GB2581796A

GB2581796A - Tracheostomy tube

Info

Publication number: GB2581796A
Application number: GB1902550.1A
Authority: GB
Inventors: Zimmermann Sara
Original assignee: Stratec SE
Current assignee: Stratec SE
Priority date: 2019-02-26
Filing date: 2019-02-26
Publication date: 2020-09-02
Also published as: GB201902550D0

Abstract

The invention relates to a tracheostomy tube which allows for speech. The tracheostomy tube comprises three channels; a respiratory channel 20 through which ventilation air (40, Fig 2) may be passed, a cuff inflation channel 30 through which air may be passed to inflate a cuff 20 provided at a distal end of the tube, and a phonation channel 1 which may be used to provide the patient with the airflow (50, Fig 2) necessary for speech. The phonation channel 1 is preferably in communication with fenestrations 5 provided proximal of the cuff 20 and opening toward the throat. A phonation unit may be connected to the proximal end of the phonation channel 1, the phonation unit preferably comprising a moistener, humidifier, heater and/or a UV light source for conditioning and/or sterilizing the airflow introduced into the phonation channel. A method of manufacturing a tracheostomy tube of this sort, as well as the use of such a tracheostomy tube for artificial respiration of a patient, are also provided.

Description

TRACHEOSTOMY TUBE

DESCRIPTION

Field of the Invention

[0001] The invention relates to a tracheostomy tube allowing patients to talk.

Brief description of the related art

[0002] Tracheotomy is one of the most important measures in emergency and intensive cart medicine. An artificial respiration of the patient is possible by this surgical intervention and the independent breathing of the patient may be simplified by tracheotomy.

[0003] A tracheal cannula is usually placed in the tracheotomy. This forms a kind of an interface between the ventilator and the patient's body. The incision is placed below the larynx so that it is located below the vocal cords. Speech is not possible during ongoing artificial respiration.

[0004] A tracheostomy tube known from the prior art may have a replaceable inner part. The inner part of the tracheostomy tube is in two different embodiments available, one for artificial respiration and one for independent breathing of the patient. The inner part of a tracheostomy tube can only he changed with some effort by the nursing staff, the patient cannot change it himself.

[0005] The active breathing center of such a tube has holes for the patient's throat and a check valve located at the outer end of the cannula. Air enters the lungs through the check valve in the tracheostomy tube when the patient inhales. During exhaling, the check valve blocks the way through the tracheostomy tube. The air will have to make its way through the throat and thus into the environment via the vocal cords. Thus, it is possible that the patient can speak. This kind of tube use can only be used with patients who are strong enough to breathe independently.

[0006] For artificial respiration. the inner part of the tracheostomy tube is completely closed towards the throat. It is not possible to speak with the patient as the air flows out of the body via the tracheostomy tube and not through the throat. Thus, the vocal cords cannot be excited to vibrate.

[0007] If the inner part of the throat is opened, the ventilator's air would flow directly through the holes in the throat and not through the lungs. Thus, it is unfortunately not possible that ventilated patients arc able to speak. For artificial respiration, the inner part of the trachcostomy tube is completely closed towards the throat. It is a disadvantage of such tubes, that it is not possible to speak with the patient when air flows out of the body via the tracheostomy tube and not through the throat. Thus, the vocal cords cannot be stimulated to vibrate and ventilated patients cannot speak [0008] Other tracheostomy tubes known from the prior art comprise a cuff which is a stretchable area on the outside of the tracheostomy tube. Inflating the cuff creates a separate pressure chamber from the cuff to the lungs. This sealing is called blocking and fully controlled ventilation is possible.

[0009] By unblocking the tracheal cannula, it can be made possible that the air flows along the outside tracheal cannula into the throat and the patient is thus able to speak. However, this method can be realized only temporarily and under observation in appropriately strong persons. There is a risk that the respiratory gas does not reach the lungs and the patient is in respiratory distress. By unblocking the cuff, ventilation control is no longer possible.

[0010] There are fenestrated tracheostomy tubes known from the prior art, which are provided with a stretchable inner part. During the ventilation cycle, this inner part is inflated and closes the fenestration of the tracheostomy tube. Thus, the patient is artificially ventilated. During exhalation, the inner part collapses, preventing air leakage in the direction of the tracheotomy. At the same time, the fenestration becomes free, i. the exhaled air is directed over the throat. (e.g., EP0730477B1) [0011] Tracheostomy tubes with a stretchable inner part have not been able to prevail, because such tubes arc comparatively expensive. The patient's secretions will further stick to the flexible pressure valve, which causes a suffocation risk. The tracheostomy tube should therefore only be worn during observation by a doctor. Finally, it is a disadvantage that suction of the lungs is not possible with the tracheostomy tube.

[0012] Thus, there is a need for a tracheostomy tube that allows speech when applied.

Object of the Invention [0013] It is an object of the present invention to provide a tracheostomy tube that can be intubatcd but allows the patient to speak.

Summary of the Invention

[0014] The present invention provides a tracheostomy tube, comprising at least three channels, a respiratory canal, a cuff channel and a phonation channel.

[0015] In a further aspect of the tracheostomy tube it may comprise a cuff.

[0016] In an embodiment, the respiratory canal may be open at both ends.

[0017] The cuff of a tracheostomy tube can he inflatable.

[0018] It is further envisaged that the cuff may surround the respiratory canal.

[0019] The tracheostomy tube may in a further aspect comprise a phonation unit connectable to the upper end of the phonation channel.

[0020] It may also be intended that the phonation unit comprises a ventilation for providing an airflow through the phonation channel [0021] In a further aspect, the tracheostomy tube may comprise a moistener for moistening ventilated air.

[0022] In another embodiment, the trachcostomy tube may comprise a heating element for heating ventilated air.

[0023] It is also envisaged that a UV source may be present for sterilizing ventilated air.

[0024] The tracheostomy tube may in a further embodiment comprise a control device for regulating ventilation, humidity and temperature of ventilated air.

[0025] The phonation channel of a tracheostomy tube according to the invention can be open at the tube's upper end and at one side of the tube above the inflatable cuff [0026] Another object of the present invention is a method for manufacturing a tracheostomy tube, comprising the steps of a. Determining a patient's tracheal physiology; b. Producing a respiratory canal; c. Applying a phonation channel and a cuff channel outside the respiratory canal; d. Applying a cuff surrounding the assembly of respiratory canal, phonation channel and cuff channel at the tub's lower end; and e. connecting cuff channel and cuff so that the cuff is inflatable.

[0027] The invention relates to the use of a tracheostomy tube as described above for artificial respiration of a person or animal.

[0028] Still other aspects, features, and advantages of the present invention are readily apparent from the following detailed description, simply by illustrating a preferable embodiments and implementations. The present invention is also capable of other and different embodiments and its several details can be modified in various obvious respects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. Additional objects and advantages of the invention will be set forth in part in the description which follows and in part will be obvious from the description, or may be learned by practice of the invention.

Summary of the Figures

[0029] The invention will be described based on figures. It will be understood that the embodiments and aspects of the invention described in the figures are only examples and do not limit the protective scope of the claims in any way. The invention is defined by the claims and their equivalents. It will be understood that features of one aspect or embodiment of the invention can be combined with a feature of a different aspect or aspects of other embodiments of the invention, in which: [0030] Figure 1 shows an overview of a tracheostomy tube according to the invention.

[0031] Figure 2 shows the path of the ventilation air (double arrows) and ambient air for speaking (single arrows).

Detailed Description of the Invention and the Figures [0032] The technical problem is solved by the independent claims. The dependent claims cover further specific embodiments of the invention.

[0033] The present invention provides a tracheostomy tube comprising a phonation device, i.e. a device which provides the necessary air for speech, and thus allows patients who arc being ventilated via a tracheal cannul a to speak.

[0034] The tracheostomy tube comprises at least. three channels (FIG. 1). The largest channel is the respiratory canal 20, which is always open on both sides of the tube so that ventilation is ensured at all times. The tube further comprises a cuff channel 30, this allows to inflate cuff 10. The patient's trachea is completely blocked with inflated cuff 10, except respiratory canal 20. Breathing is possible as well as an exactly controlled artificial respiration. The ventilation with a tracheostomy tube according to the present invention is carried out as it is already known from the state of the art.

[0035] The core of the invention relates to an additional channel, the so-called phonation channel 1 (FIG. 1), which has a fenestration 5 and is therefore open towards the throat. At the upper end of phonation channel 1, outside the body, a phonation unit (not shown) can he connected. This phonation unit or speech ventilation device provides the patient with the necessary airflow for speaking. Ambient air 50 (single arrows) is blown into the trachea above cuff 10 in parallel to ventilation air 40 (double arrows), but without influencing it (FIG. 2).

[0036] The system of the present invention has thus no influence on the ventilation process itself. Surveillance of ventilation is still possible, so that there is no additional risk for the patient related to the use of a system according to the invention, for example through the use of a valve. At the same time, the system of the present invention allows the patient to speak.

[0037] The phonation unit provides the air flow necessary for speech. The phonation air is moistened in the device and heated to body temperature. The mucous membranes are protected by moistening and the airflow heated to body temperature is pleasant for the user. For sterilization, a UV unit is used. A control module permanently regulates temperature and humidity. The device can be operated via a display.

[0038] The following types of control are provided for the phonation unit: - Providing a constant air flow; - Air flow can be switched on and off via a switch, - Logic allows the phonation unit to be paired with the ventilator so that the phonation unit generates a controllable air flow. The airflow for speech is controlled by the expiratory air measured by the ventilator. In such an embodiment, it is possible for the user to speak in different volumes.

[0039] Optionally a subglottic suction, as known from European patent application EP 2 708 257 A 1, can he added to the tracheal cannula.

[0040] In order to be able to aspirate liquids such as saliva or possibly also food residues that penetrate into the trachea, there are tracheostomy tubes with a so-called subglottic suction. This means that such a tracheostomy tube has a further additional channel. The canal protrudes inwards along the cannula. The lower opening of the channel ends just above the cuff. From the outside, a negative pressure can be connected, with which an unwanted liquid can be sucked.

[0041] With respect to a tracheostomy tube according to the present invention, the phonation holes will he located at an anatomically appropriate location, so that it is not necessary for them to be obscured by the vent tube itself or the area of the tracheotomy. The phonation channel is designed to be large enough to allow optimal mass flow for vocalization. The phonation unit is adapted to the speech process. With a combination of the trachcostomy tube and the phonation device, it will be possible for a person being ventilated via the tracheal cannulas to speak.

[0042] In addition, the tracheal cannula of the present invention allows to be adapted to the anatomy of the individual patient by means of a corresponding manufacturing process. The tracheal cannula can be made according to the physiology of a patient. using X-ray images, computer tomography or other method the geometry of the trachea of the patient can be measured and a trachcostomy tube specifically adapted to the patient's physiology can he manufactured. A possible manufacturing process may be 3D printing. Through such a custom fabrication, the tracheostomy tube fits as good as possible and the phonation holes are located appropriately.

[0043] The advantages of the present invention may be summarized as follows: - Existing artificial respiratory devices can be connected without any modifications.

- The internal cross section of the tracheostomy tube can be kept large.

- The openings of the breathing channel are optimized regarding the patient's anatomy.

- The breathing process can he completely controlled, including expiration (exhalation).

- The ventilated patient is able to speak.

The artificial respiratory device can be connected to various controllers.

- The tracheal cannula can he adapted to the patient's physiology through additive manufacturing. The physiology or anatomy of a patient can be determined using X-rays, computed tomography or other comparable imaging methods.

[0044] The foregoing description of the preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to he exhaustive or to limit the invention to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. The embodiment was chosen and described in order to explain the principles of the invention and its practical application to enable one skilled in the art to utilize the invention in various embodiments as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims appended hereto, and their equivalents. The entirety of each of the aforementioned documents is incorporated by reference herein.

Reference Numerals 1 phonation channel fenestration cuff respiratory canal cuff channel ventilation air ambient air for speaking

Claims

CLAIMS1. A tracheostomy tube, comprising at least three channels, a respiratory canal, a cull channel and a phonation channel.
2. The tube of claim 1, further comprising a cuff.
3. The tube of claim 1 or 2, wherein the respiratory canal is open at both ends.
4. The tube of any one of claims 2 or 3, wherein the cuff is inflatable.
5. The tube of any of claims 2 to 4, wherein the cuff surrounds the respiratory canal.
6. The tracheostomy tube of any one of claims 1 to 5, further comprising a phonation unit connectable to the upper end of the phonation channel.
7. The tracheostomy tube of claim 6, wherein the phonation unit comprises a ventilation for providing an airflow through the phonation channel.
8. The tracheostomy tube of any one of claims 1 to 7, further comprising a moistener for moistening ventilated air.
9. The tracheostomy tube of any one of claims 1 to 8, further comprising a heating clement for heating ventilated air.
10. The tracheostomy tube of any one of claims 1 to 9, further comprising a UV source for sterilizing ventilated air.
11. The tracheostomy tube of any one of claims 1 to 10, further comprising a control device for regulating ventilation, humidity and temperature of ventilated air.
12. The tracheostomy tube of any one of claims 1 to 11, wherein the phonation channel is open at the tube's upper end and at one side of the tube above the inflatable cuff.241P-Ref: 95117GB STRATEC SE
13. A method for manufacturing a tracheostomy tube, comprising the steps of a. Determining a patient's tracheal physiology; b. Producing a respiratory canal; c. Applying a phonation channel and a cuff channel outside the respiratory canal; d. Applying a cuff surrounding the assembly of respiratory canal, phonation channel and cuff channel at the tub's lower end; and e. connecting cuff channel and cuff so that the cuff is inflatable.
14. The use of a tracheostomy tube of any one of claims 1 to 12 for artificial respiration of a person or animal.