WO2008074470A1

WO2008074470A1 - Respirator comprising an introduction aid

Info

Publication number: WO2008074470A1
Application number: PCT/EP2007/011120
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: DE102006060969B3

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 a first and a second tube (1, 2), each of which has a distal and a proximal opening, the length of the tube arrangement (33) allowing the distal opening (14) of the first tube (1) to reach the entrance to the trachea (12) and the distal opening (5) of the second tube (2) to be inserted into the oesophagus (6), with the proximal openings 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, the distal end of the second tube (2) running through the distal section (37) of the balloon (4) and a reversible guide rod (17), which can be introduced and removed, running through the second tube (2). This allows a simple but nevertheless secure introduction into the oesophagus (6). 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

MSTR0032 (2266/07)

D60 / D 12284

XD / ...

Beatmunαsαerät with insertion aid

The invention relates to a ventilator with a tube assembly which is intended to be inserted through the mouth and throat of a patient, the tube assembly comprising a first and a second tube, each having a proximal and a distal opening, the tube assembly a Length, which is adapted to introduce the distal opening of the first tube to the entrance area of the trachea and the distal opening of the second tube in the esophagus, while the proximal openings remain outside the mouth, wherein the distal portion of the tube assembly comprises a balloon passing through Supplying a fluid is expandable and in the expanded state creates a seal between the inserted tube assembly and the inner wall of the pharynx, the distal balloon having a distal portion intended to at least partially penetrate into the esophagus and this in the expanded state and with the distal end of the second tube passing through the distal portion of the balloon. The invention further relates to a ventilator having 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 between the vocal cords. which is a significant risk because the vocal cords are very sensitive and can easily be damaged. This can lead to infections, the formation of scar tissue, obstruction of the trachea or permanent hoarseness of the patient. In addition, the introduction is possible only under view, ie with the aid of a laryngoscope or the like, as well as with the administration of a muscle relaxant.

On the other hand, 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 hermetically seals the pharynx above the trachea. Since the masks are not inserted into the trachea itself, there is no danger to the vocal cords.

However, the likelihood of developing a leak is greater with laryngeal masks. 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 ventilator in which the balloon or the sealing cuff, which in the expanded state creates a seal between the tube and the throat, has its distal end End protrudes into the esophagus 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.

In order to facilitate the insertion of the balloon / the sealing cuff into the esophagus, WO 2005/058402 A1 proposes a more or less flexible rod (stiletto) within the balloon, which extends as far as the distal end of the balloon

Balloons extends and because of its size and rigidity in comparison to the balloon itself simplifies the advancement. In addition, the rod has atraumatic rounding at its distal end to prevent injury to the inner wall of the esophagus.

The problem here is that the spherical configuration of the distal end of the rod makes it difficult to find and insertion into the entrance area of the esophagus, since the entrance into the esophagus is very narrow at rest. Although finding the entrance area could be improved by providing the flexible bar with a distal tip of correspondingly smaller dimensions, this would involve the risk of injuring or at least adhering to the esophageal inner wall as it continues to enter the esophagus to stay. This is mainly due to the fact that the esophagus inner wall is not smooth, but rather has a variety of small sac-like protuberances and bulges, which are referred to as esophageal diverticula or Zenker's diverticulum. If the attending physician remains in one of the said Zenker diverticula when advancing the device with the distal tip, further advancement is no longer possible. In addition, there is a risk that if too much force is applied, the diverticula will be ruptured by the tip of the device. This danger would be particularly in emergency situations, since in this case the ventilator must be introduced very quickly.

Overall, the conflict of objectives is that it would be desirable to find the tip of the esophagus as narrow as possible, but this is associated with the danger of becoming caught on esophageal diverticula. Although this danger is largely eliminated by making the distal end of the rod spherical and relatively thick, which in turn makes it difficult to insert into the entrance area of the esophagus.

Also in terms of flexibility, the previously arranged in the distal balloon area bars are not optimal. On the one hand, the highest possible flexibility is desirable so that the area of the ventilator introduced into the esophagus is as atraumatic as possible, while on the other hand, high flexibility makes it difficult to insert it into the esophagus. Conversely, with a relatively stiff rod, insertion into the esophagus is relatively easy, but the risk of rupture or injury to Zenker's diverticula is all the greater.

Similar compromises have to be made with regard to the design of the tip of the rod, because on the one hand a rounded, spherical tip reduces the risk of wall ruptures, but in turn hinders the insertion into the esophagus.

Based on the above-described disadvantages of the prior art, therefore, the task arises, a respirator of the aforementioned type

To make available, with the help of which the distal sections of the balloon Well inserted into the esophagus without running the risk of injuring esophageal diverticulum.

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, the tube arrangement comprising a first and a second tube, each with a proximal and a distal opening, the tube assembly has a length adapted to introduce the distal opening of the first tube to the entrance region of the trachea and the distal opening of the second tube into the esophagus while leaving the proximal openings outside the mouth, the distal region of the tube assembly having a balloon which is expandable by supplying a fluid and, when expanded, establishes a seal between the inserted tube assembly and the inner wall of the pharynx, the distal balloon having a distal portion intended to at least partially enter the esophagus and sen in the expanded state to close and wherein the distal end of the second tube extends through the distal portion of the balloon, wherein a reversibly insertable and executable guide rod extends through the second tube.

According to the invention, no rod which is firmly integrated into the distal section of the balloon is used, but rather a guide rod which can be easily inserted and removed through the second tube projecting into the esophagus. The guide rod itself is carried out relatively stiff, while the surrounding areas of the balloon are very soft and thus atraumatic. In order to insert the distal section of the balloon into the esophagus, the guide rod itself can be advanced carefully, which due to its stiffness can be relatively easily inserted into the esophagus. The guide stick protrudes a piece out of the distal end of the balloon. Once the guide rod and surrounding balloon have been inserted into the entrance of the esophagus, the guide rod can be withdrawn slightly (about 10 mm) to continue advancement. In this way, the stylet no longer protrudes out of the distal end of the balloon, minimizing the risk of catching on Zenker diverticula or injuring them. Possibly. can he treating doctor, when he notices that he meets with the guide rod to a resistance, retract the leadership even further, and then continue the feed. In this way, the advantages of a narrow rod at the distal end (easy insertion into the entrance area of the esophagus) and a broad, rounded rod at the distal end (minimizing the risk of penetrating and injuring Zenker's diverticula) are combined. A forward and retractable guide rod allows adaptation to the current treatment situation. In addition, the guide rod at the proximal end can have markings by means of which the doctor can see how far the guide rod has been inserted into the ventilator. In the manner described, a "blind" insertion without use of a laryngoscope is possible.

Once the distal portion of the balloon has been inserted far enough into the esophagus, the guide rod can be completely removed. The remaining portions of the balloon in the esophagus are then very soft and atraumatic, so that a violation of the esophagus inner wall is hardly to be feared. The guide rod itself, however, can be made stiffer than the flexible rods of the prior art, since the guide rod is forward and retractable and ultimately completely removed. The soft and atraumatic formation of remaining in the esophagus sections of the

Balloons also have the further advantage that forces occurring here can be easily absorbed due to the flexibility of the balloon. By contrast, in the case of devices known from the prior art, these forces can be transmitted along the length of the rod into the hypopharynx, so that there too there is the danger of injuries. In principle, the greatest possible flexibility, especially lateral, is desirable, but it must be noted that the second tube extending into the esophagus should not collapse, so that access to the esophagus by the second tube remains open. This can be achieved by using a suitable material for the second tube.

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. Also However, other plastics are basically suitable, for example PVC, polyurethane or SEBS (styrene-ethylene / butylene-styrene). The production of a balloon having the desired shape in the expanded state is readily possible by conventional methods known in the art.

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 the stomach, which ensures the good fit of the ventilator 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. The distal end of the balloon / sealing cuff is accordingly, for example, the end that continues in the interior of 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 no sharp

Border has. Rather, the balloon gradually reduces its diameter to the constriction zone and in turn increases it in the direction of the distal one End, wherein the reduced diameter portion has a length in the above range.

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 respirator are dependent on the patient. For example, appropriate ventilators for treating children will generally be smaller in size 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 having a first and a second tube, each having a proximal and a distal opening. The tube arrangement comprises a length which is suitable for introducing the distal opening of the first tube into the entrance area of the trachea and the distal opening of the second tube into the esophagus the proximal openings remain outside the mouth, the distal portion of the tube assembly having first and second balloons expandable by delivery of a fluid, the first balloon in the expanded state sealing between the inserted tube assembly and the inner wall of the throat brought about and the second balloon is intended to at least partially penetrate into the esophagus and to close it in the expanded state and wherein the distal end of the second tube extends through the second balloon, wherein a reversibly insertable and executable guide rod extends through the second tube.

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.

The second tube, which extends through the distal portion of the balloon or the second balloon, according to the invention not only has the task of harboring the guide rod, but also has the advantage that caused by gases in the stomach or regurgitation overpressure from the stomach and the esophagus can escape. Even in the case of vomiting, the stomach 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 require 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 use of lower pressures is particularly advantageous in the case of long treatment times, so that the ventilator according to the invention can also be used in the elective area, ie in the area of permanent treatments, while laryngeal masks are often used only in emergency medicine since use over periods of more than 30 to 45 min 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 it allows instruments to be inserted through it, such as probes or cameras. Inspection of the esophagus or stomach. Also foods or medicaments can be introduced through the second tube.

As already mentioned, the guide rod itself should be made of a relatively stiff material to make insertion into the esophagus as easy as possible. Since the guide rod is easily inserted and withdrawn and is completely removed after the introduction of the tube assembly, a violation of the esophagus inner wall is nevertheless not to be feared.

Moreover, it is advantageous if the guide rod is already preformed, so that the guide rod, the way from the oral cavity to the esophagus quasi automatically searches without the treating physician must make major corrections. For this purpose, the guide rod should have a curvature corresponding to the course of the connection of the oral cavity, pharynx and esophagus. In particular, the guide rod should be shaped so as to preclude accidental insertion into the trachea.

Optionally, the guide rod can also be made of a deformable material, so that the treating physician can make corrections in the form of the guide rod, if necessary, in order to adapt it to the respective patient. This could be important, for example, if it gets stuck with the guide rod during insertion into the esophagus or the patient has an unusual form of the oral cavity or pharynx.

It is also useful to provide the guide rod with a soft distal tip. It also makes sense to form the distal tip rounded. Both cause the distal tip of the guide rod is as atraumatic as possible, which further reduces the risk of injury to the esophagus inner wall and in particular of the existing diverticulum.

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 further improve the fit of the respirator, 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 larger volume than distal. In this way, the ventilator or the distal areas of the ventilator provided for this purpose are pushed further in the direction of the 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. In emergency medicine, one becomes the senior staff i. d. R. form somewhat stiffer, since the rapid introduction of the ventilator in the foreground.

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

Figure 1 is a side view of a first embodiment of the ventilator according to the invention;

FIG. 2 shows the ventilator from FIG. 1 inserted in a patient;

3 shows a cross section along the line IM-III of Figure 1 and

4 shows a cross section along the line IV-IV of Figure 1.

FIG. 1 shows the ventilator according to the invention in a side view. The ventilator has a tube arrangement 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 which can easily extend into the esophagus and prevents the first tube 1 from being pushed too far into the trachea or the balloon 4 closing 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 second tube 2 extends a guide rod 17, which is relatively stiff and can be inserted and ejected through the oesophageal tube 2. The guide rod 17 has a distal tip 18, which is rounded and therefore atraumatic. To insert the ventilator, the guide rod 17, which can be relatively easily inserted into the esophagus 6 due to its stiffness, advanced, the other areas of the respirator, in particular the distal portion 37 of the balloon 4 is nachschoben accordingly. Once the entrance of the esophagus 6 has been overcome, the guide rod 17 can be withdrawn a little so that it no longer protrudes beyond the distal portion 37 of the balloon 4. Subsequently, the advancement into the esophagus 6 is continued, the risk of injury to the esophagus inner wall is minimized due to the retracted guide rod 17, on the other hand, however, the balloon 4 with its still existing guide rod 17 has sufficient rigidity to allow advancement. As soon as the ventilator including the balloon 4 has reached its final position, the guide rod 17 is pulled proximally out of the ventilator and removed. Thus, only the soft atraumatic balloon 4 itself remains in the esophagus 6.

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 guide rod 17 is already removed in this illustration. The constriction zone 16 of the balloon 4 borders on the sphincter muscle tissue 15.

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.

FIG. 3 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. 4 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.

- 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) includes first and second tubes (1, 2) having proximal and distal openings, the tube assembly (33) has a length suitable for the distal opening (14) of the tube bring the first tube (1) to the entrance area of the trachea (12) and insert the distal opening of the second tube (2) into the esophagus (6) while the proximal openings remain outside the mouth, the distal area of the tube arrangement (33) comprises a balloon (4) which is expandable by the supply of a fluid and in the expanded state creates a seal between the inserted tube assembly (33) and the inner wall of the pharynx (7), the distal balloon (4) having a distal one Section (37) which is intended to at least partially penetrate into the esophagus (6) and to close it in the expanded state and wherein the distal end of the second tube (2) through the The distal portion (37) of the balloon (4) is fully wound

20 a through the second tube (2) extending reversibly on and executable guide rod (17).

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 in the expanded state, a constriction of the

25 balloons (4) in the area of the constriction zone (16) brought about.

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 respirator with a tube assembly (33) adapted to be inserted through the mouth and throat (7) of a patient, the tube assembly (33) having first and second tubes (1, 2), respectively a proximal and a distal opening comprises,

20, the tube assembly (33) has a length suitable to the distal opening (14) of the first tube (1) to the entrance area of the trachea (12) and the distal opening (5) of the second tube (2) into the esophagus ( 6) while leaving the proximal openings outside the mouth, the distal portion of the tube assembly (33) having a

25 having first and second balloons expandable by the delivery of a fluid, the first balloon in the expanded state effecting a seal between the inserted tube assembly (33) and the inner wall of the throat (7) and the second balloon is intended, at least Partially enter the esophagus (6)

30 and to close this in the expanded state and wherein the distal End of the second tube (2) passes through the second balloon, characterized by a by the second tube (2) reversibly on and executable guide rod (17).

5 9. The ventilator according to one of claims 1 to 8, characterized in that the guide rod (17) consists of a rigid material.

10. The ventilator according to one of claims 1 to 9, characterized in that the guide rod (17) is preformed the way from the oral level to the esophagus (6).

11. The ventilator according to one of claims 1 to 10, characterized in that the guide rod (17) is made of a deformable material.

12. A ventilator according to any one of claims 1 to 11, characterized in that the guide rod (17) has a soft distal tip.

13. The ventilator according to claim 1, wherein the guide rod has a rounded distal tip.

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

15. Ventilation device according to one of claims 1 to 14, characterized in that the region of the balloon (4) or the balloon, which causes a seal between the tube arrangement (33) and the inner wall of the throat (7) in the expanded state, a has a wedge-shaped structure with a proximally larger volume than distal, so that the respirator in

25 is pushed towards the esophagus (6).

- Summary -