EP0853937A1 - Gastrostomy tube device for enteral nutrition - Google Patents
Gastrostomy tube device for enteral nutrition Download PDFInfo
- Publication number
- EP0853937A1 EP0853937A1 EP97203914A EP97203914A EP0853937A1 EP 0853937 A1 EP0853937 A1 EP 0853937A1 EP 97203914 A EP97203914 A EP 97203914A EP 97203914 A EP97203914 A EP 97203914A EP 0853937 A1 EP0853937 A1 EP 0853937A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- tubular body
- duct
- gastrostomic
- 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.)
- Granted
Links
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.
Abstract
Description
Claims (7)
- Gastrostomic tube device of the type comprising a tubular body (10) which can be inserted through a stoma in the patient's abdominal wall, the tubular body having a first end provided with an inflatable balloon (44) in order to be maintained inside the gastric cavity, and a second end having a base resting and maintained on the patient's epidermis, the second end being provided with removable closure means (28) and on-off valve means (22), characterised in that the tubular body (10) is divided into at least two ducts (12, 40), of which a first duct (12) of larger diameter is suitable for the passage of nutritional material and is connected to the removable closure means (28) and also to the on-off valve means (22), while a second duct (40) is connected to the inflatable balloon (44) and is provided with a non-return valve (38) arranged at the external end relative to the patient's epidermis, the second duct (40) being constituted by a thin-walled tube of material opaque to X-rays, and the device also comprising position-marking means (48) of material opaque to X-rays on the outer surface of the tubular body.
- Gastrostomic tube device according to Claim 1, characterised in that the second duct (40) is formed, with a small diameter, in the thickness of the wall of the first duct (12) using material opaque to X-rays, and in that the balloon (44), in the non-inflated state, is constituted by a tubular extension (60) of the first end of the tubular body (10), which extension is folded back onto the outer surface of the first end of the tubular body and is secured in a sealing manner to the outer surface of the tubular body in such a manner as to envelop the lower outlet mouth of the second duct.
- Gastrostomic tube device according to Claim 1 or Claim 2, characterised in that the position-marking means (48) are constituted by a thin silver ring which, during the manufacture of the tubular body (10), is anchored to the outer surface thereof.
- Gastrostomic tube device according to Claim 3, characterised in that the silver ring is anchored to the outer surface of the tubular body (10) in a position adjacent to that of the tubular extension (60) after the latter has been folded back onto the outer surface of the tubular body (10).
- Gastrostomic tube device according to any one of Claims 2 to 4, characterised in that the tubular extension (60) which is to form the balloon (44) and which has a reduced and variable thickness is arranged concentrically on the outside of the tubular body (10), to the outer surface of which it is secured permanently.
- Gastrostomic tube device according to any one of the preceding Claims, in which the second duct (40) is obtained by overmoulding.
- Gastrostomic tube device according to any one of Claims 2 to 6, wherein the tubular extension (60) is fixed firmly to the outer surface of the tubular body (10), to which surface it is secured by the adhesive bonding of one end (61) only.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ITMI962627 | 1996-12-16 | ||
IT96MI002627A IT1289453B1 (en) | 1996-12-16 | 1996-12-16 | GASTROSTOMIC TUBE DEVICE FOR ENTERAL NUTRITION |
Publications (2)
Publication Number | Publication Date |
---|---|
EP0853937A1 true EP0853937A1 (en) | 1998-07-22 |
EP0853937B1 EP0853937B1 (en) | 2003-04-02 |
Family
ID=11375400
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP97203914A Expired - Lifetime EP0853937B1 (en) | 1996-12-16 | 1997-12-12 | Gastrostomy tube device for enteral nutrition |
Country Status (4)
Country | Link |
---|---|
EP (1) | EP0853937B1 (en) |
DE (1) | DE69720400T2 (en) |
ES (1) | ES2191810T3 (en) |
IT (1) | IT1289453B1 (en) |
Cited By (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2003039383A1 (en) | 2001-11-08 | 2003-05-15 | Fresenius Kabi Deutschland Gmbh | Obturator for a catheter, length probe for determining the length of the stoma and set for enteral feeding |
WO2003101522A1 (en) * | 2002-05-31 | 2003-12-11 | Kimberly-Clark Worldwide, Inc. | Low profile transplyoric jejunostomy system |
WO2005016222A1 (en) * | 2003-08-06 | 2005-02-24 | Kimberly-Clark Worldwide, Inc. | Ferrule and enteral tube incorporating a ferrule |
WO2005016221A1 (en) * | 2003-08-06 | 2005-02-24 | Kimberly-Clark Worldwide, Inc. | Connector with connection mechanism adapted for releasable interconnection with tube |
US7582072B2 (en) | 2004-09-09 | 2009-09-01 | Kimberly-Clark Worldwide, Inc. | Artificial stoma and method of use |
WO2012134196A2 (en) * | 2011-04-01 | 2012-10-04 | 관동대학교 산학협력단 | Nasogastric tube for training to swallow using a balloon, and method for training to swallow using same |
WO2013059558A1 (en) * | 2011-10-20 | 2013-04-25 | Covidien Lp | Fistula catheter |
WO2014009824A1 (en) * | 2012-07-13 | 2014-01-16 | Kimberly-Clark Worldwide, Inc. | Feeding tube tip reinforcement |
EP1974685A4 (en) * | 2006-01-13 | 2015-05-27 | Olympus Medical Systems Corp | Indwelling medical device |
US10071026B2 (en) | 2012-05-25 | 2018-09-11 | Cook Medical Technologies Llc | Low profile gastrostomy tubes |
JP2021037347A (en) * | 2020-11-26 | 2021-03-11 | 株式会社ジェイ・エム・エス | Male connector |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN112754814A (en) * | 2021-01-12 | 2021-05-07 | 李香珍 | Gastroenterology nursing is fed with liquid food and is eaten device |
Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4225371A (en) * | 1979-04-24 | 1980-09-30 | The Kendall Company | Method of making a catheter |
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 |
US4702252A (en) * | 1983-10-13 | 1987-10-27 | Smiths Industries Public Limited Company | Catheters |
EP0318918A2 (en) * | 1987-12-01 | 1989-06-07 | Terumo Kabushiki Kaisha | Balloon cathether |
US4863424A (en) * | 1983-11-18 | 1989-09-05 | Blake Joseph W Iii | Tubular medical device and method of making and using the same |
EP0408198A1 (en) * | 1989-07-14 | 1991-01-16 | Smiths Industries Public Limited Company | 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/en active IP Right Grant
-
1997
- 1997-12-12 ES ES97203914T patent/ES2191810T3/en not_active Expired - Lifetime
- 1997-12-12 DE DE69720400T patent/DE69720400T2/en not_active Expired - Lifetime
- 1997-12-12 EP EP97203914A patent/EP0853937B1/en not_active Expired - Lifetime
Patent Citations (9)
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 |
US4323071B1 (en) * | 1978-04-24 | 1990-05-29 | Advanced Cardiovascular System | |
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 |
EP0318918A2 (en) * | 1987-12-01 | 1989-06-07 | Terumo Kabushiki Kaisha | Balloon cathether |
EP0408198A1 (en) * | 1989-07-14 | 1991-01-16 | Smiths Industries Public Limited Company | 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 |
Cited By (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2003039383A1 (en) | 2001-11-08 | 2003-05-15 | Fresenius Kabi Deutschland Gmbh | Obturator for a catheter, length probe for determining the length of the stoma and set for enteral feeding |
WO2003101522A1 (en) * | 2002-05-31 | 2003-12-11 | Kimberly-Clark Worldwide, Inc. | Low profile transplyoric jejunostomy system |
WO2005016222A1 (en) * | 2003-08-06 | 2005-02-24 | Kimberly-Clark Worldwide, Inc. | Ferrule and enteral tube incorporating a ferrule |
WO2005016221A1 (en) * | 2003-08-06 | 2005-02-24 | Kimberly-Clark Worldwide, Inc. | Connector with connection mechanism adapted for releasable interconnection with tube |
US7582072B2 (en) | 2004-09-09 | 2009-09-01 | Kimberly-Clark Worldwide, Inc. | Artificial stoma and method of use |
EP1974685A4 (en) * | 2006-01-13 | 2015-05-27 | Olympus Medical Systems Corp | Indwelling medical device |
KR101264670B1 (en) | 2011-04-01 | 2013-05-15 | 관동대학교산학협력단 | Nasogastric tube with a baloon and Method for training swallowing using the same |
WO2012134196A3 (en) * | 2011-04-01 | 2012-12-27 | 관동대학교 산학협력단 | Nasogastric tube for training to swallow using a balloon, and method for training to swallow using same |
WO2012134196A2 (en) * | 2011-04-01 | 2012-10-04 | 관동대학교 산학협력단 | Nasogastric tube for training to swallow using a balloon, and method for training to swallow using same |
WO2013059558A1 (en) * | 2011-10-20 | 2013-04-25 | Covidien Lp | Fistula catheter |
WO2013070414A1 (en) * | 2011-10-20 | 2013-05-16 | Covidien Lp | Fistula catheter |
US8961456B2 (en) | 2011-10-20 | 2015-02-24 | Covidien Lp | Fistula catheter |
US10071026B2 (en) | 2012-05-25 | 2018-09-11 | Cook Medical Technologies Llc | Low profile gastrostomy tubes |
WO2014009824A1 (en) * | 2012-07-13 | 2014-01-16 | Kimberly-Clark Worldwide, Inc. | Feeding tube tip reinforcement |
CN104507443A (en) * | 2012-07-13 | 2015-04-08 | 阿文特公司 | Feeding tube tip reinforcement |
JP2015521934A (en) * | 2012-07-13 | 2015-08-03 | キンバリー クラーク ワールドワイド インコーポレイテッド | Strengthening the tip of the feeding tube |
US9700489B2 (en) | 2012-07-13 | 2017-07-11 | Avent, Inc. | Feeding tube tip reinforcement |
JP2021037347A (en) * | 2020-11-26 | 2021-03-11 | 株式会社ジェイ・エム・エス | Male connector |
Also Published As
Publication number | Publication date |
---|---|
ES2191810T3 (en) | 2003-09-16 |
ITMI962627A1 (en) | 1998-06-16 |
DE69720400D1 (en) | 2003-05-08 |
DE69720400T2 (en) | 2003-10-09 |
ITMI962627A0 (en) | 1996-12-16 |
EP0853937B1 (en) | 2003-04-02 |
IT1289453B1 (en) | 1998-10-15 |
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