ES2271146T3 - ENTERAL FEEDING PROBE OF A PATIENT. - 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

Enteral feeding probe of a patient.

The invention concerns a probe of enteral feeding of a patient with a tube with one end proximal and a distal end and a continuous lumen from the end proximal to the distal end with a distal outlet opening of the lumen at the distal end of the tube, being formed in the area of the distal end of the tube, distributed over the periphery of the tube, outlet openings of a feed solution introduced in the lumen of the tube through the proximal end.

The feeding probes are placed in the intestine in order to derive, discharge or take care of the stomach, These are also designated as jejunal probes.

Feeding probes of this type for Enteral feeding of a patient are known from multiple forms and are used, for example, for food postoperative period in patients, for which the probe of feeding with respect to the patient to beyond the stomach and to the intestine with its distal end zone that presents the outlet openings, so that a solution can be supplied corresponding feed and / or a medication solution to through the proximal end of the feeding probe that protrudes from the patient's nose and these solutions can pass directly to the patient's intestine for food, without that a contact of the feed solution occurs with the walls of the patient's stomach. In this way, they can also provide contrast media to a patient to Perform a bowel scan.

Conditioned by the location of the probes of feed preferably made through a channel of endoscope work, these probes have only one diameter very small exterior, preferably only 1.5 to 3.5 mm, which approximately corresponds to a value of 4 to 11 CH, but, due to a desired inner diameter as large as possible for the duct by the way, for example for the feed solution, it turns out here inevitably a reduced wall thickness of such probes of feeding, for example, only 0.5 mm. However, this circumstance brings with it the problem of easy layering or deviation of known power probes with respect to Your desired orientation.

Particularly, in patients presenting with inverted peristaltic in which the contractions exerted by the intestine develop in the reverse direction, that is, in direction to the stomach, you have to in the feeding tubes known occur frequently a deviation from the end distal of them in the direction of the stomach and, as a result of this, a bend, which leads to a partial closure or even total of the feeding probe and to which the supply of the Feeding solution is damaged or even prevented. In case that, as a result of the inverted peristaltic movement of the intestine, there is also a retrocession of the distal end of the feeding tube to the stomach, is possible thus the introduction into the stomach of solutions intended to the intestine coming out of the feeding tube, which is very Undesirable and can lead to complications. In general, these processes condition the withdrawal of the feeding tube and the placement of a new feeding tube, which carries with it a great cost and unwanted discomfort of the patient.

The peripheral outlet openings of the tube necessarily necessary in the area of the distal end of the probe feed for the output of the feed solution from the lumen set inside the tube of the probe feeding favor this unwanted deviation and bending of the distal end attributable to it, since these openings of output bring with it a weakening of the cross section of the tube and less concomitant shape and rigidity stability of the tube in this area.

From US 4,704,111 a feeding probe in which the tube is configured thickened in the area of the distal end with respect to the area that borders the proximal end of the feeding tube. The distal end of the tube is closed and the tip of the probe is loaded with weight additional. For the output of the feed solution, they are Peripheral exit grooves configured in the area thickened tube. The weight and expanded volume of the tip of the closed probe must prevent deviation and / or bending of the feeding tube in the area of its distal end. But nevertheless, feeding probes of this type with additional weights arranged in the distal end zone are expensive to manufacture and are they have also manifested as ineffective, because, due to small diameter of the feeding probes and dimensions reduced, they have only a small additional weight that does not represents, according to experience, an impediment to the deviation and bending in the case of a bowel peristaltic inverted

Also, for the document US-A-4,516,970 a probe is known of feeding with an additional weight formed in the extreme zone distal In this known feeding probe is certainly provided an outlet opening at the distal end, that is, in the tip of the probe, but the weight is fixed at the distal end of the tube as an independent part that prolongs the tube, thereby the continuous lumen is narrowed and, therefore, the obstructions thereof. If the tube is also manufactured with a wall very thin, what is desirable, the high weight of the extreme section distally causes a tendency towards bending, particularly in patients presenting with inverted intestinal peristaltic.

The document US-A-4,631,054 describes a probe of feeding with a thickening set at the distal end of it in the form of an inflatable balloon. Through thickening can act especially effective forces on a probe, particularly in the case of an intestinal peristaltic inverted, and therefore, these forces can favor the unwanted retrocession of the distal end thereof towards the stomach. Also, thickening prevents combined use within of a gastric tube Also, due to the full balloon preferably of mercury, it should be damaged, considerable dangers arise for a patient.

In case of a prolonged stay of the probe feeding in a patient's intestine, the resource of placing a second probe, namely a gastric tube, in the patient's stomach to drain gastric juices and to decompress the stomach, as described, for example, in the EP-A-0 242 051. This gastric tube, which is not used to supply a solution of feeding, it also travels through the nose, over the feeding tube already placed in the intestine, up to the stomach  of the patient, it is also designated as a nasogastric tube.

Gastric probes consist substantially of a tube that is made of a soft plastic flexible tube, used as physiologically harmless plastics material such as thermoplastic polyurethane elastomers or Soft silicone or PVC rubbers. The surface of the gastric tube It must be soft and malleable to avoid membrane wounds mucosa during the introduction of the gastric tube. Also, the gastric tube, despite soft flexible plastic, must present sufficient stability to avoid a bend in the Enter it in the stomach. In addition, the probe surface Gastric should present a good sliding ability.

Since gastric probes usually move through a patient's nose to the stomach, the outside diameter of the gastric tube - the tube - is limited by the nose canal to a maximum of approximately 16 CH, which corresponds approximately 5.3 mm and means maximum comfort for the patient. In the event that the gastric probe is placed in conjunction with a feeding probe, the feeding probe is conducted through the lumen of the gastric probe or the two probes are independently guided. For this, it is necessary to have a free internal diameter as large as possible of the lumen of the gastric probe for the internal feeding probe, while still remaining free in the lumen an intermediate space between the feeding probe and the gastric probe - a slit
void - to make possible, despite the inner feeding tube, the drainage of gastric juices through the lumen of the gastric tube. Since the feeding probes are usually used with a size of 9 CH, which corresponds to an outside diameter of the feeding probe of approximately 3 mm, problems arise for the configuration of the gastric probe with a wall thickness and stability sufficient against the bend, together with the necessary softness and flexibility of the plastic used for it.

For the configuration of a gastric tube of drainage and decompression to be used in conjunction with a feeding probe, it is desirable that

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the gastric tube with a wall thickness as small as possible to reach an inner diameter as large as possible of the lumen continuous for drainage;

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the Gastric tube tube surface be soft and malleable for avoid mucosal wounds;

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the feeding tube easily slides through the lumen of the gastric tube, should be kept as small as possible or avoid the use of sliding means additional;

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the feeding probe is set to give contrast in bone scan;

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the Feeding probe is stable against shear stresses together with sufficient softness and flexibility.

For the document US-A-4,596,563 is known the multi-layer catheter configuration with an outer layer softer and an inner layer set harder than this one.

The invention has been raised in the problem of perfect a feeding probe of the type according to the preamble in the sense that it is reliably prevented and in the most simple possible a deviation or an elbow of the extreme zone distal from it due to an inverted peristaltic of the intestine of the patient, so that a disturbance cannot be reached or an interruption of the flow through the feeding probe or to a retrocession of the feeding tube into the stomach.

In addition, the invention has been raised in the problem of using the feeding probe combined with a gastric probe for, in addition to supplying the solution of feeding and / or medication to a patient's intestine, drain and also download the patient's stomach.

The problem is solved by a feeding probe according to claim 1.

According to the invention, it is proposed that the probe feeding is formed by a segment of flexible tube, being configured a guide section free of openings that start from the distal end toward the proximal end and presenting the minus a length of 30 mm, and the outlet openings configured at the periphery of the tube are arranged outside the segment of guided and the tube has an outside diameter over its length constant and the diameter of the distal outlet opening corresponds to the diameter of the lumen set in the tube and the edge areas surrounding the distal outlet opening are shaped rounded.

It has been shown in the scope of the invention that, through the configuration of a free guidance segment of opening in the area of the distal end of the feeding tube, which is achieved by means of a distance between the peripheral outlet openings that weaken the section transverse of the tube and the distal ends thereof, are prevented reliably deflection and bending or bending of the probe extreme distal feeding zone within the intestine of A surprisingly simple way. Indeed, if due to a inverted peristaltic or unusual patient movements, it produces a deviation of the distal end probe from the area of feeding according to the invention, it then happens that this, due to the greater length of the guidance segment compared to the intestine diameter, cannot deviate in the opposite direction to the direction of introduction, since the distal end zone reaches apply in this case in advance to the walls of the intestine, which prevents any diversion movement additional.

In the field of considerations that lead to the invention has shown that the usual diameter to be expected from intestine of a patient, in which the extreme area is introduced distal of the feeding tube, will amount to approximately 20 to 40 mm Therefore, according to the invention, it is proposed to configure the length of the guidance segment by means of a distance between the peripheral outlet openings and the distal end of the tube of at least 30 mm, preferably 50 mm or more, to prevent deviation from the distal end zone, for example due to a inverted peristaltic of the intestine.

A reliable impediment to deviation can achieved with feeding probes according to the invention in the which the guiding segment has a length L and, therefore, a corresponding distance from the openings of exit to the distal end of the tube, so that the D: L ratio of at least 1: 1.2, where D designates the diameter of the patient's intestine Since the length L amounts to at least 1.2 times the diameter D, the application of the segment is guaranteed of guiding the tube to the wall of the intestine under a deviation and, therefore, the impediment of the change of address is also ensured or even the bending of it.

In practice, probes of power of different sizes with variations of the distance L for adaptation to different and different use purposes patients (size, weight, age, etc.). Preferably, the segment guiding the feeding probe has a length of 40 to 60 mm The outlet openings configured on the periphery of the tube and that are closer to the distal end of the probe tube of supply then have a minimum distance of 30 mm, preferably 40 to 60 mm, with respect to the distal end of the tube.

Another essential advantage of the probe feeding according to the invention is that it does not need additional weights in the area of the distal end zone, of the same, so that it is possible to arrange an opening of distal outlet that runs along its longitudinal axis, which also at the most forward tip - seen in the direction of introduction - of the feeding probe according to the invention can be carried out without hindrance of the solution of lumen feeding. Also, the feeding probe according to the invention is characterized by a tube with constant outside diameter in its length, which is also configured as stable against shear stress.

In this case, it is especially planned that the distal outlet opening has the same diameter as the lumen configured in the tube and therefore does not originate any narrowing in the exit direction. This way, they can't retain also in the lumen liquid insoluble medications that must be applied by means of the feeding tube according to the invention, whereby no sealing of the feeding probe or a loss of the active matter to Supply the patient.

The high safety of the feeding probe according to the invention against a deviation or bending and a retrocession of the same until the stomach can be increased also, making the tube made of an elastic material with high recovery force, for example based on materials thermoplastic synthetics and / or elastomers, elastomers thermoplastics (TPE) and thermoplasts similar to elastomers with a Shore A hardness according to ASTM D 2240 less than / equal to 90, for example a base of a polyurethane elastomer. The high forces of tube recovery act by deviating the distal end zone of the tube, for example under an inverted peristaltic of the intestine, in against deviation and support the recoil of the tube into position original and desired after each deviation made. Likewise, other suitable synthetic materials can be used with Sufficient recovery force for tube formation. At sense of the invention, suitable synthetic materials can present both a single-layer or multi-layer structure with purity of the type of material as a combination of materials; by For example, multilayer composite materials of different synthetic materials manufactured by the procedure of coextrusion

Preferably, the feeding probe is equipped to give contrast in radiography, preferring a continuous tube configuration. For this it is proposed that the tube It is made of a mass containing, referred to 100 parts in soft flexible synthetic material weight, 10 to 15 parts by weight of an X-ray contrast agent, such as barium sulfate. The tube thus obtains an opaque color and can be provided on the side. exterior, in a known way, of a longitudinal mark and a mark Ink depth

To raise the sliding capacity of the feeding tube, for example in a gastric tube, the surface of the feeding probe is configured preferably micruginously. Therefore, it can be formed an air / liquid cushion that drives the slide and counteracts adhesion For enteral feeding and decompression Simultaneous gastric of a patient is proposed to use the probe supply configured according to the invention in conjunction with a probe gastric to drain gastric juices and decompress the stomach of the patient, using as a gastric tube one that is formed by a tube with a continuous lumen from the end proximal to the end distal, as well as drainage holes that come out laterally of the gastric tube, and the catheter can be guided feeding through the lumen of the gastric tube by configuring an annular slit between the surface of the feeding tube and the surface that delimits the lumen of the gastric tube.

The conditions for the combined use of a feeding tube according to the invention with a gastric tube they are resolved in a particularly comfortable way for the patient with a gastric tube whose tube consists of several layers. By therefore, it is proposed that the gastric probe be pulled over the probe feeding consists of a tube configured in several layers with an outer layer of soft flexible synthetic material and an inner layer of a synthetic material harder than the material synthetic outer layer, finishing the inner layer before of the distal end of the gastric tube within the continuous lumen of the gastric tube and presenting the synthetic material used for the inner layer it has a good sliding property and a good non-stick property with respect to the material synthetic from which the feeding probe is manufactured. Preferably, synthetic materials are used that can coextrude and that are compatible with each other for manufacturing of a two layer tube for the gastric tube.

Coextrudable synthetic materials compatible with each other for the outer layer and inner layer They must have good adhesion between them.

Materials are preferred for the outer layer. conventional synthetics usable for gastric probes, in particular thermoplastic synthetic materials and / or elastomers, thermoplastic elastomers and thermoplasts similar to elastomers, preferably with Shore A hardness according to ASTM D 2240 less / equal than 90. Soft flexible materials particularly suitable for the outer layer of the tube are, for example, elastomers of thermoplastic polyurethane, which are polyisocyanate polyaducts and polyols, of which polyurethane elastomers are preferred thermoplastics based on polyetherurethanes, with a Shore A hardness preferably in the range between 70 to 90.

For the inner layer it is preferably used a rigid and hard synthetic material with a Shore D hardness according to ASTM D 2240 greater than 45, preferably greater than 55. For this synthetic materials also come into consideration physiologically harmless that are compatible with elastomers used for the outer layer of the tube. According to a proposal by the invention, for the inner layer also a copoli (ether-ester-amide), also called polyether block amide, with a hardness Shore D from 55 to 80, preferably a Shore D hardness greater than 60

The outer layer in the form of a flexible tube gastric tube of an elastomer synthetic material is Soft and considered by itself, it is unstable and not resistant to buckling, and stabilizes by means of the coextruded inner layer of hard synthetic material, which is very thin, so that by means of the configuration of the tube in two layers a probe is obtained stable gastric against shear stress and, nevertheless, soft and flexible. The thickness of the hard inner layer of the tube the gastric tube should be less than 0.020 mm, preferably less than 0.015 mm and, especially preferred, 0.01 mm or less. As a consequence of the action of stabilization of the inner layer of the gastric tube, is possible to keep the thickness of the tube wall, that is, due to the hard inner layer of the tube it is possible to minimize the total thickness of the tube several layers according to the invention with respect to the thickness of a tube of a layer of only a soft flexible synthetic material and, for therefore, increase the inner diameter of the lumen of the gastric tube and thereby increase the volume of drainage.

When a hard synthetic material is selected suitable for the formation of the inner layer of the various tube layers for the gastric tube, a material is also preferred synthetic that has a good sliding property and a good non-stick property to make possible a easy sliding of the feeding probe through the lumen of the gastric tube. Also, using block amides of polyether you get good sliding properties and of non-stick

However, depending on the choice of materials for the outer layer and the inner layer of the multi-layer tube of the gastric tube, the inner layer must always be very thin, preferably keeping the thickness of the inner layer of the tube a ratio of 1:20 to 1:80 with respect to the thickness of the outer layer of it.

In a gastric tube with several tubes layers with an outside diameter, for example, corresponding to 16 CH, it is possible to configure the thickness of the outer layer between 0.35 and 0.45 mm and set the thickness of the inner layer in the range from 0.015 to 0.006 mm. According to this, a probe is obtained gastric with a multilayer tube with an outside diameter, by example, corresponding to 16 CH, with a continuous lumen that is configured with an inside diameter of at least 4 mm. So, since the feeding probes usually have a size 9 CH with an outer diameter of 3.0 mm, it is possible to create a sufficiently large intermediate space between a probe supply arranged inside the gastric tube and the inner wall of the gastric tube.

To avoid stomach injuries originated by the intersection site of the hard inner layer and the layer soft outer set at the distal end of the various tube layers, it is proposed to equip the distal end of the various tube layers with a soft atraumatic probe tip that provides X-ray contrast The probe tip is constructed preferably with a flexible tube-shaped segment especially soft with a continuous lumen, being configured preferably the tip of the probe based on the same material soft flexible synthetic than the outer layer of the tube or a material compatible with a corresponding Shore A hardness approximately to the hardness of the layer's synthetic material tube outside. The inside diameter of the tube lumen and the inner diameter of the lumen of the probe tip should correspond with each other.

To equip the gastric tube so that provide contrast in radiography, it is proposed to configure only the tip of the probe so that it provides contrast in radiography. For example, the probe tip itself can be fully configured to provide contrast in radiography, for which purpose, referred to 100 parts by weight of the Soft flexible synthetic material, are contained in the tip of the probe of 10 to 15 parts by weight of a contrast agent X-rays, such as barium sulfate. The probe tip presents preferably a length of 10 to 30 mm and is joined with strong adhesion to the distal end of the tube, for example by means of welding.

For a high drainage action it is proposed that the tube of the gastric tube present in the area that borders the probe tip drain holes that come out laterally and that, coming out of the probe tip, they are distributed preferably in an area of a tube length of up to 250 mm

The gastric tube is preferably perfected so that a connector can be attached to the proximal end of the tube Y-shaped. The straight connection of the Y-connector is used here to the passage of the feeding probe while the appendix of side funnel of the Y connector is used to connect a tube flexible suction for stomach drainage by means of the gastric tube, that is, through the lumen of the tube of the tube gastric

On the contrary, it is proposed that the end proximal tube is attached with an adapter to connect it to a source of feeding solution or medication solution.

When a patient is provided with a probe gastric with an internal feeding probe, it is possible thus feed continuously through the feeding tube introducing a feeding solution into the intestine and, simultaneously, it is possible to carry out a pressure discharge of the stomach through continuous or intermittent suction or well of a drain by the force of gravity through the lumen Remaining gastric tube. The feeding tube is found in the gastric tube. Enter the outside diameter of the feeding probe of usually 9 CH and the inside diameter of the lumen of the 16 CH gastric tube there is an intermediate space large enough in the form of an annular slit with a width of at least 0.5 mm, which makes a pressure discharge possible of the stomach through the side drainage holes of the tube of the gastric tube.

A preferred embodiment of the invention provides that, for a feeding probe of a size of 9 CH and a length of at least 2 m, a gastric probe of 16 CH and a length of at least 1 m is provided that can be plugged onto the feeding tube, the continuous lumen of the gastric tube having an inner diameter of at least
4 mm

To make a slip possible especially good of the feeding probe inside the probe gastric, it is planned that the surface of the probe Power is configured with a micro-roughness. It is formed like this an air cushion / liquid cushion and adhesion of the surface of the feeding tube to the inner layer of the tube multi-layered gastric tube and is greatly improved the ability to slip. Preferably, a gastric probe configured as gastric decompression probe, that has a length of at least 1 m and is stable against shear stresses due to a tube configuration in several layers with a soft flexible outer layer of a elastomer and an inner layer of a bonded synthetic hard material with the outer layer by coextrusion, finishing the inner layer before the distal end of the gastric tube within the lumen continuous. The gastric tube is equipped with a distal end extrablading in the form of a probe tip that provides contrast in radiography. The soft and yet stable gastric tube against shear stresses it is especially suitable for your use with an internal feeding probe, preferably a nasoyeyunal feeding tube

Other details and embodiments of the probe feed according to the invention are explained below by reference to the drawings that represent only one example of realization. They show:

Figure 1, the elevation view of a probe feed according to the invention,

Figure 2, in an enlarged representation schematic, the position of the distal end zone of the probe feeding according to the invention within the intestine of a patient,

Figure 3, detail E of Figure 2 in representation in enlarged section,

Figure 4, schematically, the manufacture of a feeding probe according to the invention in the end zone distal of it,

Figure 5, a schematic representation of a gastric tube with connector,

Figure 6, the enlarged detail according to the HH section of Figure 5,

Figure 7, the detail of the probe feeding according to Figure 6 with a feeding probe interior, and

Figure 8, a schematic representation of a feeding tube with a gastric tube
for gastric decompression.

Figure 1 shows a probe of feed 1 for enteral feeding of a patient, which it comprises a tube 10 with a lumen 100 configured therein so keep going. The tube 10 of the feeding probe 1 extends from a proximal end 11 to a distal end 12, being configured the continuous lumen 100 so that it extends from the proximal end 11 to the distal end 12.

The outer diameter ADE of the tube 10 is constant and, in case of a feeding probe size of 9 CH, amounts to approximately 3 mm. The length of the probe Power can reach up to 3 m.

At the proximal end 11 it can be connected Air tight an adapter that can be connected to usual commercial containers for feed solutions, so that the feed solution can run through of the adapter and the proximal end 11 of the tube 10 and reach the 100 lumen of this one. The power solution comes out of this lumen 100 through outlet openings 120 arranged peripherally in the area of the distal end 12 of the tube 10, as well as through a distal outlet opening 121 which is located in the direction of the longitudinal axis M of the tube 10. The openings of peripheral outlets are arranged distributed on the periphery of the tube, approximately at a regular axial distance one of another, for example every 10 mm.

Each exit opening, for example six in number, has, for 9 CH, an average diameter of 2 to
2.5 mm

With the help of the feeding probe 1 is possible to feed a patient enterally or to supply him, for example, a contrast agent.

To this end, tube 10 is introduced into the intestine through the patient's stomach with its extreme area distal 12 ahead, orally or nasally, in a way per se known, eventually also with auxiliary help from a endoscope, so that the distal end 12, including the outlet openings 120 and 121 arranged come to be located in this area, inside the patient's intestine. The probe of feeding 1 protrudes from the opening of the mouth or nose of the patient with its proximal end zone 11, so that, by example, a feed solution can be provided directly to the patient's intestine for feeding from a container connected to the proximal end 11.

Figure 2 shows, in a representation enlarged schematic, the position of the distal end zone 12 inside the patient's intestine 2 to feed the patient in the previously described by means of the feeding probe one.

An essential feature of the feeding probe 1 is that the peripheral outlet openings 120, through which the feed solution of the lumen 100 of the tube 10 passes to the intestine, are arranged at a minimum distance L from the distal end 12 of the tube 10 which is 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 is located. In this way, a guiding segment F formed in the length L is configured. without lateral outlet openings, which is disposed between the outlet openings 120 and the distal end 12. For example, the ratio of the diameter D of the intestine to the distance L in the feeding probe amounts to 1: 1.3, being able to present specifically the guiding segment F, for example, a length L of approximately
40 mm

The peripheral outlet openings 120 necessarily arranged in the tube 10 cause a reduction here significant stiffness of tube 10, so they act in a manner of joints and make it possible for the guidance segment F arranged in front of them be diverted from the desired extension in the direction of the longitudinal axis L according to arrow P, which can be induced, in particular, by an inverted peristaltic of the 2 intestine of the patient.

However, since the guidance segment F it is configured in a length L greater than the diameter D of the intestine 2, its maximum deviation from the axis travel longitudinal M is limited by its application to the installation in the intestine wall 21 in the form indicated by dashed lines in Figure 2, so that a bend is reliably prevented complete from the distal end in the direction to the proximal end 11 and therefore, to the patient's stomach and at least partial closure of the feeding tube. As a consequence of this, a inverted peristaltic of the patient cannot cause a bending of the feeding probe 1 or a retrocession of the distal end 12 to the patient's stomach.

In addition, selecting a suitable material for the tube 10 of the feeding probe with high force of elastic replenishment can not only limit the deviation towards the position of application to wall 21 or intestine 2, but a return of the guiding zone F with the distal end 12 to the desired original position in the direction of the longitudinal axis M, which further increases safety against to bending, closing and recession of the distal end 12 with regarding the desired position to the patient's stomach. A elastic synthetic material of this type with a high force of replacement can be formed, for example, based on a suitable polyurethane which, in addition, also has a high patient compatibility and can be selected correspondingly by the expert.

The number and arrangement of openings of output 120 also fit the cross sections necessary and can be correspondingly chosen by the expert, being of note only the minimum distance 11 to distal end 12 in order to configure the guiding segment F, to reliably prevent a deviation and / or a bend in the distal end 12.

In addition, the distal outlet opening 121, which it is at the distal end 12 of the tube 10 in the direction of the shaft longitudinal M, as can be seen from the enlarged representation according to Figure 3, it is configured with a diameter DA that corresponds to the diameter DL of lumen 100 in tube 10. Therefore, considered in the direction of the longitudinal axis M of the tube 10, the exit opening 121 does not configure any narrowing of the lumen 100, so that insoluble drugs cannot be withheld in liquid conducted through the lumen. It counteracts like this effectively an obstruction of the feeding probe 1 and a loss of active materials.

In addition, the edge zones 122 of the tube 10 which surround the distal outlet opening 121 are shaped rounded to prevent wounds in the patient's tissue.

According to the schematic representation of the Figure 4, this configuration of the distal outlet opening 121 and the border areas 122 surrounding it, is achieved by means of a tool 3 during the manufacturing of the feeding probe 1. First, it is cut to size in a manner known per se flexible tube segment 10.1 that configures the rear tube 10 and then in the direction of the arrow X is pressed a end thereof against the heated tool 3 to form the distal end zone 12.

Tool 3 has a mandrel 30 that is enter at one end in lumen 100 to configure the distal outlet opening 121 with the diameter DA. The mandrel 30 it presents the desired diameter DA.

Extending around mandrel 30 is provided a slot 31 that is configured in a rounded form and which forms the originally sharp cutting edges of tube 10 to provide the desired rounded edge zones 122 according to Figure 3.

In Figure 5 a section is shown gastric tube 5 with a tube 50 with a continuous lumen from the proximal end 51 to distal end 52 and a probe tip 55 in the form of a flexible tube that connects to the distal end 52 of the tube, also with a continuous lumen to the distal end 52a of the gastric probe 5. Tube 50 is configured in the zone adjacent to probe tip 55 with drain holes 53 that leave laterally, that is, in the tube envelope. The drain holes 53 are arranged in the tube so that they are distanced uniformly from each other in the axial extension XM of the gastric tube or tube 50, being also displaced one about the other on the periphery. At the proximal end 51 of the tube 50 a connector 6 is arranged in Y. The gastric probe must have a soft top layer and surface to Avoid injuries The top layer / surface of the tube must be smooth on contact with water / liquid, that is, when introduced into a patient. In addition, the gastric tube must have a rigidity and stability so high that it is flexible but not fold or close the lumen. Simultaneously, the wall thickness of the tube should be as small as possible to maintain a diameter large continuous lumen to easily insert a probe of feed 1, for example according to Figure 14.

In Figure 6 it is represented in the form fragmentary, in longitudinal section, the gastric tube in the area of the tube 50 with the adjacent probe tip 55. The tube has two layers with a relatively thick outer layer 501 of a material soft flexible, in particular a synthetic material with properties elastomers and / or thermoplastics, and a very thin inner layer 502 of a hard rigid synthetic material, bonded with strong adhesion to the outer layer Preferably, the tube 50 is manufactured by coextrusion of outer layer 501 and inner layer 502, using synthetic materials compatible with one another different hardnesses, that are easily extrudable and that adhere well to each other. In case for the inner layer 502 choose a hard synthetic material, which does not establish a good adhesion with the material of the outer layer 501 during the coextrusion, it is also possible to introduce by coextrusion, such as third layer, an intermediate layer as a promoter layer of adhesion between the outer layer 501 and the inner layer 502.

The tube 50 of the gastric probe 5 constituted by two layers in the exemplary embodiment presents the lumen continuous from the proximal end to the distal end 52. The tube cutting site at outlet opening 57 at the end distal 52 is hard also due to the hard inner layer 502 that is find here uncovered so that they could occur lesions in the sensitive mucous membranes of a patient. For this reason, a multilayer tube 50 has been added to the distal end 52 flexible soft probe tip 55 having the same diameter outside AD than tube 50 and the corresponding ID inside diameter of lumen 54 of the tube. The probe tip also has the lumen continuous 54a, so that it empties into the outlet opening 57a of the distal end 52a of the gastric tube. Probe tip it has a length S of, preferably, 10 to 30 mm, for a full length of the gastric tube, usually more than 1 m. The probe tip 55 is preferably configured so that provides contrast in radiography in all its extension. The probe tip is preferably made of it soft flexible synthetic material than that of the outer layer 501 of tube 50 or of a material with corresponding properties. He tube 50 is manufactured by coextrusion of a flexible tube corresponding and cut to the corresponding desired length of the gastric tube Also, probe tip 55 is manufactured as an endless flexible tube, for example of a synthetic material filling of an X-ray contrast agent, for example sulfate  of barium, and the individual probe tips are cut to size to from the endless flexible tube. The probe tip 55 can weld directly to the distal end 52 of the tube in case same or compatible synthetic materials are used for outer layer 502 of the tube. Welding seam 551 is hinted. The probe tip is rounded at the end distal

In the area adjacent to probe tip 55 the drain holes 53 that exit are disposed in the tube 50 sideways. For example, there are 16 to 22 drain holes arranged with a distance T of 10 mm on the respective sides opposite the tube, each drain hole having a diameter of medium hole of approximately 2.5 mm.

The outside diameter AD of the gastric tube or of tube 50 amounts, for 16 CH, to approximately 5 to 5.3 mm. In the case of the two layer structure of the tube according to the invention is provides an outer layer 501 of a flexible synthetic material soft with a Shore A hardness of, for example, 80, with a thickness 0.4 mm ASD. As inner layer 502 a material is provided hard synthetic, for example an amide with polyether blocks with a Shore D hardness of 70, with an ISD thickness of 0.01 mm. In this In this case, an internal ID ID of lumen 54 of at least 4.18 results mm Therefore, a sufficiently wide lumen 54 is configured in the gastric probe 5, so that it can be placed through the gastric tube and tube 50 a feeding tube of one size 9 CH, with an ADE outer diameter of 3 mm, with sufficient intermediate space and clearance.

In Figure 7 it is represented in a view of detail the feeding tube 1 inserted in a intestine DD of a patient, on which the gastric tube 5 is placed to drainage and decompression of the patient's stomach MA. The feeding probe 1 is introduced through lumen 54 or 54a from gastric tube 5 to the intestine DD. The solution of power, which is supplied through lumen 100 of the probe Power 1, can exit through the outlet openings 120 or of the distal outlet opening 121 of the probe feeding and pass to the intestine DD. The feeding probe 1 is introduced through lumen 54, 54a of gastric tube 5 leaving the annular slit space 59 with a width of the annular slit SP. The annular slit SP is calculated from the difference of the internal ID ID of the lumen 54 of the tube 50 and the outer diameter of the feeding probe 1. Through the side drain holes 53 of tube 50 it is possible to drain the gastric juices in the direction of the arrow and decompress the stomach. The gastric tube in use according to Figure 7 is designated also as a gastric decompression probe.

Figure 8 shows once again a full schematic representation of the gastric tube and the feeding tube in use for enteral feeding and gastric decompression Feed probe 1 is applied usually by nasal route and has a size of, for example, 9 CH. This is combined with the gastric probe 5 of a size of 16 CH for enteral feeding along with a simultaneous discharge of stomach. The gastric tube has a probe tip 55 configured to give contrast in radiography with small Barium sulfate proportions, being further equipped with a scale not shown formed on the tube with ink. For the connections, adapters and connector 6 are provided. feed 1 is made, for example, of a polyurethane thermoplastic, and the same goes for the outer layer of the tube 50 of the gastric probe 5. For the hard inner layer of the probe gastric is provided, for example, an amide with blocks of polyether The gastric tube is, for example, 125 cm long, the feeding probe is 270 cm and the additional equipment comprises connector 6 in Y, as well as an adapter not shown in detail, suitable for connection of the feeding probe 1 to a container or the like.

Feed probe 1 is first inserted to the intestine of a patient and then the gastric tube 5 on the feeding tube to the stomach. The correct position of the two probes is monitored and verified 1, 5 with the help of depth marks printed on probes 1, 5 or well, radiologically through corresponding areas of the probes that provide contrast in radiography. The extreme proximal 11 of the feeding probe 1 protruding from the connector 6 on straight output 61, joins and connects so Air tight with an adapter not shown. Therefore you can begin with feeding therapy or the application of medication via feeding tube 1 introduced in the intestine DD. The nutrient solution can come out through the outlet openings 120 of the feeding probe and through the central opening at the distal end 12 and reach the intestine DD. The straight connection 61 of the Y-connector 6 is used for tube feeding or medication application. In the gastric lateral connection 62 of connector 6 which is fixed on the gastric probe 5 connects the suction duct 9 for the suction of gastric juices through lumen 54, 54a of the probe gastric 5. The gastric probe 5 is distinguished by a distal end 55 soft atraumatic that provides contrast on radiography. In the course of feeding can be carried out a continuous succession or intermittent or a drain by the force of gravity, along with a discharge of stomach pressure, through the holes of drain 53 of the laterally displaced feed probe one Regarding another. Enter the outside diameter of the probe feed 1 of, for example, 9 CH and the inside diameter of the gastric probe of, for example, 16 CH - decompression probe gastric - there is a sufficiently large intermediate space that makes possible a discharge of pressure through the holes of lateral drainage of the gastric tube, as well as the circulation of the gastric juices in the direction of the arrow during the suction.

Claims (16)

1. Enteral feeding tube of a patient, comprising a tube (10) with a proximal end (11) and a distal end (12) and a continuous lumen (100) from the proximal end to the distal end, with an opening distal outlet (121) of the lumen at the distal end (12) of the tube, outlet openings (120) formed on the periphery of the tube being formed in the area of the distal end of the tube for the exit of a feed solution introduced in the lumen of the tube through the proximal end, a guide section (F) being formed free of openings that starts from the distal end (12) in the direction of the proximal end (10), and the outlet openings (120) formed in the periphery of the tube (10) are arranged outside the guide section (F) and the tube (10) has a constant outside diameter (ADE) in its length and the edge areas (122) of the tube (10) surrounding The distal outlet opening (121) is rounded, characterized in that the feeding probe (1) is formed by a flexible tube section, the guide section (F) has at least a length (L) of 30 mm and the diameter (DA) of the distal outlet opening (121 ) corresponds to the diameter (DL) of the lumen (100) formed in the tube (10). 2. Feed probe according to claim 1, characterized in that the guide section (F) has a length (L) of 40 to 60 mm. 3. Feed probe according to one of claims 1 or 2, characterized in that the tube (10) is made of a thermoplastic and / or elastomer synthetic material, a thermoplastic elastomer or a thermoplastic similar to an elastomer with a Shore A hardness according to ASTM D 2240 less than / equal to 90. 4. Supply probe according to one of claims 1 to 3, characterized in that it is equipped to provide contrast in radiography. 5. Feeding probe according to claim 4, characterized in that, based on 100 parts by weight of the soft elastic synthetic material, it contains 10 to 15 parts by weight of an X-ray contrast agent, such as barium sulfate. 6. Supply probe according to one of claims 1 to 5, characterized in that the surface of the tube (10) is micro-roughened.
sa. 7. The feeding probe according to one of claims 1 to 6, characterized in that the proximal end (11) of the tube (10) is connected with an adapter (110) to connect it to a source of a feeding solution or a medication solution. 8. Feeding probe according to one of the claims 1 to 7 in combination with a gastric tube (5) for draining gastric juices and stomach decompression of a patient 9. Combination according to claim 8, in the that the gastric tube (5) has a tube (50) with a lumen (54) continuous from the proximal end (51) to the distal end (52), as well as drainage holes (53) that exit laterally from the tube, and the feeding probe (1) can be guided through the lumen (54) of the tube (50) of the gastric tube (5), forming the own time an annular slit between the surface of the probe feeding (1) and the inner layer of the tube (50) that delimits the lumen (54) of the gastric tube (5). 10. Combination according to claims 8 or 9, in which the gastric tube (5) is pulled over the tube feed (1) comprises a tube (50) formed by several layers, with an outer layer (501) of a flexible synthetic material soft and an inner layer (502) of a harder synthetic material with respect to the synthetic material of the outer layer (501), finishing the inner layer (501) before the distal end (52, 52a)  of the gastric tube (5) within the continuous lumen (54, 54a) of the gastric tube (5) and presenting the synthetic material used for the inner layer (502) good sliding properties and a good non-stick property with respect to the material synthetic from which the feeding probe (1) is manufactured. 11. Combination according to one of the claims 8 to 10, wherein a gastric tube is used (5) in which the tube (50) has an outer layer (501) of a thermoplastic and / or elastomer synthetic material, an elastomer thermoplastic or a thermoplast similar to an elastomer with a Shore A hardness according to ASTM D 2240 less than / equal to 90, and one layer interior of a synthetic material with a Shore D hardness according to ASTM 2240 greater than 45, preferably greater than 55, and the thickness of the inner layer (502) of the tube is formed smaller than 0.020 mm, preferably less than 0.015 mm. 12. Combination according to one of the claims 8 to 11, wherein a gastric tube is used (5) with a multi-layer tube (50), whose distal end (52) is formed by an atraumatic probe tip (55) that gives contrast in radiography, with a continuous lumen (54a), whose gastric tube (5) It can be pulled over the feeding tube (1). 13. Combination according to claim 12, in which for the formation of the tube (10) of the feeding probe (1) and the outer layer (501) of the tube (50) of the gastric tube (5) and the tip (55) of the gastric tube (5) is used the same soft flexible synthetic material with a Shore A hardness less than / equal to 90 14. Combination according to claim 13, in which uses a thermoplastic polyurethane for the formation of the tube of the feeding probe, the outer layer of the probe gastric and the tip of the gastric tube, and for the formation of the inner layer (502) of the tube (50) of the gastric tube (5) is use an amide with polyether blocks. 15. Combination according to one of the claims 8 to 14, wherein a connector is provided in Y shape with three outputs that is connected to an output to proximal end (51) of the tube (50) of the gastric tube (5) and in whose second outlet (62) can be connected a suction duct (9) for the gastric tube, and through whose third outlet (61) it is possible to guide the guided feeding tube (1) through the lumen (54, 54a) of the gastric tube (5). 16. Combination according to one of the claims 8 to 15, wherein, for a feeding probe (1) of a size of 9 CH and a length of at least 2 m, it is provided a gastric tube (5), pluggable on the tube feeding, of 16 CH and a length of at least 1 m, and in which the continuous lumen (54, 54a) of the gastric tube has a inner diameter of at least 4 mm.