EP1266646A2 - Gastrostomy tube for enteral feeding a patient and its use - Google Patents

Abstract

The apparatus for the enteral feeding of a patient is a probe (1), with a tube (10) which has a shaped guide section (F) leading from the distal end (12) toward the proximal end (11). The apparatus for the enteral feeding of a patient is a probe (1), with a tube (10) which has a shaped guide section (F) leading from the distal end (12) toward the proximal end (11). The length (L) of the guide section is longer than the diameter of the intestine into which the probe is inserted and has a minimum length of 30 mm. The outflow openings (120), at the probe periphery, are outside the guide section.

Description

The invention relates to a nutritional probe for enteral nutrition Patients with a tube with a proximal end and a distal end End and one continuous from the proximal end to the distal end Lumen with a distal exit opening of the lumen at the distal end of the Tube, being in the area of the distal end of the tube over the circumference of the tube distributes outlet openings to the outlet via the proximal End of nutritional solution introduced into the lumen of the tube are.

Feeding tubes are used for circumvention, relief or Protection of the stomach placed in the intestine, they are also called Jejunal probe called.

Such feeding tubes for enteral nutrition of a patient are widely known and become, for example, post-operative nutrition used by patients using the feeding tube with the patient its distal end region, which has the outlet openings, over the Stomach is advanced into the intestine, so that a appropriate nutritional solution and / or drug solution through the proximal end of the patient protruding from the nose Nutritional tube can be fed and directly into the intestine of the Patients can withdraw from their diet without becoming one The nutritional solution comes into contact with the patient's stomach walls. In this way, a patient can also use contrast media for the Performing an intestinal exam.

Due to the preferably through a working channel of an endoscope Placement of the feeding tubes shows this only extremely small outer diameter, preferably only 1.5 to 3.5 mm, what corresponds to about 4 to 11 CH, but results from a desired one the largest possible inner diameter for the passage z. B. the Nutritional solution inevitably a small wall thickness of such Nutritional probes from e.g. B. only 0.5 mm. However, this fact brings the problem of a slight twisting or deflection of the known Nutritional probes from their desired orientation with them.

Especially in patients with reverse peristalsis, in which the contractions exerted by the intestine in the opposite direction, d. H. oriented towards the stomach, it occurs in the known feeding tubes often lead to a deflection of the distal end same towards the stomach and consequently to one Bending, which leads to a partial or even complete closure of the Feeding tube leads and affects the supply of the nutritional solution or even prevented. If it is even subsequently due to the reverse Peristalsis of the intestine to return the distal end of the Feeding tube comes into the stomach, so access is from the Feeding tube exiting solutions intended for the intestine in the Stomach allows what is extremely undesirable and too Complications. As a rule, these processes require Remove the feeding tube and insert a new one Feeding tube, which means great effort and undesirable burdens Patient.

Mandatory in the area of the distal end of the feeding tube required circumferential outlet openings on the tube for exit the nutritional solution from within the tube of the feeding tube trained lumens favor this undesirable deflection and that kinking of the distal end due to this, since this Outlet openings a weakening of the cross section of the tube and a associated lower dimensional stability and rigidity of the tube in bring this area with it.

From US 4,704,111 a feeding tube is known in which the tube Thickened in the area of the distal end compared to the proximal end End of the feeding tube adjacent area is formed. The The distal end of the tube is closed and the tip of the probe is closed weighted additional weight. For the exit of the nutritional solution are circumferential outlet slots in the thickened area of the tube educated. The weight of the closed probe tip should do that Deflecting and / or kinking the feeding tube in the area of its Prevent distal end. Such feeding tubes in the distal However, additional weights arranged in the end region are expensive the manufacture and have also proven to be ineffective since they because of the small diameter of the feeding tubes and the small Dimensions have only a small additional weight, which Experience has shown that there is no obstacle to deflecting and kinking one represents reverse bowel peristalsis.

If the feeding tube is in the patient's intestine for a longer period of time it known a second tube, namely a gastric tube in the stomach of the Patients lay down to drain gastric juices and the stomach too dekompremieren. This gastric tube that is not feeding Serving nutritional solution is about the one already placed in the intestine Feeding tube also through the patient's nose and stomach advanced, it is also referred to as a nasogastric probe.

Gastric tubes essentially consist of a tube that consists of a soft plastic tube is made, with inert material physiologically harmless plastics such as thermoplastic polyurethane elastomers or silicone rubbers or Soft PVC can be used. The surface of the gastric tube must be soft and be pliable to prevent mucosal injuries when inserting the Avoid gastric tube. Furthermore, the gastric tube must be in spite of the soft flexible plastic have sufficient stability to avoid kinking when inserted into the stomach. Furthermore the surface of the gastric tube must have good lubricity.

Because gastric tubes usually go through a patient's nose into the The outer diameter of the gastric tube is the stomach - the tube - limited by the nasal canal to a maximum of about 16 CH what corresponds to approx. 5 to 5.3 mm and is comfortable for the patient Means maximum. In the event that the gastric tube in connection with a feeding tube is placed, the feeding tube is replaced by the Lumen of the gastric tube are passed through or the two tubes are placed managed separately. For this it is necessary to have the largest possible free Inner diameter of the lumen of the gastric tube for the internal one To have a feeding tube, with a gap between the feeding tube and the stomach tube remain free in the lumen Annular gap - to drain gastric juices through the lumen of the To allow gastric tube despite the internal feeding tube. There Nutritional probes usually used with a size of 9 CH be what an outside diameter of the feeding tube of about 3 mm corresponds, problems arise for the formation of the Gastric tube with sufficient wall thickness and stability against Kinking the necessary softness and flexibility of this plastic used.

• die Magensonde eine möglichst geringe Wandstärke aufweist, um einen möglichst großen Innendurchmesser des durchgehenden Lumens für die Drainage zu erreichen;
• die Oberfläche des Tubus der Magensonde weich und geschmeidig ist zur Vermeidung von Verletzungen der Schleimhaut;
• die Ernährungssonde leicht durch das Lumen der Magensonde gleitet, wobei die Verwendung von zusätzlichen Gleitmitteln so gering wie möglich gehalten werden soll oder vermieden werden soll;
• die Magensonde röntgenkontrastgebend ausgebildet ist;
• die Magensonde schubstabil bei ausreichender Weichheit und Flexibilität ist.

It is desirable for the formation of a gastric tube for drainage and decompression, which is to be used in conjunction with a feeding tube, that

• the gastric tube has the smallest possible wall thickness in order to achieve the largest possible inner diameter of the continuous lumen for drainage;
• the surface of the tube of the gastric tube is soft and supple to avoid injuries to the mucous membrane;
• the feeding tube slides easily through the lumen of the gastric tube, the use of additional lubricants should be kept as low as possible or should be avoided;
• the gastric tube is designed to provide X-ray contrast;
• the gastric tube is thrust-resistant with sufficient softness and flexibility.

The invention has therefore set itself the task of a feeding tube Generic type to further develop that as possible a simple way of deflecting or bending the distal end region the same due to reverse peristalsis of the patient's intestine is reliably prevented so that it does not lead to a malfunction or Interruption of flow through the feeding tube or to one Return of the feeding tube to the stomach can occur.

Furthermore, the invention has the task of Nutritional tube combined with a gastric tube to use in addition to the supply of nutritional and / or medicinal solution to the intestine a patient’s stomach and drain relieve.

To solve the problem, the invention proposes that the feeding tube is heading from the distal end proximal end is formed with a guide section and the Guide section has a length that is greater than the diameter the intestine of the patient, in which the distal end of the tube Nutritional tube is introduced, at least a length of 30 mm and which are formed on the circumference of the tube Outlet openings are arranged outside the guide section.

It has been shown in the context of the invention that by forming a opening-free guide section in the region of the distal end of the Feeding tube, which by sufficient spacing of the Cross-section of the tube-weakening circumferential outlet openings from the distal end of the same, the redirection and turning or kinking the distal end of the feeding tube inside of the intestine is reliably prevented in a surprisingly simple way. Is it because of a reverse peristalsis or unusual patient movements to deflect the distal end region of the feeding tube according to the invention, so can this due to the greater length of the guide section in comparison the diameter of the intestine is not in the direction of insertion opposite direction, since the distal end region in this case comes to premature against the intestinal walls, whereby any further deflection is prevented.

Within the framework of the considerations leading to the invention, it has been shown that the usual expected diameter of a patient's intestine, in which the distal end of the feeding tube is inserted, about 20 will be up to 40 mm. It is therefore proposed according to the invention the length of the guide section by spacing the peripheral outlets from the distal end of the tube around to form at least 30 mm, preferably 50 mm or more, in order to Deflection of the distal end area, for example, due to a to prevent reverse bowel peristalsis.

A reliable prevention of turning can be done with Nutritional probes according to the invention can be achieved in which the Guide section has a length L and thus a corresponding Distance of the outlet openings to the distal end of the tube is formed is that the D: L ratio of at least 1: 1.2 is achieved, with D the diameter of the patient's intestine. Since the length L is at least 1.2 times the diameter D, the application of the Guide section of the tube on the intestinal wall during a deflection and thus preventing it from turning or even bending guaranteed.

In practice, feeding tubes of different sizes can be used are formed according to the invention, with variations in the distance L to Adaptation to different purposes and patients (height, weight, Age etc.). The guide section preferably has the feeding tube a length of 40 to 60 mm. The distal end of the tube Feeding tube closest to the circumference of the tube Outlet openings then have a minimum distance of 30 mm, preferably 40 to 60 mm from the distal end of the tube.

Another essential advantage of the feeding tube according to the invention can be seen in the fact that they have no additional weights in the range of distal end portion of the same, so that it is possible to insert one in the longitudinal axis of the distal outlet opening in the tube to be arranged so that the foremost seen in the direction of insertion Tip of the feeding tube according to the invention the leakage of Nutritional solution can be made freely from the lumen. The The feeding tube according to the invention is also characterized by a tube with constant outer diameter over its length, which also makes it is designed to be shear stable.

It is particularly provided that the distal outlet opening has the same diameter as the lumen formed in the tube and thus does not cause a constriction in the exit direction. In this way You can also use liquid-insoluble drugs through the Nutritional probe according to the invention are to be applied, not in Lumens are retained so that there is no blockage of the Nutritional tube still a loss to be administered to the patient Active ingredient can occur.

The high security of the feeding tube according to the invention against deflection or twisting and return of the same to the stomach can also be increased in that the tube is made of an elastic material with a high restoring force, e.g. B. is based on thermoplastic and / or elastomeric plastics, thermoplastic elastomers (TPE) and elastomer-like thermoplastics with a Shore hardness A according to ASTM D 2240 less than or equal to 90, for example based on a polyurethane elastomer. The high restoring forces of the tube counteract the deflection when the distal end region of the tube is deflected, for example in the case of an inverted intestinal peristalsis, and support the return of the tube to its original and intended position after each deflection. Other suitable plastics with sufficient restoring force can also be used to form the tube. Suitable plastics in the sense of the invention can have a single-layer or multi-layer structure, as well as a material combination, e.g. B. can be used in the coextrusion process multilayer plastic composites of different plastics
According to the invention, the feeding tube is equipped with X-ray contrast, a continuous design of the tube is preferred. It is proposed that the tube be made from a mass containing 10 to 15 parts by weight of an X-ray contrast medium, such as barium sulfate, based on 100 parts by weight of the soft flexible plastic. This gives the tube an opaque color and can be provided on the outside in a known manner with a length marking, depth marking made of ink.

To increase the lubricity of the feeding tube, for example in a Gastric tube, the surface of the feeding tube is microrauh educated. This can form an air / liquid cushion that Sliding promotes and counteracts the clinging. For simultaneous enteral nutrition and gastric decompression of a patient proposed that the feeding tube designed according to the invention in Connection with a gastric tube to drain gastric juices and Decompression of the patient's stomach to be used, being as Gastric tube is used such that a tube with one of the proximal end to the distal end through lumen as well Drainage holes emerging laterally from the tube of the gastric tube is formed and wherein the feeding tube through the lumen of the tube the gastric tube, forming an annular gap between the Surface of the feeding tube and the lumen of the feeding tube limiting surface is feasible.

The conditions for the combined use of a nutritional probe according to the invention with a gastric tube are solved particularly comfortably for the patient with a gastric tube, the tube of which is constructed in multiple layers. According to the invention it is therefore proposed that the gastric tube pushed over the feeding tube is a multilayer tube with an outer layer made of a soft flexible plastic and an inner layer made of a harder plastic with respect to the plastic of the outer layer, the inner layer in front of the distal end of the gastric tube ends within the continuous lumen of the gastric tube and the plastic used for the inner layer has good sliding properties and non-stick properties with respect to the plastic from which the feeding tube is made.
Coextrudable plastics which are compatible with one another are preferably used for the production of a two-layer tube for the gastric tube.

The compatible extrudable plastics for the The outer layer and the inner layer should adhere well to each other exhibit.

For the outer layer, conventional gastric tubes are preferred usable plastics, in particular thermoplastic and / or elastomeric plastics, thermoplastic elastomers and elastomer-like ones Use thermoplastics, preferably with a Shore hardness A according to ASTM D 2240 less than or equal to 90. Particularly suitable soft, flexible materials for the outer layer of the tube are, for example, thermoplastic Polyurethane elastomers, which polyadducts from polyisocyanates and Polyols are, of which thermoplastic are preferred Polyurethane elastomers based on polyether urethanes, with a Shore hardness A preferably in the range between 70 to 90.

For the inner layer, a hard, rigid plastic with a Shore hardness D according to ASTM 2240 greater than 45, preferably greater than 55 used. For this, there are also physiologically harmless ones Plastics that are compatible with that for the outer layer of the Tube elastomers are used. According to a proposal by Invention is for the inner layer a copoly (ether-ester-amide), also as Designated polyether block amide, with a Shore hardness D of 55 to 80, preferably a Shore hardness D greater than 60 is used.

The tubular outer layer of the tube of the gastric tube from one elastomeric plastic is soft and, taken on its own, unstable and not kink-resistant and is characterized by the co-extruded inner layer hard plastic, which is very thin, stabilized so that through the two-layer design of the tube a shear-resistant, yet soft and flexible gastric tube is obtained. The thickness of the hard inner layer the tube of the gastric tube should be less than 0.020 mm, preferably less than 0.015 mm, and particularly preferably 0.01 mm or less be. As a result of the stabilizing effect of the inner layer of the tube the gastric tube makes it possible to measure the total wall thickness of the tube keep it lower, d. H. due to the hard inner layer of the tube it is possible, the total thickness of the multilayer tube according to the invention in terms of the thickness of a single-layer tube from a soft to reduce flexible plastic to a minimum and thereby the Increase the inner diameter of the lumen of the gastric tube and thus also to increase the drainage lumen.

When choosing a suitable hard plastic to form the Inner layer of the multilayer tube for the gastric tube also prefers a plastic that has good sliding properties and good ones Has non-stick properties to allow easy sliding of the feeding tube through the lumen of the gastric tube. Good sliding properties and good non-stick properties are also achieved by using Realized polyether block amides.

Depending on the choice of materials for the outer layer and the inner layer of the multilayered tube of the gastric tube, however, is the inner layer always be very thin, preferably the thickness of the inner layer the thickness of the outer layer of the tube behaves like 1:20 to 1:80.

According to the invention it is possible to use a gastric tube with a multilayer tube according to the invention with an outer diameter for example corresponding to 16 CH the thickness of the outer layer between Form 0.35 to 0.45 mm and the thickness of the inner layer in the area from 0.015 to 0.006 mm. Accordingly you get according to the invention with a gastric tube with a multilayer tube an outer diameter, for example, corresponding to 16 CH with a continuous lumen with an inside diameter of at least 4 mm is formed. Because feeding tubes are usually a size of 9 CH have an outer diameter of 3.0 mm, it succeeds thus a sufficiently large space between one in the Gastric tube internally arranged feeding tube and the To create the inner wall of the tube of the gastric tube.

To avoid lesions in the stomach by the on the invention multilayered distal tube end trained interface of hard Inner layer and soft outer layer is invented suggested the distal end of the multilayer tube with a soft atraumatic radiopaque probe tip equip. The probe tip is preferably made of a special soft tubular section with a continuous lumen formed, preferably the probe tip based on the same soft flexible plastic like the outer layer of the tube or a compatible with one of the hardness of the plastic of the outer layer of the Tube approximately corresponding Shore hardness A is formed. The Inner diameter of the lumen of the tube and the inner diameter of the Lumens of the probe tip should correspond to each other.

In order to equip the gastric tube with X-ray contrast, the invention suggested that only the probe tip be radiopaque train. For example, the probe tip itself can be perfect X-ray contrast-forming by 100 parts by weight 10 to 15 parts by weight of the soft flexible plastic X-ray contrast agents, such as barium sulfate, are contained in the probe tip are. The probe tip preferably has a length of 10 to 30 mm and is firmly attached to the distal end of the tube, for example by welding.

For an increased drainage effect, it is proposed that the tube be the Gastric tube sideways in the area adjacent to the tip of the tube has emerging drainage holes, which preferably over a region of Length of the tube of up to 250 mm starting from the probe tip are distributed.

The gastric tube is preferably developed in such a way that the proximal end of the tube a Y-connector can be connected. The straight one Connection of the Y connector is used to carry out the Feeding tube, during the lateral connector of the Y-connector the connection of a suction hose for drainage of the stomach through the Gastric tube, d. H. the lumen of the tube of the gastric tube serves.

In contrast, it is proposed that the proximal end of the tube with a Adapter to connect to a source of nutritional solution or Drug solution is connected.

If a patient with a gastric tube according to the invention with internal feeding tube is provided, so it is possible for him continuously through the feeding tube by introducing a To supply nutritional solution to the intestine and at the same time it is possible through continuous or intermittent suction or else Gravity drainage over the remaining lumen of the tube Gastric tube to depressurize the stomach. The Nutritional tube is in the gastric tube. Between the Outside diameter of the feeding tube of usually 9 CH and that Inner diameter of the lumen of the gastric tube according to the invention of 16 CH there is a sufficiently large space in the form of a Annular gap with a gap width of at least 0.5 mm, the one Relief of pressure from the stomach via the lateral drainage holes of the tube the gastric tube allows.

A preferred embodiment of the invention provides that for a Nutritional tube with a size of 9 CH and a length of at least 2 m a gastric tube of 16 CH that can be inserted via the feeding tube and a length of at least 1 m is provided, the continuous lumen of the gastric tube has an inside diameter of has at least 4 mm.

To ensure particularly good sliding of the feeding tube within the Gastric tube is intended to allow the surface of the Feeding tube with a micro-roughening is formed. This will be a Air cushion / liquid cushion formed and adhering to the surface the feeding tube on the inner layer of the multilayer tube Gastric tube is avoided and the lubricity is significantly improved. According to the invention is a gastric decompression probe trained gastric tube proposed that have a length of at least 1 m and has a multi-layered thrust-resistant design with a soft flexible outer layer made of an elastomer and a with the outer layer connected by coextrusion from an inner layer is hard plastic and the inner layer in front of the distal end of the Gastric tube ends within the continuous lumen. The gastric tube according to the invention is provided with an extra soft, radiopaque distal end in the form of a probe tip fitted. The soft and yet thrust-resistant according to the invention Gastric tube is particularly suitable for use with a internal feeding tube, preferably a nasojejunal one Feeding tube.

Figur 1

die Ansicht einer erfindungsgemäßen Ernährungssonde,

Figur 2

in einer schematisierten vergrößerten Darstellung die Lage des distalen Endbereiches der erfindungsgemäßen Ernährungssonde innerhalb des Darms eines Patienten,

Figur 3

die Einzelheit E in Figur 2 in vergrößerter Schnittdarstellung,

Figur 4

schematisch die Herstellung einer erfindungsgemäßen Ernährungssonde im Bereich des distalen Endes derselben,

Figur 5

schematische Darstellung einer Magensonde mit Konnektor,

Figur 6

das vergrößerte Detail gemäß Schnitt HH nach Figur 5,

Figur 7

den Ausschnitt der Magensonde gemäß Figur 6 mit einer innenliegenden Ernährungssonde,

Figur 8

schematische Darstellung einer Ernährungssonde mit Magensonde zur gastrischen Dekompression

Further details and refinements of the nutritional probe according to the invention are explained below with reference to the drawings which merely illustrate an exemplary embodiment. Show it:

Figure 1

the view of a feeding tube according to the invention,

Figure 2

a schematic enlarged representation of the position of the distal end region of the feeding tube according to the invention within the intestine of a patient,

Figure 3

the detail E in Figure 2 in an enlarged sectional view,

Figure 4

schematically the production of a feeding tube according to the invention in the area of the distal end thereof,

Figure 5

schematic representation of a gastric tube with connector,

Figure 6

the enlarged detail according to section HH of Figure 5,

Figure 7

the section of the gastric tube according to Figure 6 with an internal feeding tube,

Figure 8

schematic representation of a feeding tube with gastric tube for gastric decompression

1 shows a nutritional probe 1 for enteral nutrition of a Patients can be seen having a tube 10 with a continuous tube trained lumen 100 comprises. The tube 10 of the feeding tube 1 extends from a proximal end 11 to a distal end 12, the continuous lumen 100 being continuous from the proximal end 11 to the distal end 12 is formed.

The outer diameter ADE of the tube 10 is constant and is at a size of the feeding tube of 9 CH about 3 mm. The length of the Feeding tube can be up to 3 m.

An adapter can be connected airtight to the proximal end 11 be the commercial container for nutritional solutions is connectable so that nutritional solution via the adapter and that proximal end 11 of the tube 10 can reach its lumen 100. Out The nutritional solution enters this lumen 100 extensively in the area of the distal end 12 of the tube 10 arranged outlet openings 120 and a distal lying in the direction of the longitudinal axis M of the tube 10 Exit opening 121 again. The peripheral outlet openings are distributed around the circumference of the tube, for example in a regular manner axial distance from each other, e.g. every 10 mm.

Each outlet opening, for example 6 in number, has one at 9 CH average diameter from 2 to 2.5 mm.

With the help of the feeding tube 1 it is possible to enterally treat a patient feed or e.g. to administer a contrast medium.

For this purpose, the tube 10 with its distal end region 12 first orally or nasally in a manner known per se, if appropriate also under Using an endoscope through the patient's stomach to inserted into the intestine so that the distal end 12 including the in this area arranged outlet openings 120, 121 within the Gut of the patient comes to rest. With its proximal end area 11 then the feeding tube 1 protrudes from the mouth or nose opening of the patient, so that, for. B. from one to the proximal end 11 attached container a nutritional solution directly into the intestine of the Can be given to the patient's diet.

Figure 2 shows the situation in an enlarged schematic representation of the distal end region 12 within the intestine 2 of the patient this in the manner described above by means of Feed nutritional tube 1.

An essential feature of the feeding tube 1 is that the peripheral outlet openings 120, through which the nutritional solution the lumen 100 of the tube 10 exits into the intestine, in one Minimum distance L from the distal end 12 of the tube 10 are arranged, the larger than the diameter D of the intestine 2 of the patient to be fed in which the distal end 12 of the feeding tube 1 lies comes. In this way, a length L is formed Guide section F is formed without lateral outlet openings, the between the outlet openings 120 and the distal end 12 is trained. For example, the ratio of intestinal diameter is D to the distance L on the feeding tube 1: 1.3, specifically to Example, the guide section F have a length L of about 40 mm can.

This necessitates that they are arranged in the tube 10 peripheral outlet openings 120 a significant reduction in Stiffness of the tube 10, they therefore act like a joint and allow that arranged in front guide section F, from the desired extent to be deflected in the direction of the longitudinal axis M according to arrow P, what in particular by reverse peristalsis of the patient's intestine 2 can be caused.

However, since the guide portion F has a longer length L than that Diameter D of the intestine 2 is formed, its maximum Deflection from the course of the longitudinal axis M by contacting the Gut wall 21 in the manner indicated by dashed lines in FIG. 2 limited so that a complete buckling of the distal end 12 in Direction to the proximal end 11 and thus to the stomach of the Patients and at least partial occlusion of the feeding tube is reliably prevented. As a result, the reverse can also occur Peristalsis of the patient no twisting of the feeding tube 1 and one Return of the distal end 12 to the patient's stomach cause.

By selecting a suitable material for the tube 10 Nutritional probe 1 with a high elastic restoring force can also not only the deflection up to the abutment on the intestinal wall 21 of the intestine 2 be limited, but also a return of the management area F with the distal end 12 in the desired original position in the direction the longitudinal axis M, which ensures security against twisting, Closure and return of the distal end 12 from the desired Position continues up to the patient's stomach. Such an elastic Plastic material with a high restoring force can be based, for example be formed of a suitable polyurethane, which also has a high tolerance for the patient and by the specialist can be selected accordingly.

The number and arrangement of the outlet openings 120 also depends according to the required cross-sections and can be done by a specialist can be selected accordingly, with only the minimum distance 11 to the distal end 12 for the purpose of forming the guide section F. is to be noted in order to deflect and / or bend the distal end 12 reliably prevent.

The at the distal end 12 of the tube 10 in the direction of the longitudinal axis M lying distal outlet opening 121 is moreover, as from the 3, with a diameter DA formed that the diameter DL of the lumen 100 in the tube 10 equivalent. Viewed in the direction of the longitudinal axis M of the tube 10 therefore the outlet opening 121 does not constrict the lumen 100, so that liquid-insoluble drugs passed through the lumen are not can be held back. Blockage of the feeding tube 1 and an active ingredient loss is thus effectively counteracted.

In addition, those surrounding the distal outlet opening 121 Edge areas 122 of the tube 10 are rounded to prevent injuries to avoid patient tissue.

According to the schematic representation in Figure 4, this training is the distal outlet opening 121 and the peripheral regions 122 surrounding it by a tool 3 during the manufacture of the feeding tube 1 reached. First of all, one that forms the later tube 10 Hose section 10.1 cut to length in a manner known per se and subsequently one end of it becomes the distal one End region 12 pressed against the heated tool 3 in the direction of arrow X.

The tool 3 has a mandrel 30 which ends in the lumen 100 is inserted around the distal orifice 121 with the diameter Train DA. For this purpose, the mandrel 30 has the desired diameter DA on.

A groove 31, which is rounded, is provided around the mandrel 30 is formed and the originally sharp cut edges of the tube 10 to the desired rounded edge areas 122 according to FIG. 3 reshapes.

FIG. 5 shows a gastric tube 5 with a view Tube 50 with one from the proximal end 51 to the distal end 52 continuous lumen and one located at the distal end 52 of the tube subsequent tubular probe tip 55 also with continuous lumen up to the distal end 52a of the gastric tube 5. The Tube 50 is in the area adjacent to probe tip 55 sideways, d. H. drainage holes 53 emerging on the tube jacket educated. The drainage holes 53 are in the axial extension XM Gastric tube or tube 50 evenly spaced apart arranged the tube, whereby it is also offset over the circumference are arranged. At the proximal end 51 of the tube 50 is a Y connector 6 attached. The gastric tube must have a soft top layer and Have a surface to avoid injuries. The Upper layer / surface of the tube should touch when Water / moisture, d. H. be smooth when inserted into a patient. In addition, the tube of the gastric tube must have such high strength and Have stability that it is flexible, but not kinking and that Lumen is not closed. At the same time, the wall thickness of the tube should be as small as possible to have a large diameter for the continuous To get lumens to feed a feeding tube 1 e.g. 14 with Play through.

In FIG. 6, the gastric tube is cut out in the area of the tube 50 with subsequent probe tip 55 shown in longitudinal section. The The tube is made of two layers with a relatively thick outer layer 501 a soft flexible material, especially a plastic with elastomeric and / or thermoplastic properties and from a very thin inner layer 502 bonded to the outer layer made of a hard rigid plastic. Tube 50 is preferred by coextrusion of the outer layer 501 and the inner layer 502 manufactured, with compatible plastics different Hardness is used, which can be easily extruded and adheres to one another. For the case that a hard plastic is selected for the inner layer 502, which with the material of the outer layer 501 does not adhere well to the Coextrusion, it is also possible as a third layer Intermediate layer as an adhesion promoter layer between the outer layer 501 and the inner layer 502 by coextrusion.

The tube 50 of the two-layer structure in the exemplary embodiment Gastric tube 5 points this from the proximal end to the distal end 52 continuous lumens. The interface of the tube at the Exit opening 57 at the distal end 52 is due to the exposed here hard inner layer 502 also hard, so that lesions on the sensitive mucous membranes of a patient. Out for this reason, the distal end 52 of the multilayer tube 50 a soft flexible probe tip 55 attached to the same Outside diameter AD as the tube 50 and the corresponding Has inner diameter ID of the lumen 54 of the tube. The probe tip also has the continuous lumen 54a that in the Exit opening 57a opens at the distal end 52a of the gastric tube. The Probe tip has a length S of preferably between 10 to 30 mm on, with a total length of the gastric tube of usually more than 1 m. The probe tip 55 is preferably continuous X-ray contrast trained. The probe tip is preferably made of made of the same soft flexible plastic or with one corresponding properties as the outer layer 501 of the tube 50. The tube 50 is made by coextrusion of an appropriate tube manufactured and to the desired length of the gastric tube cut to length. Likewise, the probe tip 55 is an endless tube produced, for example from an X-ray contrast medium filled plastic, such as barium sulfate, and the individual Probe tips cut from the endless tube. Probe tip 55 can be used for the same or compatible plastics for the outer layer 502 of the tube is welded directly to the distal end 52 of the tube become. The weld seam 551 is indicated. The probe tip is on rounded distal end.

In the area adjacent to the probe tip 55 there are 50 in the tube the laterally emerging drainage holes 53 are arranged. For example are at a distance T of 10 mm on opposite sides Sides of the tube 16 to 22 drainage holes arranged, each Drainage hole has an average hole diameter of approximately 2.5 mm.

The outer diameter AD of the gastric tube or tube 50 is at 16 CH approx. 5 to 5.3 mm. In the two-layer according to the invention Structure of the tube is an outer layer 501 made of a soft flexible Plastic with a Shore hardness A of 80, for example, with a thickness ASD of 0.4 mm provided. An inner layer 502 becomes a hard one Plastic, for example a polyether block amide with a Shore hardness D of 70 with a thickness ISD of 0.01 mm. This results in an inner diameter ID of the lumen 54 of at least 4.18 mm. Consequently a sufficiently wide lumen 54 is formed in the gastric tube 5, so that a 9 CH feeding tube with a Outside diameter of 3 mm with sufficient space and Game through the gastric tube and tube 50 can be placed.

FIG. 7 shows excerpts of the intestinal DD of a patient introduced feeding tube 1, via which the gastric tube 5 for drainage and decompression of the patient's stomach MA. The feeding tube 1 is located inside through the lumen 54 or 54a Gastric tube 5 passed through to the intestine DD. The nutritional solution, which is fed through the lumen 100 of the feeding tube 1 through the outlet openings 120 or the distal outlet opening 121 of the Exit feeding tube into bowel DD. The feeding tube 1 is through the lumen 54, 54a of the gastric tube 5, leaving the Annular gap space 59 introduced with a width of the annular gap SP. The Annular gap SP is calculated from the difference between the inner diameter ID of the Lumens 54 of the tube 50 and outer diameter of the feeding tube 1. Through the lateral drainage holes 53 of the tube 50, it is possible Drain gastric juices in the direction of the arrow and the stomach too dekompremieren. The gastric tube in use according to Figure 7 is also called called gastric decompression probe.

FIG. 8 again shows an overall schematic representation of the Gastric tube and the feeding tube in use for enteral nutrition and gastric decompression. The feeding tube 1 will usually applied nasally and has a size of e.g. B. 9 CH. she is combined with gastric tube 5 with a size of 16 CH for enteralization Nutrition with simultaneous relief of the stomach. The gastric tube shows an X-ray contrast probe tip 55 with low Shares in barium sulfate, moreover it is not with one illustrated scale on the tube equipped with ink. For the Connections, adapters and connector 6 are provided. The Nutritional probe 1 is made of a thermoplastic, for example Polyether urethane as well as the outer layer of the tube 50 Gastric tube 5 made. For the hard inner layer of the gastric tube is for example, a polyether block amide is provided. The gastric tube is for example 125 cm long, the feeding tube 270 cm, the additional one Equipment includes the Y connector 6, further one not shown adapter, suitable for connecting the feeding tube 1 a container or the like.

First, the feeding tube 1 gets into a patient's intestine introduced, then the gastric tube 5 is placed over the feeding tube advanced into the stomach. The correct position of the two probes 1, 5 is using the printed depth markings on probes 1, 5 or radiologically by means of corresponding radiopaque areas of the Probes monitored and identified. That straight out of connector 6 Output 61 protruding proximal end 11 of the feeding tube 1 is connected with an adapter, not shown, and airtight connected. Thus, with nutritional therapy or medication application via the feeding tube inserted into the bowel DD 1 be started. The nutrient solution can pass through the outlet openings 120 the feeding tube and through the central outlet on the distal Exit late intestine DD. The straight connector 61 of the Y connector 6 is used for tube feeding or medication application. At the gastric lateral connection 62 of the connector 6, which on the Gastric tube 5 is attached, the suction line 9 for the suction of Gastric juices connected through the lumen 54, 54a of the gastric tube 5. The gastric tube 5 is characterized by a soft atraumatic as well radiopaque distal end 55. With ongoing nutrition can via the lateral offset drainage holes 53 of the Gastric tube is a continuous or intermittent suction or Gravity drainage performed pressure relief of the stomach become. Between the outside diameter of the feeding tube 1 of z. B. 9 CH and the inner diameter of the gastric tube of z. B. 16 CH - gastric decompression probe - there is a sufficiently large one Gap that releases pressure through the side drainage holes the gastric tube and the flow of gastric juices in the direction of the arrow allows for suction.

Claims (20)

Nutritional probe for enteral nutrition of a patient with a tube (10) with a proximal end (11) and a distal end (12) and a lumen (100) which extends from the proximal end to the distal end and has a distal outlet opening (121) of the lumen on distal end (12) of the tube, outlet openings (120) being formed in the region of the distal end of the tube distributed over the circumference of the tube for the exit of a nutritional solution introduced into the lumen of the tube via the proximal end, characterized in that the nutritional probe ( 1) starting from the distal end (12) in the direction of the proximal end (11) with a guide section (F) and the guide section (F) has a length (L) which is greater than the diameter (D) of the patient's intestine , into which the distal end (12) of the tube (10) of the feeding tube (1) is inserted, it having at least a length (L) of 30 mm and that on the circumference of the tube (10) trained outlet openings (120) are arranged outside the guide section (F). Nutritional probe according to claim 1, characterized in that the guide section (F) has a length (L) such that the ratio between the diameter (D) of the patient's intestine and the length (L) is at least 1: 1.2. Nutritional probe according to claim 1 or 2, characterized in that the guide section (F) has a length (L) of 40 to 60 mm. Nutritional probe according to one of Claims 1 to 3, characterized in that the outlet openings (120) closest to the distal end (12) of the tube (10) and formed on the circumference of the tube (10) have a minimum distance of 30 mm, preferably 40 mm or more the distal end (12) of the tube (10) of the feeding tube (1). Nutritional probe according to one of claims 1 to 4, characterized in that the tube (10) has a constant outer diameter (ADE) over its length. Nutritional probe according to one of claims 1 to 5, characterized in that the diameter (DA) of the distal outlet opening (121) corresponds to the diameter (DL) of the lumen (100) formed in the tube (10) and peripheral areas surrounding the distal outlet opening (121) (122) of the tube (10) are rounded. Nutritional probe according to one of claims 1 to 6, characterized in that the tube (10) made of a soft elastic material with a high restoring force, such as a thermoplastic and / or elastomeric plastic, thermoplastic elastomer or elastomer-like thermoplastic with a Shore hardness A acc. ASTM D 2240 is made less than or equal to 90. Nutritional probe according to one of claims 1 to 7, characterized in that it is equipped with X-ray contrast. Nutritional probe according to claim 8, characterized in that it contains 10 to 15 parts by weight of an X-ray contrast agent, such as barium sulfate, based on 100 parts by weight of the soft elastic plastic. Nutritional probe according to one of claims 1 to 9, characterized in that the surface of the tube (10) is micro-rough. Nutritional probe according to one of claims 1 to 10, characterized in that the proximal end (11) of the tube (10) is connected to an adapter (110) for connection to a source of nutritional solution or medicament solution. Use of a feeding tube according to one of claims 1 to 11 in connection with a gastric tube (5) for the drainage of Gastric juices and decompression of a patient's stomach. Use according to claim 12, wherein the gastric tube (5) is one Tube (50) with one from the proximal end (51) to the distal end (52) through lumens (54) and sideways out of the tube has emerging drainage holes (53) and the feeding tube (1) through the lumen (54) of the tube (50) of the gastric tube (5) below Formation of an annular gap between the surface of the Feeding tube (1) and the lumen (54) of the gastric tube (5) delimiting inner layer of the tube (50) is feasible. Use according to claim 12 or 13, wherein the over the Feeding tube (1) pushed gastric tube (5) a multi-layer trained tube (50) with an outer layer (501) from a soft flexible plastic and an inner layer (502) from an in Regarding the plastic of the outer layer (501) harder plastic The inner layer (501) in front of the distal end (52, 52a) the gastric tube (5) within the continuous lumen (54, 54a) the gastric tube (5) ends and that for the inner layer (502) Plastic used has good sliding properties and non-stick properties in relation to the plastic from which the feeding tube (1) is manufactured. Use according to one of claims 12 to 14, in which one Gastric tube (5) is used, in which the tube (50) is a Outer layer (501) made of a thermoplastic and / or elastomeric plastic, thermoplastic elastomer or elastomer-like thermoplastic with a Shore hardness A according to ASTM D 2240 less than or equal to 90 and an inner layer made of a plastic with a Shore hardness D according to ASTM 2240 greater than 45, preferably has greater than 55 and the thickness of the inner layer (502) of the tube (50) less than 0.020 mm, preferably less than 0.015 mm is trained. Use according to one of claims 12 to 15, in which one Gastric tube (5) with a multilayer tube (50) is used, the distal end (52) of an atraumatic X-ray contrast probe tip (55) with a continuous Lumen (54a) is formed. Use according to claim 16, in which for the formation of the tube (10) the feeding tube (1) and the outer layer (501) of the tube (50) the gastric tube (5) and the probe tip (55) of the gastric tube (5) the same soft flexible plastic with a Shore hardness A 90 or less is used. Use according to claim 17, wherein a thermoplastic Polyether urethane for forming the tube of the feeding tube, the outer layer of the gastric tube and the probe tip of the Gastric tube is used and for the formation of the inner layer (502) of the tube (50) of the gastric tube (5) a polyether block amide is inserted. Use according to one of claims 12 to 18, in which a Y-connector is provided with three outputs, the one output to the proximal end (51) of the tube (50) of the gastric tube (5) is connected and at its second output (62) one Suction line (9) for the gastric tube can be connected and through it third exit (61) through the lumen (54, 54a) of the gastric tube (5) guided feeding tube (1) can be removed. Use according to one of claims 12 to 19, in which for a Nutritional tube (1) with a size of 9 CH and a length of at least 2 m insertable via the feeding tube Gastric tube (5) of 16 CH and a length of at least 1 m is provided, the continuous lumen (54, 54a) of the Gastric tube has an inner diameter of at least 4 mm.

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