EP0853937B1 - Tube de gastrostomie pour nutrition entérale - Google Patents
Tube de gastrostomie pour nutrition entérale Download PDFInfo
- Publication number
- EP0853937B1 EP0853937B1 EP97203914A EP97203914A EP0853937B1 EP 0853937 B1 EP0853937 B1 EP 0853937B1 EP 97203914 A EP97203914 A EP 97203914A EP 97203914 A EP97203914 A EP 97203914A EP 0853937 B1 EP0853937 B1 EP 0853937B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- tubular body
- gastrostomic
- duct
- tube device
- balloon
- 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 - Lifetime
Links
- 235000016709 nutrition Nutrition 0.000 title claims description 7
- 230000035764 nutrition Effects 0.000 title description 5
- 239000000463 material Substances 0.000 claims description 15
- 230000002496 gastric effect Effects 0.000 claims description 11
- 210000002615 epidermis Anatomy 0.000 claims description 7
- 238000004026 adhesive bonding Methods 0.000 claims description 6
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical group [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 claims description 5
- 238000007789 sealing Methods 0.000 claims description 5
- 210000003815 abdominal wall Anatomy 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 4
- 230000000284 resting effect Effects 0.000 claims description 2
- 210000002784 stomach Anatomy 0.000 description 6
- 210000000214 mouth Anatomy 0.000 description 5
- 239000000243 solution Substances 0.000 description 4
- 235000013305 food Nutrition 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 239000000523 sample Substances 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- 230000015572 biosynthetic process Effects 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 210000002249 digestive system Anatomy 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 235000015097 nutrients Nutrition 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 235000001674 Agaricus brunnescens Nutrition 0.000 description 1
- 206010010071 Coma Diseases 0.000 description 1
- 208000003443 Unconsciousness Diseases 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 230000000737 periodic effect Effects 0.000 description 1
- 238000011458 pharmacological treatment Methods 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 238000002601 radiography Methods 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 238000011144 upstream manufacturing Methods 0.000 description 1
- 230000003313 weakening effect Effects 0.000 description 1
Images
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
- A61J15/0026—Parts, details or accessories for feeding-tubes
- A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
- A61J15/0034—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters
- A61J15/0038—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type
- A61J15/0042—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type inflatable
-
- 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
- A61J15/0015—Gastrostomy 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
- A61J15/00—Feeding-tubes for therapeutic purposes
- A61J15/0026—Parts, details or accessories for feeding-tubes
- A61J15/0053—Means for fixing the tube outside of the body, e.g. by a special shape, by fixing it to the skin
- A61J15/0065—Fixing means and tube being one part
-
- 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
- A61J15/008—Sensor means, e.g. for sensing reflux, acidity or pressure
- A61J15/0088—Sensor means, e.g. for sensing reflux, acidity or pressure for sensing parameters related to the device
Definitions
- the present invention relates in general to gastrostomic devices for medical use, in particular for the long-term enteric nutrition of patients incapable of the natural ingestion of food and/or medicaments.
- a solution generally adopted is that of introducing nasally one or more tubes extending as far as the inside of the gastric or intestinal cavity (nasogastric probe or nasojejunal probe).
- PEG Percutaneous Endoscopic Gastrostomy
- the gastrostomic tubes or “buttons” currently in use are principally of two types, namely the “balloon” and “mushroom” types, and they differ from one another principally in the form of the retaining element inside the gastric cavity and in the methods of insertion into the above-mentioned tissue passageway or "stoma" of the patient.
- the tube is introduced by means of an obturator inserted into the internal hole of the gastrostomic tube and urged in such a manner as to confer on the mushroom-head retaining element an elongate, substantially conical, profile in order to reduce its diameter and thus to facilitate passage through the stoma, releasing it when it has passed completely into the gastric cavity.
- an obturator inserted into the internal hole of the gastrostomic tube and urged in such a manner as to confer on the mushroom-head retaining element an elongate, substantially conical, profile in order to reduce its diameter and thus to facilitate passage through the stoma, releasing it when it has passed completely into the gastric cavity.
- the introduction of the balloon device is easier because it is carried out with the balloon completely deflated and adhering to the tube walls.
- the balloon is inflated and it thus maintains the end of the gastrostomic tube inside the stomach.
- the external end of the gastrostomic tube is for its part provided with a plug or a non-return valve which enables the end to be connected periodically to a supply of nutrient material or the like to be introduced into the stomach (in addition to permitting the expulsion of air or gas present in the gastric cavity).
- the length of the gastrostomic tube is of course chosen in accordance with the length of the stoma.
- the balloon-type gastrostomic devices or tubes known and constructed hitherto comprise several components assembled at the manufacturing stage, and therefore require substantial labour, but, in particular, the regions of adhesion of the various components are the critical points of the device, compromising its aesthetic and functional quality.
- tubular part a longitudinal strip produced from co-extruded radiopaque material which usually involves the entire thickness of the tube wall.
- This solution involves a weakening of that portion of the device and a reduction in the adhesiveness of the material in the regions where the expanding balloon is to be adhesively bonded.
- the principal aim of the present invention is to provide a gastrostomic tube device which is improved both from the structural point of view and from the functional point of view.
- the aim of the present invention is to provide a gastrostomic tube device of which the structure permits practical industrial manufacture and, at the same time, easy location of the position of the device using radiographic techniques.
- a device of the type comprising a tubular element which can be inserted through a stoma in the patient's abdominal wall, the tubular element having a first end provided with an inflatable balloon in order to be maintained inside the gastric cavity, and a second end which has a base resting and maintained on the patient's epidermis and which is provided with removable closure means and on-off valve means, characterised in that the tubular element is divided into two ducts, the first duct, having the larger diameter, being used for the passage of the nutritional material and being connected to the removable closure means and to the on-off valve means, and the second duct, having walls produced from radiopaque material, being connected to the inflatable balloon and being provided with a non-return valve arranged at the external end relative to the patient's epidermis, and position-marking means of material opaque to X-rays are provided on the outer surface of the gastrostomic tube.
- the second duct is formed, with a small diameter, in the thickness of the wall of the first duct, the balloon, in the non-inflated state, is constituted by a tubular extension, of variable thickness, of the first end of the tubular element, and the tubular extension is folded back onto the outer surface of the first end of the tubular element and is secured in a sealing manner to the outer surface of the tubular element in such a manner as to envelop the lower outlet mouth of the second duct.
- the position-marking means are preferably constituted by a thin silver ring which, during the manufacture of the tubular element, is anchored to the outer surface thereof, and is covered by the tubular extension forming the balloon during the adhesive bonding stage.
- the silver ring is used to indicate exactly the position of the proximal point of attachment of the balloon, while a further tube of small thickness produced from radiopaque material is inserted coaxially in the small-diameter duct in order to indicate the position of the tubular portion of the device.
- the gastrostomic tube device which, as shown by the Figures, is produced in a single piece from biocompatible plastics material (for example by means of injection or "transfer") comprises a tubular element or body, generally indicated 10, which comprises a first duct or principal duct 12 having a distal end 14 and a proximal end 16.
- the proximal end 16 starts from a cylindrical or discoidal body 18 and more precisely from a chamber 20 which accommodates a separate and removable non-return valve 22 which can be connected to a bayonet coupling 24 of an elbow connector 26 which can in turn be connected to a supply of nutrient material.
- the upper end of the chamber 20 is shaped in such a manner as to permit the releasable connection of a plug 28 formed with a strip 30 which is in a single piece with the discoidal body 18 and which is provided with a notch 32 promoting the bending of the strip.
- the discoidal body 18 has a flat base 34, which is to rest on the patient's epidermis in the area of the outer mouth of the stoma or tissue duct of the patient, and, in addition to the chamber 20, comprises a second chamber 36 which accommodates an inflating and non-return valve 38 communicating with the proximal end of a second duct 40 which extends parallel to the duct 12 over a portion of its length and which is formed in the thickness of the wall of the tubular body 10.
- the distal end of the duct 40 has a hole 42 which, as shown in Figure 1, communicates with the inside of the balloon 44, which is shown in that Figure in the inflated position and thus in the position in which it maintains the tubular body 10 inside the gastric cavity.
- the balloon 44 is formed by a tubular extension 50 or 60 of the tubular body 10.
- the upstream or proximal end 51 of the tubular extension 50 which is shown in the state before the balloon is inflated, is fixed firmly to the outer surface of the tubular body 10, while the distal end 53 is secured in position when the device is being finished (for example by adhesive bonding or heat-sealing) in the region of the distal end 14 of the tubular body 10.
- the proximal end 51 of the tubular extension 50 envelops the outlet mouth 42 of the second duct 40.
- FIG. 4 An alternative embodiment of the device is that represented in Figure 4 which shows how the balloon 44 is in this case formed by a tubular jacket 60 of reduced thickness which is concentric with the tubular body 10.
- the tubular jacket 60 is secured permanently to the outer surface of the tubular body (for example, by heat-sealing or by means of a suitable adhesive) in the area of its distal end 61 once it has been folded back onto the tubular body 10 to the extent that it envelops the mouth 42 of the duct 40.
- the proximal end 63 of the balloon 60 like the proximal end 51 of the embodiment of Figure 3, is fixed firmly to the outer surface of the tubular body 10.
- a ring of material opaque to X-rays for example a silver ring 48
- a ring of material opaque to X-rays is positioned on the outer surface of the tubular body at a predetermined distance from the base 34 of the discoidal body 18, and is simultaneously secured by adhesive bonding to the end 61 of the tubular extension 60 in the case of the embodiment of Figure 4.
- the ring is adjacent to the limit of the balloon 44 and therefore, using simple radiography, it is possible to establish from the position of the ring 48 whether the balloon 44 and thus the gastrostomic device is positioned correctly in the gastric cavity.
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)
- Media Introduction/Drainage Providing Device (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Claims (7)
- Dispositif à tube de gastrostomie comprenant un corps tubulaire (10) qui peut être inséré à travers une stomie dans la paroi abdominale du patient, le corps tubulaire ayant une première extrémité proposée avec un ballon gonflable (44) ayant une extrémité proximale et une extrémité distale afin d'être maintenu à l'intérieur de la cavité gastrique, et une seconde extrémité ayant une base qui reste et qui est maintenu sur l'épiderme du patient, la seconde extrémité étant pourvue d'un moyen de fermeture amovible (28) et d'un moyen de soupape marche-arrêt (22), le corps tubulaire (10) est divisé en au moins deux conduits (12,40), dont un premier conduit (12) de plus grand diamètre est approprié au passage d'élément nutritionnel et est relié au moyen de fermeture amovible (28) et aussi au moyen de soupape marche-arrêt (22), alors qu'un second conduit (40) est relié au ballon gonflable (44) et il est pourvu d'un clapet de non-retour (38) disposé à l'extrémité externe par rapport à l'épiderme du patient, caractérisé en ce que le second conduit (40) est constitué par un tube à paroi mince en matière opaque aux rayons X, et que le dispositif comprend aussi un moyen de marquage de position (48) en matière opaque aux rayons X sur la surface extérieure du corps tubulaire adjacent à l'extrémité proximale du ballon.
- Dispositif à tube de gastrostomie selon la revendication 1, caractérisé en ce que le second conduit (40) est formé, avec un petit diamètre, dans l'épaisseur de la paroi du premier conduit (12) en utilisant une matière opaque aux rayons X, et en ce que le ballon (44), à l'état de non-gonflement, est constitué par une extension tubulaire (60) de la première extrémité du corps tubulaire (10), cette extension étant repliée sur la surface externe de la première extrémité du corps tubulaire et étant fixée hermétiquement à la surface externe du corps tubulaire de telle façon qu'elle enveloppe la bouche de sortie inférieure du second conduit.
- Dispositif de tube de gastrostomie selon la revendication 1 ou la revendication 2, caractérisé en ce que les moyens de marquage de position (48) sont constitués d'un mince anneau d'argent qui, pendant la fabrication du corps tubulaire (10), est ancré à la surface externe de celui-ci.
- Dispositif de tube de gastrostomie selon la revendication 3, caractérisé en ce que l'anneau d'argent est ancré à la surface externe du corps tubulaire (10) dans une position adjacente à celle de l'extension tubulaire (60), une fois que cette dernière a été rabattue sur la surface extérieure du corps tubulaire (10).
- Dispositif de tube de gastrostomie selon l'une quelconque des revendications 2 à 4, caractérisé en ce que l'extension tubulaire (60) qui forme le ballon (44) et qui a une épaisseur réduite et variable est disposée sur l'extérieur du corps tubulaire (10), concentriquement à la surface externe à laquelle elle est fixée de façon permanente.
- Dispositif de tube de gastrostomie selon l'une quelconque des revendications précédentes, dans lequel le second conduit (40) est obtenu par surmoulage.
- Dispositif de tube de gastrostomie selon l'une quelconque des revendications 2 à 6, dans lequel l'extension tubulaire (60) est fixée fermement à la surface externe du corps tubulaire (10), surface à laquelle elle est fixée par un collage adhésif à une extrémité (61) uniquement.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IT96MI002627A IT1289453B1 (it) | 1996-12-16 | 1996-12-16 | Dispositivo a tubo gastrostomico per nutrizione enterale |
ITMI962627 | 1996-12-16 |
Publications (2)
Publication Number | Publication Date |
---|---|
EP0853937A1 EP0853937A1 (fr) | 1998-07-22 |
EP0853937B1 true EP0853937B1 (fr) | 2003-04-02 |
Family
ID=11375400
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP97203914A Expired - Lifetime EP0853937B1 (fr) | 1996-12-16 | 1997-12-12 | Tube de gastrostomie pour nutrition entérale |
Country Status (4)
Country | Link |
---|---|
EP (1) | EP0853937B1 (fr) |
DE (1) | DE69720400T2 (fr) |
ES (1) | ES2191810T3 (fr) |
IT (1) | IT1289453B1 (fr) |
Families Citing this family (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE10154864A1 (de) | 2001-11-08 | 2003-05-28 | Fresenius Kabi De Gmbh | Mandrin für einen Katheter, Längenmesser zur Bestimmung der Stomalänge und Set zur enteralen Ernährung |
US20030225369A1 (en) * | 2002-05-31 | 2003-12-04 | Kimberly-Clark Worldwide, Inc. | Low profile transpyloric jejunostomy system |
US20050033267A1 (en) * | 2003-08-06 | 2005-02-10 | Kimberly-Clark Worldwide, Inc. | Connector with connection mechanism adapted for releasable interconnection with tube |
US20050033269A1 (en) * | 2003-08-06 | 2005-02-10 | Kimberly-Clark Worldwide, Inc. | Ferrule and enteral tube incorporating a ferrule |
US7582072B2 (en) | 2004-09-09 | 2009-09-01 | Kimberly-Clark Worldwide, Inc. | Artificial stoma and method of use |
TWI428111B (zh) * | 2006-01-13 | 2014-03-01 | Olympus Medical Systems Corp | 醫療用保持器 |
KR101264670B1 (ko) * | 2011-04-01 | 2013-05-15 | 관동대학교산학협력단 | 풍선을 이용한 삼킴 훈련용 비위관 및 이를 이용한 삼킴훈련방법 |
JP5756734B2 (ja) | 2011-10-20 | 2015-07-29 | 日本コヴィディエン株式会社 | 瘻孔カテーテル |
EP2666455B1 (fr) | 2012-05-25 | 2017-02-01 | Cook Medical Technologies LLC | Tubes de gastrostomie à profil bas |
US9700489B2 (en) * | 2012-07-13 | 2017-07-11 | Avent, Inc. | Feeding tube tip reinforcement |
JP2021037347A (ja) * | 2020-11-26 | 2021-03-11 | 株式会社ジェイ・エム・エス | オスコネクタ |
CN112754814A (zh) * | 2021-01-12 | 2021-05-07 | 李香珍 | 一种消化科护理用流食喂食装置 |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4323071A (en) * | 1978-04-24 | 1982-04-06 | Advanced Catheter Systems, Inc. | Vascular guiding catheter assembly and vascular dilating catheter assembly and a combination thereof and methods of making the same |
US4225371A (en) * | 1979-04-24 | 1980-09-30 | The Kendall Company | Method of making a catheter |
US4702252A (en) * | 1983-10-13 | 1987-10-27 | Smiths Industries Public Limited Company | Catheters |
US4863424A (en) * | 1983-11-18 | 1989-09-05 | Blake Joseph W Iii | Tubular medical device and method of making and using the same |
JPH01145074A (ja) * | 1987-12-01 | 1989-06-07 | Terumo Corp | バルーンカテーテル |
GB8916158D0 (en) * | 1989-07-14 | 1989-08-31 | Smiths Industries Plc | Catheters |
US5342321A (en) * | 1993-05-18 | 1994-08-30 | Teleflex, Inc. | Low profile gastrostomy catheter |
US5556385A (en) * | 1994-12-06 | 1996-09-17 | Corpak, Inc. | Improved percutaneous access device |
-
1996
- 1996-12-16 IT IT96MI002627A patent/IT1289453B1/it active IP Right Grant
-
1997
- 1997-12-12 DE DE69720400T patent/DE69720400T2/de not_active Expired - Lifetime
- 1997-12-12 ES ES97203914T patent/ES2191810T3/es not_active Expired - Lifetime
- 1997-12-12 EP EP97203914A patent/EP0853937B1/fr not_active Expired - Lifetime
Also Published As
Publication number | Publication date |
---|---|
ITMI962627A0 (it) | 1996-12-16 |
ES2191810T3 (es) | 2003-09-16 |
ITMI962627A1 (it) | 1998-06-16 |
IT1289453B1 (it) | 1998-10-15 |
DE69720400T2 (de) | 2003-10-09 |
DE69720400D1 (de) | 2003-05-08 |
EP0853937A1 (fr) | 1998-07-22 |
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