EP0155009B1 - Sonde médicale - Google Patents

Sonde médicale Download PDF

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Publication number
EP0155009B1
EP0155009B1 EP85103028A EP85103028A EP0155009B1 EP 0155009 B1 EP0155009 B1 EP 0155009B1 EP 85103028 A EP85103028 A EP 85103028A EP 85103028 A EP85103028 A EP 85103028A EP 0155009 B1 EP0155009 B1 EP 0155009B1
Authority
EP
European Patent Office
Prior art keywords
probe
distal end
tube
metal head
closure cap
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.)
Expired
Application number
EP85103028A
Other languages
German (de)
English (en)
Other versions
EP0155009A3 (en
EP0155009A2 (fr
Inventor
Carsten Dr. Freie Universität Berlin Emde
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius SE and Co KGaA
Original Assignee
Fresenius SE and Co KGaA
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Fresenius SE and Co KGaA filed Critical Fresenius SE and Co KGaA
Priority to AT85103028T priority Critical patent/ATE47308T1/de
Publication of EP0155009A2 publication Critical patent/EP0155009A2/fr
Publication of EP0155009A3 publication Critical patent/EP0155009A3/de
Application granted granted Critical
Publication of EP0155009B1 publication Critical patent/EP0155009B1/fr
Expired legal-status Critical Current

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Classifications

    • 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, according to the features of the preamble of claim 1.
  • 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. or is connected to the stylet, and a stylet.
  • the stylet serves to temporarily stiffen the relatively soft probe tube. It facilitates 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 special nutrition 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.
  • nasogastric nasoduodenal and nasojejunal special nutrition.
  • probes with a sealing cap have previously been used as a guide bolus (e.g. made of mercury or water).
  • a guide bolus e.g. made of mercury or water.
  • placement of the feeding tubes requires intact gastroduodenal peristalsis. Occasionally, these probes can also be placed intraoperatively.
  • the nasoduodenal and nasojejunal feeding tubes are used primarily in the field of conservative medicine for unconscious patients, long-term ventilation patients, relaxed patients and for 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 known from DE-A 3 105 883, DE-A 2914609, DE-A 2 402 573, DE-A 2 524 030, DE-A 2 810 326, DE-A 2 721 548, the article by Rueff et al. in Kunststoff Medical Weekly (1968, pages 470-474) and the catalog of the company Hinsch (1977, pages 15-19).
  • the balloon is glued to the probe with an agent that is soluble in the small intestine and can be removed by detaching after placement.
  • 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 after placement lies safely and does not disturb the digestive process.
  • a cap enlarged in this way 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 acceptable solidifying substances, such as agar, alginic acids, starches, arabic gum, pectin PVP, methyl cellulose and gelatin, 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 broken down after placing the probe.
  • the thickness of the thickening layer is not critical and the coating layer should, however, be so thick that the placement of the probe is improved to the desired extent, but on the other hand does not hinder the placement of the probe, i.e. should be such that the probe bolus offers a favorable point of attack for peristalsis. Suitable thicknesses are 3-6, in particular 4-5 mm with a probe diameter of approximately 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 is applied to a customary cap or stopper made of a suitable, medically compatible material, such as hard gelatin or plastic (e.g. made of polyolefin, in particular polyethylene, or silicone) arranged in the distal end of the probe tube.
  • a suitable, medically compatible material such as hard gelatin or plastic (e.g. made of polyolefin, in particular polyethylene, or silicone) arranged in the distal end of the probe tube.
  • a coat or a further coating layer made of acid-resistant material is applied on the thickening layer of the 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.
  • a material for this further coating layer one is used which is resistant to gastric acid or gastric juice, but in intestinal juice, i.e. in the intestinal milieu, is soluble.
  • Such materials are medically safe materials, such as anionic polymers made from methacrylic acid and methyl methacrylate, and mixtures thereof with other materials and with one another.
  • Anionic polymers of methacrylic acid and methyl methacrylate such as Eudragit S, Eudragit L and mixtures thereof (manufactured by Röhm Pharma), in particular Eudragit S, are preferred.
  • Shellack 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 preventing any removal of the probe from the duodenum or jejunum. Suitable thicknesses are approximately 10-30 ⁇ 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 advantageously has a metal head or metal plug in its bore, which is arranged at the distal end of the probe tube, or the closure cap can be designed as a metal head or metal plug.
  • 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.
  • 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 sealing cap designed as a metal head or over the sealing cap comprising a metal head made of suitable, medically compatible material such as hard gelatin or plastic (e.g. polyolefin, such as polyethylene or silocon), over which the coating layer of gastric juice-resistant, in Intestinal juice soluble material, is applied.
  • suitable, medically compatible material such as hard gelatin or plastic (e.g. polyolefin, such as polyethylene or silocon), over which the coating layer of gastric juice-resistant, in Intestinal juice soluble material, is applied.
  • the probe tube itself consists of a conventional 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. If the metal head according to the invention is present at the distal end of the probe tube, the stylet 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. This bore is preferably provided in the neck part of the metal head.
  • the probe tube has openings in the usual way in the region of the distal end, which allow 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 is preferably inserted into the distal end of the probe tube in a plug-like manner via a neck-shaped part of the metal piece.
  • 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 in order to cover it with a further coating of gastric juice-resistant material coat what can be done in the usual way, if necessary by spraying.
  • the immersion of the distal end in the heated gelatin mass is preferably done by oblique immersion, i.e. Immerse 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 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.
  • 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 can be resorbed by the patient's body, preferably gelatin, on which 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 bolus of the probe according to the invention according to FIG. 1, the reference numbers corresponding to those used in FIG. 1.
  • the probe tip or the probe bolus 1 with the metal head 7 which is placed on the distal end of the probe tube 2 and is inserted into the tube end in the form of a plug with the neck part 7a is clearly visible in the enlarged representation.
  • the neck part 7a of the metal head 7 has 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.
  • the thickening layer 8 is first applied to the distal end of the probe tube 2 and the metal head 7, and the coating layer 9 made of gastric juice-resistant, intestinal juice-soluble material is applied thereon.
  • the openings 10 in the tube 2 are used for food leakage.
  • the cross section shown in FIG. 3 along the line 11-11 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-soluble Material is surrounded.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Materials For Medical Uses (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (5)

1. Sonde médicale, en particulier pour l'alimentation entérique, consistant en un tube de sonde souple (2) qui présente dans le domaine de son extrémité distale au moins un orifice (10) pour la sortie des aliments et est raccordé à son extrémité distale à un clapet qui présente une forure sur la face tournée vers la lumière du tube de sonde souple (2), et en un mandrin (6) qui peut être introduit dans la lumière de la sonde, caractérisée en ce que le clapet comprend une tête métallique (7) dans sa forure ou est façonné en forme de tête métallique (7), que la tête métallique (7) comprend une forure (11) dans laquelle l'extrémité distale du mandrin (6) peut être insérée, que le clapet est entouré d'une couche d'épaississement (8) d'une matière résorbable par le corps du patient et que la couche d'épaississement (8) est recouverte d'une couche de revêtement (9) d'une matière résistante au suc gastrique et soluble dans le suc intestinal.
2. Sonde médicale suivant la revendication 1, caractérisée en ce que la couche d'épaississement (8) consiste en gélatine.
3. Sonde médicale suivant la revendication 2, caractérisée en ce que l'épaississement en gélatine consiste en gélatine molle.
4. Sonde médicale suivant la revendication 1, caractérisée en ce que le revêtement résistant au suc gastrique consiste en un polymère anionique d'acide méthacrylique et d'ester méthylique d'acide méthacrylique.
5. Sonde médicale suivant la revendication 1, caractérisée en ce que la tête métallique (7) comprend une partie du col (7a) qui est insérée comme un bouchon dans l'extrémité du tube souple.
EP85103028A 1984-03-16 1985-03-15 Sonde médicale Expired EP0155009B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT85103028T ATE47308T1 (de) 1984-03-16 1985-03-15 Medizinische sonde.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE3409663 1984-03-16
DE3409663A DE3409663C2 (de) 1984-03-16 1984-03-16 Medizinische Sonde

Publications (3)

Publication Number Publication Date
EP0155009A2 EP0155009A2 (fr) 1985-09-18
EP0155009A3 EP0155009A3 (en) 1986-07-23
EP0155009B1 true EP0155009B1 (fr) 1989-10-18

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP85103028A Expired EP0155009B1 (fr) 1984-03-16 1985-03-15 Sonde médicale

Country Status (7)

Country Link
US (1) US4692152A (fr)
EP (1) EP0155009B1 (fr)
AT (1) ATE47308T1 (fr)
AU (1) AU577839B2 (fr)
DE (2) DE3409663C2 (fr)
ES (1) ES296032Y (fr)
PT (1) PT80114B (fr)

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FR2499858A1 (fr) * 1981-02-18 1982-08-20 Ruesch Gmbh & Co Kg Willy Sonde pour traitement intestinal

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PT80114A (en) 1985-04-01
ES296032Y (es) 1989-02-01
US4692152A (en) 1987-09-08
EP0155009A3 (en) 1986-07-23
ES296032U (es) 1988-05-16
AU3976885A (en) 1985-09-19
DE3573721D1 (en) 1989-11-23
ATE47308T1 (de) 1989-11-15
DE3409663C2 (de) 1987-02-19
EP0155009A2 (fr) 1985-09-18
DE3409663A1 (de) 1985-09-19
PT80114B (en) 1986-10-28
AU577839B2 (en) 1988-10-06

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