EP0824929B1 - Cathéter percutané d'alimentation entérale - Google Patents

Cathéter percutané d'alimentation entérale Download PDF

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Publication number
EP0824929B1
EP0824929B1 EP97114439A EP97114439A EP0824929B1 EP 0824929 B1 EP0824929 B1 EP 0824929B1 EP 97114439 A EP97114439 A EP 97114439A EP 97114439 A EP97114439 A EP 97114439A EP 0824929 B1 EP0824929 B1 EP 0824929B1
Authority
EP
European Patent Office
Prior art keywords
tube
outer tube
probe
probe tube
support part
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
Application number
EP97114439A
Other languages
German (de)
English (en)
Other versions
EP0824929A2 (fr
EP0824929A3 (fr
Inventor
Judith Resch
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius SE and Co KGaA
Original Assignee
Fresenius SE and Co KGaA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius SE and Co KGaA filed Critical Fresenius SE and Co KGaA
Publication of EP0824929A2 publication Critical patent/EP0824929A2/fr
Publication of EP0824929A3 publication Critical patent/EP0824929A3/fr
Application granted granted Critical
Publication of EP0824929B1 publication Critical patent/EP0824929B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J15/00Feeding-tubes for therapeutic purposes
    • A61J15/0026Parts, details or accessories for feeding-tubes
    • A61J15/0053Means for fixing the tube outside of the body, e.g. by a special shape, by fixing it to the skin
    • A61J15/0061Means for fixing the tube outside of the body, e.g. by a special shape, by fixing it to the skin fixing at an intermediate position on the tube, i.e. tube protruding the fixing means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J15/00Feeding-tubes for therapeutic purposes
    • A61J15/0015Gastrostomy feeding-tubes
    • A61J15/0023Gastrostomy feeding-tubes inserted by using a sheath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J15/00Feeding-tubes for therapeutic purposes
    • A61J15/0026Parts, details or accessories for feeding-tubes
    • A61J15/003Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A61J15/0034Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters
    • A61J15/0038Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type

Definitions

  • the invention relates to a catheter for percutaneous enteral nutrition a tube for feeding a nutrient solution into the gastric lumen is insertable and a holding part that can be placed on the abdominal wall from the outside is.
  • Gastrostomy probes for enteral nutrition are known, which are by means of a Balloons or a flexible cuff are secured against slipping out.
  • the balloon is released filled with a liquid from the outside via a valve or the cuff relaxed.
  • the balloon expands or the cuff unfolds their final shape and the trained retention member fix the system distally.
  • a movable holding device that is connected to the probe tube or is pulled onto the probe tube, supports the catheter from the outside on the abdominal wall.
  • the known catheters for percutaneous enteral nutrition are disadvantageous than the length of the probe tube the length of the stoma channel must correspond. So there are a variety of stoma canals of different lengths offered by probes in discrete lengths. Another disadvantage is that it the length of the stoma channel must be increased before inserting the probe measure up. In addition, it is disadvantageous that for filling the balloon and Stretch the cuff further aids, e.g. a syringe, an obturator or Like. are needed. Otherwise there is a risk that a balloon at Leakage caused by loss of volume from the stoma canal slides out.
  • US-A-4,666,433 describes a catheter for percutaneous enteral Nutrition with a tube for feeding a nutrient solution that is in the gastric lumen is insertable, and a holding part that is on the outside Abdominal wall can be put on.
  • the retention member consists of a piece of hose that is provided with a plurality of circumferentially distributed longitudinal slots. To insert the probe tube, the retaining member is attached by means of a Retracted stylets in the probe tube. Then that will Retaining member advanced again so that it spreads. adversely is that a separate instrument is required for this.
  • the invention has for its object an easy to use To create catheters for percutaneous enteral nutrition that are distal and safe can be fixed proximally, an adaptation to different stoma lengths allowed and against the ingress of stomach acid and other liquids is protected.
  • the probe tube is guided in an outer tube, with probe and Outer tubing connected at its distal ends and axially below Widening of the outer tube can be moved relative to one another.
  • the Widening of the with several circumferentially distributed slots or Outer tube provided with weakening zones is made by a Linear movement of probe and outer hose.
  • the expanding one Outer tube forms a retaining member with which the catheter attaches to the Can support the wall of the stomach. Placing and removing the probe are simple operations that can be carried out without any additional aids can.
  • the displacement of the probe tube or outer tube does not result only to form a restraining member, but also enables the to vary the effective length of the probe tube.
  • the catheter can thus be on different ostomy lengths can be individually adjusted.
  • the outer tube is a balloon-like surface enclosed by a flexible envelope that with the distal end of the outer tube is connected.
  • the wrapping serves as it were to protect the hoses moving against each other and prevent them penetration of stomach acid and other liquids through the Longitudinal slots in the hose arrangement.
  • the Outer tube formed distally such that the sheath described above as thin skin between the webs by forming a locally smaller one Wall thickness is created.
  • the catheter according to the invention can be used endoscopically for percutaneous controlled gastrostomy or as an exchange probe for an existing one Gastric stoma can be used.
  • the outer tube is preferably slotted four times. If foreign and Probe tube are axially displaced against each other, the slotted spread Areas of the outer tube in the manner of an expansion plug, so that a secure hold is guaranteed.
  • the material of the outer tube and / or the wall thickness is to be dimensioned such that the slotted areas on the one hand let it spread slightly and on the other hand have sufficient strength have to ensure a secure hold.
  • Friction surfaces i.e. on the inner wall of the outer tube or the outer wall a lubricant, e.g. Silicone or MCT oil applied become.
  • a lubricant e.g. Silicone or MCT oil applied
  • the probe and outer tubing are adjusted and locked advantageously on the holding part of the catheter, which on the abdominal wall of the Patient rests.
  • the holding part expediently has one with the proximal end of the probe tube connected connector, preferably a Luerl-Lock connector, on that with the connector of the known Transfer hoses can be connected.
  • a check valve may be used to prevent from the stomach.
  • the outer tube is on one Fixed adjustment element, which is guided in the holding part linearly displaceable, while the connector of the probe tube is firmly connected to the holding part is.
  • the adjusting element is preferably locked in place on the holding part. But it is also possible to prestress the adjusting element in such a resilient manner that the outer tube is deformed to form the retaining member.
  • the connector of the Probe tube in the holding part guided linearly during the Outer hose is firmly connected to the holding part.
  • a long displacement path in the smallest possible space can be achieved be that both the connecting part of the probe tube and the Outer hose can be moved.
  • the holding part has one Turntable on which the connecting part of the probe tube outside the Axis of rotation is attached. By turning the turntable, the length of the The probe shaft varies and the catheter is fixed to the wall of the stomach become.
  • the catheter has a holding part 1 in the form of an elongated one Plastic housing with its bottom 2 on the abdominal wall of the On the patient. For better ventilation are on the bottom of the the abdominal wall resting part 1 webs or knobs 2a provided.
  • the Holding part is on one of its end faces with a Luer lock connector 3 provided on which the Luerlock connector of the known transfer hoses is connected to supply a nutrient solution.
  • the Luer-Lock connector 3 of the holding part 1 is connected to a flexible probe tube 4, which itself extends between the side walls 5 of the housing and through a recess 6 is led out of the housing in the housing base.
  • the probe tube 4 is enclosed by a flexible outer tube 7, the diameter is slightly larger than the diameter of the probe tube.
  • the Outer tube 7 is at its distal end with the distal end of the Probe hose 4 connected (e.g. glued, jammed, welded).
  • the Outer hose 7 extends through the bottom housing recess 6 in the housing.
  • the proximal end of the outer tube 7 is with a Adjusting element 8 connected, which is longitudinally displaceable in the holding part 1 e.g. on a rack 9 is guided.
  • the adjustment element 8 has a resilient biased locking element 10, which with the toothing of the rack is engaged and the adjusting element 8 locks onto the holding part 1.
  • the locking element can also be in the holes one in the Enclose provided hole pattern so that the outer hose in different positions can be locked.
  • the distal end piece of the outer tube 7 is distributed circumferentially with four arranged longitudinal slots 11 which extend over part of the length of the Extend the outer hose and enclose an angle of 90 °.
  • Fig. 3 shows the slotted end of the outer tube in the starting position. If the locking element 10 against the spring tension with the teeth of Rack 9 disengaged and the adjusting element 8 in the in Figures 1 and 2 shown front position is moved, the spread slotted areas 12 of the outer tube 7 radially outwards, so that a Retaining member 13 is formed with four radially projecting loops on the the catheter can be supported from the inside on the wall of the stomach (Fig. 1a).
  • the outer tube 7 is above the longitudinal slots 11 with respect to the inner tube 4 by an annular sealing element 14 sealed, which closes the annular gap between the tubes 4, 7 and a Prevents gastric acid or other liquids from entering.
  • FIGS. 5 to 10 show further embodiments of the catheter, the Parts which correspond to the parts of FIG. 1 to 3 correspond to the embodiment described, with the same reference numerals are provided.
  • the embodiment according to Figures 4 and 5 differs from that Embodiment according to Figures 1 to 3 in that the connecting part 3 ' is arranged for the transfer hose on the top of the housing, whereby whose accessibility is improved.
  • Figures 6 and 7 show an embodiment with the top Connection part 3 ', in which the outer tube 7 is firmly connected to the holding part 1 and the probe tube 4 is axially displaceable relative to the outer tube 7.
  • the connecting part 3 ' is slidable in a longitudinal slot 15 of the housing cover guided and connected to the proximal end of the probe tube 4.
  • FIGS 8 and 9 show a further embodiment of the catheter top connection part 3 'for the transfer hose.
  • the holding part 1 has a housing with an oval base plate 16 and a rotatably mounted round lid 17.
  • the bottom plate 16 is on its underside with webs or Provide knobs 16a for better ventilation.
  • the connector part 3, the Luer lock connector or can also be designed as a funnel connection is on the Lid 17 is arranged in its outer peripheral region.
  • FIG. 10 shows a section through the distal end piece of the probe tube 4 and of the outer tube 7 of an embodiment of the catheter according to the Invention, with the probe and outer tube of a flexible sheath 18 are enclosed in the form of a flexible plastic hose.
  • the flexible Sheath 18 is connected to the distal end of the outer tube 7 and extends over the holding part. But it is also possible that the flexible Cover only pulled over the slotted areas 12 of the outer tube 7 is. When the slotted regions of the outer tube 7 are expanded, they expand the flexible envelope balloon-like, similar to a flattened ball, so that secure support is guaranteed.
  • Figure 11 shows a perspective view of the distal end of the probe Outer tube of an embodiment of the catheter according to the invention, in which the casing 19 is an integral part of the outer tube 20.
  • the distal end piece of the outer tube 20 includes the distal end piece of the outer tube 20 several distributed circumferentially and in the axial direction extending weakening zones 21 provided.
  • the non-continuous slots to weaken the material can, for example, with a laser in the wall of the outer tube be introduced.
  • the envelope 19, which is an integral part of the Outer tube 20 prevents gastric acid or other intrusion Liquids.

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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)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (11)

  1. Cathéter pour l'alimentation entérale percutanée avec un tuyau sonde (4) pour introduction d'une solution alimentaire, qui peut être inséré dans la lumière de l'estomac, et un élément de maintien (1) qui peut être placé de l'extérieur sur la paroi intestinale, dans lequel, à l'extrémité distale du tuyau sonde, est fourni un élément de rétention (13), caractérisé en ce que le tuyau sonde (4) est entouré d'un tuyau externe flexible (7) et en ce que le tuyau sonde (4) et le tuyau externe (7), à leur extrémité distale, sont liés et coulissent l'un contre l'autre et peuvent être arrêtés en des positions différentes, en ce que le tuyau externe (7) est doté de fentes longitudinales (11) réparties en circonférence pour former l'élément de rétention (13), de sorte que celui-ci puisse être déployé lors du coulissement du tuyau sonde et du tuyau externe et en ce qu'au moins la zone fendue (12) du tuyau externe est entourée d'une enveloppe flexible (18).
  2. Cathéter pour l'alimentation entérale percutanée avec un tuyau sonde (4) pour introduction d'une solution alimentaire, qui peut être introduit dans la lumière de l'estomac, et un élément de maintien (1) qui peut être placé de l'extérieur sur la paroi intestinale, dans lequel, à l'extrémité distale du tuyau sonde, est fourni un élément de rétention (13), caractérisé en ce que le tuyau sonde (4) est entouré d'un tuyau externe flexible (7) et en ce que le tuyau sonde (4) et le tuyau externe (7), à leur extrémité distale, sont liés et coulissent l'un contre l'autre et peuvent être arrêtés en des positions différentes, et en ce que le tuyau externe (7) est doté, pour former l'élément de rétention (13), de zones d'atténuation (21) réparties en circonférence et s'étendant en direction axiale, de sorte que lors du coulissement du tuyau sonde et du tuyau externe entre les talons s'écartant (22) il reste une peau fine comme enveloppe (19).
  3. Cathéter pour l'alimentation entérale percutanée avec un tuyau sonde (4) pour introduction d'une solution alimentaire, qui peut être inséré dans la lumière de l'estomac, et un élément de maintien (1) qui peut être placé de l'extérieur sur la paroi intestinale, dans lequel, à l'extrémité distale du tuyau sonde, est fourni un élément de rétention (13), caractérisé en ce que le tuyau sonde (4) est entouré d'un tuyau externe flexible (7) et en ce que le tuyau sonde (4) et le tuyau externe (7), à leur extrémité distale, sont liés et coulissent l'un contre l'autre et peuvent être arrêtés en des positions différentes, en ce que le tuyau externe (7) est doté de fentes longitudinales (11) réparties en circonférence pour former l'élément de rétention (13), de sorte que celui-ci puisse être déployé lors du coulissement du tuyau sonde et du tuyau externe et en ce qu'au-dessus des entailles longitudinales (11) le tube externe (7) est étanché contre le tuyau interne (4) par un élément de joint annulaire (14), qui ferme une fente annulaire entre les tubes.
  4. Cathéter selon la revendication 1, caractérisé en ce que le tuyau externe (7) est fendu quatre fois.
  5. Cathéter selon la revendication 2, caractérisé en ce que quatre zones d'atténuation (21) sont fournies dans le tube externe (7).
  6. Cathéter selon l'une des revendications 1 à 5, caractérisé en ce qu'entre la paroi externe du tuyau sonde (4) et la paroi interne du tuyau externe (7) un lubrifiant est appliqué.
  7. Cathéter selon l'une des revendications 1 à 6, caractérisé en ce que l'élément de maintien (1) présente une pièce de raccordement (3, 3') reliée à l'extrémité proximale du tuyau sonde, à laquelle la pièce de raccordement d'un tuyau de conduite peut être raccordée.
  8. Cathéter selon la revendication 7, caractérisé en ce que le tuyau externe (7) est fixé à un élément de réglage (8) qui est introduit dans l'élément de maintien (1) de manière à pouvoir coulisser linéairement, la pièce de raccordement (3) du tuyau sonde (4) étant solidement reliée à l'élément de maintien (1).
  9. Cathéter selon la revendication 7, caractérisé en ce que la pièce de raccordement (3') du tuyau sonde (4) est introduite de manière à pouvoir coulisser linéairement dans l'élément de maintien (1), le tuyau externe (7) étant solidement relié à l'élément de maintien (1).
  10. Cathéter selon l'une des revendications 7 à 9, caractérisé en ce que l'élément de réglage (8) ou la pièce de raccordement (3') est fixé par enclenchement à l'élément de maintien (1).
  11. Cathéter selon l'une des revendications 1 à 10, caractérisé en ce que l'élément de maintien (1) présente un plateau tournant (17) sur lequel la pièce de raccordement (3') du tuyau sonde (4) est fixée en dehors de l'axe de rotation.
EP97114439A 1996-08-23 1997-08-21 Cathéter percutané d'alimentation entérale Expired - Lifetime EP0824929B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19634116 1996-08-23
DE19634116A DE19634116C2 (de) 1996-08-23 1996-08-23 Katheter für die perkutane enterale Ernährung

Publications (3)

Publication Number Publication Date
EP0824929A2 EP0824929A2 (fr) 1998-02-25
EP0824929A3 EP0824929A3 (fr) 1998-05-20
EP0824929B1 true EP0824929B1 (fr) 2003-10-29

Family

ID=7803515

Family Applications (1)

Application Number Title Priority Date Filing Date
EP97114439A Expired - Lifetime EP0824929B1 (fr) 1996-08-23 1997-08-21 Cathéter percutané d'alimentation entérale

Country Status (4)

Country Link
EP (1) EP0824929B1 (fr)
DE (2) DE19634116C2 (fr)
ES (1) ES2205100T3 (fr)
NO (1) NO311406B1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITMO20090169A1 (it) * 2009-06-26 2010-12-27 De Magistris Ludovico Ambrosi Dispositivo per nutrizione enterale
CN101184468B (zh) * 2005-04-21 2012-08-29 科文迪安有限公司 体内留置装置
US9211234B2 (en) 2010-09-27 2015-12-15 Avent, Inc. Configurable percutaneous endoscopic gastrostomy tube

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL364778A1 (en) 2000-02-26 2004-12-13 Nico Kleinknecht Multiple lumen probe system for percutaneously and enterally applying liquid food
DE10055283B4 (de) * 2000-11-08 2004-07-15 Fresenius Kabi Deutschland Gmbh Adapter für eine PEG-Sonde
DE10055281B4 (de) 2000-11-08 2004-12-23 Fresenius Kabi Deutschland Gmbh Adapter für eine PEG-Sonde
DE10131152B4 (de) 2001-04-30 2004-05-27 Nutricia Healthcare S.A. Medizinisches Ballon-Button-System
JP4588356B2 (ja) 2004-04-30 2010-12-01 日本シャーウッド株式会社 胃瘻形成管用伸展具
US8709018B2 (en) * 2005-09-16 2014-04-29 Applied Medical Technology, Inc. Non-balloon low profile feed device with insertion/removal tool
WO2014203259A1 (fr) 2013-06-20 2014-12-24 Hadasit Medical Research Services And Development Ltd. Dispositifs et procédés pour une gastrostomie endoscopique percutanée et autres interventions de stomie
WO2017109788A1 (fr) 2015-12-23 2017-06-29 Fidmi Medical Ltd. Dispositifs et procédés pour accès à un tissu vivant et/ou des lumières et protocoles associés
US10702304B2 (en) 2014-12-23 2020-07-07 Fidmi Medical Ltd. Devices and methods for ports to living tissue and/or lumens and related procedures
EP3236912A4 (fr) * 2014-12-23 2018-07-18 Fidmi Medical Ltd. Dispositifs et procédés pour gastronomie endoscopique percutanée et autres interventions de stomie

Family Cites Families (10)

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US3108595A (en) * 1960-08-08 1963-10-29 Alfred P Overment Retention catheter
US3397699A (en) * 1966-05-05 1968-08-20 Gerald C. Kohl Retaining catheter having resiliently biased wing flanges
US3938530A (en) * 1974-11-15 1976-02-17 Santomieri Louis Catheter
DE2611107C2 (de) * 1976-03-16 1983-12-22 Edwin Lloyd 80110 Englewood Col. Adair Katheter
US4393873A (en) * 1980-03-10 1983-07-19 Nawash Michael S Gastrostomy and other percutaneous transport tubes
US4666433A (en) * 1984-11-05 1987-05-19 Medical Innovations Corporation Gastrostomy feeding device
US5001009A (en) * 1987-09-02 1991-03-19 Sterilization Technical Services, Inc. Lubricious hydrophilic composite coated on substrates
US4834712A (en) * 1988-01-15 1989-05-30 Corpak, Inc. Tube fixation device
US5073166A (en) * 1989-02-15 1991-12-17 Medical Innovations Corporation Method and apparatus for emplacement of a gastrostomy catheter
US5112310A (en) * 1991-02-06 1992-05-12 Grobe James L Apparatus and methods for percutaneous endoscopic gastrostomy

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101184468B (zh) * 2005-04-21 2012-08-29 科文迪安有限公司 体内留置装置
ITMO20090169A1 (it) * 2009-06-26 2010-12-27 De Magistris Ludovico Ambrosi Dispositivo per nutrizione enterale
WO2011018682A3 (fr) * 2009-06-26 2011-05-05 Azzolini, Graziano Dispositif d'alimentation enterale
US9211234B2 (en) 2010-09-27 2015-12-15 Avent, Inc. Configurable percutaneous endoscopic gastrostomy tube

Also Published As

Publication number Publication date
NO311406B1 (no) 2001-11-26
DE19634116C2 (de) 1998-08-20
NO973354L (no) 1998-02-24
EP0824929A2 (fr) 1998-02-25
EP0824929A3 (fr) 1998-05-20
ES2205100T3 (es) 2004-05-01
NO973354D0 (no) 1997-07-21
DE59710910D1 (de) 2003-12-04
DE19634116A1 (de) 1998-03-05

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