WO2007057127A1

WO2007057127A1 - Expandable device for insertion into organ and/or body orifices

Info

Publication number: WO2007057127A1
Application number: PCT/EP2006/010795
Authority: WO
Inventors: Andreas Horn
Original assignee: Andreas Horn
Priority date: 2005-11-15
Filing date: 2006-11-10
Publication date: 2007-05-24
Also published as: DE202005017959U1

Abstract

The invention relates to an expandable device for insertion into organ and/or body orifices, for different medical instruments, in particular for intubation. Starting out from the disadvantages of the known prior art, an expandable device for insertion into organ and/or body orifices is to be made available which permits lesion-free insertion, can be produced inexpensively and is safe and easy to handle. To this end, a solution is proposed in which the tube 1 is designed as an unstable system made up of two concentric, collapsible tubular sleeves 2, 3 at least of the same length and made of thin-walled elastic films, namely an inner sleeve 2 and an outer sleeve 3. The axial lumen 7 is defined by the inner sleeve. Between the outside wall of the inner sleeve 2 and the inside wall of the outer sleeve 3, an annular lumen is formed which extends in the axial direction and which is closed at its distal end. Before insertion into the organ or body orifice, the tube 1 is fixed and stabilized in a position in which it is stretched lengthwise with a small diameter. The expansion element is designed as a one-piece, elongate sleeve-shaped element 13 which, after the tube 1 with small diameter has been inserted into the organ or body orifice, can be guided into the annular lumen, as a result of which the tube 1 is expanded to a greater diameter. The sleeve-shaped element 13 remains in the tube 1 in the expanded state.

Description

description

Expandable device for introduction into organ and / or Körperöffnunqen

The invention relates to an expandable device for introduction into organ and / or body openings, for different medical instruments, in particular for intubation.

Endotracheal intubation is an indispensable part of all anesthesia techniques in which the patient has to be relaxed and ventilated intraoperatively. Endotracheal tubes consist of a relatively stable tubular body (tube) of flexible material and have a proximal and a distal end. At the outer circumference of the tube, at a small distance from the distal end, an inflatable balloon (cuff) is arranged, which is connected to a tube for inflating. At the end of the hose, a bellows with vent valve is connected. The cuff is inflated after insertion of the tube into the trachea, protects against aspiration and allows by its seal to the trachea wall sufficient ventilation. To insert the tube into the trachea, a flexible guide rod can be used to allow the anatomical conditions adapted sliding of the tube into the trachea. As part of the tracheostomy, an artificial airlift is surgically created. This measure is required for long-term ventilation of patients in an intensive care unit. In order to protect the patient from asphyxiation, a provisional, artificial airlift is created as an emergency, percutaneously (emergency tracheotomy, cotoniotomy).

For the treatment of patients of different ages, from infants to adults, endotracheal tubes with different internal diameters are available. The inner diameter determines the resistance to respiration and ventilation. To keep the resistance as low as possible, the largest possible tube should be chosen, which can be advanced without force into the trachea. Too large tubes damage the larynx and trachea, too small tubes increase the resistance to the air flow. Since a tube with a large internal diameter should be used for sufficient ventilation if possible, the insertion of the tube into the larynx is associated with some risks and should therefore only be performed by medical personnel with particularly long experience in this field. In patients with anatomical or pathological features additional intubation difficulties occur. For anesthesiologists and emergency physicians, unpredictable difficult intubations are extremely critical moments. If the tube can not be inserted into the trachea within a very short time, the patient suffocates.

During intubation there is a risk of injury to the larynx, vocal cords, nasal septa and trachea. Long-term consequences include vocal cord damage, dysphagia, hoarseness, intubation granulomas, chronic nosebleeds and odor losses. If the glottis is narrowed by tumors or injuries, use a tube with a diameter that is too small for the patient. As a result, only an insufficient ventilation is possible. For intubation problems usually a small tube must be used, which then allows no optimal ventilation. There is a high risk of injury with nasal intubation, despite the use of a small diameter tube.

Especially in the field of endotracheal intubation there is therefore a need for instruments or tube variants which enable a lesion-free intubation. During surgical tracheotomy, after successful puncture and insertion of the guidewire, a dilator is inserted into the trachea with slight rotational movement through the pretracheal tissue to extend the tissue around the wire. Dilators are generally used to dilate access channels to body organs. In order to achieve large access channels according to the respective requirements, dilators with a correspondingly large diameter are used. Also known is the use of radially expanding dilators, which are expandable after insertion to a larger diameter. Such a dilator is known, for example, from EP 0 585406 B1. This consists of an elongated tube with a proximal and a distal end and an axial lumen, wherein the tube is radially expandable by introducing a Aufweitelementes from a small diameter to a larger diameter. The tube is made of an elastic material or a permanently deformable plastic material. The expansion element consists of an outer tube and an inner rod. By inserting the expansion element in the axial lumen of the tube this is radially expanded, z. B. to a diameter which is twice as large as the initial diameter. After expansion, the inner rod is removed again. The tube remains in the tube to stabilize the extended access channel. This dilator is complicated to manufacture and difficult to handle in practical use. It is not excluded that with the removal of the rod, the pipe is moved or even pulled out again. The outer tube and the expansion member are made of relatively rigid material, such as plastic or metal. As a result, can be The dilator does not adapt individually to the respective anatomical conditions and pathologically altered tissue structures. In case of surgery-related body movements there is an increased risk of injury.

The invention has for its object to provide an expandable device for introduction into organ and / or body openings, which allows a lesion-free introduction, inexpensive to produce and easy and safe to handle. According to the invention the object is achieved by the features specified in claim 1. Advantageous embodiments and further developments are subject matter of claims 2 to 20.

The tube of the device consists of two concentrically arranged, foldable tubular sheaths, one inner and one outer sheath, made of thin-walled elastic plastic films. The two sheaths have at least the same length, preferably the inner sheath is longer than the outer sheath and projects beyond this at the proximal end. The inner shell limits the axial lumen. Formed between the outer wall of the inner shell and the inner wall of the outer shell is an axially extending annular lumen closed at its distal end. The tube is unstable before use. Prior to insertion into the organ or body opening, it is fixed and stabilized in a longitudinally stretched, small diameter layer. After positioning the tube at the desired location, it can be radially increased by a multiple of its initial diameter by inserting an expansion element, which is formed as a one-piece, elongate sleeve-shaped element, into the annular lumen. In the expanded state, the sleeve-shaped element remains in the annular lumen of the tube. Since the tube is reduced to a very small diameter during insertion into the organ or body opening, this can be inserted lesion-free in the anatomically existing or pathologically narrowed body opening and then expand to a significantly enlarged outer diameter to the largest possible access channel for initiation further medical measures. The expansion of the tube is extremely gentle on the patient. Despite anatomical or work-related bends of the tube, the diameter of the access channel remains constant. The sleeve-shaped element used as expansion element is stable and flexible. This can be made of plastic or metal, preferably in one embodiment as a spiral. To improve the lubricity, a special coating is applied to the outer jacket of the sleeve or spiral. A spiral made of metal consists of a mesh of thin steel threads. These ensure sufficient stability and high flexibility of the sleeve. A made of plastic Sleeve may also already be preformed for adaptation to the respective anatomical conditions or bent accordingly in the longitudinal direction.

The sleeve can be used as a disposable sleeve or be intended for multiple use. The cross section of the sleeve is usually circular. For certain applications, this may also be formed oval or triangular. In this case, the sheaths of the tube are matched to the respective cross-sectional shape. The two concentrically arranged casings can be formed in different ways. One possibility is to use a single-walled tubular film that is at least twice as long as one of the sheaths. The tubular film is turned to the formation of the two sheaths with one end to the inside by 180 °, and pulled in the opposite direction, at least to the other end. Thus, a flexible double wall tube with an axial lumen and an annular lumen, which is closed or limited at its distal end by the Stülpvorgang the tubular film.

Alternatively, two tubular films are arranged concentrically with each other, e.g. one tubular film is pulled through the other tubular film and the two tubular films are joined together at one end, e.g. by welding or gluing. The two tubular films may differ in diameter. The tubular film with the larger outer diameter forms the outer shell.

The outer shell of the tube is attached with its proximal end to a stable connector (connector), which serves as a guide during insertion of the expander and this fixed in the inserted state. If necessary, the inner shell can also be attached to a separate connector. The connector can also be designed for the connection of a ventilator.

The tube formed from the two shells is fixed and stabilized prior to insertion into the organ or body opening in a longitudinally stretched position with a small diameter. For this purpose, various possible embodiments are proposed.

To perform intubations, such as by means of an endotracheal tube, a guide rod is usually used, which is inserted into the axial lumen of the tube. The guide rod has at its distal end an attached tip made of metal or plastic, by means of which the distal end of the tube or the two sleeves is clamped. The proximal ends of the two sheaths, at least that of the outer sheath, are attached to connectors of conventional design and, if necessary, held at the proximal end of the guide rod, so that the tube assumes a stretched position. During insertion of the expander, the flexible sheath or coil, when it is inserted close to the distal end, the clamped distal end of the tube is pulled out of the anchorage at the tip of the guide rod, thereby fully releasing the central access channel.

In order to reduce the initial diameter of the tube before insertion into the organ or body opening to the smallest possible degree, in addition, the annular lumen and / or C uff, if present, be subjected to vacuum. As a result, the two flexible sleeves wrap tightly around the guide rod. For this purpose, it is necessary that the proximal end of the annular lumen be closed, e.g. by clamping on the guide rod. Immediately before the introduction of the sleeve or spiral, to widen the tube, the clamping connection is released again. According to a further embodiment, the outer shell can be permeable to air in the immediate area of the cuff, so that a connecting line to the Cuff suffice to generate the vacuum. After inserting the sleeve or spiral, the proximal end of the annular lumen is closed again, so that during the inflation of the cuff and air enters the annular lumen, whereby this is additionally widened. The guide rod can be equipped with an axial channel, sucked through the liquid or oxygen is insuffliert. The guide rod can also be equipped with a light source arranged at the tip. Especially during emergency intubation, it is thus possible to check whether the inserted endotracheal tube is in the correct position in the trachea.

At the distal end portion of the outer shell, the cuff is arranged in a conventional manner. Via the cuff-carrying line, which is equipped with a check valve, air is supplied by means of the plunger syringe and the cuff, which is placed with its proximal side on the underside of the vocal folds, is inflated. Before inserting the tube into the trachea, the cuff can also be subjected to a vacuum, eg by means of a conventional plunger syringe connected to the cuff line. Another variant for fixation and stabilization of the tube consists in that a flexible thin-walled sleeve which is continuously slotted longitudinally is wound onto it, which gives the unstable tube the required stability in order to introduce it into the organ or body opening. In this case, the use of a management staff can be dispensed with. The sleeve can be used instead of a guide rod in all intubation devices. After placing the tube at the desired location, the expander element (spiral or sleeve) is inserted into the annular lumen, thereby spreading the slotted outer sleeve, which can now easily be pulled upwards. Thereafter, the expansion element is fixed by means of a conventional bayonet lock on the connector. The advantage is that injuries to the trachea are avoided. When using a guide rod there is a risk of injury to the trachea, due to the leadership tip. The sleeve also provides an external protection of the tube from damage, eg by the teeth, during insertion into the trachea. The sleeve also prevents unwanted twists or displacements of the tube. It is also possible, for fixation and stabilization of the tube with a small outer diameter, to insert the sleeve into the annular lumen and to remove it again when the tube is placed. This has the advantage that then the sleeve or spiral can be inserted easier to widen the tube. The flexible sheaths of the tube consist of thin-walled foils with a thickness of approx. 10 to 20 μ, which can be used for medical purposes. If the casings are formed from two foils, then it is expedient if one of the casings consists of a thicker foil, whereby a better guidance for the introduction of the expansion element is achieved. The films for the two flexible shells should be easily stretchable and have a resilience, so strive after stretching to return to their original position.

The tube according to the invention has a very small outer diameter prior to introduction into the organ or body opening, and can therefore be inserted without any problems, even by untrained personnel, without injury, eg between the vocal cords into the trachea. The double-walled tube can be radially expanded after placement at the desired location with little effort by an elongated, flexible sleeve or spiral is inserted into the annular lumen, between the inner wall of the outer shell and the outer wall of the inner shell. The flexible sleeve is preferably rolled up in a special insertion unit, which is arranged at the proximal end of the tube. From the staff, the flexible sleeve can be easily inserted with one hand in the annular lumen of the tube and pushed to the distal end. The sleeve is tuned in its diameter to the diameter of the outer shell. The sleeve-shaped expansion element, for example a spiral, can also have a thread structure (internal and / or external thread). The connecting pieces fastened to the proximal end of the inner and outer sheath are provided with a corresponding internal or external thread, so that the expanding element can be screwed into the annular lumen. To seal the annular lumen upon application of a vacuum, a seal may be inserted into the threads of the connectors. The proposed solution can be used for a variety of medical instruments and applications, such as endotracheal tube for all intubation anesthesia, emergency tube, laryngeal mask, syringe barrel, spiral tube, jumping tube, and cricothyrotomy Emergency tracheotomy device, gastric tube with safety balloon, nasal tamponade with respiratory opening, atraumatic system for the creation of arthroscopic and endoscopic working channels (drainage), urine catheter, intestinal tube and system for multiple opening and closing of wounds.

The individual instruments are equipped with the double wall tube according to the invention and the otherwise customary accessories, such as C uff, connector, guide wire. Since the proposed Tubusvarianten consist of thin-walled flexible shells made of plastic films, the manufacturing cost is reduced. The tube as a single part has only a small weight, is zusammenleg- or - foldable and can be packaged in small packaging units.

The invention will be explained in more detail below with reference to several examples. In the accompanying drawing show

1 shows the tube according to the invention with guide rod in the expanded state as a longitudinal section.

2 shows the tube of FIG. 1 in the state of the smallest diameter as a longitudinal section,

3 shows the formed of a tubular film inner and outer shell in a simplified representation,

Fig. 4 shows the tube of FIG. 2 with a slotted sleeve for fixation

5 shows a variant embodiment as endotracheal tube with laryngeal mask prior to intubation,

6 shows the endotracheal tube with laryngeal mask according to FIG. 5 after intubation, FIG.

7 shows a variant embodiment as a tracheal tube,

8 shows a variant embodiment as Koniotomietubus,

9 shows the syringe component of the coniotomy tube according to FIG. 8, FIG.

10 shows a variant embodiment as a syringe or 2/3-tube in the state of the smallest diameter as a longitudinal section,

11 shows the tube according to FIG. 10 in the expanded state, FIG.

Fig. 12 is a section along the line A-A in Fig. 11 and

Fig. 13 the syringe die of FIG. 10 as a single part.

FIGS. 1 and 2 show an inventive tube 1 (double wall tube). This has an inner shell 2 and an outer shell 3, which are formed from a thin-walled elastic plastic tube film. The two shells 2, 3 are arranged concentrically with each other. The outer shell 3 is attached to the proximal end 4 at a first annular fitting 6, a Konnexteil. The inner shell 2 is To form the two shells 2, 3 of a tubular film that is turned at one end by 180 ° inwards, and pulled in the opposite direction, so far until the inner shell. 2 the outer shell 3 projects beyond, as shown in Fig. 3. Due to the concentric arrangement of the two shells 2, 3, an axial lumen 7 and an annular lumen 8 are formed. Instead of a tubular film, two tubular foils can be used to form the two shells 2, 3, which are firmly connected to one another at the distal end 5. since the annular lumen 8 at the distal end 5 must be closed. At the distal portion of the outer shell 3, a C uff 9 is arranged, which is designed as an inflatable balloon, which can also be subjected to vacuum. The C uff 9 is connected via a flexible line 10 with an inflator 11, which may be formed for example as a syringe, by means of which in C uff 9, a negative pressure can be generated. The inflator 11 is equipped with a check valve and an internal pressure gauge. In the useless state, the tube 1 is an unstable component with collapsible sheaths 2, 3. For putting the tube 1 into use, the two flexible sheaths 2, 3 must be brought into a longitudinally stretched position and fixed or stabilized. In the present example, this is done by means of a guide rod 12, as shown in Fig. 2. The trained as a stable, flexible member guide rod 12 has a guide tip with a mounting portion 12a, with inwardly directed lugs for attachment of the distal end 5 of the two flexible sheaths 2, 3. The guide rod 12 is pushed through the axial lumen 7 and serves as an intubation aid , The guide rod 12 may still have a continuous, axial channel. It can be used to aspirate mucus and secretions and, if required, to insufflate oxygen. In addition, the tip of the guide rod 12 may still be equipped with a light source, which is angled at 90 °. This allows the anesthesiologist to know immediately whether the tube, eg a tracheal tube, is placed in the right place. If the tube is in the esophagus, the light source can not be seen through. Quickly determining the correct tube position is often life-saving for the patient. In order for the two sheaths 2, 3 to make tight contact with the guide rod before introduction into the body or organ opening, vacuum is applied to the collar 9. As a result, a displacement of the tube during the intubation process is prevented. The vacuum is displayed on the check valve with integrated pressure measurement. Thereafter, the two cases 2, 3 are clamped to the fixing part 12 a. The tube 1 now has a very small outer diameter (Figure 2) and can be easily inserted into the body opening and placed at the desired location. In order to expand the tube 1 to a larger diameter, a sleeve or sleeve-shaped spiral 13 is inserted into the annular lumen 8, whereby the outer Case 3 is radially stretched or stretched to its maximum outside diameter (FIG. 1). During the insertion of the sleeve 13, the distal end of the two sheaths 2, 3 is released from the anchoring of the fastening element 12a. The sleeve or coil 13 has at its distal end about 15 mm long, tapering forward, plugged flexible rubber ring, which ensures a gentle, atraumatic insertion.

To insert the sleeve or spiral 13, this can also be rolled up on a special insertion mechanism, by which it is possible to unroll with one hand, the flexible, about 300 mm long sleeve or spiral 13 and push it in full. The sleeve-shaped spiral 13 is preferably made of a mesh of very thin wires with sufficiently high flexibility and stability. For improved lubricity of the sleeve or spiral 13 whose outer shell is coated with a non-stick coating. The sleeve or coil 13 is sterilizable and can be provided for a single or multiple use. The sleeve or spiral 13 may also have an oval or triangular cross-sectional shape. An oval shape comes z. B. in patients with a jaw clamp or small mouth opening for use and a triangular shape during long-term intubation to protect the vocal cords.

The inner shell 2 of the tube 1 is guided in the expanded state along the inner wall of a second Konnexteiles 14 which is in the fully inserted state of the sleeve or coil 13 with the first Konnexteil 6 in touching contact, as shown in Fig. 1. The spiral or sleeve 13 ends at the end in an approximately 20 mm long coil spring with a spring wire spacing of 5 mm. The spring end merges into the second connex 14. The two connex pieces 6, 14 can be connected to one another by a bayonet closure.

If the spiral 13 is inserted to the end position, the two Konnexteile 6 and 14 are locked by means of the bayonet lock. In this case, the spring is compressed at the end of the sleeve / coil 13 and by the applied spring force, the two shells 2, 3 of the tube 1 are tightened wrinkle-free. The slight contact pressure is absorbed by the flexible rubber tip on the sleeve / spiral 13. Thereafter, the cuff 9 is inflated as a seal to the tracheal wall. On the non-return valve with integrated cuffin pressure indicator, the optimum internal pressure range is color-coded and can also be read directly on a measuring scale. Any pressure losses can be compensated immediately. In the expanded state of the tube 1, the sleeve / coil 13 remains in the annular lumen 8 and forms an access channel, for example as a trachea for artificial respiration of the patient. After the expansion of the tube 1, the guide rod 12 is removed again. In certain applications in which it can be dispensed with the use of a guide rod, the two flexible sheaths 2, 3 can be fixed or stabilized by means of an attached, longitudinally slotted sleeve 15 in an extended position, as shown in Fig. 4. The sleeve 15 with the longitudinal slot 15a and guide tip 15b is flexible and also serves as an intubation aid. In nasal intubation, this ensures a bleeding-free gliding through the nostril and an otherwise frequent injury of the choanae is avoided. In addition, the sheath 15 provides external protection for the cup 9 during intubation. When inserting a conventional tube, especially in difficult intubations with a Magill Grasping Forceps, there is a risk that the cuff may be damaged and can no longer be inflated.

During the expansion of the tube 1 by means of the sleeve / coil 13, the slotted sleeve 15 is bent and can be easily removed after completion of the expansion process.

FIGS. 5 and 6 show the embodiment of the inventive tube 1 as an endotracheal tube in conjunction with a laryngeal mask. In Fig. 5 of the laryngeal mask only a portion can be seen. The endotracheal tube 1 corresponds in its construction to the tube shown in FIGS. 1 and 2 with collar 9 and guide rod 12. The laryngeal mask 16 consists of an attachable mask attachment piece 17 with a connection 17 a for the ventilation tube of a respirator, the mask shaft 18 and the mask 19 The laryngeal mask shaft 18 is formed in the example shown from a thin-walled flexible tubular film 18 a, which is connected to the mask 19. The film 18a is provided with a flexible elongated guide member, similar to a guide rod, which is connected to a handle 21 disposed on the connective member 20 and serves as an insertion aid. The mask 19 is flexible and connected to a hose 23 for inflating and applying a vacuum. The proximal end of the flexible thin-walled tubular film 18 a is connected to the connection part 20. Prior to insertion of the laryngeal mask, the flexible mask shaft 18 and the mask 19 are brought to a small outer diameter by applying a vacuum. By means of the arranged on the Konnexteil 20 handle 21, the larynx mask is introduced with a small shaft diameter through the mouth into the trachea. Thereafter, the flexible film 18a of the mask shaft 18 is expanded by inserting a flexible tube 22. The tube 22 is fixed with its end pointing in the direction of the mask attachment piece 17 in a second connection part 24. After insertion of the tube 22 to the end position, the two connexions are locked by means of a bayonet lock and the tubular film 18a tightened by spring action, analogous to the spiral or sleeve 13. Subsequently, the mask attachment piece 17 is attached to the second Konnexteil 24. The axial opening of the mask attachment piece 17 is closed with a seal or cap 25. This is designed so that an unhindered insertion of the endotracheal tube 1 with guidewire is possible. After insertion of the endotracheal tube 1 into the tube 22 and the placement of the tip of the guide rod 12 in the trachea, the endotracheal tube 1 is radially expanded by advancing the sleeve or coil 13, in a manner analogous to the previously mentioned embodiments. By locking the two Konnexteile 14 and 6 by means of bayonet closure, the two flexible sheaths 2 and 3 are tightened by spring action. Now, the guide rod 12 is removed and the ventilator connected to the endotracheal tube.

By reducing the tube diameter prior to intubation, the endotracheal tube can be blind inserted into the trachea via the laryngeal mask shaft. This greatly reduces the risk of injury to the vocal cords. Since the tube and laryngeal mask have a very small diameter during insertion and can easily be guided through narrowed rows of teeth or gullets, these are particularly suitable for use in ENT, maxillofacial and tumor surgery in the case of difficult intubation.

A tracheotomy is usually performed under general anesthesia. There is a tube for ventilation in the trachea. In tracheostomy, the tube in the trachea may be disturbed or its cuff may be damaged. This could lead to considerable ventilation difficulties. Furthermore, there is a risk of injury to the tracheal posterior wall when opening the trachea and the introduction of the tracheostoma.

In Fig. 7 a special tracheal tube (tracheostoma) is shown, which is used in addition to the aforementioned tube as part of a tracheostomy cutlery. The tracheal tube according to the invention consists of a tube 1 with guide wire and cuff, analogously to the embodiments according to FIGS. 1 and 2. The sleeve or spiral 13 is used to widen the tube 1 into the first connective part 6. At the opposite end to the first Konnexteil 6, the sleeve or coil 13 is fixed in a second Konnexteil 14. The inner shell 2 of the flexible tube 1 is guided along the inner wall of the sleeve or spiral 13 and projects beyond the second Konnexteil 14. In the tubular cavity of the sleeve or spiral 13, an expansion screw 26 is inserted. The expansion screw 26 has an axial channel 26 a, for receiving the guide wire, which is not shown in Fig. 7. The expansion screw 26 has, at its end pointing in the screwing direction, a conically tapering section 26b with a blunt external thread 26c. The expansion screw serves to dilate the skin, tissue and trachea. In the area of the flexible sheaths 2, 3, a cannula 27 is arranged. The two flexible sheaths 2, 3 are in an extended position in the hollow channel the cannula 27. The cannula 27 is such that it can be opened or split after the puncture by a tearing mechanism in two half-shells. Immediately before intubation of the tracheal tube, the trachea is punctured in a manner known per se by means of a syringe with a hollow needle and the hollow needle is advanced to the trachea. Thereafter, the syringe part is removed from the hollow needle and inserted into the guidewire to the trachea. Subsequently, the hollow needle is removed, threaded onto the guide wire of the tracheal tube according to the invention and this advanced by means of the cannula 27 to the trachea. After unfolding and removing the cannula 27, the expansion screw 26 is moved together with the sleeve or coil 13, wherein the tissue is forced apart by the threaded portion 26b. Beforehand, the collar 9 is slightly inflated to prevent the tube from sliding out of the trachea when inserting the sleeve or coil 13. The expansion screw 26 is moved along the axial lumen 7 and the sleeve or spiral 13 along the annular lumen 8. Due to the constantly maintained contact pressure when screwing in the expansion screw larger bleeding is avoided. When the expansion screw 26 and sleeve 13 are advanced to the end position, the expansion screw 26 is removed together with the guide wire again and the flexible sheaths 2, 3 tightened and the sleeve 13 fixed, as already mentioned above.

In FIGS. 8 and 9, a coniotomy or tracheotomy tube is shown as a further embodiment variant.

A conniotomy tube is intended to be inserted through an opening in the cricothyroid membrane which extends through the anterior wall of the larynx between the anterior part of the cricoid cartilage and the thyroid cartilage. From an emergency medical point of view, it is better to create a respiratory canal via the cricothyroid membrane than via the trachea, as the cricothyroid membrane is closer to the skin. The proposed Koniotomietubus consists of a tube 1 with the same basic structure as in Figures 1 and 2. The intended for expansion of the tube 1 sleeve or coil 13 is fixed in the initial state of Koniotomietubus between the first Konnexteil 6 and the second Konnexteil 14 and has at its projecting into the Konnexteil 14 end of a coil spring. In the axial cavity of the sleeve / coil 13, a syringe 28 is inserted with a hollow needle 29. The syringe consists of a punch or piston 28a, which is guided in a cylindrical component 28b. The hollow needle 29 of the syringe 28 extends through the axial lumen of the two flexible sheaths 2, 3. At the front end of the hollow needle 29, a fastening element 29a is arranged on which the distal end of the two shells 2, 3 is releasably attached. The hollow needle 29 has an opening, not shown in detail, just before the front end of the syringe barrel 28b in order to be able to inject a local anesthetic subcutaneously. The syringe die 28a has a continuous axial channel of identical diameter as the channel of the hollow needle. After insertion of the hollow needle of the coniotomy tube into the trachea, a guide wire is inserted through the axial channel in the syringe punch 28a and the hollow needle 29. The syringe barrel 28b has an external thread 28c. It is also possible to equip the corresponding portion of the inner shell 2 with an external thread. At the rear end of the Konnexteils 14, a rotary member 30 is disposed with an internal thread, which sits on the external thread of the syringe barrel 28b. The inner shell 2 is guided between the outer shell of the syringe barrel 28b and the inner wall of the sleeve / coil 13 and attached to the annular flange of the syringe barrel 28b. By means of the rotary member 30, the sleeve / coil 13 is inserted into the annular lumen 8 between the two shells 2, 3. During advancement of the sleeve / coil 13, the distal ends of the two sheaths 2, 3 are pulled out of the fastening element 29a. After reaching the end position of the sleeve / coil 13 of the tube is radially expanded. In order to provide the required ventilation channel, the complete syringe 28 including hollow needle 29, rotary member 30 and guidewire is removed. Subsequently, the two connexion parts 6 and 14 are locked by means of a bayonet closure, the two flexible sheaths 2, 3 of the tube 1 are tightened by the spring effect of the coil spring resting on the sleeve / spiral 13 and connected to the rear connection part 14 of the breathing tube.

The proposed Koniotomie- or Tracheotomietubus with integrated syringe allows emergency in a particularly rapid and tissue-preserving creation of a required ventilation channel. In the case of a threatened asphyxiation of a patient, a local anesthetic can be injected subcutaneously for painless puncturing via the syringe and the hollow needle can be punctured directly into the trachea. Before puncturing, vacuum is applied to the Cuff 9, whereby the two flexible sheaths 2, 3 are applied to the hollow needle and the tube 1 is reduced to a very small outer diameter. The film portion of the outer shell 3 in the region of the cuff 9 may have perforations, whereby the applied vacuum also acts in the region of the annular lumen 8 to achieve a closer application of the two shells 2, 3 on or around the hollow needle or cannula 29 ,

The diameter-reduced tube 1 is advanced in an angle of 45 degrees, in a caudal direction in the trachea. Air may be aspirated via the empty syringe 28 and the hollow needle 29 to check if the tip of the cannula 29 is in the trachea. Subsequently, the guide wire is guided through the syringe 28 and hollow needle 29 into the trachea and the C uff 9 inflated. Thereafter, the tube 1, as explained above, radially expanded, the syringe and guide wire removed and the ventilator connected. FIGS. 10 to 13 show a further embodiment variant as a so-called syringe barrel (2/3-tube), which is used for routine routine intubations, for intubations in spontaneous breathing and for difficult intubations. The syringe barrel consists of a syringe barrel 31, which is formed of two concentric flexible tubes 31a and 31b made of plastic material. The two relatively stable tubes 31a and 31b are interconnected by two opposite webs 31c and form a kind of double-walled hose. The syringe barrel has a length of about 2/3 of the syringe barrel. At the front end of the syringe barrel 31, the unstable tube 1 is arranged, consisting of the two flexible shells 2, 3. This has a length of about 1/3 of the syringe barrel. The outer shell 3 is connected to the outer tube 31a and the inner shell 2 to the inner tube 31b, wherein the two shells 2, 3 have approximately the same outer diameter as the corresponding tubes 31a and 31b. The syringe die 32 is formed as a stable, possibly also as a flexible, tube which has two longitudinally extending, opposing slots 32a, which correspond to the webs 31c of the syringe barrel 31 (FIG. 13). On the outer shell 3, a C uff 9 is arranged, which is connected via a line 10 with a device 11 for applying a vacuum and for inflating the cuff 9. By applying a vacuum and withdrawing the syringe plunger 32, the front 1/3 section of the syringe barrel can be fixed in a stretched position and brought to a small outer diameter (FIG. 10). After insertion of the syringe barrel with reduced 1/3 tube into the body opening, the tubular syringe plunger 32 is advanced into the annular lumen as far as the distal end, thereby expanding the 1/3 tube. The axial lumen now has a nearly constant diameter and can be used as a working channel (FIG. 12). After inserting the raw-shaped syringe punch 32 into the final position, the cup 9 is inflated. Without cuff, this 2/3-tube can be used in shortened form as a nasopharyngeal tube (spiral tube).

Claims

claims

An expandable device for insertion into organ and / or body openings, in particular for intubation, consisting of an elongate tube having a proximal and a distal end and an axial lumen, wherein the tube by inserting a Aufweitelementes from a small diameter to a larger diameter is radially expandable, characterized in that the tube (1) is formed as an unstable system consisting of two concentrically arranged, foldable tubular sheaths (2, 3), at least the same length, of thin-walled elastic plastic films, an inner shell (2) and an outer shell (3), having an axial lumen (7) bounded by the inner shell (2) and an axially extending annular lumen (8) extending between the outer wall of the inner shell (2) and the inner wall of the outer sheath (3), the annular lumen (8) being closed at its distal end (5) in that the tube (1) is fixed and stabilized prior to insertion into the organ or body opening in a longitudinally stretched, small diameter ply, and the expansion element is formed as a one-piece, elongated sleeve-shaped element (13, 32) the insertion of the tube (1) with a small diameter into the organ or body opening into the annular lumen (8) is insertable, whereby the tube (1) is expandable to a larger diameter, and the sleeve-shaped element (13, 32) in the expanded state of the tube (1) remains in this.

2. Apparatus according to claim 1, characterized in that the tubular sheaths (2, 3) of the tube (1) are formed from a single-walled tubular film which is at least twice as long as one of the sheaths (2, 3), wherein the tubular film for forming the two sheaths (2, 3) with one end, turned inwards by 180 °, and drawn in the opposite direction, at least to the other end.

3. Apparatus according to claim 1, characterized in that the tube (1) consists of two separate, concentrically arranged tubular sheaths (2, 3), which are annularly connected to one another at one of its ends, is formed.

4. Device according to one of claims 1 to 3, characterized in that for fixing and stabilizing the tube (1) in the axial lumen (7), an elongated, rod-shaped element (12, 29) is arranged, at the tip of the distal ends the two shells (2, 3) are releasably secured by means of a fastening element (12a, 29a).

5. Device according to one of claims 1 to 4, characterized in that the rod-shaped element is a flexible guide rod (12) or a hollow needle (29 a).

6. Device according to one of claims 1 to 5, characterized in that during the insertion of the sleeve-shaped element (13) in the annular lumen (8) the two sheaths (2, 3) automatically from the fastener (12a, 29a) solve.

7. Device according to one of claims 1 to 6, characterized in that at the distal end portion of the tube (1) an inflatable or can be acted upon with vacuum C uff (9) is arranged.

8. Device according to one of claims 1 to 7, characterized in that to support the fixation and stabilization of the tube (1) the C uff (9) is subjected to vacuum, wherein the two shells (2, 3) close to the Place the guide rod (12) or the hollow needle (29).

9. Device according to one of claims 1 to 8, characterized in that to support the fixation and stabilization of the tube (1), the annular lumen (8) is temporarily acted upon with vacuum.

10. Device according to one of claims 1 to 9, characterized in that the flexible sheaths (2, 3) in the state of the tube (1) with a small diameter of a longitudinally slotted, flexible sleeve (15) is surrounded, which serves as a guide serves and after insertion of the tube (1) in the organ or body opening is removable again.

11. Device according to one of claims 1 to 10, characterized in that the device (11) for inflating and applying a vacuum for the C uff (9) is equipped with a cuff-internal pressure indicator.

12. Device according to one of claims 1 to 11, characterized in that the sleeve-shaped element (13) for widening the tube (1) is designed as a spiral.

13. Device according to one of claims 1 to 12, characterized in that at least the proximal end of the outer sheath (3) is fixed to a first stable, annular connector / connector part (6).

14. Device according to one of claims 1 to 13, characterized in that the sleeve-shaped element (13) for widening the tube (1) in the first connector part (6) is guided and at its opposite direction to the insertion direction with a spring in Contact and is held with this in a second connector part (14).

15. Device according to one of claims 1 to 14, characterized in that after the insertion of the sleeve-shaped element (13) to the end position, the first connector part (6) and the second connector part (14) are locked together by means of a bayonet lock.

16. Device according to one of claims 1 to 15, characterized in that the sleeve-shaped element (13) is equipped at its pointing in the insertion direction end with a forward tapered, plugged flexible rubber ring.

17. Device according to one of claims 1 to 16, characterized in that this in the shaft (18) of a laryngeal mask (16) is insertable, wherein the shaft (18) consists of a thin-walled, tubular film (18 a) formed with its one end is connected to the mask (16) and with its other end connected to a first connector part (20), in the shaft (18) a flexible tube (22) for widening the shaft (18) is insertable, with a second Connector part (24) is connected and held in this resiliently, after insertion of the flexible tube (22), the two connector parts (20, 24) are locked together and on the rear connector part (24) the mask attachment piece (17) is placed, and inserted and expanded state of the tube (1), the sleeve-shaped expansion element (13) in the mask attachment piece (17) and the two connector parts (20, 24) out and the two connector parts (6, 14) of the tube (1) are resiliently locked together ,

18. Device according to one of claims 1 to 17, characterized in that on the flexible sheaths (2, 3) of the tube (1) in the state of reduced diameter, a cannula (27) is placed, which by separation in the longitudinal direction in two half-shells after insertion and placement in the body opening again can be removed, in which between the two connector parts (6, 14) arranged sleeve-shaped expansion element (13) an expansion screw (26) with an axial channel (26 a) and a conically tapered portion (26 b) with external thread (26 c) is inserted, which is screwed into the body opening through the axial lumen (7) and by the rotational movement of the expansion screw (26) the sleeve-shaped expansion element (13) in the annular lumen (8) can be inserted, and the device before insertion into the body opening over the axial Lumen (7) and the channel (23 a) can be threaded onto a guide wire located in the body opening, and after the radial expansion of the tube (1), the expansion screw (26) and guidewire are removable again.

19. Device according to one of claims 1 to 18, characterized in that in the tube (1) in the state of reduced diameter, a removable syringe (28) with hollow needle (29) is inserted, wherein the hollow needle (29) in the axial Lumen (7) is located and the syringe (28) in the cavity of between the two connector parts (6, 14) arranged sleeve-shaped expansion element (13), syringe plunger (28a) and hollow needle (29) for threading onto a guide wire have a common axial channel, the syringe barrel (28b) or the portion of the inner shell (2) which is guided along the syringe barrel (28b) is provided with an external thread (28c) on which a rotary member (30) is arranged, which in the installed position before the second Connex part (14) and is in contact with this, wherein by a rotational movement of the rotary member (30), the sleeve-shaped expansion element (13) in the annular lumen (8) for expanding the tube (1) can be inserted is.

20. Device according to one of claims 1 to 19, characterized in that the tube (1) forms the front portion of a 2/3-tube (syringe barrel), wherein the two flexible sheaths (2, 3) with a syringe barrel (31) consisting of two concentrically arranged flexible tubes (31a, 31b) which are longitudinally interconnected by two opposed webs (31c), wherein in the space between the two tubes (31a, 31b) as expander for the tube ( 1) a tubular syringe plunger (32) can be inserted as far as the end of the annular lumen (8), which has slots (32a) corresponding to the webs (31c).