WO2005058401A1 - Dispositif a introduire dans la trachee ou entre la trachee et l'oesophage - Google Patents
Dispositif a introduire dans la trachee ou entre la trachee et l'oesophage Download PDFInfo
- Publication number
- WO2005058401A1 WO2005058401A1 PCT/EP2004/052498 EP2004052498W WO2005058401A1 WO 2005058401 A1 WO2005058401 A1 WO 2005058401A1 EP 2004052498 W EP2004052498 W EP 2004052498W WO 2005058401 A1 WO2005058401 A1 WO 2005058401A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- opening
- trachea
- membrane
- esophagus
- shaft
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/20—Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/20—Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith
- A61F2/203—Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith comprising an air passage from trachea to oesophagus or to pharynx; Artificial epiglottis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
- A61M16/0468—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters with valves at the proximal end limiting exhalation, e.g. during speaking or coughing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0475—Tracheal tubes having openings in the tube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0434—Cuffs
Definitions
- the present invention relates to a device for insertion into the trachea or between trachea and esophagus, with a hollow shaft (1), wherein the shaft (1) has a first opening (16) for the entry of breathing air and a second opening (3) for having the escape of breathing air.
- Tracheostomy tubes are used to optimally oxygenate patients with a tracheotomy even after surgery or to allow them to breathe independently.
- a curved cannula is introduced through the tracheotomy into the region of the trachea.
- the trachea is directly connected to the outside world and the patient can breathe via the cannula.
- fluid e.g.
- tracheostomy tubes that can be filled with a fluid (mostly air) that separates the space between the shaft of the tracheostomy cannula and the shaft Sheath surrounding trachea cross section fills. If the cuff is filled with the fluid, it rests against the inner wall of the trachea and seals the trachea. Breathing can then take place exclusively via the cannula.
- a fluid mostly air
- Tracheostomy tubes are now known from the prior art, in which the cannula inside the trachea above the annular sleeve has an air outlet opening, so that at least part of the air exhaled by the patient can escape in the direction of the vocal cords and the pharynx. Thus, it allows the patient at least restricted to speak.
- valves are known from the prior art which close the air outlet opening during inhalation so that the patient breathes only via the cannula.
- the trachea Since the patients can not cough up, the trachea must be evacuated by the medical staff at regular intervals. In this case, the valve must remain closed at the air outlet opening in any case, to continue to ensure a complication-free breathing of the patient.
- the flap valves known from the prior art open during the aspiration of the trachea.
- the trachea can be surgically separated from the esophagus.
- the trachea then ends in the tracheotomy. Because the air and esophagus are separated, inhalation through the tracheotomy will not allow any fluids or food particles to enter the trachea. On the other hand, speaking is impossible for the patient since no breathing air can reach the pharynx.
- voice prostheses are known from the prior art. These have a hollow shaft, which is inserted between the esophagus and the esophagus and thus creates a passage between the two tubes.
- the voice prostheses are provided with a flap or ball valve at their end extending into the esophagus.
- these valves are sometimes leaking, so that food particles from the esophagus pass into the trachea, which leads to significant discomfort and can cause complications.
- both the tracheostomy tubes and the voice prostheses are relatively stiff. This means that the patient must build a high pressure in the respiratory tract, so that the valve opens to the throat, so that with the help of the air flowing into the throat space sounds can be generated. For bedridden patients, therefore, speaking with the help of a tracheostomy tube or a voice prosthesis is often a great effort.
- the present invention has the object to provide a tracheostomy tube or a voice prosthesis, which avoid the disadvantages mentioned.
- the object is achieved according to the invention by providing a device for insertion into the trachea or between the trachea and the esophagus after a tracheotomy or after laryngeal detachment, with a hollow shaft, wherein the shaft has a first opening for the entry of respiratory air and a second opening for the escape of breathing air, wherein in the discharge direction of the second opening is followed by a preferably tubular thin-walled membrane which collapses in the absence or reversal of an air flow from the air outlet opening and thereby closes the outlet opening.
- an embodiment of the invention is preferred in which the membrane adjoining the second opening is tubular.
- the cross-section through the membrane in its open state in a plane parallel to the opening is part-circular or it has the course of a straight line.
- the air flow through the air outlet opening is caused by the pressure difference between the pressure inside the shaft and the pressure in the vicinity of the shaft outside the air outlet opening. If the patient exhales, a higher pressure is created in the shaft than outside, so that the valve is opened and the air can flow out. If the exhalation ends, a pressure equilibrium occurs and the membrane collapses due to gravity. During inhalation, a lower pressure prevails within the shaft than outside, so that the membrane is pressed against the air outlet opening.
- the device is a tracheostomy cannula for insertion into the trachea.
- this has a shaft and an annular collar which fills the space between the shaft and the tracheal cross-section surrounding the shaft, the shaft having in the region of the trachea on the side of the collar facing the vocal cords a second opening for the air outlet, which preferably is arranged so that it points in the direction of the pharynx and wherein in the exit direction to the air outlet opening, the self-closing valve connects, which is made of a thin-walled membrane.
- the device in an alternative embodiment of the invention, it is expedient for the device to be a voice prosthesis for insertion between the trachea and the esophagus.
- the shaft is made of a first, soft material, preferably silicone, wherein the shaft is preferably reinforced in the region of the passage between the esophagus and the esophagus with a material that is harder than the first material.
- the valve according to the invention preferably consists for all embodiments of an open tube section made of a thin-walled membrane, one opening of which adjoins the air outlet opening, while the at least one other opening of the device is free, the length of the tube section being greater than its cross-sectional radius.
- the air outlet opening is preferably provided in the region of the convex bend of the cannula from its vertical section running in the trachea into the horizontal and points in the direction of the pharyngeal space.
- the tube valve is expediently formed by a thin-walled membrane tube which connects like a chimney to the air outlet opening, It is essential that the wall thickness of the membrane tube is so small that the tube collapses under normal pressure conditions and collapses.
- the patient inhales, i. If a negative pressure arises in the tracheostomy cannula or the voice prosthesis, then the collapsed walls of the membrane tube seal the second opening for the air outlet, so that air can only flow into the respiratory tract through the lumen of the tracheostomy cannula or the trachea. Among other things, this prevents the passage of fluid and solids from the esophagus into the cannula or trachea.
- Such a configuration of a tracheostomy cannula or a voice prosthesis with a valve closing off the air outlet opening is advantageous, since such a self-closing valve is not opened during the aspiration of mucus from the tracheal cannula or the trachea, but already at a slight overpressure in the tracheostomy tube or the Voice prosthesis opens and so the patient is able to speak even with only weak exhalation. This is useful because many bedridden and elderly patients are greatly weakened especially after surgery and can only build up a slight overpressure when exhaling, but this allows them with the device according to the invention already speaking. Furthermore does not apply the valve and the membrane does not irritate the surrounding esophagus, even if it should touch them.
- the membrane has a wall thickness of less than 50 microns and their length is preferably two to three times the diameter of the opening. If the membrane is designed as a hose, then it is advantageous if the length of the hose is at least equal to the hose diameter.
- Such a design of the self-closing valve is particularly suitable to allow an effective closing of the air outlet opening during inhalation, while it opens at a low exhalation pressure and allows the patient to speak.
- the membrane of the valve is made of an elastomer, such as.
- an elastomer such as.
- PU polyvinyl styrene
- silicone polyvinyl styrene
- latex polyvinyl styrene
- PTFE polystyrene
- these materials can be additionally hydrophobicized.
- These elastomers can be produced as thin-walled hoses or thin membranes and prevent sticking of the collapsed walls even in moist and slimy surroundings.
- the flexural rigidity of the membrane is preferably such that the membrane driven by gravity can collapse without the material experiencing permanently material-changing kinks which subsequently lead to damage to the membrane.
- the end of a tracheostomy tube located outside the body has a valve which opens on inhalation, so that air can flow from the outside into the cannula and thus into the lungs, while it closes when exhaling, so that the entire air flows out through the air outlet and the pharynx of the patient. This ensures optimal patient breathing and speech articulation while effectively preventing the aspiration of particles.
- a grid which carries the collapsed hose and prevents an inner flaps of the hose.
- the grid also prevents the tube of food debris or fluids from the feed or trachea from being forced inwardly into the shaft.
- FIG. 1 shows a three-dimensional representation of a tracheostomy cannula according to the invention with an open tube valve.
- FIG. 2 shows a three-dimensional view of the tracheostomy cannula from FIG. 1 with closed tube valve.
- FIG. 3 shows a sectional view of a voice prosthesis according to the invention with an open tube valve.
- FIG. 1 shows a tracheostomy cannula according to the invention in a lateral three-dimensional view.
- the tubular shaft 1 of the cannula and the annular collar 2 can be clearly seen.
- the tubular shaft of the cannula in the embodiment shown, has an internal diameter between 6 mm and 12 mm, e.g. 8 mm up.
- the course of the shaft 1 is angled, so that the machine end 5 of the cannula can be led out substantially horizontally from the trachea, while the patient end 6 opens into the trachea.
- the two substantially straight portions of the shaft 1 have a bending angle of about 90 ° to 120 °, typically about 100 ° to each other.
- the length of the straight, located in the trachea section 8 is just like that of the horizontal, out of the trachea leading section 7 about 30 to 40 mm.
- an inflatable plastic sleeve 2 Attached to the outer wall of the section 8 extending parallel to the trachea is an inflatable plastic sleeve 2 which can be filled with air via a filling hose with control balloon 11 located outside the body, so that the lateral surface of the annular collar is firmly against the inner wall of the balloon the cuff surrounds the trachea.
- the space between the inner wall of the trachea and the shaft 1 of the tracheostomy tube is sealed, so that no foreign body can enter the trachea.
- the cuff 2 is made of a soft plastic, which is elastic, so that it adapts well to the contour of the trachea, without affecting them. Thus, no additional complaints occur in the patient.
- the inflatable cuff 2 provides additional support to the tracheostomy tube.
- the tracheostomy cannula is provided on the convex side with an air outlet opening 3, through which the air exhaled by the patient can pass into the region of the trachea lying above the cuff 2.
- the air outlet opening 3 is arranged in the shaft 1 of the tracheostomy tube such that its opening points upward, ie in the direction of the pharyngeal space.
- a hose valve 4 is connected at the Heilaustrittsöffnu ⁇ g 3 .
- the hose is attached to the outer wall of the shaft 1 so that the entire breathing air exiting from the air outlet opening 3 flows through the hose valve 4.
- the tube valve 4 consists of a thin-walled membrane tube whose wall thickness is 50 microns in the illustrated embodiment of the invention.
- the hose itself is made of PU. If the patient exhales when closing the outer opening 15 of the shaft, the overpressure in the Tracheostomy tube that breathing air exiting the air outlet opening 3 and the membrane tube of the tube valve 4 opens and flows through.
- the membrane tube is placed by the adjacent internal pressure, so that it can flow through the air unhindered.
- the air passing through the membrane tube passes into the upper part of the trachea and flows through the vocal cords of the patient so that it can express itself vocally.
- the outlet opening 3 is formed by a plurality of individual air outlets 3a, which are arranged in the wall of the shaft 1, that in the region of the air outlet opening 3, a grid is formed. This grid serves to support the membrane tube 4 in the collapsed state.
- a flap valve may be provided at the upper end 5 . This opens upon inhalation, so that air can flow through the tracheostomy tube into the lungs, while it closes when exhaling, so that the breathing air must escape through the air outlet opening 3 substantially.
- the outer opening 15 can be closed, for example, during exhalation by placing a finger to allow speaking.
- FIG 2 the same tracheostomy tube as shown in Figure 1 is shown, the case being shown that the patient inhales, i. the flapper valve 9 is opened. Since inhalation relative to the environment a negative pressure in the tracheostomy tube, the thin-walled membrane tube collapses. This effect is reinforced by the force acting on the membrane tube gravity, so that the hose not only collapses in itself but also angled. As a result, the air outlet opening 3 is closed and, during the inhalation, no air or other material can pass from the part of the trachea located above the cuff 2 into the tracheostomy cannula. Thus, it is effectively prevented that liquid or foreign particles, e.g. Food debris, enter the tracheostomy tube and the underlying behind the tracheostomy cannula respiratory organs.
- liquid or foreign particles e.g. Food debris
- FIG. 3 shows a side sectional view of a voice prosthesis 120 according to the invention.
- the voice prosthesis 120 has a hollow shaft 101 which, in the installed state of the voice prosthesis, extends between the patient's air and esophagus.
- the shaft 101 of the voice prosthesis 120 in the illustrated embodiment of at least one hohlzyli ⁇ - derförmigen element.
- a first member 121 of the airway and esophagus fitting silicone conforms to a flange 122 which conforms to the esophagus in the vicinity of the opening.
- the second hollow cylindrical element 123 has an outer diameter which is slightly smaller than the inner diameter of the first hollow cylinder. Linderförmigen element 121.
- the flange 124 of the second element 123 abuts against the wall of the trachea in the vicinity of the opening.
- the element 123 is made of a harder material compared to the silicone of the element 121, so that the second element 123 can be clamped in the first element 121, wherein both elements are in frictional engagement with each other and the shaft 101 of the voice prosthesis from the flanges 122 and 124 is held in the opening between the esophagus and the esophagus.
- a tube valve 104 is arranged at the opening 126 of the voice prosthesis 120 on the side of the esophagus.
- the tube is attached to the outer wall of the stem 122 so that all of the breath exiting through the air outlet 103 flows through the tube valve 104.
- the air outlet opening 103 is formed by a plurality of air outlet openings 103a, which are arranged in a wall extending over the outlet opening 103 of the shaft 122.
- the grid thus formed also serves as a support for the collapsed tube valve 104.
- the tube valve 104 consists of a thin-walled membrane tube whose wall thickness in the illustrated embodiment is 70 microns.
- the hose itself is made of PU.
- the respiratory air passes through the shaft 101 of the voice prosthesis.
- the membrane tube of the hose valve 4 apart so that the air can flow into the esophagus and into the throat area via the esophagus.
- the overpressure in the area of the trachea during exhalation is insufficient to force the hose of the hose valve 104 apart and set up, with the result that the hose valve 104 remains closed and the patient exhales via the tracheotomy.
- the closed tube valve 104 then prevents liquid and food particles from passing through the exit opening 103 of the voice prosthesis 120 from the esophagus into the trachea of the patient.
- the shaft is made in one piece from a soft silicone.
- a tube is slipped over the entire voice prosthesis, the inner diameter of which is slightly larger than the outer diameter of the shaft.
- the flanges of the prosthesis are stretched so that they extend axially in the extension of the shaft within the tube.
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- Health & Medical Sciences (AREA)
- Pulmonology (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Otolaryngology (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Emergency Medicine (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Prostheses (AREA)
Abstract
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10359220A DE10359220A1 (de) | 2003-12-17 | 2003-12-17 | Tracheostomiekanüle |
DE10359220.2 | 2003-12-17 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2005058401A1 true WO2005058401A1 (fr) | 2005-06-30 |
Family
ID=34683462
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2004/052498 WO2005058401A1 (fr) | 2003-12-17 | 2004-10-11 | Dispositif a introduire dans la trachee ou entre la trachee et l'oesophage |
Country Status (2)
Country | Link |
---|---|
DE (1) | DE10359220A1 (fr) |
WO (1) | WO2005058401A1 (fr) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB2429919A (en) * | 2005-06-29 | 2007-03-14 | Smiths Group Plc | Adjustable trachoestomy tube |
US8313687B2 (en) | 2007-09-20 | 2012-11-20 | Kimberly-Clark Worldwide, Inc. | Method of making an improved balloon cuff tracheostomy tube |
US8607795B2 (en) | 2007-09-20 | 2013-12-17 | Kimberly-Clark Worldwide, Inc. | Balloon cuff tracheostomy tube |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102005015045A1 (de) * | 2005-03-31 | 2006-10-05 | Tracoe Medical Gmbh | Beschichtete Manschette |
DE102006003442A1 (de) * | 2006-01-25 | 2007-07-26 | Tracoe Medical Gmbh | Vorrichtung zur Einstellung und Kontrolle des Druckes in Manschetten von Endotracheal- oder Tracheostomiekanülen |
DE102017131137A1 (de) * | 2017-12-22 | 2019-06-27 | Tracoe Medical Gmbh | Tracheaostomiekanüle mit einer Phonationsöffnung |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4044402A (en) * | 1974-03-01 | 1977-08-30 | National Research Development Corporation | Laryngeal prosthesis |
US4459984A (en) * | 1982-09-15 | 1984-07-17 | Liegner Kenneth B | Speaking tracheostomy tube |
US4794924A (en) * | 1987-01-20 | 1989-01-03 | The Cleveland Clinic Foundation | Laryngeal stent |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5443064A (en) * | 1994-03-24 | 1995-08-22 | Bivona, Inc. | Tracheostomy tube with adjustable neck plate |
GB9617545D0 (en) * | 1996-08-21 | 1996-10-02 | Smiths Industries Ltd | Medical tube assemblies |
DE10109935C2 (de) * | 2000-03-10 | 2003-07-03 | Primed Medizintechnik Gmbh | Tracheostomaprothese |
-
2003
- 2003-12-17 DE DE10359220A patent/DE10359220A1/de not_active Withdrawn
-
2004
- 2004-10-11 WO PCT/EP2004/052498 patent/WO2005058401A1/fr active Application Filing
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4044402A (en) * | 1974-03-01 | 1977-08-30 | National Research Development Corporation | Laryngeal prosthesis |
US4459984A (en) * | 1982-09-15 | 1984-07-17 | Liegner Kenneth B | Speaking tracheostomy tube |
US4794924A (en) * | 1987-01-20 | 1989-01-03 | The Cleveland Clinic Foundation | Laryngeal stent |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB2429919A (en) * | 2005-06-29 | 2007-03-14 | Smiths Group Plc | Adjustable trachoestomy tube |
GB2429919B (en) * | 2005-06-29 | 2010-07-07 | Smiths Group Plc | Tracheostomy tube assemblies |
US8313687B2 (en) | 2007-09-20 | 2012-11-20 | Kimberly-Clark Worldwide, Inc. | Method of making an improved balloon cuff tracheostomy tube |
US8607795B2 (en) | 2007-09-20 | 2013-12-17 | Kimberly-Clark Worldwide, Inc. | Balloon cuff tracheostomy tube |
Also Published As
Publication number | Publication date |
---|---|
DE10359220A1 (de) | 2005-07-28 |
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