EP0155009A2 - Medical tube - Google Patents

Medical tube Download PDF

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Publication number
EP0155009A2
EP0155009A2 EP85103028A EP85103028A EP0155009A2 EP 0155009 A2 EP0155009 A2 EP 0155009A2 EP 85103028 A EP85103028 A EP 85103028A EP 85103028 A EP85103028 A EP 85103028A EP 0155009 A2 EP0155009 A2 EP 0155009A2
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EP
European Patent Office
Prior art keywords
medical probe
tube
probe
probe according
distal end
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP85103028A
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German (de)
French (fr)
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EP0155009B1 (en
EP0155009A3 (en
Inventor
Carsten Dr. Freie Universität Berlin Emde
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Fresenius SE and Co KGaA
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Fresenius SE and Co KGaA
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Priority to AT85103028T priority Critical patent/ATE47308T1/en
Publication of EP0155009A2 publication Critical patent/EP0155009A2/en
Publication of EP0155009A3 publication Critical patent/EP0155009A3/en
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Publication of EP0155009B1 publication Critical patent/EP0155009B1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0003—Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/60—General characteristics or adaptations biodegradable

Definitions

  • the present invention relates to a medical probe, in particular for enteral nutrition, comprising a probe tube which has a loading body at its distal end and at least one opening in the region of its distal end, at least part of the loading body being removable after the placement of the probe tube.
  • Medical probes for enteral nutrition are already known.
  • these probes consist of the actual probe tube, at the distal end of which a closure cap is arranged, and the proximal end of which there are connecting devices via which the probe with the nutritional pump and further feed devices (such as further tubes and the like) for food and the like.
  • the stylet serves to temporarily stiffen the relatively soft probe tube. He relieved ters the placement of the probe and is removed after the placement or placement of the probe.
  • PVC, polyurethane or silicone is generally used as the material for the probe tube, while the sealing cap is made of polyethylene or silicone.
  • Tube feeding has become particularly important in recent years.
  • the indication for artificial nutrition is always given when a patient is not allowed to eat, cannot eat or does not want to eat.
  • the respective nutritional therapy is tailored to the condition of the respective patient.
  • This nutritional therapy is not only important in the postoperative or post-traumatic area, but also in diseases that are associated with a disturbance in the absorption or digestion of nutrients and as a complementary therapy for cancer patients.
  • So tube feeding is carried out for oral diseases, e.g. Operations in the oral and maxillary sinuses, paralysis of the chewing muscles, with continued loss of consciousness, e.g. in traumatic brain injuries, in ventilated and relaxed patients, e.g. Tetanus patients, in patients with refusal to eat for a psychogenic cause, e.g.
  • Tube studies as studies have shown, involve fewer and less serious complications compared to total parenteral nutrition and, moreover, are less expensive than parenteral nutrition. However, this means that tube feeding is more advantageous than parenteral nutrition and, with a few exceptions, is therefore preferred in malnutrition therapy.
  • nasogastric nasoduodenal and nasojejunal tube feeding.
  • probes with a sealing cap as a guide bolus have been used for nasoduodenal and nasojejunal nutrition (e.g. from mercury or water).
  • the placement of the feeding tubes requires an intact g a-stroduodenal peristalsis. Occasionally, these probes can also be placed intraoperatively.
  • the nasoduodenal and nasojejunal feeding tubes are mainly used in the field of conservative medicine for unconscious patients, long-term ventilation patients, relaxed patients and premature babies.
  • Probes are already known which have a balloon as the guide bolus which can be filled with a liquid, for example mercury or water, which is intended to facilitate the placement of the tube.
  • a liquid for example mercury or water
  • Such probes are from DE-PS 31 05 883, DE-OS 29 14 609, DE-OS 24 02 573, DE-OS 25 24 030, DE-AS 28 10 326, DE-PS 27 21 540, the article of Ruombal. in Kunststoff's medical weekly (1968, page 470-474) and the catalog of the company Hinsch (1977, page 15-19).
  • the balloon is glued to the probe with a small intestine-soluble agent and can be placed after placement be removed by peeling.
  • the invention has for its object to develop the probe of the type mentioned in such a way that it can be easily moved by the peristaltic movement of the esophageal gastrointestinal tract, is safe after placement and does not interfere with the digestive process.
  • the load body has a fixed closure cap with a thickening layer made of a material that can be absorbed by the patient's body.
  • Such an enlarged closure cap offers a better point of attack for the peristalsis of the esophagus, stomach and / or intestine, which is particularly important in the case of passive patients (eg, unconscious patients).
  • Suitable materials that can be absorbed by the patient's body are pharmacologically harmless solidifying substances, such as agar, alginic acids, starches, arabic gum, pectin PVP, methyl cellulose and gelatin, with gelatin being preferred.
  • Suitable as gelatin are all commercially available, usable for medical purposes gelatins, such as soft gelatin and hard gelatin, or gelatin masses, which, if appropriate, further additives suitable for medical purposes, such as plasticizers (such as sorbitol) glycerol, alkali metal salts (sodium salts) of ethyl p-hydroxybenzoate or propyl p-hydroxybenzoate, and water and the like. contain.
  • plasticizers such as sorbitol
  • alkali metal salts sodium salts of ethyl p-hydroxybenzoate or propyl p-hydroxybenzoate, and water and the like.
  • Soft gelatin or a gelatin mass is preferably used which, in addition to gelatin, also contains sorbitol, glycerol, the sodium salt of ethyl p-hydroxybenzoate, the sodium salt of propyl p-hydroxybenzoate and water.
  • This gelatin is digested after placing the probe.
  • the thickness of the thickening layer is not critical, but the overcoat should be so thick that the placement of the probe is improved to the extent desired, but on the other hand does not interfere with the placement of the probe, ie, should be such that the probe bolus is beneficial handle for peristalsis. Suitable thicknesses are 3 - 6, in particular 4 - 5 mm with a probe diameter of about 2 mm.
  • the jump in thickness between the thickening layer and the probe is of particular importance, since this jump ensures improved probe transport.
  • the thickness jump (or the maximum wall thickness of the thickening) is advantageously in a range from 0.5-2, preferably 1-1.5 mm.
  • the thickening layer can be applied directly to the distal end of the probe tube or can be applied to a conventional cap or stopper made of suitable, medically compatible material, such as hard gelatin or plastic (for example made of polyolefin, in particular polyethylene, or silicone), which is arranged in the distal end of the probe tube .
  • suitable, medically compatible material such as hard gelatin or plastic (for example made of polyolefin, in particular polyethylene, or silicone), which is arranged in the distal end of the probe tube .
  • a jacket or a further coating layer made of acid-resistant material is preferably applied to the thickening layer of the closure cap.
  • This additional coating layer not only further enlarges and solidifies the closure cap or probe tip and thus further facilitates the placement of the probe tube, but in particular provides a probe for nasoduodenal and / or nasojejunal nutrition, which due to the enlargement of the closure cap or probe tip (- bolus) easily - even in passive patients - and unaffected by gastric acid passes through the stomach and can be safely placed in the duodenum or jejunum.
  • the material used for this additional coating layer is one which is resistant to gastric acid or gastric juice, but is soluble in the intestinal juice, ie in the intestinal milieu.
  • Such materials are medically safe materials, such as anionic polymers of methacrylic acid and methyl methacrylate, and mixtures thereof with other materials and with one another.
  • Anionic polymers of methacrylic acid are preferred and methyl methacrylate, such as Eudragit S, Eudragit L and mixtures thereof (manufactured by Röhm Pharma), in particular Eudragit S.
  • Shellac and cellulose acetate phthalate are also suitable as coating material.
  • the thickness of the coating layer is not critical, but the coating layer should be so thick that the thickening layer is protected from the attack of the gastric juices and on the other hand not so thick that it dissolves too slowly and thus a possible removal of the probe from the duodenum or Jejunum disabled. Suitable thicknesses are approximately 10 to 30 ⁇ m, in particular approximately 25 ⁇ m.
  • the coating can be colorless, transparent, white or pigmented in a different color; it is preferably matched to the color of the probe tube.
  • the closure cap can advantageously have a metal head or metal stopper which is arranged at the distal end of the probe tube.
  • a metal head increases the weight of the probe and stiffens the distal end of the probe, thus considerably simplifying the placement or placement of the probe, particularly in the case of passive patients.
  • Suitable materials for the metal head or the metal plug are suitable, suitable metals for medical purposes, such as e.g. Stainless steel, precious metals and the like Metal heads or plugs made of V4A and V2A steel are used in particular.
  • the size of the metal head is not critical and should be in the usual size range for sealing caps or can be somewhat smaller, but should be large enough that the metal head can perform the desired function.
  • the metal head suitably has approximately the same outer diameter as the probe, while its length is determined by the weight or the holder in the probe becomes.
  • the metal head can have any suitable shape. It is preferably inserted in the shape of a plug into the distal end of the probe tube by means of a neck.
  • the thickening layer is then arranged over the metal head directly or over a cap of suitable, medically compatible material, such as hard gelatin or plastic (for example polyolefin, such as polyethylene, or silocon), which may still surround the metal head, over which the coating layer of gastric juice-resistant, material soluble in the intestinal juice.
  • suitable, medically compatible material such as hard gelatin or plastic (for example polyolefin, such as polyethylene, or silocon), which may still surround the metal head, over which the coating layer of gastric juice-resistant, material soluble in the intestinal juice.
  • the probe tube itself consists of customary material suitable for probes, such as PVC, silicone or polyurethane, preferably of silicone or polyurethane.
  • a stylet designed in the usual way is used to temporarily stiffen the relatively soft probe tube.
  • the stylet When the metal head according to the invention is present at the distal end of the probe tube, the stylet preferably opens into a depression or bore in the metal head or the neck part of this metal head in order to prevent the probe tube from kinking at the tip.
  • a bore is preferably provided in the neck part of the metal head.
  • the probe tube preferably has openings in the area of the distal end, which allow the food to escape.
  • the number of openings is not critical. However, there should be so many openings that proper food leakage is permitted. There are preferably two to four, in particular three, openings.
  • marking lines are preferably provided in the usual way on the probe tube, which serve for orientation when the probe is placed.
  • nasogastric probes are 75 cm long and have an inner diameter of 2-4 mm;
  • Nasoduodenal or nasojejunal probes have a length of preferably 1.25 m, an inner diameter of 1.2-1.6 mm and an outer diameter of 2-2.4 mm.
  • connection devices which are used once for attaching the stylet or later after placing the probe in the usual manner for receiving or connecting connecting lines or hoses, via which the probe with the nutritional pump or other supply lines for the food is attached, attached.
  • connection devices can be present, for example, in the form of a connector part with a Luer connection, a plug connection or the like.
  • a plug-in connection or a connector part with a Luer cone is preferably used, in particular a connector part with a Luer cone.
  • the probe according to the invention is produced in the usual way.
  • the metal head for example, is preferably plug-shaped into the distal end of the probe tube over a part of the metal piece that has a neck shape.
  • the distal end of the probe tube equipped with the metal head can be provided with the thickening layer by immersing the end of the distal probe tube provided with the metal head in a heated gelatin mass and then pulling it out so that it can be coated with an additional layer of gastric juice-resistant material to coat what can be done in the usual way, if necessary by spraying.
  • Immersing the distal end in the heated Gelatin mass is preferably done by oblique immersion, ie immersion at an angle of less than 90 °.
  • connection or connection device 3 for the stylet 6 or other supply or connection lines, which, as shown, can be in the form of a luer connection or can have any other suitable shape, e.g. can be in the form of a plug connection.
  • connection device 4 of the stylet 6 is inserted, which is preferably so-called to facilitate handling.
  • Handle strips 5 carries.
  • the metal head 7 is arranged in the probe tube 2 in the form of a plug.
  • a thickening layer 8 made of a material that is resorbable by the patient's body, preferably white gelatin, on which preferably a coating layer 9 made of an enteric, enteric material (preferably Eudragit S) is applied.
  • This thickening layer 8 advantageously has the dimensions mentioned above.
  • one or more openings 10 are provided in the probe tube for the food to exit.
  • FIG. 2 illustrates an enlarged longitudinal section through the region of the distal end and the closure cap or the bolus of the probe according to the invention according to FIG. 1, the reference numbers corresponding to those used in FIG. 1.
  • the neck part 7a of the metal head 7 can have a bore 11 for receiving the distal end of the stylet 6.
  • This metal head can also have another suitable shape, e.g. it can be pear-shaped, or it can be essentially cylindrical.
  • FIG. 3 The cross-section shown in Fig. 3 along the line II-II according to Fig. 1 or 2 shows how the distal end of the probe tube 2 surrounds the neck part 7a of the metal head 7 and even of the thickening layer 8 and the coating layer 9 made of the enteric, enteric material is surrounded.

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  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Veterinary Medicine (AREA)
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Abstract

Medical probe or tube suitable in particular for enteral feeding and comprising a flexible tube which has at its distal end a closure cap and at its proximal end a connecting means, and a mandrin with securing means formed corresponding to the connecting means, wherein at the distal end of the tube near the closure cap in the tube openings are disposed and the closure cap has a gelatin coating, and preferably on the closure cap over the gelatin coating a further coating of gastric-juice-resistant material is disposed and preferably in the cap a metal head is located.

Description

Die vorliegende Erfindung betrifft eine medizinische Sonde, insbesondere für die enterale Ernährung, umfassend einen Sondenschlauch, der an seinem distalen Ende einen Belastungskörper und im Bereich seines distalen Endes wenigstens eine Öffnung aufweist, wobei zumindest ein Teil des Belastungskörpers nach dem Plazieren des Sondenschlauches entfernbar ist.The present invention relates to a medical probe, in particular for enteral nutrition, comprising a probe tube which has a loading body at its distal end and at least one opening in the region of its distal end, at least part of the loading body being removable after the placement of the probe tube.

Medizinische Sonden für die enterale Ernährung sind bereits bekannt. Im allgemeinen bestehen diese Sonden aus dem eigentlichen Sondenschlauch, an dessem distalen Ende eine Verschlußkappe angeordnet ist und dessem proximales Ende Anschlußeinrichtungen, über welche die Sonde mit der Ernährungspumpe und weiteren Zuführungseinrichtungen (wie weiteren Schläuchen u. dgl.) für die Nahrung u. dgl. bzw. mit dem Mandrin verbunden wird, aufweist, sowie einem Mandrin. Der Mandrin dient zur temporären Versteifung des relativ weichen Sondenschlauches. Er erleichtert das Plazieren der Sonde und wird nach dem Plazieren bzw. Legen der Sonde entfernt. Als Material für den Sondenschlauch wird im allgemeinen PVC, Polyurethan oder Silicon verwendet, während die Verschlußkappe aus Polyethylen oder Silicon besteht.Medical probes for enteral nutrition are already known. In general, these probes consist of the actual probe tube, at the distal end of which a closure cap is arranged, and the proximal end of which there are connecting devices via which the probe with the nutritional pump and further feed devices (such as further tubes and the like) for food and the like. Like. or is connected to the stylet, and a stylet. The stylet serves to temporarily stiffen the relatively soft probe tube. He relieved ters the placement of the probe and is removed after the placement or placement of the probe. PVC, polyurethane or silicone is generally used as the material for the probe tube, while the sealing cap is made of polyethylene or silicone.

Die Sondenernährung hat in den letzten Jahren insbesondere an Bedeutung gewonnen. Die Indikation zur künstlichen Ernährung ist immer dann gegeben, wenn ein Patient nicht essen darf, nicht essen kann oder nicht essen will. Die jeweilige Ernährungstherapie wird dabei auf den Zustand des jeweiligen Patienten abgestimmt. Diese Ernährungstherapie hat nicht nur ihre Bedeutung im postoperativen oder posttraumatischen Bereich, sondern auch bei Erkrankungen, die mit einer Störung der Aufnahme oder der Verdauung von Nährstoffen einhergehen sowie als ergänzende Therapie bei Krebspatienten. So wird Sondenernährung durchgeführt bei oralen Erkrankungen, z.B. Operationen im Mund- und Kieferhöhlenbereich, Lähmungen der Kaumuskulatur, bei anhaltender Bewußlosigkeit, z.B. bei Schädel-Hirn-Traumen, bei beatmeten und relaxierten Patienten, z.B. Tetanuspatienten, bei Patienten mit Nahrungsverweigerung aus psychogener Ursache, z.B. bei Magersucht, bei Krebspatienten, die häufig Geschmacksmißempfindungen haben, sowie in der Pädiatrie. Sondenernährung ist, wie Untersuchungen ergeben haben, verglichen mit der totalen parenteralen Ernährung mit weniger und weniger schweren Komplikationen verbunden und darüber hinaus preisgünstiger als die parenterale Ernährung. Das bedeutet jedoch, daß die Sondenernährung gegenüber der parenteralen Ernährung vorteilhafter ist und ihr somit, bis auf wenige Ausnahmen, in der Therapie der Mangelernährung der Vorzug gegeben wird.Tube feeding has become particularly important in recent years. The indication for artificial nutrition is always given when a patient is not allowed to eat, cannot eat or does not want to eat. The respective nutritional therapy is tailored to the condition of the respective patient. This nutritional therapy is not only important in the postoperative or post-traumatic area, but also in diseases that are associated with a disturbance in the absorption or digestion of nutrients and as a complementary therapy for cancer patients. So tube feeding is carried out for oral diseases, e.g. Operations in the oral and maxillary sinuses, paralysis of the chewing muscles, with continued loss of consciousness, e.g. in traumatic brain injuries, in ventilated and relaxed patients, e.g. Tetanus patients, in patients with refusal to eat for a psychogenic cause, e.g. in anorexia, in cancer patients who often have taste sensations, and in pediatrics. Tube studies, as studies have shown, involve fewer and less serious complications compared to total parenteral nutrition and, moreover, are less expensive than parenteral nutrition. However, this means that tube feeding is more advantageous than parenteral nutrition and, with a few exceptions, is therefore preferred in malnutrition therapy.

Im allgemeinen wird zwischen nasogastrischer, nasoduodenaler und nasojejunaler Sondenernährung unterschieden. Für die nasoduodenale und nasojejunale Ernährung wurden bisher Sonden mit einer Verschlußkappe als Führungsbolus (z.B. aus Quecksilber oder Wasser) eingesetzt. Die Plazierung der Ernährungssonden setzt jedoch eine intakte ga-stroduodenale Peristaltik voraus. Gelegentlich können diese Sonden auch intraoperativ plaziert werden. Die nasoduodenalen und nasojejunalen Ernährungssonden werden vor allem im Bereich der konservativen Medizin bei bewußtlosen Patienten, Dauerbeatmungspatienten, relaxierten Patienten und bei Frühgeborenen eingesetzt. Sie haben darüber hinaus im chirurgischen Bereich bei stark mangelernährten Patienten zur Operationsvorbereitung, als Alternative zur Operation und in der Nachbehandlung (z.B. Chemo- oder Strahlentherapie maligner Tumoren) unstreitbare Bedeutung. Insbesondere bei Verwendung zur Ernährung von bewußtlosen Patienten, krebskranken Patienten, Frühgeborenen und Kleinkindern, die selbst bei der Plazierung nicht aktiv mithelfen können, treten beim Plazieren der Sonden bei Verwendung der bisherigen Sonden erhebliche Schwierigkeiten und Probleme auf, so daß häufig die gezielte und erfolgreiche Ernährung dieser Patienten in Frage gestellt ist.A general distinction is made between nasogastric, nasoduodenal and nasojejunal tube feeding. So far, probes with a sealing cap as a guide bolus have been used for nasoduodenal and nasojejunal nutrition (e.g. from mercury or water). However, the placement of the feeding tubes requires an intact g a-stroduodenal peristalsis. Occasionally, these probes can also be placed intraoperatively. The nasoduodenal and nasojejunal feeding tubes are mainly used in the field of conservative medicine for unconscious patients, long-term ventilation patients, relaxed patients and premature babies. They are also of undisputed importance in the surgical field of severely malnourished patients for preparation for surgery, as an alternative to surgery and in post-treatment (e.g. chemotherapy or radiation therapy of malignant tumors). Especially when used for the nutrition of unconscious patients, cancer patients, premature babies and small children, who cannot actively help even with the placement, there are considerable difficulties and problems when placing the probes when using the previous probes, so that often the targeted and successful nutrition this patient is questioned.

Es sind bereits Sonden bekannt, die als Führungsbolus einen Ballon aufweisen, der mit einer Flüssigkeit, beispielsweise Quecksilber oder Wasser, gefüllt werden kann, wodurch die Plazierung des Schlauches erleichtert werden soll. Derartige Sonden sind aus der DE-PS 31 05 883, DE-OS 29 14 609, DE-OS 24 02 573, DE-OS 25 24 030, DE-AS 28 10 326, DE-PS 27 21 540, dem Artikel von Rueffetal. in Münchner Medizinischer Wochenschrift (1968, Seite 470-474) und dem Katalog der Firma Rüsch (1977, Seite 15-19) bekannt.In der erstgenannten Patentschrift ist der Ballon mit einem im Dünndarm löslichen Mittel an der Sonde angeklebt und kann nach dem Plazieren durch Ablösen entfernt werden.Probes are already known which have a balloon as the guide bolus which can be filled with a liquid, for example mercury or water, which is intended to facilitate the placement of the tube. Such probes are from DE-PS 31 05 883, DE-OS 29 14 609, DE-OS 24 02 573, DE-OS 25 24 030, DE-AS 28 10 326, DE-PS 27 21 540, the article of Rueffetal. in Munich's medical weekly (1968, page 470-474) and the catalog of the company Rüsch (1977, page 15-19). In the first-mentioned patent, the balloon is glued to the probe with a small intestine-soluble agent and can be placed after placement be removed by peeling.

Sämtliche bekannten Sonden, die einen Ballon aufweisen, besitzen den Nachteil, daß sie zunächst beim Setzen durch die Nase nur in einem beschränkten Umfang gefüllt werden können, also bereits das Plazieren in der Nase Schwierigkeiten macht.All known probes, which have a balloon, have the disadvantage that they can only be filled to a limited extent when they are first inserted through the nose, thus already placing them in the nose makes them difficult.

Beim weiteren Fortbewegen der Sonde durch die Speiseröhre wird dann der Ballon mit der Flüssigkeit gefüllt. Auch hier bestehen erhebliche Schwierigkeiten bei der Fortbewegung der Sonde durch die Speiseröhre, da die im Ballon enthaltene Flüssigkeit der peristaltischen Bewegung von Speiseröhre und Magen ausweicht, so daß auch hier ernsthafte Plazierungsprobleme beobachtet werden. Andererseits wurden bisher jedoch nur Sonden mit einer metallischen Verschlußkappe am distalen Ende eingesetzt, die nur unwesentlich dicker war als der Schlauch selbst, so daß hierdurch keine Plazierungshilfe gegeben ist.As the probe moves further through the esophagus, the balloon is then filled with the liquid. Here, too, there are considerable difficulties in moving the probe through the esophagus, since the liquid contained in the balloon evades the peristaltic movement of the esophagus and stomach, so that serious placement problems are also observed here. On the other hand, however, so far only probes with a metallic cap at the distal end have been used, which was only insignificantly thicker than the tube itself, so that this does not provide any placement aid.

Insofern liegt der Erfindung die Aufgabe zugrunde, die Sonde der eingangs erwähnten Art so fortzubilden, daß sie sich durch die peristaltische Bewegung des Speiseröhre-Magendarmkanals problemlos fortbewegen läßt, nach der Plazierung sicher liegt und nicht den Verdauungsvorgang stört.In this respect, the invention has for its object to develop the probe of the type mentioned in such a way that it can be easily moved by the peristaltic movement of the esophageal gastrointestinal tract, is safe after placement and does not interfere with the digestive process.

Die Lösung dieser Aufgabe erfolgt dadurch, daß der Belastungskörper eine feste Verschlußkappe mit einer Verdickungsschicht aus einem vom Körper des Patienten resorbierbaren Material aufweist.This object is achieved in that the load body has a fixed closure cap with a thickening layer made of a material that can be absorbed by the patient's body.

Eine so vergrößerte Verschlußkappe bietet einen besseren Angriffspunkt für die Peristaltik von Speiseröhre, Magen und/oder Darm, was insbesondere bei passiven Patienten (z. B. bewußtlosen Patienten) besonders wichtig ist.Such an enlarged closure cap offers a better point of attack for the peristalsis of the esophagus, stomach and / or intestine, which is particularly important in the case of passive patients (eg, unconscious patients).

Als vom Körper des Patienten resorbierbare Materialien eignen sich pharmakologisch unbedenkliche erstarrende Substanzen, wie Agar, Alginsäuren, Stärken, Arabisch-Gummi, Pektin PVP, Methylcellulose und Gelatine, wobei Gelatine bevorzugt ist.Suitable materials that can be absorbed by the patient's body are pharmacologically harmless solidifying substances, such as agar, alginic acids, starches, arabic gum, pectin PVP, methyl cellulose and gelatin, with gelatin being preferred.

Als Gelatine geeignet sind alle handelsüblichen, für medizinische Zwecke brauchbaren Gelatinen, wie Weichgelatine und Hartgelatine, bzw. Gelatinemassen, die gegebenenfalls weitere, für medizinische Zwecke geeignete Zusätze, wie Weichmacher, (wie z.B. Sorbit) Glycerin, Alkalisalze (Natriumsalze) von p-Hydroxybenzoesäureethylester oder p-Hydroxybenzoesäurepropylester, sowie Wasser u.dgl. enthalten. Vorzugsweise wird Weichgelatine oder eine Gelatinemasse verwendet, die neben Gelatine noch Sorbit, Glycerin, das Natriumsalz von p-Hydroxybenzoesäureethylester, das Natriumsalz von p-Hydroxybenzoesäurepropylester und Wasser enthält, verwendet. Eine geeignete und bevorzugte Zusammensetzung der erfindungsgemäß verwendeten Gelatinemasse ist folgende:

Figure imgb0001
Suitable as gelatin are all commercially available, usable for medical purposes gelatins, such as soft gelatin and hard gelatin, or gelatin masses, which, if appropriate, further additives suitable for medical purposes, such as plasticizers (such as sorbitol) glycerol, alkali metal salts (sodium salts) of ethyl p-hydroxybenzoate or propyl p-hydroxybenzoate, and water and the like. contain. Soft gelatin or a gelatin mass is preferably used which, in addition to gelatin, also contains sorbitol, glycerol, the sodium salt of ethyl p-hydroxybenzoate, the sodium salt of propyl p-hydroxybenzoate and water. A suitable and preferred composition of the gelatin mass used according to the invention is as follows:
Figure imgb0001

Diese Gelatine wird nach Plazieren der Sonde abgedaut.This gelatin is digested after placing the probe.

Die Dicke der Verdickungsschicht ist nicht kritisch, und die Überzuqsschicht sollte jedoch so dick sein, daß das Plazieren der Sonde im gewünschten Maße besser wird, andererseits jedoch die Plazierung der Sonde nicht behindert wird, d.h. sollte so sein, daß der Sondenbolus einen günstigen Angriffspunkt für die Peristaltik bietet. Geeignete Dicken sind 3 - 6, insbesondere 4 - 5 mm bei einem Sondendurchmesser von etwa 2 mm. Von besonderer Bedeutung ist der Dickensprung zwischen der Verdickungsschicht und der Sonde, da dieser Sprung einen verbesserten Sondentransport gewährleistet. Vorteilhafterweise liegt der Dickensprung (oder die maximale Wanddicke der Verdickung) in einem Bereich von 0,5 - 2, vorzugsweise 1 - 1,5 mm.The thickness of the thickening layer is not critical, but the overcoat should be so thick that the placement of the probe is improved to the extent desired, but on the other hand does not interfere with the placement of the probe, ie, should be such that the probe bolus is beneficial handle for peristalsis. Suitable thicknesses are 3 - 6, in particular 4 - 5 mm with a probe diameter of about 2 mm. The jump in thickness between the thickening layer and the probe is of particular importance, since this jump ensures improved probe transport. The thickness jump (or the maximum wall thickness of the thickening) is advantageously in a range from 0.5-2, preferably 1-1.5 mm.

Die Verdickungsschicht kann direkt auf das distale Ende des Sondenschlauches aufgebracht werden oder aber auf einer im distalen Ende des Sondenschlauches angeordneten üblichen Kappe oder Stopfen aus geeignetem, medizinisch verträglichem Material, wie Hartgelatine oder Kunststoff (z.B. aus Polyolefin, insbesondere Polyethylen, oder Silicon) aufgebracht werden.The thickening layer can be applied directly to the distal end of the probe tube or can be applied to a conventional cap or stopper made of suitable, medically compatible material, such as hard gelatin or plastic (for example made of polyolefin, in particular polyethylene, or silicone), which is arranged in the distal end of the probe tube .

Vorzugsweise ist auf der Verdickungsschicht der Verschlußkappe eine Mantel- bzw. eine weitere Überzugsschicht aus säurefestem Material aufgebracht. Durch diese weitere Überzugsschicht wird nicht nur die Verschlußkappe bzw. Sondenspitze weiter vergrößert und verfestigt und damit die Plazierung des Sondenschlauches weiter erleichtert, sondern insbesondere für die nasoduodenale und/oder nasojejunale Ernährung eine Sonde bereitgestellt, die infolge der Vergrößerung der Verschlußkappe bzw. Sondenspitze (-bolus) leicht - auch bei passiven Patienten - und von der Magensäure unangegriffen den Magen passiert und sicher im Duodenum bzw. Jejunum plaziert werden kann. Als Material für diese weitere Überzugsschicht wird ein solches verwendet, das gegenüber der Magensäure bzw. dem Magensaft resistent ist, aber im Darmsaft, d.h. im Milieu des Darmes, löslich ist. Beispiele für solche Materialien sind medizinisch unbedenkliche Materialien, wie anionische Polymerisate aus Methacrylsäure und Methacrylsäuremethylester, sowie Gemische derselben mit anderen Materialien sowie miteinander. Bevorzugt sind anionische Polymerisate aus Methacrylsäure und Methacrylsäuremethylester, wie Eudragit S, Eudragit L und Gemische derselben (hergestellt von Röhm Pharma), insbesondere Eudragit S. Weiterhin geeignet sind Schellack und Celluloseacetatphthalat als Überzugsmaterial.A jacket or a further coating layer made of acid-resistant material is preferably applied to the thickening layer of the closure cap. This additional coating layer not only further enlarges and solidifies the closure cap or probe tip and thus further facilitates the placement of the probe tube, but in particular provides a probe for nasoduodenal and / or nasojejunal nutrition, which due to the enlargement of the closure cap or probe tip (- bolus) easily - even in passive patients - and unaffected by gastric acid passes through the stomach and can be safely placed in the duodenum or jejunum. The material used for this additional coating layer is one which is resistant to gastric acid or gastric juice, but is soluble in the intestinal juice, ie in the intestinal milieu. Examples of such materials are medically safe materials, such as anionic polymers of methacrylic acid and methyl methacrylate, and mixtures thereof with other materials and with one another. Anionic polymers of methacrylic acid are preferred and methyl methacrylate, such as Eudragit S, Eudragit L and mixtures thereof (manufactured by Röhm Pharma), in particular Eudragit S. Shellac and cellulose acetate phthalate are also suitable as coating material.

Die Dicke der Überzugsschicht ist nicht kritisch, jedoch sollte die Überzugsschicht so dick sein, daß die Verdickungsschicht vor dem Angriff der Magensäfte geschützt wird und andererseits nicht so dick sein, daß sie sich zu langsam auflöst und damit eine eventuelle Entfernung der Sonde aus dem Duodenum oder Jejunum behindert. Geeignete Dicken sind etwa 10 - 30 µm, insbesondere ca 25 gm. Der Überzug kann farblos, transparent, weiß oder andersfarbig pigmentiert sein; vorzugsweise ist er der Farbe des Sondenschlauches angepaßt.The thickness of the coating layer is not critical, but the coating layer should be so thick that the thickening layer is protected from the attack of the gastric juices and on the other hand not so thick that it dissolves too slowly and thus a possible removal of the probe from the duodenum or Jejunum disabled. Suitable thicknesses are approximately 10 to 30 μm, in particular approximately 25 μm. The coating can be colorless, transparent, white or pigmented in a different color; it is preferably matched to the color of the probe tube.

Zur weiteren Erleichterung der Plazierung der Sonden, insbesondere der Nasoduodenal- und Nasojejunalsonden, kann die Verschlußkappe vorteilhafterweise einen Metallkopf oder Metallstopfen aufweisen, der am distalen Ende des Sondenschlauches angeordnet ist. Ein solcher Metallkopf vergrößert das Gewicht der Sonde und versteift das distale Ende der Sonde, erleichtert somit das Legen bzw. Plazieren der Sonde erheblich, insbesondere bei passiven Patienten.To further facilitate the placement of the probes, in particular the nasoduodenal and nasojejunal probes, the closure cap can advantageously have a metal head or metal stopper which is arranged at the distal end of the probe tube. Such a metal head increases the weight of the probe and stiffens the distal end of the probe, thus considerably simplifying the placement or placement of the probe, particularly in the case of passive patients.

Geeignete Materialien für den Metallkopf bzw. den Metallstopfen sind für medizinische Zwecke geeignete, verträgliche Metalle, wie z.B. Edelstahl, Edelmetalle u.dgl. Insbesondere verwendet werden Metallköpfe bzw. Stopfen aus V4A- und V2A-Stahl.Suitable materials for the metal head or the metal plug are suitable, suitable metals for medical purposes, such as e.g. Stainless steel, precious metals and the like Metal heads or plugs made of V4A and V2A steel are used in particular.

Die Größe des Metallkopfes ist nicht kritisch und sollte im üblichen Größenbereich für Verschlußkappen liegen bzw. kann etwas kleiner sein, sollte jedoch so groß sein, daß der Metallkopf die gewünschte Funktion erfüllen kann. Geeigneterweise weist der Metallkopf etwa den gleichen Außendurchmesser auf wie die Sonde, während seine Länge von dem Gewicht bzw. der Halterung in der Sonde bestimmt wird. Desgleichen kann der Metallkopf jede geeignete Form aufweisen. Vorzugsweise ist er mittels eines Halses stopfenförmig in das distale Ende des Sondenschlauches eingefügt.The size of the metal head is not critical and should be in the usual size range for sealing caps or can be somewhat smaller, but should be large enough that the metal head can perform the desired function. The metal head suitably has approximately the same outer diameter as the probe, while its length is determined by the weight or the holder in the probe becomes. Likewise, the metal head can have any suitable shape. It is preferably inserted in the shape of a plug into the distal end of the probe tube by means of a neck.

Über dem Metallkopf direkt oder über einer gegebenenfalls den Metallkopf noch umgebenden Kappe aus geeignetem, medizinisch verträglichem Material, wie Hartgelatine oder Kunststoff (z.B. Polyolefin, wie Polyethylen, oder Silocon), ist dann die Verdickungsschicht angeordnet, über welchem dann vorzugsweise die Überzugsschicht aus magensaftresistentem, im Darmsaft löslichen Material, aufgebracht ist.The thickening layer is then arranged over the metal head directly or over a cap of suitable, medically compatible material, such as hard gelatin or plastic (for example polyolefin, such as polyethylene, or silocon), which may still surround the metal head, over which the coating layer of gastric juice-resistant, material soluble in the intestinal juice.

Der Sondenschlauch selbst besteht aus üblichem, für Sonden geeignetem Materil, wie PVC, Silicon oder Polyurethan, vorzugsweise aus Silicon oder Polyurethan.The probe tube itself consists of customary material suitable for probes, such as PVC, silicone or polyurethane, preferably of silicone or polyurethane.

Zur temporären Versteifung des relativ weichen Sondenschlauches wird ein in üblicher Weise ausgestalteter Mandrin verwendet. Bei erfindungsgemäß vorhandenem Metallkopf am distalen Ende des Sondenschlauches mündet der Mandrin vorzugsweise in einer Senkung oder Bohrung des Metallkopfes bzw. des Halsteiles dieses Metallkopfes, um ein Abknicken des Sondenschlauches an der Spitze zu verhindern. Vorzugsweise ist eine Bohrung im Halsteil des Metallkopfes vorgesehen.A stylet designed in the usual way is used to temporarily stiffen the relatively soft probe tube. When the metal head according to the invention is present at the distal end of the probe tube, the stylet preferably opens into a depression or bore in the metal head or the neck part of this metal head in order to prevent the probe tube from kinking at the tip. A bore is preferably provided in the neck part of the metal head.

Der Sondenschlauch weist vorzugsweise in üblicher Weise im Bereich des distalen Endes Öffnungen auf, die den Nahrungsaustritt gestatten. Die Zahl der Öffnungen ist nicht kritisch. Jedoch sollten soviele Öffnungen vorhanden sein, daß ein einwandfreier Nahrungsaustritt gestattet ist. Vorzugsweise sind zwei bis vier, insbesondere drei Öffnungen, vorhanden. Desgleichen sind vorzugsweise in üblicher Weise Markierungsstriche am Sondenschlauch vorgesehen, die beim Legen der Sonde zur Orientierung dienen.The probe tube preferably has openings in the area of the distal end, which allow the food to escape. The number of openings is not critical. However, there should be so many openings that proper food leakage is permitted. There are preferably two to four, in particular three, openings. Likewise, marking lines are preferably provided in the usual way on the probe tube, which serve for orientation when the probe is placed.

Der Durchmesser und die Länge des Sondenschlauches hängen vom jeweiligen Verwendungszweck ab und liegen im üblicher Weise angewandten Bereich. Typischerweise sind nasogastrale Sonden 75 cm lang und weisen einen Innendurchmesser von 2 - 4 mm auf; Nasoduodenal- oder Nasojejunalsonden weisen eine Länge von vorzugsweise 1,25 m, einen Innendurchmesser von 1,2 - 1,6 mm und einen Außendurchmesser von 2 - 2,4 mm auf.The diameter and the length of the probe tube depend on the intended use and are in the usual range. Typically, nasogastric probes are 75 cm long and have an inner diameter of 2-4 mm; Nasoduodenal or nasojejunal probes have a length of preferably 1.25 m, an inner diameter of 1.2-1.6 mm and an outer diameter of 2-2.4 mm.

Am proximalen Ende des Sondenschlauches sind übliche Anschlußeinrichtungen, die einmal zur Befestigung des Mandrins bzw. später nach Plazierung der Sonde in üblicher Weise zur Aufnahme bzw. zum Anschluß von Verbindungsleitungen bzw. Schläuchen dienen, über die die Sonde mit der Ernährungspumpe bzw. weiteren Zuführungsleitungen für die Nahrung verbunden ist, angebracht. Diese Anschlußeinrichtungen können beispielsweise in Form eines Konnektorteils mit Lueranschluß, eines Steckanschlusses oder dgl. vorliegen. Vorzugsweise verwendet wird ein Steckanschluß oder ein Konnektorteil mit Luerkonus, insbesondere ein Konnektorteil mit Luerkonus.At the proximal end of the probe tube are customary connection devices, which are used once for attaching the stylet or later after placing the probe in the usual manner for receiving or connecting connecting lines or hoses, via which the probe with the nutritional pump or other supply lines for the food is attached, attached. These connection devices can be present, for example, in the form of a connector part with a Luer connection, a plug connection or the like. A plug-in connection or a connector part with a Luer cone is preferably used, in particular a connector part with a Luer cone.

Die Herstellung der erfindungsgemäßen Sonde erfolgt in üblicher Weise. Gemäß der bevorzugten Ausführungsform unter Verwendung des Metallkopfes wird beispielsweise der Metallkopf vorzugsweise über einen halsförmig ausgebildeten Teil des Metallstückes stopfenförmig in das distale Ende des Sondenschlauches eingesteckt. Anschliessend kann dann beispielsweise das so mit dem Metallkopf ausgestattete distale Ende des Sondenschlauches mit der Verdickungsschicht versehen werden, indem man das mit dem Metallkopf versehene Ende des distalen Sondenschlauches in eine erwärmte Gelatinemasse eintaucht und dann herauszieht, um es gegebenenfalls mit einem weiteren Überzug aus magensaftresistentem Material zu überziehen, was in üblicher Weise, gegebenenfalls durch Aufsprühen, erfolgen kann. Das Eintauchen des distalen Endes in die erwärmte Gelatinemasse geschieht vorzugsweise durch schräges Eintauchen, d.h. Eintauchen unter einem Winkel von weniger als 90°.The probe according to the invention is produced in the usual way. According to the preferred embodiment using the metal head, the metal head, for example, is preferably plug-shaped into the distal end of the probe tube over a part of the metal piece that has a neck shape. Then, for example, the distal end of the probe tube equipped with the metal head can be provided with the thickening layer by immersing the end of the distal probe tube provided with the metal head in a heated gelatin mass and then pulling it out so that it can be coated with an additional layer of gastric juice-resistant material to coat what can be done in the usual way, if necessary by spraying. Immersing the distal end in the heated Gelatin mass is preferably done by oblique immersion, ie immersion at an angle of less than 90 °.

Nachfolgend wird die vorliegende Erfindung weiter unter Bezugnahme auf die Zeichnungen erläutert.In the following, the present invention is further explained with reference to the drawings.

Es zeigen:

  • Fig. 1 eine schematische Seitenansicht einer bevorzugten Ausführungsform einer erfindungsgemäßen Sonde.
  • Fig. 2 einen vergrößerten Längsschnitt durch das distale Ende der Sonde gemäß Fig. 1 entlang der Linie I - I.
  • Fig. 3 einen Querschnitt durch das distale Ende der Sonde gemäß Fig. l bzw. 2 entlang der Linie II - II.
Show it:
  • Fig. 1 is a schematic side view of a preferred embodiment of a probe according to the invention.
  • 2 shows an enlarged longitudinal section through the distal end of the probe according to FIG. 1 along the line I - I.
  • 3 shows a cross section through the distal end of the probe according to FIGS. 1 and 2 along the line II-II.

In Fig. 1 ist mit 1 die Verschlußkappe bzw. Sondenspitze oder der Bolus am distalen Ende der erfindungsgemäßen Sonde und mit 2 der Sondenschlauch bezeichnet. Am proximalen Ende der Sonde befindet sich eine übliche Anschluß-oder Verbindungseinrichtung 3 für den Mandrin 6 bzw. andere Zuführungs- oder Verbindungsleitungen, die, wie dargestellt, in Gestalt eines Lueranschlusses vorliegen kann oder aber jede andere geeignete Form haben kann, z.B. in Form eines Steckanschlusses vorliegen kann. In dieser Anschlußeinrichtung ist die entsprechende Anschluß- bzw. Verbindungseinrichtung 4 des Mandrins 6 eingefügt, die zur Erleichterung der Handhabung vorzugsweise sogen. Griffleisten 5 trägt.In Fig. 1, 1 denotes the closure cap or probe tip or the bolus at the distal end of the probe according to the invention and 2 the probe tube. At the proximal end of the probe there is a usual connection or connection device 3 for the stylet 6 or other supply or connection lines, which, as shown, can be in the form of a luer connection or can have any other suitable shape, e.g. can be in the form of a plug connection. In this connection device, the corresponding connection or connection device 4 of the stylet 6 is inserted, which is preferably so-called to facilitate handling. Handle strips 5 carries.

Am distalen Ende des Sondenschlauches ist stopfenförmig der Metallkopf 7 im Sondenschlauch 2 angeordnet. Über dem Metallkopf 7 befindet sich eine Verdickungsschicht 8 aus einem vom Körper des Patienten resorbierbaren Material, vorzugsweise Gelatine, auf welcher vorzugsweise eine Überzugsschicht 9 aus einem magensaftresistenten, darmsaftlöslichen Material (vorzugsweise Eudragit S) aufgebracht ist. Diese Verdickungsschicht 8 weist vorteilhafterweise die vorstehend erwähnten Abmessungen auf.At the distal end of the probe tube, the metal head 7 is arranged in the probe tube 2 in the form of a plug. Above the metal head 7 is a thickening layer 8 made of a material that is resorbable by the patient's body, preferably white gelatin, on which preferably a coating layer 9 made of an enteric, enteric material (preferably Eudragit S) is applied. This thickening layer 8 advantageously has the dimensions mentioned above.

Im Bereich des distalen Endes sind im Sondenschlauch eine oder mehrere Öffnungen 10 zum Austritt der Nahrung vorgesehen.In the area of the distal end, one or more openings 10 are provided in the probe tube for the food to exit.

Die Fig. 2 veranschaulicht einen vergrößerten Längsschnitt durch den Bereich des distalen Endes und der Verschlußkappe bzw. des Bolus der erfindungsgemäßen Sonde gemäß Fig. 1, wobei die Bezugszahlen den in Fig. 1 verwendeten entsprechen. Deutlich sichtbar in der vergrößerten Darstellung ist die Verschlußkappe bzw. die Sondenspitze oder der Sondenbolus 1 mit dem auf dem distalen Ende des Sondenschlauches 2 aufgesetzten Metallkopf 7, der mit dem Halsteil 7a stopfenförmig in das Schlauchende eingefügt ist. Gegebenenfalls kann der Halsteil 7a des Metallkopfes 7 eine Bohrung 11 zur Aufnahme des distalen Endes des Mandrins 6 aufweisen. Dieser Metallkopf kann auch eine andere geeignete Form besitzen, z.B. kann er birnenförmig gestaltet sein, oder auch im wesentlichen zylinderförmig vorliegen.FIG. 2 illustrates an enlarged longitudinal section through the region of the distal end and the closure cap or the bolus of the probe according to the invention according to FIG. 1, the reference numbers corresponding to those used in FIG. 1. The closure cap or the probe tip or the probe bolus 1 with the metal head 7 placed on the distal end of the probe tube 2, which is inserted with the neck part 7a into the end of the tube, is clearly visible in the enlarged representation. If necessary, the neck part 7a of the metal head 7 can have a bore 11 for receiving the distal end of the stylet 6. This metal head can also have another suitable shape, e.g. it can be pear-shaped, or it can be essentially cylindrical.

Wie aus Fig. 2 ersichtlich, ist über das distale Ende des Sondenschlauches 2 und den Metallkopf 7 zunächst diP VerdiQkungsschicht: 8 und auf diesem die Überzugsschicht 9 aus magensaftrresistentem, darmsaftlöslichem Material aufgebracht. Die Öffnungen 10 im Schlauch 2 dienen zum Nahrungsaustritt.. As can be seen from Figure 2, is initially VerdiQkungsschicht beyond the distal end of the probe tube 2 and the metal head 7 di P: 8 and that the coating layer 9 applied from magensaftrresistentem, darmsaftlöslichem material. The openings 10 in the tube 2 are used for food leakage.

Der in Fig. 3 dargestellte Querschnitt entlang der Linie II- IIgemäß Fig. 1 oder 2 zeigt, wie das distale Ende des Sondenschlauches 2 den Halsteil 7a des Metallkopfes 7 umgibt und selbst von der Verdickungsschicht 8 und der Überzugsschicht 9 aus dem magensaftresistenten, darmsaftlöslichen Material umgeben ist.The cross-section shown in Fig. 3 along the line II-II according to Fig. 1 or 2 shows how the distal end of the probe tube 2 surrounds the neck part 7a of the metal head 7 and even of the thickening layer 8 and the coating layer 9 made of the enteric, enteric material is surrounded.

Claims (10)

1. Medizinische Sonde, insbesondere für die enterale Ernährung, umfassend einen Sondenschlauch, der an seinem distalen Ende einen Belastungskörper und im Bereich seines distalen Endes wenigstens eine Öffnung aufweist, wobei zumindest ein Teil des Belastungskörpers nach dem Plazieren des Sondenschlauches entfernbar ist, dadurch gekennzeichnet, daß der Belastungskörper eine feste Verschlußkappe mit einer Verdickungsschicht aus einem vom Körper des Patienten resorbierbaren Material aufweist.1. A medical probe, in particular for enteral nutrition, comprising a probe tube which has a loading body at its distal end and at least one opening in the region of its distal end, at least part of the loading body being removable after the placement of the probe tube, characterized in that that the load body has a fixed closure cap with a thickening layer made of a material that is resorbable by the patient's body. 2. Medizinische Sonde nach Anspruch 1, dadurch gekennzeichnet, daß die Verdickungsschicht (8) aus Gelatine besteht.2. Medical probe according to claim 1, characterized in that the thickening layer (8) consists of gelatin. 3. Medizinische Sonde nach Anspruch 2, dadurch gekennzeichnet, daß die Gelatineverdickung aus Weichgelatine besteht.3. Medical probe according to claim 2, characterized in that the gelatin thickening consists of soft gelatin. 4. Medizinische Sonde nach einem der Ansprüche 1 - 3, dadurch gekennzeichnet, daß über der Verdickungsschicht (8) eine Überzugsschicht (9) aus einem magensaftresistenten Material angeordnet ist.4. Medical probe according to one of claims 1-3, characterized in that a coating layer (9) made of an enteric material is arranged over the thickening layer (8). 5. Medizinische Sonde nach Anspruch 1 - 4, dadurch gekennzeichnet, daß der magensäureresistente Überzug aus einem anionischen Polymerisat aus Methacrylsäure und Methacrylsäuremethylester besteht.5. Medical probe according to claims 1-4, characterized in that the gastric acid-resistant coating consists of an anionic polymer made of methacrylic acid and methyl methacrylate. 6. Medizinische Sonde nach Anspruch 1, dadurch gekennzeichnet, daß die Verschlußkappe (1) aus Hartgelatine, Polyolefin, insbesondere Polyehtylen, oder Silicon besteht.6. Medical probe according to claim 1, characterized in that the closure cap (1) consists of hard gelatin, polyolefin, in particular polyethylene, or silicone. 7. Medizinische Sonde nach Anspruch 1, dadurch gekennzeichnet, daß die Verschlußkappe (1) einen Metallkopf (7) aus Edelstahl aufweist.7. Medical probe according to claim 1, characterized in that the closure cap (1) has a metal head (7) made of stainless steel. 8. Medizinische Sonde nach Anspruch 6, dadurch gekennzeichnet, daß der Metallkopf (7) ein Halsteil (7a), das stopfenförmig in das Schlauchende eingefügt ist und eine Bohrung (11) zur Aufnahme des distalen Endes eines Mandrins (6) aufweist.8. Medical probe according to claim 6, characterized in that the metal head (7) has a neck part (7a) which is inserted in the shape of a plug in the end of the tube and has a bore (11) for receiving the distal end of a stylet (6). 9. Medizinische Sonde nach Anspruch 1, dadurch gekennzeichnet, daß der Sondenschlauch an seinem proximalen Ende eine Anschlußeinrichtung aufweist.9. Medical probe according to claim 1, characterized in that the probe tube has a connecting device at its proximal end. 10.Medizinische Sonde nach Anspruch 1 - 9, dadurch gekennzeichnet, daß die Anschlußeinrichtung ein Konnektorteil mit einem Luerkonus oder einen Steckanschluß aufweist.10.Medical probe according to claim 1-9, characterized in that the connection device has a connector part with a Luer cone or a plug connection.
EP85103028A 1984-03-16 1985-03-15 Medical tube Expired EP0155009B1 (en)

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EP0155009A3 EP0155009A3 (en) 1986-07-23
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AT (1) ATE47308T1 (en)
AU (1) AU577839B2 (en)
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Also Published As

Publication number Publication date
ES296032Y (en) 1989-02-01
ES296032U (en) 1988-05-16
ATE47308T1 (en) 1989-11-15
EP0155009B1 (en) 1989-10-18
AU577839B2 (en) 1988-10-06
EP0155009A3 (en) 1986-07-23
DE3573721D1 (en) 1989-11-23
DE3409663A1 (en) 1985-09-19
PT80114B (en) 1986-10-28
DE3409663C2 (en) 1987-02-19
AU3976885A (en) 1985-09-19
PT80114A (en) 1985-04-01
US4692152A (en) 1987-09-08

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