WO2005058401A1 - Device for insertion into the trachea or between the trachea and the esophagus - Google Patents

Abstract

The invention concerns a device for insertion into the trachea or between the trachea and the esophagus following a tracheotomy or following a laryngotomy and for producing an opening between the trachea and the esophagus. Said device comprises a hollow stem (1) having a first opening (16) for breathing air intake and a second opening (3) for breathing air exit. The invention aims at improving said device. Therefor, a thin-walled membrane (4), preferably tubular, is connected, in the exit direction, to the second opening (3). Said membrane collapses in the absence of an air flow or in case of a reverse air flow from the air exit opening (3) thus sealing the latter (3).

Description

TRACOE medical GmbH

Device for insertion into the trachea or between trachea and esophagus

The present invention relates to a device for insertion into the trachea or between trachea and esophagus, with a hollow shaft (1), wherein the shaft (1) has a first opening (16) for the entry of breathing air and a second opening (3) for having the escape of breathing air.

Tracheostomy tubes are used to optimally oxygenate patients with a tracheotomy even after surgery or to allow them to breathe independently. In this case, a curved cannula is introduced through the tracheotomy into the region of the trachea. Thus, the trachea is directly connected to the outside world and the patient can breathe via the cannula. To prevent inhalation of fluid, e.g. Saliva, or leftovers from the trachea into the region of the lungs, most of the tracheostomy tubes known in the art have an annular cuff that can be filled with a fluid (mostly air) that separates the space between the shaft of the tracheostomy cannula and the shaft Sheath surrounding trachea cross section fills. If the cuff is filled with the fluid, it rests against the inner wall of the trachea and seals the trachea. Breathing can then take place exclusively via the cannula.

Since due to the sealing cuff no air flow in the direction of the throat of the patient is possible, this also has no way to articulate vocally, since no air is passed through the vocal cords.

Tracheostomy tubes are now known from the prior art, in which the cannula inside the trachea above the annular sleeve has an air outlet opening, so that at least part of the air exhaled by the patient can escape in the direction of the vocal cords and the pharynx. Thus, it allows the patient at least restricted to speak. In order to prevent liquid or food particles getting into the cannula via the third air outlet when swallowed incorrectly, valves are known from the prior art which close the air outlet opening during inhalation so that the patient breathes only via the cannula. From DE 198 03 572 such a tracheostomy cannula is known, in which the third air inlet opening is closed by an air-permeable membrane, for example made of polytetrafluoroethylene (PTFE). Such a membrane is permeable to air, but prevents the penetration of liquids or solids into the cannula. US Pat. No. 5,957,978 discloses further valve closures for the air outlet opening, all of which represent variations of a flap valve. The known from DE 198 03 572 diaphragm valve allows only a small air flow through the trachea and thus only a very quiet speaking of the patient. The flap valves shown in US Pat. No. 5,957,978 prove to be disadvantageous, since their function is quickly impaired by contamination (slime). In addition, the flap valves for opening require a comparatively high overpressure in the tracheostomy cannula so that speech utterances of the patient are possible only at a comparatively high pressure during exhalation.

Since the patients can not cough up, the trachea must be evacuated by the medical staff at regular intervals. In this case, the valve must remain closed at the air outlet opening in any case, to continue to ensure a complication-free breathing of the patient. However, the flap valves known from the prior art open during the aspiration of the trachea.

As an alternative to the previously described tracheostomy cannulas, after removal of the larynx, the trachea can be surgically separated from the esophagus. The trachea then ends in the tracheotomy. Because the air and esophagus are separated, inhalation through the tracheotomy will not allow any fluids or food particles to enter the trachea. On the other hand, speaking is impossible for the patient since no breathing air can reach the pharynx.

In order to still allow the patient to speak, so-called voice prostheses are known from the prior art. These have a hollow shaft, which is inserted between the esophagus and the esophagus and thus creates a passage between the two tubes. To prevent the tracheostomy tubes from getting liquids and food particles from the esophagus into the trachea, the voice prostheses are provided with a flap or ball valve at their end extending into the esophagus. However, these valves are sometimes leaking, so that food particles from the esophagus pass into the trachea, which leads to significant discomfort and can cause complications.

The known from the prior art air outlet valves, usually resiliently against the valve seats biased flaps or ball valves, both the tracheostomy tubes and the voice prostheses are relatively stiff. This means that the patient must build a high pressure in the respiratory tract, so that the valve opens to the throat, so that with the help of the air flowing into the throat space sounds can be generated. For bedridden patients, therefore, speaking with the help of a tracheostomy tube or a voice prosthesis is often a great effort. Compared with the known prior art, the present invention has the object to provide a tracheostomy tube or a voice prosthesis, which avoid the disadvantages mentioned.

The object is achieved according to the invention by providing a device for insertion into the trachea or between the trachea and the esophagus after a tracheotomy or after laryngeal detachment, with a hollow shaft, wherein the shaft has a first opening for the entry of respiratory air and a second opening for the escape of breathing air, wherein in the discharge direction of the second opening is followed by a preferably tubular thin-walled membrane which collapses in the absence or reversal of an air flow from the air outlet opening and thereby closes the outlet opening.

An embodiment of the invention is preferred in which the membrane adjoining the second opening is tubular. In alternative embodiments, the cross-section through the membrane in its open state in a plane parallel to the opening is part-circular or it has the course of a straight line.

The air flow through the air outlet opening is caused by the pressure difference between the pressure inside the shaft and the pressure in the vicinity of the shaft outside the air outlet opening. If the patient exhales, a higher pressure is created in the shaft than outside, so that the valve is opened and the air can flow out. If the exhalation ends, a pressure equilibrium occurs and the membrane collapses due to gravity. During inhalation, a lower pressure prevails within the shaft than outside, so that the membrane is pressed against the air outlet opening.

An embodiment of the invention is preferred in which the device is a tracheostomy cannula for insertion into the trachea. According to the invention, this has a shaft and an annular collar which fills the space between the shaft and the tracheal cross-section surrounding the shaft, the shaft having in the region of the trachea on the side of the collar facing the vocal cords a second opening for the air outlet, which preferably is arranged so that it points in the direction of the pharynx and wherein in the exit direction to the air outlet opening, the self-closing valve connects, which is made of a thin-walled membrane.

In an alternative embodiment of the invention, it is expedient for the device to be a voice prosthesis for insertion between the trachea and the esophagus. It is advantageous if the shaft is made of a first, soft material, preferably silicone, wherein the shaft is preferably reinforced in the region of the passage between the esophagus and the esophagus with a material that is harder than the first material. The valve according to the invention preferably consists for all embodiments of an open tube section made of a thin-walled membrane, one opening of which adjoins the air outlet opening, while the at least one other opening of the device is free, the length of the tube section being greater than its cross-sectional radius.

In the case of a tracheostomy cannula, the air outlet opening is preferably provided in the region of the convex bend of the cannula from its vertical section running in the trachea into the horizontal and points in the direction of the pharyngeal space.

The tube valve is expediently formed by a thin-walled membrane tube which connects like a chimney to the air outlet opening, It is essential that the wall thickness of the membrane tube is so small that the tube collapses under normal pressure conditions and collapses. The patient inhales, i. If a negative pressure arises in the tracheostomy cannula or the voice prosthesis, then the collapsed walls of the membrane tube seal the second opening for the air outlet, so that air can only flow into the respiratory tract through the lumen of the tracheostomy cannula or the trachea. Among other things, this prevents the passage of fluid and solids from the esophagus into the cannula or trachea. This is particularly important in patients who are struggling with dysphagia following larynx surgery. On the other hand, when exhaling an overpressure in the cannula or the voice prosthesis is built up to the environment, for example by a valve on the outer opening of the cannula or on the trachea, this pushes apart the walls of the membrane tube and allows air flow through the second air outlet of the Tracheostomy cannula or the voice prosthesis and the membrane tube in the direction of the pharynx or the esophagus.

Such a configuration of a tracheostomy cannula or a voice prosthesis with a valve closing off the air outlet opening is advantageous, since such a self-closing valve is not opened during the aspiration of mucus from the tracheal cannula or the trachea, but already at a slight overpressure in the tracheostomy tube or the Voice prosthesis opens and so the patient is able to speak even with only weak exhalation. This is useful because many bedridden and elderly patients are greatly weakened especially after surgery and can only build up a slight overpressure when exhaling, but this allows them with the device according to the invention already speaking. Furthermore does not apply the valve and the membrane does not irritate the surrounding esophagus, even if it should touch them.

It is useful if the membrane has a wall thickness of less than 50 microns and their length is preferably two to three times the diameter of the opening. If the membrane is designed as a hose, then it is advantageous if the length of the hose is at least equal to the hose diameter. Such a design of the self-closing valve is particularly suitable to allow an effective closing of the air outlet opening during inhalation, while it opens at a low exhalation pressure and allows the patient to speak.

Particularly preferred is an embodiment of the device in which the membrane of the valve is made of an elastomer, such as. As PU, PVC, silicone, latex, PTFE, etc., these materials, if necessary, can be additionally hydrophobicized. These elastomers can be produced as thin-walled hoses or thin membranes and prevent sticking of the collapsed walls even in moist and slimy surroundings.

The flexural rigidity of the membrane is preferably such that the membrane driven by gravity can collapse without the material experiencing permanently material-changing kinks which subsequently lead to damage to the membrane. In addition, it is expedient if the end of a tracheostomy tube located outside the body has a valve which opens on inhalation, so that air can flow from the outside into the cannula and thus into the lungs, while it closes when exhaling, so that the entire air flows out through the air outlet and the pharynx of the patient. This ensures optimal patient breathing and speech articulation while effectively preventing the aspiration of particles.

It proves to be advantageous embodiment of the device according to the invention, in which in the air outlet opening a grid is arranged, which carries the collapsed hose and prevents an inner flaps of the hose. Thus, the functionality of the valve is maintained in the long term. The grid also prevents the tube of food debris or fluids from the feed or trachea from being forced inwardly into the shaft.

Further advantages, features and possible applications of the present invention will become apparent from the following description of a preferred embodiment and the associated figures. FIG. 1 shows a three-dimensional representation of a tracheostomy cannula according to the invention with an open tube valve.

FIG. 2 shows a three-dimensional view of the tracheostomy cannula from FIG. 1 with closed tube valve. FIG. 3 shows a sectional view of a voice prosthesis according to the invention with an open tube valve.

FIG. 1 shows a tracheostomy cannula according to the invention in a lateral three-dimensional view. The tubular shaft 1 of the cannula and the annular collar 2 can be clearly seen. The tubular shaft of the cannula, in the embodiment shown, has an internal diameter between 6 mm and 12 mm, e.g. 8 mm up. The course of the shaft 1 is angled, so that the machine end 5 of the cannula can be led out substantially horizontally from the trachea, while the patient end 6 opens into the trachea. The two substantially straight portions of the shaft 1 have a bending angle of about 90 ° to 120 °, typically about 100 ° to each other. The length of the straight, located in the trachea section 8 is just like that of the horizontal, out of the trachea leading section 7 about 30 to 40 mm.

Attached to the outer wall of the section 8 extending parallel to the trachea is an inflatable plastic sleeve 2 which can be filled with air via a filling hose with control balloon 11 located outside the body, so that the lateral surface of the annular collar is firmly against the inner wall of the balloon the cuff surrounds the trachea. The space between the inner wall of the trachea and the shaft 1 of the tracheostomy tube is sealed, so that no foreign body can enter the trachea. The cuff 2 is made of a soft plastic, which is elastic, so that it adapts well to the contour of the trachea, without affecting them. Thus, no additional complaints occur in the patient. The inflatable cuff 2 provides additional support to the tracheostomy tube.

In the region of the bend 10, the tracheostomy cannula is provided on the convex side with an air outlet opening 3, through which the air exhaled by the patient can pass into the region of the trachea lying above the cuff 2. In this case, the air outlet opening 3 is arranged in the shaft 1 of the tracheostomy tube such that its opening points upward, ie in the direction of the pharyngeal space. At the Luftaustrittsöffnuπg 3 a hose valve 4 is connected. In this case, the hose is attached to the outer wall of the shaft 1 so that the entire breathing air exiting from the air outlet opening 3 flows through the hose valve 4. The tube valve 4 consists of a thin-walled membrane tube whose wall thickness is 50 microns in the illustrated embodiment of the invention. The hose itself is made of PU. If the patient exhales when closing the outer opening 15 of the shaft, the overpressure in the Tracheostomy tube that breathing air exiting the air outlet opening 3 and the membrane tube of the tube valve 4 opens and flows through. The membrane tube is placed by the adjacent internal pressure, so that it can flow through the air unhindered. The air passing through the membrane tube passes into the upper part of the trachea and flows through the vocal cords of the patient so that it can express itself vocally.

The outlet opening 3 is formed by a plurality of individual air outlets 3a, which are arranged in the wall of the shaft 1, that in the region of the air outlet opening 3, a grid is formed. This grid serves to support the membrane tube 4 in the collapsed state.

In order to allow the largest possible part of the breathing air to escape through the air outlet opening 3 and the Schlauchventϊl 4 when exhaling, as shown in the illustrated embodiment, at the upper end 5 a valve 9, in the illustrated embodiment, a flap valve may be provided. This opens upon inhalation, so that air can flow through the tracheostomy tube into the lungs, while it closes when exhaling, so that the breathing air must escape through the air outlet opening 3 substantially. Likewise, the outer opening 15 can be closed, for example, during exhalation by placing a finger to allow speaking.

In Figure 2, the same tracheostomy tube as shown in Figure 1 is shown, the case being shown that the patient inhales, i. the flapper valve 9 is opened. Since inhalation relative to the environment a negative pressure in the tracheostomy tube, the thin-walled membrane tube collapses. This effect is reinforced by the force acting on the membrane tube gravity, so that the hose not only collapses in itself but also angled. As a result, the air outlet opening 3 is closed and, during the inhalation, no air or other material can pass from the part of the trachea located above the cuff 2 into the tracheostomy cannula. Thus, it is effectively prevented that liquid or foreign particles, e.g. Food debris, enter the tracheostomy tube and the underlying behind the tracheostomy cannula respiratory organs.

FIG. 3 shows a side sectional view of a voice prosthesis 120 according to the invention. The voice prosthesis 120 has a hollow shaft 101 which, in the installed state of the voice prosthesis, extends between the patient's air and esophagus. Here, the shaft 101 of the voice prosthesis 120 in the illustrated embodiment of at least one hohlzyliπ- derförmigen element. A first member 121 of the airway and esophagus fitting silicone conforms to a flange 122 which conforms to the esophagus in the vicinity of the opening. The second hollow cylindrical element 123 has an outer diameter which is slightly smaller than the inner diameter of the first hollow cylinder. Linderförmigen element 121. The flange 124 of the second element 123, abuts against the wall of the trachea in the vicinity of the opening. The element 123 is made of a harder material compared to the silicone of the element 121, so that the second element 123 can be clamped in the first element 121, wherein both elements are in frictional engagement with each other and the shaft 101 of the voice prosthesis from the flanges 122 and 124 is held in the opening between the esophagus and the esophagus.

At the opening 126 of the voice prosthesis 120 on the side of the esophagus, a tube valve 104 is arranged. The tube is attached to the outer wall of the stem 122 so that all of the breath exiting through the air outlet 103 flows through the tube valve 104. In this case, the air outlet opening 103 is formed by a plurality of air outlet openings 103a, which are arranged in a wall extending over the outlet opening 103 of the shaft 122. The grid thus formed also serves as a support for the collapsed tube valve 104. The tube valve 104 consists of a thin-walled membrane tube whose wall thickness in the illustrated embodiment is 70 microns. The hose itself is made of PU. If the patient closes the tracheotomy, for example with the aid of a finger or a valve, and exhales at the same time, then the respiratory air passes through the shaft 101 of the voice prosthesis. On the side of the esophagus, all the air exits through the outlet openings 103a of the voice prosthesis 120, and the positive air pressure forces the membrane tube of the hose valve 4 apart so that the air can flow into the esophagus and into the throat area via the esophagus. When the patient reopens the tracheotomy, the overpressure in the area of the trachea during exhalation is insufficient to force the hose of the hose valve 104 apart and set up, with the result that the hose valve 104 remains closed and the patient exhales via the tracheotomy. The closed tube valve 104 then prevents liquid and food particles from passing through the exit opening 103 of the voice prosthesis 120 from the esophagus into the trachea of the patient.

In an alternative embodiment of the voice prosthesis according to the invention, the shaft is made in one piece from a soft silicone. For insertion of the voice prosthesis in the opening between the esophagus and the air, a tube is slipped over the entire voice prosthesis, the inner diameter of which is slightly larger than the outer diameter of the shaft. The flanges of the prosthesis are stretched so that they extend axially in the extension of the shaft within the tube. After insertion of the tube in the opening between the esophagus and the esophagus, the voice prosthesis is pushed out of the tube while the tube is pulled out of the opening. In this case, the flanges spring back into their original, substantially perpendicular to the shaft of the voice prosthesis position so that they fix the prosthesis within the opening. For purposes of the original disclosure, it is to be understood that all such features as will become apparent to those skilled in the art from the present description, drawings, and claims, even though they have been specifically described only in connection with certain further features, both individually and separately any combination with other of the features or feature groups disclosed herein are combinable, unless this has been expressly excluded or technical conditions make such combinations impossible or pointless. On the comprehensive, explicit representation of all conceivable combinations of features is omitted here only for the sake of brevity and readability of the description.

Claims

claims 1. A device for insertion into the trachea or between trachea and esophagus after a tracheotomy or after removal of the larynx and making an opening between the esophagus and the esophagus, with a hollow shaft (1, 101), wherein the shaft (1, 101) a first opening (16, 116) for the entry of breathing air and the second opening (3, 103) for the escape of breathing air, characterized in that in the outlet direction to the second opening (3, 103) has a preferably tubular, thin-walled Membrane (4, 104) connects, which coincides in the absence or reversal of an air flow from the air outlet opening (3, 103) in itself, while the outlet opening (3, 103) closes. 2. Apparatus according to claim 1, characterized in that the device is a tracheostomy tube for insertion into the trachea through an opening in the trachea, with an annular sleeve (2), the space between the shaft (1) and the shaft ( 1) surrounding the tracheal cross-section, the shaft (1) for the inlet and outlet of breathing air having an outer end (5) with a third opening (15) and an inner end (6) with the first opening (16), and wherein the second opening (3) is arranged on the shaft in the region of the trachea. 3. A device according to claim 1, characterized in that the device is a voice prosthesis (120) for insertion between the trachea and the esophagus. 4. Apparatus according to claim 3, characterized in that the shank (1, made of a first, soft material, preferably silicone. 5. Apparatus according to claim 4, characterized in that the shaft (101) is reinforced in the region of the passage between the esophagus and the esophagus with a harder compared to the first material. 6. Device according to one of claims 1 to 5, characterized in that the second opening (3, 103) in the direction of the pharyngeal space or the esophagus shows. 7. Device according to one of claims 1 to 6, characterized in that the membrane (4, 104) has a wall thickness of less than 100 microns, preferably 50 microns or less up has. 8. Device according to one of claims 1 to 7, characterized in that the membrane (4, 104) has a length which is at least equal to the diameter of the air outlet opening (3, 103). 9. Device according to one of claims 1 to 8, characterized in that the membrane (4, 104) has a length which is 1.5 to 2.5 times the diameter of the air outlet opening (3). 10. Device according to one of claims 1 to 9, characterized in that the membrane (4, 104) is made of a hydrophobic material. 11. Device according to one of claims 1 to 10, characterized in that the membrane has sufficient bending stiffness. 12. Device according to one of claims 1 to 11, characterized in that the membrane (4, 104) made of an elastomeric material, such as polyurethane or latex. 13. Device according to one of claims 1 to 12, characterized in that in the air outlet opening (3, 103) a grid is arranged, which carries the collapsed membrane (4, 104) and an inner flaps of the membrane (4, 104 ) prevented. 14. The device according to claim 2, characterized in that the located outside of the body end (5) of the cannula has a valve (9). 15. Device according to one of claims 1 to 14, characterized in that at the air outlet opening (3, 103) in addition a further valve, preferably a Klappan- or ball valve is arranged.