EP0155009A2 - Sonde médicale - Google Patents

Sonde médicale 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
Authority
EP
European Patent Office
Prior art keywords
probe
probe according
medical probe
distal end
tube
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
Other languages
German (de)
English (en)
Other versions
EP0155009A3 (en
EP0155009B1 (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, 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.

Landscapes

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

Family

ID=6230695

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)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4000570A1 (de) * 1990-01-10 1991-07-11 Pfrimmer Viggo Gmbh Co Kg Sonde zum einfuehren in eine koerperhoehle
EP0500756A4 (en) * 1989-11-13 1993-01-13 Boston Scientific Corporation Catheter with dissolvable tip

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US5670111A (en) * 1990-01-10 1997-09-23 Rochester Medical Corporation Method of shaping structures with an overcoat layer including female urinary catheter
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US5269770A (en) * 1990-01-10 1993-12-14 Rochester Medical Corporation Microcidal agent releasing catheter with balloon
US5037387A (en) * 1990-01-24 1991-08-06 Corpak, Inc. Method of positioning an enteral feeding tube within a patient's body
US5152756A (en) * 1990-01-24 1992-10-06 Corpak, Inc. Distal gripping tip for enteral feeding tube
US5242429A (en) * 1992-05-14 1993-09-07 Nwaneri Ngozika J Enteral feeding tube with guide wire
US5401257A (en) * 1993-04-27 1995-03-28 Boston Scientific Corporation Ureteral stents, drainage tubes and the like
AT402683B (de) * 1995-05-16 1997-07-25 Hafslund Nycomed Pharma Gerät für endoskopische oder laparoskopische applikation von chirurgischem material
US5795288A (en) * 1996-08-08 1998-08-18 Cohen; Kenneth L. Apparatus with valve for treating incontinence
US5792042A (en) * 1996-08-08 1998-08-11 Cohen; Kenneth L. Apparatus for treating incontinence in females
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US6511474B1 (en) 2000-07-12 2003-01-28 Corpak, Inc. Bolus for non-occluding high flow enteral feeding tube
US20030225369A1 (en) * 2002-05-31 2003-12-04 Kimberly-Clark Worldwide, Inc. Low profile transpyloric jejunostomy system
US20030225392A1 (en) * 2002-05-31 2003-12-04 Kimberly-Clark Worldwide, Inc. Low profile transpyloric jejunostomy system and method to enable
US20030225393A1 (en) * 2002-05-31 2003-12-04 Kimberly-Clark Worldwide, Inc. Low profile transpyloric jejunostomy system and method to enable
US7976518B2 (en) 2005-01-13 2011-07-12 Corpak Medsystems, Inc. Tubing assembly and signal generator placement control device and method for use with catheter guidance systems
US7785291B2 (en) * 2005-03-01 2010-08-31 Tulip Medical Ltd. Bioerodible self-deployable intragastric implants
US8864730B2 (en) 2005-04-12 2014-10-21 Rochester Medical Corporation Silicone rubber male external catheter with absorbent and adhesive
US9265865B2 (en) 2006-06-30 2016-02-23 Boston Scientific Scimed, Inc. Stent having time-release indicator
USD561329S1 (en) 2006-10-04 2008-02-05 Kimberly-Clark Worldwide, Inc. Low profile transpyloric jejunostomy catheter
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US9707375B2 (en) 2011-03-14 2017-07-18 Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. Catheter grip and method
WO2013036772A1 (fr) 2011-09-08 2013-03-14 Corpak Medsystems, Inc. Appareil et procédé utilisés avec un système de guidage pour l'alimentation et l'aspiration
EP2570107A1 (fr) * 2011-09-15 2013-03-20 Ludwig-Maximilians-Universität München Ensemble de tube gastrique auto-applicable
US10507127B2 (en) 2012-06-07 2019-12-17 Epitomee Medical Ltd. Expandable device
US9872969B2 (en) 2012-11-20 2018-01-23 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Catheter in bag without additional packaging
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CN105899198A (zh) 2013-12-05 2016-08-24 图利普医疗有限公司 用于药物活性试剂的原位释放的滞留装置和系统
KR102462510B1 (ko) 2014-08-26 2022-11-01 씨. 알. 바드, 인크. 요로 카테터
JP7350722B2 (ja) 2017-09-19 2023-09-26 シー・アール・バード・インコーポレーテッド 尿カテーテルブリッジ装置、そのシステムおよび方法

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0500756A4 (en) * 1989-11-13 1993-01-13 Boston Scientific Corporation Catheter with dissolvable tip
DE4000570A1 (de) * 1990-01-10 1991-07-11 Pfrimmer Viggo Gmbh Co Kg Sonde zum einfuehren in eine koerperhoehle

Also Published As

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

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