DE102007011220B3 - Medical multi-lumen device used as a breathing device for animals and humans comprises sections in the longitudinal direction with tubes extending through the reusable section up to a part of the disposable section - Google Patents

Abstract

Medical multi-lumen device comprises sections (19, 20) in the longitudinal direction with tubes (1, 2, 8) extending through the reusable section (19) up to a part of the disposable section (20). Both sections are detachedly connected together using an insertion connection (17). Preferred Features: The tubes are hollow. The insertion connection is structured so that the tubes running through the sections are connected together when the insertion connection is closed.

Description

The The invention relates to a medical multi-lumen device for introduction in the human or animal body with two or more tubes.

In various areas of medicine become multi-lumen devices needed in the body at least partially introduced become. An example of this are about respirators like endotracheal tubes or laryngeal masks that pass through the oral cavity and pharynx into the Trachea or to the entrance of the trachea introduced to allow ventilation of the patient. Other examples for multi-lumen devices are those from the infusion technique, endoscopes, catheters etc. The different lumens passing through the device may be different Serve purposes, such as the gas or liquid exchange, the introduction of objects such as A stent, or therapeutics or else the accommodation of electrical or optical connections and Connections, for example cables.

Frequently poses The problem is that at least parts of the device only are difficult to sterilize because they have a complicated structure, for example have many hard to reach edges or pockets. Often Therefore, such devices are made only for single use and used as so-called "disposable" products. Because of the only one-time use is hereby, however relatively high cost connected.

on the other hand the use as disposable product limits the use of high quality materials, the principle from a medical point of view often would be advantageous. In a respirator is about a rotatability of the tube assembly in the proximal region, d. H. in the area that points to the outside of the body, often desirable, for example if the attending physician wants to expose the surgical field or if a patient is lying on his stomach. The necessary flexibility and Rotatability of the tubes, however, can only be achieved with materials of a relative high flexibility be achieved, for example, with tubes containing a metal insert but that is too reasonable Costs with disposable items is not achievable. If so Such demands on the device must be reusable Article used become, which in turn concerns the problems described in the beginning Sterilization may result. Although they would be proximally lying areas of a ventilator because of their relatively simple tube assembly in principle Well sterilizable, but this is usually not the case for the distal located area, often has a complicated structure with inflatable balloon o. Ä. In the field of respiratory devices is therefore currently strictly distinguished between so-called reusable and disposable articles, d. H. between those that are reusable and those that for the are intended for one-time use.

in view of the described problem would be it therefore desirable the advantages of easy sterilization and the benefits connect the use of high quality materials together to be able to. The associated problem is solved by a medical Multi-lumen device for the introduction in the human or animal body with two or more tubes, being the device at least two successive in the longitudinal direction Has sections, of which at least one section reusable is while at least another section is for single use, and wherein the tubes through the reusable section through at least in a part of the section for the extend single use and where the two sections have a Plug connection detachable from each other are connectable.

According to the invention thus providing medical multi-lumen devices, which consist of a reusable and a disposable section. Through the reusable section run at least two, preferably at least three tubes or tubes from the proximal to the distal end of the section in the longitudinal direction of the device considered. This section otherwise has a comparatively simple construction and is therefore easy to sterilize. by virtue of The training as a reusable section can be high quality Materials, in particular plastics, for example with metal insert, use all the requirements, which the attending physician puts on them, in particular with regard to the mentioned flexibility and twistability.

On the other hand, at least one other portion is provided for single use, which is usually the portion which has a more complicated structure in terms of its exterior and therefore more difficult to sterilize. In the field of respiratory masks, for example, this is the section that is located distally and is inserted into the trachea, the esophagus, or the hypopharynx. At least through a part of this section thereby extend the already extending through the reusable section tubes, ie when connecting the two sections using the said connector must be ensured that the corresponding Tubes in the first section are connected to the corresponding tubes in the second section.

in the In connection with the invention, the terms distal and proximal used as follows: proximal refers to the direction to the outside of the body, d. H. to the attending physician, distally the direction to the inside of the body into it.

The Plug connection should be designed so that when closing the Plug the running through the sections tubes below unique association. Around Plug connection is a mechanical coding makes sense in the shape that connects the sections only in one way possible is, so that there is a clear assignment that makes mistakes impossible. This can be achieved by placing on the front sides of the connector projections and tailored recesses are provided, which are a mating only allow in one way. Furthermore, the coupling point should be interspersed between the sections without play, what through appropriate guides can be achieved.

The named tubes can especially hollow inside. In the case of respirators, for example can the tubes the gas or liquid exchange serve. ventilators point frequently a breathing tube on, in the trachea or in the entrance area the trachea protrudes and with which ensures the air supply to the patient becomes. Furthermore you can roar for the esophagus to disposal through which a build-up in the stomach overpressure escape or vomit is dissipated to the outside. Further tubes (tubes) can serve to place balloons that are placed in the pharynx or esophagus, to expand.

According to the invention under tubes but also understood compounds by which electrical or optical connections run. Such tubes can have significance in the area of endoscopy, in the distal Range is attached to a camera whose signals are in the direction of proximal outward be directed. Likewise is common an electrical connection makes sense.

The Configuration of the connector can in different ways take place, the person skilled in plug connections of various types known in principle are. A particularly advantageous possibility, a plug connection to create predetermined breaking points in the area of the section for the one-off Use that allow a one-time joint of sections and while solving the Connection destroyed so that reuse of the section is impossible. For this purpose, the reusable section may have a mandrel, which tapers towards the other section, allowing insertion into the counterpart relatively easy possible is. The two sections can After use, although again separated from each other, this but only under elevated Effort, causing destruction the predetermined breaking points causes. In this way will be beyond doubt excluded that the non-reusable part is inappropriate is used again. About that In addition, this embodiment the advantage that it comes up without moving parts and therefore Cheap is to produce.

A alternative embodiment a connector has a pivotable lever, whose activity a release allows the connector. Also in this case can basically a distally tapered mandrel may be provided which extends by mere Plugging in the opposite Connect section with this and thereby engages behind a corresponding area in the other section. A release the connection is made only when by pivoting the lever the distal pointed mandrel is released and withdrawn can be. A spring can ensure that a pivoting the lever only when operated of the same can be done with the application of a certain degree of force.

Logically, have the interconnectable sections in the area of each other connectable tubes sealing surfaces on, for example, at the end faces of the tubes or laterally thereof. Sealing surfaces are Of course especially important if the tubes the gas or liquid exchange serve.

Special Significance possesses the multi-lumen device according to the invention in Range of respirators, Although the invention, as described, in other areas can be used. Such a ventilator is intended to be introduced through the mouth and throat of a patient which is one of the tubes is a respiratory tube, which is intended to be in the trachea or on the Entrance area of the trachea to be placed to the patient during surgery or at To be able to ventilate unconsciousness. The proximal end of the breathing tube points outwards of the body and usually stays outside of the mouth.

Conventionally, ventilators are divided into two categories, endotracheal tubes and laryngeal masks. Endotracheal tubes are inserted across the oral cavity and throat into the trachea, with the distal end of the en dotracheal tube a balloon is attached, which seals the space between the outer wall of the tube and the walls of the trachea after expansion. The 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, 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. 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 danger to the vocal cords. However, the likelihood of laryngeal mask leakage is greater and, therefore, the inflatable body must be expanded under very high pressure to obtain an airtight seal.

To reduce the risk of gastric contents entering the trachea, the international patent application suggests WO 2005/058402 A1 a ventilator, in which the balloon, which has the shape of a sealing cuff, 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 or other instruments can.

In corresponding manner, the multi-lumen device according to the invention also has in shape a ventilator Preferably, a balloon expandable by the supply of a fluid is and in the expanded state, a seal between the breathing tube and the inner wall of the pharynx. That way, one becomes Placement of the ventilation tube reached.

at the described ventilators with Balloon should be the connector as close as possible to the balloon be educated. As a rule, the distal area of such ventilator a relatively complicated one Form on, just the balloon is often preformed in that he adapts well to the inner wall of the pharynx. Im not expanding anymore Condition, such a balloon has wrinkles and depressions, the can be sterilized only very badly. That's why it makes sense to use this area for to provide the unique area. Proximal of the balloon, however includes the section that essentially contains the various tubes and the therefore has a comparatively simple structure. This proximal Area can be relatively good sterilize and can therefore be reused. Furthermore Does it make sense in this area, higher quality, flexible materials to use, which allow the attending physician, if necessary, the proximal Section of the ventilator move to the side or twist to get optimal access to To ensure mouth and throat area.

Like the one in the WO 2005/058402 A1 In the case of the ventilator according to the invention, it is also expedient to provide the balloon with a distal section which is intended to penetrate at least partially into the esophagus and to close it in the expanded state. The occlusion of the esophagus to the pharynx eliminates the risk of gastric contents entering the trachea. Since the stomach contents are very acidic, penetration into the trachea must be prevented at all costs.

Another way to seal the esophagus is to provide the ventilator with a second balloon designed to at least partially invade the esophagus and expandable by the delivery of a fluid, which balloon occludes the esophagus in the expanded state , Such a ventilator is basically in the WO 96/27404 A1 disclosed.

at ventilators with one or more balloons are usually also a corresponding or more tubes (Tubes) for it provided, a fluid, i. d. R. Luft, in order to expand the balloon in to initiate this.

Advantageously, one of the tubes is an esophageal tube which protrudes with its distal end into the esophagus after insertion of the ventilator. The length of the tube must be selected accordingly. However, the proximal end of the tube usually remains outside the mouth. Such a second tube, which extends into the esophagus, has the advantage that the overpressure caused by gases or regurgitation 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 in conventional laryngeal masks, pressures in the range of 60 cm water column often have to be used, pressures in the range of 15 to 20 cm water column are generally sufficient here. The application 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 because use over periods of more than 30 to 45 min is difficult. In contrast, with the described embodiment, a lengthy operation of three or more hours can also be performed. Finally, the esophageal tube has the additional advantage that instruments can be inserted through it, such as probes or cameras for inspection of the esophagus or stomach. Also foods or medicaments can be introduced through the second tube.

One typical ventilator according to the invention therefore at least three tubes / tubes on, namely a ventilation tube for air supply, an esophageal tube, the overpressure can derive from the stomach, and at least one tube through which a fluid i. d. R. Air into which or the balloons are introduced can. It goes without saying that when joining the sections the multi-lumen device requires a clear assignment of the tubes is to prevent, for example, a connection between the esophageal tube and Respiratory tube is generated.

The esophageal tube extends Advantageously, through the balloon or the distal portion of the Balloons containing the esophagus closes in the expanded state. The balloon points in this Case a shape similar a sealing sleeve on.

Around the introduction of the ventilator in the esophagus To facilitate, a stylet may be provided by the distal portion of the balloon or the second balloon runs. at The stiletto is a rod that, while a sufficient high flexibility to conform to the shape of the oral cavity, pharynx and esophagus, However, much stiffer than the balloons themselves. Beyond The stylet may be preformed so that the way to the esophagus is virtually automatically found by the attending physician, without take the risk of the distal area of the ventilator in the windpipe introduce. On this way is a "blind" insertion without Use of a laryngoscope possible. In particular, the second tube can also pass through the stylet.

It may also be a through the esophageal tube single and executable Corporate Office be provided, the relatively stiff accomplished is while the surrounding areas of the balloon very much and thus atraumatic are. Such a management staff serves for insertion of the distal portion of the balloon into the esophagus, to which initially careful the senior staff itself is advanced, which due to its stiffness relative simply into the esophagus retract. The management staff sticks out a piece out of the distal end of the balloon. Once the management staff and the surrounding balloon in the entrance area of the esophagus introduced can be, the senior staff withdrawn a bit be (about 10 mm), then to to continue the feed. This is how the management staff stands no longer out of the distal end of the balloon, what the danger the injury of the esophageal inner wall minimized.

The described ventilators become common made of silicone. in principle However, other plastics are suitable, for example PVC, Polyurethane or SEES (styrene-ethylene / butylene-styrene). The exact Dimensions of the ventilator are partly dependent on the patient. For example, appropriate ventilators are used to treat children usually smaller dimensions as such have for adult treatment. In addition, the use is also the ventilators according to the invention in veterinary medicine Conceivable area, where in turn other dimensions are required.

The Invention will be with reference to the accompanying figures explained in more detail. The Invention will be described with reference to a ventilator, as in the beginning accomplished However, the invention is not limited thereto. Show it:

1 a side view of the ventilator according to the invention;

2 the ventilator off 1 , introduced into a patient;

3 a cross section through the ventilator in the region of the connector;

4 the connector in longitudinal section;

5 a detailed view of the connector in longitudinal section and

6 a detailed view of an alternative connector in longitudinal section.

In 1 an inventive ventilator is shown in the side view. The ventilator has a tube assembly with a breathing tube 1 and an esophageal tube 2 on. The distal opening 14 of the breathing tube 1 is intended to be placed at the entrance of the trachea.

The ventilator also includes a balloon 4 which consists of a proximal portion of comparatively large extent and a distal portion 37 composed of a constriction zone. The balloon 4 is by supplying a fluid across the channel 8th expandable. In the expanded state, the balloon leads 4 a seal between the ventilator and the inner wall of the pharynx while the distal section 37 of the balloon 4 extending into the esophagus. The distal section 37 is substantially tubular and typically has a length in the range of 1.5 to 10 cm, while the necking zone 16 typically has a length of 1 to 4 cm.

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

A stylet runs through the distal area of the ventilator 10 in the form of a flexible rod, in a manner that correctly positions the ventilator during insertion. This is indicated by the stiletto 10 a greater stiffness than the balloon 4 itself, which simplifies the insertion of the device. In addition, the stiletto causes 10 Also, that the blockage of the esophagus, especially during movements of the patient is always ensured. The stiletto 10 runs inside the balloon 4 , by the stiletto 10 again the esophageal tube runs 2 , At its distal end 11 has the stiletto 10 Rounding and is therefore atraumatic. The balloon 4 has the form of a sealing cuff around the esophageal tube 2 ,

The ventilator consists of two sections, a proximal, reusable section 19 and a distal section intended for single use 20 , It can be seen that the proximal section 19 Its shape is much simpler than the distal section 20 , which is why the proximal section 19 much easier to sterilize. Proximal section 19 and distal section 20 are via a plug connection 17 coupled together.

In 2 is the ventilator off 1 in the throat 7 and the esophagus 6 presented to the patient introduced. One recognizes how the distal area of the balloon 4 in the esophagus 6 protrudes and this closes after expansion, whereby on the esophageal tube 2 with its distal opening 5 deriving an overpressure from the stomach as much as possible. The constriction zone 16 of the balloon 4 is adjacent to the sphincter muscle tissue 15 ,

The breathing tube 1 is positioned so that the distal opening 14 of the breathing tube 1 at the entrance of the trachea 12 is positioned, but does not have to be pushed into this. That's how the vocal cords are made 13 protected from injury.

In 3 the ventilator is near the connector 17 shown in cross section. The ventilator has a total of three tubes, namely the breathing tube 1 , the esophageal tube 2 as well as a tube 8th , which serves to supply a fluid into the balloon. All tubes are in a common shell 3 accommodated. To connect the distal and proximal sections 19 . 20 the ventilator is a lock 18 intended.

In 4 are the proximal section 19 and the distal section 20 of the ventilator shown in longitudinal section. It can be seen that the sections as well as the tubes are coordinated with each other in such a way that an unambiguous assignment takes place, ie the respiration tube 1 of the proximal and distal sections 19 . 20 are connected with each other, the same applies to the esophageal tube 2 , breathing tube 1 and esophageal tube 2 are thus kept strictly separated from each other over the entire ventilator.

In 5 a first embodiment of a connector is shown in longitudinal section, wherein the reusable proximal portion 19 with a thorn 21 is provided, which is sharpened arrow-shaped at its distal end. To induce the locking of the mandrel 21 , which may for example consist of stainless steel, in the corresponding recess in the distal section 20 hineinge suppressed. There are in the distal section 20 Predetermined breaking points 22 provided on which the spine 21 with its arrowhead while snapping past can be easily passed, but then hooked, so that a release of the sections 19 . 20 only under a certain amount of force with destruction of the predetermined breaking points 22 is possible. After the section 19 and 20 Once separated, are the predetermined breaking points 22 destroyed, allowing a reconnection with the distal section 20 is no longer possible. The disposable section 20 is then replaced by a sterile, new section 20 and, after sterilization of the proximal section 19 to be connected to this again.

An alternative embodiment of a latch is shown in FIG 6 shown, in which case also an arrow-shaped pointed mandrel in a corresponding recess in the distal portion 20 is introduced. After insertion, the arrowhead engages in the distal section 20 a, allowing a separation of the sections 19 and 20 by pulling apart is no longer possible. In this case, however, a pivotable lever 23 be operated, which releases the lock and a separation of the sections 19 and 20 allowed. The feather 24 prevents unintentional pivoting of the lever 23 ,

Claims (18)

Medical multi-lumen device for introduction into the human or animal body with two or more tubes ( 1 . 2 . 8th ), characterized in that the device comprises at least two successive sections ( 19 . 20 ), of which at least one section ( 19 ) is reusable while at least one other section ( 20 ) serves the single use, wherein the tubes ( 1 . 2 . 8th ) through the reusable section ( 19 ) into at least part of the section ( 20 ) for single use and the two sections ( 19 . 20 ) via a plug connection ( 17 ) are releasably connectable to each other. Multilumen device according to claim 1, characterized in that the plug connection ( 17 ) is designed so that when closing the connector ( 17 ) through the sections ( 19 . 20 ) extending tubes are associated with clear assignment. Multilumen device according to claim 1 or 2, characterized in that the tubes ( 1 . 2 . 8th ) are hollow inside. Multilumen device according to claim 3, characterized in that the tubes ( 1 . 2 . 8th ) serve the gas or liquid exchange. Multilumen device according to claim 1 or 2, characterized characterized in that electrical through the tubes or optical connections run. Multilumen device according to one of claims 1 to 5, characterized in that the plug connection ( 17 ) in the area of the section ( 20 ) for single use over predetermined breaking points ( 22 ), which is a one-time connection of the sections ( 19 . 20 ) and destroyed when the connection is loosened so that a re-use of the section ( 20 ) is impossible. Multilumen device according to one of claims 1 to 5, characterized in that the plug connection ( 17 ) by actuating a pivotable lever ( 23 ) is solvable. Multilumen device according to one of claims 1 to 7, characterized in that the interconnectable sections ( 19 . 20 ) in the region of connectable tubes ( 1 . 2 . 8th ) Have sealing surfaces. Multilumen device according to one of claims 1 to 8, characterized in that the multi-lumen device comprises a ventilator with tubes ( 1 . 2 . 8th ), which is intended, through the mouth and throat ( 7 ) of a patient, wherein one of the tubes is a respiration tube ( 1 ), which is intended to be in the trachea ( 12 ) or at the entrance of the trachea ( 12 ) to be placed. Multilumen device according to claim 9, characterized characterized in that the ventilator is an endotracheal tube or a laryngeal mask is. Multilumen device according to claim 9 or 10, characterized in that the ventilator at least one balloon ( 4 ), which is expandable by supplying a fluid and in the expanded state, a seal between the breathing tube ( 1 ) and the inner wall of the pharynx ( 7 ) brought about. Multilumen device according to claim 11, characterized in that the plug connection ( 17 ) proximal to the balloon ( 4 ) is arranged. Multilumen device according to claim 11 or 12, characterized in that the balloon ( 4 ) a distal portion ( 37 ), which is intended at least partially into the esophagus ( 6 ) and to close this in the expanded state. Multi-lumen device according to claim 11 or 12, characterized in that the ventilator has a second balloon, the for is provided, at least partially into the esophagus ( 6 ) and which is expandable by the supply of a fluid, wherein the balloon is the esophagus ( 6 ) closes in the expanded state. Multilumen device according to one of claims 11 to 14, characterized in that one or more of the tubes ( 1 . 2 . 8th ) with one or more balloons ( 4 ) and the supply of a fluid for expansion of the balloon ( 4 ) serve. Multilumen device according to one of claims 9 to 15, characterized in that one of the tubes is an esophageal tube ( 2 ) after insertion of the ventilator with its distal end into the esophagus ( 6 ) protrudes. Multilumen device according to claim 16, characterized in that the esophageal tube ( 2 ) through an esophagus ( 6 ) in the expanded state occluding balloon ( 4 ) runs. Multilumen device according to claim 16 or 17, characterized by a through the esophageal tube ( 2 ) executable and executable staff.