DE10329818A1 - Nose mask unit, in particular, for maintenance of a continuous positive airway pressure comprises a mask section, bendable yet stable connector elements, and a fixing element - Google Patents

Abstract

The nose mask unit, in particular, for maintenance of a continuous positive airway pressure (CPAP) comprises a self-holding mask section (1), bendable yet stable connector elements (2), and a fixing element (3).

Description

The The invention relates to a nasal mask device, which acts as a coupling part between a respiratory support system and the patient to realize a constant positive airway pressure (positive pressure respiration or CPAP = contineous positive airway pressure) for treatment restrictive lung diseases especially in premature and newborns or infants as well as apnea-brachycardia conditions is applicable.

The Nasal mask device as a coupling part at the transition of device system Patient is the most critical part of all known systems and has shortcomings on. These consist in difficulties of attachment to the patient, Painfulness due to excessive application pressure, possibility of lesions in the skin and mucous membrane area of the nose, restricted mobility and in particular variable leaks. The latter cause incalculable functional impairments and thus loss of effectiveness of a very effective form of treatment.

It is therefore an object of the invention to provide a nose mask device, the flexible, adaptable, painless and dense for the treatment of restrictive lung diseases especially for early and Newborn or infants and apnea brachycardia conditions is.

• – applikative Probleme bei der Fixierung des Systems mittels Bändern, Pflastern, Klettverschlüssen oder Mützen
• – Einschränkung der freien Kopfbeweglichkeit und/oder Anwendbarkeit nur in Rückenlage
• – Undichtigkeiten wechselnden Ausmaßes und Druckverluste
• – Druckstellen bis Gewebsnekrosen an prominenten Stellen, Wundscheuern der Nasenschleimhäute durch diese Schlauchstücke

zu vermeiden und eine medizinisch, mechanisch und pneumatisch sichere Funktion zu gewährleisten.The invention is based on the problem that indicated deficiencies of the available systems

• - Applicative problems with the fixation of the system by means of tapes, patches, Velcro closures or caps
• - Restriction of free head movement and / or applicability only in the supine position
• - leaks of varying magnitude and pressure losses
• - Pressure points to tissue necrosis at prominent sites, chafing of the nasal mucous membranes through these pieces of tubing

to avoid and to ensure a medically, mechanically and pneumatically safe function.

According to the invention the object is achieved by a nasal mask device, which consists of an elastic, with self-adhesive lips provided on the skin support mask part ( 1 ), an adaptable, then formbehaltenden, flexible connecting element ( 2 ) and a fastening and fixing element ( 3 ) consists.

The mask part ( 1 ) is designed so that it is elastically deformable to adapt to facial contours and by means of an adhesive ( 1g ), preferably adhesive silicone, releasably fixate on parts of the face.

The connecting element ( 2 ) has a deformable, contour-retaining reinforcement ( 2a ), preferably a wire insert and can be tension-free individually adapted to different facial contours shape-retaining. It thus contributes to the fixation of the mask.

The fastening and fixing element ( 3 ) consists of elastic material, which on the connecting element ( 2 ) is displaceable, via a grip tab ( 3a ) and by an adhesive coating ( 3b ), preferably glued silicone, on the forehead or another suitable head section is detachably fastened. It thus serves to fix the entire system.

• – unter Gewährleistung des voreingestellten Atemwegsdruckes Sekrete im Naso-Pharyngealbereich ohne Abnahme des Beatmungssystems und damit ohne Unterbrechung der Atemgaszufuhr entfernen zu können und Atemgas zu Kontroll- und Messzwecken zu entnehmen und/oder
• – direkte Druck- oder Temperaturmessungen vorzunehmen.

The mask part is advantageous ( 1 ) with a closable passage opening ( 1e ) and with a closure element ( 1f ), preferably a stopper closable. The means of closure element ( 1f ) resealable passage opening ( 1e ) is usable

• - Provide the preset airway pressure secretions in the naso-pharyngeal area without removing the ventilation system and thus to be able to remove without interrupting the supply of breathing gas and to remove breathing gas for control and measurement purposes and / or
• - make direct pressure or temperature measurements.

• – Sichere Atemwegsdruckstabilität bis 100 mmWS durch pneumatisch dichte, hautfreundliche Fixierung der Atemmaske um die Nase des Patienten mittels selbstklebender Lippen an der Maske und mittels selbstklebendem Fixierteil, das den Zu- und Abluftschlauch in der Symmetrieachse des Kopfes führt.
• – Sichere, rasche und den Patienten wenig beeinträchtigende Applikation und hautfreundliche Fixierung durch o.g. Selbstklebetechnik
• – Das über dem Verbindungsstück zu verschiebende Fixierstück kann in Abhängigkeit von der Kopfgröße in optimaler Position an der Stirn befestigt werden. Eine Lasche erleichtert die genaue Positionierung wie auch später die Ablösung.
• – Das Verbindungsstück selbst kann auf Grund seiner verformbaren, konturhaltenden Armierung dem Gesichtsprofil angepasst werden, so dass dieses Teil zum spannungsarmen, sicheren Sitz der Nasenmaske wesentlich beiträgt.
• – Das Gerät befindet sich exakt in der Mittellinie des Kopfes und kann zugfrei den Kopfbewegungen folgen, so dass keine Fixation des Kopfes selbst erforderlich ist. Es ist auch schwer von den Händen des Kindes zu erreichen und abzulösen.
• – Die Gewährleistung der freien Beweglichkeit des Kopfes in allen Lagen schließt als wichtigen Vorteil eine Anwendbarkeit in Bauchlage ein.
• – Haut- oder Schleimhautläsionen oder -nekrosen sind ausgeschlossen
• – Kein zusätzlicher Atmungstotraum, keine Geräuschemmission durch strömende Luft.
• – Medizinische Unbedenklichkeit, geringes Gewicht und gesicherte Formstabilität bei Raum- und Körpertemperatur durch die Verwendung hochwertiger Kunststoffe.

The nasal mask device according to the invention has the following advantages:

• - Safe airway pressure stability up to 100 mmWS by pneumatically sealed, skin-friendly fixation of the breathing mask around the nose of the patient by means of self-adhesive lips on the mask and by means of self-adhesive fixing part, which leads the supply and exhaust hose in the symmetry axis of the head.
• - Safe, rapid and gentle on the patient application and skin-friendly fixation by the above-mentioned self-adhesive technology
• - The over the connector to be moved fixing can be fixed depending on the size of the head in an optimal position on the forehead. A tab facilitates the exact positioning as well as the replacement later.
• - The connector itself can be adapted due to its deformable, contour-preserving reinforcement of the facial profile, so that this part significantly contributes to the low-tension, secure fit of the nasal mask.
• - The device is located exactly in the center line of the head and can follow the head movements without tension, so that no fixation of the head itself is required. It is also difficult of the To reach and detach the child's hands.
• - Ensuring the free mobility of the head in all positions includes an important advantage of a prone position.
• - Skin or mucosal lesions or necroses are excluded
• - No additional breath dead space, no noise emission by flowing air.
• - Medical safety, low weight and secure dimensional stability at room and body temperature through the use of high quality plastics.

Based enclosed Drawings of the invention will be explained. Showing:

1 Nose mask device in spatial representation

2 Mask part in spatial representation

3 Mask part in section

4 Connecting elements in spatial representation

5 Fixing and fixing element in spatial representation

1 shows a nose mask device in a spatial representation. It consists of a nosepiece of the patient covering, but the nostril releasing fitting 1 (Mask part), a connecting element ( 2 ) and a fixing element ( 3 ).

2 shows the mask part ( 1 ) in spatial representation. The mask part ( 1 ) consists of an elastic body ( 1a ) with lip-shaped, with adhesive ( 1g ) provided contact surfaces ( 1b ), supplemented by wing-like adhesive surfaces ( 1c ) for an abutment surface enlargement, from connection openings ( 1d ) for the supply and exhaust air ducts, a passage opening ( 1e ) and a closure element ( 1f ).

3 shows the mask part ( 1 ) in section through the passage opening ( 1e ). The coating of the contact surfaces ( 1b ) with an adhesive ( 1g ), preferably Klebsilikon. The main body of the mask part ( 1 ) shows at the contact surfaces a taper of the elastic material. This improves the adaptability to the facial contour.

4 shows interconnected tubular connectors ( 2 ), through which the mask part ( 1 ) acc. 2 with the fastening and fixing element ( 3 ) is connected. At the hose end opposite the mask part, the remaining part of the breathing assistance system is connected. Integrated into the hose-like connecting elements ( 2 ) is an easily deformable, yet dimensionally stable metal element ( 2a ). Thus, the mask can be tension-free adapted to the facial contour of the patient.

5 represents the fastening and fixing element ( 3 ) as the second adhesion point of the device with a tab ( 3a ) for easier detachability or position correction. As out 1 it can be seen on the hose-like connecting elements ( 2 ) arranged displaceably.

All Parts are made of sterilizable, recyclable, legal Regulations of appropriate plastic or other suitable materials.

1

mask portion

1a

elastic body

1b

lip-shaped contact surfaces

1c

wing-like surfaces

1d

connection openings

1e

Through opening

1f

closure element

1g

adhesives

2

connecting element

2a

metal element

3

mounting and fixing element

3a

flap

3b

adhesives

Claims (6)

Nose mask device, in particular for use as nasal Contineous Positive Airway Pressure (CPAP), characterized in that it consists of an elastic, with self-adhesive lips provided on the skin support mask part ( 1 ), an adaptable, then formbehaltenden, flexible connecting element ( 2 ) and a fastening and fixing element ( 3 ) consists. Nose mask device according to claim 1, characterized in that its mask part ( 1 ) is elastically deformable to fit facial contours and by means of an adhesive ( 1g ), preferably Klebsilikon, releasably fixable on parts of the face. Nose mask device according to claim 1 or 2, characterized in that the connecting element ( 2 ) by a deformable, contour-retaining reinforcement ( 2a ), preferably a wire insert, tension-free individually adaptable to different facial contours shape-retaining and contributes to the fixation of the mask. Nose mask device according to any one of claims 1-3, characterized in that the fixing and fixing element ( 3 ) consists of elastic material, which on the connecting element ( 2 ) is displaceable, via a grip tab ( 3a ) and by an adhesive coating ( 3b ), preferably glued silicone, on the forehead or other suitable head portion is detachably fastened and serves to fix the entire system. Nose mask device according to any one of claims 1-4, characterized in that the mask part ( 1 ) with a closable passage opening ( 1e ) is provided. Nasal mask device according to claim 5, characterized in that its opening and by means of closure element ( 1f ) resealable passage opening ( 1e ) can be used to remove secretions in the naso-pharyngeal area without removing the ventilation system and thus without interruption of the respiratory gas supply and to remove breathing gas for control and measurement purposes and / or make direct pressure or temperature measurements while ensuring the preset airway pressure.