MXPA00001328A - Endotracheal or tracheotomy tube - Google Patents

Abstract

The invention relates to an endotracheal or tracheotomy tube with a central lumen (2) for supplying and carrying off respiratory air. The tube comprises the following:an inflatable sealing cuff (3) which surrounds the tube (1);a pipe for supplying compressed air to the cuff (3);an aspiration duct (6) situated above or below the cuff (3) and ending outside the tube (1);and a supply pipe (7), which is also above the cuff (3) and ends outside the tube (1). The invention aims to create an endotracheal or tracheotomy tube which ensures safe tracheal aspiration, i.e. with which even viscous mucus or larger mucus lumps, which might have accumulated above the sealing cuff in a patient's trachea, can be reliably aspirated. To this end, the wall (9) of the tube (1) has a thickened hollow section (11) along a sector of its periphery, whose inner hollow space forms the aspiration duct.

Description

Endotracheal or tracheostomy tube The invention relates to a tracheotomy or endotracheal tube whose central passage serves to supply and discharge air for respiration, comprising a sealing fist that spans the tube, a conduit for the supply of pressurized air to the patient. fist, a suction duct that opens above the fist towards the outside of the tube and a feeding duct that opens towards the outside of the tube, above the fist. A corresponding endotracheal tube is known from U.S. Patent No. 5,582,167. In the known endotracheal tube, in addition to the actual tube defining the passage for artificial respiration, it also has a hose that surrounds the tube and that is of a flexible material with thin walls. The wrapping hose has an internal diameter that is between 1 and 8 mm larger than that corresponding to the outer diameter of the actual breathing tube, while that which is placed near the cuff has a smaller diameter at the end of the hose. housing so that between the outer wall of the tube and the inner part of the casing hose an annular passage is formed which ends near the cuff and serves to suction remove the secretion or something similar. Provided in the lower region of the tube, that is, just above the pulo, for this purpose, there are separators for the casing hose since there are no corresponding support devices in the uppermost walls. A serious disadvantage of this configuration of the endotracheal tube or for tracheotomy lies in the flexibility of the outer wrapping hose. While a reduced pressure is obtained in the suction removal operation between the outer wall of the actual tube and the casing hose, there is a high level of risk that the outer flexible casing hose will collapse and be recharged against the outer wall. of the tube. It will be appreciated, then, that the suction removal function can not be performed through the annular passage placed between the outer wall of the tube and the inner wall of the outer wrap hose. Even the spacers placed in the lower region and just above the fist, between the tube and the wrapping hose, can, at best, slightly alleviate the problem but can not eliminate it completely. In addition, the annular separation between the tube and the outer jacket hose can be completely transverse, which in principle is sufficient, but this annular gap is extremely small so that mucosal locks can not be suctioned or can only be suctioned with difficulty, and they block with relative ease the narrow separation between the tube and the wrapping hose.

The purpose of the suction removal operation above the fist is made in particular to suck and remove as much as possible, fluids that accumulate and that contain bacteria as well as other pathogens that, in a moist and warm environment such as prevailing in the trachea, it finds an excellent environment to be nourished, so that the patient who has been intubated or has a tracheotomy cannula does not suffer, as far as possible, an infection of the bronchial tubes or lungs. However, if the suction removal operation is improperly implemented by virtue of the collapse of the outer wrap hose, then the protection of the infection, which is the purpose of the suction removal operation, will also be incomplete. In comparison with the technique, the objective of the present invention is to offer an endotracheal or tracheotomy tube that ensures a reliable suction removal function, that is, even if it is very viscous mucus or relatively large clots that may have accumulated above the fist in the trachea of the patient, can be relied upon for withdrawal by suction. This objective is achieved since in a sector of its periphery, the wall of the tube has a thin hollow portion whose cavity defines a suction passage.

However, since, until now, the suction passage is integrated into the wall of the tube, for which purpose the portion of the wall also has to be thin to achieve sufficient suction removal, this arrangement offers a relatively high suction pitch. stable which does not undergo deformations easily and thus does not collapse, and whose minimum diameter may be greater than the minimum width of the passage surrounding the tube in the annular configuration. It is admitted that, the thickening of the portion of the wall in a sector (with respect to the peripheral direction) of the tube depends on the cross section of the passage, but this reduction in the cross section of the lumen can be kept comparatively low, of the order of 10% magnitude, for example, in which case, the diameter of the suction passage can be - substantially larger than the width of the annular gap extending around the tube. If desired, in order to restore the entire cross section of the passage, it is possible to slightly increase the outer diameter and, with this, the diameter of the passage of the tube. In this case, a reduction of the transverse portion of the passage by virtue of the wall portion enlarged by 10% for example, is fully compensated by increasing the diameter of the passage and of the entire tube only between 3 and 4%. In contrast, based on a cross-section of the predetermined pitch, the outer diameter of the pipe must be increased by 20% if the width of the gap between the outer jacket hose and the outer wall of the pipe does not exceed one tenth of the diameter of the pipe. He passed. A preferred embodiment of the invention is one in which the sector of the enlarged wall portion includes less than 120 ° and preferably less than 90 ° from the periphery of the tube (seen in cross-section). The minimum diameter of the suction passage must be at least 1.5 mm, preferably at least 2 mm. In this sense, for example with an outside diameter of the tube of 12 mm and a thickness of the normal tube wall on the outside of the widened region of about 1 mm, it is possible to have a suction passage with a minimum diameter of 3 mm in a portion of the thickened wall extending in a sector of less than 90 °, in which case the transverse part of the free passage is only reduced by 10%. If, in this embodiment, it is desired to have a transverse portion of the complete passage (as compared to a tube without suction passage) it is only necessary, while maintaining the thickness of the wall by 1 mm, increasing the outer diameter of the tube for example up to 12.4 mm, while keeping the circular suction passage with a diameter of 3 mm. The portion of the thickened wall, incorporated in the suction passage, can have a maximum thickness of between 3.5 and 4 mm; in this specific case, for the suction passage itself, portions of the short wall are formed which are only possible between 0.2 and 0.5 mm thick, on the outside and inside of the tube, but these short portions combine or harmonize with the thick portions of the walls of the tube and thus do not impair the overall stability of the tube. Optionally, the cross section of the suction passage may be circular but may also have an elliptical configuration, in which case the ratio of the long axis to the short of the elliptical cross section should, if possible, not be less than a value between 2. and 3 as otherwise, even the minimum diameter in the shape of the cutting axis of the elliptical cross-section becomes very small or the proportion of the suction passage and thus the wall portion thickened in relation to the total cross-section of the tube It becomes very big. However, an elliptical cross section for the suction passage may be an optimal way to achieve the objective of the invention, in terms of the maximum use of the cross section available, at the same time, with stability and flexibility of the tube and its portions of wall. It is desired, in the preferred embodiment of the invention, that the suction and feeding ducts are placed on diametrically opposite sides of the tube. The suction opening or mouth of the suction passage at the distal end thereof is preferably immediately above the edge of the cuff. The opening of the mouth of the feeding passage which, preferably provided for the supply of a rinsing fluid and / or disinfectant or for medicaments can also have the same axial level, ie relatively close just above the upper edge of the fist, but also It can be placed up. In this sense, the cross section of the suction passage is substantially larger than the cross section of the supply conduit, for example it is between five and fifteen times greater than the latter. The cross section of the suction passage turn 5 and 15% the lumen of the tube. It is desired that both the supply conduit and the conduit for the pressurized air supply for the cuff be integrated into the tube wall. The two abovementioned ducts should only have a relatively small cross-section since air passes in one and the other gas supplied to inflate the fist and in the other, if possible, is used for low viscosity flushing fluid, these passages or ducts, which have a typical diameter between 0.5 and 0.8 mm, can be easily integrated into the wall of the other tube that does not necessarily have to be swollen for this purpose. However, optionally, in a manner similar to the thickened portion for the suction duct, the wall of the tube may be thickened in some way in the region of the feed duct to pass a rinsing or washing fluid in the duct region. of supply of pressure of the fist, even to a minor point in the case of the suction duct. According to a further embodiment of the present invention, an additional suction step is considered to be opened near the distal end of the tube, more specifically on the other side of the cuff. Thanks to this additional suction step it is possible to suck the fluid or secretion from the patient's trachea, which still accumulates behind the cuff or on the side of the cuff that is removed from the tube adapter connection. Preferably, this suction passage is integrated into the wall of the tube, more specifically if possible, close to the first suction passage that opens above the cuff and, if possible, also on the same portion of the thickened wall. In this sense, one of the two suction steps could also be a suction passage that is secured separately by means of an adhesive on the outer wall of the tube. In addition, it is also desired that the mouth openings of the passage or suction passages have a device for keeping the openings of the mouth clean and free, such as, for example, one or more rods or the like, which are also placed in a configuration transverse and projecting from the opening of the passage and thus can be placed in contact with the wall of the trachea but at the same time hold the wall of the trachea e a separation from the opening of the mouth or the opening of the passage way such that there is still access to the passage in the last rod or the like, Alternatively, it would also be possible to provide a filter cover for protection in the mouth of the passage or suction steps. Other advantages, aspects and possible uses of the present invention are apparent from the following description of the preferred embodiment and the attached drawings, in which: Figure 1 is a longitudinal sectional view through a cannula for tracheostomy according to the invention; Figure 2 is a cross-sectional view of the tracheostomy cannula with a section taken along line II-II of Figure 1; Figure 3 is a cross-sectional view of the tracheostomy cannula with a section taken along line III-III of Figure 1; Figure 4 is a cross-sectional view of a tracheostomy cannula with a section taken along line IV-IV of Figure 1; Figure 5 is a longitudinal sectional view through another embodiment of the tracheostomy cannula according to the invention; Figure 6 is a cross-sectional view of the tracheostomy cannula as shown in Figure 5 with a section taken along line VI-VI of Figure 5; Figure 7 is a cross-sectional view of the tracheostomy cannula as shown in Figure 5 with a section taken along line VII-VII of Figure 5; Figure 8 is a cross-sectional view of the tracheostomy cannula as shown in Figure 5 with a section taken along line VIII-VIII of Figure 5; Figure 9 is a cross-sectional view of the cannula for tracheotomy as shown in Figure 5 with a section taken along line IX-IX of Figure 5, and Figure 10 is a cross-sectional view of the cannula for tracheotomy according to the technique. The views presented in the Figures are only partially true on the scale and in this sense do not represent limitations, even if in practice some of the illustrated aspects can be adopted identically in the relative dimensions. Referring to Figure 1, it shows a tracheotomy tube or a tracheostomy cannula that is generally identified with the number 10 and is used to insert it through the neck of a patient in the trachea, after performing an adequate operative cut. The tracheostomy cannula comprises a tube 1, called a protective plate 12 which bears against the neck of the patient and therefore defines the position of the cannula, a sealing cuff 3 and a standard adapter 20 at the inlet end of the cannula for connection to an artificial respiration device or for anesthesia. The lower portion of the cannula 10, with the cuff 3, is placed in the trachea of the patient, generally below the larynx and the vocal cords. After insertion of the cannula, the cuff 3 is in the deflated condition near the tube 1 and then inflated by means of a conduit 4 and the outer connection 5 thereof to slightly increase the pressure, typically from 15 to 20 mm Hg in order to form a seal and fix the tube in the patient's trachea. The endotracheal tube differs from the tracheostomy cannula, essentially in that it is substantially longer and does not have the protective plate 12, since, generally, the endotracheal tube is inserted into the patient's trachea through the mouth or through the mouth. of the patient's nose. A valve and a pressure regulator or control system for the cuff 3 are shown in Figure 1 by means of a balloon 18 and the elements connected thereto. A problem arises with the tubules being prolonged or when the cannula for the tracheotomy is inserted, and that fluid and mucus accumulate in the patient's trachea immediately above the cuff 3 and outside the tube 1 and, due to the humid and warm environment that It predominates in the area, an ideal medium is formed to nourish the bacteria and other pathogenic bodies. Under these circumstances they can also pass through the cuff 3 due to variations in the pressure in the cuff 3 due to movements by the patient or when the tube is removed, since in that interval this bacteria can penetrate into the bronchial tubes as to the lungs of the patient and, therefore, cause severe complications such as inflammation of the lungs and other diseases for which a high proportion of patients who are intubated for relatively long periods are affected, for example after the operations . In order to eliminate or alleviate this problem, integrated into the tube 1 shown in Figure 1, there is a suction passage 6, with an external suction connection 16 and an internal suction opening 8, which makes the communication from the external environment of the tube 1 towards the suction passage 6, directly above the fist. The mucus and fluid that accumulates in the trachea above the cuff 3 can be sucked easily and removed through the suction passage 6, and thus the bacteria as well as other germs contained therein can be removed and considerably reduced in number of they also remove most of the nutrient medium that would otherwise be present, so that the number of pathogens and the density of germs in this region is comparatively lower and even the immune system of a weakened patient can offer a defense against the rest of the germs. In addition, the longitudinal cut of Figure 1 also shows a step for cleaning or rinsing 7 with an outer connection 17 and an internal opening 9 that also opens outwardly of the tube 1. A fluid can be sprayed through this step 7. towards the region around the tube, above the cuff 3, and then this sprayed fluid is also sucked again through the opening 8 and the suction passage 6. In this way, the number of pathogens in the region can be further reduced and, in addition, it is possible to provide antibiotic substances that have a bactericidal effect by adding said substances to the cleaning or rinsing fluid in order to kill any germs that may be present or to prevent them from multiplying. The combination of flow cleaning and suction removal can greatly reduce the risk of patient illness. In this sense, in addition, it is possible for the opening 9 of the cleaning or rinsing step 7 to open further to the opening for suction removal, if for example it is desired that the fluid acts in a larger portion above the fist 3 and around the tube 1. The suction removal operation can also be effected by feeding the cleaning or rinsing fluid, by a procedure in which, for example, first the mucus or fluid present is sucked through the opening 8, then the cleaning or rinsing fluid is supplied through the internal conduit 7 and possibly sucked at the same time, in which case the withdrawal operation can then be interrupted by suction in order to allow the level of the cleaning or rinsing fluid to increase to the desired level so that a larger region of the trachea is cleared of pathogens or the concentration thereof is reduced considerably in this region. Medications that are absorbed in this region through the trachea and thus pass into the patient's bloodstream can also be delivered through the passage for cleaning or rinsing fluid 7.

In a particular embodiment of the present invention, as shown in Figures 5 to 8, in addition to the passage for the suction 6, there is a second passage for the suction 6 'that opens below the cuff 6 and in the distant end of the cannula. Preferably, the suction passage 6 'is integrated into the wall of the tube, while the original suction passage 6, which is still present and which opens above the cuff, is optionally integrated into the wall of the tube or sticks on the wall of the tube on the outer side of it. Step 4 for pumping or regulating the pressure in the cuff 3 can also be integrated into the passage for the cleaning or rinsing fluid in the wall of the tube 1, but moves 90 ° with respect to the two illustrated steps 7 and 6 and, therefore, only indicated by dotted lines in the illustrations of Figures 1 and 5. The patient breathes through the central lumen 2 of tube 1 or in case of artificial respiration through the lumen or step 2 if his condition requires Depending on the use situation the tube 1 may have different dimensions and in particular, also different diameters for the children, for example, which need substantially smaller tubes and also smaller lumen diameters, in comparison with the adults. It will be appreciated that it is essential that the central lumen 2 has a sufficiently large cross section so that the patient can breathe on his or her own without difficulty and without excessive effort, or to be able to provide artificial respiration. However, on the other hand, specific anatomical factors in relation to a patient impose limits on the internal diameter of tube 1 or 1 '. In this regard, it is essential that the arrangement as well as the size of the cannula 4, 6, 6 'and 7 be selected such that the cross section of the lumen, the outer diameter of the tube, are not excessively large. In relation to this, it is considered that the mucus that can form in the patient's trachea and that sometimes is so viscous that it can not be easily removed by suctioning it through small cross sections, easily conforming it into a blockage in the passage. As can be seen in relation to the longitudinal cut in Figure 1, but in particular with reference to the cross section in Figure 2, the present invention provides a portion of. thickened wall 11, which has a hollow configuration and a passage 6 for suction removal, the cross section is sufficiently wide to allow suction even if the mucus is very viscous or mucus clots have formed in the trachea of the patient on top of the fist 3. In specific terms, the suction passage 6 is a substantially circular or oval cross section which, in terms of magnitude, constitutes approximately 10% of the cross section of lumen 2. As can be seen, the cross section of lumen 2 or 2 'is respectively reduced somewhat by the portion of the thickened wall 11, but the reduction in cross section of the lumen or passage at the cross-sectional rate, which is essentially shown in Figure 2, is only a small percentage relative to the cross section of the circular lumen of the same diameter but without the portion of the thickened wall 11. However, if it is necessary to retain a transverse section If the whole lumen is present without the thickened wall portion 11, it is sufficient to increase the overall diameter size of tube 1 by approximately 3 to 4% so that the internal diameter of lumen 2 is also increased by 3 to 4. %, which results in an increase in the cross-sectional size of the lumen by a magnitude of about 10 to 15% such that the component in the cross section occupied by the thickened wall portion 11 is compensated by a slight increase in the size of the total diameter. The passage for the cleaning or rinsing fluid 7 is arranged diametrically opposite the suction passage 6 and has a substantially smaller cross section so that it has a space within the normal thickness of the wall 13 of the tube 1, and likewise, also the passage of pressurized air 4 to inflate the cuff 3. The cleaning and rinsing fluid can be selected so that it has a low, suitable viscosity, and if necessary also pass through step 7. under an increased pressure so that it is sufficient if step 7 has a diameter of 0.5 mm. A corresponding diameter is also sufficient for the passage of pressurized air 4. In contrast, the reduced pressure that can be produced in the suction removal operation is limited to the order of magnitude of the air at normal pressure and the fluid or mucus that possibly , has accumulated in the trachea of the patient above the cuffs 3 has a relatively high viscosity so that a larger cross section is required for the suction passage 6. In this sense, the portion of the thickened wall 11 has at the same time , a sufficient stability for step 6 so that, in no way, it collapses under a pressure difference of the order of magnitude of 1 bar. By referring to the various views of the cross section in Figures 2 through 4 and the sections shown in Figures 6 through 9 in various axial positions of the tracheotomy tubes of the first and second embodiments, respectively, it will be clear to which axial positions the individual cannula extends and how the cross section of the individual cannula behaves in relation to the other and to the central lumen or passage, even if, as mentioned above, the relative and absolute dimensions of The individual cannula may differ from the ones illustrated.

For comparison purposes, Figure 10 shows a cross-sectional view of an endotracheal tube which is known in the art and which, in particular, must have the same outer diameter as tube 1 or 1 'as shown in Figure 1. to 9 of the present invention. In this case, the suction passage 26 is defined by an annular gap that is defined outside the tube 21 by a coating hose or tubular coating 24. However, with this coating hose, in the case of a removal operation by suction, there is a danger that the cover tube 24 may collapse and stick against or lean against the wall of the tube 21 and considerably reduce or even completely close the cross section of the passage 26. The total cross section of the passage for suction 26 may be even larger than the total cross section of the suction passage 6, but the suction passage 26 is presented only in the form of a narrow annular passage 26 whose width (in the radial direction) is only about one third of the diameter of 1 suction passage 6 so that the viscous mucus can only be removed by suction with great difficulty through passage 26. The spacers can serve to prevent The tubular coating or the coating hose 24 is in contact with the outer wall of the tube 21, but is only successful if the outer coating 24 is made of a sufficiently strong material and even if the radial width of the annular gap 26 is still very high. small in relation to the diameter of the suction passage 6 shown in Figure 2. The comparison of the novel cannula illustrated in Figure 10 further shows, in the case of the present invention, with a given outside diameter for the tube 1 or 1 'respectively, that the cross section of the lumen or central passage 2 is substantially greater than that of the known art. On the contrary, with the same cross section for the central lumen 2 the outside diameter of the tube 1, 1 'could be reduced in comparison with the tube 21 of the novel cannula, in which case, however, at the same time, the for suction removal it will be improved.

Claims (15)

1. An endotracheal or tracheotomy tube whose passage or central lumen serves for the supply and discharge of breathing air, comprising an inflatable sealing cuff that spans the tube, a conduit for the supply of pressurized air to the cuff, a conduit of suction that opens above the fist towards the outside of the tube and a supply conduit or supply that also opens towards the outside of the tube above the fist, the tube is characterized because in a region along its periphery the wall of the tube has a thickened hollow portion whose internal cavity forms a suction duct.

2. The endotracheal or tracheostomy tube according to claim 1, characterized in that the sector of the thickened wall portion, seen in a cross section of the tube, comprises less than 120 °, preferably less than 90 °.

3. The endotracheal or tracheotomy tube according to claim 1 or claim 2, characterized in that the minimum diameter of the passage for suction is at least 1.5 mm, preferably at least 2 mm.

4. The tracheostomy or endotracheal tube according to one of claims 1 to 3, characterized in that the suction passage has a substantially circular cross-section. The endotracheal or tracheostomy tube according to one of claims 1 to 3, characterized in that the suction passage has an oval or elliptical cross section, in which the ratio of the long axis to the short of the cross section elliptical, preferably it is less than 2. 6. The endotracheal or tracheostomy tube according to one of claims 1 to 5 characterized in that the openings for the mouth of the suction passage and the feeding passage are placed in diametrically opposite sides of the tube. The endotracheal or tracheostomy tube according to one of claims 1 to 6, characterized in that the suction opening of the suction passage is arranged directly on the upper edge of the cuff. 8. The endotracheal or tracheotomy tube according to one of claims 1 to 7, characterized in that the opening for the mouth of the feeding conduit is moved axially with respect to the opening of the mouth of the suction passage. . The endotracheal or tracheostomy tube according to one of claims 1 to 8, characterized in that the mouth of the pressure conduit for the cuff and also of the supply conduit are integrated in the wall of the tube. The tracheostomy or endotracheal tube according to one of claims 1 to 9, characterized in that the cross section of the suction passage is much larger than the cross section for the supply conduit and is at least five fifteen times the size of the cross section of the feed pipe. The endotracheal or tracheostomy tube according to one of claims 1 to 10, characterized in that the cross section of the suction passage is between 3% and 15% of the cross section of the lumen. The tracheostomy tube according to one of claims 1 to 11, characterized in that the connection portions for the suction passage and the feed passage respectively open at the distal end of the tube, in front of the protection plate of the tube. tube for tracheotomy. 13. The tracheostomy tube according to one of claims 1 to 12 characterized in that it further has a suction passage that opens near the distal end of the tube, beyond the cuff. The tracheostomy tube according to claim 13, characterized in that the additional suction passage is integrated into the wall of the tube while the suction passage, which opens above the cuff, sticks to the outer wall of the tube. tube. 1

5. The tracheostomy tube according to claims 1 to 14, characterized in that the opening for the mouth of the suction passage or the suction passages has a mechanism to keep the passage of the opening free.