EP2037863B1 - Gastrostomy tube, production methods thereof and insertion tool - Google Patents
Gastrostomy tube, production methods thereof and insertion tool Download PDFInfo
- Publication number
- EP2037863B1 EP2037863B1 EP07787194A EP07787194A EP2037863B1 EP 2037863 B1 EP2037863 B1 EP 2037863B1 EP 07787194 A EP07787194 A EP 07787194A EP 07787194 A EP07787194 A EP 07787194A EP 2037863 B1 EP2037863 B1 EP 2037863B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- tube
- bulb
- strips
- wall
- 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.)
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Links
- 238000003780 insertion Methods 0.000 title claims abstract 5
- 230000037431 insertion Effects 0.000 title claims abstract 5
- 238000004519 manufacturing process Methods 0.000 title claims abstract 4
- 238000000605 extraction Methods 0.000 claims description 7
- 239000000463 material Substances 0.000 claims description 5
- 229920002635 polyurethane Polymers 0.000 claims description 5
- 239000004814 polyurethane Substances 0.000 claims description 5
- 230000002496 gastric effect Effects 0.000 claims description 4
- 238000010438 heat treatment Methods 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 229920003023 plastic Polymers 0.000 claims 1
- 239000004033 plastic Substances 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 description 4
- 230000000694 effects Effects 0.000 description 3
- 210000002784 stomach Anatomy 0.000 description 3
- 241000446313 Lamella Species 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 241000222122 Candida albicans Species 0.000 description 1
- 229940095731 candida albicans Drugs 0.000 description 1
- 210000004051 gastric juice Anatomy 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 239000012815 thermoplastic material Substances 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
-
- 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
- A61J15/0015—Gastrostomy feeding-tubes
Definitions
- the invention relates to a gastrostomy tube according to claim 1 which has at its distal end a deformable bulb between a so-called stable configuration where the bulb is too wide to pass through a passage ("stoma") formed through the skin and the gastric wall and a so-called retaining configuration, caused by the action of appropriate solicitation, where the bulb is sufficiently reduced to pass in said passage, the bulb elastically resuming its stable configuration when the solicitation is removed, as well as a gastrostomy tube placement instrument.
- stomy tube which has at its distal end a deformable bulb between a so-called stable configuration where the bulb is too wide to pass through a passage (“stoma") formed through the skin and the gastric wall and a so-called retaining configuration, caused by the action of appropriate solicitation, where the bulb is sufficiently reduced to pass in said passage, the bulb elastically resuming its stable configuration when the solicitation is removed, as well as a gastrostomy tube placement instrument.
- EP 0742708 discloses an embodiment in which the distal end of the tube is open and has been expanded and curved to form a hollow retaining bulb around the end of the tube, this end remaining protruding forward of the bulb.
- the material of the bulb is chosen so that the bulb is elastically deformable from one configuration to another under the effect of an action exerted on the bulb from the outside of the skin.
- this deformation can be caused by a pull on the tube.
- the present invention aims to avoid such an accident.
- a gastrostomy tube which has at its distal end a bulb adapted to retain the tube in the gastric cavity and adapted to be elastically reduced on demand to allow the introduction or extraction of the tube by the stoma, characterized in that the bulb is constituted by wall lamellae formed in an area of the wall of the tube remote from the end of the distal end, these lamellae being separated by slots in the wall of the tube but remaining attached to this wall at each end of the lamella, in that the lamellae have been curved outwards to form the bulb, and in that the end of the distal end of the tube is recessed in the bulb, so that it is necessary to push this end out of the bulb so that the slats are stretched and return to their original positions, which eliminates the bulb and allows to introduce or remove the tube by the stoma.
- the gastrostomy tube shown in the figures is a rectilinear cylindrical tube (1) which has at its distal end a closed end (2).
- the end is completely closed but, in variants, it could include orifices provided that they do not compromise the possibility of pushing the end by means of a mandrel introduced by the other end (3). (open) of the tube.
- slots (4), ( figure 1 ) have been made in a zone (5) of the wall of the tube, at a distance, but preferably not far from the closed end (2), so as to determine in the wall of the tube wall lamellae, each lamella (6) being determined by two successive slits and remaining adjacent to the tube at each end (6a, 6b) of the slat.
- the slots (4) can be directed parallel to the axis of the tube, which is the simplest case, or be oblique with respect to this axis.
- the slots can be made by cutting or molding.
- the closed end (2) of the tube is then pushed axially towards the open end (3) of the tube, which forces the slats (6) to bend outwardly of the tube forming a bulb (10) to inside which is the closed end (2) which has been pushed back ( figures 2 and 3 ).
- the ready-to-use tube therefore has the bulb at its closed end.
- a stoma (9) into the gastric cavity (7), it is stretched by means of a mandrel (8) introduced into the tube to push the closed end (2) and return the lamellae in the wall of the tube ( Figure 5A ).
- each slat (6) before being connected to the tube near the closed end (2) has an inflection (10) which constitutes a pre-bend opposite the elongation so that a force exerted on the tube ( figure 4 ) would cause the bulb to contract without being sufficiently reduced to allow extraction of the tube by the stoma.
- the tube has been shown in a simplified manner, especially with regard to its open end (3) which will remain outside the skin in a manner known per se.
- the number of lamellae (6) which are like the petals of the bulb is chosen on demand and it is for example four.
- the invention is not limited to the embodiment which has been described.
- a polyurethane tube or the like is used.
- Polyurethane is a thermoplastic material that is injected into a mold or extruded at temperatures of 170 to 200 ° C. It can also be formed hot in an oven at 150 ° C.
- the polyurethane material is best suited for this use, because of its resistance to gastric juices, bacteria (candida albicans), its biocompatibility, its elasticity.
- the laying instrument (100) comprises a body (110) and a mandrel (8).
- the mandrel (8) has a shaft (122) extending along a longitudinal axis X of the delivery instrument (100), a distal end (123) and a proximal end bent at about 90 ° including a sleeve (121). .
- the body (110) is of cylindrical shape which can be of revolution about the longitudinal axis X. It comprises at a proximal end a handle (115). Further, at a distal end (130), the body (110) has a thread (133) extending along a length in the direction of the longitudinal axis X, and two flats (134) which are diametrically opposed to each other according to the longitudinal axis X. In addition, the distal end (130) of the body (110) comprises a groove (131) circumferential and oriented substantially perpendicular to the axis X, which is adapted to receive a circlip (132).
- the thread (133) extends approximately distally from the groove (131) to a proximally abutment (135) forming a stop.
- the body (110) has a slot (112) substantially perpendicular to the longitudinal axis X and extending about 90 ° along a circumference of the body (110), and a series of slots (111) inclined relative to the longitudinal axis X and substantially parallel to each other. This series of slots (111), like the slot (112), extend over substantially 90 ° along a circumference of the body (110).
- the body (110) has a longitudinal slot (113) substantially parallel to the longitudinal axis X, along a generatrix of the body (110) which connects the ends located on the same side of the slots (112) and (111).
- the body (110) has an X-axis longitudinal hole extending from the distal end (130) to at least the slot (112).
- the distal end (123) of the mandrel shank (122) is inserted into the longitudinal X-axis hole through the slot (113). of the body (110).
- the shank (122) is threaded into this X-axis longitudinal hole until the angled proximal end of the mandrel (8) can be inserted into the slot (112) of the body (110).
- a nut (141) is screwed onto the distal end (130) to engage the threads (133) of the body (110).
- the circlip (132) is mounted in the groove (131) of the distal end (130) of the body (110).
- This circlip (132) serves as a stop to the nut (141), when the latter is screwed or unscrewed towards the distal end of the body (110).
- a sleeve (142) is fitted onto the nut (141) to provide an assembly (140).
- the sleeve (142) is screwed onto the nut (141) or welded or glued.
- the sleeve (142) has at a distal end (144) two bayonets (145) diametrically opposite one another along the longitudinal axis X of the laying instrument (100).
- the gastrostomy tube (1) Prior to the use of the delivery instrument (100), the gastrostomy tube (1) according to the invention is equipped with a base (20) having mounting means (23) on the gastrostomy tube (1). ) located on a lower face of the base (20). On an upper face of the base (20), the latter has an opening (21) on the periphery of which are located, diametrically opposed to the longitudinal axis X, notches (24), here at the number of two. Finally, the base (20) has a plug (22) adapted to come into the orifice (21) to close the gastrostomy tube sealingly. Further information concerning the base (20) and its mounting on the gastrostomy tube (1) are contained in the French patent application no. FR 0606140 , to which it is possible to refer.
- the assembly (140) formed of the sleeve (142) and the nut (141) is screwed onto the body (110) of the laying instrument (100) towards a distal end until the nut (141) comes into abutment against the circlip (132).
- the proximal end bent of the mandrel (8) is placed in the slot (112) of the body (110) of the delivery instrument (100), the distal end (123) of the mandrel (8) protruding from the distal end of the sleeve (142).
- the distal end (123) of the mandrel (8) is introduced into the gastrostomy tube (1) through the orifice (21) of the base (20) along the longitudinal axis X in the direction of the F1 arrow.
- a movement along the arrow F1 is performed until the distal end (144) of the sleeve (142) is introduced into the orifice (21) of the base (20), the bayonets (145) passing through the notches (24).
- the sleeve (140) is then locked in the base (20) during a rotational movement T1 about the axis X in order to make the base (20) and the laying instrument (100) integral with a bayonet assembly, as illustrated in figure 9b .
- the bent proximal end of the mandrel (8) is extracted from the slot (112) to the longitudinal slot (113). Therefore, the mandrel (8) can slide in a movement F2 while the bent proximal end moves within the longitudinal slot (113).
- the movement F2 is carried out lightly until the distal end (123) of the mandrel (8) comes into contact with the closed end (2) of the gastrostomy tube (1), the bulb (10) of the tube gastrostomy (1) is then formed at rest.
- the bent proximal end of the mandrel (8) is then inserted into one of the slots (111) which are then facing, in a rotational movement T3. Therefore, the body (110) is rotated along T4 which has the effect of screwing the body (110) into the assembly (140) by engagement of the nut (142) of the assembly (140) on the thread (133) of the distal end (130) of the body (110) of the delivery instrument (100) . This screwing movement takes place over a predetermined and limited distance (d).
- the nut (142) of the assembly (140) then abuts at a proximal end of the thread (133) on the flange (135), as illustrated in FIG. figure 9f .
- the distal end (123) of the mandrel (8) pushes the closed end (2) of the gastrostomy tube (1) out of the bulb (10) until the latter disappears. the blades forming the bulb (10) being completely stretched, the distance (d) traveled.
- the gastrostomy tube (1) can be either removed from the patient or introduced into the patient through the stoma.
- the laying instrument (100) which has just been described and its use avoids having to push the mandrel manually and directly to stretch the lamellae forming the bulb and thus avoid the risk of perforating the wall opposite of the stomach if the mandrel passes through or escapes from the closed end of the gastrostomy tube.
- the laying instrument (100) is adjustable according to the length of the gastrostomy tube with which it is intended to cooperate and this laying instrument then allows a thrust stroke always identical, necessary for stretching the lamellae forming the bulb. The controlled realization of this race assures the user that the gastrostomy tube is ready to be placed or removed.
- the laying instrument (100) according to the invention allows manipulation with optimum safety of a gastrostomy tube according to the invention.
- the invention is not limited either to the embodiment which has been described or to the material which has been recommended.
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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)
- Pulmonology (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
Abstract
Description
L'invention concerne un tube de gastrostomie d'après la revendication 1 qui présente à son extrémité distale un bulbe déformable entre une configuration stable dite de retenue où ce bulbe est trop large pour passer dans un passage (« stoma ») formé à travers la peau et la paroi gastrique et une configuration dite de retenue, provoquée par l'action d'une sollicitation appropriée, où ce bulbe est suffisamment réduit pour passer dans ledit passage, le bulbe reprenant élastiquement sa configuration stable lorsque la sollicitation est supprimée, ainsi qu'un instrument de pose de tube de gastrostomie.The invention relates to a gastrostomy tube according to
La publication
La publication
Dans les deux cas, le matériau du bulbe est choisi pour que le bulbe soit élastiquement déformable d'une configuration à l'autre sous l'effet d'une action exercée sur le bulbe depuis l'extérieur de la peau.In both cases, the material of the bulb is chosen so that the bulb is elastically deformable from one configuration to another under the effect of an action exerted on the bulb from the outside of the skin.
De fait, dans les exemples susdits, cette déformation peut être provoquée par une traction exercée sur le tube.In fact, in the aforementioned examples, this deformation can be caused by a pull on the tube.
Il peut arriver que cette traction soit exercée par le patient de façon inopportune.It may happen that this traction is exerted by the patient inappropriately.
La présente invention vise à éviter un tel accident.The present invention aims to avoid such an accident.
On y parvient selon l'invention avec un tube de gastrostomie qui présente à son extrémité distale un bulbe apte à retenir le tube dans la cavité gastrique et apte à être réduit élastiquement à la demande pour permettre l'introduction ou l'extraction du tube par le stoma, caractérisé en ce que le bulbe est constitué par des lamelles de paroi formées dans une zone de la paroi du tube à distance du bout de l'extrémité distale, ces lamelles étant séparées par des fentes de la paroi du tube mais restant attenantes à cette paroi à chaque extrémité de la lamelle, en ce que les lamelles ont été incurvées vers l'extérieur pour constituer le bulbe, et en ce que le bout de l'extrémité distale du tube est en retrait dans le bulbe, en sorte qu'il soit nécessaire de repousser ce bout hors du bulbe pour que les lamelles soient étirées et reprennent leurs positions d'origine, ce qui supprime le bulbe et permet d'introduire ou de retirer le tube par le stoma.It is achieved according to the invention with a gastrostomy tube which has at its distal end a bulb adapted to retain the tube in the gastric cavity and adapted to be elastically reduced on demand to allow the introduction or extraction of the tube by the stoma, characterized in that the bulb is constituted by wall lamellae formed in an area of the wall of the tube remote from the end of the distal end, these lamellae being separated by slots in the wall of the tube but remaining attached to this wall at each end of the lamella, in that the lamellae have been curved outwards to form the bulb, and in that the end of the distal end of the tube is recessed in the bulb, so that it is necessary to push this end out of the bulb so that the slats are stretched and return to their original positions, which eliminates the bulb and allows to introduce or remove the tube by the stoma.
Il a été proposé dans
Pour repousser le bout du tube suivant l'invention on utilise un mandrin que l'on introduit à la demande dans le tube.To push the end of the tube according to the invention is used a mandrel that is introduced on demand in the tube.
Il a été proposé (brevet
On décrira ci-après un exemple de réalisation d'un tube de gastrostomie conforme à l'invention, en référence aux figures du dessin joint sur lequel :
- la
figure 1 est un schéma longitudinal d'un exemple de réalisation d'un tube de gastrostomie conforme à l'invention, au cours d'une phase préparatoire à la formation d'un bulbe à une extrémité du tube ; - la
figure 1 bis est une coupe axiale du tube de lafigure 1 ; - la
figure 2 est un schéma analogue au cours de la formation du bulbe ; - la
figure 2 bis est une coupe horizontale du bulbe ; - la
figure 3 est une vue de bout du bulbe formé ; - la
figure 4 représente des schémas du bulbe en coupe verticale au cours de différentes phases d'une traction exercée sur le tube ; - la
figure 5 représente des schémas du tube au cours d'une opération d'introduction du tube dans le stoma ; - la
figure 6 représente des schémas du tube au cours d'une opération d'extraction du tube hors du stoma ; - les
figures 7a et 7b sont des vues de face et profil d'un instrument de pose d'un tube de gastrostomie selon l'invention, l'instrument ne présentant pas de manchon ; - les
figures 8a et 8b sont une vue partielle de profil de l'extrémité distale de l'instrument de pose d'un tube de gastrostomie desfigures 7a et 7b montrant le montage du manchon ; et - les
figures 9a à 9f sont des vues tridimentionnelles des différentes étapes d'utilisation de l'instrument de pose d'un tube de gastrostomie desfigures 7a à 8b avec un tube de gastrostomie selon l'invention.
- the
figure 1 is a longitudinal diagram of an exemplary embodiment of a gastrostomy tube according to the invention, during a preparatory phase for the formation of a bulb at one end of the tube; - the
figure 1 bis is an axial section of the tube of thefigure 1 ; - the
figure 2 is a similar pattern during the formation of the bulb; - the
figure 2 bis is a horizontal section of the bulb; - the
figure 3 is an end view of the bulb formed; - the
figure 4 represents diagrams of the bulb in vertical section during different phases of a pull on the tube; - the
figure 5 represents schemas of the tube during an operation of introduction of the tube into the stoma; - the
figure 6 represents schemas of the tube during an extraction operation of the tube out of the stoma; - the
Figures 7a and 7b are front views and profile of an instrument for fitting a gastrostomy tube according to the invention, the instrument having no sleeve; - the
Figures 8a and 8b are a partial profile view of the distal end of the instrument for fitting a gastrostomy tubeFigures 7a and 7b showing the fitting of the sleeve; and - the
Figures 9a to 9f are three-dimensional views of the different stages of use of the instrument for placing a gastrostomy tubeFigures 7a to 8b with a gastrostomy tube according to the invention.
Le tube de gastrostomie représenté sur les figures est un tube cylindrique rectiligne (1) qui présente à son extrémité distale un bout fermé (2). Dans cet exemple, le bout est intégralement fermé mais, dans des variantes, il pourrait comporter des orifices à condition que ceux-ci ne compromettent pas la possibilité de pousser le bout au moyen d'un mandrin introduit par l'autre extrémité (3) (ouverte) du tube.The gastrostomy tube shown in the figures is a rectilinear cylindrical tube (1) which has at its distal end a closed end (2). In this example, the end is completely closed but, in variants, it could include orifices provided that they do not compromise the possibility of pushing the end by means of a mandrel introduced by the other end (3). (open) of the tube.
Conformément à l'invention, des fentes (4),(
Les fentes (4) peuvent être dirigées parallèlement à l'axe du tube, ce qui est le cas le plus simple, ou être obliques par rapport à cet axe.The slots (4) can be directed parallel to the axis of the tube, which is the simplest case, or be oblique with respect to this axis.
Les fentes peuvent être réalisées par découpage ou par moulage.The slots can be made by cutting or molding.
Le bout fermé (2) du tube est ensuite repoussé axialement en direction de l'extrémité ouverte (3) du tube, ce qui force les lamelles (6) à se courber vers l'extérieur du tube en formant un bulbe (10) à l'intérieur duquel se trouve le bout fermé (2) qui a été repoussé (
Lors de cet écrasement, le bout du tube a tourné sur lui-même en sorte que les lamelles qui constituent le bulbe ont subi un certain vrillage.During this crash, the tip of the tube turned on itself so that the slats that constitute the bulb have undergone some twisting.
Pour figer le bulbe dans sa forme, on chauffe l'extrémité du tube.To freeze the bulb in its shape, the end of the tube is heated.
Le tube prêt à l'emploi présente donc le bulbe à son extrémité fermée. Pour introduire le tube par un stoma (9) jusque dans la cavité gastrique (7), on l'étire au moyen d'un mandrin (8) introduit dans le tube pour repousser le bout fermé (2) et ramener les lamelles dans la paroi du tube (
On retire ensuite le mandrin (
On remarquera sur la
Pour que cette extraction soit possible, il faut réintroduire un mandrin dans le tube pour repousser le bout fermé et allonger le tube jusqu'à supprimer le bulbe (
Sur les
Le nombre des lamelles (6) qui constituent comme les pétales du bulbe est choisi à la demande et il est par exemple de quatre.
L'invention n'est pas limitée à la réalisation qui a été décrite.The number of lamellae (6) which are like the petals of the bulb is chosen on demand and it is for example four.
The invention is not limited to the embodiment which has been described.
De préférence, on utilise un tube en polyuréthane ou similaire.Preferably, a polyurethane tube or the like is used.
Le polyuréthane est un matériau thermoplastique qu'on injecte dans un moule ou qu'on extrude à des températures de 170 à 200°C. On peut aussi le former à chaud dans un four à 150°C.Polyurethane is a thermoplastic material that is injected into a mold or extruded at temperatures of 170 to 200 ° C. It can also be formed hot in an oven at 150 ° C.
Dans l'estomac et à la température ambiante, il garde sa forme et est élastique. Quand on le déforme, il reprend sa forme dès la cessation de l'effort.In the stomach and at room temperature, it keeps its shape and is elastic. When it is deformed, it resumes its form at the end of the effort.
Le matériau polyuréthane est le mieux adapté à cette utilisation, de part sa résistance aux sucs gastriques, aux bactéries (candida albicans), sa biocompatibilité, son élasticité.The polyurethane material is best suited for this use, because of its resistance to gastric juices, bacteria (candida albicans), its biocompatibility, its elasticity.
En référence aux
L'instrument de pose (100) comporte un corps (110) et un mandrin (8).The laying instrument (100) comprises a body (110) and a mandrel (8).
Le mandrin (8) comporte une tige (122) s'étendant selon un axe longitudinal X de l'instrument de pose (100), une extrémité distale (123) et une extrémité proximale coudée à 90° environ comprenant un manchon (121).The mandrel (8) has a shaft (122) extending along a longitudinal axis X of the delivery instrument (100), a distal end (123) and a proximal end bent at about 90 ° including a sleeve (121). .
Le corps (110) est de forme cylindrique qui peut être de révolution autour de l'axe longitudinal X. Il comporte à une extrémité proximale une poignée (115). En outre, au niveau d'une extrémité distale (130), le corps (110) comporte un filetage (133) s'étendant sur une certaine longueur selon la direction de l'axe longitudinal X, ainsi que deux méplats (134) qui sont diamétralement opposés l'un par rapport à l'autre selon l'axe longitudinal X. De plus, l'extrémité distale (130) du corps (110) comprend une gorge (131) circonférentielle et orientée sensiblement perpendiculairement à l'axe X, qui est apte à recevoir un circlips (132). Le filetage (133) s'étend depuis distalement environ la gorge (131) jusqu'a proximalement un rebord (135) formant butée. Entre la poignée (115) et le filetage (133), le corps (110) comporte une fente (112) sensiblement perpendiculaire à l'axe longitudinal X et s'étendant sur environ 90° selon une circonférence du corps (110), ainsi qu'une série de fentes (111) inclinées par rapport à l'axe longitudinal X et sensiblement parallèles entre elles. Cette série de fentes (111), comme la fente (112), s'étendent sur sensiblement 90° selon une circonférence du corps (110). De plus, le corps (110) comporte une fente longitudinale (113) sensiblement parallèle à l'axe longitudinal X, selon une génératrice du corps (110) qui relie entre elles les extrémités situées d'un même côté des fentes (112) et (111). D'autre part, le corps (110) comporte un trou longitudinal d'axe X s'étendant de l'extrémité distale (130) à au moins la fente (112).The body (110) is of cylindrical shape which can be of revolution about the longitudinal axis X. It comprises at a proximal end a handle (115). Further, at a distal end (130), the body (110) has a thread (133) extending along a length in the direction of the longitudinal axis X, and two flats (134) which are diametrically opposed to each other according to the longitudinal axis X. In addition, the distal end (130) of the body (110) comprises a groove (131) circumferential and oriented substantially perpendicular to the axis X, which is adapted to receive a circlip (132). The thread (133) extends approximately distally from the groove (131) to a proximally abutment (135) forming a stop. Between the handle (115) and the thread (133), the body (110) has a slot (112) substantially perpendicular to the longitudinal axis X and extending about 90 ° along a circumference of the body (110), and a series of slots (111) inclined relative to the longitudinal axis X and substantially parallel to each other. This series of slots (111), like the slot (112), extend over substantially 90 ° along a circumference of the body (110). In addition, the body (110) has a longitudinal slot (113) substantially parallel to the longitudinal axis X, along a generatrix of the body (110) which connects the ends located on the same side of the slots (112) and (111). On the other hand, the body (110) has an X-axis longitudinal hole extending from the distal end (130) to at least the slot (112).
Lors d'un montage de l'instrument de pose (100), l'extrémité distale (123) de la tige (122) du mandrin (8) est introduite dans le trou longitudinal d'axe X à travers la fente (113) du corps (110). La tige (122) est enfilée dans ce trou longitudinal d'axe X jusqu'à ce que l'extrémité proximale coudée du mandrin (8) puisse être introduite dans la fente (112) du corps (110). Un écrou (141) est vissé sur l'extrémité distale (130) de manière à ce qu'il soit en prise avec les filets (133) du corps (110). Ensuite, le circlips (132) est monté dans la gorge (131) de l'extrémité distale (130) du corps (110). Ce circlips (132) sert de butée à l'écrou (141), lorsque ce dernier est vissé ou dévissé vers l'extrémité distale du corps (110). Un manchon (142) est emmanché sur l'écrou (141) afin de réaliser un ensemble (140). Dans une variante de réalisation, le manchon (142) est vissé sur l'écrou (141) ou soudé ou collé. Le manchon (142) présente à une extrémité distale (144) deux baïonnettes (145) diamétralement opposées l'une par rapport à l'autre selon l'axe longitudinal X de l'instrument de pose (100).When mounting the delivery instrument (100), the distal end (123) of the mandrel shank (122) is inserted into the longitudinal X-axis hole through the slot (113). of the body (110). The shank (122) is threaded into this X-axis longitudinal hole until the angled proximal end of the mandrel (8) can be inserted into the slot (112) of the body (110). A nut (141) is screwed onto the distal end (130) to engage the threads (133) of the body (110). Then, the circlip (132) is mounted in the groove (131) of the distal end (130) of the body (110). This circlip (132) serves as a stop to the nut (141), when the latter is screwed or unscrewed towards the distal end of the body (110). A sleeve (142) is fitted onto the nut (141) to provide an assembly (140). In an alternative embodiment, the sleeve (142) is screwed onto the nut (141) or welded or glued. The sleeve (142) has at a distal end (144) two bayonets (145) diametrically opposite one another along the longitudinal axis X of the laying instrument (100).
En référence aux
Préalablement à l'utilisation de l'instrument de pose (100), le tube de gastrostomie (1) selon l'invention est équipé d'une embase (20) présentant des moyens de montage (23) sur le tube de gastrostomie (1) situé sur une face inférieure de l'embase (20). Sur une face supérieure de l'embase (20), cette dernière présente une ouverture (21) à la périphérie de laquelle se situent, de manière diamétralement opposée par rapport à l'axe longitudinal X, des encoches (24), ici au nombre de deux. Enfin, l'embase (20) présente un bouchon (22) apte à venir dans l'orifice (21) pour fermer le tube de gastrostomie de manière étanche. De plus amples renseignements concernant l'embase (20) et son montage sur le tube de gastrostomie (1) sont contenus dans la demande de brevet en France n°
Dans un premier temps, l'ensemble (140) formé du manchon (142) et de l'écrou (141) est vissé sur le corps (110) de l'instrument de pose (100) vers une extrémité distale jusqu'à ce que l'écrou (141) vienne en butée contre le circlips (132). L'extrémité proximale coudée du mandrin (8) est placée dans la fente (112) du corps (110) de l'instrument de pose (100), l'extrémité distale (123) du mandrin (8) dépassant de l'extrémité distale du manchon (142). Ensuite, l'extrémité distale (123) du mandrin (8) est introduite dans le tube de gastrostomie (1) à travers l'orifice (21) de l'embase (20) selon l'axe longitudinal X dans le sens de la flèche F1. Un mouvement selon la flèche F1 est effectué jusqu'à ce que l'extrémité distale (144) du manchon (142) soit introduite dans l'orifice (21) de l'embase (20), les baïonnettes (145) passant par les encoches (24). Le manchon (140) est alors bloqué dans l'embase (20) lors d'un mouvement de rotation T1 autour de l'axe X afin de rendre solidaires l'embase (20) et l'instrument de pose (100) par un montage dit « baïonnette », tel qu'illustré en
Puis, selon un mouvement de rotation T2, l'extrémité proximale coudée du mandrin (8) est extraite de la fente (112) jusqu'à la fente longitudinale (113). Dès lors, le mandrin (8) peut coulisser selon un mouvement F2 alors que l'extrémité proximale coudée se déplace au sein de la fente longitudinale (113). Le mouvement F2 est effectué de manière légère jusqu'à ce que l'extrémité distale (123) du mandrin(8) vienne en contact avec le bout fermé (2) du tube de gastrostomie (1), le bulbe (10) du tube de gastrostomie (1) étant alors formé au repos. Une fois l'extrémité distale (123) du mandrin (8) en appui de contact avec le bout fermé (2), l'extrémité proximale coudée du mandrin (8) est alors insérée dans l'une fentes (111) se trouvant alors en regard, selon un mouvement de rotation T3. Dès lors, le corps (110) est mis en mouvement de rotation selon T4 qui a pour conséquence de visser le corps (110) dans l'ensemble (140) par coopération de l'écrou (142) de l'ensemble (140) sur le filetage (133) de l'extrémité distale (130) du corps (110) de l'instrument de pose (100). Ce mouvement de vissage s'effectue sur une distance prédéterminée et limitée (d). Une fois la distance (d) parcourue, l'écrou (142) de l'ensemble (140) vient alors en butée au niveau d'une extrémité proximale du filetage (133) sur le rebord (135), comme cela est illustré en
L'instrument de pose (100) qui vient d'être décrit et son utilisation évitent d'avoir à pousser de manière manuelle et directe le mandrin afin d'étirer les lamelles formant le bulbe et de ce fait évitent le risque de perforer la paroi opposée de l'estomac si le mandrin traverse ou échappe du bout fermé du tube de gastrostomie. De plus, grâce à la série de fentes (111), l'instrument de pose (100) est réglable en fonction de la longueur du tube de gastrostomie avec lequel il est destiné à coopérer et cet instrument de pose permet ensuite une course de poussée toujours identique nécessaire à l'étirage des lamelles formant le bulbe. La réalisation contrôlée de cette course assure l'utilisateur que le tube de gastrostomie est prêt à être posé ou enlevé. Ceci est surtout important lors d'un retrait du tube de gastrostomie, car l'utilisateur ne voit pas l'état de déformation du bulbe dans l'estomac avant le retrait. De ce fait, l'instrument de pose (100) selon l'invention permet une manipulation avec une sécurité optimale d'un tube de gastrostomie selon l'invention.The laying instrument (100) which has just been described and its use avoids having to push the mandrel manually and directly to stretch the lamellae forming the bulb and thus avoid the risk of perforating the wall opposite of the stomach if the mandrel passes through or escapes from the closed end of the gastrostomy tube. In addition, thanks to the series of slots (111), the laying instrument (100) is adjustable according to the length of the gastrostomy tube with which it is intended to cooperate and this laying instrument then allows a thrust stroke always identical, necessary for stretching the lamellae forming the bulb. The controlled realization of this race assures the user that the gastrostomy tube is ready to be placed or removed. This is especially important when removing the gastrostomy tube because the user do not see the state of deformation of the bulb in the stomach before removal. Therefore, the laying instrument (100) according to the invention allows manipulation with optimum safety of a gastrostomy tube according to the invention.
L'invention n'est pas limitée ni à la réalisation qui a été décrite ni au matériau qui a été préconisé.The invention is not limited either to the embodiment which has been described or to the material which has been recommended.
Claims (11)
- Gastrostomy tube (1) which at its distal end has a bulb (10) designed to retain the tube in the gastric cavity (7) and suitable for elastic reduction on demand to allow the introduction or extraction of the tube through the stoma, the bulb (10) consisting of strips (6) in an area of the tube wall located at a distance from the end (2) of the distal end, such strips being separated by slits (4) in the wall but remaining adjacent to the wall of the tube at either end (6a, 6b) of the strip, the strips having being curved outwardly to form the bulb (10), characterized in that end (2) of the tube is withdrawn into the bulb so that it is necessary to push the end of the tube out of the bulb for the strips to be extended, thus eliminating the bulb and allowing the tube to be inserted or withdrawn via the stoma.
- A tube according to claim 1 wherein strips (6) forming the bulb are twisted.
- A tube according to claim 1 or 2 wherein each strip (6), before being connected to the tube near end (2) of the distal end has an inflection (10) forming a preliminary curve opposing the extension so that any force applied to the tube (figure 4) causes the bulb to contract without being able to be reduced sufficiently to allow the extraction of the tube through the stoma.
- A tube according to one of claims 1 to 3 whose slits (4) in the tube wall are parallel to the tube wall.
- A tube according to one of claims 1 to 4 whose said end (2) is closed.
- A tube according to one of claims 1 to 5 the material of which is polyurethane or similar.
- A process for manufacturing a tube according to one of claims 1 to 6, comprising operations consisting in splitting a closed tube at one end to form in the wall of the tube said wall strips, crushing the closed end of the tube to push the strips outward and form the bulb and heating the tube to stabilise the bulb.
- A process of manufacturing a tube according to one of claims 1 to 6 wherein the tube is moulded by the injection of polyurethane plastic or similar material into a mould forming the tube, its closed end and said slits, then crushing the end of the tube to form the bulb and heating the tube to stabilise the bulb.
- Insertion tool (100) for a gastrostomy tube (1) according to one of claims 1 to 6 incorporating a mandrel (8) of which a distal end (123) is designed to come to bear against end (2) of gastrostomy tube (1) characterized wherein it includes means (111, 133 and 140) for gradually driving the mandrel (8) over a limited predetermined distance (d) so that, during implementation, distal end (123) pushes end (2) of tube (1) out of bulb (10) so that strips (6) are drawn out.
- Insertion tool according to claim 9 characterized in that the driving means include a nut (142) meshing with threads (133) and capable of screwing in/out solely along distance (d).
- Insertion tool according to one of claims 9 to 10 characterized in that, the mandrel having a bent proximal end, the driving means comprise a series of slits (111) capable of receiving the bent proximal end.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PL07787194T PL2037863T3 (en) | 2006-07-06 | 2007-07-06 | Gastrostomy tube, production methods thereof and insertion tool |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR0606139A FR2903301B1 (en) | 2006-07-06 | 2006-07-06 | GASTROSTOMY TUBE AND METHODS OF MANUFACTURING THE SAME |
PCT/EP2007/056912 WO2008003784A1 (en) | 2006-07-06 | 2007-07-06 | Gastrostomy tube, production methods thereof and insertion tool |
Publications (2)
Publication Number | Publication Date |
---|---|
EP2037863A1 EP2037863A1 (en) | 2009-03-25 |
EP2037863B1 true EP2037863B1 (en) | 2012-05-16 |
Family
ID=37866251
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP07787194A Active EP2037863B1 (en) | 2006-07-06 | 2007-07-06 | Gastrostomy tube, production methods thereof and insertion tool |
Country Status (10)
Country | Link |
---|---|
US (1) | US20090306600A1 (en) |
EP (1) | EP2037863B1 (en) |
JP (2) | JP2009542270A (en) |
CA (1) | CA2656512C (en) |
DK (1) | DK2037863T3 (en) |
ES (1) | ES2384896T3 (en) |
FR (1) | FR2903301B1 (en) |
PL (1) | PL2037863T3 (en) |
PT (1) | PT2037863E (en) |
WO (1) | WO2008003784A1 (en) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP5762017B2 (en) * | 2011-01-28 | 2015-08-12 | 日本コヴィディエン株式会社 | Fistula catheter |
JP5780778B2 (en) * | 2011-02-25 | 2015-09-16 | 日本コヴィディエン株式会社 | Fistula catheter |
US11103377B1 (en) | 2021-03-31 | 2021-08-31 | Lumopol, Llc | Irising drainage device and irising rectal catheter |
Family Cites Families (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4758219A (en) * | 1985-05-17 | 1988-07-19 | Microvasive, Inc. | Enteral feeding device |
US5193533A (en) * | 1990-07-09 | 1993-03-16 | Brigham And Women's Hospital | High-pressure jet ventilation catheter |
US5112310A (en) * | 1991-02-06 | 1992-05-12 | Grobe James L | Apparatus and methods for percutaneous endoscopic gastrostomy |
US5356391A (en) * | 1992-06-22 | 1994-10-18 | Medical Innovations Corp. | Flexible retainer flange for gastrostomy tube and the method of installing it |
US5273528A (en) * | 1992-07-10 | 1993-12-28 | Skeen Mikell L | Livestock inoculator |
US5257975A (en) * | 1992-08-14 | 1993-11-02 | Edward Weck Incorporated | Cannula retention device |
US5273529A (en) * | 1992-12-04 | 1993-12-28 | Olajire Idowu | Gastrostomy tube with expandable insertion tip |
US5957900A (en) * | 1996-07-10 | 1999-09-28 | Asahi Kogaku Kogyo Kabushiki Kaisha | Treatment accessory for endoscope |
US5749826A (en) * | 1996-11-06 | 1998-05-12 | Faulkner; James W. | Urinary incontinence control device |
US5928260A (en) * | 1997-07-10 | 1999-07-27 | Scimed Life Systems, Inc. | Removable occlusion system for aneurysm neck |
WO2002066108A1 (en) * | 2001-02-15 | 2002-08-29 | Sherwood Services, Ag | Securing device for a low profile gastrostomy tube |
JP4237673B2 (en) * | 2004-05-20 | 2009-03-11 | 日本シャーウッド株式会社 | Gastrostomy tube extender |
JP4721329B2 (en) * | 2005-04-21 | 2011-07-13 | 日本シャーウッド株式会社 | Indwelling device |
-
2006
- 2006-07-06 FR FR0606139A patent/FR2903301B1/en not_active Expired - Fee Related
-
2007
- 2007-07-06 JP JP2009517287A patent/JP2009542270A/en active Pending
- 2007-07-06 EP EP07787194A patent/EP2037863B1/en active Active
- 2007-07-06 PT PT07787194T patent/PT2037863E/en unknown
- 2007-07-06 DK DK07787194.5T patent/DK2037863T3/en active
- 2007-07-06 PL PL07787194T patent/PL2037863T3/en unknown
- 2007-07-06 ES ES07787194T patent/ES2384896T3/en active Active
- 2007-07-06 WO PCT/EP2007/056912 patent/WO2008003784A1/en active Application Filing
- 2007-07-06 US US12/306,354 patent/US20090306600A1/en not_active Abandoned
- 2007-07-06 CA CA2656512A patent/CA2656512C/en active Active
-
2012
- 2012-02-15 JP JP2012030839A patent/JP5273267B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
JP2012115705A (en) | 2012-06-21 |
FR2903301A1 (en) | 2008-01-11 |
JP5273267B2 (en) | 2013-08-28 |
CA2656512A1 (en) | 2008-01-10 |
PT2037863E (en) | 2012-06-26 |
CA2656512C (en) | 2014-08-26 |
FR2903301B1 (en) | 2008-08-29 |
PL2037863T3 (en) | 2012-09-28 |
WO2008003784A1 (en) | 2008-01-10 |
ES2384896T3 (en) | 2012-07-13 |
US20090306600A1 (en) | 2009-12-10 |
DK2037863T3 (en) | 2012-08-13 |
JP2009542270A (en) | 2009-12-03 |
EP2037863A1 (en) | 2009-03-25 |
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