WO2008074469A1

WO2008074469A1 - Respirator comprising an oesophageal seal

Info

Publication number: WO2008074469A1
Application number: PCT/EP2007/011119
Authority: WO
Inventors: Daniel Oser
Original assignee: Masterflex Ag
Priority date: 2006-12-20
Filing date: 2007-12-18
Publication date: 2008-06-26
Also published as: DE102006060968B3

Abstract

The invention relates to a respirator comprising a tube arrangement (33) that is designed to be introduced through the mouth and the pharynx (7) of a patient. The tube arrangement (33) comprises at least one tube (1) with a distal and a proximal opening, the length of the tube arrangement (33) allowing the distal opening (14) of the tube (1) to reach the entrance to the trachea (12) with the proximal opening remaining outside the mouth. The distal region of the tube arrangement (33) has a balloon (4), which can be expanded by the supply of a fluid and when expanded forms a seal between the introduced tube arrangement (33) and the inner wall of the pharynx (7). The balloon (4) has a distal section (37), designed to at least partially penetrate the oesophagus (6), sealing the latter when expanded, at least some parts of said distal section (37) of the expanded balloon (4) having a greater extension along a first axis (17) than along a second axis (18) that runs perpendicularly to the first axis (17). This allows the oesophagus (6) to be sealed securely whilst the trachea (12) remains free. Alternatively, the respirator can have two separate balloons, one of which is placed in the pharynx region (7) and the other in the oesophagus (6).

Description

MSTR0031 (2211/07)

D54 / D6800

XD / co / ...

Bθatmunqsqθrät with ösophaqusverschluss

The invention relates to a ventilator with a tube assembly intended to be inserted through the mouth and throat of a patient, the tube assembly comprising at least one tube having a distal and a proximal opening, the tube assembly having a length that is suitable to bring the distal opening of the tube to the entrance area of the trachea while the proximal opening remains outside the mouth and wherein the distal portion of the tube assembly comprises a balloon which is expandable by supplying a fluid and in the expanded state sealing between the inserted tube assembly and the inner wall of the pharynx, said balloon having a distal portion which is intended to at least partially penetrate into the esophagus and to close it in the expanded state. Furthermore, the invention relates to a ventilator with two separate balloons.

Conventionally, ventilators have been divided into two categories, endotracheal tubes and laryngeal masks. Endotracheal tubes are inserted into the trachea via the oral cavity and throat, with a balloon attached to the distal end of the endotracheal tube which, when expanded, seals the space between the outer wall of the tube and the walls of the trachea. Their advantage is that they are very reliable and allow the patient to be ventilated for long periods of time. On the other hand, the distal end of the tube must be passed between the vocal cords, which poses a considerable risk, since the vocal cords are very sensitive and can easily be damaged. This can lead to infections. tion, scar tissue, obstruction of the trachea or permanent hoarseness of the patient. In addition, de introduction is possible only under view, ie with the aid of a laryngoscope or the like, as well as by administering a muscle relaxant.

In addition, laryngeal masks are known, which are introduced through the mouth and throat to the entrance of the trachea, but without passing through the larynx. At the distal end of the laryngeal mask an inflatable body is arranged, which closes the throat airtight above the trachea. Since the masks are not inserted into the trachea itself, there is no risk for the vocal cords.

On the other hand, however, the likelihood of laryngeal mask leakage is greater. In addition, the inflatable body of a laryngeal mask must be expanded under very high pressure to obtain an airtight seal.

European Patent EP 0 971 765 B1 discloses a ventilator with an expandable sealing cuff which creates a closure between the tube and the throat. The ventilator has a delimiting strip which projects into the upper area of the esophagus and places the tube in the entrance area of the trachea. Inserting the tube beyond the vocal cords is therefore no longer necessary.

However, with this ventilator, there is the problem that the trachea is insufficiently protected against the ingress of fluid from the esophagus (esophagus). This poses a significant risk because the penetration of the strongly acidic gastric contents into the lungs can lead to serious pneumonia. The likelihood of penetration of gastric contents into the pharyngeal area is considerable, as often an overpressure builds up in the stomach or the patient also has to vomit. In addition, the ventilator may slip in the event of coughing or movement of the patient.

In order to reduce the risk of gastric contents entering the trachea, international patent application WO 2005/058402 A1 proposes a beat tion device, in which the balloon or the sealing sleeve, which creates a seal between the tube and the throat in the expanded state, projects with its distal end into the esophagus in order to close it in the expanded state. In this case, the sealing collar has a constriction zone, which is adjoined distally by the tubular distal region of the sealing collar. Placement of at least a portion of the esophageal seal in the esophagus closes it against the throat and eliminates the risk of gastric contents entering the trachea. In addition, the ventilator may have a second tube which extends from outside the patient through the sealing cuff into the esophagus to be able to divert into the stomach-building overpressure to the outside or to introduce probes and other instruments can.

Another way to bring about a closure of the esophagus with respect to the throat is to place a second balloon here, as shown in WO 96/27404 A1.

Despite the considerable improvement brought about in this way, the problem still remains of how to design the balloon to be placed in the esophagus. In order to effect a good seal, in principle a high elasticity of the balloon / the sealing sleeve is advantageous, since a high elasticity ensures that even irregularities in the inner wall of the esophagus do not lead to leakage. On the other hand, however, there is a considerable risk when using an elastic balloon with high compliance of the shell, since too much filling of the balloon by supplying a fluid (usually air) such a strong pressure is exerted on the inner wall of the esophagus, that these forces are transmitted to the inner wall of the adjacent trachea and this closes partially or completely. This makes the air supply more difficult or even impossible. Accordingly, the attending physician will have to pay very close attention to the fact that the pressure prevailing in the balloon just enough to close the esophagus safely, on the other hand, is not so high that the trachea is completely or partially closed. Success therefore depends first and foremost on the skill of the attending physician, although in some patients an optimal result can not be achieved. To make the balloon less elastic, ie to provide a more rigid shell, on the other hand, only partially promising, since such a balloon seals less well. A balloon with little elasticity is usually unable to fully adapt to irregularities and movements on the inner wall of the esophagus.

Based on the disadvantages in the above-described prior art, therefore, the object is to provide a ventilator available that allows a tight seal of the esophagus, on the other hand, however, causes no restrictions in the cross section of the trachea.

The object is achieved according to the invention by a ventilator with a tube arrangement which is intended to be inserted through the mouth and throat of a patient, wherein the tube arrangement comprises at least one tube with a distal and a proximal opening, the tube arrangement has a length, which is adapted to bring the distal opening of the tube to the entrance area of the trachea, while the proximal opening remains outside of the mouth and wherein the distal portion of the tube assembly comprises a balloon which is expandable by supplying a fluid and in the expanded state a seal between inserted Tube arrangement and the inner wall of the pharynx, wherein the balloon has a distal portion which is intended to at least partially penetrate into the esophagus and to close it in the expanded state, wherein the distal portion of the balloon in the expanded state at least partially in cross-section along a first axis has a greater extent than along a second axis orthogonal to the first axis.

According to the invention, the portion of the balloon to be placed in the esophagus is at least partially not round, but uneven in cross section, so that the portion of the balloon viewed in the cross section of the esophagus is wider in one direction than in the orthogonal direction to the first direction. The section of the balloon in the direction facing the trachea should be smaller in size. Ideally, the section of the balloon along the axis towards the trachea has the least Measure, but at least smaller, than along the axis that is orthogonal to the line connecting the esophagus and trachea. Typically, the section of the balloon viewed in cross-section is oval, ie along the connecting line esophagus - trachea relatively thin, perpendicular to this relatively wide.

In the manner described above, a secure seal of the esophagus can be brought about without running the risk that the trachea also experiences a restriction. The expansion of the balloon in the direction of the trachea is reduced due to the non-circular cross-section, so that exposure to pressure that limits the trachea is unlikely. On the other hand, however, the balloon can expand greatly perpendicular thereto, so that a corresponding seal of the esophagus is brought about.

The balloon may be made of a relatively thin-walled material that does not wrinkle to ensure a good seal. A typical material for the production of the ventilator is, for example, silicone. However, other plastics are also suitable in principle, for example PVC, polyurethane or SEBS (styrene-ethylene / butylene-styrene). The production of a balloon which has the desired shape in the expanded state is without conventional methods known from the prior art

Other possible.

Advantageously, the balloon between the proximal and distal ends of a constriction zone, which causes a constriction of the balloon in the region of the constriction zone in the expanded state. Accordingly, both the proximal end and the distal end of the elongate balloon are thicker than the area of the constriction. The larger dimensions at the proximal and distal ends each cause a tight seal once in the area of the pharynx, on the other hand in the area of the esophagus. The constriction zone is advantageous in that there is a sphincter muscle in the entrance area of the esophagus, which intervenes in the area of the constriction and fix the balloon in the longitudinal direction. In addition, the sphincter muscle tissue of the esophagus causes peristalsis toward Stomach that ensures the ventilator's fit and occlusion of the esophagus. In particular, it is prevented in this way that due to gases in the stomach escalating pressure escapes in the direction of the trachea.

In the context of the invention, the terms distal and proximal are used as follows: Proximal means the direction outside the body, d. H. towards the attending physician, distally the direction inside the body. Accordingly, the distal end of the balloon / gasket is, for example, the end that extends farther in the body, i. H. located in the esophagus.

Conveniently, the constriction zone has a length of 1 to 4 cm, in particular 1, 5 to 3 cm, for example 2 cm. It should be noted that the integrally formed balloon will usually have no sharp transitions, so that the constriction zone has no sharp boundary. Rather, the balloon gradually reduces its diameter to the necking zone and in turn increases it in the direction of the distal end, with the reduced diameter portion having a length in the range indicated above.

Furthermore, it is advantageous if the distal portion of the balloon in the expanded state is at least partially tubular, d. H. in the area distal to the constriction zone. This area preferably has a length of 1, 5 to 10 cm. In principle, however, the length of 10 cm can also be exceeded, since the length of the esophagus from the pharynx to the entrance of the stomach is significantly longer. However, insertion of the ventilator through the patient's mouth becomes more difficult with a longer tubular portion. However, to achieve a good seal, it is preferred that the length of the tubular section is greater than about 2 cm, and preferably greater than about 3.5 cm. On the other hand, however, the area should preferably not be longer than 8, preferably not longer than 6 cm.

It should be noted that the exact dimensions of the ventilator are dependent on the patient. For example, talking ventilators to treat children generally have smaller proportions than those used to treat adults. In addition, the use of the ventilators according to the invention in the veterinary field is conceivable, where in turn other dimensions are required.

According to an alternative embodiment of the invention, the ventilator does not have a balloon extending from the pharynx into the esophagus, but two balloons which are independently expandable or also have a connection which compensates for the pressure between the balloons. Accordingly, in accordance with this alternative embodiment, the invention relates to a ventilator having a tube assembly intended to be inserted through the mouth and throat of a patient, the tube assembly comprising at least one tube having a distal and a proximal opening, the tube assembly having a length which is adapted to bring the distal opening of the tube to the entrance area of the trachea, while the proximal opening remains outside the mouth, and wherein the distal area of the tube arrangement has a first and a second balloon which are expandable by supplying a fluid, wherein the first balloon in the expanded state causes a seal between the inserted tube assembly and the inner wall of the pharynx and the second balloon is intended to at least partially enter the esophagus and close it in the expanded state, the second e balloon in the expanded state at least partially in cross-section along a first axis has a greater extent than along a second axis orthogonal to the first axis.

Basically, in this alternative embodiment, with respect to the shape of the second balloon, that said to the distal portion of the balloon with respect to the first embodiment, that is, the balloon should have a smaller extent along the axis pointing in the direction of the trachea than in FIG this orthogonal axis, so that an excessive expansion of the balloon causes no constriction of the trachea. In particular, the second balloon should be oval in cross-section so as to provide a good To ensure sealing of the esophagus while leaving the trachea free. Again, the second balloon in the expanded state in the distal region may be at least partially tubular, with respect to the dimensions of the said for the first embodiment applies.

Moreover, it is advantageous if the tube arrangement comprises a second tube with a length which is suitable for introducing the distal end of the second tube into the esophagus, while the proximal end of the second tube remains outside the mouth. Such a second tube, which extends into the esophagus, has the advantage that the overpressure caused by gases or eruptions can escape from the stomach and the esophagus. Even in the case of vomiting, the gastric contents can escape through the second tube. Since the pressure in the area of the stomach is kept low, a lower pressure will be sufficient to hold the balloon in place. For example, while conventional laryngeal masks often have to use pressures in the range of 60 cm H ₂ O, pressures in the range of 15 to 20 cm H ₂ O are generally sufficient here. The application of lower pressures is particularly advantageous for long treatment times, so that the ventilator according to the invention is also used in the elective area, ie in the area of permanent treatments

While laryngeal masks are often used only in emergency medicine, use over periods of more than 30 to 45 minutes is difficult. In contrast, with the ventilator according to the invention also a lengthy operation of three, four or more hours can be performed.

Another advantage of the second tube is that instruments can be inserted through it, such as probes or cameras for the inspection of the esophagus or stomach. Also foods or medicaments can be introduced through the second tube.

Advantageously, the end of the second tube extends through the distal portion of the balloon or the second balloon, which closes the esophagus. Accordingly, the balloon is a sealing collar enclosing the second tube. The interior of the two tubes of the tube assembly should be completely separated. In this way, a mixing of gases or liquids, which are introduced or discharged through the tubes, prevented.

To facilitate insertion of the ventilator into the esophagus, a stylet may be provided that extends through the distal portion of the balloon or the second balloon. The stylet is a rod that has sufficient flexibility to conform to the shape of the oral cavity, pharynx, and esophagus but is significantly stiffer than the balloons themselves. In addition, the stylet may be so preformed that the path to the esophagus is virtually automatically found by the attending physician, without the risk of introducing the distal portion of the ventilator into the trachea. In this way, a "blind" insertion is possible without the use of a laryngoscope, in particular, the second tube can also pass through the stylet.

To further enhance the fit of the ventilator, the area of the balloon or balloon which in the expanded state causes a seal between the tube assembly and the inner wall of the pharynx may have a wedge-shaped structure with a proximally greater volume than distally. In this way, the respirator or the distal regions of the respirator provided for this purpose are moved further in the direction of the ventilator

Pushed esophagus.

The respirator according to the invention can be used in various fields of medicine, both in human and in veterinary medicine. The ventilator can be used both in the field of emergency medicine as well as in the field of intensive care, anesthesia, surgery, etc.

The invention will be explained in more detail with reference to the accompanying figures. Show it:

FIG. 1 shows a side view of a first embodiment of the respiratory device according to the invention; FIG. 2 shows the ventilator of FIG. 1 inserted into a patient;

3 shows a section through the balloon of the ventilator according to the invention in the region of the esophagus;

Figure 4 is a cross-section along the line IM-III of Figure 1;

Figure 5 shows a cross section along the line IV-IV of Figure 1 and

6 shows the side view of a second embodiment of the ventilator according to the invention.

FIG. 1 shows the ventilator according to the invention in a side view. The ventilator has a tube assembly 33 with a first tube (the breathing tube) 1 and a second tube (the esophageal tube) 2. The distal opening 14 of the breathing tube 1 is intended to be placed at the entrance of the trachea.

Furthermore, the ventilator comprises a balloon 4, which is composed of a proximal portion 34 and a distal portion 37, which are connected to each other via a constriction zone 16. The balloon 4 is expandable by supplying a fluid through the channel 8. In the expanded state, the proximal portion 34 of the balloon 4 seals between the inserted tube assembly 33 and the inner wall of the pharynx as the distal portion 37 of the balloon 4 extends into the esophagus. The distal portion 37 is substantially tubular and typically has a length C in the range of 1.5 to 10 cm, while the necking zone 16 typically has a length B of 1 to 4 cm.

First tube 1 and second tube 2 are housed in a common shell 3. For proper placement, the ventilator has a strip 9 that can easily extend into the esophagus and prevents the first tube 1 is pushed too far into the trachea or the balloon 4 closes the trachea. The air supply and breathing is still possible according to the arrow 41. The second tube 2 with its distal opening 5 causes excess, build-up in the stomach pressure can escape easily.

Through the distal region of the ventilator, a stylet 10 in the form of a flexible rod extends in a manner that correctly positions the ventilator during insertion. For this purpose, the stylet 10 has a greater rigidity than the balloon 4 itself, which simplifies the insertion of the device. In addition, the stylet 10 also causes a better fixation of the ventilator, especially during movements of the patient. The stylet 10 extends inside the balloon 4, by the stiletto 10 in turn extends the second tube 2. The balloon 4 thus forms a total of a sealing collar around the second tube 2.

In Figure 2, the ventilator of Figure 1 is shown inserted into the throat 7 and the esophagus 6 of the patient. It can be seen how the distal region of the balloon 4 protrudes into the esophagus 6 and closes it after expansion, wherein over the second tube 2 with its distal opening 5, a discharge of an overpressure out of the stomach is still possible. The stylet 10 has a rounding at its distal end 11 and is therefore atraumatic overall. The constriction zone 16 of the balloon 4 is adjacent to the sphincter muscle tissue.

The first tube 1 is positioned so that the distal opening 14 of the breathing tube 1 is positioned at the entrance of the trachea 12, but does not have to be pushed into it. In this way, the vocal cords 13 are protected from injury.

In Figure 3, the distal portion 37 of the balloon 4 is shown in cross-section. It can be seen that the balloon 4 is oval in cross section and along the axis 17 has a significantly greater extent than along the axis orthogonal thereto 18. Here, the axis 18 in the direction of the trachea 12. Due to the smaller expansion of the balloon in this direction ensures that the trachea 12 is not subject to the risk of being restricted or even closed by the expanded balloon 4. Furthermore, the stylet 10 with the second tube 2 passing through it can be seen in the center of the balloon 4.

FIG. 4 shows a cross section through the tube arrangement 33 along the line III-III. In the common shell 3 of the breathing tube 1, the second tube 2 and a channel 8 are arranged through which a fluid, usually air, is introduced into the balloon 4.

FIG. 5 shows a cross section through the proximal section 34 of the balloon 4 along the line IV-IV. The proximal portion 34 has a U-shaped cross section with two lateral arms 36, so that there is a gap in which the distal end 14 of the breathing tube 1 and the strip 9 are arranged. This space is bounded to the right by a wall A of the balloon.

Finally, FIG. 6 shows an alternative embodiment which dispenses with a second tube 2 for the esophagus 6. Again, however, a flexible rod (stylet) 10 is provided to allow insertion into the esophagus 6 and there to place the balloon 4 with its distal portion 37 and the constriction zone 16 and to close after expansion. Also according to this embodiment, a closure of the esophagus 6 is certainly possible, but not the derivation of pressure from the area of the stomach through a second tube.

- Claims -

Claims

claims

A ventilator with a tube assembly (33) intended to be inserted through the mouth and throat (7) of a patient

5, wherein the tube assembly (33) comprises at least one tube (1) having a distal and a proximal opening, the tube assembly (33) has a length suitable for connecting the distal opening (14) of the tube (1) to the Entrance of the trachea (12) to bring while the proximal opening remains outside the mouth and wherein the distal portion of the Röhrenan- lo order (33) has a balloon (4) which is expandable by supplying a fluid and in the expanded state a seal between the inserted tube assembly (33) and the inner wall of the pharynx (7), the balloon (4) having a distal portion (37) intended to at least partially enter the esophagus (6) and expand it in the lumen Condition, characterized in that the distal portion (37) of the balloon (4) in the expanded state at least partially in cross-section along a first Axis (17) has a greater extent than along a second, to the first axis (17)

20 orthogonal axis (18).

2. The ventilator according to claim 1, characterized in that the balloon (4) has a constriction zone (16) between the proximal and distal ends of the balloon, which causes a constriction of the balloon (4) in the region of the constriction zone (16) in the expanded state.

3. The ventilator according to claim 2, characterized in that the constriction zone (16) has a length of 1 to 4 cm, in particular 1, 5 to 3 cm, for example 2 cm.

4. The ventilator according to one of claims 1 to 3, characterized 5 indicates that the distal portion (37) of the balloon (4) in the expanded

Condition is at least partially tubular.

5. The ventilator according to claim 4, characterized in that the tubular portion (37) of the balloon (4) has a length between 1, 5 and 10 cm.

The ventilator according to claim 4 or 5, characterized in that the tubular portion (37) of the balloon (4) is longer than 2 cm and preferably longer than 3.5 cm.

7. The ventilator according to one of claims 4 to 6, characterized in that the tubular portion (37) of the balloon (4) is shorter than i5 8 cm and preferably shorter than 6 cm.

A ventilator having a tube assembly (33) adapted to be inserted through the mouth and throat (7) of a patient, the tube assembly (33) comprising at least one tube (1) having a distal and a proximal opening , the tube assembly (33) a

20 having a length adapted to bring the distal opening (14) of the tube (1) to the entrance area of the trachea while the proximal opening remains outside the mouth, and wherein the distal area of the tube assembly (33) has a first and a second one Balloon, which are expandable by supplying a fluid, wherein the first balloon in the expanded

25 state causes a seal between the inserted tube assembly (33) and the inner wall of the pharynx (7) and the second balloon is intended to at least partially enter the esophagus (6) and close it in the expanded state, d a d u c h e c e n e c e n e,

30 that the second balloon in the expanded state at least partially in the transverse section along a first axis (17) has a greater extent than along a second, to the first axis (17) orthogonal axis (18).

9. The ventilator according to one of claims 1 to 8, characterized in that the second axis (18) in the direction of the trachea (12).

10. The ventilator according to one of claims 1 to 9, characterized in that the distal portion (37) of the balloon (4) or the second balloon in cross-section are at least partially oval.

11. A ventilator according to any one of claims 1 to 10, characterized in that the tube assembly (33) comprises a second tube (2) of a length suitable for inserting the distal end of the second tube (2) into the esophagus (6). while the proximal end of the second tube (2) remains outside the esophagus (6).

The ventilator of claim 1 1, characterized in that the distal end of the second tube (2) extends through the distal portion (37) of the balloon (4) or the second balloon.

13. The ventilator according to claim 1 1 or 12, characterized in that the interior of the two tubes (1, 2) of the tube assembly (33) is separated from each other.

14. A respirator according to any one of claims 1 to 13, characterized in that a flexible rod (10) extends through the distal portion (37) of the balloon (4) or the second balloon.

15. The ventilator according to one of claims n to 14, characterized in that the second tube (2) extends through the flexible rod (10).

16. A respirator according to any one of claims 1 to 15, characterized in that the area of the balloon (4) or the balloon, in the expan- In the illustrated state, sealing between the tube assembly (33) and the inner wall of the pharynx (7) has a wedge-shaped structure with a proximally greater volume than distally so that the ventilator is pushed towards the esophagus (6).

- Summary -