Enteral feeding tube for feeding patients such as newborns, especially premature infants

Abstract

The invention relates to a tube (1) for enteral feeding of patients, in particular premature newborns, comprising a first tube constituting a feeding tube (2) having a proximal end (2a) and a distal end (2b) intended to be housed in the digestive tract of the patient, this feeding tube (2) being housed in a second tube (3) having a proximal end (3a) and a distal end (3b), the distal end (2b) of the feeding tube (2) extending in projection from the distal end (3b) of this second tube (3), and an inflatable and deflatable balloon (5).The invention consists in that the balloon (5) is positioned around a portion of the distal end (2b) of the feeding tube (2) which protrudes from the second tube (3), the probe further comprising a third tube (4) having a distal end which is connected to the balloon (5) and a proximal end (4a) connectable to means for inflating and deflating the balloon (5), the probe (1) being sized to be inserted into the patient's digestive tract such that the distal end (2b) of the feeding tube (2) is lodged in the stomach, the balloon (5), once inflated, being positioned against the cardia to close the stomach, while the distal end (3b) of the second tube (3) is positioned in the esophagus anterior to the cardia. Figure 1.

Description

Title of the invention: Enteral feeding tube for feeding patients such as newborns, particularly premature infants

[0001] The present invention relates to a medical device for enteral feeding of a patient, in particular an enteral feeding tube for feeding patients such as newborns, especially premature ones.

[0002] In the field of neonatology, there has been an increase in the number of so-called premature births, that is, before 37 completed weeks of amenorrhea (WA), which in 2010 represented 11% of live births. Among these premature births, 85% occur between 32 and 33 WA or between 34 and 36 WA, and 5% involve extreme prematurity before 28 WA. Thus, in France, 60,000 newborns are born prematurely each year, including 12,000 before 32 WA.

[0003] Neonatology is a relatively new specialty in which the progress of recent years has made it possible to reduce the mortality and morbidity rate associated with prematurity.

[0004] The most essential needs of premature infants are: - respiratory: requiring respiratory assistance - nutritional: requiring enteral nutrition via gastric tube or parenteral nutrition via intravenous line.

[0005] However, this type of respiratory or nutritional support requires care that can be invasive for the premature infant, causing discomfort. Advances have led to significant progress in less invasive and more personalized care.

[0006] Thus, at the respiratory level, in the case of intubation and ventilation, the aim is to limit the duration of this mechanical and invasive procedure by favoring, as soon as possible, non-invasive ventilation by blowing air or O2 into the nostrils at different pressures according to the newborn's needs, in order to indirectly transmit it to the still immature lungs. Such a system is therefore less invasive but not airtight; consequently, there is a more or less significant leakage of gas flow from the mouth to the outside, but also to the patient's stomach and abdomen.

[0007] Consequently, non-invasive ventilation has significant side effects such as: - gastric and abdominal distension due to air accumulating in the stomach and esophagus, which is known as "CP AP (Continuous Positive Airway Pressure) Belly Syndrome" because, at this age, the oropharyngeal structures and the gastric sphincter are soft and loose structures; - poor digestive tolerance to milk administered via gastric lavage; - lung compression due to abdominal distension and less efficient ventilation which requires an increase in ventilation pressures.

[0008] All of this results in major discomfort for the newborn, which can generate frequent discomfort and the beginning of a vicious cycle.

[0009] In order to remedy these disadvantages, the diet is reduced, which is a bad solution for a non-issue since parenteral nutrition is then prolonged, for example intravenously, which increases the risk of infection.

[0010] The ventilation level can also be lowered, which leads to respiratory consequences, as respiratory assistance is then less effective, or even ineffective. To limit the effects related to a "bloated" abdomen, air can also be manually evacuated by massage or by suction via the gastric tube, for example.

[0011] It is therefore important to be able to implement non-invasive ventilation safely while allowing safe enteral feeding using an enteral feeding tube.

[0012] Indeed, enteral nutrition is the most "natural" method of artificial nutrition because it utilizes a large part of the digestive system. Nutrients are thus delivered directly to the stomach or jejunum via various medical devices. The nutrients are then transformed for absorption in the intestine. Enteral nutrition is a complete medical procedure and requires rigorous hygiene.

[0013] Thus, a small tube is inserted through the nose or mouth and lowered directly into the newborn patient's stomach. Small amounts of expressed breast milk or formula are then slowly introduced into the stomach. If the baby responds well to this feeding, the dose is gradually increased. This method is therefore less invasive than parenteral feeding.

[0014] Among gastric feeding tubes used for enteral feeding, document WO-A-2018 / 009662 proposes a feeding tube comprising: a main tube, which can be adapted to the nose or mouth of a patient, the distal end of the main tube being designed to be positioned at the patient's pylorus and having an inflatable balloon. This feeding device includes a secondary tube that extends through the main tube and whose distal end extends beyond the distal end of the main tube into the jejunum. Once introduced into the stomach, the main tube is guided to the pylorus, so that the secondary tube, which serves for feeding, protrudes into the jejunum. The balloon is then inflated to engage with the pylorus and close it. The main tube has orifices suction allowing fluids present in the stomach to be aspirated into a suction tube.

[0015] Such a tube thus allows for safe feeding. However, it does not solve the problem of air entering the stomach when the premature infant is receiving non-invasive respiratory support. Furthermore, it does not promote digestive activity in the stomach.

[0016] The invention therefore aims to provide a tube for enteral feeding of patients, particularly premature newborns, comprising: - a first tube constituting a feeding tube having a proximal end and a distal end intended to be housed in the patient's digestive system, - this supply tube being housed within a second tube having a proximal end and a distal end, the distal end of the supply tube extending outward from the distal end of this second tube, - an inflatable and deflatable balloon, characterized in that the balloon is positioned around a portion of the distal end of the supply tube that protrudes from the second tube, - the probe further comprising a third tube having a distal end which is connected to the balloon and a proximal end which is connectable to means for inflating and deflating the balloon, - the probe being sized to be inserted into the patient's digestive system so that the distal end of the feeding tube containing the balloon is lodged in the stomach, the balloon once inflated being positioned against the cardia, to close the stomach while the distal end of the second tube is positioned in the esophagus before the cardia.

[0017] Thus, advantageously, the feeding tube according to the invention allows the premature newborn to be fed while closing the stomach at the level of the cardia or gastric sphincter, which blocks the entry of air when the premature newborn is also under non-invasive ventilation.

[0018] Advantageously, the second tube has at its distal end at least one orifice provided in its cylindrical wall while its proximal end is connected to suction means, said second tube constituting a suction tube for the air contained in the esophagus.

[0019] Thus, the orifice(s) provided at the distal end of the second tube allow the air contained in the esophagus to be aspirated, which also avoids esophageal distension linked to the accumulation of air or O2 from non-invasive ventilation.

[0020] The feeding tube according to the invention makes it possible to avoid gastric and abdominal distension caused by aeration associated with non-invasive ventilation while still allowing for effective feeding. In particular, it prevents the accumulation of air in The stomach does not push against the diaphragm, which could then compress the lungs. This improves the well-being and digestive and respiratory comfort of the premature infant, thus providing conditions that promote growth.

[0021] The feeding tube according to the invention is also usable for other child or adult patients, for example suffering from neuromuscular diseases, who, fed enterally and under non-invasive ventilation may suffer from gastric and abdominal distension, due to air accumulating in the stomach.

[0022] Advantageously, the third tube is also housed within the second tube. The supply tube and the third tube connected to the balloon thus extend adjacently for a large part of their length inside the second tube; however, each proximal end of these tubes protrudes from the second tube to allow their respective connection to the various supply and inflation means, while the proximal end of the second tube can be shaped to be connected to suction means.

[0023] The medical device according to the invention therefore consists of a tri-lumen (light) power supply probe made up of three independent tubes defining the three lumens. Each tube is preferably a long, thin tube made of a biocompatible material such as polyurethane, silicone, rubber, or any other suitable material. The probe according to the invention is therefore simple to manufacture.

[0024] The second tube or suction tube containing the other two tubes is for example a silicone tube whose distal end has in its cylindrical wall over a length of 5 cm for example, at least one orifice, preferably five, and whose proximal end is connectable to suction means such as a wall suction.

[0025] Inside this tube are housed two other lumens or tubes. One of the tubes is the feeding tube, and for newborn patients, silicone tubes ranging in size from 6 to 14 Fr are generally used, preferably 6 Fr. The French unit (Fr) for the diameters of this type of tube represents 0.3 millimeters. The open distal end of this tube allows the feeding to be delivered into the stomach. Additional openings can also be provided in the cylindrical wall of this end of the feeding tube.

[0026] The third tube or lumen allows air to be insufflated towards the balloon and extends into the second tube along the supply tube. A tube such as a pediatric-type silicone urinary catheter, preferably size 6Fr, can be used.

[0027] The balloon consists of at least one flexible tubular wall positioned around the distal end portion of the supply tube which protrudes from the second The balloon, whose ends are attached to the feeding tube at its distal end, is positioned after the distal end of the second tube. The balloon can be inflated to occlude the cardia. Preferably, the proximal end of the balloon can be shaped to fit over the cardia without exerting excessive pressure on the stomach, ideally with an end that is complementary in shape to the cardia.

[0028] The invention also relates to a method of placing a probe according to the invention into the digestive system of a patient, in which the distal end of the probe is inserted through the mouth or nose of the patient, until the distal end of the feeding tube including the balloon is lodged in the stomach, the balloon is inflated and a withdrawal traction is exerted on the probe until the balloon is against the cardia of the stomach and the probe is fixed in position.

[0029] Advantageously, the probe according to the invention is used when the patient is on non-invasive ventilation, by supplying the patient via the feeding tube and aspirating air from the esophagus through the orifices provided at the distal end of the suction tube, the proximal end of which is connected to suction means. Such a probe can, of course, also be used when the patient is not on non-invasive ventilation.

[0030] To remove this probe, the balloon is deflated and the probe is removed.

[0031] The invention will now be described in more detail with reference to the drawing in which the figures represent:

[0032] [Fig.1] an elevation view of a probe according to the invention;

[0033] [Fig.2] a cross-sectional view of the probe of the [Fig.1] according to section AA; And

[0034] [Fig.3] a schematic cross-sectional view of a patient equipped with non-ventilation invasive and a probe according to the invention.

[0035] An enteral feeding tube 1 according to the invention is intended to feed premature newborns in order to enable their feeding while they are under non-invasive ventilation.

[0036] Non-invasive ventilation allows air or oxygen to be blown into the patient's lungs using a mask placed on the nose or oxygen glasses.

[0037] The air thus ventilated enters the lungs but also accesses the digestive system, which risks causing gastric distension.

[0038] A feeding tube 1 according to the invention is then used. This tube 1 consists of three tubes or lumens. The first tube 2 has a proximal end 2a and an opposite distal end 2b, the distal end 2b being the end that delivers the food into the digestive system while the proximal end 2a is connected to means containing the food such as a milk bag. breast milk or infant formula. This supply tube 2 is housed in a second tube 3 forming a lumen of larger diameter, the supply tube 2 extends through this second tube 3 and has a length greater than that of the second tube 3 so that the distal end 2b of the supply tube 2 protrudes from the distal end 3b of the second tube 3.

[0039] The probe according to the invention further comprises an inflatable and deflatable balloon 5. This balloon 5 consists of at least one flexible tubular wall positioned around the distal end 2b of the supply tube 2, which protrudes from the second tube 3. The balloon 5, whose ends are fixed to the supply tube 2 at its distal end 2b, is thus positioned after the distal end 3b of said tube 3. The balloon 5 can therefore be positioned at approximately a distance d of 4 cm from the end of the distal end 2b of the supply tube 2.

[0040] A third tube 4 is housed in the tube 3 (see [Fig.2]), and has a distal end which is connected to the balloon 5 while its proximal end 4a is connected to means for inflating and deflating balloon 5. The enclosure defined by the flexible wall of the balloon 5 fills with air which inflates the balloon 5 (visible on [Fig.1] where the wall is shown in a rounded shape once the balloon is inflated (bold line).

[0041] Tubes 2 and 4 extend for a large part of their length inside tube 3, but each proximal end 2a and 4a protrudes from tube 3 to allow their respective connection to the different supply and inflation means, the proximal end 3a of tube 3 being shaped to be connected to the suction means.

[0042] Thus, the feeding tube 1 is inserted into the patient's digestive tract. The length of the feeding tube 2 is suitable for extending into the patient's stomach, while the length of the second tube 3 is shorter and extends mainly into the esophagus. The distal end 2b may have additional openings 21 in the cylindrical wall of this end of the feeding tube 2 to facilitate the delivery of nutrition.

[0043] Once the tube 1 is inserted into the digestive tract, until the distal end of the first tube 2 is inside the stomach, the balloon 5 is inflated. The tube 1 can then be pulled until the balloon 5 comes to rest against the cardia, thus closing the stomach and blocking the access of air from non-invasive ventilation. The balloon 5 therefore ensures a seal between the stomach and the patient's esophagus, thus preventing the entry of air from non-invasive ventilation and consequently abdominal distension.

[0044] The balloon 5 is then advantageously located between the distal end of the second tube 3, which extends into the esophagus, and the distal end of the first tube 2, which... found in the stomach.

[0045] The second tube 3 comprises, at its distal end 3b, orifices 31 formed in the cylindrical wall of said tube 3, while its proximal end 3a is connected to suction means. In this way, air from non-invasive ventilation and located in the esophagus can also be aspirated through the orifices 31 of said tube 3, which then constitutes a suction tube. It can be envisaged that five orifices 31 extend over a length L of 5 cm from the end of the distal end 3b.

[0046] Thus, the probe 1 being insertable into the stomach so that the distal end of the feeding tube 2 is lodged in the stomach, the balloon 5 once inflated allows the cardia of the stomach to be closed preventing the entry of air from a non-invasive ventilation 6 while the aspiration orifices 31 of the distal end 3b of the aspiration tube 3 are positioned in the esophagus and evacuate the air from said esophagus (cf. [Fig.3]).

Claims

Demands

1. A feeding tube (1) for enteral feeding of patients, in particular premature newborns, comprising: - a first tube constituting a feeding tube (2) having a proximal end (2a) and a distal end (2b) intended to be lodged in the patient's digestive tract, - this feeding tube (2) being lodged in a second tube (3) having a proximal end (3a) and a distal end (3b), the distal end (2b) of the feeding tube (2) extending in projection from the distal end (3b) of this second tube (3), - an inflatable and deflatable balloon (5), characterized in that the balloon (5) is positioned around a portion of the distal end (2b) of the feeding tube (2) which is projecting from the second tube (3),- the probe (1) further comprising a third tube (4) having a distal end (4b) which is connected to the balloon (5) and a proximal end (4a) connectable to means for inflating and deflating the balloon (5), - the probe (1) being sized to be inserted into the patient's digestive tract such that the distal end (2b) of the feeding tube (2) is lodged in the stomach, the balloon (5) once inflated being positionable against the cardia, to close the stomach while the distal end (3b) of the second tube (3) is positioned in the esophagus before the cardia, the second tube (3) having at its distal end at least one orifice (31) formed in its cylindrical wall while its proximal end (3a) is connectable to suction means, said second tube (3) constituting a suction tube for the air contained in the esophagus.

2. Probe (1) according to claim 1, characterized in that the third tube (4) is housed in the second tube (3).

3. Probe (1) according to any one of claims 1 or 2, characterized in that each tube (2, 3, 4) is a long, thin tube made of biocompatible material such as polyurethane, silicone, rubber or any other suitable material.

4. Probe (1) according to any one of claims 1 to 3, characterized in that the balloon (5) comprises at least one flexible tubular wall (5a) po-

5. positioned around a part of the distal end (2b) of the feed tube (2) which protrudes from the second tube (3). Probe (1) according to claim 4, characterized in that the proximal end of the balloon (5) is shaped to fit at the level of the cardia without exerting too much pressure.

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