preferably have a proximally open recess 6a from which secretions collected in the trachea in front of the balloon 6 can be aspirated. For this purpose, a suction lumen 7 opens into the recess 6a or proximally in front of the recess 6a into the wall of the tube section. This suction lumen 7 in the tube section 5, e.g., as shown in Figure 3, may extend laterally from the tube section 5 as a suction tube section 7a in front of the distal end 2. A surfactant tube section 9a may also be provided, which leads a surfactant lumen 9 out of the tube section 5, e.g., as shown in Figure 3. The surfactant lumen 9 opens into the distal end 1. Surfactant is an acronym for surface-active agent and here refers to a mixture of phospholipids and proteins that is produced in the lungs and femoral membranes and reduces the surface tension of the alveoli.Surfactant is also available as a naturally or synthetically derived drug and can be administered via the tubing section 9a described here.

[0039] Figure 2 shows a modification of the embodiment according to Figure 1, in which the balloon 6 is double-walled. In the double-walled section, the balloon 6 is preferably filled with a gel, in particular in which at least one pressure sensor 11 is embedded for receiving pressure measurements. The measured values ​​can be transmitted to a data acquisition device 14 via at least one signal line 13 routed in the hose section 5, and preferably signaled by this device. The pressure sensor 11 can also be arranged externally to the balloon 6 and, in this case, preferably has a fluid connection that leads into the double-walled section and is preferably also routed through the hose section 5.

[0040] Figure 3 shows a possible cross-section of the tube section 5 in an area where all the existing lumens are guided within the cross-section. It can be seen that the amniotic fluid lumen 13 occupies the largest cross-sectional area, thus ensuring that the amniotic fluid can be moved back and forth between a premature infant and the amniotic fluid reservoir 4 during respiratory movements without excessive resistance, in particular allowing it to "swing".

[0041] For this purpose, the amniotic fluid lumen 13 occupies at least substantially one half of the cross-sectional area of ​​the tubal section 5, in particular up to the necessary wall thicknesses. Over an angular range of at least 100 degrees around the center of the cross-section, the wall of the amniotic fluid lumen 13 is parallel to the outer wall of the tubal section 5. The amniotic fluid lumen 13 is thus not circular in shape, in particular at least substantially semicircular.

[0042] The other lumens, e.g., the suction lumen 7, the filling lumen 8, and the surfactant lumen 9, are arranged in a circular cross-section within the other half of the cross-sectional area, with the suction lumen having the largest cross-section of the circular lumens. The wall thickness of the material of the tube section 5 between adjacent lumens is in the range of 0.15 to 0.25 mm, preferably 0.2 mm. The various lumens can also have cross-sectional shapes other than those shown here; in particular, the amniotic fluid lumen always has the largest cross-section.

[0043] The outer diameter of the tube section 5 is dimensioned such that the tube section 5 can also be inserted into the trachea of ​​premature infants born before the 37th week of gestation, in particular before the 28th, preferably before the 24th week of gestation, or who have a body mass of less than 1000 grams, in particular a body mass of 400 grams to 1000 grams. Preferably, the outer diameter of the tube section 5 is less than or equal to 2.5 mm.

[0044] All dimensions mentioned in the description of Figure 3 are to be understood as examples, without limiting the invention to the dimensions shown in the combination.

[0045] Figure 4 shows an incubator 10 in which a premature infant 15 lies. The lungs of the premature infant 15 are filled with amniotic fluid from the amniotic fluid reservoir 4 via the endotracheal tube according to the invention, in particular via its amniotic fluid lumen 13 in the tube section 5. Oxygen supply can be provided via the blood and the umbilical cord, e.g., by extracorporeal membrane oxygenation (ECMO) using an oxygenator 12. In this way, the premature infant 15 can mature its lungs in an in-utero situation within the incubator 10, where, for example, temperature and humidity can be controlled, and does not need to be ventilated with air immediately after premature birth.

[0046] Figure 5 shows the distal end of a preferred endotracheal tube in detail. The tube section 5 terminates distally in a preferably beveled end 1 and has a balloon 6 in a region upstream of the distal end 1, which can be expanded by filling its inner volume with a fluid. Figure 5 shows the balloon in an expanded state.

[0047] Here, the balloon 6 transitions distally from a circular cylindrical section 6' into a conical section 6" that tapers distally. The maximum expanded diameter of the cylindrical section 6' is preferably less than 5 mm. The balloon 6 can preferably be manufactured by blow molding. For example, it can be attached to the tube section 5 in front of its distal end 1 by means of ring elements arranged at its axial ends, e.g., by shrinking, gluing, etc.

Claims

Patent claims 1. Endotracheal tube for supplying the lungs of a premature infant (15), in particular a premature infant (15) with a body mass of less than 1000 grams, with amniotic fluid, in particular artificial amniotic fluid, comprising a tube section (5) with a proximal end (2) and with a distal end (1), wherein the two ends (1, 2) are connected by an amniotic fluid lumen (13) in the tube section (5) for the amniotic fluid supply, wherein the amniotic fluid lumen (13) at the proximal end (2) of the tube section (5) is connected to an amniotic fluid reservoir (4) or at least the tube section (5) has a connector (3) at its proximal end (2) for connecting the amniotic fluid lumen (13) to an amniotic fluid reservoir (4), and the tube section (5) has a sealing device (6) in an end region upstream of the distal end (1) that surrounds the end region and can be enlarged in cross-section.wherein the sealing device (6) comprises a fluid-fillable balloon (6) arranged around the end region in front of the distal end (1) of the hose section (5), wherein the balloon (6) can be filled by a filling lumen (8) arranged at least partially in the hose section (5), which opens into the interior of the balloon (6), and the balloon (6) has a cylindrical balloon section (6') when filled, which transitions distally into a distally tapering, in particular a conical section (6").

2. Endotracheal tube according to one of the preceding claims, characterized in that the balloon (6) has at least one of the following features: a. the balloon (6) forms a recess (6a) surrounding the tube section on its proximal region, wherein in the recess (6a) or proximal to the recess (6a) in the surface of the tube section (5) there is an orifice of at least a. the suction lumen (7) is arranged in the hose section (5) in a certain area, and / or b. the balloon (6) is double-walled, wherein the interior of the double wall is filled with a gel, preferably in which at least one pressure sensor (11) is embedded, or which is fluidically connected to a pressure sensor, wherein the inner wall of the double wall surrounds the fluid-fillable interior of the balloon (6) at least in certain areas, and / or c. the interior of the balloon (6) is divided into at least two compartments, preferably axially arranged compartments, each of which can be fluid-filled independently of another compartment by its own filling lumen guided at least in certain areas in the hose section (5), and / or d. the interior of the balloon (6) is filled with an open-pore foam, the pores of which can be fluid-filled by the filling lumen.

3. Endotracheal tube according to one of the preceding claims, characterized in that the cylindrical balloon section (6') has a length of less than or equal to 5 mm and the conical balloon section (6") has a length of less than or equal to 5.5 mm.

4. Endotracheal tube according to one of the preceding claims, characterized in that the tube section (5) has an outer diameter of less than or equal to 3 mm, preferably less than or equal to 2.5 mm, in particular the outer diameter in the area of ​​the sealing device (6) minimized in cross-section, in particular the unfilled balloon (6), is less than or equal to 2.6 mm.

5. Endotracheal tube according to one of the preceding claims, characterized in that the outer diameter of the sealing device (6) maximized in cross-section, in particular of the filled balloon (6), is less than or equal to 5 mm.

6. Endotracheal tube according to one of the preceding claims, characterized in that the [unclear] arranged in the tube section (5) The amniotic fluid lumen (13) is non-circular in cross-section, in particular at least substantially elliptical or kidney-shaped, or preferably extends equidistantly to the outer wall of the tubal section (5) over an angular extent of at least 100 degrees around the center of the tubal section, preferably wherein the minimum cross-sectional dimension of the amniotic fluid lumen (13) in one direction, in particular in the radial direction, is greater than 0.8 mm, preferably greater than 0.85 mm, preferably wherein the minimum cross-sectional dimension of the amniotic fluid lumen (13) is less than 1 mm, preferably less than 0.95 mm.

7. Endotracheal tube according to claim 6, characterized in that the amniotic fluid lumen (13) is arranged as the only lumen within one half of the tube section cross-section and all other lumens (7, 8, 9) of the tube section (5) are arranged in the other half of the cross-section, in particular wherein all other lumens (7, 8, 9) have a circular cross-section.

8. Endotracheal tube according to one of the preceding claims, characterized in that the tube section (5) and / or the balloon (6) have a hydrogel coating on the outside, in particular with a thickness of less than or equal to 15 micrometers.

9. Incubator (10) comprising an endotracheal tube according to one of the preceding claims, the amniotic fluid reservoir (4) of which is height-adjustable in or on the incubator.

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