EP-3990072-B1 - BLOCKING ELEMENT

Inventors

• FUSCH, CHRISTOPH

Dates

Publication Date

20260513

Application Date

20200615

Claims (4)

1. Blocking element for suppressing the ingress and accumulation of respiratory air in the stomach (4), with a gastric probe (3) formed by a tube which extends through the oesophagus (1), with a cuff (2) which can be inflated with air and which closes the oesophagus (1) in the inflated state, and with a device for removing saliva penetrating into the oesophagus (1), characterized in that the device comprises a suction probe (6) for saliva penetrating into the oesophagus (1) and constructed as a suction tube which protrudes into the oesophagus (1) and with its free end terminating at the cuff (2), with suction openings (7) in the regions of the tube sheath located in the oesophagus (1), and characterized by a collecting vessel (8) for the saliva aspirated with the suction probe (6) at the probe outlet facing away from the free end of the suction probe (6) and by a selector valve (9) which is conductively connected to the gastric probe (3) for introducing the saliva collected in the collecting vessel (8) into the stomach (4) through the gastric probe (3).
2. Blocking element as claimed in claim 1, characterized in that the cuff (2) is constructed to be intermittently emptied and subsequently refilled in order to serve as a combined device for removing saliva penetrating into the oesophagus.
3. System as claimed in claim 1 or claim 2, characterized in that the cuff (2) is disposed in the region of the cardia (5) at the end of the oesophagus (1).
4. System as claimed in claim 1, claim 2 or claim 3, characterized in that the cuff (2) is disposed in the superior mediastinum.

Description

The invention relates to a barrier element for suppressing the ingress and accumulation of respiratory air in the stomach during artificial, non-invasive ventilation, in particular nasal CPAP ventilation. The medical background for the invention is the need to treat respiratory distress syndrome in newborns. This respiratory distress syndrome, also known as surfactant deficiency syndrome, occurs predominantly in premature infants, and the more premature the infants are, the more frequent and severe the symptoms. Surfactant is essential for normal lung function. Surfactant is a surface-active substance that reduces and modulates the surface tension of the alveoli. It is produced by type II pneumocytes and forms a film over the surface of the alveoli. Surfactant enables the lungs to fill with air at normal pressures, prevents end-expiratory collapse of the alveoli, and thus maintains a sufficient functional residual volume. Due to its modulation of surface tension, surfactant also prevents air distribution disturbances in the lungs, which would otherwise exhibit areas of collapsed and overinflated sections. Surfactant is generally not produced in sufficient quantities until after the 34th week of pregnancy. This is why premature infants are more frequently affected by surfactant-deficient respiratory distress syndrome. However, older children can also develop the condition through secondary inactivation. Treatment of respiratory distress syndrome (RDS) usually requires some form of ventilation or respiratory support. A distinction is made between invasive and non-invasive ventilation methods. In invasive procedures, a tube is typically inserted endotracheally into the trachea through the mouth or nose. Gas exchange is facilitated by a connected ventilator, which, like a medical air pump, uses positive pressure to deliver an air-oxygen mixture into the lungs. Exhalation occurs either passively or, as with high-frequency ventilation, actively through the application of negative pressure. Besides achieving a For adequate gas exchange, it is important to apply continuous positive end-expiratory pressure (PEEP). This keeps the alveoli open at the end of expiration and ensures the functional residual volume, which is crucial for survival. This ensures that even in premature infants, the exchange of oxygen and carbon dioxide occurs during the relatively longer expiration. However, it has been known for some years that invasive ventilation is not always necessary, and that non-invasive respiratory support is perfectly sufficient for many children. In non-invasive ventilation, the air-oxygen mixture is delivered at a specific pressure into the nasopharynx via a nasal cannula or mask. If spontaneous breathing is maintained, this pressure and gas flow continue intrapulmonarily, facilitating inspiration and the maintenance of the functional residual volume. This form of ventilation is called CPAP (continuous positive airway pressure), and the most important parameter here is again the previously mentioned PEEP. Many studies have now shown that non-invasive CPAP ventilation is equivalent to invasive ventilation and superior in some aspects. In industrialized countries, more than 50% of very premature infants are now treated exclusively with CPAP. However, in practice, CPAP use can lead to side effects that may be clinically significant or limiting. In very premature infants, the development of a so-called "CPAP belly" poses a problem. Air enters the pharynx through both the nose and mouth. The pharynx contains not only the trachea, into which the air is meant to pass, but also the esophageal inlet. With non-invasive CPAP ventilation using a mask, the problem arises that the pressurized air passes not only through the trachea into the lungs but also through the esophagus into the stomach. This causes the stomach to continuously inflate, which is undesirable. In particular, an inflated stomach presses against the lungs from below, reducing airflow. Functional residual capacity. Additionally, this makes inhalation into and exhalation from the lungs more difficult. From a gastrointestinal perspective, this inadvertently introduced air can also lead to intolerances of enterally administered nutrition. This can result in a reduction in nutritional intake, which in turn necessitates prolonged parenteral nutrition and can therefore lead not only to insufficient growth but also to a higher sepsis rate. Overall, the unintentional introduction of air into the gastrointestinal tract via CPAP is a problem of significant clinical importance. From the WO2017/036846 A gastric tube with a cuff positioned in the esophagus is known. This gastric tube has a suction section located in the patient's pharynx to remove saliva or secretions and prevent them from entering the trachea. The saliva is therefore drained via the suction section before it reaches the trachea. However, if a patient is being ventilated with positive pressure through the